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Sample records for patients undergoing drug-eluting

  1. Safety and efficacy of everolimus-eluting stents compared with first-generation drug-eluting stents in patients undergoing primary percutaneous coronary intervention

    Energy Technology Data Exchange (ETDEWEB)

    Escárcega, Ricardo O.; Baker, Nevin C.; Magalhaes, Marco A.; Lipinski, Michael J.; Minha, Sa’ar; Torguson, Rebecca; Satler, Lowell F.; Pichard, Augusto D.; Suddath, William O.; Waksman, Ron, E-mail: ron.waksman@medstar.net

    2014-09-15

    Objective: To assess the safety and efficacy everolimus-eluting stents (EES) compared with first-generation drug-eluting stents (DES) in patients with acute myocardial infarction (MI) undergoing primary percutaneous coronary intervention (PCI). Background: EES have been associated with improved clinical outcomes compared to paclitaxel-eluting stents (PES) and with similar outcomes compared to sirolimus-eluting stents (SES). Methods: A total of 520 patients who presented with ST-elevation myocardial infarction (STEMI) from 2003 to 2013, who underwent primary PCI with DES, were retrospectively analyzed. Of these, 247 received SES, 136 PES, and 137 EES. Patients were followed up to 2 years for major adverse cardiac events (MACE). Univariate and multivariate models detected correlates to outcome. Results: EES implantation, compared with PES and SES, resulted in comparable rates of MACE (8.8% vs. 16.2%, p = 0.06 and 8.8% vs. 12.6%, respectively, p = 0.26), stent thrombosis, MI, and target lesion revascularization. Patients who received EES had lower rates of all-cause mortality (3.7% vs. 12.6% vs. 9.4%, p = 0.03) at 1-year follow up. However, in the univariate and multivariate analyses, stent type was not independently associated with the primary outcome or with all-cause mortality. Diabetes mellitus and number of stents implanted were independently associated with the primary outcome. Conclusion: While EES seem to be associated with better outcome when compared to PES, the main correlates of STEMI patients are the presence of diabetes and number of stents implanted, and not the type of stent used for intervention.

  2. Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction

    DEFF Research Database (Denmark)

    Holmvang, Lene; Kelbæk, Henning; Kaltoft, Anne Kjer

    2013-01-01

    This study sought to compare the long-term effects of drug-eluting stent (DES) compared with bare-metal stent (BMS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention.......This study sought to compare the long-term effects of drug-eluting stent (DES) compared with bare-metal stent (BMS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention....

  3. Cost-effectiveness of drug-eluting stents versus bare-metal stents in patients undergoing percutaneous coronary intervention

    OpenAIRE

    Baschet, Louise; Bourguignon, Sandrine; Marque, S?bastien; Durand-Zaleski, Isabelle; Teiger, Emmanuel; Wilquin, Fanny; Levesque, Karine

    2016-01-01

    Objective To determine the cost-effectiveness of drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients requiring a percutaneous coronary intervention in France, using a recent meta-analysis including second-generation DES. Methods A cost-effectiveness analysis was performed in the French National Health Insurance setting. Effectiveness settings were taken from a meta-analysis of 117?762 patient-years with 76 randomised trials. The main effectiveness criterion was major c...

  4. Correlates and Impact of Coronary Artery Calcifications in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents

    DEFF Research Database (Denmark)

    Giustino, Gennaro; Mastoris, Ioannis; Baber, Usman

    2016-01-01

    OBJECTIVES: The aim of this study was to investigate the clinical correlates and prognostic impact of coronary artery calcification (CAC) in women undergoing percutaneous coronary intervention with drug-eluting stents (DES). BACKGROUND: The clinical correlates and the prognostic significance of CAC...

  5. 3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

    Science.gov (United States)

    Alfonso, Fernando; Pérez-Vizcayno, María José; Cuesta, Javier; García Del Blanco, Bruno; García-Touchard, Arturo; López-Mínguez, José Ramón; Masotti, Mónica; Zueco, Javier; Cequier, Angel; Velázquez, Maite; Moreno, Raúl; Mainar, Vicente; Domínguez, Antonio; Moris, Cesar; Molina, Eduardo; Rivero, Fernando; Jiménez-Quevedo, Pilar; Gonzalo, Nieves; Fernández-Pérez, Cristina

    2018-05-28

    This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). Treatment of patients with DES-ISR remains a challenge. The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p 1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940). Published by Elsevier Inc.

  6. Red blood cell distribution width and long-term outcome in patients undergoing percutaneous coronary intervention in the drug-eluting stenting era: a two-year cohort study.

    Science.gov (United States)

    Yao, Hai-Mu; Sun, Tong-Wen; Zhang, Xiao-Juan; Shen, De-Liang; Du, You-You; Wan, You-Dong; Zhang, Jin-Ying; Li, Ling; Zhao, Luo-Sha

    2014-01-01

    Previous studies suggest the higher the red blood cell distribution width (RDW) the greater the risk of mortality in patients with coronary artery disease (CAD). However, the relationship between RDW and long-term outcome in CAD patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) remains unclear. This study was designed to evaluate the long-term effect of RDW in patients treated with drug-eluting stent for CAD. In total of 2169 non-anemic patients (1468 men, mean age 60.2 ± 10.9 years) with CAD who had undergone successful PCI and had at least one drug-eluting stent were included in this study. Patients were grouped according to their baseline RDW: Quartile 1 (RDW<12.27%), Quartile 2 (12.27% ≤ RDW <13%), Quartile 3 (13% ≤ RDW<13.5%), and Quartile 4 (RDW ≥ 13.5). The incidence of in-hospital mortality and death or myocardial infarction was significantly higher in Quartiles 3 and 4 compared with Quartile 1 (P<0.05). After a follow-up of 29 months, the incidence of all-cause death and stent thrombosis in Quartile 4 was higher than in Quartiles 1, 2, and 3 (P<0.05). The incidence of death/myocardial infarction/stroke and cardiac death in Quartile 4 was higher than in Quartiles 1 and 2 (P<0.05). Multivariate Cox regression analysis showed that RDW was an independent predictor of all-cause death (hazard ratio (HR) = 1.37, 95% confidence interval (CI) = 1.15-1.62, P<0.001) and outcomes of death/myocardial infarction/stroke (HR = 1.21, 95% CI = 1.04-1.39, P = 0.013). The cumulative survival rate of Quartile 4 was lower than that of Quartiles 1, 2, and 3 (P<0.05). High RDW is an independent predictor of long-term adverse clinical outcomes in non-anemic patients with CAD treated with DES.

  7. Red blood cell distribution width and long-term outcome in patients undergoing percutaneous coronary intervention in the drug-eluting stenting era: a two-year cohort study.

    Directory of Open Access Journals (Sweden)

    Hai-Mu Yao

    Full Text Available BACKGROUND: Previous studies suggest the higher the red blood cell distribution width (RDW the greater the risk of mortality in patients with coronary artery disease (CAD. However, the relationship between RDW and long-term outcome in CAD patients undergoing percutaneous coronary intervention (PCI with a drug-eluting stent (DES remains unclear. This study was designed to evaluate the long-term effect of RDW in patients treated with drug-eluting stent for CAD. METHODS: In total of 2169 non-anemic patients (1468 men, mean age 60.2 ± 10.9 years with CAD who had undergone successful PCI and had at least one drug-eluting stent were included in this study. Patients were grouped according to their baseline RDW: Quartile 1 (RDW<12.27%, Quartile 2 (12.27% ≤ RDW <13%, Quartile 3 (13% ≤ RDW<13.5%, and Quartile 4 (RDW ≥ 13.5. RESULTS: The incidence of in-hospital mortality and death or myocardial infarction was significantly higher in Quartiles 3 and 4 compared with Quartile 1 (P<0.05. After a follow-up of 29 months, the incidence of all-cause death and stent thrombosis in Quartile 4 was higher than in Quartiles 1, 2, and 3 (P<0.05. The incidence of death/myocardial infarction/stroke and cardiac death in Quartile 4 was higher than in Quartiles 1 and 2 (P<0.05. Multivariate Cox regression analysis showed that RDW was an independent predictor of all-cause death (hazard ratio (HR = 1.37, 95% confidence interval (CI = 1.15-1.62, P<0.001 and outcomes of death/myocardial infarction/stroke (HR = 1.21, 95% CI = 1.04-1.39, P = 0.013. The cumulative survival rate of Quartile 4 was lower than that of Quartiles 1, 2, and 3 (P<0.05. CONCLUSION: High RDW is an independent predictor of long-term adverse clinical outcomes in non-anemic patients with CAD treated with DES.

  8. Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction

    DEFF Research Database (Denmark)

    Räber, Lorenz; Kelbæk, Henning; Ostojic, Miodrag

    2012-01-01

    The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).......The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI)....

  9. Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI)

    DEFF Research Database (Denmark)

    Raungaard, Bent; Jensen, Lisette Okkels; Tilsted, Hans-Henrik

    2015-01-01

    BACKGROUND: New-generation drug-eluting coronary stents have reduced the risk of coronary events, especially in patients with complex disease or lesions. To what extent different stent platforms, polymers, and antiproliferative drugs affect outcomes, however, is unclear. We investigated the safety...... and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent. METHODS: This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All......-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent. The primary endpoint was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target-lesion revascularisation) at 12 months, analysed by intention to treat...

  10. Meta-analysis comparing efficacy and safety of first generation drug-eluting stents to bare-metal stents in patients with diabetes mellitus undergoing primary percutaneous coronary intervention

    DEFF Research Database (Denmark)

    De Luca, Giuseppe; Dirksen, Maurits T; Spaulding, Christian

    2013-01-01

    revascularization (hazard ratio 0.42, 95% confidence interval 0.29 to 0.59, p 1 year) with DES. In conclusion, this meta-analysis, based on individual patients' data from 11 randomized trials, showed that among patients with diabetes with STEMIs who undergo primary percutaneous coronary intervention, sirolimus...... with high rates of target vessel revascularization after bare-metal stent (BMS) implantation but also higher rates of ST after DES implantation. Therefore, the aim of this study was to perform a meta-analysis of individual patients' data to evaluate the long-term safety and effectiveness of DES compared......Several concerns have emerged regarding the higher risk for stent thrombosis (ST) after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Few data have been reported so far in patients with diabetes mellitus, which is associated...

  11. Risk of stent thrombosis among bare-metal stents, first-generation drug-eluting stents, and second-generation drug-eluting stents: results from a registry of 18,334 patients.

    Science.gov (United States)

    Tada, Tomohisa; Byrne, Robert A; Simunovic, Iva; King, Lamin A; Cassese, Salvatore; Joner, Michael; Fusaro, Massimiliano; Schneider, Simon; Schulz, Stefanie; Ibrahim, Tareq; Ott, Ilka; Massberg, Steffen; Laugwitz, Karl-Ludwig; Kastrati, Adnan

    2013-12-01

    This study sought to compare the risk of stent thrombosis among patients treated with bare-metal stents (BMS), first-generation drug-eluting stents (G1-DES), and second-generation drug-eluting stents (G2-DES) for a period of 3 years. In patients undergoing coronary stenting, there is a scarcity of long-term follow-up data on cohorts large enough to compare rates of stent thrombosis across the stent generations. A total of 18,334 patients undergoing successful coronary stent implantation from 1998 to 2011 at 2 centers in Munich, Germany, were included in this study. Patients were stratified into 3 groups according to treatment with BMS, G1-DES, and G2-DES. The cumulative incidence of definite stent thrombosis at 3 years was 1.5% with BMS, 2.2% with G1-DES, and 1.0% with G2-DES. On multivariate analysis, G1-DES compared with BMS showed a significantly higher risk of stent thrombosis (odds ratio [OR]: 2.05; 95% confidence interval [CI]: 1.47 to 2.86; p stent thrombosis compared with BMS (OR: 0.82; 95% CI: 0.56 to 1.19; p = 0.30). Beyond 1 year, the risk of stent thrombosis was significantly increased with G1-DES compared with BMS (OR: 4.72; 95% CI: 2.01 to 11.1; p stenting, compared with BMS, there was a significant excess risk of stent thrombosis at 3 years with G1-DES, driven by an increased risk of stent thrombosis events beyond 1 year. G2-DES were associated with a similar risk of stent thrombosis compared with BMS. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  12. All-cause mortality after drug-eluting stent implantation in African-Americans.

    Science.gov (United States)

    Poludasu, Shyam; Cavusoglu, Erdal; Khan, Waqas; Marmur, Jonathan D

    2008-12-01

    Recent studies have questioned the safety of drug-eluting stents because of a higher incidence of late stent thrombosis, raising the possibility that drug-eluting stents may be associated with an increased mortality. The effect of drug-eluting stents on mortality in African-Americans is unknown. We evaluated 628 African-American patients (354 patients treated with drug-eluting stents and 274 patients treated with bare metal stents) between January 2003 and August 2005, using data from our bolus-only platelet glycoprotein IIb/IIIa inhibitor database. The primary end point was all-cause mortality obtained using social security death index. After a mean follow-up of 3+/-0.9 years, the mortality rate in the bare metal stents group was 12.8% compared with 7.1% in the drug-eluting stents group [adjusted P value=0.19; hazard ratio (HR) for bare metal stents group compared with drug-eluting stents group for death=1.4; 95% confidence interval (CI): 0.8-2.4]. In a subgroup analysis, patients presenting with acute coronary syndrome had a higher mortality when treated with bare metal stents compared with drug-eluting stents (17.1 vs. 6.3%, P=0.022; HR=2.2; 95% CI: 1.1-4.4). Patients with chronic kidney disease (all patients with creatinine >1.5 mg/dl) also had a higher mortality with bare metal stents compared with drug-eluting stents (36.7 vs. 20.4%, P=0.044; HR=2.3; 95% CI: 1.02-5.2). Drug-eluting stents seem to be safe in African-Americans and may improve survival in certain subgroups such as patients with acute coronary syndromes and chronic kidney disease.

  13. The stenting strategy of drug-eluting stents for coronary artery disease in patients on dialysis

    Directory of Open Access Journals (Sweden)

    Hiroshi Fujita

    2014-12-01

    Full Text Available Background: Reports regarding the relationship between the length and diameter of implanted drug-eluting stents and clinical and angiographic outcomes in dialysis patients are limited. Aim: We investigated the efficiency of drug-eluting stents for coronary artery disease in patients on dialysis from the viewpoint of stent sizing. Methods: Sirolimus-eluting stents were implanted in 88 lesions and bare metal stents were implanted in 43 lesions. We compared stenting strategy, major adverse cardiac events, and angiographic results between sirolimus-eluting stent and bare metal stent groups. Results: Stent diameter was smaller and stent length was longer in the sirolimus-eluting stent group than in the bare metal stent group in our routine practices. There was no significant between-group difference in late diameter loss. Rates of angiographic restenosis and target lesion revascularization were significantly higher in the sirolimus-eluting stent group than in the bare metal stent group. Although stent length was significantly longer and stent diameter was smaller in the sirolimus-eluting stent group, sirolimus-eluting stents did not improve the subsequent clinical and angiographic results compared with bare metal stents in dialysis patients. Conclusion: In dialysis patients, a longer length and/or smaller diameter sirolimus-eluting stent implantation was associated with high rates of restenosis and target lesion revascularization compared with bare metal stents.

  14. Clinical outcomes with drug-eluting and bare-metal stents in patients with ST-segment elevation myocardial infarction

    DEFF Research Database (Denmark)

    Palmerini, Tullio; Biondi-Zoccai, Giuseppe; Della Riva, Diego

    2013-01-01

    The authors investigated the relative safety and efficacy of different drug-eluting stents (DES) and bare metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) using a network meta-analysis.......The authors investigated the relative safety and efficacy of different drug-eluting stents (DES) and bare metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) using a network meta-analysis....

  15. Paclitaxel-eluting versus sirolimus-eluting stents in diabetes mellitus: a report from the National Heart, Lung, and Blood Institute Dynamic Registry.

    Science.gov (United States)

    Wolf, William M; Vlachos, Helen A; Marroquin, Oscar C; Lee, Joon S; Smith, Conrad; Anderson, William D; Schindler, John T; Holper, Elizabeth M; Abbott, J Dawn; Williams, David O; Laskey, Warren K; Kip, Kevin E; Kelsey, Sheryl F; Mulukutla, Suresh R

    2010-02-01

    Diabetes is a powerful predictor of adverse events in patients undergoing percutaneous coronary intervention. Drug-eluting stents reduce restenosis rates compared with bare metal stents; however, controversy remains regarding which drug-eluting stents provides greater benefit in patients with diabetes. Accordingly, we compared the safety and efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry. Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 2-year outcomes of diabetic patients undergoing percutaneous coronary interventions with SES (n=677) and PES (n=328). Clinical and demographic characteristics, including age, body mass index, insulin use, left ventricular function, and aspirin/clopidogrel use postprocedure, did not differ significantly between the groups except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. At the 2-year follow-up, no significant differences were observed between PES and SES with regard to safety or efficacy end points. PES- and SES-treated patients had similar rates of death (10.7% versus 8.2%, P=0.20), death and myocardial infarction (14.9% versus 13.6%, P=0.55), repeat revascularization (14.8% versus 17.8%, P=0.36), and stent thrombosis (1.3% versus 1.3%, P=0.95). After adjustment, no significant differences between the 2 stent types in any outcome were observed. PES and SES are equally efficacious and have similar safety profiles in diabetic patients undergoing percutaneous coronary interventions in clinical practice.

  16. Second generation drug-eluting stents versus bare-metal stents for percutaneous coronary intervention of the proximal left anterior descending artery

    DEFF Research Database (Denmark)

    Mangione, Fernanda Marinho; Biering-Sørensen, Tor; Nochioka, Kotaro

    2017-01-01

    OBJECTIVES: To compare mid-term outcomes between patients undergoing proximal left anterior descending artery (LAD) percutaneous coronary intervention (PCI) with second generation drug-eluting stent (DES) or bare-metal stent (BMS). BACKGROUND: PCI with BMS and first-generation DES have shown to b...

  17. Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease

    DEFF Research Database (Denmark)

    Raungaard, Bent; Christiansen, Evald H; Bøtker, Hans Erik

    2017-01-01

    artery disease or acute coronary syndromes and at least 1 coronary artery lesion requiring treatment with a drug-eluting stent. Endpoints included major adverse cardiac events (MACE), a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion......OBJECTIVES: The authors sought to compare the safety and efficacy of the biocompatible durable-polymer zotarolimus-eluting stent with the biodegradable-polymer biolimus-eluting stent in unselected coronary patients. BACKGROUND: Biodegradable-polymer biolimus-eluting stents are superior to first......-generation durable-polymer drug-eluting stents in long-term randomized all-comer trials. Long-term data comparing them to second-generation durable-polymer drug-eluting stents are lacking. METHODS: The study was a randomized, multicenter, all-comer, noninferiority trial in patients with chronic stable coronary...

  18. Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 3-year follow-up of the randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial

    DEFF Research Database (Denmark)

    Kaltoft, Anne; Kelbaek, Henning; Thuesen, Leif

    2010-01-01

    The purpose of this study was to compare long-term clinical outcomes after implantation of drug-eluting stents (DES) and bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI).......The purpose of this study was to compare long-term clinical outcomes after implantation of drug-eluting stents (DES) and bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI)....

  19. Cost effectiveness of drug eluting coronary artery stenting in a UK setting: cost-utility study.

    Science.gov (United States)

    Bagust, A; Grayson, A D; Palmer, N D; Perry, R A; Walley, T

    2006-01-01

    To assess the cost effectiveness of drug eluting stents (DES) compared with conventional stents for treatment of symptomatic coronary artery disease in the UK. Cost-utility analysis of audit based patient subgroups by means of a simple economic model. Tertiary care. 12 month audit data for 2884 patients receiving percutaneous coronary intervention with stenting at the Cardiothoracic Centre Liverpool between January 2000 and December 2002. Risk of repeat revascularisation within 12 months of index procedure and reduction in risk from use of DES. Economic modelling was used to estimate the cost-utility ratio and threshold price premium. Four factors were identified for patients undergoing elective surgery (n = 1951) and two for non-elective surgery (n = 933) to predict risk of repeat revascularisation within 12 months. Most patients fell within the subgroup with lowest risk (57% of the elective surgery group with 5.6% risk and 91% of the non-elective surgery group with 9.9% risk). Modelled cost-utility ratios were acceptable for only one group of high risk patients undergoing non-elective surgery (only one patient in audit data). Restricting the number of DES for each patient improved results marginally: 4% of stents could then be drug eluting on economic grounds. The threshold price premium justifying 90% substitution of conventional stents was estimated to be 112 pound sterling (212 USD, 162 pound sterling) (sirolimus stents) or 89 pound sterling (167 USD, 130 pound sterling) (paclitaxel stents). At current UK prices, DES are not cost effective compared with conventional stents except for a small minority of patients. Although the technology is clearly effective, general substitution is not justified unless the price premium falls substantially.

  20. Cost-effectiveness of drug-eluting stents versus bare-metal stents in patients undergoing percutaneous coronary intervention.

    Science.gov (United States)

    Baschet, Louise; Bourguignon, Sandrine; Marque, Sébastien; Durand-Zaleski, Isabelle; Teiger, Emmanuel; Wilquin, Fanny; Levesque, Karine

    2016-01-01

    To determine the cost-effectiveness of drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients requiring a percutaneous coronary intervention in France, using a recent meta-analysis including second-generation DES. A cost-effectiveness analysis was performed in the French National Health Insurance setting. Effectiveness settings were taken from a meta-analysis of 117 762 patient-years with 76 randomised trials. The main effectiveness criterion was major cardiac event-free survival. Effectiveness and costs were modelled over a 5-year horizon using a three-state Markov model. Incremental cost-effectiveness ratios and a cost-effectiveness acceptability curve were calculated for a range of thresholds for willingness to pay per year without major cardiac event gain. Deterministic and probabilistic sensitivity analyses were performed. Base case results demonstrated that DES are dominant over BMS, with an increase in event-free survival and a cost-reduction of €184, primarily due to a diminution of second revascularisations, and an absence of myocardial infarction and stent thrombosis. These results are robust for uncertainty on one-way deterministic and probabilistic sensitivity analyses. Using a cost-effectiveness threshold of €7000 per major cardiac event-free year gained, DES has a >95% probability of being cost-effective versus BMS. Following DES price decrease, new-generation DES development and taking into account recent meta-analyses results, the DES can now be considered cost-effective regardless of selective indication in France, according to European recommendations.

  1. Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

    Science.gov (United States)

    Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; Otaegui, Imanol; Masotti, Mónica; Zueco, Javier; Veláquez, Maite; Sanchís, Juan; García-Touchard, Arturo; Lázaro-García, Rosa; Moreu, José; Bethencourt, Armando; Cuesta, Javier; Rivero, Fernando; Cárdenas, Alberto; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Fernández, Cristina

    2016-06-27

    The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR). The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown. The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire. A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p 1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms. The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  2. Impaired health status in Type D patients following PCI in the drug-eluting stent era

    DEFF Research Database (Denmark)

    Pedersen, Susanne S.; Denollet, Johan; Ong, Andrew T L

    2007-01-01

    Drug-eluting stenting reduces restenosis post-percutaneous coronary intervention (PCI), but subgroups of patients may not benefit optimally from this procedure. We examined the impact of Type D personality on health status over time and the clinical relevance of Type D as a predictor of impaired...... health status at 12 months in unselected post-PCI patients....

  3. Current manufacturing processes of drug-eluting sutures.

    Science.gov (United States)

    Champeau, Mathilde; Thomassin, Jean-Michel; Tassaing, Thierry; Jérôme, Christine

    2017-11-01

    Drug-eluting sutures represent the next generation of surgical sutures since they fulfill their mechanical functions but also deliver the drug in their vicinity after implantation. These implants are produced by a variety of manufacturing processes. Drug-eluting sutures represent the next generation of surgical sutures since they fulfill their mechanical functions but also deliver the drug in their vicinity after implantation. These implants are produced by a variety of manufacturing processes. Two general approaches can be followed: (i) the ones that add the API into the material during the manufacturing process of the suture and (ii) the ones that load the API to an already manufactured suture. Areas covered: This review provides an overview of the current manufacturing processes for drug-eluting suture production and discusses their benefits and drawbacks depending on the type of drugs. The mechanical properties and the drug delivery profile of drug-eluting sutures are highlighted since these implants must fulfill both criteria. Expert opinion: For limited drug contents, melt extrusion and electrospinning are the emerging processes since the drug is added during the suture manufacture process. Advantageously, the drug release profile can be tuned by controlling the processing parameters specific to each process and the composition of the drug-containing polymer. If high drug content is targeted, the coating or grafting of a drug layer on a pre-manufactured suture allows for preservation of the tensile strength requirements of the suture.

  4. Clopidogrel discontinuation within the first year after coronary drug-eluting stent implantation

    DEFF Research Database (Denmark)

    Thim, Troels; Johansen, Martin Berg; Chisholm, Gro Egholm

    2014-01-01

    BACKGROUND: The impact of adherence to the recommended duration of dual antiplatelet therapy after first generation drug-eluting stent implantation is difficult to assess in real-world settings and limited data are available. METHODS: We followed 4,154 patients treated with coronary drug-eluting ......BACKGROUND: The impact of adherence to the recommended duration of dual antiplatelet therapy after first generation drug-eluting stent implantation is difficult to assess in real-world settings and limited data are available. METHODS: We followed 4,154 patients treated with coronary drug......-eluting stents in Western Denmark for 1 year and obtained data on redeemed clopidogrel prescriptions and major adverse cardiovascular events (MACE, i.e., cardiac death, myocardial infarction, or stent thrombosis) from medical databases. RESULTS: Discontinuation of clopidogrel within the first 3 months after...... stent implantation was associated with a significantly increased rate of MACE at 1-year follow-up (hazard ratio (HR) 2.06; 95% confidence interval (CI): 1.08-3.93). Discontinuation 3-6 months (HR 1.29; 95% CI: 0.70-2.41) and 6-12 months (HR 1.29; 95% CI: 0.54-3.07) after stent implantation were...

  5. Patient-Centered Tablet Application for Improving Medication Adherence after a Drug-Eluting Stent.

    Science.gov (United States)

    Shah, Vicki; Dileep, Anandu; Dickens, Carolyn; Groo, Vicki; Welland, Betty; Field, Jerry; Baumann, Matthew; Flores, Jose D; Shroff, Adhir; Zhao, Zhongsheng; Yao, Yingwei; Wilkie, Diana J; Boyd, Andrew D

    2016-01-01

    This study's objective was to evaluate a patient-centered educational electronic tablet application, "My Interventional Drug-Eluting Stent Educational App" (MyIDEA) to see if there was an increase in patient knowledge about dual antiplatelet therapy (DAPT) and medication possession ratio (MPR) compared to treatment as usual. In a pilot project, 24 elderly (≥50 years old) research participants were recruited after a drug-eluting stent. Eleven were randomized to the control arm and 13 to the interventional arm. All the participants completed psychological and knowledge questionnaires. Adherence was assessed through MPR, which was calculated at 3 months for all participants who were scheduled for second and third follow-up visits. Relative to control, the interventional group had a 10% average increase in MPR. As compared to the interventional group, more patients in the control group had poor adherence (<80% MPR). The psychological data revealed a single imbalance in anxiety between the control and interventional groups. On average, interventional participants spent 21 min using MyIDEA. Consumer health informatics has enabled us to engage patients with their health data using novel methods. Consumer health technology needs to focus more on patient knowledge and engagement to improve long-term health. MyIDEA takes a unique approach in targeting DAPT from the onset. MyIDEA leverages patient-centered information with clinical care and the electronic health record highlighting the patients' role as a team member in their own health care. The patients think critically about adverse events and how to solve issues before leaving the hospital.

  6. Chronic Kidney Disease in the Second-Generation Drug-Eluting Stent Era: Pooled Analysis of the Korean Multicenter Drug-Eluting Stent Registry.

    Science.gov (United States)

    Lee, Joo Myung; Kang, Jeehoon; Lee, Euijae; Hwang, Doyeon; Rhee, Tae-Min; Park, Jonghanne; Kim, Hack-Lyoung; Lee, Sang Eun; Han, Jung-Kyu; Yang, Han-Mo; Park, Kyung Woo; Na, Sang-Hoon; Kang, Hyun-Jae; Koo, Bon-Kwon; Kim, Hyo-Soo

    2016-10-24

    The purpose of this study was to evaluate the clinical impact of chronic kidney disease (CKD) on clinical outcomes in contemporary practice of percutaneous coronary intervention (PCI) using second-generation drug-eluting stents (DES). Although second-generation DES have improved the safety and efficacy issues in PCI, data regarding the performance of second-generation DES in patients with CKD are still limited. We performed a patient-level pooled analysis on 12,426 patients undergoing PCI using second-generation DES from the Korean Multicenter Drug-Eluting Stent Registry. Endpoints were stent-oriented outcomes (target lesion failure [TLF]) and patient-oriented composite outcomes (POCO) during a median follow-up of 35 months. CKD patients were stratified by the estimated glomerular filtration rate (eGFR) from mild CKD to end-stage renal disease patients, and by the coexistence of diabetes mellitus (DM). A total of 2,927 patients had CKD (23.6%), who showed a significantly higher risk of TLF (adjusted hazard ratio [HR adjust ]: 1.50; 95% confidence interval [CI]: 1.21 to 1.86) and POCO (HR adjust 1.34; 95% CI: 1.17 to 1.55) compared to patients with preserved renal function. Stratified analysis by eGFR showed that TLF was not increased in the mild to moderate CKD, whereas severe CKD and dialysis-dependent patients showed significantly higher risk of TLF (HR adjust 2.44; 95% CI: 1.54 to 3.86; HR adjust 3.58; 95% CI: 2.52 to 5.08, respectively). The eGFR threshold of increased clinical events was 40 to 45 ml/min/1.73 m 2 . Among CKD patients, DM CKD patients showed a higher incidence of TLF compared to non-DM CKD patients (HR adjust : 1.82; 95% CI: 1.32 to 2.52), driven by the increase in target vessel-related events. In the era of second-generation DES, CKD patients were at a significantly higher risk of clinical outcomes only in severe CKD and end-stage renal disease patients. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All

  7. Patient Centered Tablet Application for improving medication adherence after a Drug Eluting Stent

    Directory of Open Access Journals (Sweden)

    Vicki Shah

    2016-12-01

    Full Text Available Background/Aims: This study’s objective was to evaluate a patient-centered educational electronic tablet application, My Interventional Drug-Eluting Stent Educational App (MyIDEA to see if there was an increase in patient knowledge about dual antiplatelet therapy (DAPT and medication possession ratio (MPR compared to treatment as usual. Methods: In a pilot project, 24 elderly (≥50 years-old research participants were recruited after a Drug Eluting Stent. 11 were randomized to the control arm and 13 to the interventional arm. All participants completed psychological and knowledge questionnaires. Adherence was assessed through MPR, which was calculated at three months for all participants who were scheduled for a second and third follow-up visit.Results: Relative to control, the interventional group had a 10% average increase in MPR. As compared to the interventional group, more patients in the control group had poor adherence (<80% MPR. The psychological data revealed a single imbalance in anxiety between the control and interventional groups. On average interventional participants spent 21 minutes using MyIDEA. Discussion: Consumer health informatics has enabled us to engage patients with their health data using novel methods. Consumer health technology needs to focus more on patient knowledge and engagement to improve long term health. MyIDEA takes a unique approach in targeting DAPT from the onset.Conclusion: MyIDEA leverages patient centered information with clinical care and the electronic health record highlighting the patients’ role as a team member in their own healthcare. The patients think critically about adverse events and how to solve issues before leaving the hospital.

  8. Stent Thrombosis With Drug-Eluting Stents and Bioresorbable Scaffolds: Evidence From a Network Meta-Analysis of 147 Trials.

    Science.gov (United States)

    Kang, Si-Hyuck; Chae, In-Ho; Park, Jin-Joo; Lee, Hak Seung; Kang, Do-Yoon; Hwang, Seung-Sik; Youn, Tae-Jin; Kim, Hyo-Soo

    2016-06-27

    This study sought to perform a systematic review and network meta-analysis to compare the relative safety and efficacy of contemporary DES and BVS. To improve outcomes of patients undergoing percutaneous coronary revascularization, there have been advances in the design of drug-eluting stents (DES), including the development of drug-eluting bioresorbable vascular scaffolds (BVS). Prospective, randomized, controlled trials comparing bare-metal stents (BMS), paclitaxel-eluting stents (PES), sirolimus-eluting stents (SES), Endeavor zotarolimus-eluting stents (E-ZES), cobalt-chromium (CoCr) everolimus-eluting stents (EES), platinum-chromium (PtCr)-EES, biodegradable polymer (BP)-EES, Resolute zotarolimus-eluting stents (R-ZES), BP biolimus-eluting stents (BP-BES), hybrid sirolimus-eluting stents (H [Orsiro]-SES), polymer-free sirolimus- and probucol-eluting stents, or BVS were searched in online databases. The primary endpoint was definite or probable stent thrombosis at 1 year. A total of 147 trials including 126,526 patients were analyzed in this study. All contemporary DES were superior to BMS and PES in terms of definite or probable stent thrombosis at 1 year. CoCr-EES, PtCr-EES, and H-SES were associated with significantly lower risk than BVS. CoCr-EES and H-SES were superior to SES and BP-BES. The risk of myocardial infarction was significantly lower with H-SES than with BVS. There were no significant differences regarding all-cause or cardiac mortality. Contemporary devices including BVS showed comparably low risks of repeat revascularization. Contemporary DES, including biocompatible DP-DES, BP-DES, and polymer-free DES, showed a low risk of definite or probable stent thrombosis at 1 year. BVS had an increased risk of device thrombosis compared with CoCr-EES, PtCr-EES, and H-SES. Data from extended follow-up are warranted to confirm the long-term safety of contemporary coronary devices. Copyright © 2016 American College of Cardiology Foundation. Published by

  9. Optimization of Drug Delivery by Drug-Eluting Stents.

    Directory of Open Access Journals (Sweden)

    Franz Bozsak

    Full Text Available Drug-eluting stents (DES, which release anti-proliferative drugs into the arterial wall in a controlled manner, have drastically reduced the rate of in-stent restenosis and revolutionized the treatment of atherosclerosis. However, late stent thrombosis remains a safety concern in DES, mainly due to delayed healing of the endothelial wound inflicted during DES implantation. We present a framework to optimize DES design such that restenosis is inhibited without affecting the endothelial healing process. To this end, we have developed a computational model of fluid flow and drug transport in stented arteries and have used this model to establish a metric for quantifying DES performance. The model takes into account the multi-layered structure of the arterial wall and incorporates a reversible binding model to describe drug interaction with the cells of the arterial wall. The model is coupled to a novel optimization algorithm that allows identification of optimal DES designs. We show that optimizing the period of drug release from DES and the initial drug concentration within the coating has a drastic effect on DES performance. Paclitaxel-eluting stents perform optimally by releasing their drug either very rapidly (within a few hours or very slowly (over periods of several months up to one year at concentrations considerably lower than current DES. In contrast, sirolimus-eluting stents perform optimally only when drug release is slow. The results offer explanations for recent trends in the development of DES and demonstrate the potential for large improvements in DES design relative to the current state of commercial devices.

  10. Randomized clinical comparison of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent with the sirolimus-eluting Orsiro stent in patients treated with percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Jakobsen, Lars; Christiansen, Evald H; Maeng, Michael

    2018-01-01

    Background: The Combo stent (OrbusNeich, Hoevelaken, the Netherlands) combining an abluminal, bioabsorbable polymer eluting sirolimus with a luminal CD34+ antibody to capture endothelial progenitor cells has been developed to further improve safety and efficacy of coronary interventions. We have...... designed a large-scale registry-based randomized clinical trial to compare the Combo stent to the Orsiro stent (Biotronik, Bülach, Switzerland) in patients undergoing percutaneous coronary intervention. Methods: The SORT OUT X study will randomly assign 3,140 patients to treatment with Combo or Orsiro...... stents at 3 sites in Western Denmark. Patients are eligible if they are ≥18 years old, have chronic stable coronary artery disease or acute coronary syndromes, and have ≥1 coronary lesion with >50% diameter stenosis requiring treatment with a drug-eluting stent. The primary end point target lesion...

  11. Efficacy and Safety of Drug-Eluting Stents in the Real World: 8-Year Follow-Up

    Energy Technology Data Exchange (ETDEWEB)

    Pellegrini, Denise Oliveira, E-mail: dennizmo@yahoo.com.br; Gomes, Vitor Osório; Lasevitch, Ricardo; Smidt, Luis; Azeredo, Marco Aurélio; Ledur, Priscila; Bodanese, Rodrigo; Sinnott, Leonardo; Moriguchi, Emílio; Caramori, Paulo [Hospital São Lucas PUC, Porto Alegre, RS (Brazil)

    2014-09-15

    Drug-eluting stents have been used in daily practice since 2002, with the clear advantages of reducing the risk of target vessel revascularization and an impressive reduction in restenosis rate by 50%-70%. However, the occurrence of a late thrombosis can compromise long-term results, particularly if the risks of this event were sustained. In this context, a registry of clinical cases gains special value. To evaluate the efficacy and safety of drug-eluting stents in the real world. We report on the clinical findings and 8-year follow-up parameters of all patients that underwent percutaneous coronary intervention with a drug-eluting stent from January 2002 to April 2007. Drug-eluting stents were used in accordance with the clinical and interventional cardiologist decision and availability of the stent. A total of 611 patients were included, and clinical follow-up of up to 8 years was obtained for 96.2% of the patients. Total mortality was 8.7% and nonfatal infarctions occurred in 4.3% of the cases. Target vessel revascularization occurred in 12.4% of the cases, and target lesion revascularization occurred in 8% of the cases. The rate of stent thrombosis was 2.1%. There were no new episodes of stent thrombosis after the fifth year of follow-up. Comparative subanalysis showed no outcome differences between the different types of stents used, including Cypher®, Taxus®, and Endeavor®. These findings indicate that drug-eluting stents remain safe and effective at very long-term follow-up. Patients in the 'real world' may benefit from drug-eluting stenting with excellent, long-term results.

  12. Long-term clinical outcome in STEMI patients treated with primary PCI and drug-eluting or bare-metal stents: insights from a high-volume single-center registry

    DEFF Research Database (Denmark)

    Pedersen, Sune; Galatius, Soren; Mogelvang, Rasmus

    2011-01-01

    Use of drug-eluting stents (DES) in patients with ST-elevation myocardial infarction (STEMI) during routine primary percutaneous coronary intervention (pPCI) is controversial.......Use of drug-eluting stents (DES) in patients with ST-elevation myocardial infarction (STEMI) during routine primary percutaneous coronary intervention (pPCI) is controversial....

  13. Porous Polymer Drug-Eluting Coating Prepared by Radiation Induced Polymerization

    Energy Technology Data Exchange (ETDEWEB)

    Veres, M.; Tóth, S.; Koós, M. [Research Institute for Solid State Physics and Optics, Budapest (Hungary); Beiler, B. [Institute of Isotopes, HAS, Budapest (Hungary)

    2009-07-01

    Drug-eluting stents have several advantages over bare metal implants. They eliminate restenosis, the main drawback of bare metal stents. In addition the locally delivered drug is more effective and causes less side-effects. However in some cases dangerous stent thrombosis, inflammatory and allergy reactions were observed after their implantation, which first of all related to the drug-eluting coating. This project is aimed to develop a novel biocompatible nanoporous polymer layer by radiation induced polymerization that is capable of holding and eluting drugs and promotes endothelization after the release of the drug. (author)

  14. Porous Polymer Drug-Eluting Coating Prepared by Radiation Induced Polymerization

    International Nuclear Information System (INIS)

    Veres, M.; Tóth, S.; Koós, M.; Beiler, B.

    2009-01-01

    Drug-eluting stents have several advantages over bare metal implants. They eliminate restenosis, the main drawback of bare metal stents. In addition the locally delivered drug is more effective and causes less side-effects. However in some cases dangerous stent thrombosis, inflammatory and allergy reactions were observed after their implantation, which first of all related to the drug-eluting coating. This project is aimed to develop a novel biocompatible nanoporous polymer layer by radiation induced polymerization that is capable of holding and eluting drugs and promotes endothelization after the release of the drug. (author)

  15. Use of drug-eluting stents in Victorian public hospitals.

    Science.gov (United States)

    Yan, Bryan P; Ajani, Andrew E; Duffy, Stephen J; New, Gishel; Horrigan, Mark; Szto, Gregory; Walton, Antony; Eccleston, David; Lefkovits, Jeffery; Black, Alexander; Sebastian, Martin; Brennan, Angela L; Reid, Christopher M; Clark, David J

    2006-10-02

    We aimed to assess the pattern of use of drug-eluting stents (DESs) in patients undergoing percutaneous coronary interventions (PCIs) in Victorian public hospitals. Prospective study comparing the use of one or more DESs versus bare-metal stents (BMSs) only, in consecutive patients undergoing 2428 PCIs with stent implantation from 1 April 2004 to 31 December 2005 at seven Victorian public hospitals. Adherence to current Victorian Department of Human Services guidelines which recommend DES use in patients with high-risk features for restenosis (diabetes, small vessels, long lesions, in-stent restenotic lesions, chronic total occlusions and bifurcation lesions). Of the 2428 PCIs performed, at least one DES was implanted in 1101 (45.3%) and BMSs only were implanted in 1327 (54.7%). In 87.7% (966/1101) of PCI with DESs, there was at least one criterion for high risk of restenosis. DESs were more likely to be used in patients with diabetes (risk ratio [RR], 2.45; 95% CI, 2.02-2.97), small vessels (RR, 3.35; 95%CI, 2.35-4.76), long lesions (RR, 3.87; 95% CI, 3.23-4.65), in-stent restenotic lesions (RR, 3.98; 95%CI, 2.67-6.06), chronic total occlusions (RR, 1.30; 95% CI, 0.51-2.88) and bifurcation lesions (RR, 2.23; 95%CI, 1.57-3.17). However, 66.2% (1608/2428) of all PCIs were in patients eligible for DESs according to Victorian guidelines, and in 39.9% (642/1608) of these PCIs, a BMS was used. In Victorian public hospitals, DESs have been largely reserved for patients at high risk of restenosis in accordance with Department of Human Services guidelines. However, many patients with high-risk criteria for restenosis did not receive DESs. Greater use of DESs in these patients may improve outcomes by reducing the need for repeat revascularisation.

  16. XIENCE V everolimus-eluting coronary stent system: a novel second generation drug-eluting stent

    NARCIS (Netherlands)

    Beijk, Marcel A. M.; Piek, Jon J.

    2007-01-01

    Drug-eluting stents (DES) have been shown to be safe and significantly reduce clinical events and angiographic restenosis in the percutaneous treatment of coronary artery disease. Currently, three DES have been approved in Europe and Northern America: the sirolimus-eluting stent (SES), the

  17. Transarterial chemoembolization with drug-eluting beads in hepatocellular carcinoma

    Science.gov (United States)

    Nam, Hee Chul; Jang, Bohyun; Song, Myeong Jun

    2016-01-01

    Transarterial chemoembolization (TACE) is a widely used standard treatment for patients with hepatocellular carcinoma (HCC) who are not suitable candidates for curative treatments. The rationale for TACE is that intra-arterial chemotherapy using lipiodol and chemotherapeutic agents, followed by selective vascular embolization, results in a strong cytotoxic effect as well as ischemia (conventional TACE). Recently, drug-eluting beads (DC Beads®) have been developed for transcatheter treatment of HCC to deliver higher doses of the chemotherapeutic agent and to prolong contact time with the tumor. DC Beads® can actively sequester doxorubicin hydrochloride from solution and release it in a controlled sustained fashion. Treatment with DC Beads® substantially reduced the amount of chemotherapeutic agent that reached the systemic circulation compared with conventional, lipiodol-based regimens, significantly reducing drug-related adverse events. In this article, we describe the treatment response, survival, and safety of TACE used with drug-eluting beads for the treatment of HCC and discuss future therapeutic possibilities. PMID:27833376

  18. Long-Term Safety of Drug-Eluting and Bare-Metal Stents

    DEFF Research Database (Denmark)

    Palmerini, Tullio; Benedetto, Umberto; Biondi-Zoccai, Giuseppe

    2015-01-01

    BACKGROUND: Previous meta-analyses have investigated the relative safety and efficacy profiles of different types of drug-eluting stents (DES) and bare-metal stents (BMS); however, most prior trials in these meta-analyses reported follow-up to only 1 year, and as such, the relative long-term safety....... RESULTS: Fifty-one trials that included a total of 52,158 randomized patients with follow-up duration ≥3 years were analyzed. At a median follow-up of 3.8 years, cobalt-chromium everolimus-eluting stents (EES) were associated with lower rates of mortality, definite stent thrombosis (ST), and myocardial...... infarction than BMS, paclitaxel-eluting stents (PES), and sirolimus-eluting stents (SES) and less ST than BES. Phosphorylcholine-based zotarolimus-eluting stents had lower rates of definite ST than SES and lower rates of myocardial infarction than BMS and PES. The late rates of target...

  19. From drug eluting stents to bioresorbable scaffolds; to new horizons in PCI

    NARCIS (Netherlands)

    Tenekecioglu, Erhan; Bourantas, Christos; Abdelghani, Mohammad; Zeng, Yaping; Silva, Rafael Cavalcante; Tateishi, Hiroki; Sotomi, Yohei; Onuma, Yoshinobu; Yılmaz, Mustafa; Serruys, Patrick W.

    2016-01-01

    Drug eluting stents and particularly the fully bioresorbable drug-eluting scaffolds herald a new era in percutaneous treatment of coronary artery disease. There has been tremendous progress in drug eluting stents with fully biodegradable coating polymers and polymer-free devices with reservoir

  20. Biodegradable Polymer Biolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents in Patients With Coronary Artery Disease: Final 5-Year Report From the COMPARE II Trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent).

    Science.gov (United States)

    Vlachojannis, Georgios J; Smits, Pieter C; Hofma, Sjoerd H; Togni, Mario; Vázquez, Nicolás; Valdés, Mariano; Voudris, Vassilis; Slagboom, Ton; Goy, Jean-Jaques; den Heijer, Peter; van der Ent, Martin

    2017-06-26

    This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention. Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce. The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization. Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17). The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights

  1. Drug-eluting versus bare-metal stents in large coronary arteries

    DEFF Research Database (Denmark)

    Kaiser, Christoph; Galatius, Soeren; Erne, Paul

    2010-01-01

    Recent data have suggested that patients with coronary disease in large arteries are at increased risk for late cardiac events after percutaneous intervention with first-generation drug-eluting stents, as compared with bare-metal stents. We sought to confirm this observation and to assess whether...

  2. Patient-rated health status predicts prognosis following percutaneous coronary intervention with drug-eluting stenting

    DEFF Research Database (Denmark)

    Pedersen, Susanne S.; Versteeg, Henneke; Denollet, Johan

    2011-01-01

    In patients treated with percutaneous coronary intervention (PCI) with the paclitaxel-eluting stent, we examined whether patient-rated health status predicts adverse clinical events.......In patients treated with percutaneous coronary intervention (PCI) with the paclitaxel-eluting stent, we examined whether patient-rated health status predicts adverse clinical events....

  3. Clinical benefits of drug-eluting stent implantation in septuagenarians with coronary artery disease

    International Nuclear Information System (INIS)

    Fang Yuehua; Shen Weifeng; Zhang Ruiyan; Zhang Jiansheng; Hu Jian; Zhang Xian; Zheng Aifang

    2005-01-01

    Objective: This study evaluated the safety and long-term outcomes of drug-eluting stents in septuagenarians with coronary artery disease. Methods: Two hundred and thirty-nine consecutive patients with coronary artery disease underwent drug-eluting stenting, including 88 patients aged ≥70 years (group A) and 151 aged <70 years (group B). Baseline clinical characteristics, procedural success rate, occurrence of cardiac events during follow-up were recorded and compared between the two groups. Results: Procedural success rate and complications were similar for the two groups. During follow-up, group A had higher recurrence rate of chest pain than group B (23.9% vs. 7.3%, P<0.001), and occurrence of cardiac events was higher in group A than in group B (5.7% vs. 2.7%, P<0.296). There was no significant difference in the frequency of restenosis between the two groups. Conclusions: Drug-eluting stent implantation for septuagenarians with coronary artery disease is safe but may have more recurrence of angina than younger ones during long-term follow-up. (authors)

  4. Meta-Analysis of Randomized Clinical Trials Comparing Biodegradable Polymer Drug-Eluting Stent to Second-Generation Durable Polymer Drug-Eluting Stents.

    Science.gov (United States)

    El-Hayek, Georges; Bangalore, Sripal; Casso Dominguez, Abel; Devireddy, Chandan; Jaber, Wissam; Kumar, Gautam; Mavromatis, Kreton; Tamis-Holland, Jacqueline; Samady, Habib

    2017-03-13

    The authors sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) to second-generation durable polymer drug-eluting stents (DP-DES). Prior meta-analyses have established the superiority of BP-DES over bare-metal stents and first-generation DP-DES; however, their advantage compared with second-generation DP-DES remains controversial. The authors searched PubMed and Scopus databases for RCTs comparing BP-DES to the second-generation DP-DES. Outcomes included target vessel revascularization (TVR) as efficacy outcome and cardiac death, myocardial infarction (MI), and definite or probable stent thrombosis (ST) as safety outcomes. In addition, we performed landmark analysis for endpoints beyond 1 year of follow-up and a subgroup analysis based on the stent characteristics. The authors included 16 RCTs comprising 19,886 patients in the meta-analysis. At the longest available follow-up (mean duration 26 months), we observed no significant differences in TVR (p = 0.62), cardiac death (p = 0.46), MI (p = 0.98), or ST (risk ratio: 0.83, 95% confidence interval: 0.64 to 1.09; p = 0.19). Our landmark analysis showed that BP-DES were not associated with a reduction in the risk of very late ST (risk ratio: 0.87, 95% confidence interval: 0.49 to 1.53; p = 0.62). Similar outcomes were seen regardless of the eluting drug (biolimus vs. sirolimus), the stent platform (stainless steel vs. alloy), the kinetics of polymer degradation or drug release (6 months), the strut thickness of the BP-DES (thin 100 μm), or the DAPT duration (≥6 months vs. ≥12 months). BP-DES have similar safety and efficacy profiles to second-generation DP-DES. Published by Elsevier Inc.

  5. Outcomes of coronary artery bypass grafting versus percutaneous coronary intervention with drug-eluting stents for patients with multivessel coronary artery disease.

    Science.gov (United States)

    Javaid, Aamir; Steinberg, Daniel H; Buch, Ashesh N; Corso, Paul J; Boyce, Steven W; Pinto Slottow, Tina L; Roy, Probal K; Hill, Peter; Okabe, Teruo; Torguson, Rebecca; Smith, Kimberly A; Xue, Zhenyi; Gevorkian, Natalie; Suddath, William O; Kent, Kenneth M; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

    2007-09-11

    Advances in coronary artery bypass grafting (CABG) surgery and percutaneous coronary intervention (PCI) with drug-eluting stents have dramatically improved results of these procedures. The optimal treatment for patients with multivessel coronary artery disease is uncertain given the lack of prospective, randomized data reflecting current practice. This study represents a "real-world" evaluation of current technology in the treatment of multivessel coronary artery disease. A total of 1680 patients undergoing revascularization for multivessel coronary artery disease were identified. Of these, 1080 patients were treated for 2-vessel disease (196 CABG and 884 PCI) and 600 for 3-vessel disease (505 CABG and 95 PCI). One-year mortality, cerebrovascular events, Q-wave myocardial infarction, target vessel failure, and composite major adverse cardiovascular and cerebrovascular events were compared between the CABG and PCI cohorts. Outcomes were adjusted for baseline covariates and reported as hazard ratios. The unadjusted major adverse cardiovascular and cerebrovascular event rate was reduced with CABG for patients with 2-vessel disease (9.7% CABG versus 21.2% PCI; P<0.001) and 3-vessel disease (10.8% CABG versus 28.4% PCI; P<0.001). Adjusted outcomes showed increased major adverse cardiovascular and cerebrovascular event with PCI for patients with 2-vessel (hazard ratio 2.29; 95% CI 1.39 to 3.76; P=0.01) and 3-vessel disease (hazard ratio 2.90; 95% CI 1.76 to 4.78; P<0.001). Adjusted outcomes for the nondiabetic subpopulation demonstrated equivalent major adverse cardiovascular and cerebrovascular event with PCI for 2-vessel (hazard ratio 1.77; 95% CI 0.96 to 3.25; P=0.07) and 3-vessel disease (hazard ratio 1.70; 95% CI 0.77 to 3.61; P=0.19). Compared with PCI with drug-eluting stents, CABG resulted in improved major adverse cardiovascular and cerebrovascular event in patients with 2- and 3-vessel coronary artery disease, primarily in those with underlying diabetes

  6. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent

    DEFF Research Database (Denmark)

    Stone, Gregg W; Teirstein, Paul S; Meredith, Ian T

    2011-01-01

    We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI).......We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI)....

  7. Transarterial chemoembolization with drug-eluting beads for hepatocellular carcinoma: its research progress

    International Nuclear Information System (INIS)

    Zhao Yan; Han Guohong; Bai Wei; Fan Daiming

    2012-01-01

    Transarterial chemoembolization (TACE) has been the main treatment for patients with intermediate-stage hepatocellular carcinoma (HCC). However, the clinical application of TACE is limited due to the technical deficiencies, such as uncontrolled local drug delivery and systemic toxicity. Recently, the new drug-eluting beads (DEB), loading with doxorubicin, have be used in the TACE procedures. This new technique can not only maintain the local drug level for quite a long time and thus get a higher objective response, but also decrease the systemic toxicity. Transarterial chemoembolization with drug-eluting beads (DEB-TACE) have already been widely used abroad, and more related clinical trials are underway to clarify its advantages. This paper aims to make a comprehensive review in the respects of its characteristics and the latest research progress in DEB-TACE. (authors)

  8. Intimal hyperplasia and vascular remodeling after everolimus-eluting and sirolimus-eluting stent implantation in diabetic patients the randomized diabetes and drug-eluting stent (DiabeDES) IV intravascular ultrasound trial

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Maeng, Michael; Thayssen, Per

    2013-01-01

    OBJECTIVE: To evaluate the effects of the everolimus-eluting Xience™/Promus™ stent (EES) and the sirolimus-eluting Cypher™ stent (SES) on intimal hyperplasia (IH) in diabetic patients. BACKGROUND: Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent...... implantation due to intimal hyperplasia (IH). METHODS: In a sub study of the Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV trial), serial intravascular ultrasound (IVUS) 10-month follow-up data were available...... in 88 patients, including 48 EES and 40 SES treated patients. IVUS endpoints included IH volume, in-stent % volume obstruction and changes in external elastic membrane (EEM) volume. RESULTS: Compared with the SES group, IH volume was increased in the EES group [median (interquartile range): 2.8 mm(3) (0...

  9. Successful drug-eluting stent implantation in a male patient with dextrocardia: a case report

    Directory of Open Access Journals (Sweden)

    Long Wenjie

    2017-12-01

    Full Text Available Situs inversus with dextrocardia is a rare condition, with complete transposition of all the body organs, including the heart. Percutaneous coronary intervention (PCI in these patients is technically difficult because of the mirror image of organs. Here, we describe a 56-year-old man with coronary heart disease with known situs inversus with dextrocardia and coronary percutaneous intervention was performed for stenosis in the right coronary artery. A drug eluting stent was implanted at this site successfully. This case suggested that the interventional management of such patients follows the same general rules as for non-dextrocardia patients, but the manipulation of the catheter and projection position choices need to be taken into consideration to obtain optimal benefits for the patient.

  10. Spectral Analysis Related to Bare-Metal and Drug-Eluting Coronary Stent Implantation

    Energy Technology Data Exchange (ETDEWEB)

    Silva, Rose Mary Ferreira Lisboa da, E-mail: roselisboa@cardiol.br [Faculdade de Medicina da UFMG, Divinópolis, MG (Brazil); Silva, Carlos Augusto Bueno [Faculdade de Medicina da UFMG, Divinópolis, MG (Brazil); Belo Horizonte, Hospital São João de Deus, Divinópolis, MG (Brazil); Greco, Otaviano José [Belo Horizonte, Hospital São João de Deus, Divinópolis, MG (Brazil); Moreira, Maria da Consolação Vieira [Faculdade de Medicina da UFMG, Divinópolis, MG (Brazil)

    2014-08-15

    The autonomic nervous system plays a central role in cardiovascular regulation; sympathetic activation occurs during myocardial ischemia. To assess the spectral analysis of heart rate variability during stent implantation, comparing the types of stent. This study assessed 61 patients (mean age, 64.0 years; 35 men) with ischemic heart disease and indication for stenting. Stent implantation was performed under Holter monitoring to record the spectral analysis of heart rate variability (Fourier transform), measuring the low-frequency (LF) and high-frequency (HF) components, and the LF/HF ratio before and during the procedure. Bare-metal stent was implanted in 34 patients, while the others received drug-eluting stents. The right coronary artery was approached in 21 patients, the left anterior descending, in 28, and the circumflex, in 9. As compared with the pre-stenting period, all patients showed an increase in LF and HF during stent implantation (658 versus 185 ms2, p = 0.00; 322 versus 121, p = 0.00, respectively), with no change in LF/HF. During stent implantation, LF was 864 ms2 in patients with bare-metal stents, and 398 ms2 in those with drug-eluting stents (p = 0.00). The spectral analysis of heart rate variability showed no association with diabetes mellitus, family history, clinical presentation, beta-blockers, age, and vessel or its segment. Stent implantation resulted in concomitant sympathetic and vagal activations. Diabetes mellitus, use of beta-blockers, and the vessel approached showed no influence on the spectral analysis of heart rate variability. Sympathetic activation was lower during the implantation of drug-eluting stents.

  11. Enhanced performance of magnesium alloy for drug-eluting vascular scaffold application

    Science.gov (United States)

    Dong, Hongzhou; Li, Daikun; Mao, Daoyong; Bai, Ningning; Chen, Yashi; Li, Qing

    2018-03-01

    Bio-absorbable magnesium alloys drug-eluting vascular scaffold was developed to resolve the defect of permanent metal and drug-eluting stents, most notably a chronic vessel wall inflammation and the risk of stent thrombosis. Nevertheless, violent chemical reaction and rapid degradation under physiological conditions limits their application. Furthermore, multifunctional drug-eluting stents which could reduce the formation of thrombus and repair the damaged vessels need more attention to fundamentally cure the coronary artery disease. Herein, a drug delivery system (Mg/MgO/PLA-FA) which can realize sustainable release of ferulaic acid was designed via anodic oxidation process and dip coating process. Electrochemical tests and immersion experiments showed that the superior anticorrosion behavior, it is due to the dense MgO-PLA composite layer. The released ferulaic acid can effectively decrease platelets adhesion and aggregation during the early stage of implantation. Besides, hemolysis tests showed that the composite coatings endowed the Mg alloy with a low hemolysis ratio. The Mg/MgO/PLA-FA composite materials may be appropriate for applications on biodegradable Mg alloys drug-eluting stents.

  12. Prognostic Value of Plasma Pentraxin-3 Levels in Patients with Stable Coronary Artery Disease after Drug-Eluting Stent Implantation

    Directory of Open Access Journals (Sweden)

    Liu Haibo

    2014-01-01

    Full Text Available Pentraxin-3 (PTX3 is an inflammatory marker thought to be more specific to cardiovascular inflammation than C-reactive protein (CRP. Our aim was to assess the prognostic value of PTX3 in patients with stable coronary artery disease (CAD after drug eluting stent (DES implantation. Plasma PTX3 levels were measured before percutaneous coronary intervention (PCI and at 24 h post-PCI in 596 consecutive patients with stable CAD. Patients were followed up for a median of 3 years (range 1–5 for major adverse cardiovascular events (MACEs. We found that the post-PCI plasma PTX3 levels were significantly higher at 24 h after PCI than pre-PCI, patients with MACEs had higher post-PCI PTX3 levels compared with MACEs-free patients, patients with higher post-PCI PTX3 levels (median > 4.384 ng/mL had a higher risk for MACEs than those with PTX3 < 4.384 ng/mL, and post-PCI PTX3, cTnI, multiple stents, and age but not high-sensitivity CRP (hsCRP were independently associated with the prevalence of MACEs after DES implantation. The present study shows that post-PCI PTX3 may be a more reliable inflammatory predictor of long-term MACEs in patients with stable CAD undergoing DES implantation than CRP. Measurement of post-PCI PTX3 levels could provide a rationale for risk stratification of patients with stable CAD after DES implantation.

  13. Hepatic Arterial Chemoembolization Using Drug-Eluting Beads in Gastrointestinal Neuroendocrine Tumor Metastatic to the Liver

    International Nuclear Information System (INIS)

    Gaur, Shantanu K.; Friese, Jeremy L.; Sadow, Cheryl A.; Ayyagari, Rajasekhara; Binkert, Christoph A.; Schenker, Matthew P.; Kulke, Matthew; Baum, Richard

    2011-01-01

    Purpose: This study was designed to evaluate short ( 3 months) follow-up in patients with metastatic neuroendocrine tumor to the liver who underwent hepatic arterial chemoembolization with drug-eluting beads at a single institution. Methods: Institutional review board approval was obtained for this retrospective review. All patients who were treated with 100–300 or 300–500 μm drug-eluting LC Beads (Biocompatibles, UK) preloaded with doxorubicin (range, 50–100 mg) for GI neuroendocrine tumor metastatic to the liver from June 2004 to June 2009 were included. CT and MRI were evaluated for progression using Response Evaluation Criteria In Solid Tumors (RECIST) or European Association for the Study of the Liver (EASL) criteria. Short-term ( 3 months) imaging response was determined and Kaplan–Meier survival curves were plotted. Results: Thirty-eight drug-eluting bead chemoembolization procedures were performed on 32 hepatic lobes, comprising 21 treatment cycles in 18 patients. All procedures were technically successful with two major complications (biliary injuries). At short-term follow-up (<3 months), 22 of 38 (58%) procedures and 10 of 21 (48%) treatment cycles produced an objective response (OR) with the remainder having stable disease (SD). At intermediate-term follow-up (mean, 445 days; range, 163–1247), 17 of 26 (65%) procedures and 8 of 14 (57%) treatment cycles produced an OR. Probability of progressing was approximately 52% at 1 year with a median time to progression of 419 days. Conclusions: Drug-eluting bead chemoembolization is a reasonable alternative to hepatic arterial embolization and chemoembolization for the treatment of metastatic neuroendocrine tumor to the liver.

  14. Zotarolimus-eluting vs. sirolimus-eluting coronary stents in patients with and without acute coronary syndromes

    DEFF Research Database (Denmark)

    Thim, Troels; Maeng, Michael; Kaltoft, Anne Kjer

    2012-01-01

    To compare clinical outcomes among patients with acute coronary syndrome treated with zotarolimus-eluting and sirolimus-eluting stents in the SORT OUT III trial.......To compare clinical outcomes among patients with acute coronary syndrome treated with zotarolimus-eluting and sirolimus-eluting stents in the SORT OUT III trial....

  15. Drug-eluting stents and bare metal stents in patients with NSTE-ACS

    DEFF Research Database (Denmark)

    Pedersen, Sune Haahr; Pfisterer, Matthias; Kaiser, Christoph

    2014-01-01

    the randomised BASKET-PROVE trial (sirolimus-eluting stent vs. everolimus-eluting stent vs. bare metal stent in large-vessel stenting). The primary endpoint was the combined two-year rate of cardiovascular death or non-fatal myocardial infarction (MI). Secondary endpoints were each component of the primary...... implantation in large vessels was associated with a reduction in both TVR and the combined endpoint consisting of cardiovascular death/MI. Thus, DES use improves both efficacy and safety. These findings support the use of DES in NSTE-ACS patients....

  16. Coronary Artery Bypass Surgery Versus Drug-Eluting Stent Implantation for Left Main or Multivessel Coronary Artery Disease A Meta-Analysis of Individual Patient Data

    NARCIS (Netherlands)

    Lee, Cheol Whan; Ahn, Jung-Min; Cavalcante, Rafael; Sotomi, Yohei; Onuma, Yoshinobu; Suwannasom, Pannipa; Tenekecioglu, Erhan; Yun, Sung-Cheol; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Serruys, Patrick W.; Park, Seung-Jung

    2016-01-01

    OBJECTIVES The authors undertook a patient-level meta-analysis to compare long-term outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in 3,280 patients with left main or multivessel coronary artery disease (CAD).

  17. Stent Coating Integrity of Durable and Biodegradable Coated Drug Eluting Stents.

    Science.gov (United States)

    Yazdani, Saami K; Sheehy, Alexander; Pacetti, Stephen; Rittlemeyer, Brandon; Kolodgie, Frank D; Virmani, Renu

    2016-10-01

    Coatings consisting of a polymer and drug are widely used in drug-eluting stents (DES) and are essential in providing programmable drug release kinetics. Among other factors, stent coating technologies can influence blood compatibility, affect acute and sub-acute healing, and potentially trigger a chronic inflammatory response. The aim of this study was to investigate the short-term (7 and 28 days) and long-term (90 and 180 days) coating integrity of the Xience Prime Everolimus-Eluting Stent (EES), Resolute Zotarolimus-Eluting Stent (ZES), Taxus Paclitaxel-Eluting Stent (PES), and Nobori Biolimus A9-Eluting Stent (BES) in a rabbit ilio-femoral stent model. Stented arteries (n = 48) were harvested and the tissue surrounding the implanted stents digested away with an enzymatic solution. Results demonstrated that the majority of struts of EES were without any coating defects with a few struts showing minor defects. Similarly, for the ZES, most of the struts were without coating defects at all time points except at 180 days. The majority of PES demonstrated mostly webbing and uneven coating. In the BES group, the majority of strut coating showed polymer cracking. Overall, the EES and ZES had fewer coating defects than the PES and BES. Coating defects, however increase over time for the ZES, whereas the percent of coating irregularities remained constant for the EES. These results provide, for the first time, a comparison of the long-term durability of these drug-eluting stent coatings in vivo. © 2016, Wiley Periodicals, Inc.

  18. Cost-effectiveness analysis of biodegradable polymer versus durable polymer drug-eluting stents incorporating real-world evidence.

    Science.gov (United States)

    Teng, Monica; Zhao, Ying Jiao; Khoo, Ai Leng; Ananthakrishna, Rajiv; Yeo, Tiong Cheng; Lim, Boon Peng; Chan, Mark Y; Loh, Joshua P

    2018-06-05

    Compared with second-generation durable polymer drug-eluting stents (DP-DES), the cost-effectiveness of biodegradable polymer drug-eluting stents (BP-DES) remains unclear in the real-world setting. We assessed the cost-effectiveness of BP-DES in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). We developed a decision-analytic model to compare the cost-effectiveness of BP-DES to DP-DES over one year and five years from healthcare payer perspective. Relative treatment effects during the first year post-PCI were obtained from a real-world population analysis while clinical event risks in the subsequent four years were derived from a meta-analysis of published studies. At one year, based on the clinical data analysis of 497 propensity-score matched pairs of patients, BP-DES were associated with an incremental cost-effectiveness ratio (ICER) of USD20,503 per quality-adjusted life-year (QALY) gained. At five years, BP-DES yielded an ICER of USD4,062 per QALY gained. At the willingness-to-pay threshold of USD50,400 (one gross domestic product per capita in Singapore in 2015), BP-DES were cost-effective. Sensitivity analysis showed that the cost of stents had a significant impact on the cost-effectiveness of BP-DES. Threshold analysis demonstrated that if the cost difference between BP-DES and DP-DES exceeded USD493, BP-DES would not be cost-effective in patients with one-year of follow-up. BP-DES were cost-effective compared with DP-DES in patients with coronary artery disease at one year and five years after PCI. It is worth noting that the cost of stents had a significant impact on the findings. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  19. Impact of Clinical Presentation (Stable Angina Pectoris vs Unstable Angina Pectoris or Non-ST-Elevation Myocardial Infarction vs ST-Elevation Myocardial Infarction) on Long-Term Outcomes in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents

    DEFF Research Database (Denmark)

    Giustino, Gennaro; Baber, Usman; Stefanini, Giulio Giuseppe

    2015-01-01

    The long-term risk associated with different coronary artery disease (CAD) presentations in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is poorly characterized. We pooled patient-level data for women enrolled in 26 randomized clinical trials. Of 11......,577 women included in the pooled database, 10,133 with known clinical presentation received a DES. Of them, 5,760 (57%) had stable angina pectoris (SAP), 3,594 (35%) had unstable angina pectoris (UAP) or non-ST-segment-elevation myocardial infarction (NSTEMI), and 779 (8%) had ST......-segment-elevation myocardial infarction (STEMI) as clinical presentation. A stepwise increase in 3-year crude cumulative mortality was observed in the transition from SAP to STEMI (4.9% vs 6.1% vs 9.4%; p clinical...

  20. DMSO inhibits human platelet activation through cyclooxygenase-1 inhibition. A novel agent for drug eluting stents?

    International Nuclear Information System (INIS)

    Asmis, Lars; Tanner, Felix C.; Sudano, Isabella; Luescher, Thomas F.; Camici, Giovanni G.

    2010-01-01

    Background: DMSO is routinely infused together with hematopoietic cells in patients undergoing myeloablative therapy and was recently found to inhibit smooth muscle cells proliferation and arterial thrombus formation in the mouse by preventing tissue factor (TF), a key activator of the coagulation cascade. This study was designed to investigate whether DMSO prevents platelet activation and thus, whether it may represent an interesting agent to be used on drug eluting stents. Methods and results: Human venous blood from healthy volunteers was collected in citrated tubes and platelet activation was studied by cone and platelet analyzer (CPA) and rapid-platelet-function-assay (RPFA). CPA analysis showed that DMSO-treated platelets exhibit a lower adherence in response to shear stress (-15.54 ± 0.9427%, n = 5, P < 0.0001 versus control). Additionally, aggregometry studies revealed that DMSO-treated, arachidonate-stimulated platelets had an increased lag phase (18.0% ± 4.031, n = 9, P = 0.0004 versus control) as well as a decreased maximal aggregation (-6.388 ± 2.212%, n = 6, P = 0.0162 versus control). Inhibitory action of DMSO could be rescued by exogenous thromboxane A2 and was mediated, at least in part, by COX-1 inhibition. Conclusions: Clinically relevant concentrations of DMSO impair platelet activation by a thromboxane A2-dependent, COX-1-mediated effect. This finding may be crucial for the previously reported anti-thrombotic property displayed by DMSO. Our findings support a role for DMSO as a novel drug to prevent not only proliferation, but also thrombotic complications of drug eluting stents.

  1. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V)

    DEFF Research Database (Denmark)

    Christiansen, Evald Høj; Jensen, Lisette Okkels; Thayssen, Per

    2013-01-01

    Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer......-coated sirolimus-eluting stent in a population-based setting....

  2. Drug-eluting stents to prevent stent thrombosis and restenosis.

    Science.gov (United States)

    Im, Eui; Hong, Myeong-Ki

    2016-01-01

    Although first-generation drug-eluting stents (DES) have significantly reduced the risk of in-stent restenosis, they have also increased the long-term risk of stent thrombosis. This safety concern directly triggered the development of new generation DES, with innovations in stent platforms, polymers, and anti-proliferative drugs. Stent platform materials have evolved from stainless steel to cobalt or platinum-chromium alloys with an improved strut design. Drug-carrying polymers have become biocompatible or biodegradable and even polymer-free DES were introduced. New limus-family drugs (such as everolimus, zotarolimus or biolimus) were adopted to enhance stent performances. As a result, these new DES demonstrated superior vascular healing responses on intracoronary imaging studies and lower stent thrombotic events in actual patients. Recently, fully-bioresorbable stents (scaffolds) have been introduced, and expanding their applications. In this article, the important concepts and clinical results of new generation DES and bioresorbable scaffolds are described.

  3. Prevalence and impact of high platelet reactivity in chronic kidney disease: results from the Assessment of Dual Antiplatelet Therapy with Drug-Eluting Stents registry.

    Science.gov (United States)

    Baber, Usman; Mehran, Roxana; Kirtane, Ajay J; Gurbel, Paul A; Christodoulidis, Georgios; Maehara, Akiko; Witzenbichler, Bernhard; Weisz, Giora; Rinaldi, Michael J; Metzger, D Christopher; Henry, Timothy D; Cox, David A; Duffy, Peter L; Mazzaferri, Ernest L; Xu, Ke; Parise, Helen; Brodie, Bruce R; Stuckey, Thomas D; Stone, Gregg W

    2015-06-01

    Chronic kidney disease (CKD) is associated with increased rates of adverse events after percutaneous coronary intervention. We sought to determine the impact of CKD on platelet reactivity in clopidogrel-treated patients and whether high platelet reactivity (HPR) confers a similar or differential risk for adverse events among patients with CKD and non-CKD. We performed a post hoc analysis of the Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) registry, which included 8582 patients undergoing percutaneous coronary intervention with drug-eluting stents and platelet function testing using the VerifyNow assay. We compared HPR and its impact on ischemic and bleeding events >2 years among patients with CKD and non-CKD. Patients with CKD (n=1367) were older, more often female, diabetic, and had lower ejection fraction compared with their non-CKD counterparts (n=7043). Although HPR prevalence increased with worsening renal function in unadjusted analyses, these associations were no longer present after adjustment. Major adverse cardiac event rates at 2 years among those without CKD or HPR, HPR alone, CKD alone, and both CKD and HPR were 9.0%, 11.2%, 13.3%, and 17.5%, respectively (Pimpact of HPR on ischemic and bleeding events is similar irrespective of CKD status. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00638794. © 2015 American Heart Association, Inc.

  4. First-Generation Versus Second-Generation Drug-Eluting Stents in Coronary Chronic Total Occlusions: Two-Year Results of a Multicenter Registry.

    Directory of Open Access Journals (Sweden)

    Jong-Hwa Ahn

    Full Text Available Limited data are available regarding the long-term clinical outcomes of second-generation drug-eluting stents (DES versus first-generation DES in patients with coronary chronic total occlusion (CTO who undergo percutaneous coronary intervention (PCI. The aim of this study was to compare the clinical outcomes of second-generation DES with those of first-generation DES for the treatment of CTO.Between March 2003 and February 2012, 1,006 consecutive patients with CTO who underwent successful PCI using either first-generation DES (n = 557 or second-generation DES (n = 449 were enrolled in a multicenter, observational registry. Propensity-score matching was also performed. The primary outcome was cardiac death over a 2-year follow-up period. No significant differences were observed between the two groups regarding the incidence of cardiac death (first-generation DES versus second-generation DES; 2.5% vs 2.0%; hazard ratio [HR]: 0.86; 95% confidence interval [CI]: 0.37 to 1.98; p = 0.72 or major adverse cardiac events (MACE, 11.8% vs 11.4%; HR: 1.00; 95% CI: 0.67 to 1.50; p = 0.99. After propensity score matching, the incidences of cardiac death (HR: 0.86; 95% CI: 0.35 to 2.06; p = 0.86 and MACE (HR: 0.93; 95% CI: 0.63 to 1.37; p = 0.71 were still similar in both groups. Furthermore, no significant differences were observed between sirolimus-eluting, paclitaxel-eluting, zotarolimus-eluting, and everolimus-eluting stents regarding the incidence of cardiac death or MACE.This study shows that the efficacy of second-generation DES is comparable to that of first-generation DES for treatment of CTO over 2 years of follow-up.

  5. The role of drug-eluting balloons alone or in combination with drug-eluting stents in the treatment of de novo diffuse coronary disease.

    Science.gov (United States)

    Costopoulos, Charis; Latib, Azeem; Naganuma, Toru; Sticchi, Alessandro; Figini, Filippo; Basavarajaiah, Sandeep; Carlino, Mauro; Chieffo, Alaide; Montorfano, Matteo; Naim, Charbel; Kawaguchi, Masanori; Giannini, Francesco; Colombo, Antonio

    2013-11-01

    This study sought to investigate the role of drug-eluting balloons (DEB) alone or in combination with drug-eluting stents (DES) in the treatment of diffuse de novo coronary artery disease (CAD) (>25 mm). The use of DEB in diffuse CAD, either alone or in combination with DES, offers an alternative to stenting alone. Data regarding DEB in this context are limited. We retrospectively evaluated all patients treated with DEB for diffuse CAD between June 2009 and October 2012. Endpoints analyzed were major adverse cardiac events, defined as all-cause death, myocardial infarction, and target vessel revascularization (TVR), as well as TVR and target lesion revascularization separately. Results were compared with those obtained from a cohort of patients with similar characteristics treated with DES alone. A total of 69 patients (93 lesions) were treated with DEB ± DES, and 93 patients with DES alone (93 lesions). A high proportion of patients were diabetic (46.4% vs. 44.1%, p = 0.77). Of the DEB-treated lesions, 56.0% were treated with DEB alone, 7.4% with DEB and DES as bail out, and 36.6% with DES and DEB as part of a hybrid approach for very long disease. Outcome rates with DEB ± DES were comparable to those with DES alone at 2-year follow-up (major adverse cardiac events = 20.8% vs. 22.7%, p = 0.74; TVR = 14.8% vs. 11.5%, p = 0.44; target lesion revascularization = 9.6% vs. 9.3%, p = 0.84). DEB may have a role in the treatment of diffuse de novo CAD, either alone in smaller vessels or in combination with DES in very long disease. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  6. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis.

    Science.gov (United States)

    Palmerini, Tullio; Biondi-Zoccai, Giuseppe; Della Riva, Diego; Stettler, Christoph; Sangiorgi, Diego; D'Ascenzo, Fabrizio; Kimura, Takeshi; Briguori, Carlo; Sabatè, Manel; Kim, Hyo-Soo; De Waha, Antoinette; Kedhi, Elvin; Smits, Pieter C; Kaiser, Christoph; Sardella, Gennaro; Marullo, Antonino; Kirtane, Ajay J; Leon, Martin B; Stone, Gregg W

    2012-04-14

    The relative safety of drug-eluting stents and bare-metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between bare-metal and drug-eluting stents. For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with bare-metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. 49 trials including 50,844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13-0·41). The significant difference in stent thrombosis between CoCr-EES and bare-metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11-0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08-0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16-0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24-0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10-0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03-0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were bare-metal (OR 0·35, 95% CI 0·17-0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19-0·62). No other drug-eluting stent had lower definite thrombosis rates compared with bare

  7. Late lumen loss and intima hyperplasia after sirolimus-eluting and zotarolimus-eluting stent implantation in diabetic patients: the diabetes and drug-eluting stent (DiabeDES III) angiography and intravascular ultrasound trial

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Mæng, Michael; Thayssen, Per

    2011-01-01

    Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to neointimal hyperplasia (NIH). The aim of this study was to use quantitative coronary angiography (QCA) and volumetric intravascular ultrasound (IVUS) to evaluate the effects...... of the sirolimus-eluting Cypher® stent (SES) and the zotarolimus-eluting Endeavor® stent (ZES) on angiographic late lumen loss and intima hyperplasia in diabetic patients....

  8. Impact of Age on Long-Term Outcome After Primary Angioplasty With Bare-Metal or Drug-Eluting Stent (From the DESERT Cooperation)

    DEFF Research Database (Denmark)

    De Luca, Giuseppe; Dirksen, Maurits T; Spaulding, Christian

    2013-01-01

    Despite mechanical reperfusion, elderly patients with ST-segment elevation myocardial infarction (STEMI) still experience unsatisfactory outcomes. Drug-eluting stents (DES) have significantly reduced target-vessel revascularization (TVR), but concerns have emerged about the higher risk of late st...... angioplasty and stent implantation included in the Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation database. Age was significantly associated with female gender (p...

  9. Long-term prognostic value of risk scores after drug-eluting stent implantation for unprotected left main coronary artery: A pooled analysis of the ISAR-LEFT-MAIN and ISAR-LEFT-MAIN 2 randomized clinical trials.

    Science.gov (United States)

    Xhepa, Erion; Tada, Tomohisa; Kufner, Sebastian; Ndrepepa, Gjin; Byrne, Robert A; Kreutzer, Johanna; Ibrahim, Tareq; Tiroch, Klaus; Valgimigli, Marco; Tölg, Ralf; Cassese, Salvatore; Fusaro, Massimiliano; Schunkert, Heribert; Laugwitz, Karl L; Mehilli, Julinda; Kastrati, Adnan

    2017-01-01

    To evaluate the long-term prognostic value of risk scores in the setting of drug-eluting stent (DES) implantation for uLMCA. Data on the prognostic value of novel risk scores developed to select the most appropriate revascularization strategy in patients undergoing DES implantation for uLMCA disease are relatively limited. The study represents a patient-level pooled analysis of the ISAR-LEFT-MAIN (607 patients randomized to paclitaxel-eluting or sirolimus-eluting stents) and the ISAR-LEFT-MAIN-2 (650 patients randomized to everolimus-eluting or zotarolimus-eluting stents) randomized trials. The Syntax Score (SxScore) as well the Syntax Score II (SS-II), the EuroSCORE and the Global Risk Classification (GRC) were calculated. The primary outcome was all-cause mortality. At a mean follow-up of 3 years there were 160 deaths (12.7%). The death-incidence was significantly higher in the upper tertiles than in the intermediate or lower ones for all risk scores (log-rank test P risk scores were able to stratify the mortality risk at long-term follow-up. EuroSCORE was the only risk score that significantly improved the discriminatory power of a multivariable model to predict long-term mortality. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  10. Comparison of clinical outcomes after drug-eluting balloon and drug-eluting stent use for in-stent restenosis related acute myocardial infarction: a retrospective study

    Directory of Open Access Journals (Sweden)

    Chih-Yuan Fang

    2018-04-01

    Full Text Available Background Good results of drug-eluting balloon (DEB use are achieved in in-stent restenosis (ISR lesions, small vessel disease, long lesions, and bifurcations. However, few reports exist about DEB use in acute myocardial infarction (AMI with ISR. This study’s aim was to evaluate the efficacy of DEB for AMI with ISR. Methods Between November 2011 and December 2015, 117 consecutive patients experienced AMI including ST-segment elevation MI, and non-ST-segment elevation MI due to ISR, and received percutaneous coronary intervention (PCI. We divided our patients into two groups: (1 PCI with further DEB, and (2 PCI with further drug-eluting stent (DES. Clinical outcomes such as target lesion revascularization, target vessel revascularization, recurrent MI, stroke, cardiovascular mortality, and all-cause mortality were analyzed. Results The patients’ average age was 68.37 ± 11.41 years; 69.2% were male. A total of 75 patients were enrolled in the DEB group, and 42 patients were enrolled in the DES group. The baseline characteristics between the two groups were the same without statistical differences except for gender. Peak levels of cardiac biomarker, pre- and post-PCI cardiac function were similar between two groups. The major adverse cardiac cerebral events rate (34.0% vs. 35.7%; p = 0.688 and cardiovascular mortality rate (11.7% vs. 12.8%; p = 1.000 were similar in both groups. Conclusions DEB is a reasonable strategy for AMI with ISR. Compared with DES, DEB is an alternative strategy which yielded acceptable short-term outcomes and similar 1-year clinical outcomes.

