WorldWideScience

Sample records for generation drug eluting

  1. Next-generation drug-eluting stents in coronary artery disease: focus on everolimus-eluting stent (Xience V®

    Directory of Open Access Journals (Sweden)

    Imad Sheiban

    2008-02-01

    Full Text Available Imad Sheiban1, Gianluca Villata1, Mario Bollati1, Dario Sillano1, Marzia Lotrionte2, Giuseppe Biondi-Zoccai11Interventional Cardiology, Division of Cardiology, University of Turin, Turin, Italy; 2Institute of Cardiology, Catholic University, Rome, ItalyAbstract: Percutaneous coronary revascularization has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently, first-generation drug-eluting stents (DES, such as sirolimus-eluting (Cypher® and paclitaxel-eluting stents (Taxus®, have further improved results of percutaneous coronary intervention (PCI by improving early results and reducing the risk of restenosis. There is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. There are well known caveats on the performance of their respective metallic stent platforms, delivery, and dilation systems, and polymer coatings. Second-generation DES, such as zotarolimus-eluting (Endeavor® and everolimus-eluting stents (Xience V®, have recently become available in the USA and/or Europe. The Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety. In addition, this stent is based on the Multi-link platform and delivery system. Recently available data already suggest the superiority of the Xience V stent in comparison to the Taxus stent in terms of prevention of restenosis, without significant untoward events. Nonetheless, the number of patients studied and the follow-up duration are still too limited to enable definitive conclusions. Only indirect meta-analyses can be used to date to compare the Xience V with the Cypher. This systematic review tries to provide a concise and critical appraisal of the data in support of the Xience V everolimus-eluting stent.Keywords: coronary artery disease, everolimus, percutaneous

  2. Impact of diabetes on the benefits from everolimus-eluting stent as compared to first-generation drug-eluting stent in patients with ST elevation myocardial infarction

    NARCIS (Netherlands)

    Luca, G. De; Sauro, R.; Capasso, M.; Lanzillo, T.; Manganelli, F.; Carbone, G.; Lanni, F.; Pagliuca, M.R.; Palmieri, V.; Serino, V.; Rosato, G.; Suryapranata, H.; Lorenzo, E. Di

    2015-01-01

    BACKGROUND: Drug-eluting stent has been shown to reduce the risk of repeated revascularization. However, as shown for first-generation drug-eluting stent, they may be counterbalanced by a potential higher risk of stent thrombosis, especially among ST-segment elevation myocardial infarction patients.

  3. Second- and third-generation drug-eluting coronary stents: progress and safety.

    Science.gov (United States)

    Akin, I; Schneider, H; Ince, H; Kische, S; Rehders, T C; Chatterjee, T; Nienaber, C A

    2011-05-01

    Drug-eluting stents (DES) have revolutionized the treatment of coronary artery disease by reducing the rate of in-stent restenosis from 20-40% with bare-metal stent (BMS) to 6-8% with DES. However, with widespread use of DES, safety concerns have risen due to the observation of late stent thrombosis. With this in mind and better understanding of mechanism and pathophysiology of stent thrombosis, the technological platform, especially innovative anti-restenotic agents, polymeric coatings, and stent platforms, improved with newer DES. Two second-generation DES, the Endeavor zotarolimus-eluting stent (ZES) and the Xience-V everolimus-eluting stent (EES), have provided promising results in both randomized controlled trials (SPIRIT and ENDEAVOR) and registries (E-Five, COMPARE) compared with bare-metal stents (BMS) and first-generation DES. Newer third-generation stent technology, especially biodegradable polymers, polymer-free stents, and biodegradable stents on the basis of poly-L-lactide (PLLA) or magnesium, has been evaluated in preclinical and initial clinical trials. However, despite encouraging initial results, long-term data of large-scale randomized trials as well as registries comparing them to currently approved first- and second-generation DES are still lacking.

  4. Kissing inflation is feasible with all second-generation drug-eluting balloons.

    Science.gov (United States)

    Sgueglia, Gregory A; Todaro, Daniel; Bisciglia, Andrea; Conte, Micaela; Stipo, Antonino; Pucci, Edoardo

    2011-01-01

    To assess the feasibility of kissing second-generation drug-eluting balloons (DEB), which have better mechanical properties than the first-generation DEB, in order to optimize provisional bare-metal stenting (BMS) when treating coronary bifurcation lesions in patients with contraindication to drug-eluting stents. Consecutive patients with anticipated low compliance to dual antiplatelet therapy who are undergoing provisional stenting with an open-cell design BMS and final kissing balloon with second-generation DEB were enrolled in this feasibility study. Angiographic success and procedural success (i.e., angiographic success in absence of in hospital major cardiovascular events) were registered. Clinical follow-up was also attempted in all patients. A total of 14 patients (mean age 66±9 years, nine men) participated on the study. The DEB used were SeQuent Please (B. Braun Melsungen, Berlin, Germany) in six patients, In.Pact Falcon (Medtronic Invatec, Roncadelle, Italy) in four patients, New Dior (Eurocor, Bonn, Germany) in two patients and Pantera Lux (Biotronik, Berlin, Germany) in another two patients. All procedures, but one, were performed by transradial access through a 6-French high-flow guiding catheter. True bifurcation was present in 50% of the patients. Angiographic and procedural success was obtained in all patients. At a mean follow-up of 234±81 days, all contacted patients were asymptomatic and free from major adverse cardiac events (including cardiac death, nonfatal myocardial infarction and target bifurcation revascularization). At the advent of dedicated bifurcation stents, kissing DEB appears safe and effective and can be used to implement innovative, simpler, safer and possibly more effective bifurcation techniques. These remarkable results have laid the ground for an ongoing prospective registry of the kissing DEB technique (KISSING DEBBIE study, ClinicalTrials.gov NCT01009996). Copyright © 2011 Elsevier Inc. All rights reserved.

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

    NARCIS (Netherlands)

    Tandjung, K.; Tandjung, K.; von Birgelen, Clemens; (et al.), [Unknown

    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

  6. The next generation of drug-eluting stents: What's on the horizon?

    NARCIS (Netherlands)

    S. Ramcharitar (Steve); S. Vaina (Sophia); P.W.J.C. Serruys (Patrick)

    2007-01-01

    textabstractDrug-eluting stents have radically changed the way we treat coronary artery disease. They offer lower restenotic rates compared with the bare metal stents and this enables more challenging and complex lesions to be treated. However, there are still limitations as restenosis has not been

  7. 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.

  8. 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.

  9. 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

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

    Science.gov (United States)

    Yu, Cheol Woong; Kim, Je Sang; Lee, Hyun Jong; Choi, Rak Kyeong; Kim, Tae Hoon; Jang, Ho Joon; Choi, Young Jin; Roh, Young Moo; Shim, Won-Heum; Song, Young Bin; Hahn, Joo-Yong; Choi, Jin-Ho; Lee, Sang Hoon; Gwon, Hyeon-Cheol; Choi, Seung-Hyuk

    2016-01-01

    Background 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. Methods and Results 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. Conclusion 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. PMID:27314589

  11. Drug-Eluting Intraocular Lenses

    Directory of Open Access Journals (Sweden)

    Angel Concheiro

    2011-11-01

    Full Text Available Notable advances in materials science and in surgical techniques make the management of cataract by replacement of the opaque crystalline with an intraocular lens (IOL, one of the most cost-effective interventions in current healthcare. The usefulness and safety of IOLs can be enhanced if they are endowed with the ability to load and to sustain drug release in the implantation site. Drug-eluting IOLs can prevent infections and untoward reactions of eye tissues (which lead to opacification and also can act as drug depots for treatment of several other ocular pathologies. Such a myriad of therapeutic possibilities has prompted the design of drug-IOL combination products. Several approaches are under study, namely combination of the IOL with an insert in a single device, soaking in drug solutions, impregnation using supercritical fluids, coating with drug/polymer layers, and covalent grafting of the drug. The advantages/limitations of each technique are discussed in the present review on selected examples. Although more in vivo data are required, the information already available proves the interest of some approaches in ocular therapeutics.