  11. 2-year clinical outcomes after implantation of sirolimus-eluting, paclitaxel-eluting, and bare-metal coronary stents: results from the WDHR (Western Denmark Heart Registry)

    DEFF Research Database (Denmark)

    Kaltoft, Anne; Jensen, Lisette Okkels; Maeng, Michael

    2009-01-01

    OBJECTIVES: This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS). BACKGROUND: Drug-eluting stents may increase the risk of stent thrombosis (ST...... databases. We used Cox regression analysis to control for confounding. RESULTS: The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1...

  12. Response rates of hepatocellular carcinoma and hepatic colorectal cancer metastases to drug eluting bead regional liver therapy

    Institute of Scientific and Technical Information of China (English)

    Glenn W. Stambo; Deborah Cragan

    2017-01-01

    Aim: The purpose of this study was to evaluate and compare how hepatocellular carcinoma (HCC) and colorectal metastases respond to LC Bead chemoembolization using doxorubicin and irinotecan. Methods: The authors report their experience with doxorubicin and irinotecan eluting beads to treat 13 patients with primary HCC and 25 patients with colorectal metastases over a 1-year period at a single community based oncology practice. Within the colorectal cancer group they compared irinotecan eluting beads to doxorubicin eluting beads. Results:Nine of the 11 (81.8%) doxorubicin treated HCC patients had either complete response or partial response. All of the HCC lesions showed reduction in size and tumor enhancement and 10/11 (91%) HCC patients were alive at 24 months post treatment. Fisher's exact test revealed that among the 22 with colorectal metastases for whom follow-up data were available, those 11 who were treated with doxorubicin were significantly more likely to demonstrate complete or partial response compared to the 11 in the irinotecan treated group (P < 0.001). Conclusion:Overall, HCC and colon metastasis patients clearly demonstrated the effectiveness of drug eluting beads with 91% of the HCC patients alive 24 months after treatment.

  13. Histologic Assessment of Drug-Eluting Grafts Related to Implantation Site

    Directory of Open Access Journals (Sweden)

    Jean-Christophe Tille

    2016-02-01

    Full Text Available Drug-eluting vascular prostheses represent a new direction in vascular surgery to reduce early thrombosis and late intimal hyperplasia for small calibre grafts. Subcutaneous implantation in rats is a rapid and cost-effective screening model to assess the drug-elution effect and could, to some extent, be useful to forecast results for vascular prostheses. We compared biological and histological responses to scaffolds in different implantation sites. Polycaprolactone (PCL, paclitaxel-loaded PCL (PCL-PTX and dexamethasone-loaded PCL (PCL-DXM electrospun scaffolds were implanted subcutaneously and in an infrarenal abdominal aortic model in rats for up to 12 weeks. At the conclusion of the study, a histological analysis was performed. Cellular graft invasion revealed differences in the progression of cellular infiltration between PCL-PTX and PCL/PCL-DXM groups in both models. Cell infiltration increased over time in the aortic model compared to the subcutaneous model for all groups. Cell counting revealed major differences in fibroblast, macrophage and giant cell graft colonisation in all groups and models over time. Macrophages and giant cells increased in the PCL aortic model; whereas in the subcutaneous model these cell types increased only after three weeks or even decreased in the drug-eluting PCL groups. Other major findings were observed only in the aortic replacement such as extracellular matrix deposition and neo-angiogenesis. The subcutaneous implant model can be used for screening, especially when drug-eluting effects are studied. However, major histological differences were observed in cell type reaction and depth of cell penetration compared to the aortic model. Our results demonstrate that the implantation site is a critical determinant of the biological response.

  14. Drug loading of nanoporous TiO2 films

    International Nuclear Information System (INIS)

    Ayon, Arturo A; Cantu, Michael; Chava, Kalpana; Agrawal, C Mauli; Feldman, Marc D; Johnson, Dave; Patel, Devang; Marton, Denes; Shi, Emily

    2006-01-01

    The loading of therapeutic amounts of drug on a nanoporous TiO 2 surface is described. This novel drug-loading scheme on a biocompatible surface, when employed on medical implants, will benefit patients who require the deployment of drug-eluting implants. Anticoagulants, analgesics and antibiotics can be considered on the associated implants for drug delivery during the time of maximal pain or risk for patients undergoing orthopedic procedures. Therefore, this scheme will maximize the chances of patient recovery. (communication)

  15. [Drug-eluting stent thrombosis and its pharmacological prevention].

    Science.gov (United States)

    Pershukov, I V; Batyraliev, T A

    2007-01-01

    The problem of drug eluting stents (DES) safety has been actively discussed throughout 2006 because of increase of frequency of development of late stent thromboses which were noted during almost 2 years after stenting. In December 2006 US Food and Drug Administration (FDA) advisory panel acknowledged increase of development of late stent thrombosis. At the same time FDA accepted new definition of stent-thrombosis suggested by the Academic Research Consortium. According to this definition thrombosis can be definite, probable and possible. Any unexplained death before end of follow-up in a trial should be considered thrombosis related. Recalculation of thrombosis rate using this definition caused pronounced increase of this parameter in previously conducted trials. Thrombosis rate rose from 0,6 to 3,3% for bare metal stents, from 0,8 to 3,6% for sirolimus eluting stents and from 1,3 to 3,5% for paclitaxel eluting stents. Professional cardiological and angiographical societies (ACC, AHA, SCAI) responding to FDA advisory panel published their proofs and vision of the problem of stent thrombosis. In February 2007 ACC, AHA, SCAI, American College of Surgeons and Association of Dentists published scientific bulletin in which described preventive measures aimed at lowering of risk of thrombosis development. This document contains strict recommendation to continue double antithrombotic therapy with aspirin and clopidogrel for 12 months after implantation of DES or abandonment of the use of this type of stents when long term double antithrombotic therapy is not possible.

  16. Drug-eluting stents: from bench-top to clinical research

    NARCIS (Netherlands)

    Basalus, Mounir Welson Zakhary

    2013-01-01

    The development of drug-eluting stents (DES) has improved the invasive treatment of obstructive coronary artery disease by reducing both, restenosis rate and need for reinterventions. This success resulted in a widespread utilization of DES in clinical practice and entailed many clinical research

  17. Economic Outcomes of Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ABSORB III Trial.

    Science.gov (United States)

    Baron, Suzanne J; Lei, Yang; Chinnakondepalli, Khaja; Vilain, Katherine; Magnuson, Elizabeth A; Kereiakes, Dean J; Ellis, Stephen G; Stone, Gregg W; Cohen, David J

    2017-04-24

    The purpose of this study was to evaluate the economic impact of the Absorb bioresorbable vascular scaffold compared with the Xience everolimus-eluting stent in patients undergoing percutaneous coronary intervention. The ABSORB III trial (Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease) demonstrated that the Absorb scaffold was noninferior to the Xience stent with respect to target lesion failure at 1 year. Whether health care costs differ between the Absorb scaffold and the Xience stent is unknown. We performed a prospective health economic study alongside the ABSORB III trial, in which patients undergoing percutaneous coronary intervention for stable or unstable angina were randomized to receive the Absorb scaffold (n = 1,322) or Xience stent (n = 686). Resource use data were collected through 1 year of follow-up. Costs were assessed using resource-based accounting (for procedures), MedPAR data (for other index hospitalization costs), and Medicare reimbursements (for follow-up costs and physician fees). Initial procedural costs were higher with the Absorb scaffold than the Xience stent ($6,316 ± 1,892 vs. $6,103 ± 1,895; p = 0.02), driven mainly by greater balloon catheter use and the higher cost of the scaffold in the Absorb group. Nonetheless, index hospitalization costs ($15,035 ± 2,992 for Absorb vs. $14,903 ± 3,449 for Xience; p = 0.37) and total 1-year costs ($17,848 ± 6,110 for Absorb vs. $17,498 ± 7,411 for Xience; p = 0.29) were similar between the 2 groups. Although initial procedural costs were higher with the Absorb scaffold, there were no differences in total 1-year health care costs between the 2 cohorts. Longer term follow-up is needed to determine whether meaningful cost savings emerge after scaffold resorption. (A Clinical Evaluation of Absorb™ BVS, the Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT01751906). Copyright © 2017

  18. Drug-eluting stents studies in mice: Do we need atherosclerosis to study restenosis?

    NARCIS (Netherlands)

    Pires, N.M.M.; Jukema, J.W.; Daemen, M.J.A.P.; Quax, P.H.A.

    2006-01-01

    In 2001, the first human study with drug-eluting stents (DES) was published showing a nearly complete abolition of restenosis by using a sirolimus-eluting stent. This success was very encouraging to test new compounds in combination with the DES platform. Nevertheless, several other anti-restenotic

  19. Association Between Helicobacter Pylori Infection and Long-term Outcome in Patients with Drug-eluting Stent Implantation

    Science.gov (United States)

    Wang, Rui; Chen, Lei-Lei; Wang, De-Zhao; Chen, Bu-Xing

    2017-07-01

    To investigate the relationship between Helicobacter pylori (Hp) infection and the long-term outcome in acute coronary syndrome (ACS) patients with drug-eluting stent (DES) implantation and so as to explore the significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and upper gastrointestinal bleeding (UGIB). 539 ACS patients with DES implantation from January 1, 2010 to December 31, 2012 were analyzed. All the patients were divided into two groups according to the result of 13C urea breath test. 253 patients with Hp infection were put into group A (Hp+), and 286 cases without Hp infection were put into group B (Hp-). Demographic data was collected and all patients went through biochemical indicators and other routine blood examinations. We explored the correlations of Hp infection with MACE and UGIB after 3 to 5 years of follow-up using survival analysis. Survival analysis showed that Hp infection was a predictor of MACE and UGI. Sub-group analysis showed that patients with Hp eradication therapy had no relationship with MACE but had a lower rate of UGIB than those without Hp eradication therapy.

  20. Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study)

    DEFF Research Database (Denmark)

    Maeng, Michael; Tilsted, Hans Henrik; Jensen, Lisette Okkels

    2014-01-01

    received two different types of drug-eluting stents. METHODS: We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug......-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone...

  1. Posterior reversible leukoencephalopathy syndrome secondary to hepatic transarterial chemoembolization with doxorubicin drug eluting beads

    Science.gov (United States)

    Kistler, C. Andrew; McCall, Joseph Caleb; Ghumman, Saad Sultan; Ali, Ijlal Akbar

    2014-01-01

    Posterior reversible encephalopathy syndrome (PRES) is a rare complication of transarterial chemoembolization (TACE) used to treat liver metastases and has never been reported in a patient with metastatic uveal melanoma (UM) to the liver. We report the first case of PRES secondary to TACE with drug eluting beads (DEBs) loaded with doxorubicin in a 56-year-old woman with metastatic UM to the liver. PMID:24772346

  2. Drug-eluting stents for acute coronary syndrome: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Lishan Wang

    Full Text Available Drug-eluting stents (DES are increasingly used for treatment of acute coronary syndrome (ACS. However, clinical efficacy and safety of various types of DES is not well established in these subjects. We therefore evaluated clinical utility of second-generation and first-generation DES in patients with ACS by conducting a meta-analysis.A search of Medline, Embase, the Cochrane databases, and Web of Science was made. Randomized controlled trials (RCTs which compared second-generation DES (everolimus-eluting stents [EES] or zotarolimus-eluting stents [ZES] versus first-generation DES (sirolimus-eluting stents [SES] or paclitaxe-eluting stents [PES] in patients with ACS and provided data on clinical efficacy or safety endpoints were included. Pooled estimates were calculated using random-effects model.A total of 2,757 participants with ACS in 6 RCTs were included. Compared with first-generation one, second-generation DES trended to be associated with the decreased incidence of definite or probable stent thrombosis in ACS patients (risk ratio [RR]  = 0.60, 95% confidence intervals [CI] 0.33 to 1.07, p = 0.09. However, the rate of target lesion revascularization (TLR significantly increased in second-generation DES (RR = 2.08, 95%CI 1.25 to 3.47, p = 0.005. There were no significant differences in the incidence of major adverse cardiac events (MACEs, all-cause death, cardiac death, and recurrent myocardial infarction between the two arms (all p>0.10. The second-generation EES showed a tendency towards lower risk of MACEs (p = 0.06 and a beneficial effect on reducing stent thrombosis episodes (p = 0.009, while the second-generation ZES presented an increased occurrence of MACEs (p = 0.02 and TLR (p = 0.003.Second-generation DES, especially EES, appeared to present a lower risk of stent thrombosis, whereas second-generation ZES might increase the need for repeat revascularization in ACS patients. During coronary

  3. REUSABILITY OF BOND ELUT CERTIFY COLUMNS FOR THE EXTRACTION OF DRUGS FROM PLASMA

    NARCIS (Netherlands)

    CHEN, XH; FRANKE, JP; WIJSBEEK, J; DEZEEUW, RA

    1993-01-01

    The reusability of Bond Elut Certify columns for the extraction of toxicologically relevant drugs from plasma has been evaluated. Pentobarbital, hexobarbital, mepivacaine, trimipramine and clonazepam were selected as test drugs to represent various classes of drugs. The columns were regenerated

  4. Comparison between Exclusive and Selective Drug-Eluting Stent Strategies in Treating Patients with Multivessel Coronary Artery Disease.

    Science.gov (United States)

    Tung, Ying-Chang; Hsiao, Ping-Gune; Hsu, Lung-An; Kuo, Chi-Tai; Chang, Chi-Jen

    2014-05-01

    The expanded usage of drug-eluting stents (DES) in treating patients with multivessel coronary artery disease (CAD) may sometimes be limited in real-world practice due to cost concerns. We compared the clinical outcomes of exclusive and selective DES use in treating patients with multivessel CAD. From November 2004 to December 2011, 110 patients with multivessel CAD who received four or more stents were enrolled into this study, and divided into two groups according to the DES strategy employed: exclusive DES (n = 52), or selective DES (n = 58). In the selective DES group, DES was reserved for complex lesions only, such that the incidence and predictors of clinical events were assessed. At a mean follow-up of 41.4 ± 26.5 months, there were no significant differences between the two strategies in terms of baseline characteristics, all-cause mortality (exclusive vs. selective: 1.9% vs. 6.9%, p = 0.21), cardiac death (1.9% vs. 1.7%, p = 0.94) and nonfatal myocardial infarction (3.8% vs. 5.2%, p = 0.74). Despite the presence of more ostial lesions in the exclusive DES group, there was a trend such that major adverse cardiac events (MACE) and target lesion revascularization (TLR) rates were higher in the selective DES group (MACE: 17.3% vs. 31%, p = 0.16; TLR: 11.5% vs. 24.1%, p = 0.08). The higher MACE rate in the selective DES group was mainly driven by a higher target vessel revascularization (TVR) rate (15.4% vs. 29.3%, p = 0.08). In the exclusive DES group, SYNTAX score was an independent predictor of MACE [Haxard ratio (HR): 1.09, 95% confidence internal (CI): 1.02-1.16, p = 0.01] and TVR (HR 1.08, 95% CI 1.01-1.15, p = 0.04). Compared to the exclusive DES strategy, the selective DES strategy with reservation of DES for complex lesions is associated with numerically higher, but not statistically significant, rates of MACE and all-cause mortality in this small group of patients with multivessel CAD receiving four or more stents. Bare metal stent; Drug-eluting

  5. A randomized study to compare bioactive titanium stents and everolimus-eluting stents in diabetic patients (TITANIC XV): 1-year results.

    Science.gov (United States)

    López-Mínguez, José R; Nogales-Asensio, Juan M; Doncel-Vecino, Luis J; Merchán-Herrera, Antonio; Pomar-Domingo, Francisco; Martínez-Romero, Pedro; Fernández-Díaz, José A; Valdesuso-Aguilar, Raúl; Moreu-Burgos, José; Díaz-Fernández, José

    2014-07-01

    Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients. A total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter 28 mm in vessels < 3mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients). Baseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001). The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  6. Randomized comparison of a sirolimus-eluting Orsiro stent with a biolimus-eluting Nobori stent in patients treated with percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Maeng, Michael

    2015-01-01

    BACKGROUND: Third-generation coronary drug-eluting stents (DES) with biodegradable polymers have been designed to improve safety and efficacy. We designed a large scale registry-based randomized clinical trial to compare 2 third-generation DES: a thin strut, cobalt-chromium DES with silicon carbide......-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents (N-BES, Nobori; Terumo, Tokyo, Japan) in an all-comer patient population. DESIGN: The multicenter SORT OUT VII trial (NCT01879358...... will be used. An event rate of 6.5% is assumed in each stent group. With a sample size of 1,157 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the O-SES compared with the N...

  7. Porous Polymer Drug-Eluting Coating Prepared by Radiation Induced Polymerization

    International Nuclear Information System (INIS)

    Veres, M.; Beiler, B.; Himics, L.; Tóth, S.; Koós, M.

    2010-01-01

    Many areas of modern medicine are almost unimaginable without the use of different kinds of implants. They used as replacements, supports, auxiliary devices etc. for various parts or functions of the body. Their use has many advantages, however there could be some drawbacks too, like the possibility of rejection, inflammation and other side-effects. Many of these drawbacks are directly related to the materials used for the implant fabrication. Coatings are widely used to eliminate the unwanted effects appearing after the implantation. In addition to the protection and separation of tissues from the implant material they could also enhance the functionality and the acceptance of the artificial device and also promote the regeneration of the tissues after the intervention. Drug-eluting coatings are a good example for the latter. By delivery and controlled elution of drugs they could actively suppress inflammatory reactions, allergy and rejection of the implant, and their activity is localized to the place where these effects could mainly occur – to the region of the implant. This project is aimed to develop a drug-eluting porous polymer coating by radiation induced polymerization that can be used in different medical implants. The primary objects for this research are coronary stents however these porous layers could have perspective in other types of medical devices too. The main objectives are to develop a method for coating the surface of medical grade metallic alloy wires, plates and tubes with a porous polymer nanocomposite layer prepared by radiation induced polymerization and to characterize the obtained coatings

  8. Porous Polymer Drug-Eluting Coating Prepared by Radiation Induced Polymerization

    Energy Technology Data Exchange (ETDEWEB)

    Veres, M.; Beiler, B.; Himics, L.; Tóth, S.; Koós, M., E-mail: vm@szfki.hu [Hungarian Academy of Sciences, Research Institute for Solid State Physics and Optics, Department of Laser Applications, Konkoly Thege Miklós ut 29-33, 1121 Budapest, P.O. Box 49, 1525 Budapest (Hungary)

    2010-07-01

    Many areas of modern medicine are almost unimaginable without the use of different kinds of implants. They used as replacements, supports, auxiliary devices etc. for various parts or functions of the body. Their use has many advantages, however there could be some drawbacks too, like the possibility of rejection, inflammation and other side-effects. Many of these drawbacks are directly related to the materials used for the implant fabrication. Coatings are widely used to eliminate the unwanted effects appearing after the implantation. In addition to the protection and separation of tissues from the implant material they could also enhance the functionality and the acceptance of the artificial device and also promote the regeneration of the tissues after the intervention. Drug-eluting coatings are a good example for the latter. By delivery and controlled elution of drugs they could actively suppress inflammatory reactions, allergy and rejection of the implant, and their activity is localized to the place where these effects could mainly occur – to the region of the implant. This project is aimed to develop a drug-eluting porous polymer coating by radiation induced polymerization that can be used in different medical implants. The primary objects for this research are coronary stents however these porous layers could have perspective in other types of medical devices too. The main objectives are to develop a method for coating the surface of medical grade metallic alloy wires, plates and tubes with a porous polymer nanocomposite layer prepared by radiation induced polymerization and to characterize the obtained coatings.

  9. In-hospital management and outcome of patients on warfarin undergoing coronary stent implantation: results of the multicenter, prospective WARfarin and coronary STENTing (WAR-STENT) registry.

    Science.gov (United States)

    Rubboli, Andrea; Sciahbasi, Alessandro; Briguori, Carlo; Saia, Francesco; Palmieri, Cataldo; Moroni, Luigi Andrea; Calabrò, Paolo; Leone, Antonio Maria; Franco, Nicoletta; Valgimigli, Marco; Varani, Elisabetta; Santi, Michela; Pasqualini, Paola; Capecchi, Alessandro; Piccalò, Giacomo; Margheri, Massimo; di Pasquale, Giuseppe; Galvani, Marcello; Bolognese, Leonardo; Gonzini, Lucio; Maggioni, Aldo Pietro

    2013-04-01

    The in-hospital management of patients on warfarin undergoing coronary stent implantation (PCI-S) is variable, and the in-hospital outcome incompletely defined. To determine the adherence to the current recommendations, and the incidence of adverse events, we carried out the prospective, multicenter, observational WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319). All consecutive patients on warfarin undergoing PCI-S at 37 Italian centers were enrolled and followed for 12 months. Outcome measures were: major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, need for urgent revascularization, stroke, and venous thromboembolism, and major and minor bleeding. In this paper, we report the in-hospital findings. Out of the 411 patients enrolled, 92% were at non-low (ie, moderate or high) thromboembolic risk. The radial approach and bare-metal stents were used in 61% and 60% of cases, respectively. Drug-eluting stents were essentially reserved to patients with diabetes, which in turn, significantly predicted the implantation of drug-eluting stents (odds ratio [OR], 2.02; 95% confidence interval [CI], 1.29-3.17; P=.002). The in-hospital MACE and major bleeding rates were 2.7% and 2.1%, respectively. At discharge, triple therapy (TT) of warfarin, aspirin, and clopidogrel was prescribed to 76% of patients. Prescription of TT was significantly more frequent in the non-low thromboembolic risk group. Non-low thromboembolic risk, in turn, was a significant predictor of TT prescription (OR, 11.2; 95% CI, 4.83-26.3; P<.0001). In conclusion, real-world warfarin patients undergoing PCI-S are largely managed according to the current recommendations. As a consequence, the risk of in-hospital MACE and major bleedings appears limited and acceptable.

  10. Preparation of paclitaxel/chitosan co-assembled core-shell nanofibers for drug-eluting stent

    Energy Technology Data Exchange (ETDEWEB)

    Tang, Jing; Liu, Yongjia [Instrumental Analysis Center, Shanghai Jiao Tong University, 200240 Shanghai (China); State Key Laboratory of Metal Matrix Composites, School of Chemistry and Chemical Engineering, Shanghai Jiao Tong University, 200240 Shanghai (China); Zhu, Bangshang, E-mail: bshzhu@sjtu.edu.cn [Instrumental Analysis Center, Shanghai Jiao Tong University, 200240 Shanghai (China); State Key Laboratory for Modification of Chemical Fibers and Polymer Materials, Donghua University, 201620 Shanghai (China); Su, Yue; Zhu, Xinyuan [State Key Laboratory of Metal Matrix Composites, School of Chemistry and Chemical Engineering, Shanghai Jiao Tong University, 200240 Shanghai (China)

    2017-01-30

    Highlights: • The core-shell nanofibers (NFs) were made by the co-assembly of paclitaxel (PTX) and chitosan(CS). • The PTX/CS NFs have high PTX loading content, slow drug release and low adherence of platelets. • The PTX/CS NFs have low cytotoxicity and good haemocompatibility. • The PTX/CS NFs which could be easily coated on stents could have potential application for drug eluting stents. - Abstract: The paclitaxel/chitosan (PTX/CS) core-shell nanofibers (NFs) are easily prepared by co-assembly of PTX and CS and used in drug-eluting stent. The mixture solution of PTX (dissolved in ethanol) and CS (dissolved in 1% acetic acid water solution) under sonication will make the formation of NFs, in which small molecule PTX co-assembles with biomacromolecular CS through non-covalent interactions. The obtained NFs are tens to hundreds nanometers in diameter and millimeter level in length. Furthermore, the structure of PTX/CS NFs was characterized by confocal laser scanning microscopy (CLSM), zeta potential, X-ray photoelectron spectroscopy (XPS) and nanoscale infra-red (nanoIR), which provided evidences demonstrated that PTX/CS NFs are core-shell structures. The ‘shell’ of CS wrapped outside of the NFs, while PTX is located in the core. Thus it resulted in high drug loading content (>40 wt.%). The well-controlled drug release, low cytotoxicity and good haemocompatibility were also found in drug carrier system of PTX/CS NFs. In addition, the hydrophilic and flexible properties of NFs make them easily coating and filming on stent to prepare drug-eluting stent (DES). Therefore, this study provides a convenient method to prepare high PTX loaded NFs, which is a promising nano-drug carrier used for DES and other biomedical applications. The possible molecular mechanism of PTX and CS co-assembly and core-shell nanofiber formation is also explored. Statement of significance: We develop a convenient and efficient approach to fabricate core-shell nanofibers (NFs) through

  11. Factors Associated with the Use of Drug-Eluting Stents in Patients Presenting with Acute ST-Segment Elevation Myocardial Infarction

    Directory of Open Access Journals (Sweden)

    Jose F. Chavez

    2015-01-01

    Full Text Available Background. Drug-eluting stents (DES have proven clinical superiority to bare-metal stents (BMS for the treatment of patients with ST-segment elevation myocardial infarction (STEMI. Decision to implant BMS or DES is dependent on the patient’s ability to take dual antiplatelet therapy. This study investigated factors associated with DES placement in STEMI patients. Methods. Retrospective analysis was performed on 193 patients who presented with STEMI and were treated with percutaneous coronary intervention at an urban, tertiary care hospital. Independent factors associated with choice of stent type were determined using stepwise multivariate logistic regression. Odds ratio (OR was used to evaluate factors significantly associated with DES and BMS. Results. 128 received at least one DES, while 65 received BMS. BMS use was more likely in the setting of illicit drug or alcohol abuse ([OR] 0.15, 95% CI 0.05–0.48, p≤0.01, cardiogenic shock (OR 0.26, 95% CI 0.10–0.73, p=0.01, and larger stent diameter (OR 0.28, 95% CI 0.11–0.68, p≤0.01. Conclusions. In this analysis, BMS implantation was associated with illicit drug or alcohol abuse and presence of cardiogenic shock. This study did not confirm previous observations that non-White race, insurance, or income predicts BMS use.

  12. Outcome of everolimus eluting bioabsorbable vascular scaffold (BVS) compared to non BVS drug eluting stent in the management of ST-segment elevation myocardial infarction (STEMI) — A comparative study

    International Nuclear Information System (INIS)

    Chakraborty, Rabin; Patra, Soumya; Banerjee, Suvro; Pande, Arindam; Khan, Aftab; Mandol, Prakash Chandra; Ghosh, Debashish; De, Swapan Kumar; Das, Sankha Subhro; Nag, Raja

    2016-01-01

    Background: The safety and efficacy of everolimus eluting bioabsorbable vascular scaffold (BVS) in the management of “ST” segment elevation myocardial infarction (STEMI) are yet to be established. Aims: To evaluate immediate and short term safety and efficacy of the everolimus-eluting ABSORB BVS compared with non BVS drug eluting stent (DES) in patients with STEMI. Methods: From December 2013 to December 2014, 220 patients with STEMI were included in this study. Among them, 35 patients treated with BVS were compared with a control group composed of 180 patients who underwent non BVS DES implantation in the same time period. The incidence of major adverse cardiac events (MACE: stent thrombosis: death, non-fatal myocardial infarction, or target vessel/lesion revascularization) before discharge and up to six months was evaluated. Results: 1 vessel disease was more frequent whereas, 2 and 3 vessel disease was less frequent in BVS group. Procedural characteristics were also similar between groups, except for the use of post dilation (p = 0.04). Procedural success, in-hospital, and up to six-month MACE rates were similar between both groups. Definite or probable stent thrombosis did not occur (according to the ARC criteria) in BVS patients, though two patients during the index admission and another two patients in the first month after DES implantation had stent thrombosis. Conclusion: The use of the ABSORB BVS for STEMI is feasible and associated with good procedural safety, and angiographic success rate.

  13. Outcome of everolimus eluting bioabsorbable vascular scaffold (BVS) compared to non BVS drug eluting stent in the management of ST-segment elevation myocardial infarction (STEMI) — A comparative study

    Energy Technology Data Exchange (ETDEWEB)

    Chakraborty, Rabin; Patra, Soumya, E-mail: dr_soumyapatra@rediffmail.com; Banerjee, Suvro; Pande, Arindam; Khan, Aftab; Mandol, Prakash Chandra; Ghosh, Debashish; De, Swapan Kumar; Das, Sankha Subhro; Nag, Raja

    2016-04-15

    Background: The safety and efficacy of everolimus eluting bioabsorbable vascular scaffold (BVS) in the management of “ST” segment elevation myocardial infarction (STEMI) are yet to be established. Aims: To evaluate immediate and short term safety and efficacy of the everolimus-eluting ABSORB BVS compared with non BVS drug eluting stent (DES) in patients with STEMI. Methods: From December 2013 to December 2014, 220 patients with STEMI were included in this study. Among them, 35 patients treated with BVS were compared with a control group composed of 180 patients who underwent non BVS DES implantation in the same time period. The incidence of major adverse cardiac events (MACE: stent thrombosis: death, non-fatal myocardial infarction, or target vessel/lesion revascularization) before discharge and up to six months was evaluated. Results: 1 vessel disease was more frequent whereas, 2 and 3 vessel disease was less frequent in BVS group. Procedural characteristics were also similar between groups, except for the use of post dilation (p = 0.04). Procedural success, in-hospital, and up to six-month MACE rates were similar between both groups. Definite or probable stent thrombosis did not occur (according to the ARC criteria) in BVS patients, though two patients during the index admission and another two patients in the first month after DES implantation had stent thrombosis. Conclusion: The use of the ABSORB BVS for STEMI is feasible and associated with good procedural safety, and angiographic success rate.

  14. Advantages and disadvantages of biodegradable platforms in drug eluting stents.

    Science.gov (United States)

    Rodriguez-Granillo, Agustina; Rubilar, Bibiana; Rodriguez-Granillo, Gaston; Rodriguez, Alfredo E

    2011-03-26

    Coronary angioplasty with drug-eluting stent (DES) implantation is currently the most common stent procedure worldwide. Since the introduction of DES, coronary restenosis as well as the incidence of target vessel and target lesion revascularization have been significantly reduced. However, the incidence of very late stent thrombosis beyond the first year after stent deployment has more commonly been linked to DES than to bare-metal stent (BMS) implantation. Several factors have been associated with very late stent thrombosis after DES implantation, such as delayed healing, inflammation, stent mal-apposition and endothelial dysfunction. Some of these adverse events were associated with the presence of durable polymers, which were essential to allow the elution of the immunosuppressive drug in the first DES designs. The introduction of erodable polymers in DES technology has provided the potential to complete the degradation of the polymer simultaneously or immediately after the release of the immunosuppressive drug, after which a BMS remains in place. Several DES designs with biodegradable (BIO) polymers have been introduced in preclinical and clinical studies, including randomized trials. In this review, we analyze the clinical results from 6 observational and randomized studies with BIO polymers and discuss advantages and disadvantages of this new technology.

  15. The effect of stent coating on stent deliverability: direct randomised comparison of drug eluting and bare metal stents using the same stent platform.

    Science.gov (United States)

    Siminiak, Tomasz; Link, Rafał; Wołoszyn, Maciej; Kałmucki, Piotr; Baszko, Artur

    2012-01-01

    There is certain experimental and clinical evidence indicating that the covering of bare metal stents (BMS) with drug eluting polymers to produce drug eluting stents (DES) results in increased stent stiffness and modifies the mechanical properties of the stent platform. In addition, it has been speculated that the mechanical performance of DES, compared to BMS, may be related to the type of polymer used to cover stents. We aimed at evaluating the deliverability of DES with a lactate based biodegradable polymer and BMS in patients with stable coronary artery disease in a prospective randomised study. One hundred eleven consecutive patients (age: 36-77, mean 58.8 years) scheduled for routine angioplasty due to stable coronary disease were randomised to receive BMS (Chopin II(TM), Balton, Poland) or paclitaxel eluting stent (Chopin Luc(TM), Balton, Poland) using the same metal platform. Only patients scheduled for angioplasty using the direct implantation technique of a single stent were randomised. The exclusion criteria included patients 〉 80 years, multivessel disease and reference diameter of the target vessel 〉 3.5 mm. In the BMS group (n = 55; 35 males and 20 females), the mean diameter of implanted stents was 3.09 ± 0.40 and the mean length was 11.37 ± 2.80, whereas in the DES group (n = 56; 34 males and 22 females) the mean stent sizes were 3.02 ± 0.34 and 17.90 ± 7.38 mm, respectively (p 〉 0.05 for length). The groups did not significantly differ regarding the frequency of stent implantation to particular coronary vessels. The direct stenting technique was attempted and failed, leading to the stents' implantation after predilatation in five patients in the BMS group and six patients in the DES group. Failure of stent implantation and subsequent implantation of another stent type was observed in no BMS patients and in one DES patient (NS). Although stent covering with lactate based drug eluting polymer may increase its stiffness, it does not affect

  16. Recent developments in drug eluting devices with tailored interfacial properties.

    Science.gov (United States)

    Sanchez-Rexach, Eva; Meaurio, Emilio; Sarasua, Jose-Ramon

    2017-11-01

    Drug eluting devices have greatly evolved during past years to become fundamental products of great marketing importance in the biomedical field. There is currently a large diversity of highly specialized devices for specific applications, making the development of these devices an exciting field of research. The replacement of the former bare metal devices by devices loaded with drugs allowed the sustained and controlled release of drugs, to achieve the desired local therapeutic concentration of drug. The newer devices have been "engineered" with surfaces containing micro- and nanoscale features in a well-controlled manner, that have shown to significantly affect cellular and subcellular function of various biological systems. For example, the topography can be structured to form an antifouling surface mimicking the defense mechanisms found in nature, like the skin of the shark. In the case of bone implants, well-controlled nanostructured interfaces can promote osteoblast differentiation and matrix production, and enhance short-term and long-term osteointegration. In any case, the goal of current research is to design implants that induce controlled, guided, and rapid healing. This article reviews recent trends in the development of drug eluting devices, as well as recent developments on the micro/nanotechnology scales, and their future challenges. For this purpose medical devices have been divided according to the different systems of the body they are focused to: orthopedic devices, breathing stents, gastrointestinal and urinary systems, devices for cardiovascular diseases, neuronal implants, and wound dressings. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. The study of drug eluting biodegradable intravascular stent with antiproliferation agent-paclitaxel in preventing vascular restenosis

    International Nuclear Information System (INIS)

    Xiao Yueyong; Zhang Jinshan; Cui Fuzhai; Meng Bo

    2004-01-01

    Objective: To define the effect of drug eluting BIS with antiproliferation agent-paclitaxel in preventing vascular restenosis. Methods: Bare BIS and drug BIS with 60 μg paclitaxel were prepared. Both types of the BIS were implanted into the infrarenal restenosis aortas in canine models, and the animals were euthanized 6 weeks after implantation for histopathological, morphometric and immunohistochemical assessment. Results: The mean lumen area of bare BIS group was (77 586.5 ± 66.0) μm 2 , and lumen of paclitaxel eluting BIS group was (113 435.9 ±71.0) μm 2 . The mean neointima area of bare BIS group was (24 803 ± 56) μm 2 , and paclitaxel eluting BIS group was (12 931 ± 63) μm 2 . The PCNA-positive ratio was (38 ± 15)% in bare BIS group and (11 ± 0.31)% in paclitaxel eluting BIS group. The statistically significant difference between the two groups were noted (P<0.01). Conclusion: BIS as a vehicle of loading and releasing drugs could significantly inhibit the VSMC and neointimal hyperplasia with antiproliferation agent-paclitaxel. BIS is a promising and new strategy in preventing the restenosis

  18. In-Stent Restenosis of Drug-Eluting Stents Compared With a Matched Group of Patients With De Novo Coronary Artery Stenosis.

    Science.gov (United States)

    Buchanan, Kyle D; Torguson, Rebecca; Rogers, Toby; Xu, Linzhi; Gai, Jiaxiang; Ben-Dor, Itsik; Suddath, William O; Satler, Lowell F; Waksman, Ron

    2018-03-13

    Drug-eluting stents (DES) significantly reduced the incidence of in-stent restenosis (ISR). However, ISR still exists in the contemporary DES era. Previously deemed to be a benign process, ISR leads to complex presentation and intervention. This study aimed to compare the presentation and outcome of DES-ISR versus de novo lesions. We performed a retrospective analysis of 11,666 patients receiving percutaneous coronary intervention from 2003 to 2017 and divided them into 2 groups by de novo stenosis and ISR. They were matched based on common cardiovascular risk factors at a 4:1 ratio, respectively. After matching, a total of 1,888 patients with 3,126 de novo lesions and 472 patients with 508 ISR lesions were analyzed. Patients with ISR presented more often with unstable angina (61% vs 45%, p stent technique and should motivate the continued development of fully bioresorbable scaffolds. Copyright © 2018 Elsevier Inc. All rights reserved.

  19. Drug-Eluting Balloons in the Treatment of Coronary De Novo Lesions

    DEFF Research Database (Denmark)

    Richelsen, Rasmus Kapalu Broge; Overvad, Thure Filskov; Jensen, Svend Eggert

    2016-01-01

    Drug-eluting balloons (DEBs) have emerged as a new application in percutaneous coronary intervention. DEBs have proven successful in the treatment of in-stent restenosis, but their role in de novo lesions is less clear. This paper provides a review of the current studies where DEBs have been used...

  20. Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis).

    Science.gov (United States)

    Kandzari, David E; Smits, Pieter C; Love, Michael P; Ben-Yehuda, Ori; Banai, Shmuel; Robinson, Simon D; Jonas, Michael; Kornowski, Ran; Bagur, Rodrigo; Iniguez, Andres; Danenberg, Haim; Feldman, Robert; Jauhar, Rajiv; Chandna, Harish; Parikh, Manish; Perlman, Gidon Y; Balcells, Mercedes; Markham, Peter; Ozan, Melek Ozgu; Genereux, Philippe; Edelman, Elazer R; Leon, Martin B; Stone, Gregg W

    2017-10-03

    The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, P noninferiority =0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P =0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm ( P noninferiority =0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively ( P noninferiority =0.01). In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice. URL: http

  1. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial

    DEFF Research Database (Denmark)

    Galløe, Anders M; Thuesen, Leif; Kelbaek, Henning

    2008-01-01

    Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients.......Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients....

  2. Towards Hypoxia-responsive Drug-eluting Embolization Beads.

    Science.gov (United States)

    Ashrafi, Koorosh; Heaysman, Clare L; Phillips, Gary J; Lloyd, Andrew W; Lewis, Andrew L

    2017-05-30

    Drug release from chemoembolization microspheres stimulated by the presence of a chemically reducing environment may provide benefits for targeting drug resistant and metastatic hypoxic tumours. A water-soluble disulfide-based bifunctional cross-linker bis(acryloyl)-(l)-cystine (BALC) was synthesised, characterised and incorporated into a modified poly(vinyl) alcohol (PVA) hydrogel beads at varying concentrations using reverse suspension polymerisation. The beads were characterised to confirm the amount of cross-linker within each formulation and its effects on the bead properties. Elemental and UV/visible spectroscopic analysis confirmed the incorporation of BALC within the beads and sizing studies showed that in the presence of a reducing agent, all bead formulations increased in mean diameter. The BALC beads could be loaded with doxorubicin hydrochloride and amounts in excess of 300mg of drug per mL of hydrated beads could be achieved but required conversion of the carboxylic acid groups of the BALC to their sodium carboxylate salt forms. Elution of doxorubicin from the beads demonstrated a controlled release via ionic exchange. Some formulations exhibited an increase in size and release of drug in the presence of a reducing agent, and therefore demonstrated the ability to respond to an in vitro reducing environment. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  3. General Anaesthesia Protocols for Patients Undergoing Electroconvulsive Therapy

    Science.gov (United States)

    Narayanan, Aravind; Lal, Chandar; Al-Sinawi, Hamed

    2017-01-01

    Objectives This study aimed to review general anaesthesia protocols for patients undergoing electroconvulsive therapy (ECT) at a tertiary care hospital in Oman, particularly with regards to clinical profile, potential drug interactions and patient outcomes. Methods This retrospective study took place at the Sultan Qaboos University Hospital (SQUH), Muscat, Oman. The electronic medical records of patients undergoing ECT at SQUH between January 2010 and December 2014 were reviewed for demographic characteristics and therapy details. Results A total of 504 modified ECT sessions were performed on 57 patients during the study period. All of the patients underwent a uniform general anaesthetic regimen consisting of propofol and succinylcholine; however, they received different doses between sessions, as determined by the treating anaesthesiologist. Variations in drug doses between sessions in the same patient could not be attributed to any particular factor. Self-limiting tachycardia and hypertension were periprocedural complications noted among all patients. One patient developed aspiration pneumonitis (1.8%). Conclusion All patients undergoing ECT received a general anaesthetic regimen including propofol and succinylcholine. However, the interplay of anaesthetic drugs with ECT efficacy could not be established due to a lack of comprehensive data, particularly with respect to seizure duration. In addition, the impact of concurrent antipsychotic therapy on anaesthetic dose and subsequent complications could not be determined. PMID:28417028

  4. Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy.

    Science.gov (United States)

    Kereiakes, Dean J; Yeh, Robert W; Massaro, Joseph M; Driscoll-Shempp, Priscilla; Cutlip, Donald E; Steg, P Gabriel; Gershlick, Anthony H; Darius, Harald; Meredith, Ian T; Ormiston, John; Tanguay, Jean-François; Windecker, Stephan; Garratt, Kirk N; Kandzari, David E; Lee, David P; Simon, Daniel I; Iancu, Adrian Corneliu; Trebacz, Jaroslaw; Mauri, Laura

    2015-10-01

    This study sought to compare rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE) (composite of death, myocardial infarction, or stroke) after coronary stenting with drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who participated in the DAPT (Dual Antiplatelet Therapy) study, an international multicenter randomized trial comparing 30 versus 12 months of dual antiplatelet therapy in subjects undergoing coronary stenting with either DES or BMS. Despite antirestenotic efficacy of coronary DES compared with BMS, the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Many clinicians perceive BMS to be associated with fewer adverse ischemic events and to require shorter-duration dual antiplatelet therapy than DES. Prospective propensity-matched analysis of subjects enrolled into a randomized trial of dual antiplatelet therapy duration was performed. DES- and BMS-treated subjects were propensity-score matched in a many-to-one fashion. The study design was observational for all subjects 0 to 12 months following stenting. A subset of eligible subjects without major ischemic or bleeding events were randomized at 12 months to continued thienopyridine versus placebo; all subjects were followed through 33 months. Among 10,026 propensity-matched subjects, DES-treated subjects (n = 8,308) had a lower rate of stent thrombosis through 33 months compared with BMS-treated subjects (n = 1,718, 1.7% vs. 2.6%; weighted risk difference -1.1%, p = 0.01) and a noninferior rate of MACCE (11.4% vs. 13.2%, respectively, weighted risk difference -1.8%, p = 0.053, noninferiority p stent thrombosis that are lower than BMS-treated subjects. (The Dual Antiplatelet Therapy Study [DAPT study]; NCT00977938). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. Long-Term Follow-up of the PADI Trial : Percutaneous Transluminal Angioplasty Versus Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia

    NARCIS (Netherlands)

    Spreen, Marlon I; Martens, Jasper M; Knippenberg, Bob; van Dijk, Lukas C; De Vries, Jean-Paul P. M.; Vos, Jan Albert; de Borst, Gert Jan; Vonken, Evert-Jan P A; Bijlstra, Okker D; Wever, Jan J; Statius van Eps, Randolph G; Mali, Willem P Th M; van Overhagen, Hendrik

    2017-01-01

    BACKGROUND: Clinical outcomes reported after treatment of infrapopliteal lesions with drug-eluting stents (DESs) have been more favorable compared with percutaneous transluminal angioplasty with a bailout bare metal stent (PTA-BMS) through midterm follow-up in patients with critical limb ischemia.

  6. Functional Nanoarchitectures For Enhanced Drug Eluting Stents

    Science.gov (United States)

    Saleh, Yomna E.; Gepreel, Mohamed A.; Allam, Nageh K.

    2017-01-01

    Different strategies have been investigated to allow for optimum duration and conditions for endothelium healing through the enhancement of coronary stents. In this study, a nanoarchitectured system is proposed as a surface modification for drug eluting stents. Highly oriented nanotubes were vertically grown on the surface of a new Ni-free biocompatible Ti-based alloy, as a potential material for self-expandable stents. The fabricated nanotubes were self-grown from the potential stent substrate, which are also proposed to enhance endothelial proliferation while acting as drug reservoir to hinder Vascular Smooth Muscle Cells (VSMC) proliferation. Two morphologies were synthesized to investigate the effect of structure homogeneity on the intended application. The material was characterized by field-emission scanning electron microscope (FESEM), X-ray diffraction (XRD), Raman spectroscopy, energy dispersive X-ray spectroscopy (EDX), and X-ray photoelectron spectroscopy (XPS). Nanoindentation technique was used to study the mechanical properties of the fabricated material. Cytotoxicity and proliferation studies were performed and compared for the two fabricated nanoarchitectures, versus smooth untextured samples, using in-vitro cultured endothelial cells. Finally, the drug loading capacity was experimentally studied and further supported by computational modeling of the release profile.

  7. Clinical outcomes in low risk coronary artery disease patients treated with different limus-based drug-eluting stents--a nationwide retrospective cohort study using insurance claims database.

    Directory of Open Access Journals (Sweden)

    Chao-Lun Lai

    Full Text Available The clinical outcomes of different limus-based drug-eluting stents (DES in a real-world setting have not been well defined. The aim of this study was to investigate the clinical outcomes of three different limus-based DES, namely sirolimus-eluting stent (SES, Endeavor zotarolimus-eluting stent (E-ZES and everolimus-eluting stent (EES, using a national insurance claims database. We identified all patients who received implantation of single SES, E-ZES or EES between January 1, 2007 and December 31, 2009 from the National Health Insurance claims database, Taiwan. Follow-up was through December 31, 2011 for all selected clinical outcomes. The primary end-point was all-cause mortality. Secondary end-points included acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. Cox regression model adjusting for baseline characteristics was used to compare the relative risks of different outcomes among the three different limus-based DES. Totally, 6584 patients were evaluated (n=2142 for SES, n=3445 for E-ZES, and n=997 for EES. After adjusting for baseline characteristics, we found no statistically significant difference in the risk of all-cause mortality in three DES groups (adjusted hazard ratio [HR]: 1.14, 95% confidence interval [CI]: 0.94-1.38, p=0.20 in E-ZES group compared with SES group; adjusted HR: 0.77, 95% CI: 0.54-1.10, p=0.15 in EES group compared with SES group. Similarly, we found no difference in the three stent groups in risks of acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. In conclusion, we observed no difference in all-cause mortality, acute coronary events, heart failure needing hospitalization, and cerebrovascular disease in patients treated with SES, E-ZES, and EES in a real-world population-based setting in Taiwan.

  8. Switching the Loaded Agent from Epirubicin to Cisplatin: Salvage Transcatheter Arterial Chemoembolization with Drug-eluting Microspheres for Unresectable Hepatocellular Carcinoma

    International Nuclear Information System (INIS)

    Seki, Akihiko; Hori, Shinich

    2012-01-01

    Purpose: There is no consensus on switching anticancer agents loaded onto drug carriers in transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). This study aimed to evaluate the safety and clinical outcomes of TACE with cisplatin-loaded microspheres (CLM-TACE) in HCC patients refractory to TACE with epirubicin-loaded microspheres (ELM-TACE). Methods: Between February 2008 and June 2010, 85 patients with unresectable HCC refractory to ELM-TACE were enrolled to undergo CLM-TACE. The number of ELM-TACE sessions until judgment of resistance ranged from 1 to 4 (median, 2.1). CLM-TACE was performed using 50–100-μm superabsorbent polymer microspheres loaded with 1 mg cisplatin/1 mg microspheres together with hepatic arterial infusion of 25 mg cisplatin and 500 mg 5-fluorouracil per patient. Tumor responses were evaluated by computed tomography according to the European Association for the Study of the Liver criteria. Results: The median number of CLM-TACE treatment sessions was 1.8 (range, 1–5), and the mean total dose of cisplatin per session was 42.8 mg (range, 30.0–59.0). After 6 months, 3 (3.5%) patients achieved complete response, 31 (36.5%) had partial response, 15 (17.6%) had stable disease, and 36 (42.4%) had progressive disease. The median overall survival and time to treatment failure after initial CLM-TACE were 13.3 and 7.2 months, respectively. Overall, 9.4% of patients experienced grade 3/4 adverse events. Conclusions: witching the loaded agent from epirubicin to cisplatin is a safe, well-tolerated, and efficacious treatment strategy for salvage TACE with drug-eluting microspheres in HCC patients refractory to ELM-TACE.

  9. Risk factors for impaired health status differ in women and men treated with percutaneous coronary intervention in the drug-eluting stent era

    DEFF Research Database (Denmark)

    Pedersen, Susanne S.; Ong, Andrew T L; Lemos, Pedro A

    2006-01-01

    In patients treated with percutaneous coronary intervention (PCI) in the drug-eluting stent era, we compared women's and men's health status 6 and 12 months post-PCI and investigated whether predictors of poor health status at 12 months are similar for women and men....

  10. Mechanisms of Very Late Drug-Eluting Stent Thrombosis Assessed by Optical Coherence Tomography

    DEFF Research Database (Denmark)

    Taniwaki, Masanori; Radu, Maria D; Zaugg, Serge

    2016-01-01

    BACKGROUND: The pathomechanisms underlying very late stent thrombosis (VLST) after implantation of drug-eluting stents (DES) are incompletely understood. Using optical coherence tomography, we investigated potential causes of this adverse event. METHODS AND RESULTS: Between August 2010 and Decemb...

  11. Drug-eluting stents versus bare-metal stents for acute coronary syndrome

    DEFF Research Database (Denmark)

    Feinberg, Joshua; Nielsen, Emil Eik; Greenhalgh, Janette

    2017-01-01

    -EXPANDED, and BIOSIS from their inception to January 2017. We also searched two clinical trials registers, the European Medicines Agency and the US Food and Drug Administration databases, and pharmaceutical company websites. In addition, we searched the reference lists of review articles and relevant trials. SELECTION...... CRITERIA: Randomised clinical trials assessing the effects of drug-eluting stents versus bare-metal stents for acute coronary syndrome. We included trials irrespective of publication type, status, date, or language. DATA COLLECTION AND ANALYSIS: We followed our published protocol and the methodological...

  12. Progress in the study of drug-eluting intra-stent thrombosis

    International Nuclear Information System (INIS)

    Guo Zhifu; Zheng Xing; Qin Yongwen

    2007-01-01

    Durg-eluting stent has been regarded as the milestone in the history of PCI for their efficiency in the prevention of coronary arterial restenosis after percutaneous coronary intervention. But unfortunately intra-stent thrombosis continues to be a serious complication of contemporary DES use. The incidence of drug-eluting stents thrombosis is at least not lower than that of bare metal stents at present. The clinical consequences of stent thrombosis are frequently catastrophic, including death in 40% to 50% of the cases or major myocardial infarction in 60% to 70%. Premature discontinuation of standard antiplatelet therapy is by far the most important predictor of stent thrombosis with DES and other predictors included renal failure, diabetes, bifurcation lesions, multiple lesions or multivessel disease, long stents, female, advanced age, stent underexpansion and residual stenosis etc. The delayed endothelialization may be the underling mechanism of DES thrombosis. (authors)

  13. Drug diffusion and biological responses of arteries using a drug-eluting stent with nonuniform coating

    Directory of Open Access Journals (Sweden)

    Saito N

    2016-03-01

    Full Text Available Noboru Saito, Yuhei Mori, Sayaka Uchiyama Terumo Corporation R&D Center, Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan Abstract: The purpose of this study was to determine the effect of a nonuniform coating, abluminal-gradient coating (AGC, which leaves the abluminal surface of the curves and links parts of the stent free from the drug coating, on the diffusion direction of the drug and the biological responses of the artery to drug-eluting stent (DES by comparing the AGC-sirolimus stent and the conventional full-surface coating (CFC sirolimus stent. The study aimed to verify whether the AGC approach was appropriate for the development of a safer DES, minimizing the risks of stent thrombosis due to delayed endothelialization by the drug and distal embolization due to cracking of the coating layer on the hinge parts of the DES on stent expansion. In the in vitro local drug diffusion study, we used rhodamine B as a model drug, and rhodamine B released from the AGC stent diffused predominantly into the abluminal side of the alginate artery model. Conversely, rhodamine B released from the CFC stent quickly spread to the luminal side of the artery model, where endothelial cell regeneration is required. In the biological responses study, the luminal surface of the iliac artery implanted with the AGC-sirolimus stent in a rabbit iliac artery for 2 weeks was completely covered with endothelial-like cells. On the other hand, the luminal surface of the iliac artery implanted with the CFC-sirolimus stent for 2 weeks only showed partial coverage with endothelial-like cells. While thrombosis was observed in two of the three CFC-sirolimus stents, it was observed in only one of the three AGC-sirolimus stents. Taken together, these findings indicate that the designed nonuniform coating (AGC is an appropriate approach to ensure a safer DES. However, the number of studies is limited and a larger study should be conducted to reach a statistically

  14. Study design of the influence of SErotonin inhibition on patients with RENAl impairment or diabetes undergoing drug-eluting stent implantation (SERENADE) study: A multicenter, open-label, prospective, randomized study.

    Science.gov (United States)

    Lee, Seung-Ah; Suh, Jung-Won; Park, Jin Joo; Yoon, Chang-Hwan; Cho, Young-Suk; Youn, Tae-Jin; Chae, In-Ho; Kim, Hyo-Soo; Kim, Sang-Hyun; Choi, Dong-Ju

    2015-07-01

    The rates of stent failure after percutaneous coronary intervention have decreased since the introduction of the drug-eluting stent (DES). However, chronic kidney disease (CKD) and diabetes mellitus (DM) remain strong clinical predictors of poor prognosis despite DES implantation. Sarpogrelate, a selective serotonin (5-hydroxytryptamine (HT)2a [5-HT2A]) receptor antagonist, has antiproliferative effects, reducing neointimal hyperplasia and smooth muscle cell proliferation, as well as potent antiplatelet action, inhibiting 5-HT-induced platelet aggregation. However, efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aim to determine whether sarpogrelate has beneficial effects in patients with CDK or DM treated with DES implantation. The SERENADE trial is a multicenter, open-label, prospective, randomized study that will test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel, and sarpogrelate) to conventional dual antiplatelet therapy (DAT; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with CKD or DM. A total of 220 patients diagnosed with coronary artery disease with DM or CKD will be randomized to the TAT or DAT groups (1:1 ratio) after DES implantation. The primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography. Secondary efficacy endpoints are composites of major adverse cardiovascular events including cardiac death, nonfatal myocardial infarction, and target lesion revascularization. Secondary safety endpoints are major bleeding events and hepatic or renal impairment. The SERENADE trial will provide insight on the efficacy of adjunctive therapy with sarpogrelate after DES implantation for patients with high-risk profiles such as CKD or DM. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov NCT02294643). Copyright © 2015. Published by Elsevier Inc.

  15. The Impact of Prediabetes on Two-Year Clinical Outcomes in Patients Undergoing Elective Percutaneous Coronary Intervention.

    Science.gov (United States)

    Choi, Woong Gil; Rha, Seung Woon; Choi, Byoung Geol; Choi, Se Yeon; Byun, Jae Kyeong; Mashaly, Ahmed; Park, Yoonjee; Jang, Won Young; Kim, Woohyeun; Choi, Jah Yeon; Park, Eun Jin; Na, Jin Oh; Choi, Cheol Ung; Kim, Eung Ju; Park, Chang Gyu; Seo, Hong Seog

    2018-06-01

    Prediabetes is an independent risk factor for cardiovascular disease. However, data on the long term adverse clinical outcomes of prediabetic patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) are scarce. The study population comprised 674 consecutive non-diabetic patients who underwent elective PCI between April 2007 and November 2010. Prediabetes was defined as hemoglobin A1c (HbA1c) of 5.7% to 6.4%. Two-year cumulative clinical outcomes of prediabetic patients (HbA1c of 5.7% to 6.4%, n=242) were compared with those of a normoglycemic group (prediabetes group. There was no significant difference between the two groups in coronary angiographic parameters, except for a higher incidence of diffuse long lesion in the prediabetes group. For prediabetic patients, trends toward higher incidences of binary restenosis (15.6% vs. 9.8 %, p=0.066) and late loss (0.71±0.70 mm vs. 0.59±0.62 mm, p=0.076) were noted. During the 24 months of follow up, the incidence of mortality in prediabetic patients was higher than that in normoglycemic patients (5.5% vs. 1.5%, p=0.007). In our study, a higher death rate and a trend toward a higher incidence of restenosis in patients with prediabetes up to 2 years, compared to those in normoglycemic patients, undergoing elective PCI with contemporary DESs. © Copyright: Yonsei University College of Medicine 2018.

  16. Assessment of the use of oral fluid as a matrix for drug monitoring in patients undergoing treatment for opioid addiction.

    Science.gov (United States)

    Kunkel, Frank; Fey, Elizabeth; Borg, Damon; Stripp, Richard; Getto, Christine

    2015-01-01

    Drug testing is an important clinical tool that is available to physicians who are assessing the effectiveness of drug treatment as well as patient compliance to the administered program. While urine has traditionally been the matrix of choice for drug monitoring, oral fluid, a filtrate of the blood, has shown great promise as an alternative matrix for such applications. Oral fluid collection can be accomplished without the need for highly trained medical staff through the use of a simple, noninvasive oral fluid collection device, which obtains an adequate sample in only a few minutes. There has been a significant amount of research performed on the use of oral fluid for forensic toxicology application; however, more studies assessing the use of oral fluid drug testing are required to validate its ability to achieve clinical drug monitoring goals. Testing for various drugs in oral fluid may yield a different result when compared to the same drugs in urine, requiring an assessment of the utility of oral fluid for such practices. The purpose of this study was to examine the application of oral fluid drug testing in patients undergoing buprenorphine treatment for opioid dependence. A retrospective analysis of drug testing results obtained from 6,928 patients (4,560 unobserved urine collections and 2,368 observed oral fluid collections) monitored for heroin metabolite, amphetamine, benzodiazepines, buprenorphine, tetrahydrocannabinol, cocaine, codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, and oxymorphone was completed. Results of this statistical exercise indicated that patients undergoing observed oral fluid collection tested positive more frequently than those unobserved urine collections for several illicit drugs and prescription medications targeted. Oral fluid was shown to detect illicit drug use as well as noncompliance in this patient population under the studied conditions more often than the urine specimens.

  17. Pioglitazone Attenuates Drug-Eluting Stent-Induced Proinflammatory State in Patients by Blocking Ubiquitination of PPAR

    Directory of Open Access Journals (Sweden)

    Zhongxia Wang

    2016-01-01

    Full Text Available The inflammatory response after polymer-based drug-eluting stent (DES placement has recently emerged as a major concern. The biologic roles of peroxisome proliferator-activated receptor-γ (PPAR-γ activators thiazolidinedione (TZD remain controversial in cardiovascular disease. Herein, we investigated the antiinflammatory effects of pioglitazone (PIO on circulating peripheral blood mononuclear cells (MNCs in patients after coronary DES implantation. Methods and Results. Twenty-eight patients with coronary artery disease and who underwent DES implantations were randomly assigned to pioglitazone (30 mg/d; PIO or placebo (control; Con treatment in addition to optimal standard therapy. After 12 weeks of treatment, plasma concentrations of high-sensitivity C-reactive protein (hs-CRP, interleukin-6 (IL-6, tumor necrosis factor-α (TNF-α, and matrix metalloproteinase-9 (MMP-9 were significantly decreased in PIO group compared to the Con group (P=0.035, 0.011, 0.008, and 0.012, resp.. DES-induced mRNA expressions of IL-6, TNF-α, and MMP-9 in circulating MNC were significantly blocked by PIO (P=0.031, 0.012, and 0.007, resp.. In addition, PIO markedly inhibited DES-enhanced NF-κB function and DES-blocked PPAR-γ activity. Mechanically, DES induced PPAR-γ ubiquitination and degradation in protein level, which can be totally reversed by PIO. Conclusion. PIO treatment attenuated DES-induced PPAR loss, NF-κB activation, and proinflammation, indicating that PIO may have a novel direct protective role in modulating proinflammation in DES era.

  18. The Role Of Inflammation In Stent Restenosis More Than 1 Year Afetr Drug Eluting Stent Implantation

    Directory of Open Access Journals (Sweden)

    Hasan Shemirani

    2011-09-01

    Full Text Available Background: In stent restenosis (ISR following endovascular interventions is the main limitation of their long-term success. Despite advances have been made during recent years to decrease restenosis, it remains a challenging clinical problem.The aim of this study was to evaluate the relationship between angiographic coronary in stent restenosis, inflammation after successful stent implantation. Methods: This study included 78 patients, 35year old and higher who underwent coronary angiography more than 1 year after drug-eluting stent (DES implantation because of symptoms suggestive ischemia. Patients were divided into ISR group (case and patent stent group (control according to angiography results. For all patients blood lipids and high sensitivity C-Reactive Protein (hsCRP were measured simultaneously. Results: Age, sex, hypertension, current smoking, and lipid profile other than High Density Lipoprotein (HDL-C of patients in the case and control groups were similar .However, HDL-C < 40mg/L was more prevalent with ISR (66.7% vs. 30.8%, p=0.002. The hsCRP level was 2.98±2.06 mg/L in the case group and 2.50±1.80 mg/L in the control group. There were no significant differences in mean hsCRP concentration between the two groups (p=0.14, however mean hsCRP level was significantly higher in men of case group than control group (3.35mg/L vs. 2.21mg/L, p<0.05. Conclusion: This study demonstrates that in men but not in women inflammation may be a predictor of in stent restenosis more than 1 year after drug eluting stent implantation. Also, high-density lipoprotein (HDL probably has protective effect against stent restenosis.

  19. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial.

    Science.gov (United States)

    de Winter, Robbert J; Katagiri, Yuki; Asano, Taku; Milewski, Krzysztof P; Lurz, Philipp; Buszman, Pawel; Jessurun, Gillian A J; Koch, Karel T; Troquay, Roland P T; Hamer, Bas J B; Ophuis, Ton Oude; Wöhrle, Jochen; Wyderka, Rafał; Cayla, Guillaume; Hofma, Sjoerd H; Levesque, Sébastien; Żurakowski, Aleksander; Fischer, Dieter; Kośmider, Maciej; Goube, Pascal; Arkenbout, E Karin; Noutsias, Michel; Ferrari, Markus W; Onuma, Yoshinobu; Wijns, William; Serruys, Patrick W

    2018-02-03

    MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45

  20. Impact of Clinical Presentation (Stable Angina Pectoris vs Unstable Angina Pectoris or Non-ST-Elevation Myocardial Infarction vs ST-Elevation Myocardial Infarction) on Long-Term Outcomes in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents.

    Science.gov (United States)

    Giustino, Gennaro; Baber, Usman; Stefanini, Giulio Giuseppe; Aquino, Melissa; Stone, Gregg W; Sartori, Samantha; Steg, Philippe Gabriel; Wijns, William; Smits, Pieter C; Jeger, Raban V; Leon, Martin B; Windecker, Stephan; Serruys, Patrick W; Morice, Marie-Claude; Camenzind, Edoardo; Weisz, Giora; Kandzari, David; Dangas, George D; Mastoris, Ioannis; Von Birgelen, Clemens; Galatius, Soren; Kimura, Takeshi; Mikhail, Ghada; Itchhaporia, Dipti; Mehta, Laxmi; Ortega, Rebecca; Kim, Hyo-Soo; Valgimigli, Marco; Kastrati, Adnan; Chieffo, Alaide; Mehran, Roxana

    2015-09-15

    The long-term risk associated with different coronary artery disease (CAD) presentations in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is poorly characterized. We pooled patient-level data for women enrolled in 26 randomized clinical trials. Of 11,577 women included in the pooled database, 10,133 with known clinical presentation received a DES. Of them, 5,760 (57%) had stable angina pectoris (SAP), 3,594 (35%) had unstable angina pectoris (UAP) or non-ST-segment-elevation myocardial infarction (NSTEMI), and 779 (8%) had ST-segment-elevation myocardial infarction (STEMI) as clinical presentation. A stepwise increase in 3-year crude cumulative mortality was observed in the transition from SAP to STEMI (4.9% vs 6.1% vs 9.4%; p clinical presentations. After multivariable adjustment, STEMI was independently associated with greater risk of 3-year mortality (hazard ratio [HR] 3.45; 95% confidence interval [CI] 1.99 to 5.98; p clinical spectrum of CAD, STEMI was associated with a greater risk of long-term mortality. Conversely, the adjusted risk of mortality between UAP or NSTEMI and SAP was similar. New-generation DESs provide improved long-term clinical outcomes irrespective of the clinical presentation in women. Published by Elsevier Inc.

  1. Liver and biliary damages following transarterial chemoembolization of hepatocellular carcinoma: comparison between drug-eluting beads and lipiodol emulsion

    Energy Technology Data Exchange (ETDEWEB)

    Monier, Arnaud; Duran, Rafael; Bize, Pierre; Dunet, Vincent; Denys, Alban [Lausanne University Hospital, Department of Diagnostic and Interventional Radiology, Lausanne (Switzerland); Guiu, Boris [Lausanne University Hospital, Department of Diagnostic and Interventional Radiology, Lausanne (Switzerland); Montpellier University Hospital, Department of Diagnostic and Interventional Radiology, Montpellier (France); Aho, Serge [University Hospital, Department of Epidemiology, Dijon (France); Deltenre, Pierre [Lausanne University Hospital, Department of Gastroenterology, Lausanne (Switzerland)

    2017-04-15

    To compare transarterial chemoembolization (TACE)-related hepatic toxicities of conventional TACE (cTACE) and drug-eluting beads TACE (DEB-TACE) in patients with intermediate-stage hepatocellular carcinoma. In this retrospective study, 151 consecutive patients undergoing cTACE or DEB-TACE and MRI 3-6 weeks before and after therapy were included. Toxicity was assessed on imaging (global hepatic damages (GHD), overall biliary injuries, biliary cast, bile duct dilatation, intrahepatic biloma, portal thrombosis), and clinico-biological follow-ups. Tumour response, time to progression (TTP), and overall survival were assessed. Factors influencing complication rate were identified by generalized equation logistic regression model. Biliary injuries and intrahepatic biloma incidence were significantly higher following DEB-TACE (p < 0.001). DEB-TACE showed a significant increased risk of GHD (OR: 3.13 [1.74-5.63], p < 0.001) and biliary injuries (OR: 4.53 [2.37-8.67], p < 0.001). A significant relationship was found between baseline prothrombin value and GHD, biliary injuries and intrahepatic biloma (all p < 0.01), and between the dose of chemotherapy and intrahepatic biloma (p = 0.001). Only TTP was significantly shorter following DEB-TACE compared to cTACE (p = 0.025). DEB-TACE was associated with increased hepatic toxicities compared to cTACE. GHD, biliary injuries, and intrahepatic biloma were more frequently observed with high baseline prothrombin value, suggesting that cTACE might be more appropriate than DEB-TACE in patients with less advanced cirrhosis. (orig.)

  2. The Relationship Between Neutrophil–Lymphocyte Ratio and Primary Patency of Percutaneous Transluminal Angioplasty in Hemodialysis Arteriovenous Fistula Stenosis When Using Conventional and Drug-Eluting Balloons

    Energy Technology Data Exchange (ETDEWEB)

    Çildağ, Mehmet Burak, E-mail: mbcildag@yahoo.com [Adnan Menderes University, Department of Diagnostic and Interventional Radiology (Turkey); Çildağ, Songül, E-mail: songulcildag@yahoo.com [Adnan Menderes University, Department of Immunology and Allergy (Turkey); Köseoğlu, Ömer Faruk Kutsi, E-mail: kutsikoseoglu@yahoo.com [Adnan Menderes University, Department of Diagnostic and Interventional Radiology (Turkey)

    2016-12-15

    ObjectiveThe aim of this study is to investigate the potential association of neutrophil–lymphocyte ratio (NLR) between primary patency of percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistula stenosis and type (Conventional and Drug-Eluting) of balloons used in PTA.Material-MethodThis retrospective study consists of 78 patients with significant arteriovenous fistulas stenosis who were treated with PTA by using Drug-Eluting Balloon (DEB) (n = 29) or Conventional Balloon (CB) (n = 49). NLR was calculated from preinterventional blood samples. All patients were classified into two groups. Group A; primary patency <12 months (43/78), Group B; primary patency ≥12 months (35/78). Cox regression analysis and Kaplan–Meier method were used to determine respectively independent factors affecting the primary patency and to compare the primary patency for the two balloon types.ResultsNLR ratio and balloon type of the two groups were significantly different (p = 0.002, p = 0.010). The cut-off value of NLR was 3.18 for determination of primary patency, with sensitivity of 81.4 % and specificity of 51.4 %. Primary patency rates between PTA with DEB and CB displayed statistically significant differences (p < 0.05). The cut-off value was 3.28 for determination of 12-month primary patency with the conventional balloon group; sensitivity was 81.8 % and specificity was 81.3 %. There was no statistical relation between NLR levels and the drug-eluting balloon group in 12-month primary patency (p = 0.927).ConclusionIncreased level of NLR may be a risk factor in the development of early AVF restenosis after successful PTA. Preferring Drug-Eluting Balloon at an increased level of NLR can be beneficial to prolong patency.

  3. Improved two-year outcomes after drug-eluting versus bare-metal stent implantation in women and men with large coronary arteries

    DEFF Research Database (Denmark)

    Hansen, K W; Kaiser, C; Hvelplund, A

    2013-01-01

    To investigate the importance of vessel size on outcome differences by comparing the effects of drug-eluting stents (DES) versus bare-metal stents (BMS) in women and men with large coronary vessels.......To investigate the importance of vessel size on outcome differences by comparing the effects of drug-eluting stents (DES) versus bare-metal stents (BMS) in women and men with large coronary vessels....

  4. In vitro haematic proteins adsorption and cytocompatibility study on acrylic copolymer to realise coatings for drug-eluting stents

    International Nuclear Information System (INIS)

    Gagliardi, Mariacristina

    2012-01-01

    In the present paper, a preliminary in vitro analysis of biocompatibility of newly-synthesised acrylic copolymers is reported. In particular, with the aim to obtain coatings for drug-eluting stents, blood protein absorption and cytocompatibility were studied. For protein absorption tests, bovine serum albumin and bovine plasma fibrinogen were considered. Cytocompatibility was tested using C2C12 cell line as model, analysing the behaviour of polymeric matrices and of drug-eluting systems, obtained loading polymeric matrices with paclitaxel, an anti-mitotic drug, in order to evaluate the efficacy of a pharmacological treatment locally administered from these materials. Results showed that the amount of albumin absorbed was greater than the amount of fibrinogen (comprised in the range of 70%–85% and 10%–22% respectively) and it is a good behaviour in terms of haemocompatibility. Cell culture tests showed good adhesion properties and a relative poor proliferation. In addition, a strong effect related to drug elution and a correlation with the macromolecular composition were detected. In this preliminary analysis, tested materials showed good characteristics and can be considered possible candidates to obtain coatings for drug-eluting stents. Highlights: ► Preliminary evaluation of haemo- and cytocompatibility of newly-synthesised acrylic copolymers ► Materials adsorb higher amounts of albumin and with a faster rate than fibrinogen. ► Protein adsorption depended on the macromolecular composition and surface properties. ► Cell viability on pure samples and efficacy of paclitaxel release were verified in C2C12 cultures.

  5. In vitro haematic proteins adsorption and cytocompatibility study on acrylic copolymer to realise coatings for drug-eluting stents

    Energy Technology Data Exchange (ETDEWEB)

    Gagliardi, Mariacristina, E-mail: mariacristina.gagliardi@iit.it

    2012-12-01

    In the present paper, a preliminary in vitro analysis of biocompatibility of newly-synthesised acrylic copolymers is reported. In particular, with the aim to obtain coatings for drug-eluting stents, blood protein absorption and cytocompatibility were studied. For protein absorption tests, bovine serum albumin and bovine plasma fibrinogen were considered. Cytocompatibility was tested using C2C12 cell line as model, analysing the behaviour of polymeric matrices and of drug-eluting systems, obtained loading polymeric matrices with paclitaxel, an anti-mitotic drug, in order to evaluate the efficacy of a pharmacological treatment locally administered from these materials. Results showed that the amount of albumin absorbed was greater than the amount of fibrinogen (comprised in the range of 70%-85% and 10%-22% respectively) and it is a good behaviour in terms of haemocompatibility. Cell culture tests showed good adhesion properties and a relative poor proliferation. In addition, a strong effect related to drug elution and a correlation with the macromolecular composition were detected. In this preliminary analysis, tested materials showed good characteristics and can be considered possible candidates to obtain coatings for drug-eluting stents. Highlights: Black-Right-Pointing-Pointer Preliminary evaluation of haemo- and cytocompatibility of newly-synthesised acrylic copolymers Black-Right-Pointing-Pointer Materials adsorb higher amounts of albumin and with a faster rate than fibrinogen. Black-Right-Pointing-Pointer Protein adsorption depended on the macromolecular composition and surface properties. Black-Right-Pointing-Pointer Cell viability on pure samples and efficacy of paclitaxel release were verified in C2C12 cultures.

  6. Differentiated analysis of an everolimus-eluting stent and a paclitaxel-eluting stent among higher risk subgroups for restenosis: results from the SPIRIT II trial.

    Science.gov (United States)

    Khattab, Ahmed A; Richardt, Gert; Verin, Vitali; Kelbaek, Henning; Macaya, Carlos; Berland, Jacques; Miquel-Hebert, Karine; Dorange, Cécile; Serruys, Patrick W

    2008-03-01

    Restenosis is higher among certain subpopulations when subjected to percutaneous coronary interventions even when using drug-eluting stents. The randomised SPIRIT II trial demonstrated the superiority of the XIENCE V Everolimus Eluting Coronary Stent System over the TAXUS Paclitaxel-Eluting Stent System in terms of in-stent late loss at six months among 300 patients treated for de novo native coronary artery lesions. In this post-hoc analysis of SPIRIT II we focused on six-month angiographic outcomes of diabetic patients (n=69), left anterior descending arteries (n=149), long lesions >20 mm (n=43), small vessels B2 and C lesions (n=233). In-stent late loss was consistently less among all subgroups when treated by everolimus-eluting stents compared to paclitaxel-eluting stents: diabetics 0.15+/-0.26 mm versus 0.39+/-0.34 mm, p=0.006; LAD 0.12+/-0.23 mm versus 0.44+/-0.37 mm, pB2/C lesions 0.12+/-0.31 mm versus 0.36+/-0.36 mm, pSPIRIT II trial population.

  7. Drug-eluting stents with biodegradable polymer for the treatment of patients with diabetes mellitus: clinical outcome at 2 years in a large population of patients

    Directory of Open Access Journals (Sweden)

    Wiemer M

    2015-02-01

    Full Text Available Marcus Wiemer,1 Gian Battista Danzi,2 Nick West,3 Vassilios Voudris,4 René Koning,5 Stefan Hoffmann,6 Mario Lombardi,7 Josepa Mauri,8 Rade Babic,9 Fraser Witherow10On behalf of the NOBORI 2 Investigators 1Department of Cardiology, Heart and Diabetes Center North Rhine–Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany; 2Ospedale Maggiore Policlinico, Milan, Italy; 3Papworth Hospital, Cambridge, UK; 4Onassis Cardiac Surgery Center, Athens, Greece; 5Clinique Saint Hilaire, Rouen, France; 6Vivantes Netzwerk für Gesundheit GmbH, Berlin, Germany; 7Azienda Ospedaliera Villa Sofia, Palermo, Italy; 8Hospital Universitari Germans Trias i Pujol, Badalona, Spain; 9Institute for Cardiovascular Diseases Dedinje, Belgrade, Serbia; 10Dorset County Hospital, Dorchester, UK Objective: This study investigates the safety and efficacy of a third-generation drug-eluting stent (DES with biodegradable polymer in the complex patient population of diabetes mellitus (DM. Clinical trial registration: ISRCTN81649913. Background: Percutaneous coronary interventions in patients with DM are associated with a higher incidence of death, restenosis, and stent thrombosis as compared to non-diabetic patients. The use of a DES has been shown to improve outcomes in diabetic patients. Methods: Out of 3,067 patients, enrolled in 126 centers worldwide in the NOBORI 2 registry, 888 patients suffered from DM, 213 of them (14% being insulin-dependent DM (IDDM. Two years’ follow-up has been completed in this study. Results: At 1- and 2-year follow-up, 97% and 95% of the patients, respectively, were available. The reported target lesion failure (TLF rates at 1- and 2-year follow-up were 6.0% and 7.2% in the DM group, respectively, and 3.0% and 4.2% in the non-DM group, respectively (P<0.001 for both years. Inside the DM group, the TLF rates of 9.9% and 11.7% at the 1- and 2-year follow-ups, respectively, in patients with IDDM were significantly higher than the TLF rates of 4

  8. Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents

    DEFF Research Database (Denmark)

    Baber, Usman; Giustino, Gennaro; Sartori, Samantha

    2016-01-01

    with chronic kidney disease (CKD). BACKGROUND: The prevalence and effect of CKD in women undergoing PCI with DES is unclear. METHODS: We pooled patient-level data for women enrolled in 26 randomized trials. The study population was categorized by creatinine clearance (CrCl)

  9. The OCT-ORION Study: A Randomized Optical Coherence Tomography Study Comparing Resolute Integrity to Biomatrix Drug-Eluting Stent on the Degree of Early Stent Healing and Late Lumen Loss.

    Science.gov (United States)

    Lee, Stephen W L; Tam, Frankie C C; Lam, Simon C C; Kong, Shun-Ling; Shea, Catherine P; Chan, Kelvin K W; Wong, Michael K L; Chan, Michael P H; Wong, Anthony Y T; Yung, Arthur S Y; Lam, Yui-Ming; Zhang, Lei-Wei; Wu, Karl K Y; Mintz, Gary S; Maehara, Akiko

    2018-04-01

    Durable polymers used in drug-eluting stents are considered a potential cause of hypersensitivity inflammatory response adversely affecting stent healing. Using a sequential follow-up with optical coherence tomography, we compared the differences in healing profiles of 2 drug-eluting stents with a biodegradable or durable polymer. Sixty patients with multivessel disease were prospectively enrolled to receive both study stents, which were randomly assigned to 2 individual vessels, a Resolute Integrity zotarolimus-eluting stent with a durable BioLinx polymer and a BioMatrix NeoFlex Biolimus A9-eluting stent with a biodegradable polylactic acid polymer. Optical coherence tomography was performed at baseline, then in 5 randomly assigned monthly groups at 2 to 6 months, and at 9 months in all patients. The primary end point was the difference in optical coherence tomography strut coverage at 9 months. Key secondary end points included angiographic late lumen loss and composite major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization, and definite or probable stent thrombosis) at 9 months. Resolute Integrity zotarolimus-eluting stent showed significantly better strut coverage than BioMatrix NeoFlex Biolimus A9-eluting stent at 2 to 6 months ( P <0.001) and less variance of percent coverage at 9 months, 99.7% (interquartile range, 99.1-100) versus 99.6% (interquartile range, 96.8-99.9; difference, 0.10; 95% confidence interval, 0.00-1.05; P <0.001). No significant difference was observed in major adverse cardiac events or angiographic end points. Despite having a durable polymer, Resolute Integrity zotarolimus-eluting stent exhibited better strut coverage than BioMatrix NeoFlex Biolimus A9-eluting stent having a biodegradable polymer; both showed similar antiproliferative efficacy. This novel, longitudinal, sequential optical coherence tomography protocol using each patient as own control could achieve conclusive results in small

  10. Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Kaltoft, Anne

    2007-01-01

    OBJECTIVES: The aim of the study was to examine outcomes subsequent to implantation of drug-eluting stents (DES) and bare-metal stents (BMS). BACKGROUND: Use of DES might be associated with increased risk of stent thrombosis (ST), myocardial infarction (MI), and death. METHODS: From January 2002...... through June 2005, data from all percutaneous coronary interventions in western Denmark were prospectively recorded in the Western Denmark Heart Registry; 12,395 consecutive patients (17,152 lesions) treated with stent implantation were followed for 15 months. Data on death and MI were ascertained from...... within 15 months after implantation of DES seems unlikely to outweigh the benefit of these stents. Udgivelsesdato: 2007-Jul-31...

  11. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial.

    Science.gov (United States)

    Serruys, Patrick W; Farooq, Vasim; Kalesan, Bindu; de Vries, Ton; Buszman, Pawel; Linke, Axel; Ischinger, Thomas; Klauss, Volker; Eberli, Franz; Wijns, William; Morice, Marie Claude; Di Mario, Carlo; Corti, Roberto; Antoni, Diethmar; Sohn, Hae Y; Eerdmans, Pedro; Rademaker-Havinga, Tessa; van Es, Gerrit-Anne; Meier, Bernhard; Jüni, Peter; Windecker, Stephan

    2013-08-01

    This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority 1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  12. Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results.

    Science.gov (United States)

    Lammer, Johannes; Bosiers, Marc; Deloose, Koen; Schmidt, Andrej; Zeller, Thomas; Wolf, Florian; Lansink, Wouter; Sauguet, Antoine; Vermassen, Frank; Lauwers, Geert; Scheinert, Dierk; Popma, Jeffrey J; McGreevy, Robert; Rapoza, Richard; Schwartz, Lewis B; Jaff, Michael R

    2016-06-13

    This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA). Drug-eluting BVS has shown promise in coronary arteries. The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication. Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet. The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  13. The sirolimus-eluting Cypher Select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis: insights from the e-SELECT (Multicenter Post-Market Surveillance) registry.

    Science.gov (United States)

    Abizaid, Alexandre; Costa, J Ribamar; Banning, Adrian; Bartorelli, Antonio L; Dzavik, Vladimir; Ellis, Stephen; Gao, Runlin; Holmes, David R; Jeong, Muyng Ho; Legrand, Victor; Neumann, Franz-Josef; Nyakern, Maria; Orlick, Amy; Spaulding, Christian; Worthley, Stephen; Urban, Philip M

    2012-01-01

    This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients. There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR. The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year. Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively). Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  14. Bioresorbable polymer coated drug eluting stent: a model study.