  12. Sex difference in chest pain after implantation of newer generation coronary drug-eluting stents: a patient-level pooled analysis from the TWENTE and DUTCH PEERS trials

    NARCIS (Netherlands)

    Kok, Marlies M.; Heijden, van der Liefke C.; Sen, Hanim; Danse, Peter W.; Löwik, Marije M.; Anthonio, Rutger L.; Louwerenburg, J. (Hans) W.; Man, de Frits H.A.F.; Linssen, Gerard C.M.; IJzerman, Maarten J.; Doggen, Carine J.M.; Maas, Angela H.E.M.; Mehran, Roxana; Birgelen, von Clemens

    2016-01-01

    Objectives This study sought to assess sex differences in chest pain after percutaneous coronary intervention (PCI) with newer generation drug-eluting stents (DES). Background Sex-based data on chest pain after PCI with DES are scarce. Methods The authors performed a patient-level pooled analysis

  13. 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.

  14. Drug-eluting stents: current issues

    NARCIS (Netherlands)

    P.W.J.C. Serruys (Patrick); A.T.L. Ong (Andrew)

    2005-01-01

    textabstractEarly stent thrombosis occurs in about 1% to 1.5% of patients with drug-eluting stents, very similar to the rate with bare-metal stents. Late stent thrombosis is more of a concern with drug-eluting stents, with an incidence of at least 0.35%. I would urge caution if you feel you have to

  15. Drug-eluting stents: current issues

    NARCIS (Netherlands)

    P.W.J.C. Serruys (Patrick); A.T.L. Ong (Andrew)

    2005-01-01

    textabstractEarly stent thrombosis occurs in about 1% to 1.5% of patients with drug-eluting stents, very similar to the rate with bare-metal stents. Late stent thrombosis is more of a concern with drug-eluting stents, with an incidence of at least 0.35%. I would urge caution if you feel you have to

  16. Dual Antiplatelet Therapy for 6 Months vs 12 Months After New-generation Drug-eluting Stent Implantation: Matched Analysis of ESTROFA-DAPT and ESTROFA-2.

    Science.gov (United States)

    de la Torre Hernández, José M; Oteo Domínguez, Juan F; Hernández, Felipe; García Camarero, Tamara; Abdul-Jawad Altisent, Omar; Rivero Crespo, Fernando; Cascón, José D; Zavala, Germán; Gimeno, Federico; Arrebola Moreno, Antonio L; Andraka, Leire; Gómez Menchero, Antonio; Bosa, Francisco; Carrillo, Xavier; Sánchez Recalde, Ángel; Alfonso, Fernando; Pérez de Prado, Armando; López Palop, Ramón; Sanchis, Juan; Diarte de Miguel, José A; Jiménez Navarro, Manuel; Muñoz, Luz; Ramírez Moreno, Antonio; Tizón Marcos, Helena

    2015-10-01

    The recommendation for dual antiplatelet therapy following drug-eluting stent implantation ranges from 6 months to 12 months or beyond. Recent trials have suggested the safety of a 6-month dual antiplatelet therapy regimen, yet certain caveats to these studies limit the applicability of this shorter duration dual antiplatelet therapy strategy in real world settings. A registry was constructed with consecutive recruitment of patients undergoing new-generation drug-eluting stent implantation and prescribed 6 months of dual antiplatelet therapy. Propensity score matching was undertaken with a historical cohort of patients treated with second-generation drug-eluting stents who received 12 months of dual antiplatelet therapy from the ESTROFA-2 registry. The sample size was calculated using a noninferiority basis and the primary endpoint was the combination of cardiac death, myocardial infarction, revascularization, or major bleeding at 12 months. The analysis included 1286 patients in each group, with no significant differences in baseline characteristics. The primary endpoint occurred in 5.0% and 6.6% in the 6-month and 12-month groups, respectively (P = .001 for noninferiority). The incidence of definite or probable stent thrombosis was 0.5% and 0.7% in the 6-month and 12-month groups, respectively (P = .4). Major bleeding events were lower in the 6-month group than in the 12-month group (0.8% vs 1.4%; P = .2) CONCLUSIONS: In selected patients in this large multicenter study, the safety and efficacy of a 6-month dual antiplatelet therapy regimen after implantation of new-generation drug-eluting stents appeared to be noninferior to those of a 12-month dual antiplatelet therapy regimen. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  17. Newest-generation drug-eluting and bare-metal stents combined with prasugrel-based antiplatelet therapy in large coronary arteries

    DEFF Research Database (Denmark)

    Jeger, Raban; Pfisterer, Matthias; Alber, Hannes

    2012-01-01

    In the BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination (BASKET-PROVE), drug-eluting stents (DESs) had similar 2-year rates of death and myocardial infarction but lower rates of target vessel revascularization and major adverse cardiac events compared with bare-metal sten...... (BMSs). However, comparative clinical effects of newest-generation DES with biodegradable polymers vs second-generation DES or newest-generation BMS with biocompatible coatings, all combined with a prasugrel-based antiplatelet therapy, on 2-year outcomes are not known....

  18. Current manufacturing processes of drug-eluting sutures.

    Science.gov (United States)

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

    2017-02-24

    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.

  19. First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial.

    Science.gov (United States)

    Grundeken, Maik J; Wykrzykowska, Joanna J; Ishibashi, Yuki; Garg, Scot; de Vries, Ton; Garcia-Garcia, Hector M; Onuma, Yoshinobu; de Winter, Robbert J; Buszman, Pawel; Linke, Axel; Ischinger, Thomas; Klauss, Volker; Eberli, Franz; Corti, Roberto; Wijns, William; Morice, Marie-Claude; di Mario, Carlo; Meier, Bernhard; Jüni, Peter; Yazdani, Ashkan; Copt, Samuel; Windecker, Stephan; Serruys, Patrick W

    2016-06-01

    Historically, percutaneous coronary intervention (PCI) of bifurcation lesions was associated with worse procedural and clinical outcomes when compared with PCI of non-bifurcation lesions. Newer generation drug-eluting stents (DES) might improve long-term clinical outcomes after bifurcation PCI. The LEADERS trial was a 10-center, assessor-blind, non-inferiority, all-comers trial, randomizing 1,707 patients to treatment with a biolimus A9(TM) -eluting stent (BES) with an abluminal biodegradable polymer or a sirolimus-eluting stent (SES) with a durable polymer (ClinicalTrials.gov Identifier: NCT00389220). Five-year clinical outcomes were compared between patients with and without bifurcation lesions and between BES and SES in the bifurcation lesion subgroup. There were 497 (29%) patients with at least 1 bifurcation lesion (BES = 258; SES = 239). At 5-year follow-up, the composite endpoint of cardiac death, myocardial infarction (MI) and clinically-indicated (CI) target vessel revascularization (TVR) was observed more frequently in the bifurcation group (26.6% vs. 22.4%, P = 0.049). Within the bifurcation lesion subgroup, no differences were observed in (cardiac) death or MI rates between BES and SES. However, CI target lesion revascularization (TLR) (10.1% vs. 15.9%, P = 0.0495), and CI TVR (12.0% vs. 19.2%, P = 0.023) rates were significantly lower in the BES group. Definite/probable stent thrombosis (ST) rate was numerically lower in the BES group (3.1% vs. 5.9%, P = 0.15). Very late (>1 year) definite/probable ST rates trended to be lower with BES (0.4% vs. 3.1%, P = 0.057). In the treatment of bifurcation lesions, use of BES led to superior long-term efficacy compared with SES. Safety outcomes were comparable between BES and SES, with an observed trend toward a lower rate of very late definite/probable ST between 1 and 5 years with the BES. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  20. Modelling Simple Experimental Platform for In Vitro Study of Drug Elution from Drug Eluting Stents (DES)

    Science.gov (United States)

    Kalachev, L. V.

    2016-06-01

    We present a simple model of experimental setup for in vitro study of drug release from drug eluting stents and drug propagation in artificial tissue samples representing blood vessels. The model is further reduced using the assumption on vastly different characteristic diffusion times in the stent coating and in the artificial tissue. The model is used to derive a relationship between the times at which the measurements have to be taken for two experimental platforms, with corresponding artificial tissue samples made of different materials with different drug diffusion coefficients, to properly compare the drug release characteristics of drug eluting stents.

  1. Everolimus-eluting bioresorbable vascular scaffolds versus second generation drug-eluting stents for percutaneous treatment of chronic total coronary occlusions: Technical and procedural outcomes from the GHOST-CTO registry.

    Science.gov (United States)

    La Manna, Alessio; Chisari, Alberto; Giacchi, Giuseppe; Capodanno, Davide; Longo, Giovanni; Di Silvestro, Michele; Capranzano, Piera; Tamburino, Corrado

    2016-11-15

    We aimed at comparing the acute performance of bioresorbable scaffolds (BRS) and second-generation drug-eluting stents (DES) for the treatment of chronic total occlusions (CTO). There is a lack of knowledge regarding the use of BRS in CTO. Key outcomes of interest were technical and procedural success. Technical success was defined as successful stent delivery and implantation, postprocedural residual diameter stenosis CTO percutaneous coronary intervention (PCI) with the Absorb BRS (Abbott Vascular, Santa Clara, CA) and were compared with a historical control group of 54 patients who had undergone CTO PCI with second-generation DES. Baseline characteristics were similar between the BRS and DES groups, with the exception of a larger mean reference vessel diameter in the BRS group (2.92 ± 0.34 vs 2.50 ± 0.68; P CTO lesions, BRS were associated with lower rates of technical and procedural success. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  2. 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...... this increase in risk was also seen with second-generation drug-eluting stents....

  3. Stent fracture and longitudinal compression detected on coronary CT angiography in the first- and new-generation drug-eluting stents.

    Science.gov (United States)

    Chung, Mi Sun; Yang, Dong Hyun; Kim, Young-Hak; Roh, Jae-Hyung; Song, Jihyun; Kang, Joon-Won; Ahn, Jung-Min; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Park, Seung-Jung; Lim, Tae-Hwan

    2016-04-01

    To evaluated prevalence and clinical implication of stent fracture and longitudinal compression in first- and new-generation drug-eluting stents (DES) using coronary computed tomography angiography (CCTA). The incidence of stent fracture and longitudinal compression were compared between first- and new-generation DES in 374 patients who underwent coronary stenting using DES and follow-up CCTA due to recurrent angina. 235 and 139 patients received 322 first- and 213 new-generation DES, respectively. The crude per-stent incidence of longitudinal compression (6.1 vs. 0.3 %, p stent fracture (11.3 vs. 8.1 %, p = 0.23) was comparable. On follow-up coronary angiography for 347 stents, stent fracture (3.2 %) and longitudinal compression (0.9 %) were less detected than those on CCTA. Ostial stenting was a risk factor of longitudinal compression (p Stent fracture was associated with younger patients (p = 0.03), longer stent (p = 0.010), and excessively tortuous lesions (p = 0.001). The presence of stent fracture or longitudinal compression was not associated with poor clinical outcomes. The longitudinal compression more frequently occurred after new-generation DES implantation. The stent fracture was comparable between two DES. However, the occurrence of such mechanical deformities did not translate into a poor clinical outcome.

  4. Drug-eluting stents and acute myocardial infarction:A lethal combination or friends?

    Institute of Scientific and Technical Information of China (English)

    Shuji; Otsuki; Manel; Sabaté

    2014-01-01

    Primary percutaneous coronary intervention is the preferred reperfusion strategy for patients presenting with ST-segment elevation myocardial infarction(STEMI). First generation drug-eluting stents(DES),(sirolimus drug-eluting stents and paclitaxel drug-eluting stents), reduce the risk of restenosis and target vessel revascularization compared to bare metal stents. However, stent thrombosis emerged as a major safety concern with first generation DES. In response to these safety issues, second generation DES were developed with different drugs, improved stent platforms and more biocompatible durable or bioabsorbable polymeric coating. This article presents an overview of safety and efficacy of the first and second generation DES in STEMI.

  5. Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial

    NARCIS (Netherlands)

    Haude, Michael; Ince, Hüseyin; Abizaid, Alexandre; Toelg, Ralph; Lemos, Pedro Alves; von Birgelen, Clemens; Christiansen, Evald Høj; Wijns, William; Neumann, Franz-Josef; Kaiser, Christoph; Eeckhout, Eric; Lim, Soo Teik; Escaned, Javier; Onuma, Yoshinobu; Garcia-Garcia, Hector M.; Waksman, Ron

    2016-01-01

    Aims Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomes of a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesium scaffold backbone, have been reported. We assessed the

  6. Long-term effectiveness and safety of sirolimus drug-eluting stents

    Directory of Open Access Journals (Sweden)

    Bikkina M

    2011-08-01

    Full Text Available Mahesh Bikkina, Jayanth KoneruSt Joseph Regional Medical Center, Paterson, Seton Hall University, NJ, USAAbstract: The root cause of coronary artery disease is atherosclerosis, ie, intraluminal narrowing (stenosis of the arteries that supply blood to tissues of the heart. The introduction of the drug-eluting stent over the past decade has revolutionized the field of interventional cardiology. It is used extensively in clinical practice for the treatment of coronary artery disease. The first drug-eluting stent to receive US Food and Drug Administration approval was the sirolimus-eluting stent. Recently, two other stent analogs of sirolimus were approved, ie, the zotarolimus-eluting stent and the everolimus-eluting stent. However, concern has arisen in recent years about the long-term safety and efficacy of drug-eluting stents, due to the occurrence of late adverse clinical events, such as stent thrombosis. This review focuses on clinical studies that have been performed with the sirolimus-eluting stent or its analogs. We discuss the pharmacology, safety, and various therapeutic options that exist when choosing stents for coronary artery disease. Our aim is to provide a thorough review of the long-term efficacy and safety of sirolimus drug-eluting stents, and also to discuss currently approved and promising investigational drug-eluting stents, in an effort to provide insight into how these stents are currently evolving and generate further investigation in this area.Keywords: drug-eluting stent, long-term safety, sirolimus 

  7. Impact of Chronic Kidney Disease on Clinical Outcomes in Diabetic Patients Undergoing Percutaneous Coronary Intervention in the Era of Newer-Generation Drug-Eluting Stents

    Science.gov (United States)

    Kim, Su-Min; Tripathy, Dipti Ranjan; Park, Sang Wook; Park, Bonil; Son, Jung-Woo; Lee, Jun-Won; Ahn, Sung-Gyun; Ahn, Min Soo; Kim, Jang-Young; Yoo, Byung-Su; Lee, Seung-Hwan; Yoon, Junghan