    Science.gov (United States)

    Rossi, Filippo; Casalini, Tommaso; Raffa, Edoardo; Masi, Maurizio; Perale, Giuseppe

    2012-07-02

    In drug eluting stent technologies, an increased demand for better control, higher reliability, and enhanced performances of drug delivery systems emerged in the last years and thus offered the opportunity to introduce model-based approaches aimed to overcome the remarkable limits of trial-and-error methods. In this context a mathematical model was studied, based on detailed conservation equations and taking into account the main physical-chemical mechanisms involved in polymeric coating degradation, drug release, and restenosis inhibition. It allowed highlighting the interdependence between factors affecting each of these phenomena and, in particular, the influence of stent design parameters on drug antirestenotic efficacy. Therefore, the here-proposed model is aimed to simulate the diffusional release, for both in vitro and the in vivo conditions: results were verified against various literature data, confirming the reliability of the parameter estimation procedure. The hierarchical structure of this model also allows easily modifying the set of equations describing restenosis evolution to enhance model reliability and taking advantage of the deep understanding of physiological mechanisms governing the different stages of smooth muscle cell growth and proliferation. In addition, thanks to its simplicity and to the very low system requirements and central processing unit (CPU) time, our model allows obtaining immediate views of system behavior.

  15. A SINGLE-COLUMN PROCEDURE ON BOND ELUT CERTIFY FOR SYSTEMATIC TOXICOLOGICAL ANALYSIS OF DRUGS IN PLASMA AND URINE

    NARCIS (Netherlands)

    CHEN, XH; WIJSBEEK, J; FRANKE, JP; DEZEEUW, RA

    A single-column solid-phase extraction procedure was developed for the screening of acidic, neutral, and basic drugs from plasma. The recoveries of all 25 tested drugs exceeded 82%. After the plasma had been diluted with phosphate buffer (pH 6.0), the drugs were extracted using a single Bond Elut

  16. Disappearing and reappearing differences in drug-eluting stent use by race.

    Science.gov (United States)

    Federspiel, Jerome J; Stearns, Sally C; Reiter, Kristin L; Geissler, Kimberley H; Triplette, Matthew A; D'Arcy, Laura P; Sheridan, Brett C; Rossi, Joseph S

    2013-04-01

    Drug-eluting coronary stents (DES) rapidly dominated the marketplace in the United States after approval in 2003, but utilization rates were initially lower among African American patients. We assess whether racial differences persisted as DES diffused into practice. Medicare claims data were used to identify coronary stenting procedures among elderly patients with acute coronary syndromes (ACS). Regression models of the choice of DES versus bare mental stent controlled for demographics, ACS type, co-morbidities and hospital characteristics. Diffusion was assessed in the short run (2003-2004) and long run (2007), with the effect of race calculated to allow for time-varying effects. The sample included 381,887 Medicare beneficiaries treated with stent insertion; approximately 5% were African American. Initially (May 2003-February 2004), African American race was associated with lower DES use compared to other races (44.3% versus 46.5%, P differences were not significant (79.8% versus 80.3%, P = 0.45). Subsequent concerns regarding DES safety caused reductions in DES use, with African Americans having lower use than other racial groups in 2007 (63.1% versus 65.2%, P differences in race reflect decisions regarding treatment appropriateness. © 2011 Blackwell Publishing Ltd.

  17. Drug eluting stents and modern stent technologies for in-stent restenosis.

    Science.gov (United States)

    Werner, Martin

    2017-08-01

    The implantation of metallic stents has become a standard procedure to improve the outcome after angioplasty of peripheral vessels. However, the occurrence of in-stent restenosis is hampering the long-term efficacy of these procedures and is associated with re-occurrence of symptoms. The optimal treatment modality for in-stent-restenosis in the peripheral vasculature is not well examined. This review discusses the existing evidence for the treatment of in-stent restenosis with drug eluting stents and modern stent technologies.

  18. Intravascular ultrasound assessed incomplete stent apposition and stent fracture in stent thrombosis after bare metal versus drug-eluting stent treatment the Nordic Intravascular Ultrasound Study (NIVUS)

    DEFF Research Database (Denmark)

    Kosonen, Petteri; Vikman, Saila; Jensen, Lisette Okkels

    2012-01-01

    This prospective multicenter registry used intravascular ultrasound (IVUS) in patients with definite stent thrombosis (ST) to compare rates of incomplete stent apposition (ISA), stent fracture and stent expansion in patients treated with drug-eluting (DES) versus bare metal (BMS) stents. ST...... is a rare, but potential life threatening event after coronary stent implantation. The etiology seems to be multifactorial....

  19. Drug-eluting Ti wires with titania nanotube arrays for bone fixation and reduced bone infection

    Science.gov (United States)

    Gulati, Karan; Aw, Moom Sinn; Losic, Dusan

    2011-10-01

    Current bone fixation technology which uses stainless steel wires known as Kirschner wires for fracture fixing often causes infection and reduced skeletal load resulting in implant failure. Creating new wires with drug-eluting properties to locally deliver drugs is an appealing approach to address some of these problems. This study presents the use of titanium [Ti] wires with titania nanotube [TNT] arrays formed with a drug delivery capability to design alternative bone fixation tools for orthopaedic applications. A titania layer with an array of nanotube structures was synthesised on the surface of a Ti wire by electrochemical anodisation and loaded with antibiotic (gentamicin) used as a model of bone anti-bacterial drug. Successful fabrication of TNT structures with pore diameters of approximately 170 nm and length of 70 μm is demonstrated for the first time in the form of wires. The drug release characteristics of TNT-Ti wires were evaluated, showing a two-phase release, with a burst release (37%) and a slow release with zero-order kinetics over 11 days. These results confirmed our system's ability to be applied as a drug-eluting tool for orthopaedic applications. The established biocompatibility of TNT structures, closer modulus of elasticity to natural bones and possible inclusion of desired drugs, proteins or growth factors make this system a promising alternative to replace conventional bone implants to prevent bone infection and to be used for targeted treatment of bone cancer, osteomyelitis and other orthopaedic diseases.

  20. Application of rotational atherectomy in the drug-eluting stent era

    Science.gov (United States)

    Chen, Chun-Chi; Hsieh, I-Chang

    2013-01-01

    Rotational atherectomy (RA) was introduced in the interventional arena in 1988 as a dedicated device for calcified lesions. Due to the complexity of the technique, the development of alternative methods such as the cutting balloon procedure, and the high restenosis rate of subsequent bare metal stenting in long lesions, its use had later declined. However, with the increasing use of drug-eluting stents (DES) and the aggressive treatment of longer lesions, the number of procedure performed with RA has increased significantly again in recent years. In this article, we reviewed the application of RA in DES era. PMID:24133506

  1. Coagulation management in patients undergoing neurosurgical procedures.

    Science.gov (United States)

    Robba, Chiara; Bertuetti, Rita; Rasulo, Frank; Bertuccio, Alessando; Matta, Basil

    2017-10-01

    Management of coagulation in neurosurgical procedures is challenging. In this contest, it is imperative to avoid further intracranial bleeding. Perioperative bleeding can be associated with a number of factors, including anticoagulant drugs and coagulation status but is also linked to the characteristic and the site of the intracranial disorder. The aim of this review will be to focus primarily on the new evidence regarding the management of coagulation in patients undergoing craniotomy for neurosurgical procedures. Antihemostatic and anticoagulant drugs have shown to be associated with perioperative bleeding. On the other hand, an increased risk of venous thromboembolism and hypercoagulative state after elective and emergency neurosurgery, in particular after brain tumor surgery, has been described in several patients. To balance the risk between thrombosis and bleeding, it is important to be familiar with the perioperative changes in coagulation and with the recent management guidelines for anticoagulated patients undergoing neurosurgical procedures, in particular for those taking new direct anticoagulants. We have considered the current clinical trials and literature regarding both safety and efficacy of deep venous thrombosis prophylaxis in the neurosurgical population. These were mainly trials concerning both elective surgical and intensive care patients with a poor grade intracranial bleed or multiple traumas with an associated severe traumatic brain injury (TBI). Coagulation management remains a major issue in patients undergoing neurosurgical procedures. However, in this field of research, literature quality is poor and further studies are necessary to identify the best strategies to minimize risks in this group of patients.

  2. Coronary Artery Bypass Surgery Versus Drug-Eluting Stent Implantation for Left Main or Multivessel Coronary Artery Disease: A Meta-Analysis of Individual Patient Data.

    Science.gov (United States)

    Lee, Cheol Whan; Ahn, Jung-Min; Cavalcante, Rafael; Sotomi, Yohei; Onuma, Yoshinobu; Suwannasom, Pannipa; Tenekecioglu, Erhan; Yun, Sung-Cheol; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Serruys, Patrick W; Park, Seung-Jung

    2016-12-26

    The authors undertook a patient-level meta-analysis to compare long-term outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in 3,280 patients with left main or multivessel coronary artery disease (CAD). The relative efficacy and safety of CABG versus PCI with DES for left main or multivessel CAD remain controversial. Data were pooled from the BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease), PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery vs. Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trials. The primary outcome was a composite of all-cause death, myocardial infarction, or stroke. The median follow-up was 60 months, and follow-up was completed for 96.2% of patients. The rate of primary outcome was significantly lower with CABG than with PCI (13.0% vs. 16.0%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.69 to 1.00; p = 0.046). The difference was mainly driven by reduction in myocardial infarction (HR: 0.46; 95% CI: 0.33 to 0.64; p patients with multivessel CAD (p = 0.001), but no between-group difference in those with left main CAD (p = 0.427). The rates for all-cause death and stroke were similar between the 2 groups. By contrast, the need for repeat revascularization was significantly lower in the CABG group compared with the PCI group. CABG, as compared with PCI with DES, reduced long-term rates of the composite of all-cause death, myocardial infarction, or stroke in patients with left main or multivessel CAD. The advantage of CABG over PCI with DES was particularly pronounced in those with multivessel CAD. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights

  3. Drug-eluting stent implantation for the percutaneous treatment of vertebro-basilar arterial stenosis

    International Nuclear Information System (INIS)

    Ma Rujun; Liu Jianmin; Huang Haiqing; Hong Bo; Xu Yi; Zhao Wenyuan; Zhao Rui; Chen Jun

    2006-01-01

    Objective: To evaluate the early results and mid-term outcomes following angioplasty of vertebro-basilar arterial stenosis with drug-eluting stents. Methods: All of the patients presented with recurrent TIA or ceretral infarction with >50% stenoses in vertebro-basilar arteries, and having failure in maximal medical therapy. All of the lesions were treated with primary stenting under local or general anesthesia and followed by continual anticoagulant therapy of clopidogrel and aspirin together with clinical follow-up and vascular imagings. Results: Of 28 stenoses (27 patients), 27 lesions were successfully treated with implantation of 24 Cypher stents, 2 Taxus stents and one Firebird stent. The mean stenotic severity reduced from (74 ± 6.7)% to (8.7 ± 4.4)%. Two patients had inchemic events relating to penetration vascular obstruction. During 2-14 months follow-up, the patients were clinically asymptomatic with no recurrent TIA/stoke. Angiographic follow-up was obtained in 14 patients at a mean of 7.2 months. Proximal restenosis (<50%) occurred in one patient (3.3%), and corrected with restenting, while others were free of intra-stent restenoses. Conclusion: Using DES in cerebrovascular stenosis is safe and effective with lowing the risk of intra-stent restenosis in comparison with bare stent. Further study for long term efficiency is still in need. (authors)

  4. Irinotecan drug eluting beads used as a treatment of advanced intra hepatic cholangiocarcinoma

    Directory of Open Access Journals (Sweden)

    Jean Amede Roch

    2008-10-01

    Full Text Available

    This report describes a 74-year-old male with unresectable intrahepatic cholangiocarcinoma (ICC. However surgical procedure is the only curative treatment, it often seems to be ineffective because of the aggressive behaviour of the disease. The role of systemic chemotherapy in the ICC is undefined with a median survival between 6.43 to 12.17 months obtained by using the combination chemotherapy of gemcitabine with cisplatin. In the present case, we performed a targeted treatment using drug eluting beads (DEB with irinotecan (IRI administered as transarterial-chemoembolization (TACE. After one session, the tumour vascularity decreased significantly at the one month evaluation on computed tomography (CT scan of the liver.  This case report suggested that minimally invasive transcatheter DEB embolization could be a promising, safe and effective treatment for selective patients with unresectable ICC.

  5. Drug Utilisation Pattern and Adverse Events in Patients with Chronic Kidney Disease Undergoing Maintenance Haemodialysis at a Tertiary Care Hospital of Odisha

    Directory of Open Access Journals (Sweden)

    P. Ansuman Abhisek

    2017-10-01

    Full Text Available Introduction: The number of patients receiving renal replacement therapy in the form of dialysis or transplant has been increasing in recent years. Increased frequency of monitoring due to complex therapeutic regimen and inappropriate use of drugs may lead to increased Adverse Events (AEs, hospital stay, cost of treatment as well as increased morbidity and mortality. Aim: To analyse utilisation pattern of drugs and AEs in Chronic Kidney Disease (CKD patients undergoing maintenance haemodialysis. Materials and Methods: This prospective, observational study was conducted in the Department of Pharmacology in collaboration with Department of Nephrology, SCB Medical College and Hospital, Cuttack, from 1st June to 31st December, 2015. Demographic, clinical and medicine details were collected from patients’ case sheet, matched with nursing case records and tabulated in a predesigned case study form. The data were analysed in a descriptive manner using percentage calculation and Spearman’s correlation, multiple logistic regression using trial version SPSS v24. Results: A total number of 115 cases were included in this study. Average number of drugs used, per prescription was 12.8 during the dialysis and non-dialysis days. Most frequently used drugs were antihypertensives, 25% dextrose and heparin (before dialysis and on dialysis days were prescribed to all patients followed by haematinics in 90.43% of the patients and proton pump inhibitors were prescribed in 70.43% of the patients. Among 1472 drugs prescribed, 40.96% of the drugs were prescribed in generic name. It was observed that 72.62% of the prescribed drugs were from National List of Essential Medicine. AEs were observed with varying severity in all the patients. Frequently observed AEs as per the laboratory investigations were hyperphosphataemia, hyponatraemia, metabolic acidosis, hyperkalemia, hypoglycaemia, hypocalcaemia and hypokalemia. AEs were statistically significant with age group

  6. Nickel elution properties of contemporary interatrial shunt closure devices.

    Science.gov (United States)

    Verma, Divya Ratan; Khan, Muhammad F; Tandar, Anwar; Rajasekaran, Namakkal S; Neuharth, Renée; Patel, Amit N; Muhlestein, Joseph B; Badger, Rodney S

    2015-02-01

    We sought to compare nickel elution properties of contemporary interatrial shunt closure devices in vitro. There are two United States Food and Drug Administration (FDA)-approved devices for percutaneous closure of secundum atrial septal defect: the Amplatzer septal occluder (ASO; St Jude Medical Corporation) and Gore Helex septal occluder (HSO; W.L. Gore & Associates). The new Gore septal occluder (GSO) device is in clinical trials. These are also used off-label for patent foramen ovale closure in highly selected patients. These devices have high nickel content. Nickel allergy is the most common reason for surgical device explantation. Nickel elution properties of contemporary devices remain unknown. We compared nickel elution properties of 4 devices - ASO, GSO, HSO, and sternal wire (SW) - while Dulbecco's phosphate-buffered saline (DPBS) served as control. Three samples of each device were submerged in DPBS. Nickel content was measured at 14 intervals over 90 days. Nickel elution at 24 hours, compared to control (0.005 ± 0.0 mg/L), was significantly higher for ASO (2.98 ± 1.65 mg/L; P=.04) and SW (0.03 ± 0.014 mg/L; P=.03). Nickel levels at 90 days, compared to control (0.005 ± 0.0 mg/L) and adjusting for multiple comparisons, were significantly higher for ASO (19.80 ± 2.30 mg/L; P=.01) and similar for HSO (P=.34), GSO (P=.34), and SW (P=.34). ASO had significantly higher nickel elution compared to HSO, GSO, and SW (P=.01). There is substantial variability in nickel elution; devices with less exposed nickel (HSO and GSO) have minimal elution. The safety of low nickel elution devices in patients with nickel allergy needs to be evaluated in prospective trials.

  7. Sustained multiple organ ischaemia after transarterial chemoembolization with drug-eluting beads for hepatocellular carcinoma.

    Science.gov (United States)

    Kim, Young Woon; Kwon, Jung Hyun; Nam, Soon Woo; Jang, Jeong Won; Jung, Hyun Suk; Shin, Yu Ri; Park, Eun Su; Shim, Dong Jae

    2018-02-01

    Transarterial chemoembolization (TACE) with drug-eluting beads (DC beads) may enhance drug delivery to tumours and reduce systemic toxicity. TACE with DC beads leads to significantly fewer serious side-effects compared with conventional TACE. A 66-year-old man with hepatocellular carcinoma (HCC) complained of continuous abdominal pain 1 month after TACE with DC beads. At the time of TACE, angiography revealed severe stenosis of both hepatic arteries. The diagnostic work up on admission suggested severe bile duct injury with regional bile duct dilatation, segmental liver and spleen infarction, necrotizing pancreatitis, as well as gastric and duodenal ulcers. The pathology specimens of the duodenum contained DC beads that had passed through small vessels in the connective tissue. The patient's condition appeared to improve after 2 weeks of antibiotic treatment and supportive care, but new multifocal liver and spleen infarction subsequently developed. After 2 months, he was well enough to be discharged. His HCC partially responded to the TACE with DC beads but eventually progressed and he died after 11 months. The present case report highlights unexpected ongoing multiple organ ischaemia in a 66-year-old man treated for HCC using TACE with DC beads. The use of TACE with DC beads should be carefully considered in patients with vascular strictures or aberrant blood supply.

  8. Short and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients

    NARCIS (Netherlands)

    Navarese, E.P.; Kowalewski, M.; Cortese, B.; Kandzari, D.; Dias, S.; Wojakowski, W.; Buffon, A.; Lansky, A.; Angelini, P.; Torguson, R.; Kubica, J.; Kelm, M.; Boer, M.J. de; Waksman, R.; Suryapranata, H.

    2014-01-01

    BACKGROUND: The efficacy and safety of polymer-free drug-eluting stents (DESs) in clinical practice is currently subject of debate; randomized trials (RCTs) conducted so far provided conflicting results or were underpowered to definitively address this question; we aimed to investigate the efficacy

  9. Comparison of a Simple Angiographic Approach With a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery Score-Based Approach for Left Main Coronary Artery Stenting: A Pooled Analysis of Serial PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) Studies.

    Science.gov (United States)

    Lee, Pil Hyung; Lee, Jong-Young; Lee, Cheol Whan; Kim, Seon-Ok; Ahn, Jung-Min; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Park, Seung-Jung

    2018-01-01

    The applicability of Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores to left main coronary artery disease (CAD) has been questioned. A simplified alternative is needed for guiding decision making. We evaluated the prognostic value of a simplified angiographic classification in comparison with a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score-based approach for patients with left main CAD undergoing drug-eluting stent implantation. The proposed approach classified left main CAD as either extensive (n=819), defined as left main bifurcation lesions with an involvement of ostial left circumflex artery or as any left main lesion plus multivessel CAD, or limited (n=453), defined as ostial/midshaft lesions or left main bifurcation lesions without an involvement of ostium of left circumflex artery, alone or plus 1-vessel disease. The databases from 4 prospective Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease studies were pooled, and the primary outcome was a major adverse cardiac event, defined as death, myocardial infarction, or repeat revascularization. During follow-up (median 38 months; interquartile range, 36-61 months), the risk for major adverse cardiac event was significantly higher with extensive than with limited left main CAD (adjusted hazard ratio, 2.13; 95% confidence interval, 1.54-2.94; P Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score tertiles did not effectively stratify these 2 outcome measures. Compared with Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores, the simpler angiographic approach provided better discrimination for future cardiovascular events in patients with left main CAD undergoing drug-eluting stent implantation. © 2018 American Heart Association, Inc.

  10. Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent : 4-year results of the PROTECT randomized trial

    NARCIS (Netherlands)

    Wijns, William; Steg, Ph. Gabriel; Mauri, Laura; Kurowski, Volkhard; Parikh, Keyur; Gao, Runlin; Bode, Christoph; Greenwood, John P.; Lipsic, Erik; Alamgir, Farqad; Rademaker-Havinga, Tessa; Boersma, Eric; Radke, Peter; van Leeuwen, Frank; Camenzind, Edoardo

    2014-01-01

    Aims To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour (E-ZES) vs. Cypher (C-SES) Stenting Trial (PROTECT). At 3 years, there was no difference in the primary outcome of definite or probable

  11. Local perivascular delivery of anti-restenotic agents from a drug-eluting poly(ε-caprolactone) stent cuff

    NARCIS (Netherlands)

    Pires, N.M.M.; Hoeven, B.L. van der; Vries, M.R. de; Havekes, L.M.; Vlijmen, B.J. van; Hennink, W.E.; Quax, P.H.A.; Jukema, J.W.

    2005-01-01

    The introduction of drug-eluting stents (DES) to prevent in-stent restenosis is one of the major advances in interventional cardiology. Currently many types of DES are under evaluation for effectiveness and safety, a time-consuming and difficult procedure in humans. An animal model that allows rapid

  12. Five-year outcome after implantation of zotarolimus- and everolimus-eluting stents in randomized trial participants and nonenrolled eligible patients : A secondary analysis of a randomized clinical trial

    NARCIS (Netherlands)

    Von Birgelen, Clemens; Van Der Heijden, Liefke C.; Basalus, Mounir Welson Zakhary; Kok, Marlies M.; Sen, Hanim; Louwerenburg, Hans W.; van Houwelingen, Gert K.; Stoel, Martin G.; de Man, Frits H.A.F.; Linssen, Gerard C.M.; Tandjung, Kenneth; Doggen, Carine J.M.; Van Der Palen, Job; Löwik, Marije M.

    2017-01-01

    IMPORTANCE: Long-term follow-up after a clinical trial of 2 often-used, newer-generation drug-eluting stents (DESs) in a broad patient population is of interest. Comprehensive long-term outcome of eligible nonenrolled patients has never been reported. OBJECTIVE: To assess 5-year safety and efficacy

  13. Incidence of periprocedural myocardial infarction following stent implantation: Comparison between first- and second-generation drug-eluting stents

    NARCIS (Netherlands)

    Tandjung, Kenneth; Basalus, Mounir W.Z.; Muurman, Esther; Louwerenburg, Hans W.; van Houwelingen, Gert K.; Stoel, Martin G.; de Man, Frits H.A.F.; Jansen, Hanneke; Huisman, Jennifer; Linssen, Gerard C.M.; Droste, Herman T.; Nienhuis, Mark B.; von Birgelen, Clemens

    2012-01-01

    Background: First- and second-generation drug-eluting stents (DES) differ in coating materials, which may influence the incidence of periprocedural myocardial infarction (PMI). Objective: To compare the incidence of PMI between first- and second-generation DES, using the current Academic Research

  14. Drug-Eluting Nitinol Stent Treatment of the Superficial Femoral Artery and Above-the-Knee Popliteal Artery (The Zilver PTX Single-Arm Clinical Study): A Comparison Between Diabetic and Nondiabetic Patients

    Energy Technology Data Exchange (ETDEWEB)

    Fanelli, Fabrizio, E-mail: fabrizio.fanelli@uniroma1.it [Sapienza University of Rome, Vascular and Interventional Radiology Unit, Department of Radiological Sciences (Italy); Primo, Massimiliano Di [Hopital Europeen Georges Pompidou, University Paris Descartes (France); Boatta, Emanuele [Sapienza University of Rome, Vascular and Interventional Radiology Unit, Department of Radiological Sciences (Italy); Johnston, Krystal, E-mail: kjohnston@medinst.com [MED Institute, Inc (United States); Sapoval, Marc, E-mail: marc.sapoval2@egp.aphp.fr [Hopital Europeen Georges Pompidou, University Paris Descartes (France)

    2013-10-15

    Purpose: To describe the 1-year results of drug-eluting nitinol stent placement in the femoropopliteal artery of diabetic and nondiabetic patients. Materials and Methods: All patients enrolled in this prospective, multicenter study underwent paclitaxel-eluting stent placement for de novo or restenotic lesions of the superficial femoral and/or popliteal artery. Baseline and follow-up walking impairment questionnaire (WIQ) scores, Rutherford classifications, and ankle-brachial index (ABI) measurements were obtained. Follow-up was completed at 1, 6, and 12 months. Results: There were 285 diabetic patients and 502 nondiabetic patients treated. There were no significant differences in mean lesion length or lesion calcification between patient groups. Procedural success in both treatment groups was >97 %. There were no significant differences between diabetic and nondiabetic groups in Kaplan-Meier estimates of patency, event-free survival (EFS), or freedom from target lesion revascularization (TLR) at 6 and 12 months. Both groups experienced a significant increase in ABI and WIQ values after treatment, and these improvements were sustained to 12-month follow-up; however, nondiabetic patients had significantly greater 6- and 12-month WIQ scores compared with diabetic patients. Based on covariate analysis, the only factors shown to be significant and to negatively influence patency were longer lesion length (p = 0.009), higher Rutherford classification (p = 0.02), and lack of hypertension (p = 0.02); diabetic status was not found to be a significant factor. Conclusion: Diabetic and nondiabetic patients had similar estimates of primary patency, EFS, and freedom from TLR; however, diabetic patients showed less improvement in WIQ scores compared with nondiabetic patients.

  15. Safety and efficacy of limus-eluting stents and balloon angioplasty for sirolimus-eluting in-stent restenosis

    Energy Technology Data Exchange (ETDEWEB)

    Ota, Hideaki [Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010 (United States); Mahmoudi, Michael [University of Surrey, Guildford Road, Surrey, GU2-7XH (United Kingdom); Kitabata, Hironori; Torguson, Rebecca; Chen, Fang; Satler, Lowell F.; Suddath, William O.; Pichard, Augusto D. [Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010 (United States); Waksman, Ron, E-mail: ron.waksman@medstar.net [Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC 20010 (United States)

    2015-03-15

    Objectives: The aim of this study was to compare the safety and efficacy of everolimus-eluting stent (EES), sirolimus-eluting stent (SES), and plain old balloon angioplasty (POBA) for the treatment of SES in-stent restenosis (S-ISR). Background: The optimal treatment for drug-eluting in-stent restenosis remains controversial. Methods: The study cohort comprised 310 consecutive patients (444 lesions) who presented with S-ISR to our institution and underwent treatment with EES (43 patients), SES (102), or POBA (165). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac event (MACE) defined as the composite of death, MI, or TLR at 1-year. Results: The three groups were well matched for the conventional risk factors for coronary artery disease except for smoking. The 1-year analyzed clinical parameters were similar in the three groups: MACE (EES = 14%, SES = 18%, POBA = 20%; p = 0.65), death (EES = 2.3%, SES = 6.2%, POBA = 6.1%; p = 0.61), MI (EES = 4.8%, SES = 2.1%, POBA = 2.5%; p = 0.69), TLR (EES = 11.9%, SES = 12.1%, POBA = 24%; p = 0.78), and TVR (EES = 11.9%, SES = 24.8%, POBA = 22.2%; p = 0.23). There were no cases of definite ST. MACE-free rate was significantly lower in patients with recurrent in-stent restenosis (log-rank p = 0.006). Presentation with acute MI, number of treated lesions and a previous history of MI were found to be independent predictors of MACE. Conclusions: In patients presenting with S-ISR, treatment with implantation of an EES, SES, or POBA is associated with similar clinical outcomes. Patients presenting with recurrent ISR may have a poorer clinical outcome.

  16. Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) trials.

    Science.gov (United States)

    Sabaté, Manel; Räber, Lorenz; Heg, Dik; Brugaletta, Salvatore; Kelbaek, Henning; Cequier, Angel; Ostojic, Miodrag; Iñiguez, Andrés; Tüller, David; Serra, Antonio; Baumbach, Andreas; von Birgelen, Clemens; Hernandez-Antolin, Rosana; Roffi, Marco; Mainar, Vicente; Valgimigli, Marco; Serruys, Patrick W; Jüni, Peter; Windecker, Stephan

    2014-01-01

    This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI). Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES. Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year. Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS. Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up. Copyright © 2014 American

  17. Clinical evaluation of domestic biodegradable drug-eluting stents in the treatment of coronary heart disease

    International Nuclear Information System (INIS)

    Yu Hongying; Suo Chuantao; Shang Ruiping

    2009-01-01

    Objective: To evaluate the safety and efficacy of domestic biodegradable drug-eluting stent, EXCEL, in clinical treatment of coronary heart disease. Methods: During the period of Jan. 2008-Oct. 2008, 100 patients with coronary heart disease who consented to PCI and postoperative coronary angiography were selected and enrolled in the study. The patients were divided into EXCEL group (n = 58) and Cypher group (n = 42). The immediate successful rate of interventional therapy and the complications occurred during hospitalization were observed. Postoperative follow-up and checkup coronary angiography were conducted. Results: No significant difference in the relevant clinical data, in the number and type of diseased coronary branch and in the mean length of implanted stents existed between two groups. Also, no statistically significant difference in the occurrence of major adverse cardiac event (MACE), in-stent restenosis and thrombosis was present between two groups. Conclusion: Compared with Cypher stenting, EXCEL stenting carries similar, i.e. rather low, occurrence of MACE and in-stent restenosis. (authors)

  18. Three-year patient-related and stent-related outcomes of second-generation everolimus-eluting Xience V stents versus zotarolimus-eluting resolute stents in real-world practice (from the Multicenter Prospective EXCELLENT and RESOLUTE-Korea Registries).

    Science.gov (United States)

    Lee, Joo Myung; Park, Kyung Woo; Han, Jung-Kyu; Yang, Han-Mo; Kang, Hyun-Jae; Koo, Bon-Kwon; Bae, Jang-Whan; Woo, Sung-Il; Park, Jin Sik; Jin, Dong-Kyu; Jeon, Dong Woon; Oh, Seok Kyu; Park, Jong-Seon; Kim, Doo-Il; Hyon, Min Su; Jeon, Hui-Kyung; Lim, Do-Sun; Kim, Myeong-Gon; Rha, Seung-Woon; Her, Sung-Ho; Hwang, Jin-Yong; Kim, Sanghyun; Choi, Young Jin; Kang, Jin Ho; Moon, Keon-Woong; Jang, Yangsoo; Kim, Hyo-Soo

    2014-11-01

    Long-term outcomes are imperative to confirm safety of drug-eluting stents. There have been 2 randomized controlled trials comparing everolimus-eluting stents (EESs) and Resolute zotarolimus-eluting stents (ZES-Rs). To date, long-term clinical outcomes of these stents were limited to only 1 report, which has recently reported 4-year comparisons of these stents. Therefore, more evidence is needed regarding long-term clinical outcomes of the second-generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in "all-comer" cohorts up to 3-year follow-up. The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure) and patient-related composite events up to 3-year follow-up were compared in crude and propensity score-matched analyses. Of 5,054 patients, 3,830 patients (75.8%) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (189 [6.2%] vs 127 [6.4%], p = 0.812) and the patient-related outcome (420 [13.7%] vs 250 [12.5%], p = 0.581) did not differ between EES and ZES-R, respectively, at 3 years, which was corroborated by similar results from the propensity score-matched cohort (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.70 to 1.20, p = 0.523 and 0.85, 95% CI 0.70 to 1.02, p = 0.081, for stent- and patient-related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs 10 [0.5%], p = 0.370) was also similar. The rate of very late definite or probable stent thrombosis was very low and comparable between the 2 stents (3 [0.1%] vs 1 [0.1%], p = 0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440 to 5.354, p stents showed comparable safety and efficacy at 3-year follow-up in this robust real-world registry with unrestricted use of EES and

  19. Combined Directional Atherectomy and Drug-Eluting Balloon Angioplasty for Isolated Popliteal Artery Lesions in Patients With Peripheral Artery Disease.

    Science.gov (United States)

    Stavroulakis, Konstantinos; Bisdas, Theodosios; Torsello, Giovanni; Stachmann, Arne; Schwindt, Arne

    2015-12-01

    To evaluate the midterm results of combined directional atherectomy (DA) and drug-eluting balloon (DEB) angioplasty for atherosclerotic lesions of the popliteal artery. In a single-arm, prospective study, 21 patients (mean age 63±16 years; 16 men) with isolated popliteal artery lesions were enrolled and underwent treatment with combined DA and DEB angioplasty under filter protection between October 2009 and February 2014. The majority (18, 86%) presented with lifestyle-limiting intermittent claudication and 3 with critical limb ischemia. Fifteen (71%) target sites were de novo lesions; 4 were occlusions. The main outcome was primary patency; secondary outcomes were technical success, secondary patency, and early and midterm morbidity and mortality. The TurboHawk atherectomy device was used in 15 (71%) patients and the SilverHawk peripheral plaque excision system in the remaining 6 patients. The In.Pact Admiral/Pacific DEB was used in the majority of cases (15, 71%). The technical success rate was 90% (n=19). One flow-limiting dissection was treated with bailout stenting. Complications included a perforation of the popliteal artery and 2 puncture site hematomas; there was no distal embolic event. The mean follow-up was 18±12 months. Two restenoses were retreated successfully. Kaplan-Meier estimates of primary patency at 12 and 18 months were 95% and 90%, respectively; the secondary patency was 100%. One (5%) patient died in follow-up. None of the patients had an amputation. In this prospective single-arm study, the combined therapy of DA and DEB angioplasty for popliteal artery lesions showed promising midterm performance. The combination of DA and DEB may, in highly selected patients, overcome the challenges presented by the mobility of the knee joint. © The Author(s) 2015.

  20. Impact of Hemoglobin A1c Levels on Residual Platelet Reactivity and Outcomes After Insertion of Coronary Drug-Eluting Stents (from the ADAPT-DES Study)

    DEFF Research Database (Denmark)

    Schoos, Mikkel M.; Dangas, George D.; Mehran, Roxana

    2016-01-01

    An increasing hemoglobin A1c (HbA1c) level portends an adverse cardiovascular prognosis; however, the association between glycemic control, platelet reactivity, and outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is unknown. We sought to investigate whether Hb...... With Drug Eluting Stents registry, HbA1c levels were measured as clinically indicated in 1,145 of 8,582 patients, stratified by HbA1c 8.5% (n = 171, 14.9%). HPR on clopidogrel and aspirin was defined after PCI as P2Y12 reaction units (PRU) >208...... >208 (42.5%, 50.2%, and 62.3%, p definite or probable stent thrombosis (ST; 0.9%, 2.7%, and 4.2%, p = 0.02) increased progressively with HbA1c groups. Clinically relevant bleeding was greatest in the intermediate HbA1c group (8.2% vs 13.1% vs 9.5%, p = 0.04). In adjusted models...

  1. Histological assessment of the efficacy of drug-eluting beads in portal tumor thrombosis of hepatocellular carcinoma

    Directory of Open Access Journals (Sweden)

    Yusuke Imai, MD

    2017-03-01

    Full Text Available A 58-year-old man was diagnosed with advanced hepatocellular carcinoma with portal vein tumor thrombosis (PVTT. The tumors were multiple and existed in both lobes. Drug-eluting beads transcatheter arterial chemoembolization (DEB-TACE was performed for the tumors in the left lobe. Embosphere and Hepasphere were selected for embolization of the arterioportal shunt, followed by loaded epirubicin infusion into the left hepatic artery. Computed tomography showed reduction of PVTT. However, liver failure progressed, and the patient died 67 days after DEB-TACE. Autopsy showed that the beads reached the tumor thrombosis in the portal vein. The prognosis of hepatocellular carcinoma with PVTT is poor. Although there are no established treatments for unresectable PVTT, DEB-TACE might be a useful option for such cases.

  2. First-generation versus second-generation drug-eluting stents in current clinical practice: updated evidence from a comprehensive meta-analysis of randomised clinical trials comprising 31 379 patients

    NARCIS (Netherlands)

    Navarese, E.P.; Kowalewski, M.; Kandzari, D.; Lansky, A.; Gorny, B.; Koltowski, L.; Waksman, R.; Berti, S.; Musumeci, G.; Limbruno, U.; Schaaf, R.J. van der; Kelm, M.; Kubica, J.; Suryapranata, H.

    2014-01-01

    BACKGROUND: First-generation drug-eluting stents (DES) have become the most widely used devices worldwide for management of coronary artery disease. As remote follow-up data were becoming available, concerns emerged in regard to their long-term safety. Second-generation DES were designed to overcome

  3. Natural history of optical coherence tomography-detected non-flow-limiting edge dissections following drug-eluting stent implantation

    DEFF Research Database (Denmark)

    Radu, Maria D; Räber, Lorenz; Heo, Jungho

    2014-01-01

    history and clinical implications remain unclear. The objectives of the present study were to assess the morphology, healing response, and clinical outcomes of OCT-detected edge dissections using serial OCT imaging at baseline and at one year following drug-eluting stent (DES) implantation. METHODS...

  4. Type D personality predicts chronic anxiety following percutaneous coronary intervention in the drug-eluting stent era

    DEFF Research Database (Denmark)

    Spindler, Helle; Pedersen, Susanne S.; Serruys, Patrick W.

    2007-01-01

      Background: Anxiety is an often overlooked risk factor in coronary artery disease (CAD). Hence, little is known about predictors of unremitting chronic anxiety in CAD patients. This study examined whether the distressed personality (Type D) predicts chronic anxiety post percutaneous coronary...... months post-PCI. Results: Of 167 patients anxious at 6 months, 108 (65%) were still anxious 12 months post-PCI. Significant univariable predictors of chronic anxiety were Type D personality (OR:3.17: 95% CI:1.64-6.14) and sirolimus-eluting stents (OR:0.51; 95% CI:0.27-0.98), with sirolimus-eluting stents...... showing a protective effect. In multivariable analyses, Type D personality (OR:3.31; 95% CI:1.59-6.87) and sirolimus-eluting stents (OR:0.44; 95% CI:0.21-0.92) remained significant independent predictors of chronic anxiety adjusting for depressive symptoms at 6 months, and demographic and clinical risk...

  5. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials.

    Science.gov (United States)

    Planer, David; Smits, Pieter C; Kereiakes, Dean J; Kedhi, Elvin; Fahy, Martin; Xu, Ke; Serruys, Patrick W; Stone, Gregg W

    2011-10-01

    This study sought to compare the clinical outcomes of everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD). Although randomized trials have shown superiority of EES to PES, the safety and efficacy of EES in ACS is unknown. We performed a patient-level pooled analysis from the prospective, randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV, and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trials in which 2,381 patients with ACS and 4,404 patients with stable CAD were randomized to EES or to PES. Kaplan-Meier estimates of death, myocardial infarction (MI), ischemia-driven target lesion revascularization, and stent thrombosis were assessed at 2 years and stratified by clinical presentation (ACS vs. stable CAD). At 2 years, patients with ACS compared with stable CAD had higher rates of death (3.2% vs. 2.4%, hazard ratio [HR]: 1.37 [95% confidence interval (CI): 1.02 to 1.85], p = 0.04) and MI (4.9% vs. 3.4%, HR: 1.45 [95% CI: 1.14 to 1.85], p = 0.02). In patients with ACS, EES versus PES reduced the rate of death or MI (6.6% vs. 9.3%, HR: 0.70 [95% CI: 0.52 to 0.94], p = 0.02), stent thrombosis (0.7% vs. 2.9%, HR: 0.25 [95% CI: 0.12 to 0.52], p = 0.0002), and ischemia-driven target lesion revascularization (4.7% vs. 6.2%, HR: 0.69 [95% CI: 0.48 to 0.99], p = 0.04). In patients with stable CAD, EES reduced the rate of death or MI (4.5% vs. 7.1%, HR: 0.62 [95% CI: 0.48 to 0.80], p = 0.0002), stent thrombosis (0.7% vs. 1.8%, HR: 0.34 [95% CI: 0.19 to 0.62], p = 0.0002), and ischemia-driven target lesion revascularization (3.9% vs. 6.9%, HR: 0.55 [95% CI: 0.42 to 0.73], p SPIRIT II]; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the

  6. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial

    NARCIS (Netherlands)

    de Winter, Robbert J.; Katagiri, Yuki; Asano, Taku; Milewski, Krzysztof P.; Lurz, Philipp; Buszman, Pawel; Jessurun, Gillian A. J.; Koch, Karel T.; Troquay, Roland P. T.; Hamer, Bas J. B.; Ophuis, Ton Oude; Wöhrle, Jochen; Wyderka, Rafał; Cayla, Guillaume; Hofma, Sjoerd H.; Levesque, Sébastien; Żurakowski, Aleksander; Fischer, Dieter; Kośmider, Maciej; Goube, Pascal; Arkenbout, E. Karin; Noutsias, Michel; Ferrari, Markus W.; Onuma, Yoshinobu; Wijns, William; Serruys, Patrick W.

    2018-01-01

    Background MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical

  7. Contrast-Enhanced Ultrasonography of Hepatocellular Carcinoma After Chemoembolisation Using Drug-Eluting Beads: A Pilot Study Focused on Sustained Tumor Necrosis

    International Nuclear Information System (INIS)

    Moschouris, Hippocrates; Malagari, Katerina; Papadaki, Marina Georgiou; Kornezos, Ioannis; Matsaidonis, Dimitrios

    2010-01-01

    The purpose of this study was to assess the use of contrast-enhanced ultrasonography (CEUS) and the sustained antitumor effect of drug-eluting beads used for transarterial chemoembolisation (TACE) of unresectable hepatocellular carcinoma (HCC). Ten patients with solitary, unresectable HCC underwent CEUS before, 2 days after, and 35 to 40 days after TACE using a standard dose (4 ml) of drug-eluting beads (DC Beads; Biocompatibles, Surrey, UK) preloaded with doxorubicin (25 mg doxorubicin/ml hydrated beads). For CEUS, a second-generation contrast agent (SonoVue, Bracco, Milan, Italy) and a low mechanical-index technique were used. A part of the tumor was characterized as necrotic if it showed complete lack of enhancement. The percentage of necrosis was calculated at the sonographic section that depicted the largest diameter of the tumor. Differences in the extent of early (2 days after TACE) and delayed (35 to 40 days after TACE) necrosis were quantitatively and subjectively assessed. Early post-TACE tumor necrosis ranged from 21% to 70% (mean 43.5% ± 19%). There was a statistically significant (p = 0.0012, paired Student t test) higher percentage of delayed tumor necrosis, which ranged from 24% to 88% (mean 52.3% ± 20.3%). Subjective evaluation showed a delayed obvious increase of the necrotic areas in 5 patients. In 2 patients, tumor vessels that initially remained patent disappeared on the delayed follow-up. A part of tumor necrosis after chemoembolisation of HCC with DEB seems to take place later than 2 days after TACE. CEUS may provide evidence for the sustained antitumor effect of DEB-TACE. Nevertheless, the ideal time for the imaging evaluation of tumor response remains to be defined.

  8. Effect of trimetazidine on recurrent angina pectoris and left ventricular structure in elderly multivessel coronary heart disease patients with diabetes mellitus after drug-eluting stent implantation: a single-centre, prospective, randomized, double-blind study at 2-year follow-up.

    Science.gov (United States)

    Xu, Xiaohan; Zhang, Weijun; Zhou, Yujie; Zhao, Yingxin; Liu, Yuyang; Shi, Dongmei; Zhou, Zhiming; Ma, Hanying; Wang, Zhijian; Yu, Miao; Ma, Qian; Gao, Fei; Shen, Hua; Zhang, Jianwei

    2014-04-01

    Trimetazidine has been shown to improve angina pectoris and left ventricular (LV) function in diabetic patients with ischaemic cardiomyopathy. The objective of this study was to evaluate the effects of trimetazidine on recurrent angina pectoris and LV structure after drug-eluting stent (DES) implantation in elderly multivessel coronary heart disease (CHD) patients with diabetes mellitus (DM) and a left ventricular ejection fraction (LVEF) of ≥ 50 %. This was a single-centre, prospective, randomized, double-blind evaluation study. Between January 2010 and September 2010, 700 CHD patients with DM who were aged ≥ 65 years and undergoing coronary angiography at An Zhen Hospital (Beijing, China) were recruited and prospectively randomized to receive trimetazidine (20 mg three times daily) or placebo after DES implantation as an addition to conventional CHD treatment. The primary end points were the incidence of recurrent angina pectoris and measures of various echocardiographic parameters, which included LVEF. At 2-year follow-up, patients in the trimetazidine group (n = 255) showed significant improvements in the incidence (P = 0.024) and severity of angina pectoris, compared with the control group, as well as silent myocardial ischaemia (P = 0.009) and angina pectoris-free survival (P = 0.011). LV function and structure in trimetazidine-treated patients were relatively stable at 2-year follow-up, while they deteriorated in the control group (n = 255) with a significant difference between groups (all P angina pectoris as well as LV function and structure in elderly multivessel CHD patients with DM.

  9. Biodegradable-Polymer Biolimus-Eluting Stents versus Durable-Polymer Everolimus-Eluting Stents at One-Year Follow-Up: A Registry-Based Cohort Study.

    Science.gov (United States)

    Parsa, Ehsan; Saroukhani, Sepideh; Majlessi, Fereshteh; Poorhosseini, Hamidreza; Lofti-Tokaldany, Masoumeh; Jalali, Arash; Salarifar, Mojtaba; Nematipour, Ebrahim; Alidoosti, Mohammad; Aghajani, Hassan; Amirzadegan, Alireza; Kassaian, Seyed Ebrahim

    2016-04-01

    We compared outcomes of percutaneous coronary intervention patients who received biodegradable-polymer biolimus-eluting stents with those who received durable-polymer everolimus-eluting stents. At Tehran Heart Center, we performed a retrospective analysis of the data from January 2007 through December 2011 on 3,270 consecutive patients with coronary artery disease who underwent percutaneous coronary intervention with the biodegradable-polymer biolimus-eluting stent or the durable-polymer everolimus-eluting stent. We excluded patients with histories of coronary artery bypass grafting or percutaneous coronary intervention, acute ST-segment-elevation myocardial infarction, or the implantation of 2 different stent types. Patients were monitored for 12 months. The primary endpoint was a major adverse cardiac event, defined as a composite of death, nonfatal myocardial infarction, and target-vessel and target-lesion revascularization. Durable-polymer everolimus-eluting stents were implanted in 2,648 (81%) and biodegradable-polymer biolimus-eluting stents in 622 (19%) of the study population. There was no significant difference between the 2 groups (2.7% vs 2.7%; P=0.984) in the incidence of major adverse cardiac events. The cumulative adjusted probability of major adverse cardiac events in the biodegradable-polymer biolimus-eluting stent group did not differ from that of such events in the durable-polymer everolimus-eluting stent group (hazard ratio=0.768; 95% confidence interval, 0.421-1.44; P=0.388). We conclude that in our patients the biodegradable-polymer biolimus-eluting stent was as effective and safe, during the 12-month follow-up period, as was the durable-polymer everolimus-eluting stent.

  10. Mechanisms and Patterns of Intravascular Ultrasound In-Stent Restenosis Among Bare Metal Stents and First- and Second-Generation Drug-Eluting Stents.

    Science.gov (United States)

    Goto, Kosaku; Zhao, Zhijing; Matsumura, Mitsuaki; Dohi, Tomotaka; Kobayashi, Nobuaki; Kirtane, Ajay J; Rabbani, LeRoy E; Collins, Michael B; Parikh, Manish A; Kodali, Susheel K; Leon, Martin B; Moses, Jeffrey W; Mintz, Gary S; Maehara, Akiko

    2015-11-01

    The most common causes of in-stent restenosis (ISR) are intimal hyperplasia and stent under expansion. The purpose of this study was to use intravascular ultrasound (IVUS) to compare the ISR mechanisms of bare metal stents (BMS), first-generation drug-eluting stents (DES), and second-generation DES. There were 298 ISR lesions including 52 BMS, 73 sirolimus-eluting stents, 52 paclitaxel-eluting stents, 16 zotarolimus-eluting stents, and 105 everolimus-eluting stent. Mean patient age was 66.6 ± 1.1 years, 74.2% were men, and 48.3% had diabetes mellitus. BMS restenosis presented later (70.0 ± 66.7 months) with more intimal hyperplasia compared with DES (BMS 58.6 ± 15.5%, first-generation DES 52.6 ± 20.9%, second-generation DES 48.2 ± 22.2%, p = 0.02). Although reference lumen areas were similar in BMS and first- and second-generation DES, restenotic DES were longer (BMS 21.8 ± 13.5 mm, first-generation DES 29.4 ± 16.1 mm, second-generation DES 32.1 ± 18.7 mm, p = 0.003), and stent areas were smaller (BMS 7.2 ± 2.4 mm(2), first-generation DES 6.1 ± 2.1 mm(2), second-generation DES 5.7 ± 2.0 mm(2), p Stent fracture was seen only in DES (first-generation DES 7 [5.0%], second-generation DES 8 [7.4%], p = 0.13). In conclusion, restenotic first- and second-generation DES were characterized by less neointimal hyperplasia, smaller stent areas, longer stent lengths, and more stent fractures than restenotic BMS. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. [Anti-rheumatic therapy in patients with rheumatoid arthritis undergoing hemodialysis].

    Science.gov (United States)

    Akiyama, Yuji

    2011-01-01

    Hemodialysis (HD) patients have been increasing recently. Some rheumatoid arthritis (RA) patients need hemodialysis (HD), though the proportion is not high. At present, such patients are almost treated with corticosteroids and/or nonsteroidal anti-inflammatory drugs alone, even if they have a high disease activity that would require disease-modifying anti-rheumatic drug (DMARD) therapy, partly because the safety of DMARDs in RA patients with end-stage renal disease has not been confirmed. Their joint destruction would be inevitable and lead to impaired activities of daily living. As there are no guidelines for the use of DMARDs in HD patients, here I reviewed the previous reports about the treatment of DMARDs including biologics for patients with RA undergoing HD.

  12. Bioabsorbable drug-eluting vascular scaffold for the treatment of coronary in-stent restenosis: A two center registry

    International Nuclear Information System (INIS)

    Moscarella, Elisabetta; Varricchio, Attilio; Stabile, Eugenio; Franzone, Anna; Granata, Francesco; Rapacciuolo, Antonio; Galasso, Gennaro; Capozzolo, Claudia; Cirillo, Plinio

    2015-01-01

    Background/purpose: Coronary in-stent restenosis (ISR) is a clinical problem for which a satisfactory solution has not been found yet. Bioabsorbable drug eluting vascular scaffolds (BVSs) provide transient vessel scaffolding combined with prolonged drug delivery capability. The aim of this study was to investigate the safety of BVS for the treatment of coronary ISR. Methods/materials: Between January 2013 and June 2013, 27 patients (31 lesions), presenting with either stable or unstable angina due to coronary ISR, were enrolled in a single arm, prospective, open label registry. Primary end point was the occurrence of target vessel revascularization (TVR) at 12 months. Secondary end point was the composite of death, myocardial infarction and TVR at 12 months. Results: A diffuse ISR pattern was present in 70% of the lesions; mean lesion length was 34.6 ± 15. BVS was successfully implanted in all patients with no in hospital MACE. At twelve months of follow up, MACE rate was 18.5%. One patient died for non-cardiac reason, one patient died due to a possible stent thrombosis and TVR was necessary in 3 patients (11.1%). Conclusions: Our data suggest that BVS is safe and technically feasible for treatment of long and diffuse coronary ISR. These data could be considered hypothesis generator for a randomized clinical trial. - Highlights: • A safe therapeutic option for the treatment of diffuse ISR; • Technically feasible; • Associated to a low rate of restenosis recurrence at nine month.

  13. Bioabsorbable drug-eluting vascular scaffold for the treatment of coronary in-stent restenosis: A two center registry

    Energy Technology Data Exchange (ETDEWEB)

    Moscarella, Elisabetta [Division of Cardiology, Seconda Università degli studi di Napoli, AO Dei cColli, PO Monaldi (Italy); Varricchio, Attilio [Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli “Federico II”, Napoli (Italy); Stabile, Eugenio, E-mail: geko50@hotmail.com [Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero “Monaldi”, Azienda Ospedaliera “Dei Colli”, Napoli (Italy); Franzone, Anna [Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero “Monaldi”, Azienda Ospedaliera “Dei Colli”, Napoli (Italy); Granata, Francesco [Division of Cardiology, Seconda Università degli studi di Napoli, AO Dei cColli, PO Monaldi (Italy); Rapacciuolo, Antonio; Galasso, Gennaro [Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero “Monaldi”, Azienda Ospedaliera “Dei Colli”, Napoli (Italy); Capozzolo, Claudia [Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli “Federico II”, Napoli (Italy); Cirillo, Plinio [Laboratory of Invasive Cardiology, Dipartimento di Cardiologia, Presidio Ospedaliero “Monaldi”, Azienda Ospedaliera “Dei Colli”, Napoli (Italy); and others

    2015-10-15

    Background/purpose: Coronary in-stent restenosis (ISR) is a clinical problem for which a satisfactory solution has not been found yet. Bioabsorbable drug eluting vascular scaffolds (BVSs) provide transient vessel scaffolding combined with prolonged drug delivery capability. The aim of this study was to investigate the safety of BVS for the treatment of coronary ISR. Methods/materials: Between January 2013 and June 2013, 27 patients (31 lesions), presenting with either stable or unstable angina due to coronary ISR, were enrolled in a single arm, prospective, open label registry. Primary end point was the occurrence of target vessel revascularization (TVR) at 12 months. Secondary end point was the composite of death, myocardial infarction and TVR at 12 months. Results: A diffuse ISR pattern was present in 70% of the lesions; mean lesion length was 34.6 ± 15. BVS was successfully implanted in all patients with no in hospital MACE. At twelve months of follow up, MACE rate was 18.5%. One patient died for non-cardiac reason, one patient died due to a possible stent thrombosis and TVR was necessary in 3 patients (11.1%). Conclusions: Our data suggest that BVS is safe and technically feasible for treatment of long and diffuse coronary ISR. These data could be considered hypothesis generator for a randomized clinical trial. - Highlights: • A safe therapeutic option for the treatment of diffuse ISR; • Technically feasible; • Associated to a low rate of restenosis recurrence at nine month.

  14. Comparison of outcome in 1809 patients treated with drug-eluting stents or bare-metal stents in a real-world setting

    Directory of Open Access Journals (Sweden)

    Vogt A

    2011-11-01

    Full Text Available Alexander Vogt1, Anke Schoelmerich1, Franziska Pollner1, Manuela Schlitt1, Uwe Raaz1, Lars Maegdefessel2, Iris Reindl1, Michael Buerke1, Karl Werdan1, Axel Schlitt11Department of Medicine III, Martin Luther-University, Halle, Germany; 2Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, CA, USAPurpose: The aim of this study was to determine the long-term safety of drug-eluting stent (DES versus bare metal stent (BMS implantation in a “real-world” setting.Patients and methods: A total of 1809 patients who were treated with implantation of either BMS or DES were assessed. Kaplan-Meier and multivariate Cox regression analyses concerning primary endpoint of cardiac mortality were performed.Results: A total of 609 patients received DES. Mean age was 66.2 ± 11.3 years, 69.4% were male, and 1517 (83.8% were treated for acute coronary syndrome (unstable angina 510 [28.2%], non-ST-elevation myocardial infarction [NSTEMI] 506 [28.0%], and ST-elevation myocardial infarction [STEMI] 501 [27.7%]. Mean follow-up was 34 ± 15 months. During follow-up, 268 patients died of cardiac causes (DES 42 [7.3%]; BMS 226 [19.6%]; P < 0.001. Univariate Kaplan-Meier analysis showed an advantage of DES over BMS concerning the primary endpoint (P < 0.001. When adjusting for classic risk factors and additional factors that affect the progression of coronary heart disease (CHD, DES was not found to be superior to BMS (hazard ratio 0.996, 95% confidence interval 0.455–2.182, P = 0.993. Severely impaired renal function was an independent predictor for cardiac mortality after stent implantation.Conclusion: Treatment with DES is safe in the long term, also in patients presenting with STEMI. However, in multivariate analyses it is not superior to BMS treatment.Keywords: coronary stent, outcome, renal insufficiency, myocardial infarction, STEMI

  15. Next generation drug-eluting stents: focus on bioabsorbable platforms and polymers

    Directory of Open Access Journals (Sweden)

    Brendan Doyle

    2009-11-01

    Full Text Available Brendan Doyle, David R Holmes JrDivision of Cardiovascular Diseases, Department of Internal Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota, USAAbstract: The success of drug-eluting stents in preventing restenosis has shifted the focus of new stent development toward enhancing long term safety and efficacy of these devices, while simultaneously eliminating the need for indefinite dual antiplatelet therapy. A technical advance fulfilling these aims would hold tremendous potential to reduce morbidity, mortality and economic costs associated with the percutaneous treatment of coronary artery disease. An attractive approach is the use of bioabsorbable stent designs. These may include stents with different bioabsorbable drugs, bioabsorbable polymers or even bioabsorbable metallic backbones. A device that could achieve excellent acute and long-term results, but disappear completely within months (thereby avoiding the need for prolonged dual antiplatelet therapy, would be a tremendous advance. Too good to be true? We explore here the scientific rationale and prospects for success with this exciting concept.Keywords: percutaneous coronary intervention, biodegradable, bioabsorbable, polymer, stent

  16. Overtime evaluation of the vascular HEALing process after everolimus-eluting stent implantation by optical coherence tomography. The HEAL-EES study

    Energy Technology Data Exchange (ETDEWEB)

    Otsuki, Shuji; Brugaletta, Salvatore, E-mail: sabrugal@clinic.ub.es; Sabaté, Manel; Shiratori, Yoshitaka; Gomez-Monterrosas, Omar; Scalone, Giancarla; Romero-Villafañe, Sebastian; Hernández-Enríquez, Marco; Freixa, Xavier; Martín-Yuste, Victoria; Masotti, Mónica

    2016-06-15

    Purpose: Second-generation drug-eluting stent (DES) have shown a better safety and efficacy as compared to first generation DES due to an improved vascular healing process. This process has not been so far evaluated in vivo in an overtime fashion by optical coherent tomography (OCT). We sought to evaluate the vascular healing process after everolimus-eluting stent (EES) implantation at 6, 9 and 12 months, by OCT. Methods: Consecutive 36 patients undergoing percutaneous coronary intervention with EES were randomized 1:1:1 to receive OCT imaging at 6 (group A), 9 (group B) or 12-month follow-up (group C). One patient from group C was excluded because of target lesion revascularization at 1-month, whereas 5 patients withdraw the informed consent. Finally, 30 patients were analyzed. Results: Neointimal thickness was not different between 3 groups (group A: 99.50 [94.06–127.79] μm, group B: 107.26 [83.48–133.59] μm, group C: 127.67 [102.51–138.49] μm; p = 0.736). Although the percentage of “uncovered struts” was significantly higher in group A as compared to the other groups (8.0% vs. 4.4% vs. 2.9%, respectively; p = 0.180), the ratio of uncovered to total struts per section < 30% was similar between 3 groups (0.3% vs. 0.3% vs. 0%, respectively; p = 1.000). Conclusion: Healing process following EES implantation seems almost completed at 6-month follow-up. These data, which need to be confirmed in a larger study, may support the decision to shorten dual antiplatelet therapy. - Highlights: • Healing process following everolimus-eluting stent implantation is complete at 6-month • There are no difference in RUTTS > 30% between 6, 9 and 12 months analyses. • This finding may support to shorten dual antiplatelet therapy in this context.

  17. Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials

    DEFF Research Database (Denmark)

    Tanimoto, Shuzou; Serruys, Patrick W; Thuesen, Leif

    2007-01-01

    OBJECTIVES: This study sought to evaluate and compare in vivo acute stent recoil of a novel bioabsorbable stent and a metallic stent. BACKGROUND: The bioabsorbable everolimus-eluting coronary stent (BVS) is composed of a poly-L-lactic acid backbone, coated with a bioabsorbable polymer containing...... the antiproliferative drug, everolimus, and expected to be totally metabolized and absorbed in the human body. Because the BVS is made from polymer, it may have more acute recoil than metallic stents in vivo. METHODS: A total of 54 patients, who underwent elective stent implantation for single de novo native coronary...... artery lesions, were enrolled: 27 patients treated with the BVS and 27 patients treated with the everolimus-eluting cobalt chromium stent (EES). Acute absolute recoil, assessed by quantitative coronary angiography, was defined as the difference between mean diameter of the last inflated balloon...

  18. Enhancing cognate target elution efficiency in gel-free chemical proteomics

    Directory of Open Access Journals (Sweden)

    Branka Radic-Sarikas

    2015-12-01

    Full Text Available Gel-free liquid chromatography mass spectrometry coupled to chemical proteomics is a powerful approach for characterizing cellular target profiles of small molecules. We have previously described a fast and efficient elution protocol; however, altered target profiles were observed. We hypothesised that elution conditions critically impact the effectiveness of disrupting drug-protein interactions. Thus, a number of elution conditions were systematically assessed with the aim of improving the recovery of all classes of proteins whilst maintaining compatibility with immunoblotting procedures. A double elution with formic acid combined with urea emerged as the most efficient and generically applicable elution method for chemical proteomics

  19. Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial

    DEFF Research Database (Denmark)

    Rasmussen, Klaus; Maeng, Michael; Kaltoft, Anne

    2010-01-01

    In low-risk patients, the zotarolimus-eluting stent has been shown to reduce rates of restenosis without increasing the risk of stent thrombosis. We compared the efficacy and safety of the zotarolimus-eluting stent versus the sirolimus-eluting stent in patients with coronary artery disease who we...

  20. Impact of Anemia on Platelet Reactivity and Ischemic and Bleeding Risk: From the Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents Study.

    Science.gov (United States)

    Giustino, Gennaro; Kirtane, Ajay J; Baber, Usman; Généreux, Philippe; Witzenbichler, Bernhard; Neumann, Franz-Josef; Weisz, Giora; Maehara, Akiko; Rinaldi, Michael J; Metzger, Christopher; Henry, Timothy D; Cox, David A; Duffy, Peter L; Mazzaferri, Ernest L; Brodie, Bruce R; Stuckey, Thomas D; Gurbel, Paul A; Dangas, George D; Francese, Dominic P; Ozan, Ozgu; Mehran, Roxana; Stone, Gregg W

    2016-06-15

    Anemic patients remain at increased risk of ischemic and bleeding events. Whether the effects of hemoglobin levels on thrombotic and bleeding risk are independent of platelet reactivity on clopidogrel, however, remains unknown. Patients from the Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents study were categorized by the presence of anemia at baseline, defined according the World Health Organization criteria. Platelet reactivity was measured with VerifyNow assay; high platelet reactivity (HPR) on clopidogrel was defined as platelet reactive units value >208. Of 8,413 patients included in the study cohort, 1,816 (21.6%) had anemia. HPR was more prevalent in patients with anemia (58.3% vs 38.4%; p <0.001), an association that persisted after multivariate adjustment (adjusted odds ratio: 2.04; 95% confidence interval [CI]: 1.82 to 2.29; p <0.0001). Patients with anemia had higher 2-year rates of major adverse cardiac events (9.5% vs 5.6%; p <0.0001), major bleeding (11.8% vs 7.7%; p <0.0001), and all-cause mortality (4.0% vs 1.4%; p <0.0001); however, after adjustment for baseline clinical confounders, including HPR, anemia was no longer significantly associated with major adverse cardiac events but was still independently associated with all-cause mortality (adjusted HR 1.61, 95% CI 1.23 to 2.12; p <0.0001) and major bleeding (adjusted HR 1.42, 95% CI 1.20 to 1.68; p <0.0001). The effect of HPR on clinical outcomes was uniform according to anemia status, without evidence of interaction. In conclusion, anemia independently correlated with HPR. After percutaneous coronary intervention with drug-eluting stents, anemia at baseline was significantly associated with higher 2-year hemorrhagic and mortality risk; conversely, its association with ischemic risk was attenuated after multivariate adjustment, including HPR. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Biodegradable drug-eluting nanofiber-enveloped implants for sustained release of high bactericidal concentrations of vancomycin and ceftazidime: in vitro and in vivo studies

    Directory of Open Access Journals (Sweden)

    Hsu YH

    2014-09-01

    Full Text Available Yung-Heng Hsu,1,2 Dave Wei-Chih Chen,1 Chun-Der Tai,3 Ying-Chao Chou,1,2 Shih-Jung Liu,2 Steve Wen-Neng Ueng,1 Err-Cheng Chan4 1Department of Orthopedic Surgery, Chang Gung Memorial Hospital, Guishan Township, 2Department of Mechanical Engineering, Chang Gung University, Guishan Township, 3Graduate Institute of Medical Mechatronics, Chang Gung University, Guishan Township, 4School of Medical Technology, Chang Gung University, Guishan Township, Taiwan Abstract: We developed biodegradable drug-eluting nanofiber-enveloped implants that provided sustained release of vancomycin and ceftazidime. To prepare the biodegradable nanofibrous membranes, poly(D,L-lactide-co-glycolide and the antibiotics were first dissolved in 1,1,1,3,3,3-hexafluoro-2-propanol. They were electrospun into biodegradable drug-eluting membranes, which were then enveloped on the surface of stainless plates. An elution method and a high-performance liquid chromatography assay were employed to characterize the in vivo and in vitro release rates of the antibiotics from the nanofiber-enveloped plates. The results showed that the biodegradable nanofiber-enveloped plates released high concentrations of vancomycin and ceftazidime (well above the minimum inhibitory concentration for more than 3 and 8 weeks in vitro and in vivo, respectively. A bacterial inhibition test was carried out to determine the relative activity of the released antibiotics. The bioactivity ranged from 25% to 100%. In addition, the serum creatinine level remained within the normal range, suggesting that the high vancomycin concentration did not affect renal function. By adopting the electrospinning technique, we will be able to manufacture biodegradable drug-eluting implants for the long-term drug delivery of different antibiotics. Keywords: biodegradable nanofiber-enveloped plates, electrospinning, antibiotics, release characteristics

  2. Optical coherence tomography findings after chronic total occlusion interventions: Insights from the “AngiographiC evaluation of the everolimus-eluting stent in chronic Total occlusions” (ACE-CTO) study (NCT01012869)

    Energy Technology Data Exchange (ETDEWEB)

    Sherbet, Daniel P.; Christopoulos, Georgios; Karatasakis, Aris; Danek, Barbara Anna; Kotsia, Anna; Navara, Rachita; Michael, Tesfaldet T.; Roesle, Michele; Rangan, Bavana V.; Haagen, Donald [VA North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas, TX (United States); Garcia, Santiago [Minneapolis VA Healthcare System and University of Minnesota, Minneapolis, MN (United States); Maniu, Calin [Bon Secours Health System, Suffolk, VA (United States); Pershad, Ashish [Banner Good Samaritan Medical Center, Phoenix, AZ (United States); Abdullah, Shuaib M.; Hastings, Jeffrey L.; Kumbhani, Dharam J.; Luna, Michael; Addo, Tayo; Banerjee, Subhash [VA North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas, TX (United States); Brilakis, Emmanouil S., E-mail: esbrilakis@gmail.com [VA North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas, TX (United States)

    2016-10-15

    Background: There is limited information on optical coherence tomography (OCT) findings after percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs). OCT allows high resolution imaging that can enhance understanding of the vascular response after stenting of chronically occluded vessels. Methods: The Angiographic Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions (ACE-CTO) study collected angiographic and clinical outcomes from 100 patients undergoing CTO PCI with the everolimus-eluting stent (EES). OCT was performed 8-months post stenting in 62 patients. Every third frame was analyzed throughout the course of the stented arterial segment. Lumen contours were semi-automatically traced and stent struts were manually delineated, with automatic measurement of the strut to lumen distance. Struts on the luminal side of the lumen contour were classified as malapposed if the distance to the lumen contour exceeded 0.108 mm. Results: A total of 44,450 struts in 6047 frames were analyzed, of which 4113 9.3%, 95% confidence intervals [CI] 9.0% to 9.5%) were malapposed and 1230 (2.8%, 95% CI 2.6% to 2.9%) were uncovered. Fifty-five of 62 patients (88.7%, 95% CI 78.5% to 98.4%) had at least one malapposed stent strut and 50 patients (80.7%, 95% CI 69.2% to 88.6%) had at least one uncovered stent strut. Mean strut-intimal thickness of the apposed and malapposed struts was 0.126 ± 0.140 mm and − 0.491 ± 0.440 mm, respectively. Conclusion: High rates of stent strut malapposition and incomplete stent strut coverage were observed after CTO PCI using EES, highlighting unique challenges associated with stent implantation in CTOs. - Highlights: • Percutaneous coronary intervention with drug-eluting stents for chronic total occlusion is associated with a 40% rate of binary in-stent restenosis at 8 months • Of patients who receive a drug eluting stent for a chronic total occlusion 88.7% will have stent strut malapposition and 80.7% will

  3. Evaluation of XIENCE V everolimus-eluting and Taxus Express2 paclitaxel-eluting coronary stents in patients with jailed side branches from the SPIRIT IV trial at 2 years.

    Science.gov (United States)

    Forrest, John K; Lansky, Alexandra J; Meller, Stephanie M; Hou, Liming; Sood, Poornima; Applegate, Robert J; Wang, John C; Skelding, Kimberly A; Shah, Aakar; Kereiakes, Dean J; Sudhir, Krishnankutty; Cristea, Ecaterina; Yaqub, Manejeh; Stone, Gregg W

    2013-06-01

    The aim of this study was to determine whether patients from the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions (SPIRIT) IV trial who underwent percutaneous coronary intervention, who had target lesions with jailed side branches, had improved clinical outcomes when treated with the XIENCE V versus Taxus Express(2) drug-eluting stent. In the SPIRIT III randomized trial, patients with target lesions with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had lower 2-year rates of major adverse cardiac events. The SPIRIT IV trial represents a larger more diverse patient population compared with SPIRIT III. In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, 3,687 patients who underwent coronary stenting with up to 3 de novo native coronary artery lesions were randomized 2:1 to receive XIENCE V versus Taxus Express(2) stents. Two-year clinical outcomes of patients with or without jailed side branches after stenting were compared. A jailed side branch was defined as any side branch >1.0 mm in diameter within the target segment being stented, excluding bifurcations deemed to require treatment. Of the 3,687 patients in SPIRIT IV, a total of 1,426 had side branches that were jailed during angioplasty of the target lesion. Patients with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had significantly lower 2-year rates of target lesion failure (6.5% vs 11.9%, p = 0.001), major adverse cardiac events (6.6% vs 12.2%, p = 0.0008), ischemia-driven target vessel revascularization (4.1% vs 7.9%, p = 0.004), and stent thrombosis (0.6% vs 2.8%, p = 0.001). In conclusion, patients with jailed side branches after stenting with XIENCE V compared to Taxus Express(2) devices had superior clinical outcomes at 2 years in the large-scale randomized SPIRIT IV trial. Copyright © 2013 Elsevier Inc. All

  4. Bioabsorbable polymer-coated sirolimus-eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub-study.

    Science.gov (United States)

    Rusinaru, Dan; Vrolix, Mathias; Verheye, Stefan; Chowdhary, Saqib; Schoors, Danny; Di Mario, Carlo; Desmet, Walter; Donohoe, Dennis J; Ormiston, John A; Knape, Charlene; Bezerra, Hiram; Lansky, Alexandra; Wijns, William

    2015-12-01

    We studied coronary vasomotion in patients treated with the Mistent(®) absorbable polymer sirolimus-eluting stent (APSES) and in patients implanted with the Endeavor(®) zotarolimus-eluting stent (ZES). First generation (1st-gen) drug-eluting stents (DES) induce persistent vasomotor dysfunction in the treated coronary artery. It is unknown whether and to what extent the implantation of an absorbable polymer DES impairs coronary vasomotion. This sub-study of the DESSOLVE II trial included 19 APSES Mistent(®) and 10 ZES Endeavor(®) patients. Incremental atrial pacing and quantitative coronary angiography were used to assess vasomotion proximal and distal to the stent and in a reference segment at 9 months after implantation. Percent changes in vessel diameter with pacing versus baseline were calculated and compared. Vasomotor response of the APSES group was also compared with changes observed in a historical group of 17 patients implanted with a 1st-gen sirolimus-eluting stent (SES). Normal vasomotion (vasodilatation) was preserved and of comparable magnitude in the APSES and in the ZES group both proximally (P = 0.34) and distally (P = 0.38) to the stent. This finding was not observed in the 1st-gen SES group showing marked pacing-induced vasoconstriction at both stent edges (P absorbable polymer sirolimus-eluting stent is associated with preserved coronary vasomotion, comparable to that observed after implantation of the Endeavor(®) ZES, and distinct from 1st-gen SES which induce coronary vasomotor dysfunction. © 2015 Wiley Periodicals, Inc.

  5. Toxicity of Irinotecan-Eluting Beads in the Treatment of Hepatic Malignancies: Results of a Multi-Institutional Registry

    International Nuclear Information System (INIS)

    Martin, R. C. G.; Howard, J.; Tomalty, D.; Robbins, K.; Padr, R.; Bosnjakovic, P. M.; Tatum, Cliff

    2010-01-01

    PurposeTo evaluate the predictors of toxicity of drug-eluting beads loaded with irinotecan (DEBIRI) in the treatment of hepatic malignancies.Materials and MethodsA total of 330 patients were enrolled in a prospective, open-label, multicenter, multinational, single-arm study administering two types of drug-eluting beads (DEBIRI and drug-eluting beads loaded with doxorubicin). Complications were graded by Cancer Therapy Evaluation Program's Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. All events requiring additional physician treatment or requiring extended hospital stay or readmission within 30 days were included.ResultsA total of 109 patients received 187 DEBIRI treatments (range 1 to 5 per patient). The most common histology was metastatic colorectal cancer in 76% of patients, cholangiocarcinoma in 7% of patients, and other metastatic disease in 17% of patients. There were 35 patients (19%) with irinotecan treatments who sustained 158 treatment-related adverse events, with the median CTCAE event grade being CTCAE grade 2 (range 1 to 5). The most common adverse events were postembolic symptoms (42%). Multivariate analysis identified pretreatment and treatment-related risk factors as follows: lack of pretreatment with hepatic arterial lidocaine (p = 0.005), ≥3 treatments (p = 0.05), achievement of complete stasis (p = 0.04), treatment with >100 mg DEBIRI in 1 treatment (p = 0.03), and bilirubin >2.0 μg/dl with >50% liver involvement (p = 0.05). These factors were predictive of adverse events and significantly greater hospital length of stay.ConclusionsDEBIRI is safe when appropriate technique and treatment are used. Adverse events can be predicted based on pretreatment- and treatment-related factors, and their occurrence can become part of the informed consent process. Continued standardization of this treatment will lead to fewer adverse events and improved patient quality of life.

  6. Percutaneous coronary intervention with second-generation paclitaxel-eluting stents versus everolimus-eluting stents in United States contemporary practice (REWARDS TLX Trial).

    Science.gov (United States)

    Waksman, Ron; Ghali, Magdi; Goodroe, Randy; Ryan, Thomas; Turco, Mark; Ring, Michael; McGarry, Thomas; Dobies, David; Shammas, Nicolas; Steinberg, Daniel H; Swymelar, Stacy; Kaneshige, Kimberly; Torguson, Rebecca

    2012-10-15

    Registry Experience at the Washington Hospital Center, DES - Taxus Liberte Versus Xience V (REWARDS TLX) is a physician-initiated, retrospective, real-world, multicenter, observational study for all patients >18 years of age subjected to percutaneous coronary intervention with everolimus-eluting stents (EESs) or paclitaxel-eluting stents (PESs). Outcomes of patients receiving a TAXUS Liberté or XIENCE V drug-eluting stent were compared. Baseline clinical, procedural, and follow-up data at 12 months were collected from 10 clinical centers by an electronic data capture system. The study's primary end point was major adverse cardiac events: a composite of all-cause death, Q-wave myocardial infarction, target vessel revascularization, and stent thrombosis. The trial is registered with http://www.clinicaltrials.gov (NCT01134159). Data were entered for 1,195 patients (PES, n = 595; EES, n = 600). Baseline clinical characteristics were similar except for higher dyslipidemia, systemic hypertension, and family history of coronary artery disease in the EES group. In-hospital outcome was similar between groups, with an overall in-hospital stent thrombosis rate of 0.2%. The primary end point at 12 months was similar (EES 7.8% vs 10.8%, p = 0.082). Overall stent thrombosis rate was lower in the EES group (0.3% vs 1.2%, respectively, p = 0.107); however, target lesion revascularization was similar (PES, hazard ratio 1.46, 95% confidence interval 0.98 to 2.19, p = 0.064). There was no difference in overall mortality between groups. In conclusion, second-generation EESs and PESs demonstrated similar efficacy and safety profiles for broadened patient and lesion subsets compared to a selected population from the pivotal trials. However, for composite efficacy and safety end points, EESs outperformed second-generation PESs. Copyright © 2012 Elsevier Inc. All rights reserved.

  7. Factors that affect mass transport from drug eluting stents into the artery wall

    Directory of Open Access Journals (Sweden)

    Walsh Michael T

    2010-03-01

    Full Text Available Abstract Coronary artery disease can be treated by implanting a stent into the blocked region of an artery, thus enabling blood perfusion to distal vessels. Minimally invasive procedures of this nature often result in damage to the arterial tissue culminating in the re-blocking of the vessel. In an effort to alleviate this phenomenon, known as restenosis, drug eluting stents were developed. They are similar in composition to a bare metal stent but encompass a coating with therapeutic agents designed to reduce the overly aggressive healing response that contributes to restenosis. There are many variables that can influence the effectiveness of these therapeutic drugs being transported from the stent coating to and within the artery wall, many of which have been analysed and documented by researchers. However, the physical deformation of the artery substructure due to stent expansion, and its influence on a drugs ability to diffuse evenly within the artery wall have been lacking in published work to date. The paper highlights previous approaches adopted by researchers and proposes the addition of porous artery wall deformation to increase model accuracy.

  8. Urine Creatinine Concentrations in Drug Monitoring Participants and Hospitalized Patients.

    Science.gov (United States)

    Love, Sara A; Seegmiller, Jesse C; Kloss, Julie; Apple, Fred S

    2016-10-01

    Urine drug testing is commonly performed in both clinical and forensic arenas for screening, monitoring and compliance purposes. We sought to determine if urine creatinine concentrations in monitoring program participants were significantly different from hospital in-patients and out-patients undergoing urine drug testing. We retrospectively reviewed urine creatinine submitted in June through December 2015 for all specimens undergoing urine drug testing. The 20,479 creatinine results were categorized as hospitalized patients (H) and monitoring/compliance groups for pain management (P), legal (L) or recovery (R). Median creatinine concentrations (interquartile range, mg/dL) were significantly different (P creatinine concentrations were significantly lower in the R vs. L group (Pcreatinine concentration and may indicate participants' attempts to tamper with their drug test results through dilution means. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  9. Unenhanced and Contrast-Enhanced Ultrasonography During Hepatic Transarterial Embolization and Chemoembolization With Drug-Eluting Beads

    International Nuclear Information System (INIS)

    Moschouris, Hippocrates; Malagari, Katerina; Kornezos, Ioannis; Papadaki, Marina Georgiou; Gkoutzios, Panagiotis; Matsaidonis, Dimitrios

    2010-01-01

    The purpose of this study was to describe and evaluate the findings of unenhanced ultrasonography (US) and contrast-enhanced ultrasonography (CEUS) when these modalities are applied during transarterial embolization (TAE) or transarterial chemoembolization (TACE) of liver tumors. Sixteen tumors (9 hepatocellular carcinomas, 5 metastases from colorectal cancer, and 2 hemangiomas) were treated with TAE with microspheres and/or TACE with drug-eluting beads. All of these lesions were studied with intraprocedural unenhanced US and 12 were studied with intraprocedural CEUS. For the latter, a second-generation echo-enhancer (SonoVue; Bracco, Milan, Italy) and a low mechanical index technique were used. Intraprocedural findings were classified according to an arbitrary scale and were compared with pretreatment imaging (CEUS and computed tomography or CEUS and magnetic resonance imaging), with postembolization angiography, and with follow-up results. On unenhanced intraprocedural US, 13 of 16 tumors demonstrated intralesional high-level echoes of varying extent. These feature correlated poorly (r = 0.33, p = 0.097) with and generally underestimated the actual extent of necrosis. Exceptionally, high-level echoes that occupied the largest part of the treated lesions were associated with >50% tumor necrosis. Intraprocedural CEUS clearly depicted immediate partial or complete disappearance of tumor enhancement as a result of TAE/TACE. Three of 6 tumors with complete devascularization on postembolization angiogram showed residual enhancement on intraprocedural CEUS. Intraprocedural CEUS findings correlated closely (r = 0.91, p = 0.002) with follow-up findings. Intraprocedural sonography, particularly with echo-enhancers, could be used for intraprocedural monitoring in selected cases of liver tumors that undergo TAE or TACE.

  10. Cefoperazone and cefoperazone-sulbactam susceptibility tests with anaerobic bacteria by the thioglycolate disk elution method.

    OpenAIRE

    Barry, A L; Packer, R R; Jones, R N

    1985-01-01

    Tests were performed with 104 anaerobic microorganisms to evaluate the thioglycolate disk elution technique for the detection of resistance to cefoperazone and cefoperazone-sulbactam. An unacceptably high false-resistance rate and a poor reproducibility record make the disk elution procedure unsatisfactory for routine testing of this drug or combination of drugs.

  11. Drug-eluting stents appear superior to bare metal stents for vein-graft PCI in vessels up to a stent diameter of 4 mm

    Directory of Open Access Journals (Sweden)

    Oliver P. Guttmann

    2016-05-01

    Full Text Available BackgroundResearch trials have shown improved short-term outcome with drug-eluting stents (DES over bare metal stents (BMS in saphenous vein graft (SVG percutaneous coronary intervention (PCI, primarily by reducing target vessel revascularization (TVR for in-stent restenosis. We compared the outcomes in patients undergoing SVG stent implantation treated with DES or BMS. In exploratory analyses we investigated the influence of stent generation and diameter.MethodsData were obtained from a prospective database of 657 patients who underwent PCI for SVG lesions between 2003 and 2011. A total of 344 patients had PCI with BMS and 313 with DES. Propensity scores were developed based on 15 observed baseline covariates in a logistic regression model with stent type as the dependent variable. The nearest-neighbour-matching algorithm with Greedy 5-1 Digit Matching was used to produce two patient cohorts of 313 patients each. We assessed major adverse cardiac events (MACE out to a median of 3.3 years (interquartile range: 2.1-4.1. MACE was defined as all-cause mortality, myocardial infarction (MI, TVR and stroke.ResultsThere was a significant difference in MACE between the two groups in favour of DES (17.9% DES vs. 31.2% BMS group; p = 0.0017 over the 5-year follow-up period. MACE was driven by increased TVR in the BMS group. There was no difference in death, MI or stroke. Adjusted Cox analysis confirmed a decreased risk of MACE for DES compared with BMS 0.75 (95% confidence interval (CI 0.52-0.94, with no difference in the hazard of all-cause mortality (hazard ratio: 1.08; 95% CI: 0.77-1.68. However, when looking at stent diameters greater than 4 mm, no difference was seen in MACE rates between BMS and DES.ConclusionsOverall in our cohort of patients who had PCI for SVG disease, DES use resulted in lower MACE rates compared with BMS over a 5-year follow-up period; however, for stent diameters over 4 mm no difference in MACE rates was seen.