    2017-01-01

    Background and Objectives Chronic kidney disease (CKD) is known to be a major adverse predictor in diabetes mellitus (DM) patients undergoing percutaneous coronary intervention (PCI). It is expected that the use of newer-generation drug-eluting stents (DES) would improve clinical outcomes in these patients. We evaluated the impact of CKD on clinical outcomes in diabetic patients undergoing PCI using newer-generation DES in a real-world setting. Subjects and Methods A total of 887 patients who underwent PCI with newer-generation DES and who had a history of DM or HbA1c >6.5% at the time of hospitalization were analyzed. These patients were divided into groups without CKD (n=549) and with CKD (n=338). Among survivors at discharge, a patient-oriented composite outcome (POCO) including all-cause mortality, myocardial infarction (MI), and revascularization was evaluated, together with a device-oriented composite outcome (DOCO) including cardiac death, target vessel-related MI, and target lesion revascularization at a follow-up period of one year. Results The incidence of POCO (5.4% vs. 14.0%, log-rank pCKD. According to multivariate analysis, which was adjusted for baseline differences in demographic, clinical, and angiographic factors, the presence of CKD was an independent predictor of POCO (hazard ratio [HR]: 1.82, 95% confidence interval [CI]: 1.07 to 3.12), but not of DOCO (HR 2.08, 95% CI: 0.69-6.28). Conclusion In DM patients, CKD is an independent and powerful predictor of patient-related outcomes, but not of device-related outcomes in the era of newer-generation DES. PMID:28382078

  8. 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.

  9. Drug-eluting stents below the knee.

    Science.gov (United States)

    Bosiers, M; Deloose, K; Callaert, J; Keirse, K; Verbist, J; Peeters, P

    2011-04-01

    The fear that early thrombosis and late luminal loss due to intimal hyperplasia formation potentially leads to insufficient long-term patency rates can explain the reluctance on implanting stents in small diameter below-the-knee (BTK) arteries. Drug-eluting stent (DES) technology was developed to prevent early thrombosis and late luminal loss to potentially improve long-term patency rates. Currently, the first level 1 evidence from prospective, randomized, controlled DESTINY and ACHILLES studies indicate that the implantation of DES in short lesion lenghts in the infrapopliteal vasculature leads to favorable outcomes with high primary patency rates. This makes that primary DES placement can be recommended as treatment strategy in short BTK-lesions.

  10. 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.

  11. Long-term effectiveness and safety of sirolimus drug-eluting stents

    Science.gov (United States)

    Bikkina, Mahesh; Koneru, Jayanth

    2011-01-01

    The root cause of coronary artery disease is atherosclerosis, ie, intraluminal narrowing (stenosis) of the arteries that supply blood to tissues of the heart. The introduction of the drug-eluting stent over the past decade has revolutionized the field of interventional cardiology. It is used extensively in clinical practice for the treatment of coronary artery disease. The first drug-eluting stent to receive US Food and Drug Administration approval was the sirolimus-eluting stent. Recently, two other stent analogs of sirolimus were approved, ie, the zotarolimus-eluting stent and the everolimus-eluting stent. However, concern has arisen in recent years about the long-term safety and efficacy of drug-eluting stents, due to the occurrence of late adverse clinical events, such as stent thrombosis. This review focuses on clinical studies that have been performed with the sirolimus-eluting stent or its analogs. We discuss the pharmacology, safety, and various therapeutic options that exist when choosing stents for coronary artery disease. Our aim is to provide a thorough review of the long-term efficacy and safety of sirolimus drug-eluting stents, and also to discuss currently approved and promising investigational drug-eluting stents, in an effort to provide insight into how these stents are currently evolving and generate further investigation in this area. PMID:22915938

  12. Impact of anaemia on long-term outcomes in patients treated with first- and second-generation drug-eluting stents; Katowice-Zabrze Registry.

    Science.gov (United States)

    Wańha, Wojciech; Kawecki, Damian; Roleder, Tomasz; Pluta, Aleksandra; Marcinkiewicz, Kamil; Dola, Janusz; Morawiec, Beata; Krzych, Łukasz; Pawłowski, Tomasz; Smolka, Grzegorz; Ochała, Andrzej; Nowalany-Kozielska, Ewa; Tendera, Michał; Wojakowski, Wojciech

    2016-01-01

    Coexisting anaemia is associated with an increased risk of major adverse cardiac and cerebrovascular events (MACCE) and bleeding complications after percutaneous coronary intervention (PCI), especially in patients with acute coronary syndrome. To assess the impact of anaemia in patients with coronary artery disease (CAD) treated with first- and second-generation drug-eluting stents (DES) on one-year MACCE. The registry included 1916 consecutive patients (UA: n = 1502, 78.3%; NSTEMI: n = 283, 14.7%; STEMI/LBBB: n = 131, 6.8%) treated either with first- (34%) or second-generation (66%) DES. The study population was divided into two groups: patients presenting with anaemia 217 (11%) and without anaemia 1699 (89%) prior to PCI. Anaemia was defined according to World Heart Organisation (haemoglobin [Hb] level anaemia were older (69, IQR: 61-75 vs. 62, IQR: 56-70, p anaemia was found. Patients with anaemia more often had prior myocardial infarction (MI) (57.6% vs. 46.4%; p = 0.002) and coronary artery bypass grafting (31.3% vs. 19.4%; p anaemia. They also more often had multivessel disease in angiography (36.4% vs. 26.1%; p = 0.001) and more complexity CAD as measured by SYNTAX score (21, IQR: 12-27 points vs. 14, IQR: 8-22 points; p = 0.001). In-hospital risk of acute heart failure (2.7% vs. 0.7%; p = 0.006) and bleeding requiring transfusion (3.2% vs. 0.5%; p anaemia. One-year follow-up showed that there was higher rate of death in patients with anaemia. However, there were no differences in MI, stroke, target vessel revascularisation (TVR) and MACCE in comparison to patients with normal Hb. There were no differences according to type of DES (first vs. second generation) in the population of patients with anaemia. In patients with anaemia there is a significantly higher risk of death in 12-month follow-up, but anaemia has no impact on the incidence of MI, repeat revascularisation, stroke and MACCE. There is no advantage of II-DES over I-DES generation in terms of MACCE

  13. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial

    NARCIS (Netherlands)

    Haude, Michael; Ince, Hüseyin; Abizaid, Alexandre; Toelg, Ralph; Lemos, Pedro Alves; von Birgelen, Clemens; Christiansen, Evald Høj; Wijns, William; Neumann, Franz-Josef; Kaiser, Christoph; Eeckhout, Eric; Lim, Soo Teik; Escaned, Javier; Garcia-Garcia, Hector M.; Waksman, Ron

    2016-01-01

    Background Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting

  14. Drug-eluting stents, restenosis and revascularization.

    Science.gov (United States)

    Ramcharitar, Steve; Gaster, Anne Louise; Daemen, Joost; Serruys, Patrick

    2007-06-01

    Several meta-analyses have demonstrated the superiority of drug-eluting stents (DES) in reducing the incidence of restenosis, target vessel revascularization and target lesion revascularization compared to their predecessor, the bare-metal stent. In comparing Cypher and Taxus stents, the two most recent meta-analyses have given the edge to the Cypher. However, it must be stressed that the superiority of one DES over another remains debatable due to ever changing "real-world data" compared to those attained from randomized trials. The newer sirolimus analogs and selective inhibitors are challenging the old guard in their quest to further limit restenosis. So too are the newer "high-tech" polymers and additionally by using more biodegradable material in the stent's design. Stents aimed at targeting lesions are a new armament in the battle against restenosis and together with combination therapies are exciting key areas to watch. The ideal way to treat a DES in-stent restenosis is still a challenge and hence the impetus is to avoid it from happening in the first place.

  15. Clinical evidence-based study on new-generation drug-eluting stent:everolimus-eluting stents(Xience Ⅴ)%新一代药物洗脱支架依维莫司药物洗脱支架临床循证研究

    Institute of Scientific and Technical Information of China (English)

    高文俊; 刘文洁; 柯永胜

    2009-01-01

    Percutaneous coronary intervention (PCI) has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently,first-generation drug-eluting stents ( DES) , such as sirolimus-eluting (Cypher) and paclitaxel-eluting stents ( Tax-us) , have further improved results of percutaneous coronary intervention by improving early results and reducing the risk of restenosis. There are currently debates on the safety of these first-generation DES, given the potential for late stent thrombosis which is a first-generation drug-eluting stent of the largest security issue, es- pecially after discontinuation of dual antiplatelet therapy. Next-generation DES such as everolimus-eluting stents (Xience V) holds the promise of superior anti-restenosis efficacy as well as long-term safety. This review makes a presentation of the evidence-based clinical research according to everolimus-eluting stents (Xience V).%经皮冠状动脉介入(percutaneous coronary intervention,PCI)自20世纪70年代末应用临床以来,已成为治疗冠心病主要手段之一.第一代药物洗脱支架(drug-eluting stent,DES)如雷帕霉素洗脱支架(Cypher)和紫杉醇洗脱支架(Taxus)的循证医学证据表明其与金属裸支架比较,能进一步改善PCI的早期疗效,并减少再狭窄的风险.第一代DES在停止双重抗血小板治疗后出现的潜在的支架晚期血栓形成,是第一代DES最大的安全性问题.新一代DES依维莫司药物涂层支架(Xience Ⅴ)具有优越的抗再狭窄疗效以及长期安全性.本文就依维莫司药物涂层支架(Xience Ⅴ)的临床循证研究作一介绍.

  16. 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

  17. Drug-eluting technologies in femoral artery lesions.

    Science.gov (United States)

    Deloose, K; Lauwers, K; Callaert, J; Maene, L; Keirse, K; Verbist, J; Peeters, P; Bosiers, M

    2013-04-01

    The treatment of femoropopliteal lesions has known an important evolution in the last years. An important limitation of current endovascular therapy remains the occurrence of restenosis. In order to minimize restenosis rates, drug eluting technologies are evolving. The use of drug-eluting stents (DES) in coronary arteries shows beneficial results, leading to investigation of DES in femoropopliteal arteries. In this article, we give an overview of current available data on treatment with drug eluting technologies in the superficial femoral artery (SFA). This paper summarizes also the current available data of the use of drug-coated balloons (DCB) in the femoropopliteal tract. Currently, no data are available on the use of DCB in long lesions. A drug eluting bioresorbable scaffold seems to be very promising in coronary arteries. The transfer to the peripheral area is nowadays ongoing. Which technique and device for which lesion and patient requires further investigation to build up a real evidence based SFA treatment strategy.

  18. Fully bioresorbable drug-eluting coronary scaffolds: A review.

    Science.gov (United States)

    Charpentier, Emmanuel; Barna, Alexandre; Guillevin, Loïc; Juliard, Jean-Michel

    2015-01-01

    Following the development of stents, then drug-eluting stents (DES), bioresorbable scaffolds are proposed as a third evolution in coronary angioplasty, aiming to reduce the incidence of restenosis and stent thrombosis and to restore vascular physiology. At least 16 such devices are currently under development, but published clinical data were available for only three of them in September 2014. The first device is Abbott's BVS(®), a poly-L-lactic acid (PLLA)-based everolimus-eluting device, which has been tested in a registry and two non-randomized trials. Clinical results seem close to what is expected from a modern DES, but possibly with more post-procedural side-effects. Two randomized trials versus DES are underway. This device is already marketed in many European countries. The second device is Elixir's DESolve(®), a PLLA-based novolimus-eluting device, which has been evaluated in two single-arm trials. Results are not widely different from those expected from a DES. The third device is Biotronik's DREAMS(®), a metallic magnesium-based paclitaxel-eluting device, which has been assessed in an encouraging single-arm trial; its second version is currently undergoing evaluation in a single-arm trial. The available results suggest that the technological and clinical development of bioresorbable scaffolds is not yet complete: their possible clinical benefits are still unclear compared with third-generation DES; the impact of arterial physiology restoration has to be assessed over the long term; and their cost-effectiveness has to be established. From the perspective of a health technology assessment, there is no compelling reason to hasten the clinical use of these devices before the results of ongoing randomized controlled trials become available.

  19. Neoatherosclerosis after Drug-Eluting Stent Implantation: Roles and Mechanisms

    Directory of Open Access Journals (Sweden)

    Yuanyuan Cui

    2016-01-01

    Full Text Available In-stent neoatherosclerosis (NA, characterized by a relatively thin fibrous cap and large volume of yellow-lipid accumulation after drug-eluting stents (DES implantation, has attracted much attention owing to its close relationship with late complications, such as revascularization and late stent thrombosis (ST. Accumulating evidence has demonstrated that more than one-third of patients with first-generation DES present with NA. Even in the advent of second-generation DES, NA still occurs. It is indicated that endothelial dysfunction induced by DES plays a critical role in neoatherosclerotic development. Upregulation of reactive oxygen species (ROS induced by DES implantation significantly affects endothelial cells healing and functioning, therefore rendering NA formation. In light of the role of ROS in suppression of endothelial healing, combining antioxidant therapies with stenting technology may facilitate reestablishing a functioning endothelium to improve clinical outcome for patients with stenting.

  20. Drug eluting stents: Current status and new developments

    NARCIS (Netherlands)

    G. Ertaş; H.M.M. van Beusekom (Heleen)

    2012-01-01

    textabstractDespite the favorable impact of drug eluting stents on stent restenosis, their long-term reliability is considered worrisome by some because of stent thrombosis. Often attributed to adverse reactions to the stent platform, both the drugs and polymer characteristics have been further adva

  1. Drug eluting stents: Current status and new developments

    NARCIS (Netherlands)

    G. Ertaş; H.M.M. van Beusekom (Heleen)

    2012-01-01

    textabstractDespite the favorable impact of drug eluting stents on stent restenosis, their long-term reliability is considered worrisome by some because of stent thrombosis. Often attributed to adverse reactions to the stent platform, both the drugs and polymer characteristics have been further

  2. Recent developments in drug-eluting coronary stents.

    Science.gov (United States)

    Yildiz, Mustafa; Yildiz, Banu Sahin; Gursoy, Mustafa Ozan; Akin, Ibrahim

    2014-01-01

    The interventional treatment of coronary artery disease was introduced in 1970`s by Andreas Grüntzig. The initial treatment strategy with plain old balloon angioplasty (POBA) was associated with high restenosis rates. The introduction of coronary stents, especially drug-eluting stents (DES) in 2002 has improved the results by lowering the rate of in-stent restenosis from 20-40% in the era of bare-metal stent (BMS) to 6-8%. However, in 2006 with the observation of late stent thrombosis the reputations of DES have decreased. However, improvements in stent design especially antiproliferative agents, polymeric agents as well as stent platforms improved newer generation DES. In controlled trials as well as registries the use of second-generation DES as compared to bare-metal stents (BMS) was associated with better clinical and angiographic results. A further development of these stents with use of biodegradable polymers, polymer-free stents, and biodegradable stents on the basis of poly L-lactide (PLLA) or magnesium resulted in third-generation DES and has been evaluated in preclinical and first clinical trials. However, to date, there is a lack of data comparing these third-generation DES with first- and second-generatrion DES in a large scale.