  12. Impact of stent length on clinical outcomes of first-generation and new-generation drug-eluting stents.

    Science.gov (United States)

    Konishi, Hirokazu; Miyauchi, Katsumi; Dohi, Tomotaka; Tsuboi, Shuta; Ogita, Manabu; Naito, Ryo; Kasai, Takatoshi; Tamura, Hiroshi; Okazaki, Shinya; Isoda, Kikuo; Daida, Hiroyuki

    2016-04-01

    The aim of this study is to compare first- and new-generation drug-eluting stents (DESs) which are implanted in long lesion. Stent length is known to be a predictor of adverse events after percutaneous coronary intervention (PCI), even with the first-generation DESs. The introduction of new-generation DESs has reduced the rates of adverse clinical events. However, the impact of stent length on long-term clinical outcomes is not well known. A total of 1181 consecutive patients who underwent PCI using either a first-generation DES (n = 885) or a new-generation DES (n = 296) between 2004 and 2011 were investigated. In each of the stent groups, the patients were divided into two groups by stent length (>32 and ≤32 mm) and compared. During the follow-up period, the incidence of major adverse cardiac events (MACEs) was significantly higher for patients with long stents implanted than with short stents (P stent groups in the new-generation DES group (P = 0.24; log-rank test). On multivariate Cox regression analysis, stent length was not associated with adverse events in the new-generation DES groups [hazard ratio (HR) 0.87; 95 % confidence interval (95 % CI) 0.71-1.04; P = 0.14]. Implanted stent length was significantly associated with a higher risk of MACEs in patients who received first-generation DESs, but not in patients who received the new-generation DESs.

  13. Bradycardia Associated With Drug-Eluting Beads Loaded With Irinotecan (DEBIRI) Infusion for Colorectal Liver Metastases

    International Nuclear Information System (INIS)

    Pua, Uei

    2013-01-01

    Intra-arterial injection of drug-eluting beads loaded with irinotecan (DEBIRI) is a new treatment option being investigated, with encouraging results, for unresectable colorectal liver metastases that are refractory to systemic chemotherapy (Martin et al., Ann Surg Oncol 18:192–198, 2011). Toxicity related to DEBIRI has also been described (Martin et al., Cardiovasc Intervent Radiol 33:960–966, 2010). Nevertheless, experience and literature related to DEBIRI remain limited, and experience with this treatment is expected to increase. The purpose of this article is to describe bradycardia occurring during DEBIRI administration, which has not been reported thus far.

  14. Bradycardia Associated With Drug-Eluting Beads Loaded With Irinotecan (DEBIRI) Infusion for Colorectal Liver Metastases

    Energy Technology Data Exchange (ETDEWEB)

    Pua, Uei, E-mail: druei@yahoo.com [Tan Tock Seng Hospital, Department of Diagnostic Radiology (Singapore)

    2013-06-15

    Intra-arterial injection of drug-eluting beads loaded with irinotecan (DEBIRI) is a new treatment option being investigated, with encouraging results, for unresectable colorectal liver metastases that are refractory to systemic chemotherapy (Martin et al., Ann Surg Oncol 18:192-198, 2011). Toxicity related to DEBIRI has also been described (Martin et al., Cardiovasc Intervent Radiol 33:960-966, 2010). Nevertheless, experience and literature related to DEBIRI remain limited, and experience with this treatment is expected to increase. The purpose of this article is to describe bradycardia occurring during DEBIRI administration, which has not been reported thus far.

  15. Optical Coherence Tomography Findings in Patients With Stent Thrombosis.

    Science.gov (United States)

    Cuesta, Javier; Rivero, Fernando; Bastante, Teresa; García-Guimaraes, Marcos; Antuña, Paula; Alvarado, Teresa; Navarrete, Gonzalo; Benedicto, Amparo; Alfonso, Fernando

    2017-12-01

    Stent thrombosis (ST) is a rare but potentially serious complication. Optical coherence tomography (OCT) provides high-resolution images and additional information to angiography in the study of this event. Prospective study of patients with ST undergoing reintervention with OCT imaging. The study included a total of 40 consecutive patients with ST. Mean age was 69 ± 13 years and 83% were male. Early ST (≤ 30 days) was observed in 16 patients and late ST (> 30 days) in 24 patients. Stent thrombosis occurred in 17 bare-metal stents and 23 drug-eluting stents. In 34 patients (85%), adequate OCT images were obtained at the time of the ST. The predominant mechanism in early ST was stent malapposition (39%). In late ST, high frequencies of uncovered (46%) and malapposed struts (17%) were observed, especially in patients with drug-eluting stents. Furthermore, the presence of neoatherosclerosis was very high (67%) in patients with late ST. After intervention, improvements were observed in malapposition length and the amount of residual thrombus. OCT allows identification of the underlying mechanisms potentially involved in ST. This imaging modality is helpful in guiding reintervention in these patients, which improves the area and length of malapposition, as well as the maximal residual thrombus area. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  16. Efficacy and safety of tacrolimus treatment for rheumatoid arthritis patients undergoing hemodialysis.

    Science.gov (United States)

    Yamashita, Misuzu; Natsumeda, Masamitsu; Takasugi, Koji; Ueno, Akiko; Ezawa, Kayo; Ezawa, Kazuhiko

    2008-01-01

    Rheumatoid arthritis (RA) is an autoimmune disorder characterized by progressive joint destruction that requires aggressive treatment using appropriate disease-modifying antirheumatic drugs (DMARDs). RA patients with renal failure, however, are intolerant to most DMARDs due to the potential toxicity. In Japan, tacrolimus was approved for the treatment of RA in 2005. Based on its pharmacokinetics, tacrolimus may be administered to the patients undergoing hemodialysis. We report two cases of RA patients on hemodialysis treated effectively and safely with tacrolimus.

  17. Expression of Drug-Resistant Factor Genes in Hepatocellular Carcinoma Patients Undergoing Chemotherapy with Platinum Complex by Arterial Infusion

    Directory of Open Access Journals (Sweden)

    Shiro Ueda

    2010-09-01

    Full Text Available This study investigated gene expression of drug resistance factors in biopsy tissue samples from hepatocellular carcinoma (HCC patients undergoing chemotherapy by platinum complex. Liver biopsy was performed to collect tissue from the tumor site (T and the non-tumor site (NT prior to the start of treatment. For drug-resistant factors, drug excretion transporters cMOAT and MDR-1, intracellular metal binding protein MT2, DNA repair enzyme ERCC-l and inter-nucleic cell transport protein MVP, were investigated. The comparison of the expression between T and NT indicated a significant decrease of MT2 and MDR-1 in T while a significant increase in ERCC-1 was noted in T. Further, expression was compared between the response cases and non-response cases using the ratios of expression in T to those in NT. The response rate was significantly low in the high expression group when the cutoff value of cMOAT and MT2 was set at 1.5 and 1.0, respectively. Furthermore, when the patients were classified into A group (cMOAT ≧ 1.5 or MT2 ≧ 1.0 and B group (cMOAT < 1.5 and MT2 < 1.0, the response rate of A group was significantly lower than B group when we combined the cutoff values of cMOAT and MT2. It is considered possible to estimate the therapeutic effect of platinum complex at a high probability by combining the expression condition of these two genes.

  18. Heparin monotherapy or bivalirudin during percutaneous coronary intervention in patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease: results from the Evaluation of Drug-Eluting Stents and Ischemic Events registry.

    Science.gov (United States)

    Bangalore, Sripal; Pencina, Michael J; Kleiman, Neal S; Cohen, David J

    2014-06-01

    The use of bivalirudin versus unfractionated heparin monotherapy in patients without ST-segment-elevation myocardial infarction is not well defined. The study population consisted of patients enrolled in the Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) registry with either non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease, who underwent percutaneous coronary intervention with either unfractionated heparin or bivalirudin monotherapy. Propensity score matching was used to adjust for baseline characteristics. The primary bleeding (in-hospital composite bleeding-access site bleeding, thrombolysis in myocardial infarction major/minor bleeding, or transfusion) and primary (in-hospital death/myocardial infarction) and secondary ischemic outcomes (death/myocardial infarction/unplanned repeat revascularization at 12 months) were evaluated. Propensity score matching yielded 1036 patients with non-ST-segment-elevation acute coronary syndromes and 2062 patients with stable ischemic heart disease. For the non-ST-segment-elevation acute coronary syndrome cohort, bivalirudin use was associated with lower bleeding (difference, -3.3% [-0.8% to -5.8%]; P=0.01; number need to treat=30) without increase in either primary (difference, 1.2% [4.1% to -1.8%]; P=0.45) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% [1.3% to -1.3%]; P=1.00). Similarly, in the stable ischemic heart disease cohort, bivalirudin use was associated with lower bleeding (difference, -1.8% [-0.4% to -3.3%]; P=0.01; number need to treat=53) without increase in either primary (difference, 0.4% [2.3% to -1.5%]; P=0.70) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% [0.7% to -0.7%]; P=1.00) when compared with unfractionated heparin monotherapy. Among patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease undergoing percutaneous coronary intervention, bivalirudin use

  19. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials.

    Science.gov (United States)

    Muramatsu, Takashi; Onuma, Yoshinobu; van Geuns, Robert-Jan; Chevalier, Bernard; Patel, Tejas M; Seth, Ashok; Diletti, Roberto; García-García, Hector M; Dorange, Cécile C; Veldhof, Susan; Cheong, Wai-Fung; Ozaki, Yukio; Whitbourn, Robert; Bartorelli, Antonio; Stone, Gregg W; Abizaid, Alexandre; Serruys, Patrick W

    2014-05-01

    The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS). Clinical outcomes of diabetic patients after BVS implantation have been unreported. This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up. The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group). In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and

  20. Association of localized hypersensitivity and in-stent neoatherosclerosis with the very late drug-eluting stent thrombosis.

    Directory of Open Access Journals (Sweden)

    Kyohei Yamaji

    Full Text Available Localized hypersensitivity reaction, delayed arterial healing, and neoatherosclerosis inside the stent have been suggested as the underlying pathologic mechanisms of very late stent thrombosis (VLST of drug-eluting stent (DES. The present study sought to explore the prevalence of inflammatory cell infiltrates and evidence for fragments of atherosclerotic plaques in the aspirated thrombi in patients with DES VLST.From April 2004 to September 2012, 48 patients with stent thrombosis (ST of DES underwent thrombus aspiration with retrieved material sufficient for the histopathologic analysis; early ST (EST, within 30 days: N = 17, late ST (LST, between 31 and 365 days: N = 7, and very late ST (VLST, >1 year: N = 24. Eosinophil fraction in the aspirated thrombi was significantly higher in patients with VLST (8.2±5.7% as compared with those with EST (4.3±3.0% and LST (5.5±3.8% (P = 0.03. Eosinophil fraction in the aspirated thrombi was significantly higher in 12 VLST patients with angiographic peri-stent contrast staining (PSS and/or incomplete stent apposition (ISA by intravascular ultrasound than in 12 VLST patients without PSS or ISA (10.6±6.1% versus 5.8±4.1%, P = 0.03. Evidences for fragments of atherosclerotic plaques in the aspirated thrombi were observed only in 3 (13% out of 24 patients with DES VLST.Eosinophil fraction in the aspirated thrombi was significantly higher in patients with DES VLST as compared with those with EST and LST. Evidences for fragments of atherosclerotic plaques were relatively uncommon in patients with DES VLST.

  1. Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: The PLUS-ONE first-in-man study

    International Nuclear Information System (INIS)

    Calderas, Carlos; Condado, Jose Francisco; Condado, Jose Antonio; Flores, Alejandra; Mueller, Amy; Thomas, Jack; Nakatani, Daisaku; Honda, Yasuhiro; Waseda, Katsuhisa; Fitzgerald, Peter

    2014-01-01

    Background: The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol–gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. Methods: A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18 mm, n = 30) or group B (8 μg/18 mm, n = 30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization. Results: Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P = 1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30 mm and 0.34 ± 0.20 mm P = .773). Conclusions: In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol–gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year

  2. Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: the PLUS-ONE first-in-man study.

    Science.gov (United States)

    Calderas, Carlos; Condado, Jose Francisco; Condado, Jose Antonio; Flores, Alejandra; Mueller, Amy; Thomas, Jack; Nakatani, Daisaku; Honda, Yasuhiro; Waseda, Katsuhisa; Fitzgerald, Peter

    2014-01-01

    The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol-gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18mm, n=30) or group B (8 μg/18mm, n=30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization. Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P=1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30mm and 0.34 ± 0.20mm P=.773). In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol-gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year. © 2014.

  3. Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: The PLUS-ONE first-in-man study

    Energy Technology Data Exchange (ETDEWEB)

    Calderas, Carlos [Instituto de Clinicas Urologia Tamanaco, Caracas (Venezuela, Bolivarian Republic of); Condado, Jose Francisco; Condado, Jose Antonio [Hospital Centro Medico de Caracas y Hospital Miguel Perez Carreno, Caracas (Venezuela, Bolivarian Republic of); Flores, Alejandra [Instituto de Clinicas Urologia Tamanaco, Caracas (Venezuela, Bolivarian Republic of); Mueller, Amy; Thomas, Jack [Medlogics Device Corporation, Santa Rosa, CA (United States); Nakatani, Daisaku; Honda, Yasuhiro; Waseda, Katsuhisa [Stanford University, Stanford, CA (United States); Fitzgerald, Peter, E-mail: crci-cvmed@stanford.edu [Stanford University, Stanford, CA (United States)

    2014-01-15

    Background: The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol–gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. Methods: A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18 mm, n = 30) or group B (8 μg/18 mm, n = 30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization. Results: Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P = 1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30 mm and 0.34 ± 0.20 mm P = .773). Conclusions: In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol–gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year.

  4. Safety and patient comfort with iodixanol: a postmarketing surveillance study in 9515 patients undergoing diagnostic CT examinations

    International Nuclear Information System (INIS)

    Haeussler, Marc D.

    2010-01-01

    Background: Iodinated radiographic contrast media are considered safe diagnostic drugs with a low incidence of adverse drug reactions. Purpose: To determine prospectively the incidence and nature of immediate and delayed adverse drug reactions occurring after administration of iodixanol for contrast-enhanced computed tomography (CT) in routine practice in nonselected patients, and to assess patient comfort (pain and sensations of heat or coldness). Material and Methods: Patient characteristics (including demographics, risk factors, indication for CT, and status of the vein used to administer iodixanol) and aspects of iodixanol administration (including dose and volume) were documented on a standardized case report form. Patients were asked to report immediate (during the visit) or delayed (occurring up to 7 days after administration of iodixanol) adverse reactions; those deemed related or possibly related to iodixanol were documented on a standardized adverse drug reaction form. Discomfort was rated by patients on a scale of 0-10 for pain, heat, and coldness; individual scores were combined into a composite score (0-30). Results: Evaluable documentation was provided for 9515 patients in 77 centers across Germany. Adverse drug reactions were reported in 70 patients (0.74%), including hypersensitivity reactions in 55 patients. Thirty patients experienced immediate reactions and 40 experienced delayed reactions. Serious adverse drug reactions were evident in five patients (0.05%). Patients with allergic diathesis appeared to be at increased risk of immediate and delayed adverse drug reactions. Discomfort was generally mild, with 72% of patients reporting a composite score of 0-3. Conclusion: In the outpatient setting, where it is often difficult to properly assess patients for specific risk factors, it was reassuring that iodixanol demonstrated an excellent safety profile in over 9500 patients undergoing diagnostic CT examinations. There were no unexpected serious

  5. Safety and patient comfort with iodixanol: a postmarketing surveillance study in 9515 patients undergoing diagnostic CT examinations

    Energy Technology Data Exchange (ETDEWEB)

    Haeussler, Marc D. (Gemeinschaftspraxis fuer Radiologie und Neurologie, Praxis Mosbach, Mosbach (Germany)), e-mail: info@praxis-mosbach.de

    2010-10-15

    Background: Iodinated radiographic contrast media are considered safe diagnostic drugs with a low incidence of adverse drug reactions. Purpose: To determine prospectively the incidence and nature of immediate and delayed adverse drug reactions occurring after administration of iodixanol for contrast-enhanced computed tomography (CT) in routine practice in nonselected patients, and to assess patient comfort (pain and sensations of heat or coldness). Material and Methods: Patient characteristics (including demographics, risk factors, indication for CT, and status of the vein used to administer iodixanol) and aspects of iodixanol administration (including dose and volume) were documented on a standardized case report form. Patients were asked to report immediate (during the visit) or delayed (occurring up to 7 days after administration of iodixanol) adverse reactions; those deemed related or possibly related to iodixanol were documented on a standardized adverse drug reaction form. Discomfort was rated by patients on a scale of 0-10 for pain, heat, and coldness; individual scores were combined into a composite score (0-30). Results: Evaluable documentation was provided for 9515 patients in 77 centers across Germany. Adverse drug reactions were reported in 70 patients (0.74%), including hypersensitivity reactions in 55 patients. Thirty patients experienced immediate reactions and 40 experienced delayed reactions. Serious adverse drug reactions were evident in five patients (0.05%). Patients with allergic diathesis appeared to be at increased risk of immediate and delayed adverse drug reactions. Discomfort was generally mild, with 72% of patients reporting a composite score of 0-3. Conclusion: In the outpatient setting, where it is often difficult to properly assess patients for specific risk factors, it was reassuring that iodixanol demonstrated an excellent safety profile in over 9500 patients undergoing diagnostic CT examinations. There were no unexpected serious

  6. Association of Adventitial Vasa Vasorum and Inflammation With Coronary Hyperconstriction After Drug-Eluting Stent Implantation in Pigs In Vivo.

    Science.gov (United States)

    Nishimiya, Kensuke; Matsumoto, Yasuharu; Shindo, Tomohiko; Hanawa, Kenichiro; Hasebe, Yuhi; Tsuburaya, Ryuji; Shiroto, Takashi; Takahashi, Jun; Ito, Kenta; Ishibashi-Ueda, Hatsue; Yasuda, Satoshi; Shimokawa, Hiroaki

    2015-01-01

    The importance of adventitial inflammation has been implicated for the pathogenesis of coronary artery disease. However, the roles of adventitial changes in drug-eluting stent (DES)-induced coronary hyperconstriction remain largely unknown. In the present study, this issue in pigs in vivo with a special reference to adventitial vasa vasorum (VV) formation and Rho-kinase activation, a central mechanism of coronary vasospasm, was examined. Each animal received a sirolimus-eluting stent (SES) and a biolimus A9-eluting stent (BES), one in the left anterior descending and another in the left circumflex coronary arteries in a randomized manner (n=18). After 1, 3 and 6 months, coronary vasomotion was examined. At 1 month, coronary vasoconstriction to serotonin was significantly enhanced at the SES edges as compared with the BES edges (SES, 52±7% vs. BES, 22±3%, Pmicro-CT showed VV augmentation at the SES site, extending to the proximal and distal edges. Immunostainings demonstrated that VV formation, macrophage infiltration in the adventitia and Rho-kinase expressions/activation were significantly enhanced at the SES edges as compared with the BES edges. The DES with durable polymers enhances VV formation and inflammation in the adventitia, associating with the pathogenesis of DES-induced coronary hyperconstriction through Rho-kinase activation in pigs in vivo.

  7. Two-Year Clinical Outcomes of Newer-Generation Drug-Eluting Stent Implantation Following Rotational Atherectomy for Heavily Calcified Lesions.

    Science.gov (United States)

    Jinnouchi, Hiroyuki; Kuramitsu, Shoichi; Shinozaki, Tomohiro; Kobayashi, Yohei; Hiromasa, Takashi; Morinaga, Takashi; Mazaki, Toru; Sakakura, Kenichi; Soga, Yoshimitsu; Hyodo, Makoto; Shirai, Shinichi; Ando, Kenji

    2015-01-01

    Clinical outcomes of implantation of the newer-generation drug-eluting stent (DES) following rotational atherectomy for heavily calcified lesions remain unclear in the real-world setting. We enrolled 252 consecutive patients (273 lesions) treated with newer-generation DES following rotational atherectomy. The primary endpoint was the cumulative 2-year incidence of major adverse cardiovascular events (MACE), defined as cardiac death, myocardial infarction, clinically-driven target lesion revascularization, and definite stent thrombosis. Complete clinical follow-up information at 2-year was obtained for all patients. The mean age was 73.2±9.0 years and 155 patients (61.5%) were male. Cumulative 2-year incidence of MACE (cardiac death, myocardial infarction, clinically-driven target lesion revascularization and definite stent thrombosis) was 20.3% (7.0%, 2.1%, 18.1% and 2.1%, respectively). Predictors of MACE were presenting with acute coronary syndrome (hazard ratio [HR]: 3.80, 95% confidence interval [CI]: 1.29-11.2, P=0.02), hemodialysis (HR: 1.93, 95% CI: 1.04-3.56, P=0.04) and previous coronary artery bypass graft (HR: 2.26, 95% CI: 1.02-5.00, P=0.045). PCI for calcified lesions requiring rotational atherectomy is still challenging even in the era of newer-generation DES.

  8. Drug elution from high-dose antibiotic-loaded acrylic cement: a comparative, in vitro study.

    Science.gov (United States)

    Gasparini, Giorgio; De Gori, Marco; Calonego, Giovanni; Della Bora, Tommaso; Caroleo, Benedetto; Galasso, Olimpio

    2014-11-01

    High-dose antibiotic-loaded acrylic cement (ALAC) is used for managing peri-prosthetic joint infections (PJIs). The marked increase in resistant high-virulence bacteria is drawing the attention of physicians toward alternative antimicrobial formulations loaded into acrylic bone cement. The aim of this in vitro study was to determine the elution kinetics of 14 different high-dose ALACs. All ALAC samples showed a burst release of antibiotics in the first hour, progressively decreasing over time, and elution curves strictly adhered to a nonlinear regression analysis formula. Among aminoglycosides, commonly seen as the most appropriate antibiotics to be loaded into the bone cement, the highest elution rate was that of tobramycin. Among the glycopeptides, a class of antibiotics that should be considered to treat PJIs because of the prevalence of aminoglycoside resistance, vancomycin showed better elution than teicoplanin. Clindamycin, which can be associated with aminoglycosides to prepare ALACs and represents a useful option against the most common pathogens responsible for PJIs, showed the highest absolute and relative elutions among all the tested formulations. A noticeable elution was also detected for colistin, an antibiotic of last resort for treating multidrug-resistant bacteria. The current study demonstrates theoretical advantages in the preparation of ALAC for some antibiotics not routinely used in the clinical setting for PJIs. The use of these antibiotics based on the infecting bacteria sensitivity may represent a useful option for physicians to eradicate PJIs. In vivo testing should be considered in the future to confirm the results of this study. Copyright 2014, SLACK Incorporated.

  9. Visible Light Irradiation-Mediated Drug Elution Activity of Nitrogen-Doped TiO2 Nano tubes

    International Nuclear Information System (INIS)

    Oh, S.; Moon, K.S.; Bae, J.M.; Moon, J.H.; Jin, S.

    2013-01-01

    We have developed nitrogen-doped TiO 2 nano tubes showing photo catalytic activity in the visible light region and have investigated the triggered release of antibiotics from these nano tubes in response to remote visible light irradiation. Scanning electron microscopy (SEM) observations indicated that the structure of TiO 2 nano tubes was not destroyed on the conditions of 0.05 and 0.1 M diethanolamine treatment. The results of X-ray photoelectron spectroscopy (XPS) confirmed that nitrogen, in the forms of nitrite (TiO 2 ) and nitrogen monoxide (NO), had been incorporated into the TiO 2 nano tube surface. A drug-release test revealed that the antibiotic-loaded TiO 2 nano tubes showed sustained and prolonged drug elution with the help of polylactic acid. Visible light irradiation tests showed that the antibiotic release from nitrogen-doped nano tubes was significantly higher than that from pure TiO 2 nano tubes (ρ ≨ 0.05).

  10. Impact of lesion morphology on angiographic and clinical outcomes in patients with chronic total occlusion after recanalization with drug-eluting stents: a multislice computed tomography study

    Energy Technology Data Exchange (ETDEWEB)

    Ito, Tsuyoshi [Toyohashi Heart Center, Toyohashi (Japan); Nagoya City University Graduate School of Medical Sciences, Department of Cardio-Renal Medicine and Hypertension, Nagoya (Japan); Tsuchikane, Etsuo; Nasu, Kenya; Kimura, Masashi; Terashima, Mitsuyasu; Kinoshita, Yoshihisa; Habara, Maoto; Suzuki, Takahiko [Toyohashi Heart Center, Toyohashi (Japan); Suzuki, Yoriyasu; Ehara, Mariko [Nagoya Heart Center, Nagoya (Japan); Ohte, Nobuyuki [Nagoya City University Graduate School of Medical Sciences, Department of Cardio-Renal Medicine and Hypertension, Nagoya (Japan)

    2015-10-15

    The aim of this study was to investigate the multislice computed tomography (MSCT) parameters associated with adverse outcomes after chronic total occlusion percutaneous coronary intervention (CTO-PCI) with drug-eluting stents. A total of 285 patients who underwent MSCT before CTO-PCI were analyzed. Lesion morphology was assessed with MSCT. Angiographic restenosis, reocclusion, and MACE (a composite of cardiac death, myocardial infarction, stent thrombosis, and target lesion revascularization) were analyzed. MACE was observed in 36 patients (13.6 %). Occlusion length was greater (39.5 ± 19.9 mm vs. 22.3 ± 13.7 mm, p < 0.01), minimal vessel area smaller (11.2 ± 5.7 mm{sup 2} vs. 14.5 ± 5.6 mm{sup 2}, p < 0.01), and severe calcification more common (36 % vs. 12 %, p < 0.01) in the MACE group compared to the non-MACE group. We defined occluded length >25.4 mm, minimal vessel area <11.9 mm{sup 2}, which were identified by receiver operating characteristic analysis, and severe calcification as CT-derived risk factors. Angiographic restenosis (60 % vs. 12 % vs. 7 %, p < 0.01), reocclusion (29 % vs. 2 % vs. 2 %, p < 0.01), and MACE (43 % vs. 6 % vs. 3 %, p < 0.01) were more common in patients with 2 or more risk factors than in those with 1 or 0. MSCT characteristics associated with adverse outcomes after CTO-PCI were occlusion length, minimal vessel area, and severe calcification. (orig.)

  11. Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care (SORT OUT III): a randomised controlled superiority trial

    DEFF Research Database (Denmark)

    Rasmussen, Klaus; Maeng, Michael; Kaltoft, Anne

    2010-01-01

    BACKGROUND: In low-risk patients, the zotarolimus-eluting stent has been shown to reduce rates of restenosis without increasing the risk of stent thrombosis. We compared the efficacy and safety of the zotarolimus-eluting stent versus the sirolimus-eluting stent in patients with coronary artery...... disease who were receiving routine clinical care with no direct follow-up. METHODS: We did a single-blind, all-comer superiority trial in adult patients with chronic stable coronary artery disease or acute coronary syndromes, and at least one target lesion. Patients were treated at one of five...... Danish administrative and health-care registries. The primary endpoint was a composite of major adverse cardiac events within 9 months: cardiac death, myocardial infarction, and target vessel revascularisation. Intention-to-treat analyses were done at 9-month and 18-month follow-up. This trial...

  12. Endothelial cell repopulation after stenting determines in-stent neointima formation: effects of bare-metal vs. drug-eluting stents and genetic endothelial cell modification.

    Science.gov (United States)

    Douglas, Gillian; Van Kampen, Erik; Hale, Ashley B; McNeill, Eileen; Patel, Jyoti; Crabtree, Mark J; Ali, Ziad; Hoerr, Robert A; Alp, Nicholas J; Channon, Keith M

    2013-11-01

    Understanding endothelial cell repopulation post-stenting and how this modulates in-stent restenosis is critical to improving arterial healing post-stenting. We used a novel murine stent model to investigate endothelial cell repopulation post-stenting, comparing the response of drug-eluting stents with a primary genetic modification to improve endothelial cell function. Endothelial cell repopulation was assessed en face in stented arteries in ApoE(-/-) mice with endothelial-specific LacZ expression. Stent deployment resulted in near-complete denudation of endothelium, but was followed by endothelial cell repopulation, by cells originating from both bone marrow-derived endothelial progenitor cells and from the adjacent vasculature. Paclitaxel-eluting stents reduced neointima formation (0.423 ± 0.065 vs. 0.240 ± 0.040 mm(2), P = 0.038), but decreased endothelial cell repopulation (238 ± 17 vs. 154 ± 22 nuclei/mm(2), P = 0.018), despite complete strut coverage. To test the effects of selectively improving endothelial cell function, we used transgenic mice with endothelial-specific overexpression of GTP-cyclohydrolase 1 (GCH-Tg) as a model of enhanced endothelial cell function and increased NO production. GCH-Tg ApoE(-/-) mice had less neointima formation compared with ApoE(-/-) littermates (0.52 ± 0.08 vs. 0.26 ± 0.09 mm(2), P = 0.039). In contrast to paclitaxel-eluting stents, reduced neointima formation in GCH-Tg mice was accompanied by increased endothelial cell coverage (156 ± 17 vs. 209 ± 23 nuclei/mm(2), P = 0.043). Drug-eluting stents reduce not only neointima formation but also endothelial cell repopulation, independent of strut coverage. In contrast, selective targeting of endothelial cell function is sufficient to improve endothelial cell repopulation and reduce neointima formation. Targeting endothelial cell function is a rational therapeutic strategy to improve vascular healing and decrease neointima formation after stenting.

  13. The Effect of Cilostazol on the Angiographic Outcome of Drug-Eluting Coronary Stents Angiographic Analysis of the CILON-T (Influence of CILostazol-Based Triple Antiplatelet Therapy ON Ischemi Complication after Drug-Eluting StenT Implantation) Trial.

    Science.gov (United States)

    Suh, Jung-Won; Lee, Seung-Pyo; Park, KyungWoo; Kang, Hyun-Jae; Koo, Bon-Kwon; Cho, Young-Seok; Youn, Tae-Jin; Chae, In-Ho; Choi, Dong-Ju; Rha, Seung-Woon; Bae, Jang-Ho; Kwon, Taek-Geun; Bae, Jang-Whan; Cho, Myeong-Chan; Kim, Hyo-Soo

    2017-12-12

    It is not clear if anti-restonotic effect of cilostazol is consistent for different types of drug-eluting stents (DES).The purpose of this study was to compare the anti-proliferative effect of cilostazol between DAT and TAT with consideration of confounding influences of DES type.Nine hundred and fifteen patients were randomized to either dual antiplatelet therapy (DAT; aspirin and clopidogrel) or triple antiplatelet therapy (TAT; aspirin, clopidogrel, and cilostazol) in the previous CILON-T trial. After excluding 70 patients who received both or neither stents, we analyzed 845 patients who received exclusively PES or ZES, and compared in-stent late loss at 6 months between both antiplatelet regimens (DAT versus TAT).Baseline angiographic and clinical characteristics were similar between the DAT (656 lesions in 425 patients) and the TAT group (600 lesions in 420 patients). The 6-month follow-up angiography was completed in 745 patients (88.2%). Quantitative coronary angiography showed that TAT significantly reduced in-stent late loss (DAT 0.62 ± 0.62 mm versus TAT 0.54 ± 0.49 mm, P = 0.015). Stent type, diabetes or lesion length did not interact with difference of late loss. However, reduction of late loss by cilostazol did not lead to a significant reduction in the rate of target lesion revascularization (TLR) (DAT 7.8% versus TAT 6.9%, P = 0.69) due to a nonlinear relationship found between late loss and TLR.The TAT group showed less in-stent late loss as compared to the DAT group. This was consistently observed regardless of DES type, lesion length, or diabetic status. However, reduction of late loss by cilostazol did not lead to a significant reduction in TLR.

  14. Coronary Stents in Diabetic Patients: State of the Knowledge.

    Science.gov (United States)

    Codner, Pablo; Gurm, Hitinder Singh; Motivala, Apurva

    2017-04-01

    This review article aims to summarize the findings of the most relevant research that compared the use of paclitaxel vs. "limus" based drug eluting stent (DES) in diabetic patients and to define the current state of knowledge with new stent technologies in this patient population. Since drug eluting stents (DES) were introduced, it has been of great interest to establish whether paclitaxel or sirolimus eluting stents have the same safety and efficacy features for patients with coronary artery disease. The answer to this question is particularly relevant for diabetic patients. Several randomized trials, registry-based studies, and meta-analyses have assessed the performance of these different DES in diabetic patients. The most recently published data favors limus over paclitaxel DES in diabetic patients, but most of these studies compared first vs. second generation DES with the inherent caveats of comparing different platforms, alloys, and drug delivery vehicles. In this literature review, we found that there is robust evidence favoring the use of DES over bare metal stents in diabetic patients with coronary artery disease. We also found that the current state of knowledge is that the everolimus eluting stents have better safety and efficacy than paclitaxel eluting stents in diabetic patients and hence should be the preferred choice. New revascularization strategies including bio-absorbable scaffolds, polymer free stents, and bio-degradable polymers are being studied in diabetic patients with encouraging results.

  15. Stent implantation into the tracheo-bronchial system in rabbits: histopathologic sequelae in bare metal vs. drug-eluting stents.

    Science.gov (United States)

    Sigler, Matthias; Klötzer, Julia; Quentin, Thomas; Paul, Thomas; Möller, Oliver

    2015-12-01

    Stent implantation into the tracheo-bronchial system may be life-saving in selected pediatric patients with otherwise intractable stenosis of the upper airways. Following implantation, significant tissue proliferation may occur, requiring re-interventions. We sought to evaluate the effect of immunosuppressive coating of the stents on the extent of tissue proliferation in an animal model. Bare metal and sirolimus-coated stents (Bx Sonic and Cypher Select, Johnson & Johnson, Cordis) were implanted into non-stenotic lower airways of New Zealand white rabbits (weight 3.1 to 4.8 kg). Three stents with sirolimus coating and six bare metal stents could be analyzed by means of histology and immunohistochemistry 12 months after implantation. On a macroscopic evaluation, all stents were partially covered with a considerable amount of whitish tissue. Histologically, these proliferations contained fiber-rich connective tissue and some fibromuscular cells without significant differences between both stent types. The superficial tissue layer was formed by typical respiratory epithelium and polygonal cells. Abundant lymphocyte infiltrations and moderate granulocyte infiltrations were found in both groups correspondingly, whereas foreign-body reaction was more pronounced around sirolimus-eluting stents. After stent implantation in the tracheo-bronchial system of rabbits, we found tissue reactions comparable to those seen after stent implantation into the vascular system. There was no difference between coated and uncoated stents with regard to quality and quantity of tissue proliferation. We found, however, a significantly different inflammatory reaction with a more pronounced foreign-body reaction in sirolimus-coated stents. In our small series, drug-eluting stents did not exhibit any benefit over bare metal stents in an experimental setting.

  16. Percutaneous Coronary Intervention of Left Main Disease: Pre- and Post-EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) Era.

    Science.gov (United States)

    Park, Duk-Woo; Park, Seung-Jung

    2017-06-01

    For nearly half a century, coronary artery bypass grafting has been the standard treatment for patients with obstructive left main coronary artery (LMCA) disease. However, there has been considerable evolution in the field of percutaneous coronary intervention, and especially, percutaneous coronary intervention for LMCA disease has been rapidly expanded with adoption of drug-eluting stents. Some, but not all randomized trials, have shown that percutaneous coronary intervention with drug-eluting stents might be a suitable alternative for selected patients with LMCA disease instead of bypass surgery. However, none of previous trials involving early-generation drug-eluting stents was sufficiently powered and comparative trials using contemporary drug-eluting stents were limited. Recently, primary results of 2 new trials of EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) were reported. However, these trials showed conflicting results, which might pose uncertainty on the optimal revascularization strategy for LMCA disease. In this article, with the incorporation of a key review on evolution of LMCA treatment, we summarize the similarity or disparity of the EXCEL and NOBLE trials, focus on how they relate to previous trials in the field, and finally speculate on how the treatment strategy may be changed or recommended for LMCA treatment. © 2017 American Heart Association, Inc.

  17. A randomized multicenter comparison of hybrid sirolimus-eluting stents with bioresorbable polymer versus everolimus-eluting stents with durable polymer in total coronary occlusion: rationale and design of the Primary Stenting of Occluded Native Coronary Arteries IV study

    Directory of Open Access Journals (Sweden)

    Teeuwen Koen

    2012-12-01

    Full Text Available Abstract Background Percutaneous recanalization of total coronary occlusion (TCO was historically hampered by high rates of restenosis and reocclusions. The PRISON II trial demonstrated a significant restenosis reduction in patients treated with sirolimus-eluting stents compared with bare metal stents for TCO. Similar reductions in restenosis were observed with the second-generation zotarolimus-eluting stent and everolimus-eluting stent. Despite favorable anti-restenotic efficacy, safety concerns evolved after identifying an increased rate of very late stent thrombosis (VLST with drug-eluting stents (DES for the treatment of TCO. Late malapposition caused by hypersensitivity reactions and chronic inflammation was suggested as a probable cause of these VLST. New DES with bioresorbable polymer coatings were developed to address these safety concerns. No randomized trials have evaluated the efficacy and safety of the new-generation DES with bioresorbable polymers in patients treated for TCO. Methods/Design The prospective, randomized, single-blinded, multicenter, non-inferiority PRISON IV trial was designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (Orsiro; Biotronik, Berlin, Germany compared with everolimus-eluting stents with durable polymers (Xience Prime/Xpedition; Abbott Vascular, Santa Clara, CA, USA in patients with successfully recanalized TCOs. In total, 330 patients have been randomly allocated to each treatment arm. Patients are eligible with estimated duration of TCO ≥4 weeks with evidence of ischemia in the supply area of the TCO. The primary endpoint is in-segment late luminal loss at 9-month follow-up angiography. Secondary angiographic endpoints include in-stent late luminal loss, minimal luminal diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9-month follow-up. Additionally, optical coherence

  18. Sirolimus-eluting versus bare-metal stent implantation in patients with ostial lesions

    DEFF Research Database (Denmark)

    Jørgensen, Erik; Kelbæk, Henning; Kløvgaard, Lene

    2010-01-01

    To investigate the efficacy of implantation of sirolimus-eluting stents (SES) in the ostium of coronary arteries.......To investigate the efficacy of implantation of sirolimus-eluting stents (SES) in the ostium of coronary arteries....

  19. Expert consensus (SBC/SBHCI) on the use of drug-eluting stents: recommendations of the Brazilian society of interventional cardiology/ Brazilian society of cardiology for the Brazilian public single healthcare system.

    Science.gov (United States)

    Lima, Valter C; Mattos, Luiz Alberto P; Caramori, Paulo R A; Perin, Marco A; Mangione, José A; Machado, Bruno M; Coelho, Wilson M C; Bueno, Ronaldo R L

    2006-10-01

    The authors review percutaneous coronary intervention (PCI) evolution and its growing application in myocardial revascularization for patients with coronary heart disease in Brazil and worldwide. PCI was introduced in 1977 using only the catheter balloon. Limitations of this method (acute occlusion and coronary restenosis) led to the adoption of coronary stents and more recently the advent of drug-eluting stents2, which were developed to drastically reduce restenosis rates. These developments allowed the exponential growth of percutaneous coronary intervention (PCI) procedures in Brazil which have replaced many bypass surgery procedures and have become the gold standard for the majority of symptomatic patients suffering from coronary artery disease. The preference for this procedure gained new dimensions in 2000 when the Brazilian Public Healthcare System (SUS) began reimbursing for stent procedures. This measure exemplified the importance of the Public Healthcare System's participation in incorporating medical advances and offering a high standard of cardiovascular treatment to a large portion of the Brazilian population. It is emphasized that prevention of in-stent restenosis is complex due to its unpredictable and ubiquitous occurrence. Control of this condition improves quality of life and reduces the recurrence of angina pectoris, the need to perform new revascularization procedures and hospital readmissions. The overall success of the drug-eluting stents has proven to be reliable and consistent in overcoming restenosis and has some beneficial impact for all clinical and angiographic conditions. This paper discusses the adoption and criteria for the use of drug-eluting stents in other countries as well as the recommendations established by the Brazilian Society of Interventional Cardiology for their reimbursement by SUS. The incorporation of new healthcare technology involves two distinct stages. During the first stage, the product is registered with the

  20. Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

    Science.gov (United States)

    Lemos, Pedro A; Abizaid, Alexandre A C; Meireles, George C; Sarmento-Leite, Rogério; Prudente, Mauricio; Cantarelli, Marcelo; Dourado, Adriano D; Mariani, Jose; Perin, Marco A; Costantini, Costantino; Costa, Ricardo A; Costa, José Ribamar; Chamie, Daniel; Campos, Carlos A; Ribeiro, Expedito

    2015-12-01

    To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent. © 2015 John Wiley & Sons Ltd.

  1. Incidence of definite stent thrombosis or in-stent restenosis after drug-eluting stent implantation for treatment of coronary in-stent restenosis. From western denmark heart registry

    DEFF Research Database (Denmark)

    Jensen, Jesper; Jensen, Lisette Okkels; Terkelsen, Christian Juhl

    2012-01-01

    There are limited data on the optimal management of in-stent restenosis after percutaneous coronary intervention (PCI) with bare metal stent (BMS) or drug-eluting stent (DES) implantations. We assessed the clinical presentation, the incidence, and prognosis of definite stent thrombosis...

  2. Impact of an endothelial progenitor cell capturing stent on coronary microvascular function: comparison with drug-eluting stents.

    Science.gov (United States)

    Choi, Woong Gil; Kim, Soo Hyun; Yoon, Hyung Seok; Lee, Eun Joo; Kim, Dong Woon

    2015-01-01

    Although drug-eluting stents (DESs) effectively reduce restenosis following percutaneous coronary intervention (PCI), they also delay re-endothelialization and impair microvascular function, resulting in adverse clinical outcomes. Endothelial progenitor cell (EPC) capturing stents, by providing a functional endothelial layer on the stent, have beneficial effects on microvascular function. However, data on coronary microvascular function in patients with EPC stents versus DESs are lacking. Seventy-four patients who previously underwent PCI were enrolled in this study. Microvascular function was evaluated 6 months after PCI based on the index of microvascular resistance (IMR) and the coronary flow reserve (CFR). IMR was calculated as the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of the hyperemic mean transit time (hTmn). The CFR was calculated by dividing the hTmn by the baseline mean transit time. Twenty-one patients (age, 67.2 ± 9.6 years; male:female, 15:6) with an EPC stent and 53 patients (age, 61.5 ± 14.7 years; male:female, 40:13) with second-generation DESs were included in the study. There were no significant differences in the baseline clinical and angiographic characteristics of the two groups. Angiography performed 6 months postoperatively did not show significant differences in their CFR values. However, patients with the EPC stent had a significantly lower IMR than patients with second-generation DESs (median, 25.5 [interquartile range, 12.85 to 28.18] vs. 29.0 [interquartile range, 15.42 to 39.23]; p = 0.043). Microvascular dysfunction was significantly improved after 6 months in patients with EPC stents compared to those with DESs. The complete re-endothelialization achieved with the EPC stent may provide clinical benefits over DESs, especially in patients with microvascular dysfunction.

  3. Monitoring 5-fluorouracil in patients undergoing chemotherapy by means of F-19 MR spectroscopy

    International Nuclear Information System (INIS)

    Wolf, W.; Albright, M.J.; Silver, M.S.; Starewicz, P.M.; Weber, H.; Reichardt, U.; Saver, R.

    1986-01-01

    F-19 MR spectroscopy allows direct observation of fluorinated drugs and their metabolites in the human body without background signal from the tissue. In addition, unlike F-18, specific chemical structure information is available in vivo. The behavior of a well-known fluorinated chemotherapeutic drug, 5-fluorouracil (5-FU), and its metabolites was observed noninvasively in patients undergoing cancer chemotherapy. The time course of the drug's metabolism was examined and half-life values of the unmetabolized 5-FU in the liver were calculated from the F-19 peak intensity. Half-life values of the unmetabolized 5-FU in the liver were in the range of 15-30 minutes. Interpatient variations were correlated with the chemotherapy results. F-19 MR spectroscopy is feasible in humans and allows determination of the time course of the metabolism of fluorinated drugs in individual patients

  4. Glomerular Filtration Rate in Patients with Multiple Sclerosis Undergoing Stem Cell Transplantation and Treated With Cyclophosphamide.

    Science.gov (United States)

    Ruiz-Argüelles, Alejandro; Gastélum-Cano, Jose M; Méndez-Huerta, Mariana A; Rodríguez-Gallegos, Alma B; Ruiz-Argüelles, Guillermo J

    2018-06-15

    Glomerular filtration rate (GFR) is partially impaired in patients with multiple sclerosis (MS). When given chemotherapy before receiving hematopoietic stem-cell transplantation, GFR might be further deteriorated. To measure the effect of cyclophosphamide on GFR in patients with MS who undergo chemotherapy. We estimated GFR based on creatinine and cystatin C plasma concentrations in patients undergoing autologous hematopoietic stem-cell transplantation to treat their MS. Baseline GFR values were lower in the 28 patients with MS than in the 20 healthy individuals. Also, according to the Chronic Kidney Disease-Epidemiology Collaborative Group (CKD-EPI) 2012 Creat-CysC equation criteria, 4 of 28 patients were classified as having chronic kidney disease (CKD) before receiving the chemotherapy drugs. After receiving 4 × 50 mg per kg body weight cyclophosphamide, abnormal GFR results were recorded in 12 of 28 patients. Renal function must be monitored in patients with MS undergoing autologous stem-cell transplantation. Also, chemotherapy should be constrained as much as possible to prevent further deterioration of renal function.

  5. Direct implantation of rapamycin-eluting stents with bioresorbable drug carrier technology utilising the Svelte coronary stent-on-a-wire: the DIRECT II study.

    Science.gov (United States)

    Verheye, Stefan; Khattab, Ahmed A; Carrie, Didier; Stella, Pieter; Slagboom, Ton; Bartunek, Jozef; Onuma, Yoshinobu; Serruys, Patrick W

    2016-08-05

    Our aim was to demonstrate the safety and efficacy of the Svelte sirolimus-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) with bioresorbable drug coating compared to the Resolute Integrity zotarolimus-eluting stent with durable polymer in patients with de novo coronary artery lesions. Direct stenting, particularly in conjunction with transradial intervention (TRI), has been associated with reduced bleeding complications, procedure time, radiation exposure and contrast administration compared to conventional stenting with wiring and predilatation. The low-profile Svelte IDS is designed to facilitate TRI and direct stenting, reducing the number of procedural steps, time and cost associated with coronary stenting. DIRECT II was a prospective, multicentre trial which enrolled 159 patients to establish non-inferiority of the Svelte IDS versus Resolute Integrity using a 2:1 randomisation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Target vessel failure (TVF), as well as secondary clinical endpoints, will be assessed annually up to five years. At six months, in-stent LLL was 0.09±0.31 mm in the Svelte IDS group compared to 0.13±0.27 mm in the Resolute Integrity group (p<0.001 for non-inferiority). TVF at one year was similar across the Svelte IDS and Resolute Integrity groups (6.5% vs. 9.8%, respectively). DIRECT II demonstrated the non-inferiority of the Svelte IDS to Resolute Integrity with respect to in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.

  6. Randomised comparison of a bioresorbable everolimus-eluting scaffold with a metallic everolimus-eluting stent for ischaemic heart disease caused by de novo native coronary artery lesions

    DEFF Research Database (Denmark)

    Chevalier, Bernard; Onuma, Yoshinobu; van Boven, Ad J

    2016-01-01

    AIMS: The one-year randomised data of the ABSORB II trial showed that the everolimus-eluting bioresorbable scaffold and the everolimus-eluting metallic stent were comparable for the composite secondary clinical outcomes of patient-oriented composite endpoint (PoCE) and device-oriented composite...... Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (XIENCE; Abbott Vascular). The trial enrolled 501 patients. Clinical follow-up at two years was available in 320 patients in the Absorb BVS arm and 160 patients in the XIENCE arm. At two years, the PoCE for the Absorb and XIENCE arms......-six percent and 34% of patients remained on DAPT at two years, respectively. Ninety-two percent of patients in both arms remained on aspirin. CONCLUSIONS: Two-year clinical results demonstrate sustained low rates of PoCE, MACE, DoCE and TVF with the Absorb BVS as compared to the XIENCE stent....

  7. Novel biodegradable sandwich-structured nanofibrous drug-eluting membranes for repair of infected wounds: an in vitro and in vivo study

    Directory of Open Access Journals (Sweden)

    Chan EC

    2012-02-01

    Full Text Available Dave Wei-Chih Chen1,2, Jun-Yi Liao3, Shih-Jung Liu2, Err-Cheng Chan41Department of Orthopedic Surgery, Chang Gung Memorial Hospital, 2Department of Mechanical Engineering, 3Graduate Institute of Medical Mechatronics, 4School of Medical Technology, Chang Gung University, Kwei-San, Tao-Yuan, TaiwanBackground: The purpose of this study was to develop novel sandwich-structured nanofibrous membranes to provide sustained-release delivery of vancomycin, gentamicin, and lidocaine for repair of infected wounds.Methods: To prepare the biodegradable membranes, poly(D, L-lactide-co-glycolide (PLGA, collagen, and various pharmaceuticals, including vancomycin, gentamicin, and lidocaine, were first dissolved in 1,1,1,3,3,3-hexafluoro-2-propanol. They were electrospun into sandwich-structured membranes with PLGA/collagen as the surface layers and PLGA/drugs as the core. An elution method and a high-pressure liquid chromatography assay were used to characterize in vivo and in vitro drug release from the membranes. In addition, repair of infected wounds in rats was studied. Histological examination of epithelialization and granulation at the wound site was also performed.Results: The biodegradable nanofibrous membranes released large amounts of vancomycin and gentamicin (well above the minimum inhibition concentration and lidocaine in vivo for more than 3 weeks. A bacterial inhibition test was carried out to determine the relative activity of the antibiotics released. The bioactivity ranged from 40% to 100%. The nanofibrous membranes were functionally active in treating infected wounds, and were very effective as accelerators in early-stage wound healing.Conclusion: Using the electrospinning technique, we will be able to manufacture biodegradable, biomimetic, nanofibrous, extracellular membranes for long-term delivery of various drugs.Keywords: nanofibrous, sandwich-structured, drug-eluting membranes, electrospinning, release characteristics, repair, wound

  8. Randomized comparison between intracoronary β-radiation brachytherapy and implantation of paclitaxel-eluting stents for the treatment of diffuse in-stent restenosis

    International Nuclear Information System (INIS)

    Schukro, Christoph; Syeda, Bonni; Kirisits, Christian; Schmid, Rainer; Pichler, Philipp; Pokrajac, Boris; Lang, Irene; Poetter, Richard; Glogar, Dietmar

    2007-01-01

    Background and purpose: Intracoronary brachytherapy was the primary therapeutic option for the treatment of in-stent restenosis (ISR) during the last years. Especially for the treatment of diffuse ISR (lesions >10 mm), β-source brachytherapy was significantly superior to singular balloon angioplasty. Despite lacking clinical database, the implantation of drug eluting stents recently became a common procedure for the treatment of ISR. This randomized trial aimed to compare the efficacy of β-brachytherapy with β-radioisotopes 90 Sr/ 90 Y and paclitaxel-eluting stent implantation for the treatment of diffuse ISR. Material and methods: Thirty-seven patients with diffuse ISR were randomly assigned to β-brachytherapy after balloon angioplasty (Beta-Cath TM in 17 patients) or paclitaxel-eluting stent implantation (Taxus-Express2 TM in 20 patients). Six-month clinical follow-up was obtained for all patients, while angiographic follow-up was available for 30 patients. Results: Binary ISR (restenosis >50%) within target segment was observed in three patients treated with Beta-Cath TM , of which one needed target segment revascularisation for recurrent ISR, whereas no significant restenosis occurred in the patients treated with Taxus-Express2 TM (P = 0.037). No further major adverse cardiac (target segment revascularisation, myocardial infarction, death) was found in either group (P = NS). Stent implantation was the more time-saving (31 ± 11 min versus 60 ± 23 min, P TM arm, we found no difference in clinical outcome after implantation of paclitaxel-eluting stents for the treatment of diffuse ISR when compared to β-brachytherapy

  9. Prasugrel vs. clopidogrel in contemporary Western European patients with acute coronary syndromes receiving drug-eluting stents

    DEFF Research Database (Denmark)

    Wein, Bastian; Coslovsky, Michael; Jabbari, Reza

    2017-01-01

    BACKGROUND: Clinical and cost-effectiveness of prasugrel vs. clopidogrel in acute coronary syndrome (ACS) was only evaluated using TRITON-TIMI 38 event rates. A comparative analysis of both drugs in contemporary European ACS patients is lacking. METHODS: To address this issue, cardiac and bleedin......=0.255), but more major bleedings (4.0% vs. 1.7%, pexpenditures per patient: 1116.3 (DNK), 1063.5 (GER) and 880.8 (SUI) EURO, respectively. Accordingly, incremental cost...

  10. Absence of gender disparity in short-term clinical outcomes in patients with acute ST-segment elevation myocardial infarction undergoing sirolimus-eluting stent based primary coronary intervention: a report from Shanghai Acute Coronary Event (SACE) Registry.

    Science.gov (United States)

    Zhang, Qi; Qiu, Jian-Ping; Zhang, Rui-Yan; Li, Yi-Gang; He, Ben; Jin, Hui-Gen; Zhang, Jun-Feng; Wang, Xiao-Long; Jiang, Li; Liao, Min-Lei; Hu, Jian; Shen, Wei-Feng

    2010-04-05

    Randomized, controlled trials have demonstrated the superiority of sirolimus-eluting stent (SES) implantation during primary percutaneous coronary intervention (PCI), as opposed to bare-metal stents, in patients with ST-elevation myocardial infarction (STEMI). This study aimed to test the hypothesis that clinical benefits of SES treatment were independent of gender in this setting. A total of 2042 patients with STEMI undergoing SES-based primary PCI were prospectively enrolled into Shanghai Acute Coronary Event (SACE) registry (1574 men and 468 women). Baseline demographics, angiographic and PCI features, and in-hospital and 30-day major adverse cardiac events (MACE) were analyzed as a function of gender. Compared with men, women were older and more frequently had hypertension, diabetes, and hypercholesterolemia. Use of platelet glycoprotein IIb/IIIa receptor inhibitor (GPI, 65.5% vs. 62.2%, P = 0.10) and procedural success rate (95.0% vs. 94.2%, P = 0.52) were similar in both genders. In-hospital death and MACE occurred in 3.8% and 7.6%, and 4.5% and 8.1% in the male and female patients, respectively (all P > 0.05). At 30-day follow-up, survival (94.3% vs. 93.8%, P = 0.66) and MACE-free survival (90.2% vs. 89.3%, P = 0.52) did not significantly differ between men and women. After adjustment for differences in patient demographics, angiographic and procedural features, there were no significant difference in either in-hospital (OR = 0.77, 95%CI of 0.48 to 1.22, P = 0.30) or 30-day mortality (OR = 1.28, 95%CI of 0.73 to 2.23, P = 0.38) between women and men. Despite more advanced age and clustering of risk factors in women, female patients with STEMI treated by SES-based primary PCI had similar in-hospital and short-term clinical outcomes as their male counterparts.

  11. Efectos biológicos de los stents medicados en la circulación coronaria Biological effects of drug-eluting stents in the coronary circulation

    Directory of Open Access Journals (Sweden)

    Darío Echeverri

    2010-04-01

    Full Text Available Los stents medicados ofrecen la mejor alternativa disponible no quirúrgica para el tratamiento de la enfermedad coronaria gracias a su demostrada eficacia. Sin embargo, estos excelentes resultados han sido opacados en términos de seguridad, principalmente por la presencia de trombosis de stents de manera tardía o muy tardía. La comprensión de los efectos biológicos que ejercen a nivel de la arteria coronaria luego de su implante, se debe al efecto de la plataforma utilizada, el polímero y la droga que liberan. Los trastornos de reparación vascular inducidos favorecen la trombosis de stents y sus consecuencias clínicas. Se hace una revisión de los diferentes efectos biológicos de los stents medicados en las arterias coronarias, que permite comprender como han surgido rápidamente nuevas versiones en materiales, diseños, polímeros y medicamentos que reducen los efectos adversos a nivel coronario, mejorando su eficacia y seguridad.Drug-eluting stents offer the best available non-surgical alternative for the treatment of coronary disease, thanks to its demonstrated efficacy. However, in terms of security, these excellent results have been overshadowed by the late or very late appearance of stent thromboses.The biological effects they have in the coronary artery after its implantation are due to the effect of the platform used, the polymer and the medication released. The vascular healing disorders induced by drug-eluting stents favor stent thrombosis and its clinical consequences. This is a review of the different biological effects of drug-eluting stents in coronary arteries that allows to understand how the rapid onset of new versions of materials, designs, polymers and medications diminish adverse coronary effects and improve its efficacy and safety.

  12. Best way to revascularize patients with main stem and three vessel lesions: patients should undergo PCI!

    Science.gov (United States)

    Schächinger, Volker; Herdeg, Christian; Scheller, Bruno

    2010-09-01

    The optimal revascularization strategy for multivessel disease is under controversial discussion for long time. Until now, technical innovations have been faster than performance of clinical trials, making results of randomized studies outdated at the time of appearance. Recently, the SYNTAX trial has been published, which compared drug elutings stents (DES) implantation with Coronary artery bypass graft (CABG) patients with multivessel or left main disease in a clinically stable population. Overall, CABG was superior with respect to the clinical endpoint of death, myocardial infarction, stroke, or revascularization. However, the difference is driven by the "weakest" end point, namely repeated revascularization, whereas combined "hard" events did not demonstrate a difference. More detailed analysis demonstrates that only patients with most complex coronary anatomy gain definite benefit from CABG. In addition, SYNTAX demonstrated that left main disease is no longer a domain of CABG, since DES implantation revealed comparable results, as long as there is no concomitant multivessel disease. Regardless the results of SYNTAX, one should not forget that SYNTAX represents only a minority of daily patients in a catheterization laboratory, excluding patients with one- or two-vessel disease and those with an acute coronary syndrome. Especially in the latter, percutaneous coronary intervention has demonstrated to improve prognosis.

  13. Outcome of Sirolimus-Eluting Versus Zotarolimus-Eluting Coronary Stent Implantation in Patients With and Without Diabetes Mellitus (a SORT OUT III Substudy)

    DEFF Research Database (Denmark)

    Maeng, Michael; Jensen, Lisette O; Tilsted, Hans-Henrik

    2011-01-01

    Diabetes is associated with an increased risk of major adverse cardiac events after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus treated with the second-generation Endeavor zotarolimus-eluting stent (ZES) or the first...... cardiac events defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Secondary end points included these individual end points plus all-cause mortality and target lesion revascularization. In diabetic patients, use of ZES compared to SES was associated.......90 to 13.1), and target lesion revascularization (12.4% vs 1.2%, hazard ratio 11.0, 95% confidence interval 2.59 to 47.1). In patients without diabetes differences in absolute risk decrease were smaller but similarly favored SES. In conclusion, implantation of ZESs compared to SESs is associated...

  14. Aspirin in patients undergoing noncardiac surgery

    DEFF Research Database (Denmark)

    Devereaux, P J; Mrkobrada, Marko; Sessler, Daniel I

    2014-01-01

    BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10......,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before...... the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum...

  15. Clinical analysis of urinary tract infection in patients undergoing transurethral resection of the prostate.

    Science.gov (United States)

    Li, Y-H; Li, G-Q; Guo, S-M; Che, Y-N; Wang, X; Cheng, F-T

    2017-10-01

    To analyze the related influencing factors of urinary tract infection in patients undergoing transurethral resection of the prostate (TURP). A total of 343 patients with benign prostatic hyperplasia admitted to this hospital from January 2013 to December 2016, were selected and treated by TURP. Patients were divided into infection group and non-infection group according to the occurrence of urinary tract infection after operation. The possible influencing factors were collected to perform univariate and multivariate logistic regression analysis. There were 53 cases with urinary tract infection after operation among 343 patients with benign prostatic hyperplasia, accounting for 15.5%. The univariate analysis displayed that the occurrence of urinary tract infection in patients undergoing TURP was closely associated with patient's age ≥ 65 years old, complicated diabetes, catheterization for urinary retention before operation, no use of antibiotics before operation and postoperative indwelling catheter duration ≥ 5 d (p urinary tract infection in patients receiving TURP (p urinary tract infection after TURP, while preoperative prophylactic utilization of anti-infective drugs can reduce the occurrence of postoperative urinary tract infection.

  16. Nine-month Angiographic and Two-year Clinical Follow-up of Novel Biodegradable-polymer Arsenic Trioxide-eluting Stent Versus Durable-polymer Sirolimus-eluting Stent For Coronary Artery Disease

    Directory of Open Access Journals (Sweden)

    Li Shen

    2015-01-01

    Full Text Available Background: Despite great reduction of in-stent restenosis, first-generation drug-eluting stents (DESs have increased the risk of late stent thrombosis due to delayed endothelialization. Arsenic trioxide, a natural substance that could inhibit cell proliferation and induce cell apoptosis, seems to be a promising surrogate of sirolimus to improve DES performance. This randomized controlled trial was to evaluate the efficacy and safety of a novel arsenic trioxide-eluting stent (AES, compared with traditional sirolimus-eluting stent (SES. Methods: Patients with symptoms of angina pectoris were enrolled and randomized to AES or SES group. The primary endpoint was target vessel failure (TVF, and the second endpoint includes rates of all-cause death, cardiac death or myocardial infarction, target lesion revascularization (TLR by telephone visit and late luminal loss (LLL at 9-month by angiographic follow-up. Results: From July 2007 to 2009, 212 patients were enrolled and randomized 1:1 to receive either AES or SES. At 2 years of follow-up, TVF rate was similar between AES and SES group (6.67% vs. 5.83%, P = 0.980. Frequency of all-cause death was significantly lower in AES group (0 vs. 4.85%, P = 0.028. There was no significant difference between AES and SES in frequency of TLR and in-stent restenosis, but greater in-stent LLL was observed for AES group (0.29 ± 0.52 mm vs. 0.10 ± 0.25 mm, P = 0.008. Conclusions: After 2 years of follow-up, AES demonstrated comparable efficacy and safety to SES for the treatment of de novo coronary artery lesions.

  17. Negative and positive affect are independently associated with patient-reported health status following percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Versteeg, Henneke; Pedersen, Susanne S.; Erdman, Ruud A M

    2009-01-01

    We examined the association between negative and positive affect and 12-month health status in patients treated with percutaneous coronary intervention (PCI) with drug-eluting stents.......We examined the association between negative and positive affect and 12-month health status in patients treated with percutaneous coronary intervention (PCI) with drug-eluting stents....

  18. IVUS Findings in Late and Very Late Stent Thrombosis. A Comparison Between Bare-metal and Drug-eluting Stents.

    Science.gov (United States)

    Fuentes, Lara; Gómez-Lara, Josep; Salvatella, Neus; Gonzalo, Nieves; Hernández-Hernández, Felipe; Fernández-Nofrerias, Eduard; Sánchez-Recalde, Ángel; Alfonso, Fernando; Romaguera, Rafael; Ferreiro, José Luis; Roura, Gerard; Teruel, Luis; Gracida, Montserrat; Marcano, Ana Lucrecia; Gómez-Hospital, Joan-Antoni; Cequier, Ángel

    2018-05-01

    Stent thrombosis (ST) is a life-threatening complication after stent implantation. Intravascular ultrasound is able to discern most causes of ST. The aim of this study was to compare intravascular ultrasound findings between bare-metal stents (BMS) and drug-eluting stents (DES) in patients with late (31 days to 1 year) or very late ST (> 1 year). Of 250 consecutive patients with late or very late ST in 7 Spanish institutions, 114 patients (45.5% BMS and 54.5% DES) were imaged with intravascular ultrasound. Off-line intravascular ultrasound analysis was performed to assess malapposition, underexpansion, and neoatherosclerosis. The median time from stent implantation to ST was 4.0 years with BMS and 3.4 years with DES (P = .04). Isolated malapposition was similarly observed in both groups (36.5% vs 46.8%; P = .18) but was numerically lower with BMS (26.6% vs 48.0%; P = .07) in patients with very late ST. Isolated underexpansion was similarly observed in both groups (13.5% vs 11.3%; P = .47). Isolated neoatherosclerosis occurred only in patients with very late ST and was more prevalent with BMS (22.9%) than with DES (6.0%); P = .02. At 2.9 years' follow-up, there were 0% and 6.9% cardiac deaths, respectively (P = .06) and recurrent ST occurred in 4.0% and 5.2% of patients, respectively (P = .60). Malapposition was the most common finding in patients with late and very late ST and is more prevalent with DES in very late ST. In contrast, neoatherosclerosis was exclusively observed in patients with very late ST and mainly with BMS. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  19. Efficacy of chloral hydrate in the sedation of pediatric patients undergoing magnetic resonance

    International Nuclear Information System (INIS)

    Casillas, C.; Marti-Bonmati, L.; Ranchera-Oms, C.; Poyatos, C.; Tomas, J.; Sobejano, A.; Vilar, J.; Jimenez, N.V.

    1995-01-01

    Sedation is necessary in small or uncooperative children who are to undergo magnetic resonance (MR) studies because of the prolonged duration of the exploration. The safety and efficacy of one of the most widely used drugs, chloral hydrate, has not been evaluated in a large series of patients. A population of 713 pediatric patients (317 girls and 396 boys) who received oral chloral hydrate 20 to 40 minutes prior to MR was studied prospectively. The initial dose was 65+- 1 mg/kg body wt (mean+- standard error), with an efficacy of 78%. After a second dose administered to patients who did not respond adequately to the initial dose (n=157), the total dose was 70+- 1 mg/kg body wt, with an efficacy of 94.4%. The induction time was 26+- 1 min and the interval between completion of the exploration and spontaneous recovery of consciousness was 35 +- 2 minutes. This mode of sedation was more effective in children of younger age and lesser weight, and with higher doses of chloral hydrate, neither sex nor concomitant medication were found to influence the efficacy. Adverse reactions were detected in 73 children (10.2%), predominantly nausea and vomiting . Chloral hydrate at doses of less tan 70 mg/kg body wt is a very safe and highly effective drug for sedation in pediatric patients under the age of 7 years who to undergo MR studies. 18 refs

  20. Coagulation profile in patients undergoing video-assisted thoracoscopic lobectomy

    DEFF Research Database (Denmark)

    Christensen, Thomas Decker; Vad, Henrik; Pedersen, Søren

    2017-01-01

    -, and the first two days postoperatively by standard coagulation blood test, thromboelastometry (ROTEM®) and thrombin generation. Results: Patients undergoing potential curative surgery for lung cancer were not hypercoagulable preoperatively. There was no statistically significant difference in the majority......Background: Knowledge about the impact of Low-Molecular-Weight Heparin (LMWH) on the coagulation system in patients undergoing minimal invasive lung cancer surgery is sparse. The aim of this study was to assess the effect of LMWH on the coagulation system in patients undergoing Video......-Assisted Thoracoscopic Surgery (VATS) lobectomy for primary lung cancer. Methods: Sixty-three patients diagnosed with primary lung cancer undergoing VATS lobectomy were randomized to either subcutaneous injection with dalteparin (Fragmin®) 5000 IE once daily or no intervention. Coagulation was assessed pre-, peri...

  1. Clinical outcome after primary percutaneous coronary intervention with drug-eluting and bare metal stents in patients with ST-segment elevation myocardial infarction

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Thayssen, Per

    2008-01-01

    BACKGROUND: The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction is a matter of debate. Therefore, we examined the risk of target lesion revascularization (TLR), stent thrombosis...... Registry from January 2002 through June 2005, were followed up for 2 years. We used Cox regression analysis to control for confounding. The 2-year incidence of definite stent thrombosis was 1.9% in the DES group and 1.1% in the BMS group (adjusted relative risk [RR]=1.53; 95% CI=0.84 to 2.78; P=0.17). Very...... late definite stent thrombosis (> or =12 months) was seen in 0.4% in the DES group and 0.06% in the BMS group (adjusted RR=6.74; 95% CI=1.23 to 37.00; P=0.03). The 2-year incidence of myocardial infarction was similar in the 2 groups, 5.2% in the DES group versus 6.3% in the BMS group (P=0.28; adjusted...

  2. Serial assessment by optical coherence tomography of early and late vascular responses after implantation of an absorbable-coating Sirolimus-Eluting stent (from the first-in-human DESSOLVE I trial).

    Science.gov (United States)

    Attizzani, Guilherme F; Bezerra, Hiram G; Ormiston, John; Wang, Wei; Donohoe, Dennis; Wijns, William; Costa, Marco A

    2013-11-15

    The initial enthusiasm caused by the potent antirestenotic effect of early generation drug-eluting stents was recently plagued by concerns regarding their safety profile. Investigators worldwide were stimulated, therefore, to seek for improvement in drug-eluting stent technology, such as eliminating their permanent polymer blamed for vascular inflammation and delayed healing. Optical coherence tomography (OCT) assessments of stent-vessel interactions are used as a surrogate for vessel healing after DES implantation. Herewith, we report serial OCT assessments of vascular reactions to the implantation of a novel absorbable polymer sirolimus-eluting stent (MiStent). In total, 30 patients were included. At 4-, 6-, and 8-month follow-up, different groups of 10 patients underwent OCT imaging, whereas all the patients had OCT assessments scheduled at 18-month follow-up. A total of 13,569 stent struts were analyzed. Low rates of uncovered (14.34 ± 15.35%, 6.62 ± 10.93%, 3.51 ± 2.87%, and 0.84 ± 1.15%, respectively, p stent struts coupled with thin and increasingly homogenous neointimal proliferation were demonstrated. Neointimal area increased from 4- to 8-month follow-up (0.46 ± 0.29 and 1.12 ± 0.73 mm(2), respectively, p stent struts (8.8%, 3.1%, 0.3%, and 0%, respectively, p absorbable polymer sirolimus-eluting stent-vessel interactions up to 18-month follow-up. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Enhanced drug delivery capabilities from stents coated with absorbable polymer and crystalline drug

    OpenAIRE

    Carlyle, Wenda C.; McClain, James B.; Tzafriri, Abraham R.; Bailey, Lynn; Zani, Brett G.; Markham, Peter M.; Stanley, James R.L.; Edelman, Elazer R.

    2012-01-01

    Current drug eluting stent (DES) technology is not optimized with regard to the pharmacokinetics of drug delivery. A novel, absorbable-coating sirolimus-eluting stent (AC-SES) was evaluated for its capacity to deliver drug more evenly within the intimal area rather than concentrating drug around the stent struts and for its ability to match coating erosion with drug release. The coating consisted of absorbable poly-lactide-co-glycolic acid (PLGA) and crystalline sirolimus deposited by a dry-p...

  4. The Society for Translational Medicine: clinical practice guidelines for mechanical ventilation management for patients undergoing lobectomy.

    Science.gov (United States)

    Gao, Shugeng; Zhang, Zhongheng; Brunelli, Alessandro; Chen, Chang; Chen, Chun; Chen, Gang; Chen, Haiquan; Chen, Jin-Shing; Cassivi, Stephen; Chai, Ying; Downs, John B; Fang, Wentao; Fu, Xiangning; Garutti, Martínez I; He, Jianxing; He, Jie; Hu, Jian; Huang, Yunchao; Jiang, Gening; Jiang, Hongjing; Jiang, Zhongmin; Li, Danqing; Li, Gaofeng; Li, Hui; Li, Qiang; Li, Xiaofei; Li, Yin; Li, Zhijun; Liu, Chia-Chuan; Liu, Deruo; Liu, Lunxu; Liu, Yongyi; Ma, Haitao; Mao, Weimin; Mao, Yousheng; Mou, Juwei; Ng, Calvin Sze Hang; Petersen, René H; Qiao, Guibin; Rocco, Gaetano; Ruffini, Erico; Tan, Lijie; Tan, Qunyou; Tong, Tang; Wang, Haidong; Wang, Qun; Wang, Ruwen; Wang, Shumin; Xie, Deyao; Xue, Qi; Xue, Tao; Xu, Lin; Xu, Shidong; Xu, Songtao; Yan, Tiansheng; Yu, Fenglei; Yu, Zhentao; Zhang, Chunfang; Zhang, Lanjun; Zhang, Tao; Zhang, Xun; Zhao, Xiaojing; Zhao, Xuewei; Zhi, Xiuyi; Zhou, Qinghua

    2017-09-01

    Patients undergoing lobectomy are at significantly increased risk of lung injury. One-lung ventilation is the most commonly used technique to maintain ventilation and oxygenation during the operation. It is a challenge to choose an appropriate mechanical ventilation strategy to minimize the lung injury and other adverse clinical outcomes. In order to understand the available evidence, a systematic review was conducted including the following topics: (I) protective ventilation (PV); (II) mode of mechanical ventilation [e.g., volume controlled (VCV) versus pressure controlled (PCV)]; (III) use of therapeutic hypercapnia; (IV) use of alveolar recruitment (open-lung) strategy; (V) pre-and post-operative application of positive end expiratory pressure (PEEP); (VI) Inspired Oxygen concentration; (VII) Non-intubated thoracoscopic lobectomy; and (VIII) adjuvant pharmacologic options. The recommendations of class II are non-intubated thoracoscopic lobectomy may be an alternative to conventional one-lung ventilation in selected patients. The recommendations of class IIa are: (I) Therapeutic hypercapnia to maintain a partial pressure of carbon dioxide at 50-70 mmHg is reasonable for patients undergoing pulmonary lobectomy with one-lung ventilation; (II) PV with a tidal volume of 6 mL/kg and PEEP of 5 cmH 2 O are reasonable methods, based on current evidence; (III) alveolar recruitment [open lung ventilation (OLV)] may be beneficial in patients undergoing lobectomy with one-lung ventilation; (IV) PCV is recommended over VCV for patients undergoing lung resection; (V) pre- and post-operative CPAP can improve short-term oxygenation in patients undergoing lobectomy with one-lung ventilation; (VI) controlled mechanical ventilation with I:E ratio of 1:1 is reasonable in patients undergoing one-lung ventilation; (VII) use of lowest inspired oxygen concentration to maintain satisfactory arterial oxygen saturation is reasonable based on physiologic principles; (VIII) Adjuvant drugs

  5. Determining clinical benefits of drug-eluting coronary stents according to the population risk profile: a meta-regression from 31 randomized trials.

    Science.gov (United States)

    Moreno, Raul; Martin-Reyes, Roberto; Jimenez-Valero, Santiago; Sanchez-Recalde, Angel; Galeote, Guillermo; Calvo, Luis; Plaza, Ignacio; Lopez-Sendon, Jose-Luis

    2011-04-01

    The use of drug-eluting stents (DES) in unfavourable patients has been associated with higher rates of clinical complications and stent thrombosis, and because of that concerns about the use of DES in high-risk settings have been raised. This study sought to demonstrate that the clinical benefit of DES increases as the risk profile of the patients increases. A meta-regression analysis from 31 randomized trials that compared DES and bare-metal stents, including overall 12,035 patients, was performed. The relationship between the clinical benefit of using DES (number of patients to treat [NNT] to prevent one episode of target lesion revascularization [TLR]), and the risk profile of the population (rate of TLR in patients allocated to bare-metal stents) in each trial was evaluated. The clinical benefit of DES increased as the risk profile of each study population increased: NNT for TLR=31.1-1.2 (TLR for bare-metal stents); prisk profile of each study population, since the effect of DES in mortality, myocardial infarction, and stent thrombosis, was not adversely affected by the risk profile of each study population (95% confidence interval for β value 0.09 to 0.11, -0.12 to 0.19, and -0.03 to-0.15 for mortality, myocardial infarction, and stent thrombosis, respectively). The clinical benefit of DES increases as the risk profile of the patients increases, without affecting safety. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

  6. A Budget Impact Model for Paclitaxel-eluting Stent in Femoropopliteal Disease in France

    International Nuclear Information System (INIS)

    De Cock, Erwin; Sapoval, Marc; Julia, Pierre; Lissovoy, Greg de; Lopes, Sandra

    2013-01-01

    The Zilver PTX drug-eluting stent (Cook Ireland Ltd., Limerick, Ireland) represents an advance in endovascular treatments for atherosclerotic superficial femoral artery (SFA) disease. Clinical data demonstrate improved clinical outcomes compared to bare-metal stents (BMS). This analysis assessed the likely impact on the French public health care budget of introducing reimbursement for the Zilver PTX stent. A model was developed in Microsoft Excel to estimate the impact of a progressive transition from BMS to Zilver PTX over a 5-year horizon. The number of patients undergoing SFA stenting was estimated on the basis of hospital episode data. The analysis from the payer perspective used French reimbursement tariffs. Target lesion revascularization (TLR) after primary stent placement was the primary outcome. TLR rates were based on 2-year data from the Zilver PTX single-arm study (6 and 9 %) and BMS rates reported in the literature (average 16 and 22 %) and extrapolated to 5 years. Net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only. The model estimated a net cumulative 5-year budget reduction of €6,807,202 for a projected population of 82,316 patients (21,361 receiving Zilver PTX). Base case results were confirmed in sensitivity analyses. Adoption of Zilver PTX could lead to important savings for the French public health care payer. Despite higher initial reimbursement for the Zilver PTX stent, fewer expected SFA reinterventions after the primary stenting procedure result in net savings.

  7. A Budget Impact Model for Paclitaxel-eluting Stent in Femoropopliteal Disease in France

    Energy Technology Data Exchange (ETDEWEB)

    De Cock, Erwin, E-mail: erwin.decock@unitedbiosource.com [United BioSource Corporation, Peri- and Post-Approval Services (Spain); Sapoval, Marc, E-mail: Marc.sapoval2@egp.aphp.fr [Hopital Europeen Georges Pompidou, Universite Rene Descartes, Department of Cardiovascular and Interventional Radiology (France); Julia, Pierre, E-mail: pierre.julia@egp.aphp.fr [Hopital Europeen Georges Pompidou, Universite Rene Descartes, Cardiovascular Surgery Department (France); Lissovoy, Greg de, E-mail: gdelisso@jhsph.edu [Johns Hopkins Bloomberg School of Public Health, Department of Health Policy and Management (United States); Lopes, Sandra, E-mail: Sandra.Lopes@CookMedical.com [Cook Medical, Health Economics and Reimbursement (Denmark)

    2013-04-15

    The Zilver PTX drug-eluting stent (Cook Ireland Ltd., Limerick, Ireland) represents an advance in endovascular treatments for atherosclerotic superficial femoral artery (SFA) disease. Clinical data demonstrate improved clinical outcomes compared to bare-metal stents (BMS). This analysis assessed the likely impact on the French public health care budget of introducing reimbursement for the Zilver PTX stent. A model was developed in Microsoft Excel to estimate the impact of a progressive transition from BMS to Zilver PTX over a 5-year horizon. The number of patients undergoing SFA stenting was estimated on the basis of hospital episode data. The analysis from the payer perspective used French reimbursement tariffs. Target lesion revascularization (TLR) after primary stent placement was the primary outcome. TLR rates were based on 2-year data from the Zilver PTX single-arm study (6 and 9 %) and BMS rates reported in the literature (average 16 and 22 %) and extrapolated to 5 years. Net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only. The model estimated a net cumulative 5-year budget reduction of Euro-Sign 6,807,202 for a projected population of 82,316 patients (21,361 receiving Zilver PTX). Base case results were confirmed in sensitivity analyses. Adoption of Zilver PTX could lead to important savings for the French public health care payer. Despite higher initial reimbursement for the Zilver PTX stent, fewer expected SFA reinterventions after the primary stenting procedure result in net savings.

  8. Arterial healing following primary PCI using the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) versus the durable polymer everolimus-eluting metallic stent (XIENCE) in patients with acute ST-elevation myocardial infarction

    DEFF Research Database (Denmark)

    Räber, Lorenz; Onuma, Yoshinobu; Brugaletta, Salvatore

    2015-01-01

    Aims: The Absorb bioresorbable vascular scaffold (Absorb BVS) provides similar clinical outcomes compared with a durable polymer-based everolimus-eluting metallic stent (EES) in stable coronary artery disease patients. ST-elevation myocardial infarction (STEMI) lesions have been associated with d...

  9. In-stent neoatherosclerosis and tissue characteristics of restenotic lesions following implantation of second generation drug-eluting stents in unrestricted coronary lesions: Optical frequency domain imaging study.

    Science.gov (United States)

    Sabbah, Mahmoud; Kadota, Kazushige; El-Eraky, Azza; Kamal, Hanan M; Abdellah, Ahmed-Tageldien; El Hawary, Ahmed

    2017-06-01

    Differences in stent platform, polymer coatings, and antirestenotic drugs among the current in use second-generation drug-eluting stents (G2-DESs) may induce significant variations in neointimal response and vascular healing, which may impact the prevalence of neoatherosclerosis (NA) and morphological appearance of the restenotic tissue. Utilizing Optical frequency domain imaging, two independent reviewers, retrospectively compared the prevalence of neoatherosclerosis (NA), and the morphological differences, and tissue characteristics of 50 G2-DESs in-stent restenosis (ISR) lesions (35 everolimus-eluting stent [22 cobalt-chromium (CoCr), 13 platinum-chromium (PtCr)], and 15 biolimus-eluting stent [BES]) implanted liberally in unrestricted coronary lesions. More than half of the stents were implanted in type C lesions, while 40% of the stents were implanted primarily in lesions with recanalized chronic total occlusion. NA, defined as a neointima formation with the presence of lipids or calcification, was observed in fewer than half (24/50) of all ISR lesions with no significant in-between group differences (41%, 69%, and 40% in CoCr, PtCr, and BES respectively, P = 0.22), nor were there any significant differences in the morphological appearance or tissue characteristics between all G2-DESs subtypes. Acknowledging some limitations, our results may suggest that the prevalence of NA and the morphological appearance of restenotic lesions might not differ when G2-DESs are implanted in unrestricted, rather complex, coronary lesions. © 2017, Wiley Periodicals, Inc.

  10. Ultra Low-Dose Naloxone and Tramadol/Acetaminophen in Elderly Patients Undergoing Joint Replacement Surgery: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Ngozi N Imasogie

    2009-01-01

    Full Text Available OBJECTIVE: A pilot study was conducted to assess whether both the rationale and feasibility exist for future randomized clinical trials to evaluate the combined use of naloxone infusion and tramadol/acetaminophen as opioid-sparing drugs in elderly patients undergoing lower extremity joint replacement surgery.