  3. Drug-eluting stents in octogenarians : Early and intermediate outcome

    NARCIS (Netherlands)

    Vlaar, Pieter J.; Lennon, Ryan J.; Rihal, Charanjit S.; Singh, Mandeep; Ting, Henry H.; Bresnahan, John F.; Holmes, David R.

    2008-01-01

    Background Large randomized controlled trials have demonstrated that percutaneous coronary intervention with the routine use of drug-eluting stents is safe and effective. However, octogenarians are usually excluded from these trials. Methods We analyzed 2453 consecutive patients who underwent DES im

  4. Safety and efficacy of drug-eluting stents in women

    DEFF Research Database (Denmark)

    Stefanini, Giulio G; Baber, Usman; Windecker, Stephan

    2013-01-01

    The safety and efficacy of drug-eluting stents (DES) in the treatment of coronary artery disease have been assessed in several randomised trials. However, none of these trials were powered to assess the safety and efficacy of DES in women because only a small proportion of recruited participants ...

  5. Drug-eluting stents in superficial femoral artery treatment: could they be the standard of care?

    Science.gov (United States)

    Bosiers, Marc; Deloose, Koen; Callaert, Joren; Peeters, Patrick; Bosiers, Michel

    2016-12-01

    Endovascular techniques have improved markedly over the past several decades. Plain old balloon angioplasty can only reach patencies around 40% after 1 year. Scaffolding stents have resulted in improved short-term results but encountered limitations for longer-term durability. With the introduction of drug-eluting technologies the process of intimal hyperplasia might be slowed, resulting in improved long-term patency results. At first, limus-eluting technologies were not able to transfer the enthusiasm from the coronaries to the infrainguinal vascular bed. However, the newer generation paclitaxel-eluting technologies perform significantly better in femoropopliteal arteries than their non-eluting or non-coated counterparts. The results of a prospective randomized trial comparing DES versus DCB is eagerly awaited. For the moment there seems, based on the meta-analysis, no difference between the two treatment modalities. Although, we need to keep in mind that DCB perform worse in long calcified lesions.

  6. Drug-eluting bioabsorbable magnesium stent.

    Science.gov (United States)

    Di Mario, Carlo; Griffiths, Huw; Goktekin, Omer; Peeters, Nicolas; Verbist, Jan; Bosiers, Marc; Deloose, Koen; Heublein, Bernhard; Rohde, Roland; Kasese, Victor; Ilsley, Charles; Erbel, Raimund

    2004-12-01

    Current stent technology is based on the use of permanent implants that remain life long in the vessel wall, far beyond the time required for the prosthesis to accomplish its main goals of sealing dissection and preventing wall recoil. With the possibility to implant long vessel segments using antiproliferative drugs to prevent restenosis, the practice of transforming the coronary vessels into stiff tubes with a full metal jacket covering all side branches and being unable to adjust to the long-term wall changes, including wall remodeling with lumen ectasia becomes a serious concern. In this article, we describe the first biodegradable stent based on a magnesium alloy that allows controlled corrosion with release to the vessel wall and the blood stream of a natural body component such as magnesium with beneficial antithrombotic, antiarrhythmic, and antiproliferative properties. We also discuss the animal experiments and the initial clinical applications in 20 patients with implants below the knee, with final results soon to be released, and the plans for the first coronary study. The results of these last two studies will indicate whether the absence of a permanent implant and the antiproliferative properties shown in animals are sufficient to prevent the restenotic process in humans or whether the prosthesis must be modified by adding the biodegradable coating with conventional antiproliferative drugs.

  7. 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...

  8. Clinical assessment of drug-eluting stents: Twente trial and beyond

    NARCIS (Netherlands)

    Tandjung, K.

    2014-01-01

    Stents have revolutionized the treatment of obstructive coronary disease by improving the safety of percutaneous coronary intervention (PCI) and reducing the need for repeat revascularization. First-generation drug-eluting stents (DES) were highly efficacious, as they further reduced the need for re

  9. Suppression of scarring in peripheral nerve implants by drug elution

    Science.gov (United States)

    FitzGerald, James J.

    2016-04-01

    Objective. Medical implants made of non-biological materials provoke a chronic inflammatory response, resulting in the deposition of a collagenous scar tissue (ST) layer on their surface, that gradually thickens over time. This is a critical problem for neural interfaces. Scar build-up on electrodes results in a progressive decline in signal level because the scar tissue gradually separates axons away from the recording contacts. In regenerative sieves and microchannel electrodes, progressive scar deposition will constrict and may eventually choke off the sieve hole or channel lumen. Interface designs need to address this issue if they are to be fit for long term use. This study examines a novel method of inhibiting the formation and thickening of the fibrous scar. Approach. Research to date has mainly focused on methods of preventing stimulation of the foreign body response by implant surface modification. In this paper a pharmacological approach using drug elution to suppress chronic inflammation is introduced. Microchannel implants made of silicone doped with the steroid drug dexamethasone were implanted in the rat sciatic nerve for periods of up to a year. Tissue from within the microchannels was compared to that from control devices that did not release any drug. Main results. In the drug eluting implants the scar layer was significantly thinner at all timepoints, and unlike the controls it did not continue to thicken after 6 months. Control implants supported axon regeneration well initially, but axon counts fell rapidly at later timepoints as scar thickened. Axon counts in drug eluting devices were initially much lower, but increased rather than declined and by one year were significantly higher than in controls. Significance. Drug elution offers a potential long term solution to the problem of performance degradation due to scarring around neural implants.

  10. Detection of very early stent healing after primary angioplasty: an optical coherence tomographic observational study of chromium cobaltum and first-generation drug-eluting stents. The DETECTIVE study.

    Science.gov (United States)

    Prati, Francesco; Stazi, Filippo; Dutary, Jaime; La Manna, Alessio; Di Giorgio, Alessandro; Pawlosky, Tomasz; Gonzalo, Nieves; Di Salvo, Maria Elena; Imola, Fabrizio; Tamburino, Corrado; Albertucci, Mario; Alfonso, Fernando

    2011-11-01

    Lack of stent coverage appears to be associated with stent thrombosis, a problem of particular concern in patients with ST elevation myocardial infarction (STEMI). The DETECTIVE European Multicenter Registry was set up to address the early modality of stent healing in the setting of STEMI. The Registry compared, with an early optical coherence tomography (OCT) evaluation performed at 3-7 days, the patterns of coverage and apposition of the first generation of drug-eluting stents (DESs) and cobalt chromium non-drug-eluting stents (CCSs) that were deployed in culprit lesions and in non-culprit segments. The Registry included only patients with a multi-vessel disease to allow, at 3-7 days from the first angioplasty, a deferred OCT examination and a staged intervention in another vessel. 28 stented lesions (15 patients) eventually entered the final OCT assessment. 13 stents were first-generation DESs, while the remaining 15 were CCSs. 18 stents (64%) were deployed at culprit STEMI lesions, and the remaining 10 (36%) were deployed at non-culprit sites. The distribution of clinical and procedural variables in DES and CCS as well as in culprit and non-culprit sites was not different. In total, 27,019 struts were analysed in 28 stents. The percentage of stent uncoverage in the overall analysis was 11.7%, while the percentage of malapposition and that of struts covered with thrombus were 4.8% and 2.2%, respectively. A low percentage of strut uncoverage was found in all the four studied subgroups: DES 12.8%, CCS 10.9%, stents deployed in culprit lesions 13.2% and stents deployed in non-culprit lesions 8.7%. In conclusion, our data show that in patients with STEMI, a very high percentage of stent struts is covered by an early thin rim of tissue within 7 days after stent positioning. The present data bring new insights in the mechanism and timing of strut coverage.