  11. Successful delivery of chemotherapy to treat small-cell prostate cancer in a patient undergoing haemodialysis

    OpenAIRE

    McPartlin, Andrew; Grimaldo, Claudia; Lyons, Jeanette; Burke, Daniel; Mitra, Sandip; Choudhury, Ananya

    2014-01-01

    We report on the successful treatment of small-cell prostate cancer in a patient undergoing haemodialysis. The therapeutic regimen included 300 mg/m2 of carboplatin and 50 mg/m2 of etoposide coupled with radical radiotherapy. Adjustments to the patient's haemodialysis prescription included the use of high flux, a larger dialyser surface area and an increased dialysis time. The parameters used aided tolerance to the drug, allowing the delivery of safe, effective treatment. At an interval of ov...

  12. Phase II Study of Chemoembolization With Drug-Eluting Beads in Patients With Hepatic Neuroendocrine Metastases: High Incidence of Biliary Injury

    Energy Technology Data Exchange (ETDEWEB)

    Bhagat, Nikhil, E-mail: nbhagat1@jhmi.edu; Reyes, Diane K., E-mail: dreyes@jhmi.edu [Johns Hopkins University Medical Center, Johns Hopkins Hospital, Division of Vascular and Interventional Radiology, Department of Radiology (United States); Lin, Mingde, E-mail: ming.lin@philips.com [Philips Research North America, Clinical Informatics, Interventional, and Translational Solutions (CIITS) (United States); Kamel, Ihab [Johns Hopkins University Medical Center, Johns Hopkins Hospital, Division of Vascular and Interventional Radiology, Department of Radiology (United States); Pawlik, Timothy M. [Johns Hopkins University Medical Center, Department of Surgery (United States); Frangakis, Constantine, E-mail: cfrangak@jhsph.edu [Johns Hopkins University, Department of Biostatistics, Bloomberg School of Public Health (United States); Geschwind, J. F., E-mail: jfg@jhmi.edu [Johns Hopkins University Medical Center, Johns Hopkins Hospital, Division of Vascular and Interventional Radiology, Department of Radiology (United States)

    2013-04-15

    To evaluate safety in an interim analysis of transarterial chemoembolization (TACE) with doxorubicin-eluting beads (DEB) in 13 patients with hepatic metastases from neuroendocrine tumors (NETs) as part of a phase II trial. Institutional Review Board approval and informed consent were obtained. Thirteen patients completed preliminary safety analysis. Their mean age was 65 years, Eastern Cooperative Oncology Group status was 0/1, tumor burden range was 4-75 %, and mean targeted tumor size was 5.9 cm. Up to four DEB-TACE sessions (100-300 {mu}m beads loaded with {<=}100 mg doxorubicin) within 6 months were allowed. Tumor response was assessed by magnetic resonance imaging 1 month after treatment using contrast-enhancement [European Association for the Study of the Liver (EASL) and size Response Evaluation Criteria in Solid Tumors (RECIST)] criteria. Safety was assessed by National Cancer Institute Common Terminology Criteria. DEB-TACE was successfully performed in all 13 patients. At 1 month follow-up, there was a mean 12 % decrease in tumor size (p < 0.0003) and a 56 % decrease in tumor enhancement (p < 0.0001). By EASL criteria, the targeted lesion objective response rate was 78 %. Grade 3 to 4 toxicities were fatigue (23 %), increased alanine amino transferase (15 %), hyperglycemia (15 %), and abdominal pain (8 %). Seven patients developed bilomas (54 %); all of these patients had multiple small (<4 cm) lesions. Subsequently, four underwent percutaneous drainage, three for abscess formation and one for symptoms related to mass effect. Although biloma and liver abscess are known risks after TACE, the high incidence in our study population was unexpected and forced interruption of the trial. Although this occurred in a small group of patients, we have changed our technique and patient selection as a result of these findings, thus allowing resumption of the trial.

  13. Phase II Study of Chemoembolization With Drug-Eluting Beads in Patients With Hepatic Neuroendocrine Metastases: High Incidence of Biliary Injury

    International Nuclear Information System (INIS)

    Bhagat, Nikhil; Reyes, Diane K.; Lin, Mingde; Kamel, Ihab; Pawlik, Timothy M.; Frangakis, Constantine; Geschwind, J. F.

    2013-01-01

    To evaluate safety in an interim analysis of transarterial chemoembolization (TACE) with doxorubicin-eluting beads (DEB) in 13 patients with hepatic metastases from neuroendocrine tumors (NETs) as part of a phase II trial. Institutional Review Board approval and informed consent were obtained. Thirteen patients completed preliminary safety analysis. Their mean age was 65 years, Eastern Cooperative Oncology Group status was 0/1, tumor burden range was 4–75 %, and mean targeted tumor size was 5.9 cm. Up to four DEB-TACE sessions (100–300 μm beads loaded with ≤100 mg doxorubicin) within 6 months were allowed. Tumor response was assessed by magnetic resonance imaging 1 month after treatment using contrast-enhancement [European Association for the Study of the Liver (EASL) and size Response Evaluation Criteria in Solid Tumors (RECIST)] criteria. Safety was assessed by National Cancer Institute Common Terminology Criteria. DEB-TACE was successfully performed in all 13 patients. At 1 month follow-up, there was a mean 12 % decrease in tumor size (p < 0.0003) and a 56 % decrease in tumor enhancement (p < 0.0001). By EASL criteria, the targeted lesion objective response rate was 78 %. Grade 3 to 4 toxicities were fatigue (23 %), increased alanine amino transferase (15 %), hyperglycemia (15 %), and abdominal pain (8 %). Seven patients developed bilomas (54 %); all of these patients had multiple small (<4 cm) lesions. Subsequently, four underwent percutaneous drainage, three for abscess formation and one for symptoms related to mass effect. Although biloma and liver abscess are known risks after TACE, the high incidence in our study population was unexpected and forced interruption of the trial. Although this occurred in a small group of patients, we have changed our technique and patient selection as a result of these findings, thus allowing resumption of the trial.

  14. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction

    DEFF Research Database (Denmark)

    Sabaté, Manel; Windecker, Stephan; Iñiguez, Andres

    2015-01-01

    AIMS: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential...... to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES...... was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition...

  15. Predictive Ability of the SYNergy Between Percutaneous Coronary Intervention with TAXus and Cardiac Surgery Score II for Long-term Mortality in Patients with Three-vessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention Treated with Second-generation Drug-eluting Stents

    Directory of Open Access Journals (Sweden)

    Ji-Qiang He

    2015-01-01

    Conclusion: The SS-II is an independent predictor of 5-year mortality in patients with three-vessel CAD undergoing PCI treated with second-generation DES, and demonstrates a superior predictive ability over the SS alone.

  16. Safety of intravenous tranexamic acid in patients undergoing majororthopaedic surgery: a meta-analysis of randomised controlled trials

    Science.gov (United States)

    Franchini, Massimo; Mengoli, Carlo; Marietta, Marco; Marano, Giuseppe; Vaglio, Stefania; Pupella, Simonetta; Mannucci, Pier Mannuccio; Liumbruno, Giancarlo M.

    2018-01-01

    Among the various pharmacological options to decrease peri-operative bleeding, tranexamic acid appears to be one of the most interesting. Several trials have consistently documented the efficacy of this synthetic drug in reducing the risk of blood loss and the need for allogeneic blood transfusion in patients undergoing total hip and knee arthroplasty. The safety of intravenous tranexamic acid in major orthopaedic surgery, particularly regarding the risk of venous thromboembolism, was systematically analysed in this review. A systematic search of the literature identified 73 randomised controlled trials involving 4,174 patients and 2,779 controls. The raw overall incidence of venous thromboembolism was 2.1% in patients who received intravenous tranexamic acid and 2.0% in controls. A meta-analytic pooling showed that the risk of venous thromboembolism in tranexamic acid-treated patients was not significantly different from that of controls (risk difference: 0.01%, 95% confidence interval [CI]: −0.05%, 0.07%; risk ratio: 1.067, 95% CI: 0.760–1.496). Other severe drug-related adverse events occurred very rarely (0.1%). In conclusion, the results of this systematic review and meta-analysis show that intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopaedic surgery. PMID:29337665

  17. Discretionary decisions and disparities in receiving drug-eluting stents under a universal healthcare system: A population-based study.

    Directory of Open Access Journals (Sweden)

    Raymond N Kuo

    Full Text Available One of the main objectives behind the expansion of insurance coverage is to eliminate disparities in health and healthcare. However, researchers have not yet fully elucidated the reasons for disparities in the use of high-cost treatments among patients of different occupations. Furthermore, it remains unknown whether discretionary decisions made at the hospital level have an impact on the administration of high-cost interventions in a universal healthcare system. This study investigated the adoption of drug-eluting stents (DES versus bare metal-stents (BMS among patients in different occupations and income levels, with the aim of gauging the degree to which the inclination of health providers toward treatment options could affect treatment choices at the patient-level within a universal healthcare system.We adopted a cross-sectional observational study design using hierarchical modeling in conjunction with the population-based National Health Insurance database of Taiwan. Patients who received either a BMS or a DES between 2007 and 2010 were included in the study.During the period of study, 42,124 patients received a BMS (65.3% and 22,376 received DES (34.7%. Patients who were physicians or the family members of physicians were far more likely to receive DES (OR: 3.18, CI: 2.38-4.23 than were patients who were neither physicians nor in other high-status jobs (employers, other medical professions, or public service. Similarly, patients in the top 5% income bracket had a higher probability of receiving a DES (OR: 2.23, CI: 2.06-2.47, p 50% or between 25% and 50% was shown to be strongly associated with the selection of DESs (OR: 3.64 CI: 3.24-4.09 and OR: 2.16, CI: 2.01-2.33, respectively.Even under the universal healthcare system in Taiwan, socioeconomic disparities in the use of high-cost services remain widespread. Differences in the care received by patients of lower socioeconomic status may be due to the discretionary decisions of healthcare

  18. Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated With Percutaneous Coronary Intervention: The Scandinavian Organization for Randomized Trials With Clinical Outcome IV (SORT OUT IV)

    DEFF Research Database (Denmark)

    Okkels Jensen, Lisette; Thayssen, Per; Hansen, Henrik Steen

    2012-01-01

    was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were.......71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0...

  19. Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis.

    Science.gov (United States)

    Valgimigli, Marco; Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W; Ferrante, Giuseppe

    2014-11-04

    To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents. Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported. Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death. The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; Pstents the use of cobalt-chromium everolimus eluting stents improves global cardiovascular outcomes including cardiac survival, myocardial infarction, and overall stent thrombosis. © Valgimigli et al 2014.

  20. Prospective Randomized Study of Doxorubicin-Eluting-Bead Embolization in the Treatment of Hepatocellular Carcinoma: Results of the PRECISION V Study

    International Nuclear Information System (INIS)

    Lammer, Johannes; Malagari, Katarina; Vogl, Thomas; Pilleul, Frank; Denys, Alban; Watkinson, Anthony; Pitton, Michael; Sergent, Geraldine; Pfammatter, Thomas; Terraz, Sylvain; Benhamou, Yves; Avajon, Yves; Gruenberger, Thomas; Pomoni, Maria; Langenberger, Herbert; Schuchmann, Marcus; Dumortier, Jerome; Mueller, Christian; Chevallier, Patrick; Lencioni, Riccardo

    2010-01-01

    Transcatheter arterial chemoembolization (TACE) offers a survival benefit to patients with intermediate hepatocellular carcinoma (HCC). A widely accepted TACE regimen includes administration of doxorubicin-oil emulsion followed by gelatine sponge-conventional TACE. Recently, a drug-eluting bead (DC Bead) has been developed to enhance tumor drug delivery and reduce systemic availability. This randomized trial compares conventional TACE (cTACE) with TACE with DC Bead for the treatment of cirrhotic patients with HCC. Two hundred twelve patients with Child-Pugh A/B cirrhosis and large and/or multinodular, unresectable, N0, M0 HCCs were randomized to receive TACE with DC Bead loaded with doxorubicin or cTACE with doxorubicin. Randomization was stratified according to Child-Pugh status (A/B), performance status (ECOG 0/1), bilobar disease (yes/no), and prior curative treatment (yes/no). The primary endpoint was tumor response (EASL) at 6 months following independent, blinded review of MRI studies. The drug-eluting bead group showed higher rates of complete response, objective response, and disease control compared with the cTACE group (27% vs. 22%, 52% vs. 44%, and 63% vs. 52%, respectively). The hypothesis of superiority was not met (one-sided P = 0.11). However, patients with Child-Pugh B, ECOG 1, bilobar disease, and recurrent disease showed a significant increase in objective response (P = 0.038) compared to cTACE. DC Bead was associated with improved tolerability, with a significant reduction in serious liver toxicity (P < 0.001) and a significantly lower rate of doxorubicin-related side effects (P = 0.0001). TACE with DC Bead and doxorubicin is safe and effective in the treatment of HCC and offers a benefit to patients with more advanced disease.

  1. Revascularisation versus medical treatment in patients with stable coronary artery disease: network meta-analysis

    Science.gov (United States)

    Stortecky, Stefan; Stefanini, Giulio G; daCosta, Bruno R; Rutjes, Anne Wilhelmina; Di Nisio, Marcello; Siletta, Maria G; Maione, Ausilia; Alfonso, Fernando; Clemmensen, Peter M; Collet, Jean-Philippe; Cremer, Jochen; Falk, Volkmar; Filippatos, Gerasimos; Hamm, Christian; Head, Stuart; Kappetein, Arie Pieter; Kastrati, Adnan; Knuuti, Juhani; Landmesser, Ulf; Laufer, Günther; Neumann, Franz-Joseph; Richter, Dimitri; Schauerte, Patrick; Sousa Uva, Miguel; Taggart, David P; Torracca, Lucia; Valgimigli, Marco; Wijns, William; Witkowski, Adam; Kolh, Philippe; Juni, Peter

    2014-01-01

    Objective To investigate whether revascularisation improves prognosis compared with medical treatment among patients with stable coronary artery disease. Design Bayesian network meta-analyses to combine direct within trial comparisons between treatments with indirect evidence from other trials while maintaining randomisation. Eligibility criteria for selecting studies A strategy of initial medical treatment compared with revascularisation by coronary artery bypass grafting or Food and Drug Administration approved techniques for percutaneous revascularization: balloon angioplasty, bare metal stent, early generation paclitaxel eluting stent, sirolimus eluting stent, and zotarolimus eluting (Endeavor) stent, and new generation everolimus eluting stent, and zotarolimus eluting (Resolute) stent among patients with stable coronary artery disease. Data sources Medline and Embase from 1980 to 2013 for randomised trials comparing medical treatment with revascularisation. Main outcome measure All cause mortality. Results 100 trials in 93 553 patients with 262 090 patient years of follow-up were included. Coronary artery bypass grafting was associated with a survival benefit (rate ratio 0.80, 95% credibility interval 0.70 to 0.91) compared with medical treatment. New generation drug eluting stents (everolimus: 0.75, 0.59 to 0.96; zotarolimus (Resolute): 0.65, 0.42 to 1.00) but not balloon angioplasty (0.85, 0.68 to 1.04), bare metal stents (0.92, 0.79 to 1.05), or early generation drug eluting stents (paclitaxel: 0.92, 0.75 to 1.12; sirolimus: 0.91, 0.75 to 1.10; zotarolimus (Endeavor): 0.88, 0.69 to 1.10) were associated with improved survival compared with medical treatment. Coronary artery bypass grafting reduced the risk of myocardial infarction compared with medical treatment (0.79, 0.63 to 0.99), and everolimus eluting stents showed a trend towards a reduced risk of myocardial infarction (0.75, 0.55 to 1.01). The risk of subsequent revascularisation was noticeably

  2. First-in-human evaluation of a bioabsorbable polymer-coated sirolimus-eluting stent: imaging and clinical results of the DESSOLVE I Trial (DES with sirolimus and a bioabsorbable polymer for the treatment of patients with de novo lesion in the native coronary arteries).

    Science.gov (United States)

    Ormiston, John; Webster, Mark; Stewart, James; Vrolix, Mathias; Whitbourn, Robert; Donohoe, Dennis; Knape, Charlene; Lansky, Alexandra; Attizzani, Guilherme F; Fitzgerald, Peter; Kandzari, David E; Wijns, William

    2013-10-01

    This first-in-human multicenter study sought to examine prospectively the safety and efficacy of a new, cobalt chromium thin-strut, coronary absorbable polymer-coated, sirolimus-eluting stent. Bioabsorbable polymers on drug-eluting stents may lower the long-term risks of inflammation, delayed healing, and adverse events. We enrolled patients with symptomatic coronary artery disease with stable or unstable angina pectoris and >50% diameter stenosis, amenable to coverage with a ≤23-mm long stent in a vessel 2.5 to 3.5 mm in diameter. All patients received dual antiplatelet therapy after implantation. Patients, in groups of 10, underwent repeat angiography, intravascular ultrasound, and optical coherence tomography at 4, 6, or 8 months, and all patients were seen or contacted at 18 months of follow-up. The median (range) in-stent late lumen loss (LLL) was 0.03 mm (-0.22 to 0.21 mm), 0.10 mm (-0.03 to 1.2 mm), and 0.08 mm (-0.01 to 0.28 mm), at 4, 6, and 8 months, respectively. At 18 months, the median in-stent LLL was 0.08 mm (-0.30 to 0.46 mm). On optical coherence tomography, the proportion of uncovered stent struts decreased from a median of 7.3% (range 0.4% to 46.3%) at 4 months to 0% (range: 0% to 3.4%) at 18 months. The percentage of neointimal volume obstruction by intravascular ultrasound increased from a median of 5.3% to 9.1% between 4 and 6 months and remained nearly unchanged thereafter through 18 months of follow-up. The only recorded major adverse cardiac event was a myocardial infarction. At 18 months of follow-up, this absorbable polymer-coated, cobalt chromium sirolimus-eluting stent was associated with a low and stable in-stent LLL, complete strut coverage, and no stent thrombosis. (First-In-Human Trial of the MiStent Drug-Eluting Stent [DES] in Coronary Artery Disease [DESSOLVE-I]; NCT01247428). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. Preoperative autologous plateletpheresis in patients undergoing open heart surgery.

    OpenAIRE

    Tomar Akhlesh; Tempe Deepak; Banerjee A; Hegde R; Cooper A; Khanna S

    2003-01-01

    Blood conservation is an important aspect of care provided to the patients undergoing cardiac operations with cardiopulmonary bypass (CPB). It is even more important in patients with anticipated prolonged CPB, redo cardiac surgery, patients having negative blood group and in patients undergoing emergency cardiac surgery. In prolonged CPB the blood is subjected to more destruction of important coagulation factors, in redo surgery the separation of adhesions leads to increased bleeding and diff...

  4. Associations Between Complex PCI and Prasugrel or Clopidogrel Use in Patients With Acute Coronary Syndrome Who Undergo PCI: From the PROMETHEUS Study.

    Science.gov (United States)

    Chandrasekhar, Jaya; Baber, Usman; Sartori, Samantha; Aquino, Melissa; Kini, Annapoorna S; Rao, Sunil; Weintraub, William; Henry, Timothy D; Farhan, Serdar; Vogel, Birgit; Sorrentino, Sabato; Ge, Zhen; Kapadia, Samir; Muhlestein, Joseph B; Weiss, Sandra; Strauss, Craig; Toma, Catalin; DeFranco, Anthony; Effron, Mark B; Keller, Stuart; Baker, Brian A; Pocock, Stuart; Dangas, George; Mehran, Roxana

    2018-03-01

    Potent P2Y 12 inhibitors might offer enhanced benefit against thrombotic events in complex percutaneous coronary intervention (PCI). We examined prasugrel use and outcomes according to PCI complexity, as well as analyzing treatment effects according to thienopyridine type. PROMETHEUS was a multicentre observational study that compared clopidogrel vs prasugrel in acute coronary syndrome patients who underwent PCI (n = 19,914). Complex PCI was defined as PCI of the left main, bifurcation lesion, moderate-severely calcified lesion, or total stent length ≥ 30 mm. Major adverse cardiac events (MACE) were a composite of death, myocardial infarction, stroke, or unplanned revascularization. Outcomes were adjusted using multivariable Cox regression for effect of PCI complexity and propensity-stratified analysis for effect of thienopyridine type. The study cohort included 48.9% (n = 9735) complex and 51.1% (n = 10,179) noncomplex patients. Second generation drug-eluting stents were used in 70.1% complex and 66.2% noncomplex PCI patients (P PCI was associated with greater adjusted risk of 1-year MACE (hazard ratio [HR], 1.29; 95% confidence interval [CI], 1.20-1.39; P PCI patients (P = 0.30). Compared with clopidogrel, prasugrel significantly decreased adjusted risk for 1-year MACE in complex PCI (HR, 0.79; 95% CI, 0.68-0.92) but not noncomplex PCI (HR, 0.91; 95% CI, 0.77-1.08), albeit there was no evidence of interaction (P interaction = 0.281). Despite the use of contemporary techniques, acute coronary syndrome patients who undergo complex PCI had significantly higher rates of 1-year MACE. Adjusted magnitude of treatment effects with prasugrel vs clopidogrel were consistent in complex and noncomplex PCI without evidence of interaction. Copyright © 2018. Published by Elsevier Inc.

  5. Novel management strategy for coronary steal syndrome: case report of occlusion of a LIMA graft side branch with a combination of drug-eluting and covered-stent deployment.

    LENUS (Irish Health Repository)

    Hynes, Brian G

    2009-11-01

    We report a novel percutaneous therapeutic approach to the management of suspected coronary artery steal syndrome resulting from a large side branch of the left internal mammary artery bypass graft, using a combination of coated and drug-eluting stents. We demonstrate the feasibility and long-term efficacy of this strategy in a case report.

  6. In Vivo and In Vitro Elution of Analgesics from Multilayered Poly(D,L-lactide-co-glycolide Nanofibers Incorporated Ureteral Stents

    Directory of Open Access Journals (Sweden)

    Yi-Chia Lin

    2018-01-01

    Full Text Available We develop novel analgesic-eluting nanofiber-incorporated ureteral stents that offer sustained release of lidocaine and ketorolac for local drug delivery. Lidocaine and poly(D,L-lactide-co-glycolide (PLGA were dissolved in hexafluoroisopropanol and were electrospun into nonwoven nanofibers onto the surface of ureteral stents. This was followed by electrospinning of another layer of PLGA nanofibers containing ketorolac. Electrospun drug-loaded nanofibers were then characterized using scanning electron microscopy, Fourier transform infrared spectroscopy, and water contact angle analysis. In addition, the elution behavior characteristics of the analgesics, both in vivo and in vitro, from the nanofiber-incorporated stents were evaluated. Experimental results indicate that the analgesic-eluting ureteral stents could liberate high strengths of analgesics in vitro and in vivo for at least 50 and 30 days, respectively. The analgesic-eluting nanofiber-incorporated ureteral stents are potentially applicable for alleviating the discomfort associated with stent implant.

  7. The Society for Translational Medicine: clinical practice guidelines for mechanical ventilation management for patients undergoing lobectomy

    Science.gov (United States)

    Zhang, Zhongheng; Brunelli, Alessandro; Chen, Chang; Chen, Chun; Chen, Gang; Chen, Haiquan; Chen, Jin-Shing; Cassivi, Stephen; Chai, Ying; Downs, John B.; Fang, Wentao; Fu, Xiangning; Garutti, Martínez I.; He, Jianxing; Hu, Jian; Huang, Yunchao; Jiang, Gening; Jiang, Hongjing; Jiang, Zhongmin; Li, Danqing; Li, Gaofeng; Li, Hui; Li, Qiang; Li, Xiaofei; Li, Yin; Li, Zhijun; Liu, Chia-Chuan; Liu, Deruo; Liu, Lunxu; Liu, Yongyi; Ma, Haitao; Mao, Weimin; Mao, Yousheng; Mou, Juwei; Ng, Calvin Sze Hang; Petersen, René H.; Qiao, Guibin; Rocco, Gaetano; Ruffini, Erico; Tan, Lijie; Tan, Qunyou; Tong, Tang; Wang, Haidong; Wang, Qun; Wang, Ruwen; Wang, Shumin; Xie, Deyao; Xue, Qi; Xue, Tao; Xu, Lin; Xu, Shidong; Xu, Songtao; Yan, Tiansheng; Yu, Fenglei; Yu, Zhentao; Zhang, Chunfang; Zhang, Lanjun; Zhang, Tao; Zhang, Xun; Zhao, Xiaojing; Zhao, Xuewei; Zhi, Xiuyi; Zhou, Qinghua

    2017-01-01

    Patients undergoing lobectomy are at significantly increased risk of lung injury. One-lung ventilation is the most commonly used technique to maintain ventilation and oxygenation during the operation. It is a challenge to choose an appropriate mechanical ventilation strategy to minimize the lung injury and other adverse clinical outcomes. In order to understand the available evidence, a systematic review was conducted including the following topics: (I) protective ventilation (PV); (II) mode of mechanical ventilation [e.g., volume controlled (VCV) versus pressure controlled (PCV)]; (III) use of therapeutic hypercapnia; (IV) use of alveolar recruitment (open-lung) strategy; (V) pre-and post-operative application of positive end expiratory pressure (PEEP); (VI) Inspired Oxygen concentration; (VII) Non-intubated thoracoscopic lobectomy; and (VIII) adjuvant pharmacologic options. The recommendations of class II are non-intubated thoracoscopic lobectomy may be an alternative to conventional one-lung ventilation in selected patients. The recommendations of class IIa are: (I) Therapeutic hypercapnia to maintain a partial pressure of carbon dioxide at 50–70 mmHg is reasonable for patients undergoing pulmonary lobectomy with one-lung ventilation; (II) PV with a tidal volume of 6 mL/kg and PEEP of 5 cmH2O are reasonable methods, based on current evidence; (III) alveolar recruitment [open lung ventilation (OLV)] may be beneficial in patients undergoing lobectomy with one-lung ventilation; (IV) PCV is recommended over VCV for patients undergoing lung resection; (V) pre- and post-operative CPAP can improve short-term oxygenation in patients undergoing lobectomy with one-lung ventilation; (VI) controlled mechanical ventilation with I:E ratio of 1:1 is reasonable in patients undergoing one-lung ventilation; (VII) use of lowest inspired oxygen concentration to maintain satisfactory arterial oxygen saturation is reasonable based on physiologic principles; (VIII) Adjuvant drugs

  8. Impact of polymer formulations on neointimal proliferation after zotarolimus-eluting stent with different polymers: insights from the RESOLUTE trial.

    Science.gov (United States)

    Waseda, Katsuhisa; Ako, Junya; Yamasaki, Masao; Koizumi, Tomomi; Sakurai, Ryota; Hongo, Yoichiro; Koo, Bon-Kwon; Ormiston, John; Worthley, Stephen G; Whitbourn, Robert J; Walters, Darren L; Meredith, Ian T; Fitzgerald, Peter J; Honda, Yasuhiro

    2011-06-01

    Polymer formulation may affect the efficacy of drug-eluting stents. Resolute, Endeavor, and ZoMaxx are zotarolimus-eluting stents with different stent platforms and different polymer coatings and have been tested in clinical trials. The aim of this analysis was to compare the efficacy of zotarolimus-eluting stents with different polymers. Data were obtained from the first-in man trial or first randomized trials of each stent, The Clinical RESpOnse EvaLUation of the MedTronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (RESOLUTE), Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions (ENDEAVOR II), and ZoMaxx I trials. Follow-up intravascular ultrasound analyses (8 to 9 months of follow-up) were possible in 353 patients (Resolute: 88, Endeavor: 98, ZoMaxx: 82, Driver: 85). Volume index (volume/stent length) was obtained for vessel, stent, lumen, peristent plaque, and neointima. Cross-sectional narrowing was defined as neointimal area divided by stent area (%). Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. At baseline, vessel, lumen, and peristent plaque volume index were not significantly different among the 4 stent groups. At follow-up, percent neointimal obstruction was significantly lower in Resolute compared with Endeavor, ZoMaxx, and Driver (Resolute: 3.7±4.0, Endeavor: 17.5±10.1, ZoMaxx: 14.6±8.1, Driver: 29.4±17.2%; Ppolymer used in Resolute independently correlated with neointimal suppression among 3 zotarolimus-eluting stents. The different polymer formulations significantly affect the relative amount of neointima for zotarolimus-eluting stents. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00248079.

  9. Effect of cytochrome P450 2C19 polymorphism on adverse cardiovascular events after drug-eluting stent implantation in a large Hakka population with acute coronary syndrome receiving clopidogrel in southern China.

    Science.gov (United States)

    Zhong, Zhixiong; Hou, Jingyuan; Zhang, Qifeng; Li, Bin; Li, Cunren; Liu, Zhidong; Yang, Min; Zhong, Wei; He, Xuebo; Wu, Hesen; Zhong, Miaocai; Zhao, Pingsen

    2018-04-01

    The objective of this study is to evaluate the effects of cytochrome P450 2C19 (CYP2C19) polymorphism on adverse cardiovascular events (MACE) in Hakka patients with acute coronary syndrome (ACS) receiving clopidogrel who had undergone coronary drug-eluting stent placement after percutaneous coronary intervention (PCI) in southern China. Genotyping of CYP2C19 and MACE of 934 ACS patients with PCI on clopidogrel maintenance therapy were analyzed. Patients who carried loss-of-function CYP2C19 were treated with a 150-mg maintenance dose of clopidogrel or 90 mg of ticagrelor antiplatelet therapy, and patients who were non-carriers received clopidogrel therapy daily at a maintenance dose of 75 mg and the patients were followed-up for at least 12 months. The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction, and target vessel revascularization and stroke. The allelic frequency of CYP2C19*2 and CYP2C19*3 of Hakka patients in the current study was 31.64 and 5.19%, respectively. The CYP2C19 wild-type homozygotes (*1/*1) were the most predominant among the patients (40.36%), followed by the CYP2C19*2 heterozygotes (*1/*2) (40.26%). The distribution of CYP2C19 phenotypes was divided into extensive metabolizers (EM; 40.36%), intermediate metabolizers (IM; 45.61%), and poor metabolizers (PM; 14.03%). Based on the genotype-guided antiplatelet therapy, there was no significant association between the carrier status and the clinical outcome at 1, 6, and 12 months. In addition, no significant difference in the rates of bleeding was found among the three groups. After logistic regression analysis, hypertension was the only independent predictor of cardiovascular events (relative risk, 1.501; 95% CI, 1.011 to 2.229; P = 0.044). Our results shed new light on the important benefit of testing CYP2C19 polymorphisms before prescribing clopidogrel in patients treated with drug-eluting stent implantation after PCI. The testing may help to

  10. Long term outcomes of new generation drug eluting stents versus coronary artery bypass grafting for multivessel and/or left main coronary artery disease. A Bayesian network meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Mina, George S; Watti, Hussam; Soliman, Demiana; Shewale, Anand; Atkins, Jessica; Reddy, Pratap; Dominic, Paari

    2018-01-05

    Most data guiding revascularization of multivessel disease (MVD) and/or left main disease (LMD) favor coronary artery bypass grafting (CABG) over percutaneous coronary intervention (PCI). However, those data are based on trials comparing CABG to bare metal stents (BMS) or old generation drug eluting stents (OG-DES). Hence, it is essential to outcomes of CABG to those of new generation drug eluting stents (NG-DES). We searched PUBMED and Cochrane database for trials evaluating revascularization of MVD and/or LMD with CABG and/or PCI. A Bayesian network meta-analysis was performed to calculate odds ratios (OR) and 95% credible intervals (CrI). Primary outcome was major adverse cardiovascular events (MACE) at 3-5 years. Secondary outcomes were mortality, cerebrovascular accidents (CVA), myocardial infarction (MI) and repeat revascularization. We included 10 trials with a total of 9287 patients. CABG was associated with lower MACE when compared to BMS or OG-DES. However, MACE was not significantly different between CABG and NG-DES (OR 0.79, CrI 0.45-1.40). Moreover, there were no significant differences between CABG and NG-DES in mortality (OR 0.78, CrI 0.45-1.37), CVA (OR 0.93 CrI 0.35-2.2) or MI (OR 0.6, CrI 0.17-2.0). On the other hand, CABG was associated with lower repeat revascularization (OR 0.55, CrI 0.36-0.84). Our study suggests that NG-DES is an acceptable alternative to CABG in patients with MVD and/or LMD. However, repeat revascularization remains to be lower with CABG than with PCI. Copyright © 2018. Published by Elsevier Inc.

  11. Multifunctional surfaces with biomimetic nanofibres and drug-eluting micro-patterns for infection control and bone tissue formation

    Directory of Open Access Journals (Sweden)

    XN Chen

    2012-09-01

    Full Text Available For long-term orthopaedic implants, the creation of a surface that is repulsive to bacteria while adhesive to tissue cells represents a promising strategy to control infection. To obtain such multifunctional surfaces, two possible approaches were explored to incorporate a model antibiotic, rifampicin (Rf, into the osteogenic polycaprolactone (PCL/chitosan (CHS biomimetic nanofibre meshes by (1 blending Rf into the electrospinning solutions and then electrospinning into nanofibres (i.e., Rf-incorporating fibres, or (2 depositing Rf-containing poly(D,L-lactic-co-glycolic acid (PLGA micro-patterns onto the PCL/chitosan nanofibre meshes via ink-jet printing (i.e., Rf-eluting micro-pattern/fibre. Rapid release of Rf from both meshes was measured even though a relatively slower release rate was obtained from the Rf-eluting micro-pattern ones. Antibacterial assay with Staphylococcus epidermidis showed that both mesh surfaces could effectively kill bacteria and prevent biofilm formation. However, only Rf-eluting micro-pattern meshes favoured the attachment, spreading and metabolic activity of preosteoblasts in the cell culture study. Furthermore, the Rf-eluting micro-pattern meshes could better support the osteogenic differentiation of preosteoblasts by up-regulating the gene expression of bone markers (type I collagen and alkaline phosphatase. Clearly, compared to Rf-incorporating nanofibre meshes, Rf-eluting micro-patterns could effectively prevent biofilm formation without sacrificing the osteogenic properties of PCL/chitosan nanofibre surfaces. This finding provides an innovative avenue to design multifunctional surfaces for enhancing bone tissue formation while controlling infection.

  12. A Proactive Approach to High Risk Delirium Patients Undergoing Total Joint Arthroplasty.

    Science.gov (United States)

    Duque, Andres F; Post, Zachary D; Orozco, Fabio R; Lutz, Rex W; Ong, Alvin C

    2018-04-01

    Delirium is a common complication among elderly patients undergoing total joint arthroplasty (TJA). Its incidence has been reported from 4% to 53%. The Centers for Medicare and Medicaid Services consider delirium following TJA a "never-event." The purpose of this study is to evaluate a simple perioperative protocol used to identify delirium risk patients and prevent its incidence following TJA. Our group developed a protocol to identify and prevent delirium in patients undergoing TJA. All patients were screened and scored in the preoperative assessment, on criteria such as age, history of forgetfulness, history of agitation or visual hallucinations, history of falls, history of postoperative confusion, and inability to perform higher brain functions. Patients were scored on performance in a simple mental examination. The patients were classified as low, medium, or high risk. Patients who were identified as high risk were enrolled in a delirium avoidance protocol that minimized narcotics and emphasized nursing involvement and fluids administration. Five of 7659 (0.065%) consecutive TJA patients from 2010 to 2015 developed delirium. A total of 422 patients were identified as high risk. All 5 patients who suffered delirium were within the high risk group. No low or medium risk patients suffered a delirium complication. Three (0.039%) patients suffered drug-induced delirium, 1 (0.013%) had delirium related to alcohol withdrawal, and 1 (0.013%) had delirium after a systemic infection. This protocol is effective in identifying patients at high delirium risk and diminishing the incidence of this complication by utilizing a simple screening tool and perioperative protocol. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Investigating the motives of patients with knee OA undergoing a TKR

    DEFF Research Database (Denmark)

    Traumer, Line; Sørensen, Erik Elgaard; Kusk, Kathrine Hoffmann

    2018-01-01

    , a qualitatively assessment of what actually affects the patient's decision to undergo TKR would be important. Therefore, the purpose of this study was to investigate the motives of patients with knee OA choosing to undergo TKR and to explore the factors considered important during their decision?making process...... was a legitimate argument among patients. The prospect of avoiding taking high doses of pain?relieving medication and hearing positive experiences of others who had undergone TKR motivated patients to undergo TKR. However, negative experiences of others were neglected. Conclusions Patients' decision?making process...... revealed that the interaction between doctor and patient emerged as a factor highly influential on patients' decision?making process with patients choosing the treatment option suggested by the doctor. Using x?rays, revealing no cartilage between the bones, as a reason for choosing to undergo TKR...

  14. Successful delivery of chemotherapy to treat small-cell prostate cancer in a patient undergoing haemodialysis.

    Science.gov (United States)

    McPartlin, Andrew; Grimaldo, Claudia; Lyons, Jeanette; Burke, Daniel; Mitra, Sandip; Choudhury, Ananya

    2014-12-01

    We report on the successful treatment of small-cell prostate cancer in a patient undergoing haemodialysis. The therapeutic regimen included 300 mg/m(2) of carboplatin and 50 mg/m(2) of etoposide coupled with radical radiotherapy. Adjustments to the patient's haemodialysis prescription included the use of high flux, a larger dialyser surface area and an increased dialysis time. The parameters used aided tolerance to the drug, allowing the delivery of safe, effective treatment. At an interval of over 12 months post-treatment the patient shows no clinical evidence of recurrent disease. This case provides evidence to encourage the use of chemotherapy in otherwise potentially undertreated haemodialysed patients.

  15. Evaluation of electrochemical ion exchange for cesium elution

    International Nuclear Information System (INIS)

    Bontha, J.D.; Kurath, D.E.; Surma, J.E.; Buehler, M.F.

    1996-04-01

    Electrochemical elution was investigated as an alternative method to acid elution for the desorption of cesium from loaded ion exchange resins. The approach was found to have several potential advantages over existing technologies, in particular, electrochemical elution eliminates the need for addition of chemicals to elute cesium from the ion exchange resin. Also, since, in the electrochemical elution process the eluting solution is not in direct contact with the ion exchange material, very small volumes of the eluting solution can be used in a complete recycle mode in order to minimize the total volume of the cesium elute. In addition, the cesium is eluted as an alkaline solution that does not require neutralization with caustic to meet the tank farm specifications. Other advantages include easy incorporation of the electrochemical elution process into the present cesium recovery schemes

  16. Drug-eluting stents vs. coronary artery bypass-grafting in coronary heart disease

    Directory of Open Access Journals (Sweden)

    Hagen, Anja

    2008-12-01

    Full Text Available Background: Coronary artery bypass graft (CABG and percutaneous revascularisations with implantation of drug-eluting stents (DES are important treatment methods in coronary heart disease (CHD. Research questions: The evaluation addresses questions on medical efficacy, health economic parameters as well as ethic, social and legal implications in the use of DES vs. CABG in CHD patients. Methods: A systematic literature search was conducted in December 2006 in the most important electronic databases beginning from 2004. Register data and controlled clinical studies were included in the evaluation. Additionally, a health economic modelling was conducted. Results: Medical evaluation: The literature search yielded 2,312 hits. 14 publications about six controlled clinical studies and five publications about two registers were included into the evaluation. Register data showed low mortality (0.2% to 0.7% and low rates of myocardial infarction (0.5% to 1.4% during hospital stay. In patients with stenosis of the left anterior descending coronary artery one study showed in several analyses a significantly higher rate of reinterventions and a significantly higher rate of repeated angina pectoris for DES up to two years after the implantation (16.8% vs. 3.6% and 35% vs. 8%. In patients with left main coronary artery stenosis two studies revealed a significantly higher survival without myocardial infarction and stroke for DES up to one year (96% vs. 79% and 95% vs. 91% and two studies a significantly higher rate of revascularisations up to two years (20% vs. 4% and 25% vs. 5% after the primary intervention. In patients with multivessel disease, one study found a significantly higher mortality and myocardial infarction rate for CABG at one year (2.7% vs. 1.0% and 4.2% vs. 1.3%. The rate of revascularisations was significantly higher in two studies up to two years after DES implantation (8.5% vs. 4.2% and 14.2% vs. 5.3%. The rate at repeated angina pectoris was

  17. Time course, predictors and clinical implications of stent thrombosis following primary angioplasty. Insights from the DESERT cooperation

    DEFF Research Database (Denmark)

    De Luca, Giuseppe; Dirksen, Maurits T; Spaulding, Christian

    2013-01-01

    on the timing of stent thrombosis (ST) with both DES and bare metal stents (BMS) and its prognostic significance in patients undergoing pPCI. The Drug-Eluting Stent in Primary Angioplasty (DESERT) cooperation is based on a pooled database including individual data of randomised trials that evaluate the long...

  18. Rapid Globalization of Medical Device Clinical Development Programs in Japan - The Case of Drug-Eluting Stents.

    Science.gov (United States)

    Murakami, Madoka; Suzuki, Yuka; Tominaga, Toshiyoshi

    2018-02-23

    Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The reduction accompanied a shift in clinical development from a succession pattern (initial product development and approval overseas followed by eventual entrance into the Japanese market) to parallel development (employing multiregional clinical trials (MRCTs)). Although resource-intensive in the short-term, MRCTs are proving to be an effective tool in simultaneous global product development. Creative study designs and the absence of significant ethnic differences in Japanese subjects regarding DES safety and efficacy and the pharmacokinetic behavior of their coating drugs propel this process. More general factors such as medical need and industry incentivization also encourage this shift. Physicians' preference for DES over other percutaneous coronary interventions, the expanding global DES market, and streamlined development and approval prospects each motivate industry to continue investing in DES product development. The efforts of various stakeholders were also integral to overcoming practical obstacles, and contributions by 'Harmonization by Doing' and a premarket collaboration initiative between the USA and Japan were particularly effective. Today, USA/Japan regulatory cooperation is routine, and Japan is now integrated into global medical device development. MRCTs including Japanese subjects, sites, and investigators are now commonplace.

  19. Long-Term Effectiveness of the Zilver PTX Drug-Eluting Stent for Femoropopliteal Peripheral Artery Disease in Patients with No Patent Tibial Runoff Vessels-Results from the Zilver PTX Japan Post-Market Surveillance Study.

    Science.gov (United States)

    Cipollari, Stefano; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Saunders, Alan T; Dake, Michael D

    2018-01-01

    To evaluate 2-year results of the Zilver PTX (Cook Medical, Bloomington, Indiana) drug-eluting stent (DES) for femoropopliteal peripheral artery disease (PAD) in patients with no continuous patent infrapopliteal runoff arteries compared with patients with ≥ 1 continuous patent runoff vessels. A retrospective analysis of patients with femoropopliteal PAD enrolled in the Zilver PTX Post-Market Surveillance Study in Japan was performed. There were no exclusion criteria. Outcomes, including freedom from target lesion revascularization (TLR), patency, and clinical benefit, for the no-runoff group (n = 54) were compared with the runoff group (n = 846). The 2 groups were similar in terms of demographics, lesion characteristics, and comorbidities (P > .05). There was a higher incidence of critical limb ischemia in the no-runoff group compared with the runoff group (44.8% vs 19.7%; P < .01). There were 3 amputations (5.6%) in the no-runoff group versus 7 amputations (0.8%) in the runoff group (P = .02). At 2 years, freedom from TLR rates were 81.3% versus 83.8% (P = .87), patency rates were 68.4% versus 70.7% (P = .95), and clinical benefit rates were 73.7% versus 80.0% (P = .16) in the no-runoff versus runoff group, respectively. Results in patients with no continuous patent tibial runoff were favorable through 2 years and similar to results for patients with ≥ 1 continuous patent runoff vessels, indicating that the Zilver PTX DES may be a valid treatment option for patients with these difficult-to-treat lesions. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

  20. Thrombosis of second-generation drug-eluting stents in real practice results from the multicenter Spanish registry ESTROFA-2 (Estudio Español Sobre Trombosis de Stents Farmacoactivos de Segunda Generacion-2).

    Science.gov (United States)

    de la Torre Hernández, José M; Alfonso, Fernando; Gimeno, Federico; Diarte, Jose A; Lopez-Palop, Ramón; Pérez de Prado, Armando; Rivero, Fernando; Sanchis, Juan; Larman, Mariano; Diaz, Jose F; Elizaga, Jaime; Moreiras, Javier Martín; Gomez Jaume, Alfredo; Hernández, José M; Mauri, Josepa; Recalde, Angel Sánchez; Bullones, Juan A; Rumoroso, Jose R; Del Blanco, Bruno García; Baz, Jose A; Bosa, Francisco; Botas, Javier; Hernández, Felipe

    2010-09-01

    This study sought to evaluate second-generation drug-eluting stent (DES) thrombosis in clinical practice. First-generation DES are associated with a significant incidence of late thrombosis. There is paucity of data regarding real practice late thrombosis incidence and predictors with second-generation DES, zotarolimus-eluting stent (ZES), and everolimus-eluting stents (EES). A prospective, large-scale, non-industry-linked multicenter registry was designed. Complete clinical-procedural data and systematic follow-up of all patients treated with these stents was reported in a dedicated registry supported by the Spanish Working Group on Interventional Cardiology. From 2005 to 2008, 4,768 patients were included in 34 centers: 2,549 treated with ZES, and 2,219 with EES. The cumulative incidence of definite/probable thrombosis for ZES was 1.3% at 1 year and 1.7% at 2 years and for EES 1.4% at 1 year and 1.7% at 2 years (p = 0.8). The increment of definite thrombosis between the first and second year was 0.2% and 0.25%, respectively. In a propensity score analysis, the incidence remained very similar. Ejection fraction (adjusted hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.95 to -0.99; p = 0.008), stent diameter (adjusted HR: 0.37; 95% CI: 0.17to 0.81; p = 0.01) and bifurcations (adjusted HR: 2.1; 95% CI: 1.14 to 3.7; p = 0.02) emerged as independent predictors of thrombosis. In the subgroup of patients with bifurcations, the use of ZES was independently associated with a higher thrombosis rate (adjusted HR: 4; 95% CI: 1.1 to 13; p = 0.03). In a real practice setting, the incidence of thrombosis at 2 years with ZES and EES was low and quite similar. The incidence of very late thrombosis resulted lower than was reported in registries of first-generation DES. In the subset of bifurcations, the use of ZES significantly increased the risk of thrombosis. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  1. Speech profile of patients undergoing primary palatoplasty.

    Science.gov (United States)

    Menegueti, Katia Ignacio; Mangilli, Laura Davison; Alonso, Nivaldo; Andrade, Claudia Regina Furquim de

    2017-10-26

    To characterize the profile and speech characteristics of patients undergoing primary palatoplasty in a Brazilian university hospital, considering the time of intervention (early, before two years of age; late, after two years of age). Participants were 97 patients of both genders with cleft palate and/or cleft and lip palate, assigned to the Speech-language Pathology Department, who had been submitted to primary palatoplasty and presented no prior history of speech-language therapy. Patients were divided into two groups: early intervention group (EIG) - 43 patients undergoing primary palatoplasty before 2 years of age and late intervention group (LIG) - 54 patients undergoing primary palatoplasty after 2 years of age. All patients underwent speech-language pathology assessment. The following parameters were assessed: resonance classification, presence of nasal turbulence, presence of weak intraoral air pressure, presence of audible nasal air emission, speech understandability, and compensatory articulation disorder (CAD). At statistical significance level of 5% (p≤0.05), no significant difference was observed between the groups in the following parameters: resonance classification (p=0.067); level of hypernasality (p=0.113), presence of nasal turbulence (p=0.179); presence of weak intraoral air pressure (p=0.152); presence of nasal air emission (p=0.369), and speech understandability (p=0.113). The groups differed with respect to presence of compensatory articulation disorders (p=0.020), with the LIG presenting higher occurrence of altered phonemes. It was possible to assess the general profile and speech characteristics of the study participants. Patients submitted to early primary palatoplasty present better speech profile.

  2. Neointimal Healing Evaluated by Optical Coherence Tomography after Drug-Eluting Absorbable Metal Scaffold Implantation in de novo Native Coronary Lesions: Rationale and Design of the Magmaris-OCT Study.

    Science.gov (United States)

    Karjalainen, Pasi; Paana, Tuomas; Sia, Jussi; Nammas, Wail

    We sought to explore neointimal healing assessed by optical coherence tomography (OCT) following implantation of the Magmaris sirolimus-eluting absorbable metal scaffold. The Magmaris-OCT is a prospective, multicenter, single-arm observational clinical study, intended to enrol 60 consecutive patients with up to 2 de novo native coronary lesions, each located in different major epicardial vessels, with a reference vessel diameter of 2.5-3.5 mm, and a maximum lesion length of 20 mm. Patients will undergo Magmaris scaffold implantation in the target lesion, according to the standard practice. Clinical follow-up will take place at 30 days, and at 3, 6, 9, and 12 months. For invasive-imaging follow-up, patients will be classified into 3 groups: cohort A will be scheduled for follow-up at 3 months, cohort B at 6 months, and cohort C at 12 months. Invasive imaging will include quantitative coronary angiography, OCT evaluation, and coronary flow reserve measurement. The primary end point will be the percentage of uncovered scaffold struts assessed by OCT at the prespecified follow-up. This study will provide insight into the short- and mid-term healing properties following Magmaris scaffold implantation, with special emphasis on the neointimal coverage of scaffold struts. © 2017 S. Karger AG, Basel.

  3. Identification of Candida species in patients with oral lesion undergoing chemotherapy along with minimum inhibitory concentration to fluconazole

    Directory of Open Access Journals (Sweden)

    Mehrnoush Maheronnaghsh

    2016-01-01

    Conclusion: Data were shown that C. albicans is the most commonly identified species in oral candidiasis and majority of fluconazole resistant C. albicans were found in patients with gastrointestinal cancer and lymphoma. Therefore, we recommend an alternative drug instead of fluconazole as a first line of treatment for these type of cancers and administration of fluconazole in patients undergoing chemotherapy should be prescribed in accordance with the type of cancer.

  4. β-Blocker-Associated Risks in Patients With Uncomplicated Hypertension Undergoing Noncardiac Surgery

    DEFF Research Database (Denmark)

    Jørgensen, Mads E; Hlatky, Mark A; Køber, Lars Valeur

    2015-01-01

    IMPORTANCE: Perioperative β-blocker strategies are important to reduce risks of adverse events. Effectiveness and safety may differ according to patients' baseline risk. OBJECTIVE: To determine the risk of major adverse cardiovascular events (MACEs) associated with long-term β-blocker therapy...... antihypertensive drugs (β-blockers, thiazides, calcium antagonists, or renin-angiotensin system [RAS] inhibitors) undergoing noncardiac surgery between 2005 and 2011. INTERVENTIONS: Various antihypertensive treatment regimens, chosen as part of usual care. MAIN OUTCOMES AND MEASURES: Thirty-day risk of MACEs...... (cardiovascular death, nonfatal ischemic stroke, nonfatal myocardial infarction) and all-cause mortality, assessed using multivariable logistic regression models and adjusted numbers needed to harm (NNH). RESULTS: The baseline characteristics of the 14,644 patients who received β-blockers (65% female, mean [SD...

  5. Effects of ticagrelor versus clopidogrel on platelet function in fibrinolytic-treated STEMI patients undergoing early PCI.

    Science.gov (United States)

    Dehghani, Payam; Lavoie, Andrea; Lavi, Shahar; Crawford, Jennifer J; Harenberg, Sebastian; Zimmermann, Rodney H; Booker, Jeff; Kelly, Sheila; Cantor, Warren J; Mehta, Shamir R; Bagai, Akshay; Goodman, Shaun G; Cheema, Asim N

    2017-10-01

    Patients undergoing PCI early after fibrinolytic therapy are at high risk for both thrombotic and bleeding complications. We sought to assess the pharmacodynamic effects of ticagrelor versus clopidogrel in the fibrinolytic-treated STEMI patients undergoing early PCI. Patients undergoing PCI within 24 hours of tenecteplase (TNK), aspirin, and clopidogrel for STEMI were randomized to receive additional clopidogrel 300 mg followed by 75 mg daily or ticagrelor 180 mg followed by 90 mg twice daily. The platelet reactivity units (PRU) were measured with the VerifyNow Assay before study drug administration (baseline) at 4 and 24 hours post-PCI. The primary end point was PRU ≤208 at 4 hours. A total of 140 patients (74 in ticagrelor and 66 in clopidogrel group) were enrolled. The mean PRU values at baseline were similar for the 2 groups (257.8±52.9 vs 259.5±56.7, P=.85, respectively). Post-PCI, patients on ticagrelor, compared to those on clopidogrel, had significantly lower PRU at 4 hours (78.7±88 vs 193.6±86.5, respectively, PPCI frequently had PRU >208. In this high-risk population, ticagrelor provides more prompt and potent platelet inhibition compared with clopidogrel (Funded by Astra Zeneca; NCT01930591, https://clinicaltrials.gov/ct2/show/NCT01930591). Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Everolimus-induced Pneumonitis after Drug-eluting Stent Implantation: A Case Report

    Energy Technology Data Exchange (ETDEWEB)

    Sakamoto, Susumu, E-mail: susumu1029@gmail.com; Kikuchi, Naoshi; Ichikawa, Atsuo; Sano, Go; Satoh, Keita; Sugino, Keishi; Isobe, Kazutoshi; Takai, Yujiro [Toho University School of Medicine, Department of Respiratory Medicine (Japan); Shibuya, Kazutoshi [Toho University School of Medicine, Department of Pathology (Japan); Homma, Sakae [Toho University School of Medicine, Department of Respiratory Medicine (Japan)

    2013-08-01

    Despite the wide use of everolimus as an antineoplastic coating agent for coronary stents to reduce the rate of restenosis, little is known about the health hazards of everolimus-eluting stents (EES). We describe a case of pneumonitis that developed 2 months after EES implantation for angina. Lung pathology demonstrated an organizing pneumonia pattern that responded to corticosteroid therapy. Although the efficacy of EES for ischemic heart disease is well established, EES carries a risk of pneumonitis.

  7. Simple balloon dilation for drug-eluting in-stent restenosis: An optical coherent tomography analysis

    Energy Technology Data Exchange (ETDEWEB)

    Arikawa, Ryo [Division of Cardiology, Tenyoukai Central Hospital, Izumi-cho, Kagoshima City, Kagoshima (Japan); Yamaguchi, Hiroshi, E-mail: hyamaguchi@tsm.bbiq.jp [Division of Cardiology, Tenyoukai Central Hospital, Izumi-cho, Kagoshima City, Kagoshima (Japan); Takaoka, Junichiro; Miyamura, Akihiro; Atsuchi, Nobuhiko; Ninomiya, Toshiko; Atsuchi, Yoshihiko [Division of Cardiology, Tenyoukai Central Hospital, Izumi-cho, Kagoshima City, Kagoshima (Japan); Ohishi, Mitsuru [Department of Cardiovascular Medicine and Hypertension, Graduate School of Medical and Dental Science, Kagoshima University, Kagoshima (Japan); Terashima, Mitsuyasu [Department of Cardiology, Toyohashi Heart Center, Toyohashi (Japan); Kaneda, Hideaki [Okinaka Memorial Institute for Medical Research, Tokyo (Japan)

    2015-01-15

    Background: Although drug-eluting stent (DES) has significantly reduced restenosis, the treatment of DES-in-stent restenosis (ISR) remains a challenge with high restenosis rate. Methods: We examined whether morphologic appearance of restenosis tissue by optical coherent tomography (OCT) had an impact on outcomes after balloon angioplasty for DES-ISR. The morphologic appearance of restenosis tissue was qualitatively assessed for tissue structures such as homogeneous, layered, and heterogeneous patterns. Results: Using OCT, 50 patients with DES-ISR were divided into 2 groups: 25 lesions with homogeneous or layered patterns (homo/layered group) and 25 lesions with heterogeneous patterns (hetero group). Acute gain was larger in the hetero group (1.33 ± 0.41 mm vs. 1.06 ± 0.32 mm in the homo/layered group, P = 0.03). On intravascular ultrasound analysis, post-procedural percent neointimal area was smaller in the hetero group (27.4 ± 9.2% vs. 34.0 ± 11.2% in the homo/layered group, P = 0.05). Angiographic follow-up was performed in 37 lesions (74%). Follow-up minimal lumen diameter was larger in the hetero group (1.75 ± 0.89 mm vs. 1.01 ± 0.81 mm in the homo/layered group, P = 0.04). Target lesion revascularization rates tended to be lower in the hetero group (20% vs. 43% in the homo/layered group, P = 0.12). Conclusions: Balloon angioplasty was more effective for DES-ISR with heterogeneous tissue appearance than DES-ISR with homogeneous/layered tissue appearance. OCT assessment of DES-ISR morphology may be a useful adjunct in determining clinical strategies. Simple balloon dilatation is a possible treatment strategy for DES-ISR lesions with a heterogeneous appearance on OCT images.

  8. Evaluation of the short- and long-term safety and therapy outcomes of the everolimus-eluting bioresorbable vascular scaffold system in patients with coronary artery stenosis: Rationale and design of the German–Austrian ABSORB RegIstRy (GABI-R)

    Energy Technology Data Exchange (ETDEWEB)

    Nef, Holger, E-mail: holger.nef@innere.med.uni-giessen.de [University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen (Germany); Wiebe, Jens [University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen (Germany); Achenbach, Stefan [University of Erlangen, Medizinische Klinik II, Department of Cardiology, Erlangen (Germany); Münzel, Thomas [Department of Medicine II, University Medical Center, Johannes Gutenberg University Mainz, Mainz (Germany); Naber, Christoph [Klinik für Kardiologie und Angiologie, Elisabeth-Krankenhaus, Essen (Germany); Richardt, Gert [Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg (Germany); Mehilli, Julinda [Department of Cardiology, Klinikum Großhadern, Ludwig- Maximilian Universität, Munich (Germany); Wöhrle, Jochen [Department of Internal Medicine II, University of Ulm, Ulm (Germany); Neumann, Till; Biermann, Janine [University of Essen, Department of Cardiology, Essen (Germany); Zahn, Ralf [Abteilung für Kardiologie, Herzzentrum Ludwigshafen, Ludwigshafen (Germany); Kastner, Johannes [Department of Cardiology, University of Vienna Medical School, Vienna (Austria); Schmermund, Axel [CCB, Cardioangiologisches Centrum Bethanien, Frankfurt (Germany); Pfannebecker, Thomas [Abbott Vascular Deutschland GmbH, Wetzlar (Germany); Schneider, Steffen; Limbourg, Tobias [Institut für Herzinfarktforschung, Ludwigshafen (Germany); Hamm, Christian W. [University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen (Germany); Kerckhoff Heart and Thorax Center, Department of Cardiology, Bad Nauheim (Germany)

    2016-01-15

    Background: Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2–4 years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side effects. Methods/design: The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) in the world-wide greatest all-comers cohort will be evaluated in the prospective, non-interventional, multicenter German–Austrian ABSORB RegIstRy (GABI-R). GABI-R will include over 5000 patients from about 100 study sites in Austria and Germany. Safety endpoints such as cardiac death, myocardial infarction, and clinically driven percutaneous or surgical target lesion and vessel revascularization will be evaluated during hospitalization and in the follow-up period (minimum of 5 years). Conclusion: Although two randomized controlled trials and several registries have documented safety and efficacy as well as non-inferiority of this everolimus-eluting ABSORB device compared with drug-eluting metal stents, the current knowledge regarding clinical application, treatment success, and long-term safety of using this BRS in daily routine is limited. Thus, the goal of GABI-R is to address this lack of information. - Highlights: • The GABI-R addresses a lack of data about bioresorbable scaffolds in daily practice. • 5000 patients with minimal in- and exclusion criteria at 100 sites will

  9. Evaluation of the short- and long-term safety and therapy outcomes of the everolimus-eluting bioresorbable vascular scaffold system in patients with coronary artery stenosis: Rationale and design of the German–Austrian ABSORB RegIstRy (GABI-R)

    International Nuclear Information System (INIS)

    Nef, Holger; Wiebe, Jens; Achenbach, Stefan; Münzel, Thomas; Naber, Christoph; Richardt, Gert; Mehilli, Julinda; Wöhrle, Jochen; Neumann, Till; Biermann, Janine; Zahn, Ralf; Kastner, Johannes; Schmermund, Axel; Pfannebecker, Thomas; Schneider, Steffen; Limbourg, Tobias; Hamm, Christian W.

    2016-01-01

    Background: Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2–4 years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side effects. Methods/design: The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) in the world-wide greatest all-comers cohort will be evaluated in the prospective, non-interventional, multicenter German–Austrian ABSORB RegIstRy (GABI-R). GABI-R will include over 5000 patients from about 100 study sites in Austria and Germany. Safety endpoints such as cardiac death, myocardial infarction, and clinically driven percutaneous or surgical target lesion and vessel revascularization will be evaluated during hospitalization and in the follow-up period (minimum of 5 years). Conclusion: Although two randomized controlled trials and several registries have documented safety and efficacy as well as non-inferiority of this everolimus-eluting ABSORB device compared with drug-eluting metal stents, the current knowledge regarding clinical application, treatment success, and long-term safety of using this BRS in daily routine is limited. Thus, the goal of GABI-R is to address this lack of information. - Highlights: • The GABI-R addresses a lack of data about bioresorbable scaffolds in daily practice. • 5000 patients with minimal in- and exclusion criteria at 100 sites will

  10. The elution of certain protein affinity tags with millimolar concentrations of diclofenac.

    Science.gov (United States)

    Baliova, Martina; Juhasova, Anna; Jursky, Frantisek

    2015-12-01

    Diclofenac (2-[(2, 6-dichlorophenyl)amino] benzeneacetic acid) is a sparingly soluble, nonsteroidal anti-inflammatory drug therapeutically acting at low micromolar concentrations. In pH range from 8 to 11, its aqueous solubility can be increased up to 200 times by the presence of counter ions such as sodium. Our protein interaction studies revealed that a millimolar concentration of sodium diclofenac is able to elute glutathione S-transferase (GST), cellulose binding protein (CBD), and maltose binding protein (MBP) but not histidine-tagged or PDZ-tagged proteins from their affinity resins. The elution efficiency of diclofenac is comparable with the eluting agents normally used at similar concentrations. Native gel electrophoresis of sodium diclofenac-treated proteins showed that the interaction is non-covalent and non-denaturing. These results suggest that sodium diclofenac, in addition to its pharmaceutical applications, can also be exploited as a lead for the development of new proteomics reagents. Copyright © 2015 Elsevier B.V. All rights reserved.

  11. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis

    DEFF Research Database (Denmark)

    Fellström, Bengt C; Jardine, Alan G; Schmieder, Roland E

    2009-01-01

    . Secondary end points included death from all causes and individual cardiac and vascular events. RESULTS: After 3 months, the mean reduction in low-density lipoprotein (LDL) cholesterol levels was 43% in patients receiving rosuvastatin, from a mean baseline level of 100 mg per deciliter (2.6 mmol per liter......BACKGROUND: Statins reduce the incidence of cardiovascular events in patients at high cardiovascular risk. However, a benefit of statins in such patients who are undergoing hemodialysis has not been proved. METHODS: We conducted an international, multicenter, randomized, double-blind, prospective...... trial involving 2776 patients, 50 to 80 years of age, who were undergoing maintenance hemodialysis. We randomly assigned patients to receive rosuvastatin, 10 mg daily, or placebo. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke...

  12. Stents Eluting 6-Mercaptopurine Reduce Neointima Formation and Inflammation while Enhancing Strut Coverage in Rabbits.

    Directory of Open Access Journals (Sweden)

    Matthijs S Ruiter

    Full Text Available The introduction of drug-eluting stents (DES has dramatically reduced restenosis rates compared with bare metal stents, but in-stent thrombosis remains a safety concern, necessitating prolonged dual anti-platelet therapy. The drug 6-Mercaptopurine (6-MP has been shown to have beneficial effects in a cell-specific fashion on smooth muscle cells (SMC, endothelial cells and macrophages. We generated and analyzed a novel bioresorbable polymer coated DES, releasing 6-MP into the vessel wall, to reduce restenosis by inhibiting SMC proliferation and decreasing inflammation, without negatively affecting endothelialization of the stent surface.Stents spray-coated with a bioresorbable polymer containing 0, 30 or 300 μg 6-MP were implanted in the iliac arteries of 17 male New Zealand White rabbits. Animals were euthanized for stent harvest 1 week after implantation for evaluation of cellular stent coverage and after 4 weeks for morphometric analyses of the lesions.Four weeks after implantation, the high dose of 6-MP attenuated restenosis with 16% compared to controls. Reduced neointima formation could at least partly be explained by an almost 2-fold induction of the cell cycle inhibiting kinase p27Kip1. Additionally, inflammation score, the quantification of RAM11-positive cells in the vessel wall, was significantly reduced in the high dose group with 23% compared to the control group. Evaluation with scanning electron microscopy showed 6-MP did not inhibit strut coverage 1 week after implantation.We demonstrate that novel stents coated with a bioresorbable polymer coating eluting 6-MP inhibit restenosis and attenuate inflammation, while stimulating endothelial coverage. The 6-MP-eluting stents demonstrate that inhibition of restenosis without leaving uncovered metal is feasible, bringing stents without risk of late thrombosis one step closer to the patient.

  13. TIDES-ACS Trial: comparison of titanium-nitride-oxide coated bio-active-stent to the drug (everolimus)-eluting stent in acute coronary syndrome. Study design and objectives.

    Science.gov (United States)

    Colkesen, E B; Eefting, F D; Rensing, B J; Suttorp, M J; Ten Berg, J M; Karjalainen, P P; Van Der Heyden, J A

    2015-02-01

    Drug-eluting stents (DES), delivering antiproliferative drugs from a durable polymer, have shown to reduce in-stent restenosis after percutaneous coronary intervention (PCI) compared to bare-metal stents (BMS). However, they have been associated with a hypersensitivity reaction, delayed healing, and incomplete endothelialization, which may contribute to an increased risk of late stent thrombosis. Consequently, a prolonged duration of dual antiplatelet therapy (DAPT) is needed, with an increased risk of bleeding complication. A number of stent technologies are being developed in an attempt to modify late thrombotic events and DAPT duration. The Optimax™ stent is such a novel, next generation bioactive stent (BAS), in which a thicker layer of titanium-nitride-oxide coating is inserted over the stent struts. The rationale of this is to obtain more efficient and rapid vascular healing at the site of the stent implantation. The aim of TIDES-ACS Trial is to compare clinical outcome in patients presenting with ACS, treated with PCI using Optimax-BAS versus Synergy™-EES. Second objective is to explore whether the Optimax™-BAS use is superior compared with Synergy™-EES use with respect of hard end points (cardiac death, myocardial infarction [MI] and major bleeding). A prospective, randomized, multicenter trial (ClinicalTrials.gov Identifier: NCT02049229), will be conducted in interventional centres in Finland (six centres), France (five centres) and Holland (two centres), including a total of 1800 patients.

  14. Specialised care in patients undergoing pancreatoduodenectomy

    NARCIS (Netherlands)

    Tol, J.A.M.G.

    2014-01-01

    This thesis studies the controversies in the management of patients with pancreatic cancer undergoing pancreatoduodenectomy and determines different factors that will improve this management and thereby the postoperative outcomes. The studies were performed in both the pre-, peri- and postoperative

  15. Stent underexpansion in angiographic guided percutaneous coronary intervention, despite adjunctive balloon post-dilatation, in drug eluting stent era

    Directory of Open Access Journals (Sweden)

    Mehrdad Taherioun

    2014-01-01

    Full Text Available BACKGROUND: Stent underexpansion is the most powerful predictor of long-term stent patency and clinical outcome. The purpose of this study was to evaluate the incidence and predictors of stent underexpansion despite adjunctive post-dilatation with non-compliant balloon. METHODS: After elective coronary stent implantation and adjunctive post-dilatation with non-compliant balloon and optimal angiographic result confirmed by the operator, intravascular ultrasound (IVUS was performed for all the treated lesions. If the treated lesions fulfilled the IVUS criteria, they are considered as the optimal stent group; if not, they are considered as the suboptimal group. RESULTS: From 50 patients enrolled in this study 39 (78% had optimal stent deployment and 11 (22% had suboptimal stent deployment. In the suboptimal group 7 (14% had underexpansion, 2 (4% malposition, and 2 (4% had asymmetry. There were no stent edge dissections detected by IVUS. We did not find any correlation between lesion calcification, ostial lesions, stent length, and stent underexpansion. Stent diameter ≤ 2.75 mm had a strong correlation with stent underexpansion. CONCLUSION: Despite adjunctive post-dilatation with noncompliant balloon, using a relatively small stent diameter was a strong predictor for underexpansion. IVUS guided percutaneous coronary intervention (PCI may be considered for drug eluting stent (DES implantation in relatively small vessels.   Keywords: Stent, Percutaneous Coronary Intervention, Ultrasound, Post-dilatation 

  16. Tympanic membrane bleeding complications during hyperbaric oxygen treatment in patients with or without antiplatelet and anticoagulant drug treatment

    NARCIS (Netherlands)

    Fijen, Valerie A.; Westerweel, Peter E.; van Ooij, Pieter Jan A. M.; van Hulst, Rob A.

    2016-01-01

    Middle ear barotrauma (MEBt) is a frequently occurring complication of hyperbaric oxygen treatment (HBOT). High-grade MEBt may involve tympanic membrane (TM) haemorrhaging. Although many patients undergoing HBOT use antiplatelet or anticoagulant drugs, it is unknown whether these drugs increase the

  17. Mortality Among Patients with Pleural Effusion Undergoing Thoracentesis

    Science.gov (United States)

    DeBiasi, Erin M.; Pisani, Margaret A.; Murphy, Terrence E.; Araujo, Katy; Kookoolis, Anna; Argento, A Christine; Puchalski, Jonathan

    2016-01-01

    Background Of the 1.5 million people diagnosed with pleural effusion annually in the U.S., approximately 178,000 undergo thoracentesis. While it is known that malignant pleural effusion portends a poor prognosis, mortality of patients with nonmalignant effusions has not been well studied. Methods This prospective cohort study evaluated 308 patients undergoing thoracentesis. Chart review was performed to obtain baseline characteristics. The etiology of the effusions was determined using standardized criteria. Mortality was determined at 30-days and 1-year. Results 247 unilateral and 61 bilateral thoracenteses were performed. Malignant effusion had the highest 30-day (37%) and 1 year (77%) mortality. There was substantial patient 30-day and 1-year mortality with effusions due to multiple benign etiologies (29% and 55%), CHF (22% and 53%), and renal failure (14% and 57%). Patients with bilateral pleural effusion, relative to unilateral, were associated with higher risk of death at 30 days and 1 year (17% versus 47%; HR 2.58 CI [1.44–4.63] and 36% versus 69%; HR 2.32 CI [1.55–3.48]). Conclusions Patients undergoing thoracentesis for pleural effusion have high short and long-term mortality. Patients with malignant effusion had the highest mortality followed by multiple benign etiologies, CHF and renal failure. Bilateral pleural effusion is distinctly associated with high mortality. PMID:25837039

  18. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial

    DEFF Research Database (Denmark)

    Gutiérrez-Chico, Juan Luis; van Geuns, Robert Jan; Regar, Evelyn

    2011-01-01

    To compare the tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent (ZES) vs. a fluoropolymer-coated everolimus-eluting stent (EES) at 13 months, using optical coherence tomography (OCT) in an 'all-comers' population of patients, in order to clarify the mechanism of eventual...

  19. Rationale and Design of a Randomized Clinical Comparison of Everolimus-Eluting (Xience V/Promus) and Sirolimus-Eluting (Cypher Select+) Coronary Stents in Unselected Patients with Coronary Heart Disease

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Tilsted, Hans Henrik

    2010-01-01

    with Clinical Outcome (SORT OUT) IV trial was designed as a prospective, multi-center, open-label, all-comer, two-arm, randomized, non-inferiority study comparing the everolimus-eluting stent with the sirolimus-eluting stent in the treatment of atherosclerotic coronary artery lesions. Based on a non...

  20. Incidence and Clinical Outcomes of Stent Fractures on the Basis of 6,555 Patients and 16,482 Drug-Eluting Stents From 4 Centers.

    Science.gov (United States)

    Kan, Jing; Ge, Zhen; Zhang, Jun-Jie; Liu, Zhi-Zhong; Tian, Nai-Liang; Ye, Fei; Li, Sui-Ji; Qian, Xue-Song; Yang, Song; Chen, Meng-Xuan; Rab, Tanveer; Chen, Shao-Liang

    2016-06-13

    The present study aimed to analyze the incidence of SF and its correlation with clinical events after DES implantation and the outcome of re-intervention for symptomatic in-stent restenosis (ISR) induced by stent fracture (SF). SF is associated with a high rate of clinical events after the implantation of drug-eluting stents (DES). However, the chronological rate of SF and the effect of SF on clinical outcomes from a large patient population remain underreported. A total of 6,555 patients with 16482 DES in 10751 diseased vessels and surveillance angiography between November 2003 and January 2014 were prospectively studied. The primary endpoints included the incidence of SF, in-stent restenosis (ISR), target lesion revascularization (TLR), and definite stent thrombosis (ST) at the end of follow-up before and after propensity score matching. Clinical outcomes after TLR were also followed up. The SF rate was detected in 803 (12.3%) patients, 3,630 (22.0%) stents, and 1,852 (17.2%) diseased vessels. SF increased over time. SF was associated with higher unadjusted rates of ISR (42.1%), TLR (24.8%, n = 379), and definite ST (4.6%) compared with stents without fracture (10.7%, 6.6%, and 1.03%, all p stents after reintervention, and 6 (7.5%) stents required repeat TLR. SF is more frequently observed after DES implantation. TLR was required in almost one-fourth of fractured stents. Increased events in the SF group did not translate into a difference in mortality compared with the non-SF group. Reintervention was associated with acceptable clinical results. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  1. Development of epigallocatechin gallate-eluting polymeric stent and its physicochemical, biomechanical and biological evaluations

    International Nuclear Information System (INIS)

    Han, Dong-Wook; Lee, Jun Jae; Jung, Duk-Young; Park, Jong-Chul; Hyon, Suong-Hyu

    2009-01-01

    Localized drug delivery from drug-eluting stents has been accepted as one of the most promising treatment methods for preventing restenosis after stenting. However, hypersensitivity reactions caused by their nonresorbable polymer coatings and bare-metal stents may result in serious clinical sequelae. Epigallocatechin-3-O-gallate (EGCG), the predominant catechin from tea, has been shown to exert anti-thrombotic, anti-inflammatory and anti-proliferative activities. In this study, it was hypothesized that sustainedly released EGCG from biodegradable poly(lactide-co-ε-caprolactone, PLCL) would suppress the proliferation of vascular smooth muscle cells (VSMCs). EGCG-releasing PLCL (E-PLCL) was prepared by blending PLCL with EGCG. The surface morphology, roughness and melting temperature of PLCL were not changed despite EGCG addition. EGCG was uniformly dispersed into E-PLCL and sustainedly released for periods up to 7 days by controlled diffusion rather than PLCL degradation. Moreover, EGCG did not affect tensile strength at break, but significantly increased the elastic modulus of PLCL. The proliferation of VSMCs onto E-PLCL was significantly suppressed although the cell attachment onto E-PLCL had been higher than that onto PLCL. On the other hand, EGCG-eluting polymeric stents were prepared with neither cracks nor webbings between struts, and their structural integrity was maintained without delamination or destruction. These results suggest that E-PLCL can be potentially applied for fabricating an EGCG-eluting vascular stent, namely an EGCG-eluting polymeric stent, or even an EGCG-releasing polymer-coated metal stent, to prevent thrombosis, inflammation and in-stent restenosis.

  2. Development of epigallocatechin gallate-eluting polymeric stent and its physicochemical, biomechanical and biological evaluations

    Energy Technology Data Exchange (ETDEWEB)

    Han, Dong-Wook [Department of Nanomedical Engineering, College of Nanoscience and Nanotechnology, Pusan National University, Busan 609-735 (Korea, Republic of); Lee, Jun Jae [Division of Advanced Fibro-Science, Kyoto Institute of Technology, Kyoto 606-8585 (Japan); Jung, Duk-Young [Senior Products Industrial Center, Busan Techno-Park, Busan-617-030 (Korea, Republic of); Park, Jong-Chul [Cellbiocontrol Laboratory, Department of Medical Engineering, Yonsei University College of Medicine, Seoul 120-752 (Korea, Republic of); Hyon, Suong-Hyu, E-mail: nanohan@pusan.ac.k, E-mail: biogen@frontier.kyoto-u.ac.j [Department of Medical Simulation Engineering, Institute for Frontier Medical Sciences, Kyoto University, Kyoto 606-8507 (Japan)

    2009-08-15

    Localized drug delivery from drug-eluting stents has been accepted as one of the most promising treatment methods for preventing restenosis after stenting. However, hypersensitivity reactions caused by their nonresorbable polymer coatings and bare-metal stents may result in serious clinical sequelae. Epigallocatechin-3-O-gallate (EGCG), the predominant catechin from tea, has been shown to exert anti-thrombotic, anti-inflammatory and anti-proliferative activities. In this study, it was hypothesized that sustainedly released EGCG from biodegradable poly(lactide-co-epsilon-caprolactone, PLCL) would suppress the proliferation of vascular smooth muscle cells (VSMCs). EGCG-releasing PLCL (E-PLCL) was prepared by blending PLCL with EGCG. The surface morphology, roughness and melting temperature of PLCL were not changed despite EGCG addition. EGCG was uniformly dispersed into E-PLCL and sustainedly released for periods up to 7 days by controlled diffusion rather than PLCL degradation. Moreover, EGCG did not affect tensile strength at break, but significantly increased the elastic modulus of PLCL. The proliferation of VSMCs onto E-PLCL was significantly suppressed although the cell attachment onto E-PLCL had been higher than that onto PLCL. On the other hand, EGCG-eluting polymeric stents were prepared with neither cracks nor webbings between struts, and their structural integrity was maintained without delamination or destruction. These results suggest that E-PLCL can be potentially applied for fabricating an EGCG-eluting vascular stent, namely an EGCG-eluting polymeric stent, or even an EGCG-releasing polymer-coated metal stent, to prevent thrombosis, inflammation and in-stent restenosis.

  3. Toxic vessel reaction to an absorbable polymer-based paclitaxel-eluting stent in pig coronary arteries.

    Science.gov (United States)

    Jabara, Refat; Chronos, Nicolas; Tondato, Fernando; Conway, Damian; Molema, Warner; Park, Kenneth; Mabin, Tom; King, Spencer; Robinson, Keith

    2006-08-01

    The goal of this study was to evaluate a new drug-eluting stent (DES) comprising a bioabsorbable polymer eluting a moderate dose of paclitaxel in a clinically relevant animal model. Although DES limit restenosis, adverse vascular pathologies and toxicities continue to be of major concern. Optimization of DES components, especially completely absorbable polymers, may reduce these toxicities. Bare-metal (BM), absorbable polymer coating only (POLY), and polymer-based paclitaxel-eluting (PACL) stents were implanted in porcine coronary arteries using intravascular ultrasound (IVUS) to optimize stent apposition. The dose density of paclitaxel was 0.30-0.35 mcg/mm2, with in vitro elution studies demonstrating a gradual elution over 6-8 weeks. The animals were terminated at 1 week, 1 month and 3 months. Histopathologic and histomorphometric analyses were perform. The arteries with PACL showed extensive smooth muscle cell necrosis at 1 week and poor apposition of stent struts at 1 month (malapposition measured as gap width between strut and internal elastic lamina), with greater gap width compared to the BM and POLY groups (0.22 mm +/- 0.02 vs. 0.03 mm +/- 0.02 and 0.02 mm +/- 0.01, respectively; p stent malapposition and late neointimal thickening. Since the therapeutic window for paclitaxel may be narrower than currently inferred, thorough preclinical testing coupled with the polymer development process for stents eluting paclitaxel is needed.

  4. Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Spiliopoulos, Stavros [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece); Diamantopoulos, Athanasios [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Karnabatidis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece); Sabharwal, Tarun [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Siablis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece)

    2013-06-15

    IntroductionDrug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.Materials and MethodsPubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Primary endpoint was primary patency defined as absence of {>=}50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford-Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel-Haenszel fixed effects model, and number-needed-to-treat values are reported.ResultsThree RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18-1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford-Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002-1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28-0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02-1.62, p = 0.04; NNT = 5.9), and better overall

  5. Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

    International Nuclear Information System (INIS)

    Katsanos, Konstantinos; Spiliopoulos, Stavros; Diamantopoulos, Athanasios; Karnabatidis, Dimitris; Sabharwal, Tarun; Siablis, Dimitris

    2013-01-01

    IntroductionDrug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.Materials and MethodsPubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration’s tool. Primary endpoint was primary patency defined as absence of ≥50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford–Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel–Haenszel fixed effects model, and number-needed-to-treat values are reported.ResultsThree RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18–1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford–Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002–1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28–0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02–1.62, p = 0.04; NNT = 5.9), and better

  6. Innovative Elution Processes for Recovering Uranium from Seawater

    International Nuclear Information System (INIS)

    Wai, Chien; Tian, Guoxin; Janke, Christopher

    2014-01-01

    Utilizing amidoxime-based polymer sorbents for extraction of uranium from seawater has attracted considerable interest in recent years. Uranium collected in the sorbent is recovered typically by elution with an acid. One drawback of acid elution is deterioration of the sorbent which is a significant factor that limits the economic competitiveness of the amidoxime-based sorbent systems for sequestering uranium from seawater. Developing innovative elution processes to improve efficiency and to minimize loss of sorbent capacity become essential in order to make this technology economically feasible for large-scale industrial applications. This project has evaluated several elution processes including acid elution, carbonate elution, and supercritical fluid elution for recovering uranium from amidoxime-based polymer sorbents. The elution efficiency, durability and sorbent regeneration for repeated uranium adsorption- desorption cycles in simulated seawater have been studied. Spectroscopic techniques are used to evaluate chemical nature of the sorbent before and after elution. A sodium carbonate-hydrogen peroxide elution process for effective removal of uranium from amidoxime-based sorbent is developed. The cause of this sodium carbonate and hydrogen peroxide synergistic leaching of uranium from amidoxime-based sorbent is attributed to the formation of an extremely stable uranyl peroxo-carbonato complex. The efficiency of uranium elution by the carbonate-hydrogen peroxide method is comparable to that of the hydrochloric acid elution but damage to the sorbent material is much less for the former. The carbonate- hydrogen peroxide elution also does not need any elaborate step to regenerate the sorbent as those required for hydrochloric acid leaching. Several CO2-soluble ligands have been tested for extraction of uranium from the sorbent in supercritical fluid carbon dioxide. A mixture of hexafluoroacetylacetone and tri-n-butylphosphate shows the best result but uranium

  7. Innovative Elution Processes for Recovering Uranium from Seawater

    Energy Technology Data Exchange (ETDEWEB)

    Wai, Chien [Univ. of Idaho, Moscow, ID (United States); Tian, Guoxin [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Janke, Christopher [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2014-05-29

    Utilizing amidoxime-based polymer sorbents for extraction of uranium from seawater has attracted considerable interest in recent years. Uranium collected in the sorbent is recovered typically by elution with an acid. One drawback of acid elution is deterioration of the sorbent which is a significant factor that limits the economic competitiveness of the amidoxime-based sorbent systems for sequestering uranium from seawater. Developing innovative elution processes to improve efficiency and to minimize loss of sorbent capacity become essential in order to make this technology economically feasible for large-scale industrial applications. This project has evaluated several elution processes including acid elution, carbonate elution, and supercritical fluid elution for recovering uranium from amidoxime-based polymer sorbents. The elution efficiency, durability and sorbent regeneration for repeated uranium adsorption- desorption cycles in simulated seawater have been studied. Spectroscopic techniques are used to evaluate chemical nature of the sorbent before and after elution. A sodium carbonate-hydrogen peroxide elution process for effective removal of uranium from amidoxime-based sorbent is developed. The cause of this sodium carbonate and hydrogen peroxide synergistic leaching of uranium from amidoxime-based sorbent is attributed to the formation of an extremely stable uranyl peroxo-carbonato complex. The efficiency of uranium elution by the carbonate-hydrogen peroxide method is comparable to that of the hydrochloric acid elution but damage to the sorbent material is much less for the former. The carbonate- hydrogen peroxide elution also does not need any elaborate step to regenerate the sorbent as those required for hydrochloric acid leaching. Several CO2-soluble ligands have been tested for extraction of uranium from the sorbent in supercritical fluid carbon dioxide. A mixture of hexafluoroacetylacetone and tri-n-butylphosphate shows the best result but uranium

  8. Effects of jazz on postoperative pain and stress in patients undergoing elective hysterectomy.

    Science.gov (United States)

    Rafer, Lorenzo; Austin, Flower; Frey, Jessica; Mulvey, Christie; Vaida, Sonia; Prozesky, Jansie

    2015-01-01

    Anesthesiologists use various medications to provide surgical patients with pain relief in the postoperative period. Other modalities, such as music, could be used in conjunction with opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) to decrease pain and lower heart rate and blood pressure. Our hypothesis was that patients listening to jazz in a postanesthesia care unit (PACU) would have lower heart rates and blood pressures and reduced pain and anxiety. The study objective was to determine if listening to jazz music in the PACU, when compared to wearing noise-canceling headphones with no music playing, would decrease heart rate, blood pressure, pain, or anxiety in patients undergoing a hysterectomy. The research design was a prospective, randomized study. The study was conducted in the PACU at the Penn State Hershey Medical Center in Hershey, PA, USA. A total of 56 patients, aged 18-75 y, who were categorized as status 1 or 2 according to the American Society of Anesthesiologists (ASA) Physical Status Classification System, and who were undergoing elective laparoscopic or abdominal hysterectomies, were enrolled in the study. Patients were randomly assigned either to listen to jazz music where the beats per min (BPM) was jazz group, heart rates were significantly lower at 15, 20, 25, and 30 min when compared with baseline. The pain scores were significantly lower (P jazz group at 10 min into the recovery period. Overall, the results showed that patients responded not only to music but also to silence in the PACU. Using music and/or noise reduction could decrease opioid administration, promote relaxation, and improve patient satisfaction.

  9. The effect of solvents and hydrophilic additive on stable coating and controllable sirolimus release system for drug-eluting stent.

    Science.gov (United States)

    Kim, Seong Min; Park, Sung-Bin; Bedair, Tarek M; Kim, Man-Ho; Park, Bang Ju; Joung, Yoon Ki; Han, Dong Keun

    2017-09-01

    Various drug-eluting stents (DESs) have been developed to prevent restenosis after stent implantation. However, DES still needs to improve the drug-in-polymer coating stability and control of drug release for effective clinical treatment. In this study, the cobalt-chromium (CoCr) alloy surface was coated with biodegradable poly(D,L-lactide) (PDLLA) and sirolimus (SRL) mixed with hydrophilic Pluronic F127 additive by using ultrasonic spray coating system in order to achieve a stable coating surface and control SRL release. The degradation of PDLLA/SRL coating was studied under physiological solution. It was found that adding F127 reduced the degradation of PDLLA and improved the coating stability during 60days. The effects of organic solvent such as chloroform and tetrahydrofuran (THF) on the coating uniformity were also examined. It was revealed that THF produced a very smooth and uniform coating compared to chloroform. The patterns of in vitro drug release according to the type of organic solvent and hydrophilic additive proposed the possibility of controllable drug release design in DES. It was found that using F127 the drug release was sustained regardless of the organic solvent used. In addition, THF was able to get faster and controlled release profile when compared to chloroform. The structure of SRL molecules in different organic solvents was investigated using ultra-small angle neutron scattering. Furthermore, the structure of SRL is concentration-dependent in chloroform with tight nature under high concentration, but concentration-independent in THF. These results strongly demonstrated that coating stability and drug release patterns can be changed by physicochemical properties of various parameters such as organic solvents, additive, and coating strategy. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Comparative analysis of monotherapy versus duotherapy antiseizure drug management for postoperative seizure control in patients undergoing an awake craniotomy.

    Science.gov (United States)

    Eseonu, Chikezie I; Eguia, Francisco; Garcia, Oscar; Kaplan, Peter W; Quiñones-Hinojosa, Alfredo

    2018-06-01

    OBJECTIVE Postoperative seizures are a common complication in patients undergoing an awake craniotomy, given the cortical manipulation during tumor resection and the electrical cortical stimulation for brain mapping. However, little evidence exists about the efficacy of postoperative seizure prophylaxis. This study aims to determine the most appropriate antiseizure drug (ASD) management regimen following an awake craniotomy. METHODS The authors performed a retrospective analysis of data pertaining to patients who underwent an awake craniotomy for brain tumor from 2007 to 2015 performed by a single surgeon. Patients were divided into 2 groups, those who received a single ASD (the monotherapy group) and those who received 2 types of ASDs (the duotherapy group). Patient demographics, symptoms, tumor characteristics, hospitalization details, and seizure outcome were evaluated. Multivariable logistic regression was used to evaluate numerous clinical variables associated with postoperative seizures. RESULTS A total of 81 patients underwent an awake craniotomy for tumor resection of an eloquent brain lesion. Preoperative baseline characteristics were comparable between the 2 groups. The postoperative seizure rate was 21.7% in the monotherapy group and 5.7% in the duotherapy group (p = 0.044). Seizure outcome at 6 months' follow-up was assessed with the Engel classification scale. The duotherapy group had a significantly higher proportion of seizure-free (Engel Class I) patients than the monotherapy group (90% vs 60%, p = 0.027). The length of stay was similar, 4.02 days in the monotherapy group and 4.51 days in the duotherapy group (p = 0.193). The 90-day readmission rate was higher for the monotherapy group (26.1% vs 8.5% in the duotherapy group, p = 0.044). Multivariate logistic regression showed that preoperative seizure history was a significant predictor for postoperative seizures following an awake craniotomy (OR 2.08, 95% CI 0.56-0.90, p awake craniotomy and may

  11. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Park Kyung

    2012-03-01

    Full Text Available Abstract Background Second-generation drug-eluting stents (DES have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES. In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI. A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES and antiplatelet regimen (TAT vs DDAT. The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734.

  12. A phase I trial of tocoferol monoglucoside in patients undergoing hemi-body radiation

    Directory of Open Access Journals (Sweden)

    Huilgol N

    2005-01-01

    Full Text Available Purpose: To evaluate Tocoferol monoglucoside (TMG, a water soluble vit. E. in a phase I trial, as a radiation protector in those undergoing hemi-body radiation for disseminated disease. Materials and Methods: Patients scheduled to receive modified hemi-body radiation were accrued for the study. Patients not only had disseminated skeletal disease but, were heavily pretreated Seven patients were accrued for the study. Patients received 1 and 2 gms of TMG. 30-40 minutes before hemibody radiation. A dose of 600 cGy was delivered on telecobalt equipment at mid plane. Immediate Toxicities were evaluated as well as response to pain. Results: All the seven patients underwent radiation uneventfully. There was no drug related toxicity. Pain relief was adequate. Conclusion: Tocoferol monoglucoside an effective antioxidant with no significant acute toxicity, when administered in a dose of 1 or 2 gms per oral route. TMG being water-soluble can have global antioxidant and radio protective effects. This needs further clinical evaluation.

  13. Controlled drug delivery systems towards new frontiers in patient care

    CERN Document Server

    Rossi, Filippo; Masi, Maurizio

    2016-01-01

    This book offers a state-of-the-art overview of controlled drug delivery systems, covering the most important innovative applications. The principles of controlled drug release and the mechanisms involved in controlled release are clearly explained. The various existing polymeric drug delivery systems are reviewed, and new frontiers in material design are examined in detail, covering a wide range of polymer modification techniques. The concluding chapter is a case study focusing on use of a drug-eluting stent. The book is designed to provide the reader with a complete understanding of the mechanisms and design of controlled drug delivery systems, and to this end includes numerous step-by-step tutorials. It illustrates how chemical engineers can advance medical care by designing polymeric delivery systems that achieve either temporal or spatial control of drug delivery and thus ensure more effective therapy that eliminates the potential for both under-and overdosing.

  14. Hypovitaminosis D in patients undergoing kidney transplant: the importance of sunlight exposure

    Directory of Open Access Journals (Sweden)

    Cristiane F. Vilarta

    Full Text Available OBJECTIVES: Recent studies have shown a high prevalence of hypovitaminosis D, defined as a serum 25-hydroxyvitamin D level less than 30 ng/ml, in both healthy populations and patients with chronic kidney disease. Patients undergoing kidney transplant are at an increased risk of skin cancer and are advised to avoid sunlight exposure. Therefore, these patients might share two major risk factors for hypovitaminosis D: chronic kidney disease and low sunlight exposure. This paper describes the prevalence and clinical characteristics of hypovitaminosis D among patients undergoing kidney transplant. METHODS: We evaluated 25-hydroxyvitamin D serum levels in a representative sample of patients undergoing kidney transplant. We sought to determine the prevalence of hypovitaminosis D, compare these patients with a control group, and identify factors associated with hypovitaminosis D (e.g., sunlight exposure and dietary habits. RESULTS: Hypovitaminosis D was found in 79% of patients undergoing kidney transplant, and the major associated factor was low sunlight exposure. These patients had higher creatinine and intact parathyroid hormone serum levels, with 25-hydroxyvitamin D being inversely correlated with intact parathyroid hormone serum levels. Compared with the control group, patients undergoing kidney transplant presented a higher prevalence of 25-hydroxyvitamin D deficiency and lower serum calcium, phosphate and albumin but higher creatinine and intact parathyroid hormone levels. CONCLUSIONS: Our results confirmed the high prevalence of hypovitaminosis D in patients undergoing kidney transplant. Therapeutic strategies such as moderate sunlight exposure and vitamin D supplementation should be seriously considered for this population.

  15. Small-bowel neoplasms in patients undergoing video capsule endoscopy

    DEFF Research Database (Denmark)

    Rondonotti, E; Pennazio, M; Toth, E

    2008-01-01

    BACKGROUND AND STUDY AIM: Small-bowel tumors account for 1% - 3% of all gastrointestinal neoplasms. Recent studies with video capsule endoscopy (VCE) suggest that the frequency of these tumors may be substantially higher than previously reported. The aim of the study was to evaluate the frequency......, clinical presentation, diagnostic/therapeutic work-up, and endoscopic appearance of small-bowel tumors in a large population of patients undergoing VCE. PATIENTS AND METHODS: Identification by a questionnaire of patients with VCE findings suggesting small-bowel tumors and histological confirmation...... of the neoplasm seen in 29 centers of 10 European Countries. RESULTS: Of 5129 patients undergoing VCE, 124 (2.4%) had small-bowel tumors (112 primary, 12 metastatic). Among these patients, indications for VCE were: obscure gastrointestinal bleeding (108 patients), abdominal pain (9), search for primary neoplasm...

  16. Adherence to treatment, emotional state and quality of life in patients with end-stage renal disease undergoing dialysis.

    Science.gov (United States)

    García-Llana, Helena; Remor, Eduardo; Selgas, Rafael

    2013-02-01

    A low rate of adherence to treatment is a widespread problem of great clinical relevance among dialysis patients. The objective of the present study is to determine the relationship between adherence, emotional state (depression, anxiety, and perceived stress), and health-related quality of life (HRQOL) in renal patients undergoing dialysis. Two patient groups (30 in hemodialysis and 31 in peritoneal dialysis) participated in this study. We evaluated aspects of adherence, depression, anxiety, perceived stress, and HRQOL with self-report and standardized instruments. Peritoneal dialysis patients reported significantly higher levels of adherence to treatment and better HRQOL in Physical Function and Bodily Pain domains. Depression level is associated with HRQOL indicators. We did not find any differences regarding specific adherence to antihypertensive and phosphate binder drugs or in psychological variables depending on the modality of dialysis. Patients with adherence to antihypertensive drugs show better physical HRQOL. The predictors of HRQOL in dialysis patients were: work, gender and depression. Our results suggest that the modality of dialysis does not differentially affect the emotional state or specific adherence to drugs, but it is nevertheless related to their overall adherence to treatment and to their HRQOL.

  17. Small Versus Large-Sized Drug-Eluting Beads (DEBIRI) for the Treatment of Hepatic Colorectal Metastases: A Propensity Score Matching Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Akinwande, Olaguoke K., E-mail: gokeakin@gmail.com [University of Louisville Hospital, Department of Interventional Radiology (United States); Philips, Prejesh, E-mail: prejesh.philips@louisville.edu [University of Louisville, Division of Surgical Oncology, Department of Surgery (United States); Duras, Petr, E-mail: durasp@seznam.cz [Fakultní nemocnice Plzeň (Czech Republic); Pluntke, Stefan, E-mail: stefan.pluntke@t-online.de [Onkologe bei Kliniken Essen-Mitte (Germany); Scoggins, Charles, E-mail: charles.scoggins@louisville.edu; Martin, Robert C. G., E-mail: Robert.Martin@louisville.edu [University of Louisville, Division of Surgical Oncology, Department of Surgery (United States)

    2015-04-15

    PurposeTo compare the feasibility, safety, and efficacy with small and large irinotecan drug-eluting beads (DEBIRI) for treating hepatic colorectal metastases.MethodsUsing our prospectively maintained, multi-center, intra-arterial therapy registry, we identified 196 patients treated with a combination of large beads (100–300 to 500–700 μm) and patients treated with a combination of small beads (70–150 to 100–300 μm). To minimize selection bias, a propensity score analysis was performed to compare both groups.ResultsUnadjusted analysis consisted of 196 and 30 patients treated with large and small beads, respectively. The adjusted analysis consisted of 19 patients each. Unadjusted analysis showed decreased all-grade (p = <0.001) and high-grade adverse effects (p = 0.02) in the small bead group, with a persisting trend toward decreased overall side effects in the adjusted analysis favoring small beads (p = 0.09) The adjusted analysis showed the percentage dose delivered (delivered dose/intended dose) was significantly greater in the small bead group compared to the large bead group (96 vs 79 %; p = 0.005). There were also a lower percentage of treatments terminating in complete stasis in the adjusted analysis (0.0035). Adjusted analysis also showed increased objective response rate (ORR) at 12 months (p = 0.04), with a corresponding trend also seen in the unadjusted analysis (0.09).ConclusionSmaller beads result in increased dose delivery probably due to less propensity to reach complete stasis. It may also lead to more durable long-term efficacy. Smaller beads also demonstrate similarly low toxicity compared to large-sized beads with a trend toward less toxicity.

  18. Small Versus Large-Sized Drug-Eluting Beads (DEBIRI) for the Treatment of Hepatic Colorectal Metastases: A Propensity Score Matching Analysis

    International Nuclear Information System (INIS)

    Akinwande, Olaguoke K.; Philips, Prejesh; Duras, Petr; Pluntke, Stefan; Scoggins, Charles; Martin, Robert C. G.

    2015-01-01

    PurposeTo compare the feasibility, safety, and efficacy with small and large irinotecan drug-eluting beads (DEBIRI) for treating hepatic colorectal metastases.MethodsUsing our prospectively maintained, multi-center, intra-arterial therapy registry, we identified 196 patients treated with a combination of large beads (100–300 to 500–700 μm) and patients treated with a combination of small beads (70–150 to 100–300 μm). To minimize selection bias, a propensity score analysis was performed to compare both groups.ResultsUnadjusted analysis consisted of 196 and 30 patients treated with large and small beads, respectively. The adjusted analysis consisted of 19 patients each. Unadjusted analysis showed decreased all-grade (p = <0.001) and high-grade adverse effects (p = 0.02) in the small bead group, with a persisting trend toward decreased overall side effects in the adjusted analysis favoring small beads (p = 0.09) The adjusted analysis showed the percentage dose delivered (delivered dose/intended dose) was significantly greater in the small bead group compared to the large bead group (96 vs 79 %; p = 0.005). There were also a lower percentage of treatments terminating in complete stasis in the adjusted analysis (0.0035). Adjusted analysis also showed increased objective response rate (ORR) at 12 months (p = 0.04), with a corresponding trend also seen in the unadjusted analysis (0.09).ConclusionSmaller beads result in increased dose delivery probably due to less propensity to reach complete stasis. It may also lead to more durable long-term efficacy. Smaller beads also demonstrate similarly low toxicity compared to large-sized beads with a trend toward less toxicity

  19. Drug-eluting stent thrombosis: results from the multicenter Spanish registry ESTROFA (Estudio ESpañol sobre TROmbosis de stents FArmacoactivos).

    Science.gov (United States)

    de la Torre-Hernández, José M; Alfonso, Fernando; Hernández, Felipe; Elizaga, Jaime; Sanmartin, Marcelo; Pinar, Eduardo; Lozano, Iñigo; Vazquez, Jose M; Botas, Javier; Perez de Prado, Armando; Hernández, Jose M; Sanchis, Juan; Nodar, Juan M Ruiz; Gomez-Jaume, Alfredo; Larman, Mariano; Diarte, Jose A; Rodríguez-Collado, Javier; Rumoroso, Jose R; Lopez-Minguez, Jose R; Mauri, Josepa

    2008-03-11

    This study sought to assess the incidence, predictors, and outcome of drug-eluting stent(DES) thrombosis in real-world clinical practice. The DES thromboses in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. We designed a large-scale, nonindustry-linked multicentered registry, with 20 centers in Spain. The participant centers provided follow-up data for their patients treated with DES, reporting a detailed standardized form in the event of any angiography-documented DES-associated thrombosis occurring. Of 23,500 patients treated with DES, definite stent thrombosis(ST) developed in 301: 24 acute, 125 subacute, and 152 late. Of the late, 62 occurred >1 year(very late ST). The cumulative incidence was 2% at 3 years. Antiplatelet treatment had been discontinued in 95 cases(31.6%). No differences in incidences were found among stent types. Independent predictors for subacute ST analyzed in a subgroup of 14,120 cases were diabetes, renal failure, acute coronary syndrome, ST-segment elevation myocardial infarction, stent length, and left anterior descending artery stenting, and for late ST were ST-segment elevation myocardial infarction, stenting in left anterior descending artery, and stent length. Mortality at 1-year follow-up was 16% and ST recurrence 4.6%. Older age, left ventricular ejection fraction <45%, nonrestoration of Thrombolysis In Myocardial Infarction flow grade 3, and additional stenting were independent predictors for mortality. The cumulative incidence of ST after DES implantation was 2% at 3 years. No differences were found among stent types. Patient profiles differed between early and late ST. Short-term prognosis is poor, especially when restoration of normal flow fails.

  20. Predicting blood transfusion in patients undergoing minimally invasive oesophagectomy.

    Science.gov (United States)

    Schneider, Crispin; Boddy, Alex P; Fukuta, Junaid; Groom, William D; Streets, Christopher G

    2014-12-01

    To evaluate predictors of allogenic blood transfusion requirements in patients undergoing minimal invasive oesophagectomy at a tertiary high volume centre for oesophago-gastric surgery. Retrospective analysis of all patients undergoing minimal access oesophagectomy in our department between January 2010 and December 2011. Patients were divided into two groups depending on whether they required a blood transfusion at any time during their index admission. Factors that have been shown to influence perioperative blood transfusion requirements in major surgery were included in the analysis. Binary logistic regression analysis was performed to determine the impact of patient and perioperative characteristics on transfusion requirements during the index admission. A total of 80 patients underwent minimal access oesophagectomy, of which 61 patients had a laparoscopic assisted oesophagectomy and 19 patients had a minimal invasive oesophagectomy. Perioperative blood transfusion was required in 28 patients at any time during hospital admission. On binary logistic regression analysis, a lower preoperative haemoglobin concentration (p blood transfusion requirements. It has been reported that requirement for blood transfusion can affect long-term outcomes in oesophageal cancer resection. Two factors which could be addressed preoperatively; haemoglobin concentration and type of oesophageal resection, may be valuable in predicting blood transfusions in patients undergoing minimally invasive oesophagectomy. Our analysis revealed that preoperative haemoglobin concentration, occurrence of significant complications and type of minimal access oesophagectomy predicted blood transfusion requirements in the patient population examined. Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  1. A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: The CENTURY II high risk ACS substudy

    International Nuclear Information System (INIS)

    Jiménez, Victor A.; Iñiguez, Andrés; Baz, José A.; Valdés, Mariano; Ortiz, Alberto; Vuilliomenet, André; Mainar, Vicente; Dudek, Dariusz; Banai, Shmuel; Tüller, David; Bonnet, Jean-Louis; De Miguel, Antonio; Bastos, Guillermo; Wijns, William; Saito, Shigeru

    2016-01-01

    Background: To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymer everolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial. Methods: CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9 month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24 months. Results: The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24 months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P = 0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P = 0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate. Conclusions: BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up. - Highlights: • This study reported the 24-month clinical outcomes of new-generation BP-SES compared with PP-EES in ACS subgroup from CENTURY II study. • This is a pre-specified subgroup analysis of a large randomized, prospective, multicenter clinical trial. • The BP-SES showed good and comparable clinical performance as PP-EES at 24 months. • This substudy has a relatively small sample size and

  2. A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: The CENTURY II high risk ACS substudy

    Energy Technology Data Exchange (ETDEWEB)

    Jiménez, Victor A., E-mail: victor.alfonso.jimenez.diaz@sergas.es [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Iñiguez, Andrés; Baz, José A. [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Valdés, Mariano [Hospital Universitario V. Arrixaca, Murcia (Spain); Ortiz, Alberto [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Vuilliomenet, André [Kantonsspital Aarau, Aarau (Switzerland); Mainar, Vicente [Department of Cardiology, University General Hospital of Alicante, Alicante (Spain); Dudek, Dariusz [Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow (Poland); Banai, Shmuel [Tel Aviv Sourasky Medical Centre, Tel Aviv (Israel); Tüller, David [Department of Cardiology, Stadtspital Triemli, Zürich (Switzerland); Bonnet, Jean-Louis [Department of Cardiology, Hospital La Timone, Marseille (France); De Miguel, Antonio; Bastos, Guillermo [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Wijns, William [Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium); Saito, Shigeru [Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, Kamakura (Japan)

    2016-09-15

    Background: To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymer everolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial. Methods: CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9 month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24 months. Results: The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24 months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P = 0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P = 0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate. Conclusions: BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up. - Highlights: • This study reported the 24-month clinical outcomes of new-generation BP-SES compared with PP-EES in ACS subgroup from CENTURY II study. • This is a pre-specified subgroup analysis of a large randomized, prospective, multicenter clinical trial. • The BP-SES showed good and comparable clinical performance as PP-EES at 24 months. • This substudy has a relatively small sample size and

  3. Effect of esmolol infusion on myocardial oxygen consumption during extubation and quality of recovery in elderly patients undergoing general anesthesia: randomized, double blinded, clinical trial

    Directory of Open Access Journals (Sweden)

    Sherif A. ELokda

    2015-04-01

    Conclusions: Esmolol is a safe, effective and well-tolerated drug that can be used in elderly patients undergoing general anesthesia to reduce the myocardial oxygen consumption and improve the quality of recovery.

  4. Antibiotic prophylaxis for patients undergoing elective endoscopic ...

    African Journals Online (AJOL)

    Antibiotic prophylaxis for patients undergoing elective endoscopic retrograde cholangiopancreatography. M Brand, D Bisoz. Abstract. Background. Antibiotic prophylaxis for endoscopic retrograde cholangiopancreatography (ERCP) is controversial. We set out to assess the current antibiotic prescribing practice among ...

  5. Clostridium difficile colitis in patients undergoing lumbar spine surgery.

    Science.gov (United States)

    Skovrlj, Branko; Guzman, Javier Z; Silvestre, Jason; Al Maaieh, Motasem; Qureshi, Sheeraz A

    2014-09-01

    Retrospective database analysis. To investigate incidence, comorbidities, and impact on health care resources of Clostridium difficile infection after lumbar spine surgery. C. difficile colitis is reportedly increasing in hospitalized patients and can have a negative impact on patient outcomes. No data exist on estimates of C. difficile infection rates and its consequences on patient outcomes and health care resources among patients undergoing lumbar spine surgery. The Nationwide Inpatient Sample was examined from 2002 to 2011. Patients were included for study based on International Classification of Diseases, Ninth Revision, Clinical Modification, procedural codes for lumbar spine surgery for degenerative diagnoses. Baseline patient characteristics were determined and multivariable analyses assessed factors associated with increased incidence of C. difficile and risk of mortality. The incidence of C. difficile infection in patients undergoing lumbar spine surgery is 0.11%. At baseline, patients infected with C. difficile were significantly older (65.4 yr vs. 58.9 yr, Pinfection. Small hospital size was associated with decreased odds (odds ratio [OR], 0.5; Pinfection. Uninsured (OR, 1.62; Pinfection. C. difficile increased hospital length of stay by 8 days (Pdifficile infection after lumbar spine surgery carries a 36.4-fold increase in mortality and costs approximately $10,658,646 per year to manage. These data suggest that great care should be taken to avoid C. difficile colitis in patients undergoing lumbar spine surgery because it is associated with longer hospital stays, greater overall costs, and increased inpatient mortality. 3.

  6. Comparison of Outcomes in Patients With Versus Without Diabetes Mellitus After Revascularization With Everolimus- and Sirolimus-Eluting Stents (from the SORT OUT IV Trial)

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Junker, Anders

    2012-01-01

    Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents...... (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point...... was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients...

  7. In vitro biologic efficacy of sunitinib drug-eluting beads on human colorectal and hepatocellular carcinoma-A pilot study.

    Directory of Open Access Journals (Sweden)

    Steven Lahti

    Full Text Available Sunitinib drug eluting beads (DEB are a novel anti-angiogenic bead preparation for use in transarterial chemoembolization. However, systematic studies of sunitinib DEB's effect on cancer cells have not been reported. Herein, we assess their direct biologic efficacy against carcinoma cell lines and correlate cell viability with drug release in vitro.Sunitinib-HCl (10mg/mL in Milli-Q water was mixed with LC Bead® 300-500μm (Biocompatibles UK Ltd.. Loading and release were assessed by measurement of drug UV absorbance using UV-visible spectrophotometer. Viability of human colorectal cancer (CRC, HCT116 and HT29 and hepatocellular carcinoma (HCC, HepG2 cells upon exposure to sunitinib DEB was measured using a bioluminescent assay. Drug concentration during exposure was quantified using HPLC.When added to cultured HepG2 cells, sunitinib DEB rapidly inhibited viability with a significant decrease observed within 1 hour of incubation. Viability of HCT116 and HT29 cells decreased relatively slower, with significant reductions observed after 8 and 24 hours, respectively. After 24 hours there was nearly complete inhibition of all three cell lines. There was no difference in viability observed between cells treated with 5 μl, 10 μL, or 20 μL of sunitinib DEB. HPLC analysis of the cell culture supernatant demonstrated saturation of the cell medium within approximately 4 hours for each amount added, with sunitinib achieving a final concentration of 17.61 μM (SE ±1.01.Sunitinib can be efficiently loaded to and released from LC beads, and the resulting sunitinib DEB demonstrate strong in vitro inhibition of human CRC and HCC cells.

  8. Involvement of COX-2 in nickel elution from a wire implanted subcutaneously in mice.

    Science.gov (United States)

    Sato, Taiki; Kishimoto, Yu; Asakawa, Sanki; Mizuno, Natsumi; Hiratsuka, Masahiro; Hirasawa, Noriyasu

    2016-07-01

    Many types of medical alloys include nickel (Ni), and the elution of Ni ions from these materials causes toxicities and inflammation. We have previously reported that inflammation enhances Ni elution, although the molecular mechanisms underlying this effect remain unclear. In this study, we investigated how inflammatory responses enhanced Ni elution in a wire-implantation mouse model. Subcutaneous implantation of Ni wire induced the expression of cyclooxygenase-2 (COX-2) and microsomal prostaglandin E synthase-1 (mPGES-1) mRNA in the surrounding tissues. Immunostaining analysis showed that cells expressing COX-2 were mainly fibroblast-like cells 8h after implantation of a Ni wire, but were mainly infiltrated leukocytes at 24h. NiCl2 induced the expression of COX-2 mRNA in primary fibroblasts, neutrophils, RAW 264 cells, and THP-1 cells, indicating that Ni ions can induce COX-2 expression in various types of cells. The elution of Ni ions from the implanted Ni wire at 8h was reduced by dexamethasone (Dex), indomethacin (Ind), or celecoxib (Cel) treatment. Ni wire implantation induced an increase in mRNA levels for anaerobic glycolytic pathway components glucose transporter 1 (GLUT1), hexokinase 2 (HK2), lactate dehydrogenase A (LDHA), and monocarboxylate transporter 4 (MCT4); the expression of these genes was also inhibited by Dex, Ind, and Cel. In primary fibroblasts, the expression of these mRNAs and the production of lactate were induced by NiCl2 and further potentiated by PGE2. Furthermore, Ni wire-induced infiltration of inflammatory leukocytes was significantly reduced by Dex, Ind, or Cel. Depletion of neutrophils with a specific antibody caused reduction of both leukocyte infiltration and Ni elution. These results indicate that Ni ions eluted from wire induced COX-2 expression, which further promoted elution of Ni ions by increasing lactate production and leukocyte infiltration. Since COX inhibitors and Dex reduced the elution of Ni ions, these drugs may be

  9. Elution behaviors of elements from the hair

    International Nuclear Information System (INIS)

    Akashi, Junko; Fukushima, Ichiro; Imahori, Akira

    1981-01-01

    The elution of the neutron activated elements out of hair soaked in some organic solvents and EDTA solution was studied. Soakage of the hair sample, which was washed with water and acetone in advance as IAEA's proposal, in ether and acetone for 30 minutes each resulted in no elution of Hg, Zn, Co and Se. Elution of Zn and Co from the powdered hair sample soaked in 0.1 M EDTA solution was rapid, while Zn did not elute out from the cut hair (2 -- 3 mm length) on the same condition. Hg, Se and Au were not eluted out by 0.1 M EDTA solution in the both case of cut hair and of powdered hair. Br was removed by 0.1 M EDTA solution from the cut hair and from the powdered hair with equal ease. (author)

  10. Intra-stent tissue evaluation within bare metal and drug-eluting stents > 3 years since implantation in patients with mild to moderate neointimal proliferation using optical coherence tomography and virtual histology intravascular ultrasound.

    Science.gov (United States)

    Kitabata, Hironori; Loh, Joshua P; Pendyala, Lakshmana K; Omar, Alfazir; Ota, Hideaki; Minha, Sa'ar; Magalhaes, Marco A; Torguson, Rebecca; Chen, Fang; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

    2014-04-01

    We aimed to compare neointimal tissue characteristics between bare-metal stents (BMS) and drug-eluting stents (DES) at long-term follow-up using optical coherence tomography (OCT) and virtual histology intravascular ultrasound (VH-IVUS). Neoatherosclerosis in neointima has been reported in BMS and in DES. Thirty patients with 36 stented lesions [BMS (n=17) or DES (n=19)] >3years after implantation were prospectively enrolled. OCT and VH-IVUS were performed and analyzed independently. Stents with ≥70% diameter stenosis were excluded. The median duration from implantation was 126.0months in the BMS group and 60.0months in the DES group (p 3years to stents had evidence of intimal disruption. The percentage volume of necrotic core (16.1% [9.7, 20.3] vs. 9.7% [7.0, 16.5], p=0.062) and dense calcium (9.5% [3.8, 13.6] vs. 2.7% [0.4, 4.9], p=0.080) in neointima tended to be greater in BMS-treated lesions. Intra-stent VH-TCFA (BMS vs. DES 45.5% vs. 18.2%, p=0.361) did not differ significantly. At long-term follow-up beyond 3 years after implantation, the intra-stent neointimal tissue characteristics appeared similar for both BMS and DES. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. The prevalence of iron deficiency anaemia in patients undergoing bariatric surgery.

    Science.gov (United States)

    Khanbhai, M; Dubb, S; Patel, K; Ahmed, A; Richards, T

    2015-01-01

    As bariatric surgery rates continue to climb, anaemia will become an increasing concern. We assessed the prevalence of anaemia and length of hospital stay in patients undergoing bariatric surgery. Prospective data (anaemia [haemoglobin bariatric surgery. Results from a prospective database of 1530 patients undergoing elective general surgery were used as a baseline. Fifty-seven patients (14%) were anaemic pre-operatively, of which 98% were females. Median MCV (fL) and overall median ferritin (μg/L) was lower in anaemic patients (83 vs. 86, p=0.001) and (28 vs. 61, psurgery patients, prevalence of anaemia was similar (14% vs. 16%) but absolute iron deficiency was more common in those undergoing bariatric surgery; microcytosis pbariatric surgery. In bariatric patients with anaemia there was an overall increased length of hospital stay. Copyright © 2013 Asian Oceanian Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

  12. Efficacy and tolerability of intravenous morphine patient-controlled analgesia (PCA) in women undergoing cesarean delivery.

    Science.gov (United States)

    Andziak, Marta; Beta, Jarosław; Barwijuk, Michal; Issat, Tadeusz; Jakimiuk, Artur J

    2015-06-01

    The aim of the study was to evaluate analgesic efficacy and tolerability of patient-controlled analgesia (PCA) with intravenous morphine. Our observational study included 50 women who underwent a Misgav-Ladach or modified Misgav-Ladach cesarean section. Automated PCA infusion device (Medima S-PCA Syringe Pump, Medima, Krakow, Poland) was used for postoperative pain control. Time of morphine administration or initiation of intravenous patient-controlled analgesia (IV PCA) with morphine was recorded, as well as post-operative pain at rest assessed by a visual analogue scale (VAS). All patients were followed up for 24 hours after discharge from the operating room, taking into account patient records, worst pain score at rest, number of IV PCA attempts, and drug consumption. Median of total morphine doses used during the postoperative period was 42.9mg (IQR 35.6-48.5), with median infusion time of 687.0 min. (IQR 531.0-757.5). Pain severity and total drug consumption improved after the first 3 hours following cesarean delivery (p PCA attempts per patient was 33 (IQR: 24-37), with median of 11 placebo attempts (IQR: 3-27). Patient-controlled analgesia with morphine is an efficient and acceptable analgesic method in women undergoing cesarean section.

  13. Peri- and Postoperative Treatment with the Interleukin-1 Receptor Antagonist Anakinra Is Safe in Patients Undergoing Renal Transplantation: Case Series and Review of the Literature

    Directory of Open Access Journals (Sweden)

    Catharina M. Mulders-Manders

    2017-05-01

    Full Text Available In patients undergoing solid organ transplantation, the presence of an interleukin-1 (IL-1 driven disease may require the addition of IL-1 inhibiting drugs to the standard immunosuppressive regimen to protect against inflammation and negative graft outcome. Three patients undergoing renal transplantation were treated perioperatively with the interleukin-1 receptor antagonist anakinra. Kidney function increased rapidly in all three and the only complications seen were minor infections. In vitro studies report associations between serum and urinary levels of IL-1β and IL-1 receptor antagonist and negative graft outcome, and studies in animals and two small human trials illustrate a possible protective effect of anti-IL-1 therapy after solid organ transplantation. Peri- and postoperative use of anakinra is safe and effective in patients undergoing renal transplantation.

  14. Local anesthesia with ropivacaine for patients undergoing laparoscopic cholecystectomy

    Science.gov (United States)

    Liu, Yu-Yin; Yeh, Chun-Nan; Lee, Hsiang-Lin; Wang, Shang-Yu; Tsai, Chun-Yi; Lin, Chih-Chung; Chao, Tzu-Chieh; Yeh, Ta-Sen; Jan, Yi-Yin

    2009-01-01

    AIM: To investigate the effect of pain relief after infusion of ropivacaine at port sites at the end of surgery. METHODS: From October 2006 to September 2007, 72 patients undergoing laparoscopic cholecystectomy (LC) were randomized into two groups of 36 patients. One group received ropivacaine infusion at the port sites at the end of LC and the other received normal saline. A visual analog scale was used to assess postoperative pain when the patient awakened in the operating room, 6 and 24 h after surgery, and before discharge. The amount of analgesics use was also recorded. The demographics, laboratory data, hospital stay, and perioperative complications were compared between the two groups. RESULTS: There was no difference between the two groups preoperatively in terms of demographic and laboratory data. After surgery, similar operation time, blood loss, and no postoperative morbidity and mortality were observed in the two groups. However, a significantly lower pain score was observed in the patients undergoing LC with local anesthesia infusion at 1 h after LC and at discharge. Regarding analgesic use, the amount of meperidine used 1 h after LC and the total used during admission were lower in patients undergoing LC with local anesthesia infusion. This group also had a shorter hospital stay. CONCLUSION: Local anesthesia with ropivacaine at the port site in LC patients significantly decreased postoperative pain immediately. This explains the lower meperidine use and earlier discharge for these patients. PMID:19452582

  15. Aluminum elution and precipitation in glass vials: effect of pH and buffer species.

    Science.gov (United States)

    Ogawa, Toru; Miyajima, Makoto; Wakiyama, Naoki; Terada, Katsuhide

    2015-02-01

    Inorganic extractables from glass vials may cause particle formation in the drug solution. In this study, the ability of eluting Al ion from borosilicate glass vials, and tendencies of precipitation containing Al were investigated using various pHs of phosphate, citrate, acetate and histidine buffer. Through heating, all of the buffers showed that Si and Al were eluted from glass vials in ratios almost the same as the composition of borosilicate glass, and the amounts of Al and Si from various buffer solutions at pH 7 were in the following order: citrate > phosphate > acetate > histidine. In addition, during storage after heating, the Al concentration at certain pHs of phosphate and acetate buffer solution decreased, suggesting the formation of particles containing Al. In citrate buffer, Al did not decrease in spite of the high elution amount. Considering that the solubility profile of aluminum oxide and the Al eluting profile of borosilicate glass were different, it is speculated that Al ion may be forced to leach into the buffer solution according to Si elution on the surface of glass vials. When Al ions were added to the buffer solutions, phosphate, acetate and histidine buffer showed a decrease of Al concentration during storage at a neutral range of pHs, indicating the formation of particles containing Al. In conclusion, it is suggested that phosphate buffer solution has higher possibility of forming particles containing Al than other buffer solutions.

  16. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery.

    Science.gov (United States)

    Myles, Paul S; Smith, Julian A; Forbes, Andrew; Silbert, Brendan; Jayarajah, Mohandas; Painter, Thomas; Cooper, D James; Marasco, Silvana; McNeil, John; Bussières, Jean S; McGuinness, Shay; Byrne, Kelly; Chan, Matthew T V; Landoni, Giovanni; Wallace, Sophie

    2017-01-12

    Tranexamic acid reduces the risk of bleeding among patients undergoing cardiac surgery, but it is unclear whether this leads to improved outcomes. Furthermore, there are concerns that tranexamic acid may have prothrombotic and proconvulsant effects. In a trial with a 2-by-2 factorial design, we randomly assigned patients who were scheduled to undergo coronary-artery surgery and were at risk for perioperative complications to receive aspirin or placebo and tranexamic acid or placebo. The results of the tranexamic acid comparison are reported here. The primary outcome was a composite of death and thrombotic complications (nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery. Of the 4662 patients who were enrolled and provided consent, 4631 underwent surgery and had available outcomes data; 2311 were assigned to the tranexamic acid group and 2320 to the placebo group. A primary outcome event occurred in 386 patients (16.7%) in the tranexamic acid group and in 420 patients (18.1%) in the placebo group (relative risk, 0.92; 95% confidence interval, 0.81 to 1.05; P=0.22). The total number of units of blood products that were transfused during hospitalization was 4331 in the tranexamic acid group and 7994 in the placebo group (Ptranexamic acid group and in 2.8% of the patients in the placebo group (P=0.001), and seizures occurred in 0.7% and 0.1%, respectively (P=0.002 by Fisher's exact test). Among patients undergoing coronary-artery surgery, tranexamic acid was associated with a lower risk of bleeding than was placebo, without a higher risk of death or thrombotic complications within 30 days after surgery. Tranexamic acid was associated with a higher risk of postoperative seizures. (Funded by the Australian National Health and Medical Research Council and others; ATACAS Australia New Zealand Clinical Trials Registry number, ACTRN12605000557639 .).

  17. ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment | Division of Cancer Prevention

    Science.gov (United States)

    This randomized phase IIb trial studies how well ACTOplus met XR works in treating in patients with stage I-IV oral cavity or oropharynx cancer that are undergoing definitive treatment. Chemoprevention is the use of drugs to keep oral cavity or oropharynx cancer from forming or coming back. The use of ACTOplus met XR may slow disease progression in patients with oral cavity or

  18. [Comparison of DK crush with classical crush technique with drug-eluting stents for the treatment of coronary bifurcation lesions from DKCRUSH-1 study].

    Science.gov (United States)

    Chen, Shao-liang; Zhang, Jun-jie; Ye, Fei; Chen, Yun-dai; Lü, Shu-zheng; Tan, Huaycheem; Patel, Tejas; Kenji, Kawajiri; Tamari, Israel; Shan, Shou-jie; Zhu, Zhong-sheng; Lin, Song; Tian, Nai-liang; Li, Xiao-bo; Liu, Zhi-zhong; Lee, Michael; Wei, Meng; Xu, Ya-wei; Yuan, Zheng-bai; Qian, Jun; Sun, Xue-wen; Yang, Song; Chen, Jin-guo; He, Ben; Sumit, Suji

    2008-02-01

    To determine independent factors correlated with clinical effects of DK crush and classical crush technique with drug-eluting stents on bifurcation lesions. 311 patients with bifurcation lesions were randomized to classical (C, n = 156) or double kissing (DK) crush (n = 155) stent implantation group. The primary endpoints included major adverse cardiac events (MACE). Final kissing balloon inflation (FKBI) success rate was 76% in C and 100% in DK groups (P DK crush procedure was characterized by lower unsatisfactory FKBI rate (27.6% vs.6.3%, P DK groups (P = 0.01), respectively. Cumulative 8-month MACE was 35.9% in without-FKBI and 19.7% in with-FKBI sub-groups, and 11.4% in DK group (P = 0.02). The incidence of stent thrombosis was 3.2% in C group (5.1% without vs. 1.7% with FKBI) and 1.3% in DK group (P > 0.05). The predictive factors of MACE included minimal side branch stent lumen diameter and lack of DK crush technique. DK crush technique is an alternative of double stenting techniques in terms of improvement of restenosis and clinical outcomes.

  19. Dental Health of Patients Undergoing Hemodialysis (A Study

    Directory of Open Access Journals (Sweden)

    Vinay Mohan

    2011-01-01

    Full Text Available The primary purpose of this study was to determine the oral manifestations of patients undergoing dialysis. Two subgroups of the population were studied: (1 Those who have been on dialysis for less than one year, (2 those who have been on dialysis for more than one year. Two dental indices–periodontal index and decayed, missing, filled index were used to identify periodontal status, dental canes activity. Data were compiled and analyzed by using the unpaired t-test. Results suggested that 100% (n = 26 of the patients undergoing dialysis presented with some form of periodontal disease (mean value = 2.24, standard deviation = 1.33. Majority of the patients displayed either established periodontal disease (57.6% or the beginning of periodontal disease (38 4%. Approximately, 70% of the patients had high decayed, missing, filled index (mean value = 6.19, standard deviation = 6.40. Findings led to the conclusion that patients on dialysis need comprehensive professional oral care and self-care instructions. The source of infection in oral cavity can cause variety of systemic diseases, causing morbidity and mortality in these immune-suppressed patients.

  20. Anaesthesia in patients undergoing esophago-gastro-duodenoscopy for suspected bleeding

    DEFF Research Database (Denmark)

    Helsø, Ida; Risom, Martin; Vestergaard, Therese Risom

    2017-01-01

    INTRODUCTION: Upper gastrointestinal bleeding (UGIB) is a common emergency. Currently, there are no agreed guidelines on the level of anaesthetic support required in patients undergoing acute esophago-gastro-duodendoscopy (EGD). METHODS: An online questionnaire comprising 19 questions was distrib......INTRODUCTION: Upper gastrointestinal bleeding (UGIB) is a common emergency. Currently, there are no agreed guidelines on the level of anaesthetic support required in patients undergoing acute esophago-gastro-duodendoscopy (EGD). METHODS: An online questionnaire comprising 19 questions...

  1. Do patients fear undergoing general anesthesia for oral surgery?

    Science.gov (United States)

    Elmore, Jasmine R; Priest, James H; Laskin, Daniel M

    2014-01-01

    Many patients undergoing major surgery have more fear of the general anesthesia than the procedure. This appears to be reversed with oral surgery. Therefore, patients need to be as well informed about this aspect as the surgical operation.

  2. Antithrombotic strategies in patients undergoing percutaneous coronary intervention for acute coronary syndrome

    Directory of Open Access Journals (Sweden)

    Son V Pham

    2010-09-01

    Full Text Available Son V Pham1, Phuong-Chi T Pham2, Phuong-Mai T Pham3, Jeffrey M Miller4, Phuong-Thu T Pham5, Phuong-Anh T Pham61Bay Pines VA Medical Center, Department of Cardiology, Bay Pines, FL, USA; 2Department of Medicine, Nephrology Division, UCLA-Olive View Medical Center, 3Department of Medicine, Greater Los Angeles VA Medical Center, 4Department of Medicine, Hematology-Oncology Division, UCLA-Olive View Medical Center, 5Department of Medicine, Nephrology Division, Kidney and Pancreas Transplant Program, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 6Mercy General Hospital, Heart and Vascular Institute, Department of Cardiology, Sacramento, CA, USAAbstract: In patients undergoing percutaneous coronary intervention (PCI for acute coronary syndrome (ACS, both periprocedural acute myocardial infarction and bleeding complications have been shown to be associated with early and late mortality. Current standard antithrombotic therapy after coronary stent implantation consists of lifelong aspirin and clopidogrel for a variable period depending in part on the stent type. Despite its well-established efficacy in reducing cardiac-related death, myocardial infarction, and stroke, dual antiplatelet therapy with aspirin and clopidogrel is not without shortcomings. While clopidogrel may be of little beneficial effect if administered immediately prior to PCI and may even increase major bleeding risk if coronary artery bypass grafting is anticipated, early discontinuation of the drug may result in insufficient antiplatelet coverage with thrombotic complications. Optimal and rapid inhibition of platelet activity to suppress ischemic and thrombotic events while minimizing bleeding complications is an important therapeutic goal in the management of patients undergoing percutaneous coronary intervention. In this article we present an overview of the literature on clinical trials evaluating the different aspects of antithrombotic therapy in patients

  3. Long-term Outcomes of Paclitaxel-Eluting Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention: A Meta-Analysis

    International Nuclear Information System (INIS)

    Kong, J.; Liu, P.; Fan, X.; Wen, J.; Zhang, J.; Zhen, Y.; Li, J.; Cui, Y.; Zheng, X.; Ye, Z.

    2017-01-01

    The relative long-term efficacy and safety of sirolimus-eluting stents (SES) compared with paclitaxel-eluting stents (PES) in multiple comparative studies remains controversial. This report evaluates 29 randomized trials with 18,379 patients in whom long-term (more than 1 year) outcomes were evaluated. The primary outcomes were target lesion revascularization (TLR) and the secondary end points were death, cardiac death, myocardial infarction (MI), major adverse cardiac events (MACEs), target vessel revascularization (TVR)and stent thrombosis (ST). In comparison with PES, SES significantly reduced the long-term risk of TLR (RR=0.68; 95% CI=0.57 to 0.80, p<0.001), TVR (RR=0.69; 95% CI= 0.60 to 0.79, p<0.001) and MACE (RR=0.82; 95% CI= 0.77 to 0.88, p<0.001), while there were no significant difference with respect to death, cardiac death, MI and ST between the two groups. SES performance was significantly better for reducing the former three outcomes and comparable for the majority of the secondary end points when compared against PES. (author)

  4. The prognostic utility of the SYNTAX score on 1-year outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial

    DEFF Research Database (Denmark)

    Garg, Scot; Serruys, Patrick W; Silber, Sigmund

    2011-01-01

    This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents.......This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents....

  5. Intravenous and oral levetiracetam in patients with a suspected primary brain tumor and symptomatic seizures undergoing neurosurgery: the HELLO trial.

    Science.gov (United States)

    Bähr, Oliver; Hermisson, Mirjam; Rona, Sabine; Rieger, Johannes; Nussbaum, Susanne; Körtvelyessy, Peter; Franz, Kea; Tatagiba, Marcos; Seifert, Volker; Weller, Michael; Steinbach, Joachim P

    2012-02-01

    Levetiracetam (LEV) is a newer anticonvulsant with a favorable safety profile. There seem to be no relevant drug interactions, and an intravenous formulation is available. Therefore, LEV might be a suitable drug for the perioperative anticonvulsive therapy of patients with suspected brain tumors undergoing neurosurgery. In this prospective study (NCT00571155) patients with suspected primary brain tumors and tumor-related seizures were perioperatively treated with oral and intravenous LEV up to 4 weeks before and until 4 weeks after a planned neurosurgical procedure. Thirty patients with brain tumor-related seizures and intended neurosurgery were included. Three patients did not undergo the scheduled surgery after enrollment, and two patients were lost to follow-up. Therefore, 25 patients were fully evaluable. After initiation of therapy with LEV, 100% of the patients were seizure-free in the pre-surgery phase (3 days up to 4 weeks before surgery), 88% in the 48 h post-surgery phase and 84% in the early follow-up phase (48 h to 4 weeks post surgery). Treatment failure even after dose escalation to 3,000 mg/day occurred in three patients. No serious adverse events related to the treatment with LEV occurred. Our data show the feasibility and safety of oral and intravenous LEV in the perioperative treatment of tumor-related seizures. Although this was a single arm study, the efficacy of LEV appears promising. Considering the side effects and interactions of other anticonvulsants, LEV seems to be a favorable option in the perioperative treatment of brain tumor-related seizures.

  6. Lung Tissue Concentrations of Pyrazinamide among Patients with Drug-Resistant Pulmonary Tuberculosis

    Science.gov (United States)

    Heinrichs, M. Tobias; Nikolaishvili, Ketino; Sabulua, Irina; Bablishvili, Nino; Gogishvili, Shota; Avaliani, Zaza; Tukvadze, Nestani; Little, Brent; Bernheim, Adam; Read, Timothy D.; Guarner, Jeannette; Derendorf, Hartmut; Peloquin, Charles A.; Blumberg, Henry M.; Vashakidze, Sergo

    2017-01-01

    ABSTRACT Improved knowledge regarding the tissue penetration of antituberculosis drugs may help optimize drug management. Patients with drug-resistant pulmonary tuberculosis undergoing adjunctive surgery were enrolled. Serial serum samples were collected, and microdialysis was performed using ex vivo lung tissue to measure pyrazinamide concentrations. Among 10 patients, the median pyrazinamide dose was 24.7 mg/kg of body weight. Imaging revealed predominant lung lesions as cavitary (n = 6 patients), mass-like (n = 3 patients), or consolidative (n = 1 patient). On histopathology examination, all tissue samples had necrosis; eight had a pH of ≤5.5. Tissue samples from two patients were positive for Mycobacterium tuberculosis by culture (pH 5.5 and 7.2). All 10 patients had maximal serum pyrazinamide concentrations within the recommended range of 20 to 60 μg/ml. The median lung tissue free pyrazinamide concentration was 20.96 μg/ml. The median tissue-to-serum pyrazinamide concentration ratio was 0.77 (range, 0.54 to 0.93). There was a significant inverse correlation between tissue pyrazinamide concentrations and the amounts of necrosis (R = −0.66, P = 0.04) and acid-fast bacilli (R = −0.75, P = 0.01) identified by histopathology. We found good penetration of pyrazinamide into lung tissue among patients with pulmonary tuberculosis with a variety of radiological lesion types. Our tissue pH results revealed that most lesions had a pH conducive to pyrazinamide activity. The tissue penetration of pyrazinamide highlights its importance in both drug-susceptible and drug-resistant antituberculosis treatment regimens. PMID:28373198

  7. Lung Tissue Concentrations of Pyrazinamide among Patients with Drug-Resistant Pulmonary Tuberculosis.

    Science.gov (United States)

    Kempker, Russell R; Heinrichs, M Tobias; Nikolaishvili, Ketino; Sabulua, Irina; Bablishvili, Nino; Gogishvili, Shota; Avaliani, Zaza; Tukvadze, Nestani; Little, Brent; Bernheim, Adam; Read, Timothy D; Guarner, Jeannette; Derendorf, Hartmut; Peloquin, Charles A; Blumberg, Henry M; Vashakidze, Sergo

    2017-06-01

    Improved knowledge regarding the tissue penetration of antituberculosis drugs may help optimize drug management. Patients with drug-resistant pulmonary tuberculosis undergoing adjunctive surgery were enrolled. Serial serum samples were collected, and microdialysis was performed using ex vivo lung tissue to measure pyrazinamide concentrations. Among 10 patients, the median pyrazinamide dose was 24.7 mg/kg of body weight. Imaging revealed predominant lung lesions as cavitary ( n = 6 patients), mass-like ( n = 3 patients), or consolidative ( n = 1 patient). On histopathology examination, all tissue samples had necrosis; eight had a pH of ≤5.5. Tissue samples from two patients were positive for Mycobacterium tuberculosis by culture (pH 5.5 and 7.2). All 10 patients had maximal serum pyrazinamide concentrations within the recommended range of 20 to 60 μg/ml. The median lung tissue free pyrazinamide concentration was 20.96 μg/ml. The median tissue-to-serum pyrazinamide concentration ratio was 0.77 (range, 0.54 to 0.93). There was a significant inverse correlation between tissue pyrazinamide concentrations and the amounts of necrosis ( R = -0.66, P = 0.04) and acid-fast bacilli ( R = -0.75, P = 0.01) identified by histopathology. We found good penetration of pyrazinamide into lung tissue among patients with pulmonary tuberculosis with a variety of radiological lesion types. Our tissue pH results revealed that most lesions had a pH conducive to pyrazinamide activity. The tissue penetration of pyrazinamide highlights its importance in both drug-susceptible and drug-resistant antituberculosis treatment regimens. Copyright © 2017 American Society for Microbiology.

  8. Preoperative B-type natriuretic peptides in patients undergoing ...

    African Journals Online (AJOL)

    Southern African Journal of Anaesthesia and Analgesia ... Preoperative B-type natriuretic peptides in patients undergoing noncardiac surgery: a cumulative ... Future investigation should focus on the clinical implications of these data and the ...

  9. Short-versus long-term Dual Antiplatelet therapy after drug-eluting stent implantation in women versus men: A sex-specific patient-level pooled-analysis of six randomized trials.

    Science.gov (United States)

    Sawaya, Fadi J; Morice, Marie-Claude; Spaziano, Marco; Mehran, Roxana; Didier, Romain; Roy, Andrew; Valgimigli, Marco; Kim, Hyo-Soo; Woo Park, Kyung; Hong, Myeong-Ki; Kim, Byeong-Keuk; Jang, Yangsoo; Feres, Fausto; Abizaid, Alexandre; Costa, Ricardo A; Colombo, Antonio; Chieffo, Alaide; Giustino, Gennaro; Stone, Gregg W; Bhatt, Deepak L; Palmerini, Tullio; Gilard, Martine

    2017-02-01

    Whether the efficacy and safety of dual antiplatelet therapy (DAPT) are uniform between sexes is unclear. We sought to compare clinical outcomes between short- (≤6 months) versus long-term (≥1 year) DAPT after drug-eluting stent (DES) placement in women and men. We pooled individual patient data from 6 randomized trials of DAPT (EXCELLENT, OPTIMIZE, PRODIGY, RESET, SECURITY, ITALIC PLUS). The primary outcome was 1-year risk of major adverse cardiac events (MACE). The main secondary outcome was 1-year risk of any bleeding. Out of the 11,473 randomized patients included in the pooled dataset, 3,454 (30%) were females. At 1-year follow-up, women had higher risk of MACE (3.6% vs. 2.8%; P = 0.01) but similar risk of bleeding (1.9% vs. 1.6%; P = 0.16) as compared with men. Compared with long-term DAPT, short-term DAPT was associated with similar rates of MACE in both women (HR 0.88; 95% CI 0.62-1.25) and men (HR 1.25; 95% CI 0.95-1.6; P interaction = 0.08)]. At 1-year follow-up, short-term DAPT was associated with lower rates of bleeding as compared with long-term DAPT in both women (HR 0.84; 95% CI 0.51-1.37) and men (HR 0.58; 95% CI 0.40-0.84; P-interaction = 0.25). The presence of MVD was associated with higher MACE rates in the short-term DAPT group in women (HR: 1.16; CI 0.60-2.23) and men (HR: 2.29; CI 1.22-4.29; P interaction = 0.25). Short-term DAPT is associated with similar rates of MACE but lower risk of bleeding when as compared with prolonged DAPT. There was no significant difference between sexes in the population studied. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  10. Carotid disease in diabetic patients undergoing coronary artery bypass grafting

    International Nuclear Information System (INIS)

    Shahid, M.; Abid, A.R.; Dar, M.A.; Noeman, A.; Amin, S.; Azhar, M.

    2012-01-01

    Objective: To compare the severity of carotid artery disease in diabetic and non-diabetic patients undergoing coronary artery bypass grafting. Methods: From January to June 2008, 379 patients undergoing elective coronary artery bypass surgery were preoperatively evaluated for the presence of carotid stenoses by duplex scanning. Patients were divided into two groups, Group I, 156 (41.2%) diabetic patients and Group II, 223 (58.8%) non-diabetic patients. Results: There were 314 (82.8%) males and 65 (17.2%) females with a mean age of 57.2+-9.1 years. In diabetic group there were 125 (80.1%) males and 31 (19.9%) females with a mean age of 56.3+-8.9 years. Left main stem stenosis was present in 59 (37.8%) diabetics and 45 (20.2%) non-diabetics (p 70% stenosis was present in 20 (5.3%) with 13 (8.3%) diabetics and 7 (3.1%) non-diabetics (p<0.025). Stenosis of 50-70% was observed in 30 (7.9%) of which 17 (10.9%) were diabetics and 13 (5.8%) were non-diabetics. Conclusion: Presence of diabetes mellitus is associated with diffuse coronary artery disease and significant carotid artery disease in patients undergoing coronary artery bypass grafting. (author)

  11. Differential Clinical Outcomes Between Angiographic Complete Versus Incomplete Coronary Revascularization, According to the Presence of Chronic Kidney Disease in the Drug-Eluting Stent Era.

    Science.gov (United States)

    Kim, Jihoon; Lee, Joo Myung; Choi, Ki Hong; Rhee, Tae-Min; Hwang, Doyeon; Park, Jonghanne; Ahn, Chul; Park, Taek Kyu; Yang, Jeong Hoon; Song, Young Bin; Choi, Jin-Ho; Hahn, Joo-Yong; Choi, Seung-Hyuk; Gwon, Hyeon-Cheol

    2018-02-15

    There are limited data regarding the prognostic impact of angiographic complete revascularization (CR) in patients with chronic kidney disease (CKD). We sought to investigate the differential prognostic impact of angiographic CR over incomplete revascularization (IR), according to the presence of CKD in the drug-eluting stent era. Between 2003 and 2011 at Samsung Medical Center, consecutive patients with multivessel disease were stratified by the presence of CKD (estimated glomerular filtration rate <60 mL/min per 1.73 m 2 ) and classified according to angiographic CR (residual SYNTAX score=0) or IR. Clinical outcomes were compared between angiographic CR and IR, stratified by the presence of CKD. Primary outcome was patient-oriented composite outcomes (POCO, a composite of all-cause death, myocardial infarction, any revascularization) at 3 years. Inverse probability weighting was performed between the CR and IR groups. A total of 3224 patients were eligible for analysis: 2295 without CKD; 929 with CKD. Among non-CKD patients, angiographic CR showed a significantly lower risk of POCO than IR (17.2% versus 21.7%, adjusted hazard ratio 0.76, 95% confidence interval, 0.62-0.95, P =0.014), mainly driven by a significantly lower risk of any revascularization. Among CKD patients, however, angiographic CR was associated with a significantly higher risk of POCO than IR (37.7% versus 28.4%, adjusted hazard ratio 1.42, 95% confidence interval, 1.08%-1.85%, P =0.011), mainly driven by a significantly higher risk of nonfatal target vessel myocardial infarction. Angiographic CR was associated with reduced risk of POCO than IR in patients without CKD; however, it was associated with a significantly higher risk of POCO and nonfatal myocardial infarction in CKD patients. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  12. Surgical Site Infection in Diabetic and Non-Diabetic Patients Undergoing Laparoscopic Cholecystectomy

    International Nuclear Information System (INIS)

    Butt, U. I.; Khan, A.; Nawaz, A.; Mansoor, R.; Malik, A. A.; Sher, F.; Ayyaz, M.

    2016-01-01

    Objective: To compare the frequency of surgical site infections in patients with type II diabetes undergoing laparoscopic cholecystectomy as compared with non-diabetic patients. Study Design: Cohort study. Place and Duration of Study: Surgical Unit 2, Services Hospital, Lahore, from May to October 2012. Methodology: Patients were divided into two groups of 60 each, undergoing laparoscopic cholecystectomy. Group A comprised non-diabetic patients and group B comprised type II diabetic patients. Patients were followed postoperatively upto one month for the development of SSIs. Proportion of patients with surgical site infections or otherwise was compared between the groups using chi-square test with significance of p < 0.05. Results: In group A, 35 patients were above the age of 40 years. In group B, 38 patients were above the age of 40 years. Four patients in group A developed a surgical site infection. Seven patients in group B developed SSIs (p = 0.07). Conclusion: Presence of diabetes mellitus did not significantly affect the onset of surgical site infection in patients undergoing laparoscopic cholecystectomy. (author)

  13. Prevention of Intracranial In-stent Restenoses: Predilatation with a Drug Eluting Balloon, Followed by the Deployment of a Self-Expanding Stent

    Energy Technology Data Exchange (ETDEWEB)

    Vajda, Zsolt, E-mail: Z.Vajda@klinikum-stuttgart.de; Guethe, Thomas, E-mail: T.Guethe@klinikum-stuttgart.de; Perez, Marta Aguilar, E-mail: M.Aguilar@klinikum-stuttgart.de; Kurre, Wiebke, E-mail: w.kurre@klinikum-stuttgart.de [Klinikum Stuttgart, Katharinenhospital, Klinik fuer Neuroradiologie, Neurozentrum (Germany); Schmid, Elisabeth, E-mail: ESchmid@klinikum-stuttgart.de; Baezner, Hansjoerg, E-mail: H.Baezner@klinikum-stuttgart.de [Klinikum Stuttgart, Klinik fuer Neurologie, Neurozentrum (Germany); Henkes, Hans, E-mail: hhhenkes@aol.com [Klinikum Stuttgart, Katharinenhospital, Klinik fuer Neuroradiologie, Neurozentrum (Germany)

    2013-04-15

    Stenting in intracranial atherosclerotic disease (ICAD) is increasingly debated, due to issues of procedural safety, technical efficacy, and in-stent recurrent stenoses (ISR). In the present study, feasibility, safety, and efficacy of angioplasty using a drug-eluting balloon (DEB) followed by the implantation of a self-expanding stent (Enterprise) were evaluated for the treatment of ICAD lesions. Fifty-two patients (median age: 71 years; range: 54-86 years; male/female ratio 37:15) underwent stenting of high-grade ICAD lesions between February 2010 and November 2011 in a single center. Angioplasty using a paclitaxel coated SeQuent Please (B. Braun, Germany) or DIOR (Eurocor, Germany) coronary PTCA balloon, followed by the implantation of a self-expanding stent (Enterprise, Codman, USA) was performed in 54 lesions. Angiographic and clinical follow-up was performed at 6 and 12 weeks, 6 and 12 months, and yearly thereafter. Technical success rate, periprocedural complications, occurrence of recurrent ischemic symptoms, and the development of an ISR were analyzed. Angioplasty using a DEB followed by stent implantation was successfully performed in 44 (81 %) cases. DEB insertion failed in 19 % of the cases and angioplasty was finally performed using a conventional PTCA balloon. The combined procedure related permanent neurologic morbidity and mortality rate (stroke, ICH, and subarachnoid hemorrhage) at 30 days and beyond was 5 %. Angiographic and clinical follow-up were obtained in 33 (61 %) lesions in 32 patients. Recurrent stenosis was seen in one (3 %) lesion. Angioplasty and stenting using a DEB is safe and yields encouragingly low ISR rates. Further technical developments to improve lesion accessibility are, nevertheless, mandatory.

  14. Production of 99Tc generators with automatic elution

    International Nuclear Information System (INIS)

    Mengatti, J.; Yanagawa, S.T.I.; Mazzarro, E.; Gasiglia, H.T.; Rela, P.R.; Silva, C.P.G. da; Pereira, N.P.S. de.

    1983-10-01

    The improvements performed on the routine production of sup(99m) Tc-generators at the Instituto de Pesquisas Energeticas e Nucleares-CNEN/SP, are described. The old model generators (manual elution of sup(99m) Tc) were substituted by automatically eluted generators (Vacuum system). The alumina column, elution system and acessories were modified; the elution time was reduced from 60 to 20-30 seconds. The new generators give 80-90% elution yields using six mililiters of sodium chloride 0,9% as sup(99m) Tc eluant instead of the 10 mililiters necessary to eluate the old generators. So, the radioactive concentrations are now 70% higher. The radioactive, radiochemical, chemical and microbiological criteria were examinated for sup(99m) Tc solutions. Like old generators, automatic generators were considered safe for medical purpose. (Author) [pt

  15. Fast Gradient Elution Reversed-Phase HPLC with Diode-Array Detection as a High Throughput Screening Method for Drugs of Abuse

    Energy Technology Data Exchange (ETDEWEB)

    Peter W. Carr; K.M. Fuller; D.R. Stoll; L.D. Steinkraus; M.S. Pasha; Glenn G. Hardin

    2005-12-30

    A new approach has been developed by modifying a conventional gradient elution liquid chromatograph for the high throughput screening of biological samples to detect the presence of regulated intoxicants. The goal of this work was to improve the speed of a gradient elution screening method over current approaches by optimizing the operational parameters of both the column and the instrument without compromising the reproducibility of the retention times, which are the basis for the identification. Most importantly, the novel instrument configuration substantially reduces the time needed to re-equilibrate the column between gradient runs, thereby reducing the total time for each analysis. The total analysis time for each gradient elution run is only 2.8 minutes, including 0.3 minutes for column reequilibration between analyses. Retention times standard calibration solutes are reproducible to better than 0.002 minutes in consecutive runs. A corrected retention index was adopted to account for day-to-day and column-to-column variations in retention time. The discriminating power and mean list length were calculated for a library of 47 intoxicants and compared with previous work from other laboratories to evaluate fast gradient elution HPLC as a screening tool.

  16. Care of patients undergoing external radiotherapy

    International Nuclear Information System (INIS)

    Lang, C.

    1977-01-01

    The anxiety and associated depression suffered by most patients undergoing radiotherapy is discussed and the possibilities open to the nurse to encourage and reassure patients thus facilitating physical care are considered. The general symptoms of anorexia, nausea, tiredness, skin problems, alopecia, bonemarrow depresssion and rapid tumour destruction are described and nursing care prescribed. The side-effects which may occur following radiation of the brain, head and neck region, eyes, oesophagus, lung, abdomen, pelvis, bones, skin, spine, and spinal cord are considered from the nursing standpoint. The specialised subject of radiotherapy in children is discussed briefly. (U.K.)

  17. Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation

    DEFF Research Database (Denmark)

    Yamaji, Kyohei; Brugaletta, Salvatore; Sabaté, Manel

    2017-01-01

    OBJECTIVES: This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EE...

  18. The HRQoL of Chinese patients undergoing haemodialysis.

    Science.gov (United States)

    Yu, Hui-Dan; Petrini, Marcia A

    2010-03-01

    With the transition from infectious disease and acute illness to chronic disease and degenerative illness as leading causes of death, health-related quality of life has become an important aspect in assessing the burden of chronic disease. The quality of life of haemodialysis patients has been studied extensively; however, very limited research using exploratory descriptive design has been carried out in this area in China. The aim of this study was to explore health-related quality of life of end-stage renal disease patients undergoing haemodialysis in China. This study used the qualitative research design approach. A semi-structured, in-depth interview was conducted with 16 haemodialysis patients in two hospitals using Colaizzi's phenomenological method to transcribe and analyse the data. The results of this study showed that dialysis patients show improvement in physical competence, but they also experienced emotional instability and psychological distress, financial burdens, inadequate disease knowledge and less social support which influenced their quality of life. To optimise the patients undergoing dialysis health-related quality of life, support of psycho-social-economical aspects should be enhanced. Health care providers should give haemodialysis patients thorough health education, individualised psychological and emotional intervention and adequate social support to optimise health-related quality of life.

  19. An everolimus-eluting stent versus a paclitaxel-eluting stent in small vessel coronary artery disease: a pooled analysis from the SPIRIT II and SPIRIT III trials.

    Science.gov (United States)

    Bartorelli, Antonio L; Serruys, Patrick W; Miquel-Hébert, Karine; Yu, Shui; Pierson, Wes; Stone, Gregg W

    2010-07-01

    To evaluate the safety and efficacy of the XIENCE V everolimus-eluting stent compared to the TAXUS paclitaxel-eluting stent in small vessels. The XIENCE V everolimus-eluting stent (EES) has been shown to improve angiographic and clinical outcomes after percutaneous myocardial revascularization, but its performance in small coronary arteries has not been investigated. In this pooled analysis, we studied a cohort of 541 patients with small coronary vessels (reference diameter SPIRIT II and SPIRIT III studies. TAXUS Express (73% of lesions) and TAXUS Liberté (27% of lesions) paclitaxel-eluting stents (PES) were used as controls in SPIRIT II. In SPIRIT III, Taxus Express(2) PES was the control. Mean angiographic in-stent and in-segment late loss was significantly less in the EES group compared with the PES group, (0.15 +/- 0.37 mm vs. 0.30 +/- 0.44 mm; P = 0.011 for in-stent; 0.10 +/- 0.38 mm vs. 0.21 +/- 0.34 mm; P = 0.034 for in-segment). EES also resulted in a significant reduction in composite major adverse cardiac events at 1 year (19/366 [5.2%] vs. 17/159 [10.7%]; P = 0.037), due to fewer non-Q-wave myocardial infarctions and target lesion revascularizations. At 1 year, the rate of non-Q-wave myocardial infarction was significantly lower in the EES group compared with that of the PES group (6/366 [1.6%] vs. 8/159 [5.0%]; P = 0.037). In patients with small vessel coronary arteries, the XIENCE V EES was superior to the TAXUS PES. (c) 2010 Wiley-Liss, Inc.

  20. Serial optical coherence tomography assessment of malapposed struts after everolimus-eluting stent implantation. A subanalysis from the HEAL-EES study

    Energy Technology Data Exchange (ETDEWEB)

    Ishida, Kohki [Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona (Spain); Otsuki, Shuji [Division of Cardiology, Teikyo University Hospital, Tokyo (Japan); Giacchi, Giuseppe; Ortega-Paz, Luis [Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona (Spain); Shiratori, Yoshitaka [Division of Cardiology, Teikyo University Hospital, Tokyo (Japan); Freixa, Xavier; Martín-Yuste, Victoria; Masotti, Mónica; Sabaté, Manel [Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona (Spain); Brugaletta, Salvatore, E-mail: sabrugal@clinic.ub.es [Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona (Spain)

    2017-01-15

    Background: Incomplete stent apposition (ISA) is related to stent thrombosis, which is a serious adverse event. We aim to assess the time-course of ISA after 2nd generation everolimus-eluting stent (EES) implantation. Methods: In HEAL-EES study, we enrolled 36 patients who underwent percutaneous coronary intervention (PCI) with EES. OCT imaging was performed at baseline and follow-up. Patients were randomized 1:1:1 into 3 groups according to the time in which follow-up was performed: group A (6-month), group B (9-month), and group C (12-month). In this subanalysis, patients who had ISA segments at baseline and/or follow-up OCT were analyzed. Result: At baseline, among 41 lesions in 36 patients, 20 lesions in 18 patients had ISA segments and were analyzed. At baseline, there were 3.0% ISA struts in group A (n = 8), 2.8% in group B (n = 4), and 4.5% in group C (n = 8). At follow-up, ISA struts were present in 0.09%, 0.16% and 0.64%; respectively in groups A, B, and C. At follow-up, there was a significant decrease in the frequency of ISA: group A 3.0% vs. 0.09% (p < 0.001), group B 2.8% vs. 0.16% (p < 0.001), and group C 4.5% vs. 0.64% (p < 0.001). In group A, there was one late acquired ISA at follow-up. Conclusions: In patients undergoing 2nd generation EES implantation, area of acute ISA assessed by OCT, was almost resolved at 6-month follow-up. - Highlights: • Time-course of incomplete stent apposition of everolimus-eluting stent was assessed. • Serial optical coherence tomography images at baseline and follow-up were evaluated. • Acute incomplete stent apposition was almost resolved as early as at 6 months.

  1. The REMEDEE-OCT Study: An Evaluation of the Bioengineered COMBO Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent Compared With a Cobalt-Chromium Everolimus-Eluting Stent in Patients With Acute Coronary Syndromes: Insights From Optical Coherence Tomography Imaging Analysis

    NARCIS (Netherlands)

    Jaguszewski, Milosz; Aloysius, Romila; Wang, Wei; Bezerra, Hiram G.; Hill, Jonathan; de Winter, Robbert J.; Karjalainen, Pasi P.; Verheye, Stefan; Wijns, William; Lüscher, Thomas F.; Joner, Michael; Costa, Marco; Landmesser, Ulf

    2017-01-01

    The aim of the present study was to evaluate vascular healing of the bioengineered COMBO Dual Therapy Stent compared with a cobalt-chromium (CoCr) everolimus-eluting stent (EES) as assessed by optical coherence tomography in patients with acute coronary syndromes. CD34+ cells promote endothelial

  2. Titania nanotubes with adjustable dimensions for drug reservoir sites and enhanced cell adhesion

    Energy Technology Data Exchange (ETDEWEB)

    Çalışkan, Nazlı; Bayram, Cem; Erdal, Ebru; Karahaliloğlu, Zeynep; Denkbaş, Emir Baki, E-mail: denkbas@hacettepe.edu.tr

    2014-02-01

    This study aims to generate a bactericidal agent releasing surface via nanotube layer on titanium metal and to investigate how aspect ratio of nanotubes affects drug elution time and cell proliferation. Titania nanotube layers were generated on metal surfaces by anodic oxidation at various voltage and time parameters. Gentamicin loading was carried out via simple pipetting and the samples were tested against S. aureus for the efficacy of the applied modification. Drug releasing time and cell proliferation were also tested in vitro. Titania nanotube layers with varying diameters and lengths were prepared after anodization and anodizing duration was found as the most effective parameter for amount of loaded drug and drug releasing time. Drug elution lasted up to 4 days after anodizing for 80 min of the samples, whereas release completed in 24 h when the samples were anodized for 20 min. All processed samples had bactericidal properties against S. aureus organism except unmodified titanium, which was also subjected to drug incorporation step. The anodization also enhanced water wettability and cell adhesion results. Anodic oxidation is an effective surface modification to enhance tissue–implant interactions and also resultant titania layer can act as a drug reservoir for the release of bactericidal agents. The use of implants as local drug eluting devices is promising but further in vivo testing is required. - Highlights: • Titanium surfaces were anodized and a nanotubular titania layer was obtained. • Drug eluting time was found to be increasing with anodizaton time. • Varying nanotube diameters has no effect in drug elution time but amount of incorporated drug.

  3. Titania nanotubes with adjustable dimensions for drug reservoir sites and enhanced cell adhesion

    International Nuclear Information System (INIS)

    Çalışkan, Nazlı; Bayram, Cem; Erdal, Ebru; Karahaliloğlu, Zeynep; Denkbaş, Emir Baki

    2014-01-01

    This study aims to generate a bactericidal agent releasing surface via nanotube layer on titanium metal and to investigate how aspect ratio of nanotubes affects drug elution time and cell proliferation. Titania nanotube layers were generated on metal surfaces by anodic oxidation at various voltage and time parameters. Gentamicin loading was carried out via simple pipetting and the samples were tested against S. aureus for the efficacy of the applied modification. Drug releasing time and cell proliferation were also tested in vitro. Titania nanotube layers with varying diameters and lengths were prepared after anodization and anodizing duration was found as the most effective parameter for amount of loaded drug and drug releasing time. Drug elution lasted up to 4 days after anodizing for 80 min of the samples, whereas release completed in 24 h when the samples were anodized for 20 min. All processed samples had bactericidal properties against S. aureus organism except unmodified titanium, which was also subjected to drug incorporation step. The anodization also enhanced water wettability and cell adhesion results. Anodic oxidation is an effective surface modification to enhance tissue–implant interactions and also resultant titania layer can act as a drug reservoir for the release of bactericidal agents. The use of implants as local drug eluting devices is promising but further in vivo testing is required. - Highlights: • Titanium surfaces were anodized and a nanotubular titania layer was obtained. • Drug eluting time was found to be increasing with anodizaton time. • Varying nanotube diameters has no effect in drug elution time but amount of incorporated drug

  4. Preoperative Thyroid Ultrasound Is Indicated in Patients Undergoing Parathyroidectomy for Primary Hyperparathyroidism

    Directory of Open Access Journals (Sweden)

    Cletus A. Arciero, Zita S. Shiue, Jeremy D. Gates, George E. Peoples, Alan P. B. Dackiw, Ralph P. Tufano, Steven K. Libutti, Martha A. Zeiger, Alexander Stojadinovic

    2012-01-01

    Full Text Available Background: Primary hyperaparathyroidism (pHPT is often accompanied by underlying thyroid pathology that can confound preoperative parathyroid localization studies and complicate intra-operative decision making. The aim of this study was to examine the utility of preoperative thyroid ultrasonography (US in patients prior to undergoing parathyroidectomy for pHPT.Methods: An Institutional Review Board approved prospective study was undertaken from January 2005 through July 2008. All patients with pHPT meeting inclusion criteria (n=94 underwent preoperative thyroid ultrasound in addition to standard 99mTc-sestamibi scintigraphy for parathyroid localization. Demographics, operative management and final pathology were examined in all cases.Results: Fifty-four of the 94 patients (57% were noted to have a thyroid nodule on preoperative US, of which 30 (56% underwent further examination with fine needle aspiration biopsy. Alteration of the operative plan attributable to underlying thyroid pathology occurred in 16 patients (17%, with patients undergoing either total thyroidectomy (n=9 or thyroid lobectomy (n=7. Thyroid cancer was noted in 33% of patients undergoing thyroid resection, and 6% of all patients with HPT.Conclusions: The routine utilization of preoperative thyroid ultrasound in patients prior to undergoing parathyroid surgery for pHPT is indicated. The added information from this non-invasive modality facilitates timely management of co-incidental, and sometimes malignant, thyroid pathology.

  5. Application of Snyder-Dolan classification scheme to the selection of "orthogonal" columns for fast screening of illicit drugs and impurity profiling of pharmaceuticals--I. Isocratic elution.

    Science.gov (United States)

    Fan, Wenzhe; Zhang, Yu; Carr, Peter W; Rutan, Sarah C; Dumarey, Melanie; Schellinger, Adam P; Pritts, Wayne

    2009-09-18

    Fourteen judiciously selected reversed phase columns were tested with 18 cationic drug solutes under the isocratic elution conditions advised in the Snyder-Dolan (S-D) hydrophobic subtraction method of column classification. The standard errors (S.E.) of the least squares regressions of logk' vs. logk'(REF) were obtained for a given column against a reference column and used to compare and classify columns based on their selectivity. The results are consistent with those obtained with a study of the 16 test solutes recommended by Snyder and Dolan. To the extent these drugs are representative, these results show that the S-D classification scheme is also generally applicable to pharmaceuticals under isocratic conditions. That is, those columns judged to be similar based on the 16 S-D solutes were similar based on the 18 drugs; furthermore those columns judged to have significantly different selectivities based on the 16 S-D probes appeared to be quite different for the drugs as well. Given that the S-D method has been used to classify more than 400 different types of reversed phases the extension to cationic drugs is a significant finding.

  6. Pharmacokinetics and pharmacodynamics of rocuronium in young adult and elderly patients undergoing elective surgery.

    Science.gov (United States)

    Varrique, Renan M; Lauretti, Gabriela R; Matsumoto, Julia A; Lanchote, Vera L; de Moraes, Natalia V

    2016-11-01

    To evaluate the impact of advanced age on rocuronium kinetic disposition in ASA I-III patients undergoing elective surgeries. Young adult (20-50 years, n = 15) and elderly patients (65-85 years, n = 14) submitted to surgery under general anaesthesia were investigated. All patients were induced with individual intravenous doses of midazolam, rocuronium, fentanyl and propofol. Rocuronium-induced neuromuscular block was monitored by train of four stimulations of the adductor muscle of the thumb on the ulnar nerve. The pharmacokinetic parameters were calculated by non-compartmental analysis. The relationship between rocuronium plasma concentration and the neuromuscular blockade was described by a sigmoidal Emax model. Elderly patients presented decreased Cl (2.1 ml/kg per min vs 2.8 ml/kg per min; P = 0.0123); increased AUC/dose (507.8 μg min/ml (mg/kg) vs 392.2 μg min/ml/(mg/kg); P = 0.0168) and reduced volume of distribution (285.4 ml/kg vs 435.6 ml/kg, P = 0.0434) compared to young adults. The concentrations required to achieve 50% of maximum neuromuscular block (EC50) were similar for young adult (338.8 ng/ml) and elderly (462.7 ng/ml) patients (P > 0.05). Elderly patients showed increased AUC/D and reduced total Cl compared to young adult patients due to the age-related reduced renal function. Differences in the PK-PD properties of rocuronium in elderly population are due to changes in drug disposition rather than to alterations in the sensitivity to the drug. © 2016 Royal Pharmaceutical Society.

  7. Stent coverage and neointimal proliferation in bare metal stents postdilated with a Paclitaxel-eluting balloon versus everolimus-eluting stents: prospective randomized study using optical coherence tomography at 6-month follow-up.