  11. 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.

  12. Drug-eluting stents in renal artery stenosis

    Energy Technology Data Exchange (ETDEWEB)

    Zaehringer, M. [Marienhospital Stuttgart, Department of Radiology, Stuttgart (Germany); Pattynama, P.M.T. [Erasmus MC-University Medical Center Rotterdam, Rotterdam (Netherlands); Talen, A. [genae associates nv, Antwerp (Belgium); Sapoval, M. [Hopital Europeen Georges Pompidou, Service de Radiologie Cardio-Vasculaire, Paris (France); Inserm U 780 epidemiologie Cardio Vasculaire, Paris (France)

    2008-04-15

    Because of higher acute and long-term success rates compared with balloon angioplasty alone, percutaneous stent implantation has become an accepted therapy for the treatment of atherosclerotic renal artery stenosis. Restenosis rates after successful renal stent placement vary from 6 up to 40%, depending on the definition of restenosis, the diameter of the treated vessel segment and comorbidities. The safety and efficacy of drug-eluting stents for the treatment of renal-artery stenosis is poorly defined. The recently published GREAT study is the only prospective study, comparing bare-metal and sirolimus-coated low profile stent systems in renal artery stenosis, showing a relative risk reduction of angiographic binary in-stent restenosis by 50%. This is an opinion paper on indications, current treatment options and restenosis rates following renal artery stenting and the potential use of drug-eluting stents for this indication. (orig.)

  13. Drug- and Gene-eluting Stents for Preventing Coronary Restenosis

    Science.gov (United States)

    Lekshmi, Kamali Manickavasagam; Che, Hui-Lian; Cho, Chong-Su

    2017-01-01

    Coronary artery disease (CAD) has been reported to be a major cause of death worldwide. Current treatment methods include atherectomy, coronary angioplasty (as a percutaneous coronary intervention), and coronary artery bypass. Among them, the insertion of stents into the coronary artery is one of the commonly used methods for CAD, although the formation of in-stent restenosis (ISR) is a major drawback, demanding improvement in stent technology. Stents can be improved using the delivery of DNA, siRNA, and miRNA rather than anti-inflammatory/anti-thrombotic drugs. In particular, genes that could interfere with the development of plaque around infected regions are conjugated on the stent surface to inhibit neointimal formation. Despite their potential benefits, it is necessary to explore the various properties of gene-eluting stents. Furthermore, multifunctional electronic stents that can be used as a biosensor and deliver drug- or gene-based on physiological condition will be a very promising way to the successful treatment of ISR. In this review, we have discussed the molecular mechanism of restenosis, the use of drug- and gene-eluting stents, and the possible roles that these stents have in the prevention and treatment of coronary restenosis. Further, we have explained how multifunctional electronic stents could be used as a biosensor and deliver drugs based on physiological conditions. PMID:28184335

  14. Percutaneous drug-eluting stent implantation in dextrocardia: case report

    Institute of Scientific and Technical Information of China (English)

    ZHANG Qi; ZHANG Rui-yan; HU Jian; SHEN Wei-feng

    2007-01-01

    @@ Although situs inversus with dextrocardia is a rare clinical phenomenon, the association with coronary artery disease(CAD) is at the same frequency as in the general population.1,2 Few cases of dextrocardia complicated with CAD was reported before. The feasibility and prognosis of percutaneous coronary intervention (PCI) in such case still remains unclear because of the uncommon anatomical abnormality,especially in the drug-eluting stent (DES) era. Here we report a female case with dextrocardia and CAD was successfully treated by DES implantation.

  15. Domestic coronary drug-eluting stents on a new horizon

    Institute of Scientific and Technical Information of China (English)

    SHEN Wei-feng

    2012-01-01

    Supported by growing evidence from randomized clinical trials and observational or registry studies,percutaneous coronary intervention (PCI) with implantation of drug-eluting stents (DES) has become the standard of care for coronary artery disease,because of reduced repeat intervention and improved clinical outcomes in comparison with bare metal stent.1-3Currently,majority of coronary artery disease patients with complicated lesion subsets or clinical conditions can be successfully treated with DES-based PCI with favorable results.4-6 In 2011,around 300000 PCI procedures have been performed in China,with the penetration rate of DES reaching beyond 90% in most of the centers.

  16. Cost-Effectiveness Analysis of Infrapopliteal Drug-Eluting Stents

    Energy Technology Data Exchange (ETDEWEB)

    Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr; Karnabatidis, Dimitris; Diamantopoulos, Athanasios; Spiliopoulos, Stavros; Siablis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece)

    2013-02-15

    IntroductionThere are no cost-utility data about below-the-knee placement of drug-eluting stents. The authors determined the cost-effectiveness of infrapopliteal drug-eluting stents for critical limb ischemia (CLI) treatment. The event-free individual survival outcomes defined by the absence of any major events, including death, major amputation, and target limb repeat procedures, were reconstructed on the basis of two published infrapopliteal series. The first included spot Bail-out use of Sirolimus-eluting stents versus bare metal stents after suboptimal balloon angioplasty (Bail-out SES).The second was full-lesion Primary Everolimus-eluting stenting versus plain balloon angioplasty and bail-out bare metal stenting as necessary (primary EES). The number-needed-to-treat (NNT) to avoid one major event and incremental cost-effectiveness ratios (ICERs) were calculated for a 3-year postprocedural period for both strategies. Overall event-free survival was significantly improved in both strategies (hazard ratio (HR) [confidence interval (CI)]: 0.68 [0.41-1.12] in Bail-out SES and HR [CI]: 0.53 [0.29-0.99] in Primary EES). Event-free survival gain per patient was 0.89 (range, 0.11-3.0) years in Bail-out SES with an NNT of 4.6 (CI: 2.5-25.6) and a corresponding ICER of 6,518 Euro-Sign (range 1,685-10,112 Euro-Sign ). Survival gain was 0.91 (range 0.25-3.0) years in Primary EES with an NNT of 2.7 (CI: 1.7-5.8) and an ICER of 11,581 Euro-Sign (range, 4,945-21,428 Euro-Sign ) per event-free life-year gained. Two-way sensitivity analysis showed that stented lesion length >10 cm and/or DES list price >1000 Euro-Sign were associated with the least economically favorable scenario in both strategies. Both strategies of bail-out SES and primary EES placement in the infrapopliteal arteries for CLI treatment exhibit single-digit NNT and relatively low corresponding ICERs.

  17. Long-term effectiveness and safety of sirolimus drug-eluting stents

    OpenAIRE

    Bikkina, Mahesh; Koneru, Jayanth

    2011-01-01

    The root cause of coronary artery disease is atherosclerosis, ie, intraluminal narrowing (stenosis) of the arteries that supply blood to tissues of the heart. The introduction of the drug-eluting stent over the past decade has revolutionized the field of interventional cardiology. It is used extensively in clinical practice for the treatment of coronary artery disease. The first drug-eluting stent to receive US Food and Drug Administration approval was the sirolimus-eluting stent. Recently, t...