    Science.gov (United States)

    Poerner, Tudor C; Otto, Sylvia; Gassdorf, Johannes; Nitsche, Kristina; Janiak, Florian; Scheller, Bruno; Goebel, Björn; Jung, Christian; Figulla, Hans R

    2014-12-01

    In this randomized trial, strut coverage and neointimal proliferation of a therapy of bare metal stents (BMSs) postdilated with the paclitaxel drug-eluting balloon (DEB) was compared with everolimus drug-eluting stents (DESs) at 6-month follow-up using optical coherence tomography. We hypothesized sufficient stent coverage at follow-up. A total of 105 lesions in 90 patients were treated with either XIENCE V DES (n=51) or BMS postdilated with the SeQuent Please DEB (n=54). At follow-up, comparable results on the primary optical coherence tomography end point (percentage uncovered struts 5.64±9.65% in BMS+DEB versus 4.93±9.29% in DES; P=0.366) were found. Thus, BMS+DEB achieved the prespecified noninferiority margin of 5% uncovered struts versus DES (difference between treatment means, 0.71%; one-sided upper 95% confidence interval, 4.14%; noninferiority P=0.04). Optical coherence tomography analysis showed significantly more global neointimal proliferation in the BMS+DEB group (15.7±7.8 versus 11.0±5.2 mm(3) proliferation volume/cm stent length; P=0.002). No significant focal in-stent stenosis analyzed with angiography (percentage diameter stenosis at follow-up, 22.8±11.9 versus 16.9±10.4; P=0.014) and optical coherence tomography (peak local area stenosis, 39.5±13.8% versus 36.8±15.6%; P=0.409) was found. Good stent strut coverage of >94% was found in both therapy groups. Despite greater suppression of global neointimal growth in DES, both DES and BMS+DEB effectively prevented clinically relevant focal restenosis at 6-month follow-up. http://www.clinicaltrials.gov. Unique identifier: NCT01056744. © 2014 American Heart Association, Inc.

  8. Management of patients with hematological malignancies undergoing coronary artery bypass grafting

    Directory of Open Access Journals (Sweden)

    Deepak Borde

    2013-01-01

    Full Text Available The number of patients with a previously diagnosed malignancy who need cardiac surgery is increasing. Patients with hematological malignancies represent only 0.38% of all patients undergoing cardiac surgery. The literature in this subset of patients is limited to only a few retrospective case series, with limited number of patients undergoing emergency cardiac surgery. We describe three cases with hematological malignancies namely chronic myelogenous leukemia, acute promyelocytic leukemia and chronic lymphocytic leukemia presenting for coronary artery bypass grafting (CABG. Two patients were taken up for emergency CABG in view of ongoing ischemia, one of them was on preoperative intra-aortic balloon pump support. No mortality was observed. Two patients needed transfusion of blood products which was guided by thromboelastography. One patient developed superficial sternal wound infection requiring antibiotic therapy.

  9. Multidisciplinary perioperative protocol in patients undergoing acute high-risk abdominal surgery

    DEFF Research Database (Denmark)

    Tengberg, L. T.; Bay-Nielsen, M.; Bisgaard, T.

    2017-01-01

    Background: Acute high-risk abdominal (AHA) surgery carries a very high risk of morbidity and mortality and represents a massive healthcare burden. The aim of the present study was to evaluate the effect of a standardized multidisciplinary perioperative protocol in patients undergoing AHA surgery...... = 0·004). Conclusion: The introduction of a multidisciplinary perioperative protocol was associated with a significant reduction in postoperative mortality in patients undergoing AHA surgery. NCT01899885 (http://www.clinicaltrials.gov)....

  10. Evaluation of self-esteem in cancer patients undergoing chemotherapy treatment

    Directory of Open Access Journals (Sweden)

    Marilia Aparecida Carvalho Leite

    2015-12-01

    Full Text Available Objective: to evaluate the self-esteem of cancer patients undergoing chemotherapy. Method: descriptive analytical cross-sectional study with a quantitative approach. Around 156 patients that attended an oncology unit of a mid-sized hospital participated in the study. Results: we found a higher frequency of patients with high self-esteem, but some of them showed average or low self-esteem. The scale showed a Cronbach's alpha value of 0.746, by considering its acceptable internal consistency for the evaluated items. No independent variables showed significant associations with self-esteem. Conclusion: the cancer patients evaluated have presented high self-esteem; thus, it becomes crucial for nursing to plan the assistance of patients undergoing chemotherapy treatments, which enables actions and strategies that meet their physical and psychosocial conditions, aiming to maintain and rehabilitate these people's emotional aspects.

  11. Management of Patients with Orthopaedic Implants Undergoing Dental Procedures.

    Science.gov (United States)

    Quinn, Robert H; Murray, Jayson N; Pezold, Ryan; Sevarino, Kaitlyn S

    2017-07-01

    The American Academy of Orthopaedic Surgeons, in collaboration with the American Dental Association, has developed Appropriate Use Criteria (AUC) for the Management of Patients with Orthopaedic Implants Undergoing Dental Procedures. Evidence-based information, in conjunction with the clinical expertise of physicians, was used to develop the criteria to improve patient care and obtain best outcomes while considering the subtleties and distinctions necessary in making clinical decisions. The Management of Patients with Orthopaedic Implants Undergoing Dental Procedures AUC clinical patient scenarios were derived from indications of patients with orthopaedic implants presenting for dental procedures, as well as from current evidence-based clinical practice guidelines and supporting literature to identify the appropriateness of the use of prophylactic antibiotics. The 64 patient scenarios and 1 treatment were developed by the writing panel, a group of clinicians who are specialists in this AUC topic. Next, a separate, multidisciplinary, voting panel (made up of specialists and nonspecialists) rated the appropriateness of treatment of each patient scenario using a 9-point scale to designate a treatment as Appropriate (median rating, 7 to 9), May Be Appropriate (median rating, 4 to 6), or Rarely Appropriate (median rating, 1 to 3).

  12. Managing direct oral anticoagulants in patients undergoing dentoalveolar surgery.

    Science.gov (United States)

    Patel, J P; Woolcombe, S A; Patel, R K; Obisesan, O; Roberts, L N; Bryant, C; Arya, R

    2017-02-24

    Our objective was to describe our experience of managing a cohort of adult patients prescribed direct oral anticoagulants (DOACs) undergoing dentoalveolar procedures between November 2012 and May 2016. Prior to conducting a procedure a formal assessment was made of each patient's anticoagulation treatment. A specific plan was then formulated, balancing the risk of bleeding with the risk of thrombosis. Patients received a telephone consultation one week following treatment to assess any post-operative bleeding. Eighty-two patients underwent 111 oral surgical procedures, the majority of which were dental extractions. In the case of 35 (32%) procedures, advice was given to omit the DOAC, either before or after treatment. There was no bleeding following the majority of procedures. Persistent bleeding followed 15 (13.5%) procedures, of which 7 (6.3%) procedures required specific intervention. The majority of patients prescribed DOACs can undergo dentoalveolar procedures safely. Important considerations when planning treatment are: (i) when the patient usually takes their dose of DOAC, (ii) the time the procedure is performed and, (iii) when the DOAC is taken post-procedure. In our experience, if these factors are considered carefully, omission of DOAC doses is unlikely to be required for most patients.

  13. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

    DEFF Research Database (Denmark)

    Urban, Philip; Meredith, Ian T; Abizaid, Alexandre

    2015-01-01

    BACKGROUND: Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9......), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. METHODS: In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual...... ratio, 0.50; 95% CI, 0.37 to 0.69; Pbleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet...

  14. Optimization of elution salt concentration in stepwise elution of protein chromatography using linear gradient elution data. Reducing residual protein A by cation-exchange chromatography in monoclonal antibody purification.

    Science.gov (United States)

    Ishihara, Takashi; Kadoya, Toshihiko; Endo, Naomi; Yamamoto, Shuichi

    2006-05-05

    Our simple method for optimization of the elution salt concentration in stepwise elution was applied to the actual protein separation system, which involves several difficulties such as detection of the target. As a model separation system, reducing residual protein A by cation-exchange chromatography in human monoclonal antibody (hMab) purification was chosen. We carried out linear gradient elution experiments and obtained the data for the peak salt concentration of hMab and residual protein A, respectively. An enzyme-linked immunosorbent assay was applied to the measurement of the residual protein A. From these data, we calculated the distribution coefficient of the hMab and the residual protein A as a function of salt concentration. The optimal salt concentration of stepwise elution to reduce the residual protein A from the hMab was determined based on the relationship between the distribution coefficient and the salt concentration. Using the optimized condition, we successfully performed the separation, resulting in high recovery of hMab and the elimination of residual protein A.

  15. Factors affecting quality of life in cancer patients undergoing ...

    African Journals Online (AJOL)

    Factors affecting quality of life in cancer patients undergoing chemotherapy. ... Objective: The aim of this study was to evaluate the QoL in cancer patients with solid tumors and at the different chemotherapy cycles (CT). ... Results: A significant relationship between the cancer type, pain intensity, and fatigue was found.

  16. Myenteric plexitis: A frequent feature in patients undergoing surgery for colonic diverticular disease.

    Science.gov (United States)

    Bassotti, Gabrio; Villanacci, Vincenzo; Sidoni, Angelo; Nascimbeni, Riccardo; Dore, Maria P; Binda, Gian A; Bandelloni, Roberto; Salemme, Marianna; Del Sordo, Rachele; Cadei, Moris; Manca, Alessandra; Bernardini, Nunzia; Maurer, Christoph A; Cathomas, Gieri

    2015-12-01

    Diverticular disease of the colon is frequent in clinical practice, and a large number of patients each year undergo surgical procedures worldwide for their symptoms. Thus, there is a need for better knowledge of the basic pathophysiologic mechanisms of this disease entity. Because patients with colonic diverticular disease have been shown to display abnormalities of the enteric nervous system, we assessed the frequency of myenteric plexitis (i.e. the infiltration of myenteric ganglions by inflammatory cells) in patients undergoing surgery for this condition. We analyzed archival resection samples from the proximal resection margins of 165 patients undergoing left hemicolectomy (60 emergency and 105 elective surgeries) for colonic diverticulitis, by histology and immunochemistry. Overall, plexitis was present in almost 40% of patients. It was subdivided into an eosinophilic (48%) and a lymphocytic (52%) subtype. Plexitis was more frequent in younger patients; and it was more frequent in those undergoing emergency surgery (50%), compared to elective (28%) surgery (p = 0.007). All the severe cases of plexitis displayed the lymphocytic subtype. In conclusion, myenteric plexitis is frequent in patients with colonic diverticular disease needing surgery, and it might be implicated in the pathogenesis of the disease.

  17. Determinants of protein elution rates from preparative ion-exchange adsorbents.

    Science.gov (United States)

    Angelo, James M; Lenhoff, Abraham M

    2016-04-01

    The rate processes involved in elution in preparative chromatography can affect both peak resolution and hence selectivity as well as practical factors such as facility fit. These processes depend on the physical structure of the adsorbent particles, the amount of bound solute, the solution conditions for operation or some combination of these factors. Ion-exchange adsorbents modified with covalently attached or grafted polymer layers have become widely used in preparative chromatography. Their often easily accessible microstructures offer substantial binding capacities for biomolecules, but elution has sometimes been observed to be undesirably slow. In order to determine which physicochemical phenomena control elution behavior, commercially available cellulosic, dextran-grafted and unmodified agarose materials were characterized here by their elution profiles at various conditions, including different degrees of loading. Elution data were analyzed under the assumption of purely diffusion-limited control, including the role of pore structure properties such as porosity and tortuosity. In general, effective elution rates decreased with the reduction of accessible pore volume, but differences among different proteins indicated the roles of additional factors. Additional measurements and analysis, including the use of confocal laser scanning microscopy to observe elution within single chromatographic particles, indicated the importance of protein association within the particle during elution. The use of protein stabilizing agents was explored in systems presenting atypical elution behavior, and l-arginine and disaccharide excipients were shown to alleviate the effects for one protein, lysozyme, in the presence of sodium chloride. Incorporation of these excipients into eluent buffer gave rise to faster elution and significantly lower pool volumes in elution from polymer-modified adsorbents. Copyright © 2016 Elsevier B.V. All rights reserved.

  18. Cerebroprotective effect of piracetam in patients undergoing open heart surgery.

    Science.gov (United States)

    Holinski, Sebastian; Claus, Benjamin; Alaaraj, Nour; Dohmen, Pascal Maria; Neumann, Konrad; Uebelhack, Ralf; Konertz, Wolfgang

    2011-01-01

    Reduction of cognitive function is a possible side effect after the use of cardiopulmonary bypass (CPB) during cardiac surgery. Since it has been proven that piracetam is cerebroprotective in patients undergoing coronary bypass surgery, we investigated the effects of piracetam on the cognitive performance of patients undergoing open heart surgery. Patients scheduled for elective open heart surgery were randomized to the piracetam or placebo group in a double-blind study. Patients received 12 g of piracetam or placebo at the beginning of the operation. Six neuropsychological subtests from the Syndrom Kurz Test and the Alzheimer's Disease Assessment Scale were performed preoperatively and on day 3, postoperatively. To assess the overall cognitive function and the degree of cognitive decline across all tests after the surgery, we combined the six test-scores by principal component analysis. A total of 88 patients with a mean age of 67 years were enrolled into the study. The mean duration of CPB was 110 minutes. Preoperative clinical parameters and overall cognitive functions were not significantly different between the groups. The postoperative combined score of the neuropsychological tests showed deterioration of cognitive function in both groups (piracetam: preoperative 0.19 ± 0.97 vs. postoperative -0.97 ± 1.38, p piracetam did not perform better than those taking placebo, and both groups had the same decline of overall cognitive function (p = 0.955). Piracetam had no cerebroprotective effect in patients undergoing open heart surgery. Unlike the patients who underwent coronary surgery, piracetam did not reduce the early postoperative decline of neuropsychological abilities in heart valve patients.

  19. Investigating Effect of Drug Use on Short-term Complications and Bleeding in Patients Undergoing Off-pump CABG (OPCAB

    Directory of Open Access Journals (Sweden)

    M Hadadzadeh

    2013-08-01

    Full Text Available Introduction: Opioid abuse is a major social and health problem in many parts of the world especially in Iran. There are not much information about effect of drugs (addiction on short-term complications and bleeding after CABG. This study aimed to assess the relationship between addiction with short-term complications and bleeding after CABG. Methods: This is a descriptive study in which 100 male patients who underwent off-pump CABG in Afshar hospital in yazd were followed during 3 months to investigate their short-term complications. preoperative and post-operative Hb, Plt, Pt, Ptt, bleeding and packed cells after operation were recorded. Then, collected data was analyzed by chi-square, fisher and exact test . Results: In this study, 30 patients were addicts and 70 male patients were non-addicts. All patients were males and similar in preoperative characteristics such as HTN, DM, HLP, CAD, LIMA usage and NYHA FC. Addicted patients were younger than non-addicts and most of them were cigarette smokers. Regarding medical and dietary recommendation after operation, addicted patients observed these recommendation significantly less than non-addicted patients. After operation, pulmonary, neurologic and infective complications were significantly more common in addicted patients. Conclusion: According the study results and other similar studies, drug use in patients with cardiovascular disease is noticeable. Moreover, regarding the postoperative outcomes in addicted patients, more studies needs to be conducted in this field.

  20. post-operative morbidity of the obese patient undergoing posterior

    African Journals Online (AJOL)

    urinary tract infection, neurological injury and dural tears. Methods: One hundred consecutive patients undergoing ... muscle mass in the human body, in which weight in kilograms is divided by height in meters2). The current .... complications with the exception of one dural tear occurred in the obese patient group. Table 3.

  1. Multiple maxillofacial fractures in a patient undergoing orthodontic ...

    African Journals Online (AJOL)

    A multi-disciplinary team approach for the management of maxillofacial fractures in patients undergoing orthodontic treatment with fixed appliances is suggested. Orthodontic treatment with surgical involvement has been found to improve both facial aesthetics and occlusal function. Key words: Maxillofacial, trauma, ...

  2. Meta-analysis: adjusted indirect comparison of drug-eluting bead transarterial chemoembolization versus 90Y-radioembolization for hepatocellular carcinoma

    International Nuclear Information System (INIS)

    Ludwig, Johannes M.; Xing, Minzhi; Zhang, Di; Kim, Hyun S.

    2017-01-01

    To investigate comparative effectiveness of drug-eluting bead transarterial chemoembolization (DEB-TACE) versus Yttrium-90 ( 90 Y)-radioembolization for hepatocellular carcinoma (HCC). Studies comparing conventional (c)TACE versus 90 Y-radioembolization or DEB-TACE for HCC treatment were identified using PubMed/Medline, Embase, and Cochrane databases. The adjusted indirect meta-analytic method for effectiveness comparison of DEB-TACE versus 90 Y-radioembolization was used. Wilcoxon rank-sum test was used to compare baseline characteristics. A priori defined sensitivity analysis of stratified study subgroups was performed for primary outcome analyses. Publication bias was tested by Egger's and Begg's tests. Fourteen studies comparing DEB-TACE or 90 Y-radioembolization with cTACE were included. Analysis revealed a 1-year overall survival benefit for DEB-TACE over 90 Y-radioembolization (79 % vs. 54.8 %; OR: 0.57; 95 %CI: 0.355-0.915; p = 0.02; I-squared: 0 %; p > 0.5), but not for the 2-year (61 % vs. 34 %; OR: 0.65; 95%CI: 0.294-1.437; p = 0.29) and 3-year survival (56.4 % vs. 20.9 %; OR: 0.713; 95 % CI: 0.21-2.548; p = 0.62). There was significant heterogeneity in the 2- and 3-year survival analyses. The pooled median overall survival was longer for DEB-TACE (22.6 vs. 14.7 months). There was no significant difference in tumour response rate. DEB-TACE and 90 Y-radioembolization are efficacious treatments for patients suffering from HCC; DEB-TACE demonstrated survival benefit at 1-year compared to 90 Y-radioembolization but direct comparison is warranted for further evaluation. (orig.)

  3. Structural pathology is not related to patient-reported pain and function in patients undergoing meniscal surgery

    DEFF Research Database (Denmark)

    Christensen, Simon Tornbjerg; Nissen, Nis; Englund, Martin

    2017-01-01

    BACKGROUND: The relationship between meniscal tears and other joint pathologies with patient-reported symptoms is not clear. We investigated associations between structural knee pathologies identified at surgery with preoperative knee pain and function in patients undergoing arthroscopic meniscal...... of meniscal tears questionnaire, supplemented with information extracted from surgery reports. Following hypothesis-driven preselection of candidate variables, backward elimination regressions were performed to investigate associations between patient-reported outcomes and structural knee pathologies. RESULTS...... surgery. METHODS: This study included 443 patients from the Knee Arthroscopy Cohort Southern Denmark (KACS), a prospective cohort following patients 18 years or older undergoing arthroscopic meniscal surgery at 4 hospitals between 1 February 2013 and 31 January 2014. Patient-reported outcomes, including...

  4. Clinical results with the Resolute zotarolimus-eluting stent in total coronary occlusions

    DEFF Research Database (Denmark)

    Kelbæk, Henning; Holmvang, Lene; Richardt, Gert

    2015-01-01

    Aims: We conducted a pooled post hoc analysis (RESOLUTE All Comers and RESOLUTE International) of patients who had the Resolute® zotarolimus-eluting stent (R-ZES) implanted in revascularised total occlusions (TO) compared with patients treated with R-ZES for non-occluded lesions. Methods and resu......Aims: We conducted a pooled post hoc analysis (RESOLUTE All Comers and RESOLUTE International) of patients who had the Resolute® zotarolimus-eluting stent (R-ZES) implanted in revascularised total occlusions (TO) compared with patients treated with R-ZES for non-occluded lesions. Methods...... lesion revascularisation) and Academic Research Consortium definite or probable stent thrombosis. The rate of TLF at two years was not significantly different among patients in the CTO (9.1%), TO (9.8%), and no occlusion (10.4%) groups (log-rank p=0.800); neither were the components of TLF. Definite...... or probable stent thrombosis occurred more frequently in the TO group (2.8% vs. 1.2% in the CTO and 1.1% in the group with no occlusion, p=0.027). There were 10 late and six very late stent thrombosis events. Conclusions: Apart from a higher rate of stent thrombosis in patients with TO, patients with totally...

  5. Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Christiansen, Evald Høj

    2016-01-01

    BACKGROUND: Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown. OBJECTIVES: This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical...... rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR...... in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877)....

  6. Estimation of organ doses of patient undergoing hepatic chemoembolization procedures

    International Nuclear Information System (INIS)

    Jaramillo, G.W.; Kramer, R.; Khoury, H.J.; Barros, V.S.M.; Andrade, G.

    2015-01-01

    The aim of this study is to evaluate the organ doses of patients undergoing hepatic chemoembolization procedures performed in two hospitals in the city of Recife-Brazil. Forty eight patients undergoing fifty hepatic chemoembolization procedures were investigated. For the 20 cases with PA projection only, organ and tissue absorbed doses as well as radiation risks were calculated. For this purpose organs and tissues dose to KAP conversion coefficients were calculated using the mesh-based phantom series FASH and MASH coupled to the EGSnrc Monte Carlo code. Clinical, dosimetric and irradiations parameters were registered for all patients. The maximum organ doses found were 1.72 Gy, 0.65Gy, 0.56 Gy and 0.33 Gy for skin, kidneys, adrenals and liver, respectively. (authors)

  7. Salivary function in patients with chronic renal failure undergoing hemodialysis

    International Nuclear Information System (INIS)

    Kaya, M.; Cermik, T.F.; Uestuen, F.; Sen, S.; Berkarda, S.

    2002-01-01

    The aim of this study was to evaluate the changes in salivary gland function in patients with chronic renal failure (CRF) undergoing hemodialysis. The group consisted of 23 patients with CRF (13 female, 10 male; mean age: 40±13 yr) and 14 healthy control subjects (mean age: 40±13 yr). All underwent dynamic salivary gland scintigraphy with gustatory stimulation. After intravenous administration of 99m Tc pertechnetate, first, perfusion images at 2 seconds per frame were acquired for 1 minute, then dynamic images at 1 minute per frame were acquired for 45 minutes. At 30 minutes after injection , 10 ml lemon juice was given for 15 minutes as a gustatory stimulus. We obtained time-activity curves derived from regions of interest centered over the four major salivary glands. The following functional indices were calculated for each gland: the time of maximum radioactivity (T max ) for the prestimulated period, the time of minimum radioactivity (T min ), as an indicator of velocity of secretion after stimulation, and the Lem E 5 % value as an indicator of the secretion function. When the patients with CRF undergoing hemodialysis were compared to the controls, there were statistically significant differences in T max , T min and Lem E 5 % values for bilateral parotid glands, and T min values for bilateral submandibular glands (p max and Lem E 5 % values for bilateral submandibular glands. There were also significant differences in T max and Lem E 5 % values for bilateral parotid glands between mild oral problems and severe oral problems in patients with CRF (undergoing hemodialysis). In this study, prolonged T max and T min values, and decreased Lem E 5 % values for parotid glands and prolonged T min values for submandibular glands on salivary scintigraphy pointed out decreased parenchymatous and excretory function in patients with CRF undergoing hemodialysis. (author)

  8. Prevention of Intracranial In-stent Restenoses: Predilatation with a Drug Eluting Balloon, Followed by the Deployment of a Self-Expanding Stent

    International Nuclear Information System (INIS)

    Vajda, Zsolt; Güthe, Thomas; Perez, Marta Aguilar; Kurre, Wiebke; Schmid, Elisabeth; Bäzner, Hansjörg; Henkes, Hans

    2013-01-01

    Stenting in intracranial atherosclerotic disease (ICAD) is increasingly debated, due to issues of procedural safety, technical efficacy, and in-stent recurrent stenoses (ISR). In the present study, feasibility, safety, and efficacy of angioplasty using a drug-eluting balloon (DEB) followed by the implantation of a self-expanding stent (Enterprise) were evaluated for the treatment of ICAD lesions. Fifty-two patients (median age: 71 years; range: 54–86 years; male/female ratio 37:15) underwent stenting of high-grade ICAD lesions between February 2010 and November 2011 in a single center. Angioplasty using a paclitaxel coated SeQuent Please (B. Braun, Germany) or DIOR (Eurocor, Germany) coronary PTCA balloon, followed by the implantation of a self-expanding stent (Enterprise, Codman, USA) was performed in 54 lesions. Angiographic and clinical follow-up was performed at 6 and 12 weeks, 6 and 12 months, and yearly thereafter. Technical success rate, periprocedural complications, occurrence of recurrent ischemic symptoms, and the development of an ISR were analyzed. Angioplasty using a DEB followed by stent implantation was successfully performed in 44 (81 %) cases. DEB insertion failed in 19 % of the cases and angioplasty was finally performed using a conventional PTCA balloon. The combined procedure related permanent neurologic morbidity and mortality rate (stroke, ICH, and subarachnoid hemorrhage) at 30 days and beyond was 5 %. Angiographic and clinical follow-up were obtained in 33 (61 %) lesions in 32 patients. Recurrent stenosis was seen in one (3 %) lesion. Angioplasty and stenting using a DEB is safe and yields encouragingly low ISR rates. Further technical developments to improve lesion accessibility are, nevertheless, mandatory.

  9. Application of Snyder-Dolan Classification Scheme to the Selection of “Orthogonal” Columns for Fast Screening for Illicit Drugs and Impurity Profiling of Pharmaceuticals - I. Isocratic Elution

    Science.gov (United States)

    Fan, Wenzhe; Zhang, Yu; Carr, Peter W.; Rutan, Sarah C.; Dumarey, Melanie; Schellinger, Adam P.; Pritts, Wayne

    2011-01-01

    Fourteen judiciously selected reversed-phase columns were tested with 18 cationic drug solutes under the isocratic elution conditions advised in the Snyder-Dolan (S-D) hydrophobic subtraction method of column classification. The standard errors (S.E.) of the least squares regressions of log k′ vs. log k′REF were obtained for a given column against a reference column and used to compare and classify columns based on their selectivity. The results are consistent with those obtained with a study of the 16 test solutes recommended by Snyder and Dolan. To the extent that these drugs are representative these results show that the S-D classification scheme is also generally applicable to pharmaceuticals under isocratic conditions. That is, those columns judged to be similar based on the S-D 16 solutes were similar based on the 18 drugs; furthermore those columns judged to have significantly different selectivities based on the 16 S-D probes appeared to be quite different for the drugs as well. Given that the S-D method has been used to classify more than 400 different types of reversed phases the extension to cationic drugs is a significant finding. PMID:19698948

  10. Development of Postoperative Diabetes Mellitus in Patients Undergoing Distal Pancreatectomy versus Whipple Procedure.

    Science.gov (United States)

    Nguyen, Adrienne; Demirjian, Aram; Yamamoto, Maki; Hollenbach, Kathryn; Imagawa, David K

    2017-10-01

    Because the islets of Langerhans are more prevalent in the body and tail of the pancreas, distal pancreatectomy (DP) is believed to increase the likelihood of developing new onset diabetes mellitus (NODM). To determine whether the development of postoperative diabetes was more prevalent in patients undergoing DP or Whipple procedure, 472 patients undergoing either a DP (n = 122) or Whipple (n = 350), regardless of underlying pathology, were analyzed at one month postoperatively. Insulin or oral hypoglycemic requirements were assessed and patients were stratified into preoperative diabetic status: NODM or preexisting diabetes. A retrospective chart review of the 472 patients between 1996 and 2014 showed that the total rate of NODM after Whipple procedure was 43 per cent, which was not different from patients undergoing DP (45%). The incidence of preoperative diabetes was 12 per cent in patients undergoing the Whipple procedure and 17 per cent in the DP cohort. Thus, the overall incidence of diabetes after Whipple procedure was 54 and 49 per cent in the DP group. The development of diabetes was unrelated to the type of resection performed. Age more than 65 and Caucasian ethnicity were associated with postoperative diabetes regardless of the type of resection performed.

  11. Three-Dimensional Printing of Drug-Eluting Implants

    DEFF Research Database (Denmark)

    Water, Jorrit Jeroen; Bohr, Adam; Bøtker, Johan Peter

    2015-01-01

    The aim of the present work was to investigate the potential of three-dimensional (3D) printing as a manufacturing method for products intended for personalized treatments by exploring the production of novel polylactide-based feedstock materials for 3D printing purposes. Nitrofurantoin (NF......) and hydroxyapatite (HA) were successfully mixed and extruded with up to 30% drug load with and without addition of 5% HA in polylactide strands, which were subsequently 3D-printed into model disc geometries (10 × 2 mm). X-ray powder diffraction analysis showed that NF maintained its anhydrate solid form during...... of custom-made, drug-loaded feedstock materials for 3D printing of pharmaceutical products for controlled release....

  12. The Relationship between Self-Esteem and Coping Styles in Patients Undergoing Hemodialysis

    Directory of Open Access Journals (Sweden)

    Leila Rezaei

    2016-07-01

    Full Text Available This paper is a report of a study of The Relationship between Self-Esteem and Coping Styles in patients undergoing hemodialysis in Iran. Hemodialysis patients face with multiple physical and psychological stressful factors; they use coping styles in order to cope with the challenges. A descriptive-correlation study was conducted based on the data collected from patients undergoing hemodialysis by census method in the city of Kerman using the Endler and Parker coping style, Self-esteem and demographic information questionnaires. The mean age of patients was 56.21 ± 1.45 years and 58.5% were male. The statistically positive relationship between self-esteem and problem-oriented coping style (p=0.05 and inverse relationship between self-esteem and emotion-oriented style (p<0.001. The patients with higher and lower self-esteem used problem-oriented and emotion-oriented styles, respectively. According to the results, it is necessary for nurses to enhance their role in promoting self-esteem and help patients undergoing hemodialysis while using problem-oriented style.

  13. Music and ambient operating room noise in patients undergoing spinal anesthesia.

    Science.gov (United States)

    Ayoub, Chakib M; Rizk, Laudi B; Yaacoub, Chadi I; Gaal, Dorothy; Kain, Zeev N

    2005-05-01

    Previous studies have indicated that music decreases intraoperative sedative requirements in patients undergoing surgical procedures under regional anesthesia. In this study we sought to determine whether this decrease in sedative requirements results from music or from eliminating operating room (OR) noise. A secondary aim of the study was to examine the relationship of response to intraoperative music and participants' culture (i.e., American versus Lebanese). Eighty adults (36 American and 54 Lebanese) undergoing urological procedures with spinal anesthesia and patient-controlled IV propofol sedation were randomly assigned to intraoperative music, white noise, or OR noise. We found that, controlling for ambient OR noise, intraoperative music decreases propofol requirements (0.004 +/- 0.002 mg . kg(-1) . min(-1) versus 0.014 +/- 0.004 mg . kg(-1) . min(-1) versus 0.012 +/- 0.002 mg . kg(-1) . min(-1); P = 0.026). We also found that, regardless of group assignment, Lebanese patients used less propofol as compared with American patients (0.005 +/- 0.001 mg . kg(-1) . min(-1) versus 0.017 +/- 0.003 mg . kg(-1) . min(-1); P = 0.001) and that, in both sites, patients in the music group required less propofol (P noise, intraoperative music decreases propofol requirements of both Lebanese and American patients who undergo urological surgery under spinal anesthesia.

  14. Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-eluting stent (DiabeDES) randomized angiography trial

    DEFF Research Database (Denmark)

    Maeng, Michael; Jensen, Lisette Okkels; Galloe, Anders Michael

    2008-01-01

    group (0.23 +/- 0.54 vs 0.44 +/- 0.52 mm, p = 0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary end point, was present in 16 patients (Cypher, n = 6; Taxus, n = 10; p = 0.24). Target lesion revascularization was performed in 5 patients (6.5%) and 9 patients (11.......8%) in the Cypher and Taxus groups, respectively (p = 0.25). Definite stent thrombosis was observed in 2 patients (in the Taxus group), no patients had probable stent thrombosis, and 1 patient in each group had possible stent thrombosis. Major adverse cardiac events (cardiac death, myocardial infarction, definite...

  15. Multicenter prospective randomized phase II study of antimicrobial prophylaxis in low-risk patients undergoing colon surgery.

    Science.gov (United States)

    Shimizu, Junzo; Ikeda, Kimimasa; Fukunaga, Mutsumi; Murata, Kohei; Miyamoto, Atsushi; Umeshita, Koji; Kobayashi, Tetsuro; Monden, Morito

    2010-10-01

    Postoperative antimicrobial therapy is generally administered as standard prophylaxis against postoperative infection, despite a lack of sufficient evidence for its usefulness. This study was a phase II study to evaluate the necessity of postoperative antibiotic prophylaxis in patients undergoing a colectomy. Patients received 1 g cefmetazole or flomoxef immediately after anesthetic induction, every 3 h during surgery, and then later once again on the next day. They were randomly assigned to receive either cefmetazole or flomoxef. Ninety-one patients were enrolled in the study. A surgical site infection (SSI) occurred in 7.7% (7/91) of patients. All cases were superficial incisional infections. When comparing the two drugs, SSI occurred in 8.3% (4/48) of patients treated with cefmetazole and in 7.0% (3/43) treated with flomoxef, showing no significant difference (P > 0.99). Antimicrobial prophylaxis was well tolerated when used on the day of a colectomy and once again on the next day.

  16. Postoperative atrial fibrillation in patients on statins undergoing ...

    African Journals Online (AJOL)

    Introduction: The efficacy of perioperative statin therapy in decreasing postoperative morbidity in patients undergoing valve replacements and repairs is unknown. The aim of our study was to determine whether or not the literature supports the hypothesis that statins decrease postoperative atrial fibrillation (AF), and hence ...

  17. Experiense with remineraling means in patients undergoing orthodontic treatment

    Directory of Open Access Journals (Sweden)

    Stepanova Ye.A.

    2011-03-01

    Full Text Available In patients undergoing orthodontic treatment using bracket-technology a high risk of caries development. The algorithm of preventive interventions for the prevention of hair demineralization of enamel of the teeth

  18. Investigating the Effect of Swedish massage on Thoracic Pain in Patients Undergoing Coronary Artery Bypass Graft Surgery

    Directory of Open Access Journals (Sweden)

    Zahra Pishkarmofrad

    2016-05-01

    Full Text Available Pain is one of the common complications after coronary artery bypass graft surgery. The current study aimed to investigate the effect of Swedish massage on thoracic pain in patients undergoing coronary artery bypass graft surgery at Ali-ibn Abi Talib Hospital of Zahedan, Iran in 2015. This study was performed on 50 patients undergoing coronary artery bypass graft surgery at Ali-ibn Abi Talib Hospital of Zahedan in 2015 in a randomized controlled clinical trial method. The patients were randomly divided into two massage and control groups with 25 cases in each group. The intervention group received Swedish massage for 20 minutes on the first day of transferring to cardiac surgical ward; however, the control group went under the routine control of the ward. Patients’ pain intensity were measured and recorded 15 minutes before and after the intervention using Visual Analog Scale (VAS. Statistical analysis was done using Chi-square test, independent t-test and paired t-test and SPSS Software version 21. There was no statistical significant difference between the two groups in terms of pain intensity before the intervention. The mean pain score before and after intervention was 60.80±11.46 and 44.32±11.58 in the massage group and 58.64±14.42 and 58.60±14.40 in th e control group, respectively. The result of covariance test showed that the mean pain score after intervention was significantly lower in the massage group than the control group (P=0.0001. Considering the effect of Swedish massage on reducing pain in patients undergoing coronary artery bypass graft, massage therapy can be used as a safe and low-cost non-drug method for reducing pain in these patients.

  19. Development of a sirolimus-eluting poly (L-lactide)/poly(4-hydroxybutyrate) absorbable stent for peripheral vascular intervention.

    Science.gov (United States)

    Grabow, Niels; Bünger, Carsten M; Kischkel, Sabine; Timmermann, J Hinrich; Reske, Thomas; Martin, David P; Williams, Simon F; Schareck, Wolfgang; Sternberg, Katrin; Schmitz, Klaus-Peter

    2013-10-01

    Fully absorbable drug-eluting stent platforms are currently entering the clinical arena for the interventional treatment of coronary artery disease. This new technology also holds potential for application in peripheral vascular settings. Our study reports on the development of a sirolimus- (SIR) eluting absorbable polymer stent made from a blend of poly(l-lactide) and poly(4-hydroxybutyrate) (PLLA/P4HB) for peripheral vascular intervention. Stent prototypes were laser-cut from PLLA/P4HB tubes (I.D.=2.2 mm, t=250 µm), spray-coated with different PLLA/P4HB/SIR solutions, and bench-tested to determine expansion properties, fatigue, trackability and in vitro drug release kinetics. The stent prototypes were expanded with a 5.0 × 20 mm balloon catheter, and exhibited a recoil of 3.6% upon balloon deflation. Stent collapse pressure of 0.4 bar (300 mm Hg) was measured under external pressure load. Sustained scaffolding properties were observed in vitro over 14 weeks of radial fatigue loading (50 ± 25 mm Hg at 1.2 Hz). Trackability was demonstrated in bench tests with an 8 French contralateral introducer sheath. SIR release kinetics were adjusted over a broad range by varying the PLLA/P4HB ratio of the coating matrix. The newly developed absorbable SIR-eluting PLLA/P4HB stent successfully fulfilled the requirements for peripheral vascular intervention under in vitro conditions.

  20. Frequency of Cardiac Death and Stent Thrombosis in Patients With Chronic Obstructive Pulmonary Disease Undergoing Percutaneous Coronary Intervention (from the BASKET-PROVE I and II Trials)

    DEFF Research Database (Denmark)

    Jatene, Tannas; Biering-Sørensen, Tor; Nochioka, Kotaro

    2017-01-01

    Chronic obstructive pulmonary disease (COPD) is associated with long-term all-cause death after percutaneous coronary intervention with bare-metal stents. Regarding other outcomes, previous studies have shown conflicting results and the impact of drug-eluting stent (DES) in this population is not...

  1. Measuring pain in patients undergoing hemodialysis: a review of pain assessment tools

    OpenAIRE

    Upadhyay, Chandani; Cameron, Karen; Murphy, Laura; Battistella, Marisa

    2014-01-01

    Background Patients undergoing hemodialysis frequently report pain with multifactorial causes, not limited to that experienced directly from hemodialysis treatment. Their pain may be nociceptive, neuropathic, somatic or visceral in nature. Despite this, pain in this population remains under-recognized and under-treated. Although several tools have been used to measure pain in patients undergoing hemodialysis as reported in the literature, none of them have been validated specifically in this ...

  2. Mycoplasma in urine and blood following catheterisation of patients undergoing vascular surgery

    DEFF Research Database (Denmark)

    Levi, N; Eiberg, J; Skov Jensen, J

    1997-01-01

    The purpose of this investigation was to determine if mycoplasmas enter the bloodstream after urinary tract catheterisation in patients undergoing vascular surgery in order to evaluate the efficiency of the routine prophylactic antibiotic treatment.......The purpose of this investigation was to determine if mycoplasmas enter the bloodstream after urinary tract catheterisation in patients undergoing vascular surgery in order to evaluate the efficiency of the routine prophylactic antibiotic treatment....

  3. Size distribution of DNA molecules recovered from non-denaturing filter elution

    International Nuclear Information System (INIS)

    Bloecher, D.; Iliakis, G.

    1991-01-01

    DNA fragments removed from the filter during non-denaturing filter elution were collected and loaded on top of neutral sucrose gradients. Their size distribution was determined by low-speed centrifugation in neutral sucrose gradients. The average size of eluted DNA was found to be approximately 110 S; the average size of DNA collected after short elution times was found to be slightly larger than after long elution times. It is concluded that the size of eluted DNA fragments is not correlated with elution rate, and it is proposed that shear forces generated at the filter pores cause degradation of the DNA. Comparison of sedimentation profiles of carefully prepared cellular DNA before and after elution revealed that generated shear forces during elution break down DNA to an extent equivalent to around 20 000 DNA double-strand breaks (dsb) per G 1 cell. The size of DNA fragments decreased with increasing radiation dose; five times more dsb were found than expected after exposure to radiation alone. It is proposed that excess of dsb may derive from the transformation of other radiation-induced lesions to dsb under the action of shear forces generated during elution. (author)

  4. Coexisting lumbar spondylosis in patients undergoing TKA: how common and how serious?

    Science.gov (United States)

    Chang, Chong Bum; Park, Kun Woo; Kang, Yeon Gwi; Kim, Tae Kyun

    2014-02-01

    Information on the coexistence of lumbar spondylosis and its influence on overall levels of pain and function in patients with advanced knee osteoarthritis (OA) undergoing total knee arthroplasty (TKA) would be valuable for patient consultation and management. The purposes of this study were to document the prevalence and severity of coexisting lumbar spondylosis in patients with advanced knee OA undergoing TKA and to determine whether the coexisting lumbar spondylosis at the time of TKA adversely affects clinical scores in affected patients before and 2 years after TKA. Radiographic lumbar spine degeneration and lumbar spine symptoms including lower back pain, radiating pain at rest, and radiating pain with activity were assessed in 225 patients undergoing TKA. In addition, the WOMAC score and the SF-36 scores were evaluated before and 2 years after TKA. Potential associations of radiographic lumbar spine degeneration and lumbar spine symptom severities with pre- and postoperative WOMAC subscales and SF-36 scores were examined. All 225 patients had radiographic degeneration of the lumbar spine, and the large majority (89% [200 of 225]) had either moderate or severe spondylosis (72% and 17%, respectively). A total of 114 patients (51%) had at least one moderate or severe lumbar spine symptom. No association was found between radiographic severity of lumbar spine degeneration and pre- and postoperative clinical scores. In terms of lumbar spine symptoms, more severe symptoms were likely to adversely affect the preoperative WOMAC and SF-36 physical component summary (PCS) scores, but most of these adverse effects improved by 2 years after TKA with the exception of the association between severe radiating pain during activity and a poorer postoperative SF-36 PCS score (regression coefficient = -5.41, p = 0.015). Radiographic lumbar spine degeneration and lumbar spine symptoms are common among patients with advanced knee OA undergoing TKA. Severe lumbar spine symptoms

  5. Pulmonary hypertenstion ad leading factor in patients undergoing dialysis

    International Nuclear Information System (INIS)

    Rehman, I.U.; Sumera, A.; Idrees, M.K.; Tanweer, A.

    2014-01-01

    Objective: To determine the frequency and leading factors of pulmonary hypertension among chronic hemodialysis patients. Study Design: Case series. Place and Duration of Study: Hemodialysis Unit, Department of Nephrology, Sindh Institute of Urology and Transplantation, Karachi, from September 2011 to March 2012. Methodology: Patients of either gender aged between 16 to 60 years of age undergoing hemodialysis for at least 3 months not having pre-existing valvular heart disease, chronic lung disease or connective tissue disorder were included. Pulmonary hypertension was prospectively estimated by Doppler echocardiogram on patients undergoing dialysis. Pulmonary artery pressure was calculated on the post-dialysis day and leading factors were compared between patients with and without pulmonary hypertension. Results: A total of 178 patients were included in study with male to female ratio120/58 (2.06:1). The mean age was 33.84 +- 11.9 years. The mean duration of hemodialysis was 23.85 +- 22.48 months. Pulmonary hypertension was found in 76 (42.7%) patients. Out of the studied factors, low serum albumin ( 3.4 mg/dl, p = 0.01) was found to be statistically significant in patients with pulmonary hypertension. Conclusion: Pulmonary hypertension was frequently present in dialysis population (42.7%). This subset of patients had significantly lower albumin levels in serum. More research is needed in its pathogenesis to arrest its course. (author)

  6. The SPIRIT V study: a clinical evaluation of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions.

    Science.gov (United States)

    Grube, Eberhard; Chevalier, Bernard; Smits, Peter; Džavík, Vladimir; Patel, Tejas M; Mullasari, Ajit S; Wöhrle, Jochen; Stuteville, Marrianne; Dorange, Cécile; Kaul, Upendra

    2011-02-01

    The SPIRIT V (A Clinical Evaluation of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions) study is a post-market surveillance experience of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) in patients with higher-risk coronary anatomy. Previous pre-approval studies have shown the safety and efficacy of EES in highly selected groups of patients. The SPIRIT V trial is a prospective, open label, single arm, multicenter study. Two thousand seven hundred patients with multiple de novo coronary artery lesions suitable for treatment with a planned maximum of 4 EES were enrolled at 93 centers in Europe, Asia Pacific, Canada, and South Africa. Lesions had a reference vessel diameter between 2.25 and 4.0 mm and a length of ≤ 28 mm by visual estimation. An independent clinical events committee adjudicated all end point-related events. The primary end point was the composite rate of all death, myocardial infarction (MI), and target vessel revascularization at 30 days. Secondary end points included stent thrombosis and acute success (clinical device and procedure success). At 30 days, the primary composite end point of all death, MI, and target vessel revascularization was 2.7%. At 1 year, rates of cardiac death, overall MI, and target lesion revascularization were 1.1%, 3.5%, and 1.8%, respectively. The cumulative rate of definite and probable stent thrombosis was low at 0.66% at 1 year. Use of EES in patients with multiple, complex de novo lesions yielded 1-year major adverse cardiac events, stent thrombosis, and target lesion revascularization rates that are comparable to those of the more controlled SPIRIT II and SPIRIT III trials-which included patients with restricted inclusion/exclusion criteria-and other all-comer population, physician-initiated studies like the X-SEARCH (Xience Stent Evaluated At Rotterdam Cardiology Hospital) and COMPARE (A Randomized

  7. Comparing Stent Thrombosis associated with Zotarolimus Eluting Stents versus Everolimus Eluting Stents at 1 year follow up: a systematic review and meta-analysis of 6 randomized controlled trials.

    Science.gov (United States)

    Bundhun, Pravesh Kumar; Yanamala, Chandra Mouli; Huang, Wei-Qiang

    2017-03-16

    Two thousand fifteen has been a winning year for Drug Eluting Stents (DES). Increase in the number of patients with cardiovascular diseases treated by Percutaneous Coronary Intervention (PCI) has resulted to a high demand for second generation DES. This current analysis aimed to compare the different types of Stent Thrombosis (ST) associated with Zotarolimus Eluting Stents (ZES) versus Everolimus Eluting Stents (EES) at 1 year follow up. Electronic databases were searched for studies comparing ZES with EES. Different types of ST reported at 1 year follow up were considered as the primary endpoints in this analysis. Odds Ratios (OR) with 95% Confidence Intervals (CIs) were used as the statistical parameters and the pooled analyses were carried out by the RevMan 5 · 3 software. A total number of 10,512 patients were included in this analysis. No significant difference in any definite ST, acute definite ST, subacute definite ST, and late definite ST were observed between ZES and EES, at 1 year follow up with OR: 1.70, 95% CI: 0.92 - 3.16; P = 0.09, OR: 3.44, 95% CI: 0.82 - 14.43; P = 0.09, OR: 1.13, 95% CI: 0.43 - 2.95; P = 0.80 and OR: 2.39, 95% CI: 0.83 - 6.85; P = 0.11 respectively. Moreover, any definite or probable ST and definite/probable/possible ST were also not significantly different with OR: 1.39, 95% CI: 0.89 - 2.17; P = 0.15 and OR: 1.19, 95% CI: 0.84 - 1.70; P = 0.33 respectively. In addition, any probable ST, acute probable ST, late probable ST and possible ST were also not significantly different at 1 year follow up with OR: 1.11, 95% CI: 0.60 - 2.05; P = 0.75, OR: 0.53, 95% CI: 0.12 - 2.40; P = 0.41, OR: 1.67, 95% CI: 0.35 - 7.86; P = 0.52 and OR: 1.08, 95% CI: 0.64 - 1.82; P = 0.78 respectively. At 1 year follow up, ZES were not associated with significantly lower or higher definite and probable ST compared to EES. In addition, no significant difference was observed in acute, subacute and late

  8. Safety and efficacy of rivaroxaban compared with warfarin in patients undergoing peripheral arterial procedures.

    Science.gov (United States)

    Talukdar, Anjan; Wang, S Keisin; Czosnowski, Lauren; Mokraoui, Nassim; Gupta, Alok; Fajardo, Andres; Dalsing, Michael; Motaganahalli, Raghu

    2017-10-01

    Rivaroxaban is a United States Food and Drug Administration-approved oral anticoagulant for venous thromboembolic disease; however, there is no information regarding the safety and its efficacy to support its use in patients after open or endovascular arterial interventions. We report the safety and efficacy of rivaroxaban vs warfarin in patients undergoing peripheral arterial interventions. This single-institution retrospective study analyzed all sequential patients from December 2012 to August 2014 (21 months) who were prescribed rivaroxaban or warfarin after a peripheral arterial procedure. Our study population was then compared using American College of Chest Physicians guidelines with patients then stratified as low, medium, or high risk for bleeding complications. Statistical analyses were performed using the Student t-test and χ 2 test to compare demographics, readmissions because of bleeding, and the need for secondary interventions. Logistic regression models were used for analysis of variables associated with bleeding complications and secondary interventions. The Fisher exact test was used for power analysis. There were 44 patients in the rivaroxaban group and 50 patients in the warfarin group. Differences between demographics and risk factors for bleeding between groups or reintervention rate were not statistically significant (P = .297). However, subgroup evaluation of the safety profile suggests that patients who were aged ≤65 years and on warfarin had an overall higher incidence of major bleeding (P = .020). Patients who were aged >65 years, undergoing open operation, had a significant risk for reintervention (P = .047) when they received rivaroxaban. Real-world experience using rivaroxaban and warfarin in patients after peripheral arterial procedures suggests a comparable safety and efficacy profile. Subgroup analysis of those requiring an open operation demonstrated a decreased bleeding risk when rivaroxaban was used (in those aged <65

  9. The Indicating FTA Elute Cartridge

    Science.gov (United States)

    de Bie, Roosmarie P.; Schmeink, Channa E.; Bakkers, Judith M.J.E.; Snijders, Peter J.F.; Quint, Wim G.V.; Massuger, Leon F.A.G.; Bekkers, Ruud L.M.; Melchers, Willem J.G.

    2011-01-01

    The clinically validated high-risk human papillomavirus (hrHPV) Hybrid Capture 2 (HC2) and GP5+/6+-PCR assays were analyzed on an Indicating FTA Elute cartridge (FTA cartridge). The FTA cartridge is a solid dry carrier that allows safe transport of cervical samples. FTA cartridge samples were compared with liquid-based samples for hrHPV and high-grade cervical intraepithelial neoplasia (CIN) detection. One cervical sample was collected in a liquid-based medium, and one was applied to the FTA cartridge. DNA was eluted directly from the FTA cartridge by a simple elution step. HC2 and GP5+/6+-PCR assays were performed on both the liquid-based and the FTA-eluted DNA of 88 women. Overall agreement between FTA and liquid-based samples for the presence of hrHPV was 90.9% with GP5+/6+-PCR and 77.3% with HC2. The sensitivity for high-grade CIN of hrHPV testing on the FTA cartridges was 84.6% with GP5+/6+-PCR and only 53.8% with HC2. By comparison, these sensitivities on liquid-based samples were 92.3% and 100% for GP5+/6+-PCR and HC2, respectively. Therefore, the FTA cartridge shows reasonably good overall agreement for hrHPV detection with liquid-based media when using GP5+/6+-PCR but not HC2 testing. Even with GP5+/6+-PCR, the FTA cartridge is not yet capable of detecting all high-grade CIN lesions. PMID:21704269

  10. Assessment of renal function in patients with hematologic malignancies undergoing bone marrow transplantation

    International Nuclear Information System (INIS)

    Estorch, M.; Tembl, A.; Camacho, V.; Sancho, G.; Mena, E.; Flotats, A.; Carrio, I.; Keller, A.; Miralbell, R.

    2002-01-01

    Patients with hematologic malignancies undergoing bone marrow transplantation (BMT) may develop renal insufficiency. Isotopic determinations of glomerular filtration rate (GFR) and effective renal plasma flow (ERPF) are established methods to evaluate renal function. Aim: To asses renal function changes of patients with hematologic malignancies undergoing BMT by measurements of GFR and ERPF using 51Cr-EDTA and 131I-OIH respectively. Methods: Seventy-one patients (mean age 41 years) were studied prospectively. All patients underwent BMT for hematologic malignancies and had previous normal renal function. Their conditioning included chemotherapy and 12 Gy or 13.5 Gy fractionated total body irradiation (TBI). Kidney shielding blocks fabricated after renal opacification with non-ionic, hypo-osmolar contrast medium were used in 21 patients to limit kidney dose to 10 Gy. GFR and ERPF were measured before conditioning and at 4, 12, and 18 months, using 51Cr-EDTA and 131I-OIH respectively. A decrease of 30% in GFR or ERPF, compared with baseline values, was used to define renal insufficiency. The potential influence of patient- and treatment-related variables on renal dysfunction was assessed. Results: At 4 (early) and 12-18 (late) months, a 30% GFR decrease was observed in 54% and 49% of patients, and a 30% ERPF decrease in 44% and 34% of patients, respectively. GFR decrease at 4 months significantly correlated with age (greatest decrease if <40 years), TBI using kidney blocks (kidney shielding to 10 Gy was associated with a higher rate of renal dysfunction at 4 months compared with full TBI dose), and days of treatment with aminoglycosides/vancomycin. ERPF decrease at 4 months was independently related with amphotericin and prostaglandin E1 (PGE1) treatments. GFR and ERPF decrease at 12-18 months correlated with amphotericin and PGE1 treatments. Conclusion: Early post-BMT renal dysfunction is associated with the administration of potentially nephrotoxic drugs. Younger

  11. Fabrication of drug eluting implants: study of drug release mechanism from titanium dioxide nanotubes

    International Nuclear Information System (INIS)

    Hamlekhan, Azhang; Shokuhfar, Tolou; Sinha-Ray, Suman; Yarin, Alexander L; Takoudis, Christos; Mathew, Mathew T; Sukotjo, Cortino

    2015-01-01

    Formation of titanium dioxide nanotubes (TNTs) on a titanium surface holds great potential for promoting desirable cellular response. However, prolongation of drug release from these nano-reservoirs remains to be a challenge. In our previous work TNTs were successfully loaded with a drug. In this study the effect of TNTs dimensions on prolongation of drug release is quantified aiming at the introduction of a simple novel technique which overcomes complications of previously introduced methods. Different groups of TNTs with different lengths and diameters are fabricated. Samples are loaded with a model drug and rate of drug release over time is monitored. The relation of the drug release rate to the TNT dimensions (diameter, length, aspect ratio and volume) is established. The results show that an increase in any of these parameters increases the duration of the release process. However, the strongest parameter affecting the drug release is the aspect ratio. In fact, TNTs with higher aspect ratios release drug slower. It is revealed that drug release from TNT is a diffusion-limited process. Assuming that diffusion of drug in (Phosphate-Buffered Saline) PBS follows one-dimensional Fick’s law, the theoretical predictions for drug release profile is compatible with our experimental data for release from a single TNT. (paper)

  12. [The effects of intravenous dexketoprofen on postoperative analgesia and morphine consumption in patients undergoing abdominal hysterectomy].

    Science.gov (United States)

    Tuncer, Sema; Reisli, Ruhiye; Keçecioğlu, Melahat; Erol, Atilla

    2010-07-01

    Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug ketoprofen. The aim of this study was to investigate the effect of intravenous dexketoprofen on postoperative pain. This study was performed on 50 (ASA I-II) patients scheduled for abdominal hysterectomy. Fifty patients were randomized into two equal groups. Patients received saline solution (Group I) or 50 mg intravenous dexketoprofen (Group II) 1 hour (h) before surgery and 8-16 h after surgery. All patients received a standard anesthetic protocol. At the end of surgery, all patients received intravenous (IV) morphine via a PCA (patient- controlled analgesia) device. Pain scores were assessed at 2, 6, 12 and 24 h after surgery. Morphine consumption and adverse effects were noted during the first 24 h after the surgery. The pain scores were significantly lower in the dexketoprofen group compared with the control group (pdexketoprofen group than the control group (p0.05). We conclude that the administration of IV dexketoprofen provided a significant analgesic benefit and decreased the morphine requirements in patients undergoing abdominal hysterectomy.

  13. Biological in situ Dose Painting for Image-Guided Radiation Therapy Using Drug-Loaded Implantable Devices

    International Nuclear Information System (INIS)

    Cormack, Robert A.; Sridhar, Srinivas; Suh, W. Warren; D'Amico, Anthony V.; Makrigiorgos, G. Mike

    2010-01-01

    Purpose: Implantable devices routinely used for increasing spatial accuracy in modern image-guided radiation treatments (IGRT), such as fiducials or brachytherapy spacers, encompass the potential for in situ release of biologically active drugs, providing an opportunity to enhance the therapeutic ratio. We model this new approach for two types of treatment. Methods and Materials: Radiopaque fiducials used in IGRT, or prostate brachytherapy spacers ('eluters'), were assumed to be loaded with radiosensitizer for in situ drug slow release. An analytic function describing the concentration of radiosensitizer versus distance from eluters, depending on diffusion-elimination properties of the drug in tissue, was developed. Tumor coverage by the drug was modeled for tumors typical of lung stereotactic body radiation therapy treatments for various eluter dimensions and drug properties. Six prostate 125 I brachytherapy cases were analyzed by assuming implantation of drug-loaded spacers. Radiosensitizer-induced subvolume boost was simulated from which biologically effective doses for typical radiosensitizers were calculated in one example. Results: Drug distributions from three-dimensional arrangements of drug eluters versus eluter size and drug properties were tabulated. Four radiosensitizer-loaded fiducials provide adequate radiosensitization for ∼4-cm-diameter lung tumors, thus potentially boosting biologically equivalent doses in centrally located stereotactic body treated lesions. Similarly, multiple drug-loaded spacers provide prostate brachytherapy with flexible shaping of 'biologically equivalent doses' to fit requirements difficult to meet by using radiation alone, e.g., boosting a high-risk region juxtaposed to the urethra while respecting normal tissue tolerance of both the urethra and the rectum. Conclusions: Drug loading of implantable devices routinely used in IGRT provides new opportunities for therapy modulation via biological in situ dose painting.

  14. Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for primary percutaneous coronary revascularisation of acute myocardial infarction.

    Science.gov (United States)

    Pilgrim, Thomas; Piccolo, Raffaele; Heg, Dik; Roffi, Marco; Tüller, David; Vuilliomenet, André; Muller, Olivier; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Khattab, Ahmed A; Taniwaki, Masanori; Rigamonti, Fabio; Nietlispach, Fabian; Blöchlinger, Stefan; Wenaweser, Peter; Jüni, Peter; Windecker, Stephan

    2016-12-10

    Our aim was to compare the safety and efficacy of a novel, ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES) with a thin strut, durable polymer everolimus-eluting stent (DP-EES) in a pre-specified subgroup of patients with acute ST-segment elevation myocardial infarction (STEMI) enrolled in the BIOSCIENCE trial. The BIOSCIENCE trial is an investigator-initiated, single-blind, multicentre, randomised non-inferiority trial (NCT01443104). Randomisation was stratified according to the presence or absence of STEMI. The primary endpoint, target lesion failure (TLF), is a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation within 12 months. Between February 2012 and May 2013, 407 STEMI patients were randomly assigned to treatment with BP-SES or DP-EES. At one year, TLF occurred in seven (3.4%) patients treated with BP-SES and 17 (8.8%) patients treated with DP-EES (RR 0.38, 95% CI: 0.16-0.91, p=0.024). Rates of cardiac death were 1.5% in the BP-SES group and 4.7% in the DP-EES group (RR 0.31, 95% CI: 0.08-1.14, p=0.062); rates of target vessel myocardial infarction were 0.5% and 2.6% (RR 0.18, 95% CI: 0.02-1.57, p=0.082), respectively, and rates of clinically indicated target lesion revascularisation were 1.5% in the BP-SES group versus 2.1% in the DP-EES group (RR 0.69, 95% CI: 0.16-3.10, p=0.631). There was no difference in the risk of definite stent thrombosis. In this pre-specified subgroup analysis, BP-SES was associated with a lower rate of target lesion failure at one year compared to DP-EES in STEMI patients. These findings require confirmation in a dedicated STEMI trial.

  15. Attitudes towards drug-eluting stent use and the distribution of motivation type among interventional cardiologists.

    Science.gov (United States)

    Qian, Feng; Phelps, Charles E; Ling, Frederick S; Hannan, Edward L; Veazie, Peter J

    2012-06-01

    The safety of drug-eluting stent (DES) use was called into question in 2006. However, the attitudes towards DES use after DES safety concerns were expressed and the distribution of chronic motivation type among interventional cardiologists are unknown. This study aims to examine the current attitudes towards DES use among interventional cardiologists and to investigate the distribution of chronic motivation type among these doctors. A questionnaire survey of interventional cardiologists was conducted in New York State from October 2008 to April 2009. The questionnaire included face valid items to measure the attitudes towards DES use, valid Regulatory Focus Questionnaire to measure the chronic motivation type, and items collecting demographic information. A total of 119 valid responses were received (response rate: 47%). There were no statistically significant differences regarding the demographic factors between the respondents and the non-respondents. The vast majority of interventional cardiologists (92%) agreed that 'DES is a revolutionary technology' and that 'DES use will increase in the future' (70%). The chronic motivation type of the respondents was predominantly sensitive to positive outcomes (89%). Interventional cardiologists had a very positive attitude regarding DES technology and predicted future growth of DES use. The vast majority of interventional cardiologists were found to be concerned about achieving positive outcomes and wanted to prevent errors of omission. To the best of our knowledge, this is the first study to report the distribution of chronic motivation type among doctors. © 2011 Blackwell Publishing Ltd.

  16. Comparison of the Absorbable Polymer Sirolimus-Eluting Stent (MiStent) to the Durable Polymer Everolimus-Eluting Stent (Xience) (from the DESSOLVE I/II and ISAR-TEST-4 Studies).

    Science.gov (United States)

    Lansky, Alexandra J; Kastrati, Adnan; Edelman, Elazer R; Parise, Helen; Ng, Vivian G; Ormiston, John; Wijns, William; Byrne, Robert A

    2016-02-15

    We compared the outcomes of a novel, thin-strut, cobalt-chromium, absorbable, polymer sirolimus-eluting stent (APSES; MiStent) to the durable polymer cobalt-chromium everolimus-eluting stent (EES; Xience). A propensity-matched analysis was performed comparing data from the DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in the Native Coronary Arteries (DESSOLVE) I and II studies, evaluating the APSES to the EES arm of the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents-4 study. Target lesion failure (TLF) and its components were evaluated at 12 months and annually to 3 years; 805 patients (APSES = 153; EES = 652) were included with propensity matching in 204 patients (APSES = 102; EES = 102). APSES compared with EES had lower TLF at 1 year (3.0% vs 8.0%, p = 0.12) driven by a difference in target lesion revascularization (TLR; 1% vs 6%, p = 0.05), with no difference in target vessel myocardial infarction (p = 0.56) or stent thrombosis (p = 0.31). At 3 years, TLF (5.0% vs 12.5%, p = 0.07) and TLR (2.0% vs 8.4%, p = 0.04) remained lower with APSES. By landmark analysis, there was no significant difference in TLF between 1 and 3 years (p = 0.36). In conclusion, in a propensity-matched analysis, the APSES demonstrated reduced clinically indicated TLR rates at 1 and 3 years compared with the durable polymer EES, with minimal accrual of events between 1 and 3 years. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Fospropofol Disodium for Sedation in Elderly Patients Undergoing Flexible Bronchoscopy.

    Science.gov (United States)

    Silvestri, Gerard A; Vincent, Brad D; Wahidi, Momen M

    2011-01-01

    BACKGROUND: Fospropofol disodium is a water-soluble prodrug of propofol. A subset analysis was undertaken of elderly patients (≥65 y) undergoing flexible bronchoscopy, who were part of a larger multicenter, randomized, double-blind study. METHODS: Patients received fentanyl citrate (50 mcg) followed by fospropofol at initial (4.88mg/kg) and supplemental (1.63mg/kg) doses. The primary end point was sedation success (3 consecutive Modified Observer's Assessment of Alertness/Sedation scores of ≤4 and procedure completion without alternative sedative or assisted ventilation). Treatment success, time to fully alert, patient and physician satisfaction, and safety/tolerability were also evaluated. RESULTS: In the elderly patients subset (n=61), sedation success was 92%, the mean time to fully alert was 8.0±10.9 min, and memory retention was 72% during recovery, and these were comparable with the younger patients subgroup (age, Sedation-related adverse events occurred in 23% of the elderly and 18% of the younger patients (age, sedation, rapid time to fully alert, and high satisfaction in this elderly subset undergoing flexible bronchoscopy, which was comparable with outcomes in younger patients.

  18. Meta-analysis: adjusted indirect comparison of drug-eluting bead transarterial chemoembolization versus {sup 90}Y-radioembolization for hepatocellular carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Ludwig, Johannes M.; Xing, Minzhi [Yale School of Medicine, Division of Interventional Radiology, Department of Radiology and Biomedical Imaging, New Haven, CT (United States); Zhang, Di [University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA (United States); Kim, Hyun S. [Yale School of Medicine, Division of Interventional Radiology, Department of Radiology and Biomedical Imaging, New Haven, CT (United States); Yale School of Medicine, Yale Cancer Center, New Haven, CT (United States)

    2017-05-15

    To investigate comparative effectiveness of drug-eluting bead transarterial chemoembolization (DEB-TACE) versus Yttrium-90 ({sup 90}Y)-radioembolization for hepatocellular carcinoma (HCC). Studies comparing conventional (c)TACE versus {sup 90}Y-radioembolization or DEB-TACE for HCC treatment were identified using PubMed/Medline, Embase, and Cochrane databases. The adjusted indirect meta-analytic method for effectiveness comparison of DEB-TACE versus {sup 90}Y-radioembolization was used. Wilcoxon rank-sum test was used to compare baseline characteristics. A priori defined sensitivity analysis of stratified study subgroups was performed for primary outcome analyses. Publication bias was tested by Egger's and Begg's tests. Fourteen studies comparing DEB-TACE or {sup 90}Y-radioembolization with cTACE were included. Analysis revealed a 1-year overall survival benefit for DEB-TACE over {sup 90}Y-radioembolization (79 % vs. 54.8 %; OR: 0.57; 95 %CI: 0.355-0.915; p = 0.02; I-squared: 0 %; p > 0.5), but not for the 2-year (61 % vs. 34 %; OR: 0.65; 95%CI: 0.294-1.437; p = 0.29) and 3-year survival (56.4 % vs. 20.9 %; OR: 0.713; 95 % CI: 0.21-2.548; p = 0.62). There was significant heterogeneity in the 2- and 3-year survival analyses. The pooled median overall survival was longer for DEB-TACE (22.6 vs. 14.7 months). There was no significant difference in tumour response rate. DEB-TACE and {sup 90}Y-radioembolization are efficacious treatments for patients suffering from HCC; DEB-TACE demonstrated survival benefit at 1-year compared to {sup 90}Y-radioembolization but direct comparison is warranted for further evaluation. (orig.)

  19. Isotope selection for patients undergoing prostate brachytherapy

    International Nuclear Information System (INIS)

    Cha, Christine M.; Potters, Louis; Ashley, Richard; Freeman, Katherine; Wang Xiaohong; Waldbaum, Robert; Leibel, Steven

    1999-01-01

    Purpose: Ultrasound-guided trans perineal interstitial permanent prostate brachytherapy (TIPPB) is generally performed with either 103 Pd or 125 I. The use of 125 I for low Gleason score tumors and 103 Pd for higher Gleason scores has been suggested based on isotope dose rate and cell doubling time observed in in vitro studies. While many centers follow these isotope selection criteria, other centers have elected to use only a single isotope, regardless of Gleason score. No clinical data have been published comparing these isotopes. This study was undertaken to compare outcomes between 125 I and 103 Pd in a matched pair analysis for patients undergoing prostate brachytherapy. Methods and Materials: Six hundred forty-eight consecutively treated patients with clinically confined prostate cancer underwent TIPPB between June 1992 and February 1997. Five hundred thirty-two patients underwent TIPPB alone, whereas 116 received pelvic external beam irradiation and TIPPB. Ninety-three patients received androgen deprivation therapy prior to TIPPB. The prescribed doses for TIPPB were 160 Gy for 125 I (pre-TG43) and 120 Gy for 103 Pd. Patients treated with combination therapy received 41.4 or 45 Gy (1.8 Gy/fraction) external beam irradiation followed by a 3- to 5-week break and then received either a 120-Gy 125 I or a 90-Gy 103 Pd implant. Until November 1994, all patients underwent an 125 I implant after which the isotope selection was based on either Gleason score (Gleason score 2-5: 125 I; Gleason 5-8: 103 Pd) or isotope availability. A matched pair analysis was performed to assess any difference between isotopes. Two hundred twenty-two patients were matched according to Gleason score, prostate-specific antigen (PSA), and stage. PSA relapse-free survival (PSA-RFS) was calculated based on the American Society for Therapeutic Radiology and Oncology (ASTRO) Consensus Group definition of failure. Kaplan-Meier actuarial survival curves were compared to assess differences in

  20. Gonad Shielding for Patients Undergoing Conventional Radiological Examinations: Is There Cause for Concern?

    OpenAIRE

    Karami; Zabihzadeh; Gholami

    2016-01-01

    Background Gonad shielding is one of the fundamental methods by which to protect reproductive organs in patients undergoing conventional radiological examinations. A lack of or inadequate shielding of the gonads may increase the exposure of these organs and result in malignancies future generations. Objectives The aim of this study is to investigate the prevalence of gonad shielding in patients undergoing conventional radiological...

  1. Alkaline elution of DNA from mammalian cells on cellulose triacetate filters

    International Nuclear Information System (INIS)

    Moss, A.J. Jr.; Nagle, W.A.; Henle, K.J.; Prior, R.M.

    1984-01-01

    The alkaline elution technique is widely used for the estimation of cellular DNA damage because of its sensitivity in the biologically relevant dose range. The authors have extended the original studies and provide additional characterization of the cellulose triacetate alkaline elution method. This filter material permits the elution of approximately 80 percent of cellular DNA from untreated V79 cells. the total radioactivity in the system was compartmentalized with respect to 1) lysing solution, 2) washing solution, 3) elution fractions, and 4) membrane retained activity. In these studies [/sup 3/H]-thymidine labeled untreated internal control cells were co-eluted with X-irradiated [/sup 14/C]-thymidine labeled cells. For the estimation of DNA damage, elution profiles for treated cells were directly compared with untreated internal control cells. The quantity of DNA eluting in excess of the labeled internal control per fraction is directly proportional to the extent of DNA damage in the treated sample. Using the technique the necessity of an irradiated internal control is eliminated

  2. Percutaneous coronary intervention with second-generation drug-eluting stent versus bare-metal stent: Systematic review and cost-benefit analysis.

    Science.gov (United States)

    Poder, Thomas G; Erraji, Jihane; Coulibaly, Lucien P; Koffi, Kouamé

    2017-01-01

    Drug-eluting stents (DESs) were considered as ground-breaking technology promising to eradicate restenosis and the necessity to perform multiple revascularization procedures subsequent to percutaneous coronary intervention. Soon after DESs were released on the market, however, there were reports of a potential increase in mortality and of early or late thrombosis. In addition, DESs are far more expensive than bare-metal stents (BMSs), which has led to their limited use in many countries. The technology has improved over the last few years with the second generation of DESs (DES-2). Moreover, costs have come down and an improved safety profile with decreased thrombosis has been reported. Perform a cost-benefit analysis of DES-2s versus BMSs in the context of a publicly funded university hospital in Quebec, Canada. A systematic review of meta-analyses was conducted between 2012 and 2016 to extract data on clinical effectiveness. The clinical outcome of interest for the cost-benefit analysis was target-vessel revascularization (TVR). Cost units are those used in the Quebec health-care system. The cost-benefit analysis was based on a 2-year perspective. Deterministic and stochastic models (discrete-event simulation) were used, and various risk factors of reintervention were considered. DES-2s are much more effective than BMSs with respect to TVR rate ratio (i.e., 0.29 to 0.62 in more recent meta-analyses). DES-2s seem to cause fewer deaths and in-stent thrombosis than BMSs, but results are rarely significant, with the exception of the cobalt-chromium everolimus DES. The rate ratio of myocardial infraction is systematically in favor of DES-2s and very often significant. Despite the higher cost of DES-2s, fewer reinterventions can lead to huge savings (i.e., -$479 to -$769 per patient). Moreover, the higher a patient's risk of reintervention, the higher the savings associated with the use of DES-2s. Despite the higher purchase cost of DES-2s compared to BMSs

  3. Treatment strategies for coronary in-stent restenosis: systematic review and hierarchical Bayesian network meta-analysis of 24 randomised trials and 4880 patients

    Science.gov (United States)

    Giacoppo, Daniele; Gargiulo, Giuseppe; Aruta, Patrizia; Capranzano, Piera; Tamburino, Corrado

    2015-01-01

    Study question What is the most safe and effective interventional treatment for coronary in-stent restenosis? Methods In a hierarchical Bayesian network meta-analysis, PubMed, Embase, Scopus, Cochrane Library, Web of Science, ScienceDirect, and major scientific websites were screened up to 10 August 2015. Randomised controlled trials of patients with any type of coronary in-stent restenosis (either of bare metal stents or drug eluting stents; and either first or recurrent instances) were included. Trials including multiple treatments at the same time in the same group or comparing variants of the same intervention were excluded. Primary endpoints were target lesion revascularisation and late lumen loss, both at six to 12 months. The main analysis was complemented by network subanalyses, standard pairwise comparisons, and subgroup and sensitivity analyses. Study answer and limitations Twenty four trials (4880 patients), including seven interventional treatments, were identified. Compared with plain balloons, bare metal stents, brachytherapy, rotational atherectomy, and cutting balloons, drug coated balloons and drug eluting stents were associated with a reduced risk of target lesion revascularisation and major adverse cardiac events, and with reduced late lumen loss. Treatment ranking indicated that drug eluting stents had the highest probability (61.4%) of being the most effective for target lesion vascularisation; drug coated balloons were similarly indicated as the most effective treatment for late lumen loss (probability 70.3%). The comparative efficacy of drug coated balloons and drug eluting stents was similar for target lesion revascularisation (summary odds ratio 1.10, 95% credible interval 0.59 to 2.01) and late lumen loss reduction (mean difference in minimum lumen diameter 0.04 mm, 95% credible interval −0.20 to 0.10). Risks of death, myocardial infarction, and stent thrombosis were comparable across all treatments, but these analyses were limited by a

  4. Post-operative morbidity of the obese patient undergoing posterior ...

    African Journals Online (AJOL)

    Outcome measures: Post-operative morbidity measures – infection, seroma, pulmonary embolism, urinary tract infection, neurological injury and dural tears. Methods: One hundred consecutive patients undergoing posterior lumbar spine surgery were enrolled in the study. Three fellowship trained attending orthopaedic ...

  5. Triple antithrombotic therapy in patients with atrial fibrillation undergoing coronary artery stenting: hovering among bleeding risk, thromboembolic events, and stent thrombosis

    Directory of Open Access Journals (Sweden)

    Menozzi Mila

    2012-10-01

    Full Text Available Abstract Dual antiplatelet treatment with aspirin and clopidogrel is the antithrombotic treatment recommended after an acute coronary syndrome and/or coronary artery stenting. The evidence for optimal antiplatelet therapy for patients, in whom long-term treatment oral anticoagulation is mandatory, is however scarce. To evaluate the safety and efficacy of the various antithrombotic strategies adopted in this population, we reviewed the available evidence on the management of patients receiving oral anticoagulation, such as a vitamin-k-antagonists, referred for coronary artery stenting. Atrial fibrillation is the most frequent indication for oral anticoagulation. The need of starting antiplatelet therapy in this clinical scenario raises concerns about the combination to choose: triple therapy with warfarin, aspirin, and a thienopyridine being the most frequent and advised. The safety of this regimen appeared suboptimal because of an increased risk in hemorrhagic complications. On the other hand, the combination of oral anticoagulation and an antiplatelet agent is suboptimal in preventing thromboembolic events and stent thrombosis; dual antiplatelet therapy may be considered only when a high hemorrhagic risk and low thromboembolic risk are perceived. Indeed, the need for prolonged multiple-drug antithrombotic therapy increases the bleeding risks when drug eluting stents are used. Since current evidence derives mainly from small, single-center and retrospective studies, large-scale prospective multicenter studies are urgently needed.

  6. A multicenter post-marketing evaluation of the Elixir DESolve® Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study.

    Science.gov (United States)

    Nef, Holger; Wiebe, Jens; Boeder, Niklas; Dörr, Oliver; Bauer, Timm; Hauptmann, Karl-Eugen; Latib, Azeem; Colombo, Antonio; Fischer, Dieter; Rudolph, Tanja; Foin, Nicolas; Richardt, Gert; Hamm, Christian

    2018-03-06

    To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed. © 2018 Wiley Periodicals, Inc.

  7. Effect of nutritional status on mortality in patients undergoing coronary artery bypass grafting.

    Science.gov (United States)

    Keskin, Muhammed; İpek, Göktük; Aldağ, Mustafa; Altay, Servet; Hayıroğlu, Mert İlker; Börklü, Edibe Betül; İnan, Duygu; Kozan, Ömer

    2018-04-01

    The prognostic effects of poor nutritional status and cardiac cachexia on coronary artery disease (CAD) are not clearly understood. A well-accepted nutritional status parameter, the prognostic nutritional index (PNI), which was first demonstrated to be valuable in patients with cancer and those undergoing gastrointestinal surgery, was introduced to patients requiring coronary artery bypass grafting (CABG). The aim of the present study was to evaluate the prognostic value of PNI in patients with CAD undergoing CABG. We evaluated the in-hospital and long-term (3-y) prognostic effect of PNI on 644 patients with CAD undergoing CABG. Baseline characteristics and outcomes were compared among the patients by PNI and categorized accordingly: Q1, Q2, Q3, and Q4. Patients with lower PNI had significantly higher in-hospital and long-term mortality. Patients with lower PNI levels (Q1) had higher in-hospital mortality and had 12 times higher mortality rates than those with higher PNI levels (Q4). The higher PNI group had the lower rates and was used as the reference. Long-term mortality was higher in patients with lower PNI (Q1)-4.9 times higher than in the higher PNI group (Q4). In-hospital and long-term mortality rates were similar in the non-lower PNI groups (Q2-4). The present study demonstrated that PNI, calculated based on serum albumin level and lymphocyte count, is an independent prognostic factor for mortality in patients undergoing CABG. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Evaluation on elution feature of bentonite buffer materials

    Energy Technology Data Exchange (ETDEWEB)

    Ishikawa, Hirohisa; Kanno, Takeshi; Matsumoto, Kazuhiro

    1997-09-01

    In order to evaluate long term physical stability of artificial barrier in land disposal of high level radioactive wastes, it is necessary to know quantitatively elution behavior of buffering materials from disposal road (or cavity) to circumferential rock crack. When elution of the buffer material occurs on large scale, amount of bentonite in the disposal road (or cavity) reduces and reduction of various functions expected to the buffer materials is presumed. According to specification examples of road transverse arrangement and disposal vertical arrangement systems, evaluation on elution amount of the buffer materials at disposal environment was conducted. Opening width of rock crack in the disposal environment was supposed to be 0.5 mm. As a result, obtained mass elution ratios of the buffer materials due to extrusion phenomenon were 0.04 to 0.2% after 10,000 year and 2 to 12% after 1,000,000 years. (G.K.)

  9. Aspirin desensitization in patients undergoing percutaneous coronary intervention: a survey of current practice.

    Science.gov (United States)

    Chapman, Andrew R; Rushworth, Gordon F; Leslie, Stephen J

    2013-01-01

    Aspirin remains the mainstay of anti-platelet therapy in cardiac patients. However, if a patient is allergic to aspirin and dual anti-platelet therapy is indicated - such as with percutaneous coronary intervention (PCI), then there is no clear guidance. One possibility is aspirin desensitization. A variety of protocols exist for the rapid desensitization of patients with aspirin allergy. The aim of this survey was to assess current knowledge and practice regarding aspirin desensitization in the UK. We conducted a UK wide survey of all UK 116 PCI centers and obtained complete responses from 40 (35.4%) centers. Of these, just 7 (17.5%) centers had previously desensitised patients; 29 (87.9%) centers suggested a lack of a local protocol prevented them from desensitizing, with 10 (30.3%) unsure of how to conduct desensitization. Only 5 (12.5%) centers had a local policy for aspirin desensitization although 25 (64.1%) units had a clinical strategy for dealing with aspirin allergy; the majority (72%) giving higher doses of thienopyridine class drugs. In the UK, there appears to be no consistent approach to patients with aspirin allergy. Patients undergoing PCI benefit from dual anti-platelet therapy (including aspirin), and aspirin desensitization in those with known allergy may facilitate this. Sustained effort should be placed on encouraging UK centers to use desensitization as a treatment modality prior to PCI rather than avoiding aspirin altogether.

  10. Long-term efficacy and safety of biodegradable-polymer biolimus-eluting stents: main results of the Basel Stent Kosten-Effektivitäts Trial-PROspective Validation Examination II (BASKET-PROVE II), a randomized, controlled noninferiority 2-year outcome trial.

    Science.gov (United States)

    Kaiser, Christoph; Galatius, Soeren; Jeger, Raban; Gilgen, Nicole; Skov Jensen, Jan; Naber, Christoph; Alber, Hannes; Wanitschek, Maria; Eberli, Franz; Kurz, David J; Pedrazzini, Giovanni; Moccetti, Tiziano; Rickli, Hans; Weilenmann, Daniel; Vuillomenet, André; Steiner, Martin; Von Felten, Stefanie; Vogt, Deborah R; Wadt Hansen, Kim; Rickenbacher, Peter; Conen, David; Müller, Christian; Buser, Peter; Hoffmann, Andreas; Pfisterer, Matthias

    2015-01-06

    Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear. To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; -1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES. In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. http://www.clinicaltrials.gov. Unique identifier: NCT01166685. © 2014 American Heart Association, Inc.

  11. Evaluation of drug-drug interactions among patients with chronic ...

    African Journals Online (AJOL)

    Introduction: The risk of drug-drug interactions (DDIs) is high in patients with chronic kidney disease (CKD) necessitating dose adjustments or the avoidance of drug combinations. This study aimed to evaluate DDIs among patients with CKD in the University of Nigeria Teaching Hospital (UNTH), Enugu, South-East Nigeria.

  12. Perioperative Endocrine Therapy for Patients with Cushing's Syndrome Undergoing Retroperitoneal Laparoscopic Adrenalectomy

    Directory of Open Access Journals (Sweden)

    Xiaobo Cui

    2012-01-01

    Full Text Available Objectives. To investigate the efficacy and safety of perioperative endocrine therapy (PET for patients with Cushing’s syndrome (CS undergoing retroperitoneal laparoscopic adrenalectomy (RLA. Methods. The novel, simplified PET modality of 82 patients who underwent RLA procedures for CS were studied. Clinical manifestations were observed for all patients on days 1 and 5 postoperatively, and clinical data, such as blood pressure (BP, levels of serum cortisol, adrenocorticotropin (ACTH, blood glucose, and electrolytes, were acquired and analyzed. Results. Supraphysiological doses of glucocorticoid were administered during the perioperative period, and the dosage was reduced gradually. In all 82 cases, the RLAs were performed successfully without any perioperative complication, such as steroid withdrawal symptoms. The patient’s symptoms and signs were improved quickly and safely during the hospital days. The serum cortisol and potassium levels were rather stable on days 1 and 5 postoperatively, and most were within the normal range. The clinical manifestations, serum levels of cortisol, ACTH, and potassium in most patients restored to normal gradually after several months (mean, 6.7 ± 1.2 months, except for one patient undergoing bilateral adrenalectomy. Conclusions. This perioperative endocrine therapy for patients with Cushing’s syndrome (mainly for adrenocortical adenoma undergoing retro-laparoscopic adrenalectomy is both effective and safe.

  13. Mitral valve disease in patients with Marfan syndrome undergoing aortic root replacement.

    Science.gov (United States)

    Kunkala, Meghana R; Schaff, Hartzell V; Li, Zhuo; Volguina, Irina; Dietz, Harry C; LeMaire, Scott A; Coselli, Joseph S; Connolly, Heidi

    2013-09-10

    Cardiac manifestations of Marfan syndrome include aortic root dilation and mitral valve prolapse (MVP). Only scant data exist describing MVP in patients with Marfan syndrome undergoing aortic root replacement. We retrospectively analyzed data from 166 MFS patients with MVP who were enrolled in a prospective multicenter registry of patients who underwent aortic root aneurysm repair. Of these 166 patients, 9% had mitral regurgitation (MR) grade >2, and 10% had MR grade 2. The severity of MVP and MR was evaluated by echocardiography preoperatively and ≤ 3 years postoperatively. Forty-one patients (25%) underwent composite graft aortic valve replacement, and 125 patients (75%) underwent aortic valve-sparing procedures; both groups had similar prevalences of MR grade >2 (P=0.7). Thirty-three patients (20%) underwent concomitant mitral valve (MV) intervention (repair, n=29; replacement, n=4), including all 15 patients with MR grade >2. Only 1 patient required MV reintervention during follow-up (mean clinical follow-up, 31 ± 10 months). Echocardiography performed 21 ± 13 months postoperatively revealed MR >2 in only 3 patients (2%). One early death and 2 late deaths occurred. Although the majority of patients with Marfan syndrome who undergo elective aortic root replacement have MVP, only 20% have concomitant MV procedures. These concomitant procedures do not seem to increase operative risk. In patients with MR grade ≤ 2 who do not undergo a concomitant MV procedure, the short-term incidence of progressive MR is low; however, more follow-up is needed to determine whether patients with MVP and MR grade ≤ 2 would benefit from prophylactic MV intervention.

  14. Perioperative plasmatic presepsin levels in patients undergoing total hip or knee replacement: a preliminary study.

    Science.gov (United States)

    Vicenti, G; Pesce, V; Bizzoca, D; Nappi, V; Palmiotto, F; Carrozzo, M; Moretti, B

    2017-01-01

    Presepsin (sCD14-ST) is an emerging biomarker in the diagnosis of sepsis. In the field of orthopaedics, it could be useful in the diagnosis and management of periprosthetic joint infections (PJI). The aim of this study is to define the normal perioperative plasmatic levels of presepsin in patients undergoing primary cementless total hip replacement (THR) or primary cemented total knee replacement (TKR). For this purpose, 50 patients (19 male, 31 female, mean age= 64.04±8.88) were recruited. The patients were divided into two groups: Group A patients underwent cementless THR, whereas Group B patients underwent cemented TKR. On recruitment, anthropometric data, smocking status, osteoarthritis stage according to Kellgren and Lawrence, Harris Hip Score (HHS) for Group A patients and Knee Society Score (KSS) for Group B patients, drugs assumption and comorbidities were recorded. All the patients underwent serial blood tests, including complete blood count, presepsin (PS), C-reactive protein (CRP) and procalcitonin (PCT) 24 hours before arthroplasty (T0) and at 24 (T1), 48 (T2), 72 (T3) and 96 (T4) hours postoperatively. Body temperature (θ) was recorded every six hours in the time lapse T0-T4. Presepsin plasmatic concentration was comparable at baseline in both groups. After surgery, however, a significant increase of presepsin was observed in Group A, whereas in Group B no significant changes of presepsin were recorded. A comparable trend of this biomarker was found in the two groups, i.e. presepsin increased from T0 to T3, when it reached its maximum value, and its decrease started at T4. Finally, presepsin resulted more accurate than CRP in the evaluation of perioperative inflammatory response in patients undergoing THR or TKR. These data will be helpful in defining a reference interval for presepsin in patients with prosthetic joint implants, and a cut-off of this biomarker for the diagnosis of PJI.

  15. Red blood cell storage duration and long-term mortality in patients undergoing cardiac intervention

    DEFF Research Database (Denmark)

    Dencker, D; Pedersen, F; Engstrøm, T

    2017-01-01

    OBJECTIVES: To study the effect of red blood cell (RBC) storage duration on long-term mortality in patients undergoing cardiac intervention. BACKGROUND: RBCs undergo numerous structural and functional changes during storage. Observational studies have assessed the association between RBC storage...... duration and patient outcomes with conflicting results. METHODS: Between January 2006 and December 2014, 82 408 patients underwent coronary angiography. Of these, 1856 patients received one to four RBC units within 30 days after this procedure. Patients were allocated according to length of RBC storage...

  16. [Hereditary heterozygous factor VII deficiency in patients undergoing surgery : Clinical relevance].

    Science.gov (United States)

    Woehrle, D; Martinez, M; Bolliger, D

    2016-10-01

    A hereditary deficiency in coagulation factor VII (FVII) may affect the international normalized ratio (INR) value. However, FVII deficiency is occasionally associated with a tendency to bleed spontaneously. We hypothesized that perioperative substitution with coagulation factor concentrates might not be indicated in most patients. In this retrospective data analysis, we included all patients with hereditary heterozygous FVII deficiency who underwent surgical procedures at the University Hospital Basel between December 2010 and November 2015. In addition, by searching the literature, we identified publications reporting patients with FVII deficiency undergoing surgical procedures without perioperative substitution. We identified 22 patients undergoing 46 surgical procedures, resulting in a prevalence of 1:1500-2000. Coagulation factor concentrates were administered during the perioperative period in 15 procedures (33 %), whereas in the other 31 procedures (66 %), FVII deficiency was not substituted. No postoperative bleeding or thromboembolic events were reported. In addition, we found no differences in pre- and postoperative hemoglobin and coagulation parameters, with the exception of an improved postoperative INR value in the substituted group. In the literature review, we identified five publications, including 125 patients with FVII deficiency, undergoing 213 surgical procedures with no perioperative substitution. Preoperative substitution using coagulation factor concentrates does not seem to be mandatory in patients with an FVII level ≥15 %. For decision-making on preoperative substitution, patient history of an increased tendency to bleed may be more important than the FVII level or increased INR value.

  17. Relationship between cobalamin deficiency and delirium in elderly patients undergoing cardiac surgery

    Directory of Open Access Journals (Sweden)

    Sevuk U

    2015-08-01

    Full Text Available Utkan Sevuk,1 Erkan Baysal,2 Nurettin Ay,3 Yakup Altas,2 Rojhat Altindag,2 Baris Yaylak,2 Vahhac Alp,3 Ertan Demirtas4 1Department of Cardiovascular Surgery, Diyarbakir Gazi Yasargil Education and Research Hospital, Diyarbakir, 2Department of Cardiology, Diyarbakir Gazi Yasargil Education and Research Hospital, Diyarbakir, 3Department of General Surgery, Diyarbakir Gazi Yasargil Education and Research Hospital, Diyarbakir, 4Department of Cardiovascular Surgery, Liv Hospital, Ankara, Turkey Background: Delirium is common after cardiac surgery and is independently associated with increased morbidity, mortality, prolonged hospital stays, and higher costs. Cobalamin (vitamin B12 deficiency is a common cause of neuropsychiatric symptoms and affects up to 40% of elderly people. The relationship between cobalamin deficiency and the occurrence of delirium after cardiac surgery has not been examined in previous studies. We examined the relationship between cobalamin deficiency and delirium in elderly patients undergoing coronary artery bypass grafting (CABG surgery.Material and methods: A total of 100 patients with cobalamin deficiency undergoing CABG were enrolled in this retrospective study. Control group comprised 100 patients without cobalamin deficiency undergoing CABG. Patients aged 65 years or over were included. Diagnosis of delirium was made using Intensive Care Delirium Screening Checklist. Delirium severity was measured using the Delirium Rating Scale-revised-98.Results: Patients with cobalamin deficiency had a significantly higher incidence of delirium (42% vs 26%; P=0.017 and higher delirium severity scores (16.5±2.9 vs 15.03±2.48; P=0.034 than patients without cobalamin deficiency. Cobalamin levels were significantly lower in patients with delirium than patients without delirium (P=0.004. Delirium severity score showed a moderate correlation with cobalamin levels (Ρ=-0.27; P=0.024. Logistic regression analysis demonstrated that

  18. Development of an elution device for ViroCap virus filters.

    Science.gov (United States)

    Fagnant, Christine Susan; Toles, Matthew; Zhou, Nicolette Angela; Powell, Jacob; Adolphsen, John; Guan, Yifei; Ockerman, Byron; Shirai, Jeffry Hiroshi; Boyle, David S; Novosselov, Igor; Meschke, John Scott

    2017-10-19

    Environmental surveillance of waterborne pathogens is vital for monitoring the spread of diseases, and electropositive filters are frequently used for sampling wastewater and wastewater-impacted surface water. Viruses adsorbed to electropositive filters require elution prior to detection or quantification. Elution is typically facilitated by a peristaltic pump, although this requires a significant startup cost and does not include biosafety or cross-contamination considerations. These factors may pose a barrier for low-resource laboratories that aim to conduct environmental surveillance of viruses. The objective of this study was to develop a biologically enclosed, manually powered, low-cost device for effectively eluting from electropositive ViroCap™ virus filters. The elution device described here utilizes a non-electric bilge pump, instead of an electric peristaltic pump or a positive pressure vessel. The elution device also fully encloses liquids and aerosols that could contain biological organisms, thereby increasing biosafety. Moreover, all elution device components that are used in the biosafety cabinet are autoclavable, reducing cross-contamination potential. This device reduces costs of materials while maintaining convenience in terms of size and weight. With this new device, there is little sample volume loss due to device inefficiency, similar virus yields were demonstrated during seeded studies with poliovirus type 1, and the time to elute filters is similar to that required with the peristaltic pump. The efforts described here resulted in a novel, low-cost, manually powered elution device that can facilitate environmental surveillance of pathogens through effective virus recovery from ViroCap filters while maintaining the potential for adaptability to other cartridge filters.

  19. Nursing Care of Patients Undergoing Chemotherapy Desensitization: Part II.

    Science.gov (United States)

    Jakel, Patricia; Carsten, Cynthia; Carino, Arvie; Braskett, Melinda

    2016-04-01

    Chemotherapy desensitization protocols are safe, but labor-intensive, processes that allow patients with cancer to receive medications even if they initially experienced severe hypersensitivity reactions. Part I of this column discussed the pathophysiology of hypersensitivity reactions and described the development of desensitization protocols in oncology settings. Part II incorporates the experiences of an academic medical center and provides a practical guide for the nursing care of patients undergoing chemotherapy desensitization.
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  20. [Usefullness of Beta-blocker for Hemodynamic Changes Induced by Uterotonic Drug in a Patient with Hypertrophic Obstructive Cardiomyopathy Undergoing Elective Cesarean Section].

    Science.gov (United States)

    Tsukano, Yuri; Sugita, Michiko; Ikuta, Yoshihiro; Yamamoto, Tatsuo

    2015-06-01

    Combined spinal-epidural anesthesia (CSEA) was given to a 27-year-old woman with hypertrophic obstructive cardiomyopathy (HOCM) for a selective cesarean section. After the injection of uterotonic drug via uterine muscle and a vein after delivery, the patient developed dyspnea, tachycardia, ST-change on elecrocardiogram and hypotension. It is important in HOCM patients to control heart rate and left ventricular contractile force. We started to infuse beta-blocker (landiolol, 10 μg x kg(-1) x min(-1)) and improved these symptoms of the patient. This case demonstrates that CSEA is safe for HOCM patients and beta-blocker is effective to improve hemodynamic changes induced by uterotonic drug in these patients.

  1. Signs of knee osteoarthritis common in 620 patients undergoing arthroscopic surgery for meniscal tear

    DEFF Research Database (Denmark)

    Pihl, Kenneth; Englund, Martin; Lohmander, L. Stefan

    2017-01-01

    Background and purpose - Recent evidence has questioned the effect of arthroscopic knee surgery for middle-aged and older patients with degenerative meniscal tears with or without concomitant radiographic knee osteoarthritis (OA). We investigated the prevalence of early or more established knee OA...... and patients' characteristics in a cohort of patients undergoing arthroscopic surgery for a meniscal tear. Patients and methods - 641 patients assigned for arthroscopy on suspicion of meniscus tear were consecutively recruited from February 2013 through January 2015. Of these, 620 patients (mean age 49 (18...... established knee OA was present in 43% of patients undergoing knee arthroscopy for meniscal tear....

  2. Drug-drug interactions among recently hospitalised patients--frequent but mostly clinically insignificant

    DEFF Research Database (Denmark)

    Glintborg, Bente; Andersen, Stig Ejdrup; Dalhoff, Kim

    2005-01-01

    OBJECTIVE: Patients use and store considerable amounts of drugs. The aim of the present study was to identify potential drug-drug interactions between drugs used by patients recently discharged from the hospital and, subsequently, to estimate the clinical implications of these interactions. METHODS......: Patients were visited within 1 week following their discharge from hospital and interviewed about their drug use. Stored products were inspected. We used a bibliography (Hansten and Horn; Wolters Kluwer Health, St. Louis, Mo., 2004) to identify and classify potential drug-drug interactions. RESULTS......: eight per patient; range: 1-24). With respect to those drugs used daily or on demand, 476 potential interactions were identified (126 patients); none were class 1 (always avoid drug combination) and 25 were class 2 (usually avoid combination; 24 patients). Eleven of the potential class 2 interactions...

  3. Clinical effect of Fuzheng quyu therapy in patients undergoing ...

    African Journals Online (AJOL)

    Clinical effect of Fuzheng quyu therapy in patients undergoing radiotherapy after cervical carcinoma surgery. ... The clinical effects and the incidence of adverse events were compared between the groups. Results: The plasma prothrombin time and activated partial thromboplastin time improved after treatment in the study ...

  4. Celiac disease or positive tissue transglutaminase antibodies in patients undergoing renal biopsies.

    Science.gov (United States)

    Nurmi, Rakel; Metso, Martti; Pörsti, Ilkka; Niemelä, Onni; Huhtala, Heini; Mustonen, Jukka; Kaukinen, Katri; Mäkelä, Satu

    2018-01-01

    An association between celiac disease and renal diseases has been suggested, but the results are controversial. To investigate the prevalence of celiac disease autoimmunity among individuals undergoing renal biopsies and to evaluate whether co-existent celiac autoimmunity influences the clinical outcome of the renal disease. The prevalence of celiac autoimmunity (previous diagnosis of celiac disease or positive tissue transglutaminase antibodies) was determined in 827 consecutive patients undergoing kidney biopsies due to clinical indications. Up to 15 years' follow-up data on kidney function and co-morbidities were obtained. Celiac autoimmunity was found in 45 (5.4%) patients. Among the IgA nephropathy patients, 8.2% of had celiac autoimmunity. At the time of kidney biopsy and after a median follow-up of 5 to 6 years, renal function measured by estimated glomerular filtration rate (eGFR) was inferior in IgA nephropathy patients with celiac autoimmunity compared to those without it (P=0.048 and P=0.022, respectively). The prevalence of celiac autoimmunity seems to be high in patients undergoing renal biopsies, especially in patients with IgA nephropathy. Such autoimmunity may be associated with worse renal function in IgA nephropathy. Hence the co-existence of celiac disease should be taken into consideration when treating patients with renal diseases. Copyright © 2017 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  5. Recurrent Pseudomembranous Colitis in an Ovarian Cancer Patient Undergoing Carboplatin Chemotherapy

    Directory of Open Access Journals (Sweden)

    Valerie A. Allen

    2016-01-01

    Full Text Available Background. Diarrhea is a common problem in ovarian cancer patients undergoing chemotherapy and Clostridium difficile infection has been identified as a cause. The proper diagnosis and treatment of diarrhea are critical to patient care, especially to prevent the serious complications from a severe Clostridium difficile infection (CDI. Case. We present a heavily pretreated ovarian cancer patient who developed recurrent pseudomembranous colitis while receiving carboplatin chemotherapy. Despite treatment with oral metronidazole for fourteen days, the patient’s diarrhea relapsed and colonoscopy revealed extensive pseudomembranous colitis. The infection eventually resolved with the combination of oral vancomycin and metronidazole. Conclusions. Diarrhea is a common problem in patients undergoing chemotherapy for ovarian cancer. Management requires obtaining the proper diagnosis. Clostridium difficile associated pseudomembranous colitis must be part of the differential diagnosis. Treatment must be sufficient to prevent relapses of the Clostridium difficile infection to prevent serious consequences in an already vulnerable patient population.

  6. EVALUATION OF PETROLEUM HYDROCARBONS ELUTION FROM SOIL

    Directory of Open Access Journals (Sweden)

    Janina Piekutin

    2015-06-01

    Full Text Available The paper presents studies on oil removal from soil by means of water elution with a help of shaking out the contaminants from the soil. The tests were performed on simulated soil samples contaminated with a mixture of petroleum hydrocarbons. The study consisted in recording the time influence and the number of elution cycles to remove contaminants from the soil. The samples were then subject to the determination of petroleum hydrocarbons, aliphatic hydrocarbons, and BTEX compounds (benzene, toluene, ethylbenzene, xylene. Due to adding various concentrations of petroleum into particular soil samples and applying different shaking times, it was possible to find out the impact of petroleum content and sample shaking duration on the course and possibility of petroleum substances removal by means of elution process.

  7. Liver enzymes in patients with chronic kidney disease undergoing peritoneal dialysis and hemodialysis

    Directory of Open Access Journals (Sweden)

    Isabella Ramos de Oliveira Liberato

    2012-01-01

    Full Text Available OBJECTIVE: The present study was designed to analyze the serum levels of aspartate and alanine aminotransferases, gamma-glutamyl transferase, and the hematocrit in patients with chronic kidney disease who were undergoing peritoneal dialysis or hemodialysis. PATIENTS AND METHODS: Twenty patients on peritoneal dialysis and 40 on hemodialysis were assessed, and the patients were matched according to the length of time that they had been on dialysis. Blood samples were collected (both before and after the session for those on hemodialysis to measure the enzymes and the hematocrit. RESULTS: In the samples from the patients who were undergoing peritoneal dialysis, the aspartate and alanine aminotransferase levels were slightly higher compared with the samples collected from the patients before the hemodialysis session and slightly lower compared with the samples collected after the hemodialysis session. The levels of gamma-glutamyl transferase in the hemodialysis patients were slightly higher than the levels in the patients who were undergoing peritoneal dialysis. In addition, the levels of aminotransferases and gamma-glutamyl transferase that were collected before the hemodialysis session were significantly lower than the values collected after the session. The hematocrit levels were significantly lower in the patients who were on peritoneal dialysis compared with the patients on hemodialysis (both before and after the hemodialysis session, and the levels were also significantly lower before hemodialysis compared with after hemodialysis. CONCLUSION: The aminotransferase levels in the patients who were undergoing peritoneal dialysis were slightly higher compared with the samples collected before the hemodialysis session, whereas the aminotransferase levels were slightly lower compared with the samples collected after the session. The hematocrits and the aminotransferase and gamma-glutamyl transferase levels of the samples collected after the

  8. Dermatillomania: In patient undergoing orthodontic treatment

    Directory of Open Access Journals (Sweden)

    Adit

    2014-01-01

    Full Text Available Dermatillomania is a disorder in which a person habitually picks their skin, and this is a form of self-injury. It can involve any part of the body, but usually involves the face, neck, arms and shoulders. Symptoms often follow an event that has caused severe emotional distress. A dermatillomania or compulsive skin picking episode may be a conscious response to anxiety or depression but is frequently done as an unconscious habit. In this case report, a patient undergoing orthodontic treatment was found to be suffering from dermatillomania and was treated using psychological counseling.

  9. Report from a quality assurance program on patients undergoing the MILD procedure.

    Science.gov (United States)

    Durkin, Brian; Romeiser, Jamie; Shroyer, A Laurie W; Schiller, Robin; Bae, Jin; Davis, Raphael P; Peyster, Robert; Benveniste, Helene

    2013-05-01

    To characterize trends in pain and functional outcomes and identify risk factors in patients with lumbar spinal stenosis (LSS) and neurogenic claudication undergoing the "Minimally Invasive Lumbar Decompression" (MILD) procedure. Retrospective observational cohort study. Academic multidisciplinary pain center at Stony Brook Medicine. Patients undergoing the MILD procedure from October 2010 to November 2012. De-identified perioperative, pain and function related data for 50 patients undergoing MILD were extracted from the Center for Pain Management's quality assessment database. Data included numerical rating scale (NRS), symptom severity and physical function (Zurich Claudication Questionnaire), functional status (Oswestry Disability Index [ODI]), pain interference scores (National Institutes of Health Patient-Reported Outcomes Measurement Information System [PROMIS]), and patients' self-reported low back and lower extremity pain distribution. No MILD patient incurred procedure-related complications. Average NRS scores decreased postoperatively and 64.3% of patients reported less pain at 3 months. Clinically meaningful functional ODI improvements of at least 20% from baseline were present in 25% of the patients at 6 months. Preliminary analysis of changes in PROMIS scores at 3 months revealed that pre-MILD "severe" lumbar canal stenosis may be associated with high risk of "no improvement." No such impact was observed for NRS or ODI outcomes. Overall, pain is reduced and functional status improved in LSS patients following the MILD procedure at 3 and 6 months. Given the small sample size, it is not yet possible to identify patient subgroups at risk for "no improvement." Continued follow-up of longer-term outcomes appears warranted to develop evidence-based patient selection criteria. Wiley Periodicals, Inc.

  10. Postoperative analgesia and antiemetic efficacy after intrathecal neostigmine in patients undergoing abdominal hysterectomy during spinal anesthesia.

    Science.gov (United States)

    Lauretti, G R; Mattos, A L; Gomes, J M; Pereira, N L

    1997-01-01

    Postoperative analgesia and antiemetic efficacy after intrathecal neostigmine were investigated in a randomized, double-blind, placebo-controlled trial of 100 patients undergoing abdominal hysterectomy. The patients were assigned to one of five groups (n = 20), and received intravenous prior to the spinal block the antiemetic test drug (except propofol) and 0.05 mg/kg midazolam. The control group (group C), the neostigmine group (group N), and the propofol group (group P) received saline as the test drug. The droperidol group (group D) received 0.5 mg intravenous droperidol, and the metoclopramide group (group M) 10 mg intravenous metoclopramide. Group P was single-blinded and had an intravenous continuous propofol infusion (2-4 mg/kg/h) turned on 10 minutes after the spinal injection. The intrathecal drugs administered were 20 mg hyperbaric bupivacaine (0.5%) associated with either 100 microg neostigmine or saline (for group C). Nausea, emetic episodes, and the need for rescue medication were recorded for the first 24 hours postoperative and scored by the Visual Analog Scale (VAS). Time-to-first-rescue medication and rescue medications in 24 hours were similar among the groups (P = .2917 and P = .8780, respectively). Intrathecal 100 microg neostigmine was associated with a high incidence of nausea and vomiting perioperative, leading to a high consumption of antiemetics (P antiemetic test drugs were effective in preventing nausea and vomiting after 100 microg neostigmine. Intrathecal neostigmine (100 microg) was ineffective for postoperative analgesia after abdominal hysterectomy due to side effects of nausea and vomiting.

  11. Predicting Resilience via Social Support and Illness Perceptions Among Patients Undergoing Hemodialysis

    Directory of Open Access Journals (Sweden)

    Reihane Hajmohammadi

    2017-07-01

    Full Text Available Background and Objectives Chronic renal disease is a threatening condition for the health, economic, and social status of the affected person and his/her family. Patients undergoing hemodialysis encounter mental and health problems; the current study aimed at predicting resilience via social support and illness perceptions among patients undergoing hemodialysis. Methods The current descriptive-correlational study had a statistical population including 308 patients undergoing hemodialysis in Kerman, Iran, in 2017. Based on the Krejcie-Morgan table, the minimum required sample size was 169. The sample was selected using a convenience sampling method. Data collection tools were the Connor-Davidson resilience scale, the medical outcome study (MOS social support survey developed by Sherbourne and Stewart, and the brief illness perception questionnaire developed by Broadbent et al. Data were analyzed using a Pearson correlation coefficient and a stepwise regression analysis via SPSS version 19. Results Results indicated that resilience was significantly and positively related to social support (r = 0.318, P < 0.05 and illness perceptions (r = 0.165, P < 0.05. Among the subscales of social support, emotional support, tangible support, and social interaction could predict resilience, and among the subscales of illness perceptions, only cognitive representation could predict resilience. Conclusions The obtained results demonstrated that resilience was significantly and positively related to social support and illness perceptions. Additionally, the subscales of social support and illness perceptions could predict resilience among the patients undergoing hemodialysis.

  12. Association of Preoperative Nutritional Status with Prognosis in Patients with Esophageal Cancer Undergoing Salvage Esophagectomy.

    Science.gov (United States)

    Sakai, Makoto; Sohda, Makoto; Miyazaki, Tatsuya; Yoshida, Tomonori; Kumakura, Yuji; Honjo, Hiroaki; Hara, Keigo; Ozawa, Daigo; Suzuki, Shigemasa; Tanaka, Naritaka; Yokobori, Takehiko; Kuwano, Hiroyuki

    2018-02-01

    To investigate whether malnutrition is associated with poor prognosis of patients who undergo salvage esophagectomy. We examined the association between the preoperative prognostic nutritional index (PNI) and prognosis of patients who undergo salvage esophagectomy. We conducted a single-center retrospective study and reviewed hospital patient records for tumor characteristics and patient outcomes. Univariate and multivariate survival analyses were carried out using the Cox proportional hazards regression model. Thirty-two patients with esophageal squamous cell carcinoma (ESCC) who underwent salvage esophagectomy between 1998 and 2015 at our Institute were included in this study. Univariate analysis revealed that clinical response (p=0.045), preoperative PNI (pnutritional status is associated with the prognosis of patients undergoing salvage esophagectomy. Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

  13. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II)

    DEFF Research Database (Denmark)

    Serruys, Patrick W; Chevalier, Bernard; Sotomi, Yohei

    2016-01-01

    BACKGROUND: No medium-term data are available on the random comparison between everolimus-eluting bioresorbable vascular scaffolds and everolimus-eluting metallic stents. The study aims to demonstrate two mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions as a re...

  14. Understanding changes in the motivation of stroke patients undergoing rehabilitation in hospital

    NARCIS (Netherlands)

    Pickrell, M.; Bongers, B.; van den Hoven, E.

    2016-01-01

    Stroke patient motivation can fluctuate during rehabilitation due to a range of factors. This study reports on qualitative research, consisting of observations of stroke patients undergoing rehabilitation and interviews with patients about the changes in motivation they identified during their time

  15. Surgical RF ablation of atrial fibrillation in patients undergoing mitral valve repair for Barlow disease.

    Science.gov (United States)

    Rostagno, Carlo; Droandi, G; Gelsomino, S; Carone, E; Gensini, G F; Stefàno, P L

    2013-01-01

    At present, limited experience exists on the treatment of atrial fibrillation (AF) in patients undergoing mitral valve repair (MVR) for Barlow disease. The aim of this investigation was to prospectively evaluate the radiofrequency ablation of AF in patients undergoing MVR for severe regurgitation due to Barlow disease. From January 1, 2007 to December 31, 2010, out of 85 consecutive patients with Barlow disease, 27 with AF underwent RF ablation associated with MVR. They were examined every 4 months in the first year after surgery and thereafter twice yearly. At follow-up, AF was observed in 4/25 (16.0%). NYHA (New York Heart Association) functional class improved significantly, with no patients in class III or IV (before surgery, 81.5% had been). Otherwise, among 58 patients in sinus rhythm, 6 (11%) developed AF during follow-up. No clinical or echocardiographic predictive factor was found in this subgroup. Results from our investigation suggest that radiofrequency ablation of AF in patients with Barlow disease undergoing MVR for severe regurgitation is effective and should be considered in every patient with Barlow disease and AF undergoing valve surgical repair. Copyright © 2013 S. Karger AG, Basel.

  16. [Preoperatory sonography efficiency in paediatric patients with cholelithiasis undergoing laparoscopic cholecystectomy].

    Science.gov (United States)

    Riñón, C; de Mingo, L; Cortés, M J; Ollero, J C; Alvarez, M; Espinosa, R; Rollán, V

    2009-01-01

    Biliary lithiasis is not much frequent in paediatric patients. The manegement of cholelithiasis in patients undergoing laparoscopic cholecystectomy is still controversial. We propose the preoperatory echographic study of the biliary tree 24-48 h before surgery, as the first choice, instead of the intraoperatory cholangiography. We made a retrospective study of 42 patients undergoing laparoscopic cholecystectomy due to symptomatic biliary lithiasis during the last 15 years, with ages between 18 months and 17-years-old (mean age 9,6-years-old) and weight between 11 and 70 kg (mean weight 42 kg) at the moment of surgery. Six of them had haematological illnesses, 17 came to the hospital because of acute abdominal pain, 10 had been studied because of recurrent abdominal pain and 9 had casual diagnoses. Abdominal sonography was performed in all patients 24-48 hours before surgery. Four children were diagnosed of biliary duct lithiasis: two choledocolithiasis and two stones in the cystic duct. One of the cystic stones was extracted in the operating room and the rest resolved spontaneously. One patient presented dilatation of choledocal duct after surgery, without any stones' evidence. Also this patient resolved spontaneously. We had no complications. Biliary lithiasis is not frequent in children, even if it seems to be increasing. A few of these patients will suffer of choledocolithiasis. The intraoperatory exploration of the biliary tree during laparoscopic surgery is technically difficult due the small size of paediatric patients. Cholangiography is not always successful and can produce some important complications as pancreatitis. Preoperative sonography 24-48 hours before surgery is a safe and efficient method for the diagnosis and follow-up of paediatric patients with biliary lithiasis undergoing laparoscopic cholecystectomy. It is safe enough to be performed without intraoperatory cholangiography.

  17. Evaluation of radiophoby phenomenon among patients undergoing radioisotope therapy

    International Nuclear Information System (INIS)

    Stepien, M.; Stepien, A.; Pawlus, J.; Wasilewska-Radwanska, M.

    2005-01-01

    The aim of study was to evaluate the radiophoby symptoms among 81 patients with different type hyperthyroidism undergoing 1-131 (450-600 MBq) treatment. The state anxiety as well as the trait anxiety levels using Spielberger's scale have been evaluated. Its values were 1 - 6 points (average 3) and 3 - 7 points (average 6) respectively for state anxiety and trait one. These results indicated that radioisotope therapy causes increase of patient's anxiety level. (author)

  18. In Vivo and In Vitro Elution of Analgesics from Multilayered Poly(D,L)-lactide-co-glycolide Nanofibers Incorporated Ureteral Stents

    OpenAIRE

    Lin, Yi-Chia; Liu, Kuo-Sheng; Lee, Demei; Li, Min-Jhan; Liu, Shih-Jung; Ito, Hiroshi

    2018-01-01

    We develop novel analgesic-eluting nanofiber-incorporated ureteral stents that offer sustained release of lidocaine and ketorolac for local drug delivery. Lidocaine and poly(D,L)-lactide-co-glycolide (PLGA) were dissolved in hexafluoroisopropanol and were electrospun into nonwoven nanofibers onto the surface of ureteral stents. This was followed by electrospinning of another layer of PLGA nanofibers containing ketorolac. Electrospun drug-loaded nanofibers were then characterized using scannin...

  19. Negative and positive affect are independently associated with patient-reported health status following percutaneous coronary intervention

    NARCIS (Netherlands)

    H. Versteeg (Henneke); S.S. Pedersen (Susanne); R.A.M. Erdman (Ruud); J.W.I. van Nierop; P.P.T. de Jaegere (Peter); R.T. van Domburg (Ron)

    2009-01-01

    textabstractPurpose: We examined the association between negative and positive affect and 12-month health status in patients treated with percutaneous coronary intervention (PCI) with drug-eluting stents. Methods: Consecutive PCI patients (n = 562) completed the Global Mood Scale at baseline to

  20. Pediatric patients on ketogenic diet undergoing general anesthesia-a medical record review.

    Science.gov (United States)

    Soysal, Elif; Gries, Heike; Wray, Carter

    2016-12-01

    To identify guidelines for anesthesia management and determine whether general anesthesia is safe for pediatric patients on ketogenic diet (KD). Retrospective medical record review. Postoperative recovery area. All pediatric patients who underwent general anesthesia while on KD between 2009 and 2014 were reviewed. We identified 24 patients who underwent a total of 33 procedures. All children were on KD due to intractable epilepsy. The age of patients ranged from 1 to 15 years. General anesthesia for the scheduled procedures. Patients' demographics, seizure history, type of procedure; perioperative blood chemistry, medications including the anesthesia administered, and postoperative complications. Twenty-four patients underwent a total of 33 procedures. The duration of KD treatment at the time of general anesthesia ranged from 4 days to 8 years. Among the 33 procedures, 3 patients had complications that could be attributable to KD and general anesthesia. A 9-year-old patient experienced increased seizures on postoperative day 0. An 8-year-old patient with hydropcephalus developed metabolic acidosis on postoperative day 1, and a 7-year-old patient's procedure was complicated by respiratory distress and increased seizure activity in the postanesthesia care unit. This study showed that it is relatively safe for children on KD to undergo general anesthesia. The 3 complications attributable to general anesthesia were mild, and the increased seizure frequencies in 2 patients returned back to baseline in 24 hours. Although normal saline is considered more beneficial than lactated Ringer's solution in patients on KD, normal saline should also be administered carefully because of the risk of exacerbating patients' metabolic acidosis. One should be aware of the potential change of the ketogenic status due to drugs given intraoperatively. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Personality, function and satisfaction in patients undergoing total hip or knee replacement.

    Science.gov (United States)

    Ramaesh, Rishikesan; Jenkins, Paul; Lane, Judith V; Knight, Sara; Macdonald, Deborah; Howie, Colin

    2014-03-01

    The aim of this study was to investigate the relationships between personality and joint-specific function, general physical and general mental health in patients undergoing total hip (THA) and knee arthroplasty (TKA). One hundred and eighty-four patients undergoing THA and 205 undergoing TKA were assessed using the Eysneck Personality Questionnaire, brief version (EPQ-BV). General physical and mental health was measured using the Short-Form 12 (SF-12) questionnaire and the EuroQol (EQ-5D). Joint-specific function was measured using the Oxford hip or knee score. The "unstable introvert" personality type was associated with poorer pre-operative function and health in patients with hip arthrosis. In patients with knee arthrosis, there was poorer general health in those with "stable extrovert" and "unstable introvert" types. Personality was not an independent predictor of outcome following TKA or THA. The main predictor was pre-operative function and health. Comorbidity was an important covariate of both pre-operative and postoperative function. Personality may play a role in the interaction of these disease processes with function and health perception. It may also affect the response and interpretation of psychometric and patient-reported outcome measures. It may be important to characterise and identify these traits in potential arthroplasty patients as it may help deliver targeted education and management to improve outcomes in certain groups.

  2. Cath lab costs in patients undergoing percutaneous coronary angioplasty - detailed analysis of consecutive procedures.

    Science.gov (United States)

    Dziki, Beata; Miechowicz, Izabela; Iwachów, Piotr; Kuzemczak, Michał; Kałmucki, Piotr; Szyszka, Andrzej; Baszko, Artur; Siminiak, Tomasz

    2017-01-01

    Costs of percutaneous coronary interventions (PCI) have an important impact on health care expenditures. Despite the present stress upon the cost-effectiveness issues in medicine, few comprehensive data exist on costs and resource use in different clinical settings. To assess catheterisation laboratory costs related to use of drugs and single-use devices in patients undergoing PCI due to coronary artery disease. Retrospective analysis of 1500 consecutive PCIs (radial approach, n = 1103; femoral approach, n = 397) performed due to ST segment elevation myocardial infarction (STEMI; n = 345) and non ST-segment elevation myocardial infarction (NSTEMI; n = 426) as well as unstable angina (UA; n = 489) and stable angina (SA; n = 241) was undertaken. Comparative cost analysis was performed and shown in local currency units (PLN). The cath lab costs were higher in STEMI (4295.01 ± 2384.54PLN, p costs were positively correlated with X-ray dose, fluoroscopy, and total procedure times. Patients' age negatively correlated with cath lab costs in STEMI/NSTEMI patients. Cath lab costs were higher in STEMI patients compared to other groups. In STEMI/NSTEMI they were lower in older patients. In all analysed groups costs were related to the level of procedural difficulty. In female patients, the costs of PCI performed via radial approach were higher compared to femoral approach. Despite younger age, male patients underwent more expensive procedures.

  3. Preoperative renin-angiotensin system inhibitors protect renal function in aging patients undergoing cardiac surgery.

    Science.gov (United States)

    Barodka, Viachaslau; Silvestry, Scott; Zhao, Ning; Jiao, Xiangyin; Whellan, David J; Diehl, James; Sun, Jian-Zhong

    2011-05-15

    Renal failure (RF) represents a major postoperative complication for elderly patients undergoing cardiac surgery. This observational cohort study examines effects of preoperative use of renin-angiotensin system (RAS) inhibitors on postoperative renal failure in aging patients undergoing cardiac surgery. We retrospectively analyzed a cohort of 1287 patients who underwent cardiac surgery at this institution (2003-2007). The patients included were ≥65 years old, scheduled for elective cardiac surgery, and without preexisting RF (defined by the criteria of the Society of Thoracic Surgeons as described in Method). Of all patients evaluated, 346 patients met the inclusion criteria and were divided into two groups: using (n = 122) or not using (n = 224) preoperative RAS inhibitors. A comparison of the two groups showed no significant differences in baseline parameters, including creatinine clearance, body mass index, history of diabetes and smoking, preoperative medicines (except that more patients with RAS inhibitors had a history of hypertension or congestive heart failure, fewer RAS inhibitor patients had chronic lung disease), in intraoperative perfusion and aortic cross-clamp time, and in postoperative complications and 30-d mortality. Multivariate logistic regression analysis demonstrated, however, that preoperative RAS inhibitors significantly and independently reduced the incidence of postoperative RF in the patients undergoing cardiac surgery compared with those not taking RAS inhibitors: 1.6% versus 7.6%, yielding an odds ratio of 0.19 (95 % CI 0.04-0.84, P = 0.029). Preoperative RAS inhibitors may have significant renoprotective effects for aging patients undergoing elective cardiac surgery. Copyright © 2011 Elsevier Inc. All rights reserved.

  4. Effect of internet on Chinese patients undergoing elective laparoscopic cholecystectomy.

    Science.gov (United States)

    Xu, Xiequn; Hong, Tao; Li, Binglu; Liu, Wei

    2015-04-01

    It is a growing trend that patients seek health information on the internet to self-educate and self-diagnose, which impacts their health decisions. The aim of the study was to investigate how Chinese patients undergoing elective laparoscopic cholecystectomy (LC) sought information about their disease and treatment, how they preferred the information to be presented, and how it influenced them. A descriptive, cross-sectional-designed questionnaire was employed to obtain information from 248 Chinese patients undergoing elective LC in Peking Union Medical College Hospital. A total of 223 patients (89.9 %) sought health information from the internet. Patients searching the internet for information about LC were younger than those who did not. It varied with employment status, educational level, and household average income. Among patients searching the internet for LC information, 35.4 % felt more worried and 37.2 % felt more assured; 15.2 % went to visit other doctors and 8.5 % considered changing their treatment because of internet use. A significant proportion of patients used the internet to obtain information about their disease. Age, employment status, educational level, and household average monthly income had an effect on internet usage for LC information. The use of the internet could cause mixed emotional outcomes among patients. Physicians should guide Chinese patients to professional websites of high quality and take time to discuss the information with patients during their visits and consultations.

  5. Recovery of older patients undergoing ambulatory anaesthesia with isoflurane or sevoflurane.

    LENUS (Irish Health Repository)

    Mahajan, V A

    2007-06-01

    Delayed recovery of cognitive function is a well-recognized phenomenon in older patients. The potential for the volatile anaesthetic used to contribute to alterations in postoperative cognitive function in older patients following minor surgical procedures has not been determined. We compared emergence from isoflurane and sevoflurane anaesthesia in older surgical patients undergoing urological procedures of short duration.

  6. Formal education of patients about to undergo laparoscopic cholecystectomy.

    Science.gov (United States)

    Gurusamy, Kurinchi Selvan; Vaughan, Jessica; Davidson, Brian R

    2014-02-28

    Generally, before being operated on, patients will be given informal information by the healthcare providers involved in the care of the patients (doctors, nurses, ward clerks, or healthcare assistants). This information can also be provided formally in different formats including written information, formal lectures, or audio-visual recorded information. To compare the benefits and harms of formal preoperative patient education for patients undergoing laparoscopic cholecystectomy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2013), MEDLINE, EMBASE, and Science Citation Index Expanded to March 2013. We included only randomised clinical trials irrespective of language and publication status. Two review authors independently extracted the data. We planned to calculate the risk ratio with 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) or standardised mean difference (SMD) with 95% CI for continuous outcomes based on intention-to-treat analyses when data were available. A total of 431 participants undergoing elective laparoscopic cholecystectomy were randomised to formal patient education (215 participants) versus standard care (216 participants) in four trials. The patient education included verbal education, multimedia DVD programme, computer-based multimedia programme, and Power Point presentation in the four trials. All the trials were of high risk of bias. One trial including 212 patients reported mortality. There was no mortality in either group in this trial. None of the trials reported surgery-related morbidity, quality of life, proportion of patients discharged as day-procedure laparoscopic cholecystectomy, the length of hospital stay, return to work, or the number of unplanned visits to the doctor. There were insufficient details to calculate the mean difference and 95% CI for the difference in pain scores at 9 to 24 hours (1 trial; 93 patients); and we did not identify clear evidence of

  7. Should patients with Björk-Shiley valves undergo prophylactic replacement?

    Science.gov (United States)

    Birkmeyer, J D; Marrin, C A; O'Connor, G T

    1992-08-29

    About 85,000 patients have undergone replacement of diseased heart valves with prosthetic Björk-Shiley convexo-concave (CC) valves. These valves are prone to fracture of the outlet strut, which leads to acute valve failure that is usually fatal. Should patients with these valves undergo prophylactic replacement to avoid fracture? The incidence of strut fracture varies between 0% and 1.5% per year, depending on valve opening angle (60 degrees or 70 degrees), diameter (less than 29 mm or greater than or equal to 29 mm), and location (aortic or mitral). Other factors include the patient's life expectancy and the expected morbidity and mortality associated with reoperation. We have used decision analysis to identify the patients most likely to benefit from prophylactic reoperation. The incidence of outlet strut fracture was estimated from the data of three large studies on CC valves, and stratified by opening angle, diameter, and location. A Markov decision analysis model was used to estimate life expectancy for patients undergoing prophylactic valve replacement and for those not undergoing reoperation. Prophylactic valve replacement does not benefit patients with CC valves that have low strut fracture risks (60 degrees aortic valves and less than 29 mm, 60 degrees mitral valves). For most patients with CC valves that have high strut fracture risks (greater than or equal to 29 mm, 70 degrees CC), prophylactic valve replacement increases life expectancy. However, elderly patients with such valves benefit from prophylactic reoperation only if the risk of operative mortality is low. Patient age and operative risk are most important in recommendations for patients with CC valves that have intermediate strut fracture risks (less than 29 mm, 70 degrees valves and greater than or equal to 29 mm, 60 degrees mitral valves). For all patients and their doctors facing the difficult decision on whether to replace CC valves, individual estimates of operative mortality risk that

  8. Metabolic syndrome in patients with prostate cancer undergoing intermittent androgen-deprivation therapy.

    Science.gov (United States)

    Rezaei, Mohammadali Mohammadzadeh; Rezaei, Mohammadhadi Mohammadzadeh; Ghoreifi, Alireza; Kerigh, Behzad Feyzzadeh

    2016-01-01

    The presence of metabolic syndrome in men with prostate cancer (PCa) undergoing androgen-deprivation therapy (ADT), especially intermittent type, has not been completely evaluated. The aim of this study is to evaluate metabolic syndrome in men with PCa undergoing intermittent ADT. In this longitudinal study, we studied the prevalence of metabolic syndrome and its components in 190 patients who were undergoing intermittent ADT. The metabolic syndrome was defined according to the Adult Treatment Panel III criteria. All metabolic parameters, including lipid profile, blood glucose, blood pressures, and waist circumferences of the patients were measured six and 12 months after treatment. Mean age of the patients was 67.5 ± 6.74 years. The incidence of metabolic syndrome after six and 12 months was 6.8% and 14.7%, respectively. Analysis of various components of the metabolic syndrome revealed that patients had significantly higher overall prevalence of hyperglycemia, abdominal obesity, and hypertriglyceridemia in their six- and 12-month followups, but blood pressure has not been changed in the same period except for diastolic blood pressure after six months. Although there was an increased risk of metabolic syndrome in patients receiving intermittent ADT, it was lower than other studies that treated the same patients with continuous ADT. Also it seems that intermittent ADT has less metabolic complications than continuous ADT and could be used as a safe alternative in patients with advanced and metastatic PCa.

  9. Hormone profiles and their relation with menstrual cycles in patients undergoing hemodialysis

    Directory of Open Access Journals (Sweden)

    Deniz Cemgil Arıkan

    2011-03-01

    Full Text Available Objective: To investigate the etiology of menstrual disorders among patients undergoing hemodialysis due to chronic renal failure by assessing menstrual history, serum hormone levels, and other biochemical factors. Material and methods: Thirty patients undergoing hemodialysis and 30 healthy women at reproductive age were enrolled in our study. Demographic characteristics, hormonal and biochemical data, and sonographically measured endometrial thickness values of the subjects were compared. In addition, the present and the pre-hemodialysis menstrual pattern of the patients undergoing hemodialysis were recorded. The hormonal, hematological, and biochemical data of the patients were compared according to their menstrual patterns. Results: No statistical significance was seen between age, BMI, gravida, parity, abortion, and curettage among groups (p>0.05. Hemoglobin and hematocrit levels were significantly lower in the hemodialysis group than in the control (p0.05. Mean serum LH and prolactin levels were significantly higher in the hemodialysis group compared to the control (p0.05. Serum LH and prolactin levels were higher, and serum FSH, estradiol and TSH levels were lower in patients who developed amenorrhea after hemodialysis treatment when compared to non-amenorrheic subjects. However, these differences were not statistically significant (p>0.05. Discussion: The most important factor in the etiology of menstrual disorders seen in chronic renal failure patients was high serum LH and prolactin levels. Hemodialysis is a successful treatment that extends life expectancy and ameliorates the hypothalamo-pituitary-ovarian axis in chronic renal failure patients.

  10. Risk factors for nasal bleeding in patients undergoing transnasal gastrointestinal endoscopy

    Directory of Open Access Journals (Sweden)

    Mitsuyo Mieda

    2018-05-01

    Full Text Available Transnasal endoscopy is widely used in screening for upper gastrointestinal lesions because of less associated pain. Nasal bleeding is the most severe adverse effect, but specific risk factors have not been identified. The aim of this study is to identify risk factors for nasal bleeding during transnasal endoscopy. Nasal bleeding occurred in 160/3035 (5.3% of patients undergoing transnasal endoscopy as part of health checkups. Patient data were retrospectively evaluated including anthropometric, medical, and life-style parameters with multiple logistic regression analysis. Multiple logistic regression revealed that nasal bleeding was significantly associated with age in decades [odds ratio/10 years 0.78, 95% confidence interval (CI 0.63–0.97, p = 0.027], female gender (2.15, 95% CI 1.48–3.12, p < 0.001, a history of previous upper gastrointestinal endoscopy (0.55, 95% CI 0.36–0.82, p = 0.004, and chronic/allergic rhinitis (0.60, 95% CI 0.36–0.98, p = 0.043. Other factors including the use of antiplatelet and/or anticoagulant drugs were not significantly associated with nasal bleeding. Female and young patients are significantly associated with an increased risk of bleeding from transnasal endoscopy, but antiplatelet and/or anticoagulant medications and a history of chronic/allergic rhinitis may not be associated. Keywords: Transnasal endoscopy, Nasal bleeding, Risk factors

  11. Anaesthesia in patients undergoing esophago-gastro-duodenoscopy for suspected bleeding

    DEFF Research Database (Denmark)

    Helsø, Ida; Risom, Martin; Vestergaard, Therese Risom

    2017-01-01

    INTRODUCTION: Upper gastrointestinal bleeding (UGIB) is a common emergency. Currently, there are no agreed guidelines on the level of anaesthetic support required in patients undergoing acute esophago-gastro-duodendoscopy (EGD). METHODS: An online questionnaire comprising 19 questions...

  12. Electroacupuncture for Bladder Function Recovery in Patients Undergoing Spinal Anesthesia

    OpenAIRE

    Gao, Yinqiu; Zhou, Xinyao; Dong, Xichen; Jia, Qing; Xie, Shen; Pang, Ran

    2014-01-01

    Purpose. To determine the efficacy of electroacupuncture on recovering postanesthetic bladder function. Materials and Methods. Sixty-one patients undergoing spinal anaesthesia were recruited and allocated into electroacupuncture or control group randomly. Patients in electroacupuncture group received electroacupuncture therapy whereas ones in control group were not given any intervention. Primary endpoint was incidence of bladder overdistension and postoperative urinary retention. Secondary ...

  13. Mid-term outcomes of patients undergoing adjustable pulmonary artery banding

    Directory of Open Access Journals (Sweden)

    Sachin Talwar

    2016-01-01

    Conclusions: Patients undergoing APAB fulfilled the desired objectives of the pulmonary artery banding (PAB with minimum PA complications in the mid-term. This added to the early postoperative benefits, makes the APAB an attractive alternative to the CPAB.

  14. Direct comparison of coronary bare metal vs. drug-eluting stents: same platform, different mechanics?

    Science.gov (United States)

    Schmidt, Wolfram; Lanzer, Peter; Behrens, Peter; Brandt-Wunderlich, Christoph; Öner, Alper; Ince, Hüseyin; Schmitz, Klaus-Peter; Grabow, Niels

    2018-01-08

    Drug-eluting stents (DES) compared to bare metal stents (BMS) have shown superior clinical performance, but are considered less suitable in complex cases. Most studies do not distinguish between DES and BMS with respect to their mechanical performance. The objective was to obtain mechanical parameters for direct comparison of BMS and DES. In vitro bench tests evaluated crimped stent profiles, crossability in stenosis models, elastic recoil, bending stiffness (crimped and expanded), and scaffolding properties. The study included five pairs of BMS and DES each with the same stent platforms (all n = 5; PRO-Kinetic Energy, Orsiro: BIOTRONIK AG, Bülach, Switzerland; MULTI-LINK 8, XIENCE Xpedition: Abbott Vascular, Temecula, CA; REBEL Monorail, Promus PREMIER, Boston Scientific, Marlborough, MA; Integrity, Resolute Integrity, Medtronic, Minneapolis, MN; Kaname, Ultimaster: Terumo Corporation, Tokyo, Japan). Statistical analysis used pooled variance t tests for pairwise comparison of BMS with DES. Crimped profiles in BMS groups ranged from 0.97 ± 0.01 mm (PRO-Kinetic Energy) to 1.13 ± 0.01 mm (Kaname) and in DES groups from 1.02 ± 0.01 mm (Orsiro) to 1.13 ± 0.01 mm (Ultimaster). Crossability was best for low profile stent systems. Elastic recoil ranged from 4.07 ± 0.22% (Orsiro) to 5.87 ± 0.54% (REBEL Monorail) including both BMS and DES. The bending stiffness of crimped and expanded stents showed no systematic differences between BMS and DES neither did the scaffolding. Based on in vitro measurements BMS appear superior to DES in some aspects of mechanical performance, yet the differences are small and not class uniform. The data provide assistance in selecting the optimal system for treatment and assessment of new generations of bioresorbable scaffolds. not applicable.

  15. Hypotonic elution, a new desorption principle in immunoadsorbent chromatography

    DEFF Research Database (Denmark)

    Danielsen, Erik Michael; Sjöström, H; Norén, O

    1982-01-01

    of finding an efficient means of elution which is not denaturing to neither the purified enzyme nor the immunoadsorbent column. Common properties of the microvillar enzymes with regard to amphiphilicity, glycosylation or subunit composition could hypothetically account for the similar elution properties...

  16. PlA polymorphism and platelet reactivity following clopidogrel loading dose in patients undergoing coronary stent implantation.

    Science.gov (United States)

    Angiolillo, Dominick J; Fernandez-Ortiz, Antonio; Bernardo, Esther; Alfonso, Fernando; Sabaté, Manel; Fernández, Cristina; Stranieri, Chiara; Trabetti, Elisabetta; Pignatti, Pier Franco; Macaya, Carlos

    2004-01-01

    The PlA polymorphism (Leu33Pro) of the platelet glycoprotein (GP) IIIa gene has been suggested to play an important role in coronary thrombosis. In vitro studies have shown differences for this polymorphism in platelet sensitivity towards antiplatelet drugs (aspirin and abciximab), suggesting a pharmacogenetic modulation. The aim of the study was to assess the modulatory effect of the PlA polymorphism on clopidogrel-induced antiplatelet effects in 38 patients undergoing coronary stent implantation receiving a 300 mg clopidogrel loading-dose. Platelet reactivity was assessed as GPIIb/IIIa activation and P-selectin expression in platelets stimulated with 2 micromol/l adenosine diphosphate using whole blood flow cytometry. The distribution of the homozygous PlA1/A1 and heterozygous PlA1/A2 genotypes were 74 and 26%, respectively. PlA2 carriers had a higher degree of GPIIb/IIIa activation (P = 0.05) and P-selectin expression (P = 0.02) during the overall study time course and a lower antiplatelet effect to a 300 mg clopidogrel loading-dose up to 24 h following intervention (P < 0.05). In conclusion, the Pl polymorphism of the GPIIIa gene modulates platelet reactivity towards clopidogrel front loading in patients undergoing coronary stenting. This suggests the need for individualized antithrombotic regimens to optimally inhibit platelet reactivity. Copyright 2004 Lippincott Williams and Wilkins

  17. Pre-operative assessment of patients undergoing endoscopic, transnasal, transsphenoidal pituitary surgery.

    Science.gov (United States)

    Lubbe, D; Semple, P

    2008-06-01

    To demonstrate the importance of pre-operative ear, nose and throat assessment in patients undergoing endoscopic, transsphenoidal surgery for pituitary tumours. Literature pertaining to the pre-operative otorhinolaryngological assessment and management of patients undergoing endoscopic anterior skull base surgery is sparse. We describe two cases from our series of 59 patients undergoing endoscopic pituitary surgery. The first case involved a young male patient with a large pituitary macroadenoma. His main complaint was visual impairment. He had no previous history of sinonasal pathology and did not complain of any nasal symptoms during the pre-operative neurosurgical assessment. At the time of surgery, a purulent nasal discharge was seen emanating from both middle meati. Surgery was abandoned due to the risk of post-operative meningitis, and postponed until the patient's chronic rhinosinusitis was optimally managed. The second patient was a 47-year-old woman with a large pituitary macroadenoma, who presented to the neurosurgical department with a main complaint of diplopia. She too gave no history of previous nasal problems, and she underwent uneventful surgery using the endoscopic, transnasal approach. Two weeks after surgery, she presented to the emergency unit with severe epistaxis. A previous diagnosis of hereditary haemorrhagic telangiectasia was discovered, and further surgical and medical intervention was required before the epistaxis was finally controlled. Pre-operative otorhinolaryngological assessment is essential prior to endoscopic pituitary or anterior skull base surgery. A thorough otorhinolaryngological history will determine whether any co-morbid diseases exist which could affect the surgical field. Nasal anatomy can be assessed via nasal endoscopy and sinusitis excluded. Computed tomography imaging is a valuable aid to decisions regarding additional procedures needed to optimise access to the pituitary fossa.

  18. Quality of Life in Elderly Cancer Patients Undergoing Chemotherapy.

    Science.gov (United States)

    Lavdaniti, Maria; Zyga, Sofia; Vlachou, Eugenia; Sapountzi-Krepia, Despina

    2017-01-01

    As life expectancy increases, it is expected that 60% of all cases of cancer will be detected in elderly patients in the next two decades. Cancer treatment for older persons is complicated by a number of factors, thus negatively affecting patients' quality of life. The purpose of this study is to investigate quality of life in elderly cancer patients undergoing chemotherapy. This study was descriptive and non-experimental. It was conducted in one large hospital in a major city of Northern Greece. The sample was convenience comprising 53 elderly cancer patients undergoing cycle 3 chemotherapy. The data was collected using the Functional Assessment of Cancer Therapy scale and included questions related to demographic and clinical characteristics. The majority of participants were men (n = 27, 50.9%) who were married (n = 32, 79.5%). Their mean age was 70.07 ± 3.60. Almost half of the sample (n = 30, 56.6%) had colon cancer. There was a statistical significant difference between men and women pertaining to physical wellbeing (p = 0.004) and overall quality of life (p family wellbeing (p = 0.029), functional wellbeing (p = 0.09) and overall quality of life (p family wellbeing (p = 0.029). These findings call attention to quality of life and its related factors in elderly cancer patients. It is highly recommended to envisage measures for improving quality of life in this group of cancer patients.

  19. Effect of marital status on the outcome of patients undergoing elective or urgent coronary revascularization.

    Science.gov (United States)

    Barbash, Israel M; Gaglia, Michael A; Torguson, Rebecca; Minha, Sa'ar; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

    2013-10-01

    Marriage confers various health advantages in the general population. However, the added value of marriage among patients who undergo percutaneous coronary intervention (PCI) beyond the standard cardiovascular risk factors is not clear. This study aimed to assess the effects of marital status on outcomes of patients undergoing elective or urgent PCI. Clinical observational analysis of consecutive patients undergoing elective or urgent PCI from 1993 to 2011 was performed. Patients were stratified by marital status, comparing married to unmarried patients. Clinical outcome up to 12 months was obtained by telephone contact or office visit. A total of 11,216 patients were included in the present analysis; 55% were married and 45% unmarried. Significant differences in baseline characteristics were noted, including a lower prevalence of hypertension (86% vs 88%), diabetes (34% vs 38%), and smoking (19% vs 25%) among married vs unmarried patients, respectively (P married patients had a higher prevalence of hypercholesterolemia and family history of coronary artery disease. Early and late major adverse cardiac event rates were significantly lower for married vs unmarried patients up to 1 year (13.3% vs 8.2%, P Married status was independently associated with improved outcome in multivariable analysis (hazard ratio 0.7, 95% CI 0.6-0.9). Married patients who undergo urgent or elective PCI have superior short- and long-term outcomes up to 1 year when compared with unmarried patients. These benefits persist after adjustment for multiple traditional cardiovascular risk factors. © 2013.

  20. Patient reported outcomes in patients undergoing arthroscopic partial meniscectomy for traumatic or degenerative meniscal tears

    DEFF Research Database (Denmark)

    Thorlund, Jonas Bloch; Englund, Martin; Christensen, Robin

    2017-01-01

    OBJECTIVES: To compare patient reported outcomes from before surgery to 52 weeks after surgery between individuals undergoing arthroscopic partial meniscectomy for traumatic meniscal tears and those for degenerative meniscal tears. DESIGN: Comparative prospective cohort study. SETTING: Four public......-55, and undergoing arthroscopic partial meniscectomy for a traumatic or degenerative meniscal tear (defined by a combination of age and symptom onset). INTERVENTIONS: Both participant groups underwent arthroscopic partial meniscectomy for a meniscal tear, with operating surgeons recording relevant information......% women) with a traumatic or degenerative meniscal tear (n=141, mean age 38.7 years (standard deviation 10.9); n=256, 46.6 years (6.4); respectively) were included in the main analysis. At 52 weeks after arthroscopic partial meniscectomy, 55 (14%) patients were lost to follow-up. Statistically...

  1. Prevalence of chronic kidney disease among patients undergoing transradial percutaneous coronary interventions.

    Science.gov (United States)

    Hossain, Mohammad A; Quinlan, Amy; Heck-Kanellidis, Jennifer; Calderon, Dawn; Patel, Tejas; Gandhi, Bhavika; Patel, Shrinil; Hetavi, Mahida; Costanzo, Eric J; Cosentino, James; Patel, Chirag; Dewan, Asa; Kuo, Yen-Hong; Salman, Loay; Vachharajani, Tushar J

    2018-03-01

    While transradial approach to conduct percutaneous coronary interventions offers multiple advantages, the procedure can cause radial artery damage and occlusion. Because radial artery is the preferred site for the creation of an arteriovenous fistula to provide dialysis, patients with chronic kidney disease are particularly dependent on radial artery for their long-term survival. In this retrospective study, we investigated the prevalence of chronic kidney disease in patients undergoing coronary interventions via radial artery. Stage of chronic kidney disease was based on estimated glomerular filtration rate and National Kidney Foundation - Kidney Disease Outcomes Quality Initiative guidelines. A total of 497 patients undergoing transradial percutaneous coronary interventions were included. Over 70.4% (350/497) of the patients had chronic kidney disease. Stage II chronic kidney disease was observed in 243 (69%) patients (estimated glomerular filtration rate = 76.0 ± 8.4 mL/min). Stage III was observed in 93 (27%) patients (estimated glomerular filtration rate = 49 ± 7.5 mL/min). Stage IV chronic kidney disease was observed in 5 (1%) patients (estimated glomerular filtration rate = 25.6 ± 4.3 mL/min) and Stage V chronic kidney disease was observed in 9 (3%) patients (estimated glomerular filtration rate = 9.3 ± 3.5 mL/min). Overall, 107 of 350 patients (30%) had advanced chronic kidney disease, that is, stage III-V chronic kidney disease. Importantly, 14 of the 107 (13%) patients had either stage IV or V chronic kidney disease. This study finds that nearly one-third of the patients undergoing transradial percutaneous coronary interventions have advanced chronic kidney disease. Because many of these patients may require dialysis, the use of radial artery to conduct percutaneous coronary interventions must be carefully considered in chronic kidney disease population.

  2. Paclitaxel-eluting stents versus everolimus-eluting coronary stents in a diabetic population: two-year follow-up of the TUXEDO-India trial.

    Science.gov (United States)

    Kaul, Upendra; Bhagwat, Ajit; Pinto, Brian; Goel, Praveen K; Jagtap, Prashant; Sathe, Shireesh; Wander, Gurpreet S; Arambam, Priyadarshini; Bangalore, Sripal

    2017-11-20

    The aim of this study was to report whether the superiority of the everolimus-eluting stent (EES) vs. the paclitaxel-eluting stent (PES) at one-year follow-up in the Taxus Element versus Xience Prime in a Diabetic Population (TUXEDO)-India trial was sustained at longer-term follow-up. One thousand eight hundred and thirty (1,830) patients with diabetes mellitus and coronary artery disease were randomised to EES vs. PES. Follow-up data up to two years were available in 1,701 (92.9%) patients. The primary endpoint was target vessel failure (TVF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischaemia-driven target vessel revascularisation (TVR). Treatment with EES had a lower two-year rate of TVF (4.3% vs. 6.6%, p=0.03). Of the secondary endpoints, EES significantly reduced any MI (1.6% vs. 3.5%, p=0.01), TV-MI (0.7% vs. 3.1%, p=0.0001), ST (0.4% vs. 2.2%, p=0.001), cardiac death or target vessel MI (2.9% vs. 4.8%, p=0.04) and TLR (1.9% vs. 3.7%, p=0.02), compared with PES. Between one year and two years, no significant differences in the clinical outcomes were observed (pinteraction >0.05). In this adequately powered trial, the benefits of EES vs. PES in a diabetic population seen at one year were maintained at two years.

  3. Impact of smoking on early clinical outcomes in patients undergoing coronary artery bypass grafting surgery

    OpenAIRE

    Ji, Qiang; Zhao, Hang; Mei, YunQing; Shi, YunQing; Ma, RunHua; Ding, WenJun

    2015-01-01

    Background To evaluate the impact of persistent smoking versus smoking cessation over one month prior to surgery on early clinical outcomes in Chinese patients undergoing isolated coronary artery bypass grafting (CABG) surgery in a retrospective study. Methods The peri-operative data of consecutive well-documented patients undergoing isolated CABG surgery from January 2007 to December 2013 were investigated and retrospectively analyzed. All included patients were divided into either a non-smo...

  4. Investigation of the elution by seawater of caesium and strontium from loaded clinoptilolite

    International Nuclear Information System (INIS)

    Harder, B.R.; Mitchell, I.H.; Smyth, M.J.

    1985-07-01

    Simple investigations of the elution of caesium and strontium from loaded clinoptilolite are described. The clinoptilolite was loaded to levels expected in the British Nuclear Fuels plc SIXEP plant and contacted with seawater at approx. 15 C. (The elution time was measured until about 99% of the caesium and strontium had been eluted.) It was found that 99% of the caesium was eluted in 35 hours but the strontium (with more variable results) took at least 400 hours for 99% elution. (author)

  5. Production and setting of fractional elution facility for recovery of useful rare metals from seawater

    International Nuclear Information System (INIS)

    Seko, Noriaki; Kasai, Noboru; Tamada, Masao; Hasegawa, Shin; Katakai, Akio

    2005-01-01

    In September 1999, we have soaked 200 kg of fibrous amidoxime absorbents, synthesized by radiation-induced graft polymerization, into seawater to evaluate their performance. Fractional elution facility was set effectively to elute the rare metals on adsorbents in Mutsu-Establishment. This facility consists of two parts of pre-washing and elution. The present report dealt with planning, manufacture and setting of fractional facility. Marine organism and slime on adsorbent cassette (290 x 295 x 160 mm) were washed out and every 72 cassettes were set in elution unit (1210 x 1210 x H1460 mm) with nonwoven materials as a packing to avoid elution loss. In the elution process alkaline and alkaline earth metals were eluted with low concentration hydrochloric acid (0.01M) and rare metals were eluted with high concentration (0.5 M) after the packing of elution unit into fractional elution facility. Adsorbent cassettes were regenerated with alkaline solution after elution procedure. (author)

  6. Determinants of anxiety in patients with advanced somatic disease: differences and similarities between patients undergoing renal replacement therapies and patients suffering from cancer.

    Science.gov (United States)

    Janiszewska, Justyna; Lichodziejewska-Niemierko, Monika; Gołębiewska, Justyna; Majkowicz, Mikołaj; Rutkowski, Bolesław

    2013-10-01

    Anxiety is the most frequent emotional reaction to the chronic somatic disease. However, little is known about anxiety and coping strategies in patients with end-stage renal disease (ESRD) undergoing renal replacement therapies (RRTs). The purpose of the study was to assess the intensity and determinants of anxiety in patients treated with different RRTs in comparison with end-stage breast cancer patients and healthy controls. The study involved (1) ESRD patients undergoing different RRTs: 32 renal transplant recipients, 31 maintenance haemodialysis and 21 chronic peritoneal dialysis patients, (2) women with end-stage breast cancer (n = 25) and (3) healthy persons (n = 55). We used State-Trait Anxiety Inventory, Scale of Personal Religiousness, Mental Adjustment to Cancer Scale, Rotterdam Symptom Checklist with reference to medical history. The data thus obtained were analysed using the analysis of variance, the Tukey's HSD post hoc test and Spearman's rank correlation coefficient. Both ESRD and breast cancer patients revealed higher level of anxiety state and trait than healthy controls; however, there was no statistically significant difference found between both findings. There was a tendency towards higher levels of anxiety state in breast cancer patients when compared to ESRD patients undergoing the RRT treatment and for both groups non-constructive coping strategies correlated with the levels of anxiety state. With ESRD patients undergoing RRTs, the intensity of anxiety state did not depend on the mode of treatment but on the correlation between the levels of anxiety and the general quality of their life, psychological condition and social activity. In patients with advanced somatic disease (ESRD and end-stage breast cancer), non-constructive strategies of coping with the disease require further evaluation and possibly psychological support.

  7. Magmaris: a new generation metallic sirolimus-eluting fully bioresorbable scaffold: present status and future perspectives

    OpenAIRE

    Rapetto, Claudio; Leoncini, Massimo

    2017-01-01

    Drug-eluting stents (DES) have reached a high safety and efficacy profile, becoming the best option for percutaneous coronary interventions (PCI) based revascularization. However, despite their optimal performance, a few concerns remain regarding their use, mainly due to permanent caging of the vessels and its consequences, first of all late stent thrombosis (ST). Bioresorbable scaffolds (BRS) aim to overcome these issues. The results achieved in randomized controlled trials (RCT) by the firs...

  8. [Experience with the use of the bio-active stent coated with titanium nitric oxide compared with zotarolimus-eluting stent: experience of a unit medical high specialty].

    Science.gov (United States)

    Garcia-Gutierrez, Juan C; Palacios-Rodríguez, Juan M; Cordova-Correa, Horacio G; Becerra-Laguna, Carlos A; López-López, Hugo A; Salinas Aragón, Miguel A; García-Bonilla, Jorge

    2016-01-01

    The use of coronary stents in coronary angioplasty has evolved dramatically in its design, type materials, polymers, and a variety of drugs, the use of coronary stents covered nitric oxide have shown satisfactory results in practice, however compared to the results reported drug-eluting stents, there is little information. The aim of this study was to compare clinical outcomes of a stainless steel stent Bioactive nitric oxide coated titanium (BAS) and a drug-eluting stent zotarolimus (DES) in daily clinical practice. A retrospective, analytical, descriptive and comparative study aimed at evaluating the safety and efficacy of two devices with different characteristics in our population. The primary endpoints were: death, acute infarction (AMI), and re intervention injury Treated (RLT). A total of 759 patients were included in the study which was performed angioplasty to a single vessel. Were divided into two arms 382 with DES and 377 patients with BAS, the one year follow up was carried in 95%. After this follow-up period, primary points (cardiovascular death, myocardial infarction, TLR and stent thrombosis) for arm DES vs BAS; 9.5% vs 8.5% P=NS but with shorter periods of dual antiplatelet therapy for arm BAS 6.9±4.1 vs 11.1±2.5 months DES P=.0001. The results were independent of the clinical syndrome of presentation. After one year of follow no statistically significant difference in major clinical events, there was a trend in favour of BAS vs SM with respect to revascularization of the target lesion without reaching statistical significance. Copyright © 2015 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

  9. The efficacy of a smoking cessation programme in patients undergoing elective surgery - a randomised clinical trial

    DEFF Research Database (Denmark)

    Azodi, O. Sadr; Lindstrom, D.; Adami, J.

    2009-01-01

    It is known that smokers constitute an important risk group of patients undergoing surgery. It is unknown how smoking cessation intervention initiated 4 weeks prior to elective surgery affects the probability of permanent cessation. We randomly assigned 117 patients, scheduled to undergo elective...

  10. Perioperative glycemic control in diabetic patients undergoing coronary artery bypass graft surgery

    Directory of Open Access Journals (Sweden)

    Ehab A. Wahby

    2016-08-01

    Conclusion: Tight glycemic control improved perioperative outcome in diabetic CABG patients. Maintaining perioperative blood glucose level between 110 and 149 mg/dl is safe and should be recommended as a routine practice in diabetic patients undergoing CABG surgery.

  11. Establishing an individual dosing system for patients undergoing interventional transcatheter arterial embolization: Radiochromic film and Monte Carlo simulation

    International Nuclear Information System (INIS)

    Tsai, Hui-Yu; Lai, Pei-Ling; Li, Yang-Ying; Tyan, Yeu-Sheng

    2011-01-01

    Less invasive imaging-guided vascular interventions with fluoroscopy and digital subtraction angiography have recently become widespread and have been successfully used for treating various diseases. However, interventional fluoroscopy procedures may present deterministic and stochastic radiation risks. The International Commission on Radiological Protection (ICRP) and the Food and Drug Administration have requested identifying procedures that may involve patient doses greater than the recommended thresholds. In this study, radiochromic dosimetric media, known as self-developing films, and measurement-based Monte Carlo simulations were used to establish an interventional radiology dosing system for individual patients undergoing interventional transcatheter arterial embolization. The peak skin dose, evaluated from the entrance surface dose distribution, was 21% less than the cumulated dose reported from the console. A 3D dose map incorporated into CT images was established. The organ doses and effective doses for individual patients were evaluated using this dosing system. This system could be applied very well to other fluoroscopic or interventional procedures for patient dose management.

  12. Potential drug-drug interactions on in-patient medication ...

    African Journals Online (AJOL)

    Potential drug-drug interactions on in-patient medication prescriptions at Mbarara Regional Referral Hospital (MRRH) in western Uganda: prevalence, clinical importance and associated factors. SJ Lubinga, E Uwiduhaye ...

  13. Adverse Drug Reactions Related to Drug Administration in Hospitalized Patients.

    Science.gov (United States)

    Gallelli, Luca; Siniscalchi, Antonio; Palleria, Caterina; Mumoli, Laura; Staltari, Orietta; Squillace, Aida; Maida, Francesca; Russo, Emilio; Gratteri, Santo; De Sarro, Giovambattista

    2017-01-01

    Drug treatment may be related to the development of adverse drug reactions (ADRs). In this paper, we evaluated the ADRs in patients admitted to Catanzaro Hospital. After we obtained the approval by local Ethical Committee, we performed a retrospective study on clinical records from March 01, 2013 to April 30, 2015. The association between drug and ADR or between drug and drug-drug-interactions (DDIs) was evaluated using the Naranjo's probability scale and Drug Interaction Probability Scale (DIPS), respectively. During the study period, we analyzed 2870 clinical records containing a total of 11,138 prescriptions, and we documented the development of 770 ADRs. The time of hospitalization was significantly higher (P<0.05) in women with ADRs (12.6 ± 1.2 days) with respect to men (11.8± 0.83 days). Using the Naranjo score, we documented a probable association in 78% of these reactions, while DIPS revealed that about 22% of ADRs were related to DDIs. Patients with ADRs received 3052 prescriptions on 11,138 (27.4%) having a mean of 6.1±0.29 drugs that was significantly higher (P<0.01) with respect to patients not experiencing ADRs (mean of 3.4±0.13 drugs). About 19% of ADRs were not diagnosed and were treated as new diseases. Our results indicate that drug administration induces the development of ADRs also during the hospitalization, particularly in elderly women. Moreover, we also documented that ADRs in some patients are under-diagnosed, therefore, it is important to motivate healthcare to report the ADRs in order to optimize the patients' safety. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  14. Smoking behaviour and attitudes in patients undergoing cardiac surgery. The Radboud experience.

    NARCIS (Netherlands)

    Saksens, N.T.M.; Noyez, L.

    2010-01-01

    Changes in smoking behaviour and attitudes of 2642 patients, undergoing cardiac surgery, between January 2000 and July 2008 were studied. All patients completed a preoperative questionnaire concerning smoking behaviour and attitude. Study endpoints are behaviour and attitude in relation to tobacco

  15. Pseudo-outbreak of pseudomonas aeruginosa in HIV-infected patients undergoing fiberoptic bronchoscopy

    DEFF Research Database (Denmark)

    Kolmos, H J; Lerche, A; Kristoffersen, Kirsten Lydia

    1994-01-01

    Pseudomonas aeruginosa was isolated from bronchoalveolar lavage fluid from 8 consecutive patients undergoing bronchoscopy at an infectious diseases unit. None of the patients developed signs of respiratory tract infection that could be ascribed to the organism. The source of contamination...

  16. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy.

    LENUS (Irish Health Repository)

    Carney, John

    2008-12-01

    Patients undergoing total abdominal hysterectomy suffer significant postoperative pain. The transversus abdominis plane (TAP) block is a recently described approach to providing analgesia to the anterior abdominal wall. We evaluated the analgesic efficacy of the TAP block in patients undergoing total abdominal hysterectomy via a transverse lower abdominal wall incision, in a randomized, controlled, double-blind clinical trial.

  17. Zotarolimus-eluting stent for the treatment of recurrent, severe carotid artery in-stent stenosis in the TARGET-CAS population.

    Science.gov (United States)

    Tekieli, Lukasz; Pieniazek, Piotr; Musialek, Piotr; Kablak-Ziembicka, Anna; Przewlocki, Tadeusz; Trystula, Mariusz; Moczulski, Zbigniew; Dzierwa, Karolina; Paluszek, Piotr; Podolec, Piotr

    2012-06-01

    To evaluate the safety and efficacy of a balloon-mounted drug-eluting stent (DES) for recurrent carotid in-stent stenosis (ISS). As part of our targeted carotid artery stenting (TARGET-CAS) protocol, neurological and ultrasound evaluations have been performed at 3, 6, and 12 months and then annually since 2001 in all carotid stent patients. For angiographically-confirmed >70% ISS, balloon angioplasty was performed as a first-line treatment. Recurrent ISS was treated with a 4.0-mm zotarolimus-eluting coronary stent (ZES) that was postdilated according to intravascular ultrasound imaging. Among the 1350 neuroprotected CAS procedures performed between January 2001 and March 2011, there were 7 (0.52%) patients (5 men; ages 51-72 years), all neurologically asymptomatic, with >70% recurrent ISS that occurred at 5 to 11 months after the initial balloon angioplasty treatment for ISS. ZES implantation under distal embolic protection was technically successful and uncomplicated. Angiographic stenosis was reduced from 84.6%±7.5% to 10.7%±3.6% (p<0.01). In 5 patients with ZES implanted fully within the self-expanding carotid stent, duplex ultrasound follow-up (mean 17 months, range 6-36) revealed no evidence of restenosis or stent fracture/deformation. In the 2 other patients, the ZES had been implanted for distal edge ISS such that the ZES protruded beyond the original carotid stent. This protruding segment of the ZES demonstrated deformation/kinking in both; in one, this led to symptomatic stent occlusion. The use of coronary ZES in the treatment of recurrent carotid ISS is feasible and appears effective provided the ZES is placed entirely within the original stent. Placement of a coronary ZES outside the carotid stent scaffold should be avoided.

  18. Cerebroprotective effect of piracetam in patients undergoing coronary bypass burgery.

    Science.gov (United States)

    Holinski, Sebastian; Claus, Benjamin; Alaaraj, Nour; Dohmen, Pascal Maria; Kirilova, Kremena; Neumann, Konrad; Uebelhack, Ralf; Konertz, Wolfgang

    2008-11-01

    Reduction of cognitive function is a possible side effect after cardiac surgery using cardiopulmonary bypass. We investigated the cerebroprotective effect of piracetam on cognitive performance in patients undergoing coronary artery bypass surgery under cardiopulmonary bypass. Patients scheduled for elective, primary and isolated coronary bypass surgery were randomised either to piracetam or placebo group. The study was performed in a double blind fashion. Patients received either 12 g piracetam or placebo at the beginning of the operation. Six neuropsychological subtests from the Syndrom Kurz Test and the Alzheimer's Disease Assessment Scale were performed preoperatively and on the third postoperative day. To assess the overall cognitive function and the degree of cognitive decline across all tests after surgery we combined the six test-scores by principal component analysis. A total number of 120 patients were enrolled into the study. Preoperative overall cognitive function were not significantly different between the groups. The postoperative combined score of the neuropsychological tests showed a deterioration of cognitive function in both groups (placebo-pre: -0.06+/-0.99 vs placebo-post: -1.38+/-1.11; ppiracetam-pre: 0.06+/-1.02 vs piracetam-post: -0.65+/-0.93; ppiracetam patients performed significantly better compared to the placebo patients after the operation and had a less decline of overall cognitive function (pPiracetam has a cerebroprotective effect in patients undergoing coronary artery bypass surgery with the use of cardiopulmonary bypass. It reduces an early postoperative substantial decline of neuropsychological abilities.

  19. Orthostatic hypotension during postoperative continuous thoracic epidural bupivacaine-morphine in patients undergoing abdominal surgery

    DEFF Research Database (Denmark)

    Crawford, M E; Møiniche, S; Orbæk, Janne

    1996-01-01

    Fifty patients undergoing colonic surgery received combined thoracic epidural and general anesthesia followed by continuous epidural bupivacaine 0.25% and morphine 0.05 mg/mL, 4 mL/h, for 96 h postoperatively plus oral tenoxicam 20 mg daily. Heart rate (HR) and arterial blood pressure (BP) were...... hypotension. The results suggest that patients undergoing abdominal surgery and treated with continuous small-dose thoracic epidural bupivacaine-morphine are subjected to a decrease of BP at rest and during mobilization, but not to an extent that seriously impairs ambulation in most patients....

  20. Prevalence of unrecognized diabetes, prediabetes and metabolic syndrome in patients undergoing elective percutaneous coronary intervention.

    Science.gov (United States)

    Balakrishnan, Revathi; Berger, Jeffrey S; Tully, Lisa; Vani, Anish; Shah, Binita; Burdowski, Joseph; Fisher, Edward; Schwartzbard, Arthur; Sedlis, Steven; Weintraub, Howard; Underberg, James A; Danoff, Ann; Slater, James A; Gianos, Eugenia

    2015-09-01

    Diabetes mellitus (DM) and metabolic syndrome are important targets for secondary prevention in cardiovascular disease. However, the prevalence in patients undergoing elective percutaneous coronary intervention is not well defined. We aimed to analyse the prevalence and characteristics of patients undergoing percutaneous coronary intervention with previously unrecognized prediabetes, diabetes and metabolic syndrome. Data were collected from 740 patients undergoing elective percutaneous coronary intervention between November 2010 and March 2013 at a tertiary referral center. Prevalence of DM and prediabetes was evaluated using Haemoglobin A1c (A1c ≥ 6.5% for DM, A1c 5.7-6.4% for prediabetes). A modified definition was used for metabolic syndrome [three or more of the following criteria: body mass index ≥30 kg/m2; triglycerides ≥ 150 mg/dL; high density lipoprotein prediabetes at time of percutaneous coronary intervention. Overall, 54.9% met criteria for metabolic syndrome (69.2% of patients with DM and 45.8% of patients without DM). Among patients undergoing elective percutaneous coronary intervention, a substantial number were identified with a new DM, prediabetes, and/or metabolic syndrome. Routine screening for an abnormal glucometabolic state at the time of revascularization may be useful for identifying patients who may benefit from additional targeting of modifiable risk factors. Copyright © 2015 John Wiley & Sons, Ltd.