  18. Outcome of overlapping heterogenous drug-eluting stents and of overlapping drug-eluting and bare metal stents.

    Science.gov (United States)

    Burzotta, Francesco; Siviglia, Massimo; Altamura, Luca; Trani, Carlo; Leone, Antonio Maria; Romagnoli, Enrico; Mazzari, Mario Attilio; Mongiardo, Rocco; Niccoli, Giampaolo; Brancati, Marta; Biondi-Zoccai, Giuseppe; Rebuzzi, Antonio Giuseppe; Schiavoni, Giovanni; Crea, Filippo

    2007-02-01

    Overlapping homogenous drug-eluting stents (DESs) may be used instead of overlapping bare metal stents (BMSs) to treat coronary lesions longer than available stents. Yet, no data are available on patients treated with overlapping heterogenous DESs or DESs and BMSs. We prospectively assessed 9-month clinical outcome and 6-month angiographic late loss (evaluated at 5 different lesion segments) in a consecutive series of 40 patients who received overlapping homogenous DESs (sirolimus-eluting stent [SES] or paclitaxel-eluting stent [PES]), heterogenous DESs (SES + PES), or overlapping DESs and BMSs. In 8 patients (7 with angiographic follow-up) with overlapping heterogenous DESs, no angiographic or clinical adverse event was observed. Moreover, in-segment late loss was similar to that of patients who received homogenous DESs. In 8 patients (7 with angiographic follow-up) with overlapping DESs and BMSs, there was a higher incidence of major adverse events (3 repeat percutaneous coronary interventions and 1 death, 50% adverse event rate) and worse in-segment binary restenosis rate compared with patients treated with homogenous or heterogenous DESs (p = 0.02 and 0.012, respectively). Late lumen loss at the site of stent overlap showed significant differences according to type of overlapped stent (1.00 +/- 0.76 mm in DES-BMS overlap, 0.32 +/- 0.55 mm in PES-PES overlap, 0.13 +/- 0.11 in SES-PES overlap, and 0.08 +/- 0.10 mm in SES-SES overlap, p = 0.005). In conclusion, the present study suggests that overlap of DESs and BMSs should be avoided because the antirestenotic effect of DESs is skewed by contiguous BMS implantation. Overlap between SESs and PESs in this very preliminary report was associated with no specific adverse event.

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

    Science.gov (United States)

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

    2012-07-01

    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.

  20. 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

  1. Are drug-eluting stents the future of SFA treatment?

    Science.gov (United States)

    Bosiers, M; Deloose, K; Keirse, K; Verbist, J; Peeters, P

    2010-02-01

    Drug-eluting stent (DES) technology was developed to prevent early thrombosis and late luminal loss to potentially improve long-term patency rates. Although favorable DES results have recently become available with the Zilver PTX and STRIDES studies, the high price of DES is a major drawback for this technology to become the golden standard for peripheral endovascular therapy in de novo femoro-popliteal (FP) lesions. Nevertheless, DES has the potential to make the difference and to establish itself as an important treatment option in patients presenting with TASC C&D FP lesions who are at high-risk for surgery and for the treatment of in-stent restenosis, where until now, no valuable treatment option has proven to be beneficial.

  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. Polymer-Free Drug-Eluting Stents : An Overview of Coating Strategies and Comparison with Polymer-Coated Drug-Eluting Stents

    NARCIS (Netherlands)

    Chen, Weiluan|info:eu-repo/dai/nl/371747198; Habraken, Tom C J; Hennink, Wim E.|info:eu-repo/dai/nl/070880409; Kok, Robbert J.|info:eu-repo/dai/nl/170678326

    2015-01-01

    Clinical evaluations have proven the efficacy of drug-elution stents (DES) in reduction of in-stent restenosis rates as compared to drug-free bare metal stents (BMS). Typically, DES are metal stents that are covered with a polymer film loaded with anti-inflammatory or antiproliferative drugs that

  4. Advances in drug eluting stents – focus on the Endeavor® zotarolimus stent

    Directory of Open Access Journals (Sweden)

    Jonathan Bridges

    2008-12-01

    Full Text Available Jonathan Bridges, Donald CutlipBeth Israel Deaconess Medical Center, Boston, Massachusetts, USAAbstract: Coronary artery disease remains one of the leading causes of death in the United States. Over the last 30 years, the development of coronary artery angioplasty and stenting has drastically reduced mortality during acute coronary syndromes while also reducing symptoms of chronic coronary artery disease. Unfortunately, the placement of stents in a coronary artery can be complicated by in-stent thrombosis or restenosis. In 2003–2004, a new generation of stents was introduced to the market with the goal of reducing the rate of restenosis. These stents, called drug eluting stents (DES, are coated with a pharmacological agent designed to reduce the neointimal hyperplasia associated with restenosis. Within a year, approximately 80% of all percutaneous coronary interventions performed within the US involved placement of a DES. In 2006, a controversy arose about the possibility of a statistically significant increased risk of acute stent thrombosis associated with DES especially when used for an “off label” indication. This risk was attributed to delayed endothelization. This controversy has led to a reduction in the use of DES along with longer use of dual platelet inhibition with aspirin and clopidogrel. Recently Medtronic introduced a new DES to the market called the Endeavor® stent – a zotarolimus eluting stent.Keywords: Endeavor® stent, zotarolimus stent, drug eluting stent

  5. Local drug-delivery balloon for proliferative occlusive in-stent restenosis after drug-eluting stent

    Institute of Scientific and Technical Information of China (English)

    Gianluca Rigatelli; Paolo Cardaioli; Fabio Dell'Avvocata; Massimo Giordan

    2011-01-01

    Drug-coated balloon has been developed as an alternative to drug-eluting stents for in-stent restenosis but the performance of drug infusion balloon in such setting has not been previously described. We present a case of particularly aggressive in-stent restenosis after drug eluting stent implantation treated with a new kind of drug infusion balloon developed in order to overcome the impossibility to inflate regular drug-coated balloon for several dilatation.

  6. Drug-eluting stents in percutaneous coronary intervention: a benefit-risk assessment.

    Science.gov (United States)

    Byrne, Robert A; Sarafoff, Nikolaus; Kastrati, Adnan; Schömig, Albert

    2009-01-01

    Drug-eluting stent (DES) therapy has represented a very significant milestone in the evolution of percutaneous coronary intervention (PCI) therapy. This review attempts to provide a balanced overview of the unprecedented wealth of data generated on this new technology, by examining the evidence bases for anti-restenotic efficacy, safety and cost effectiveness. The performance of a DES may be related to each of its three components: stent backbone; carrier polymer (to control drug-release kinetics); and active drug. In terms of anti-restenotic efficacy, the most appropriate parameters to examine are target lesion revascularization, angiographic restenosis and late luminal loss. The principal safety parameters are overall mortality, myocardial infarction (MI) and stent thrombosis. Anti-restenotic superiority of DES over bare metal stents (BMS) has been demonstrated across a spectrum of disease from straightforward 'vanilla lesions' through higher disease complexity in pivotal clinical trials to phase IV studies of efficacy in 'off-label' populations. The treatment effect of DES versus BMS is consistent in terms of a reduction in the need for repeat intervention of the order of 35-70%. Regarding differential efficacy of first-generation DES, a benefit may exist in favour of the Cypher (sirolimus-eluting) stent over Taxus (paclitaxel-eluting), particularly in high-risk lesion subsets. The second-generation approved devices are the Endeavor (zotarolimus-eluting) and Xience (everolimus-eluting) DES. While all four of these stents are permanent polymer-based, the current focus of development is towards DES platforms that are devoid of durable polymer, the presence of which has been implicated in late adverse events. In terms of safety concerns raised in relation to DES therapy, it is reasonable to conclude the following at 4- to 5-year post-stent implantation: (i) that there is no increased risk of death or MI with DES (neither is there a general signal of mortality

  7. Webbing and Delamination of Drug Eluting Stent Coatings.

    Science.gov (United States)

    Hopkins, C; Sweeney, C A; O'Connor, C; McHugh, P E; McGarry, J P

    2016-02-01

    The advancement of the drug-eluting stent technology raises the significant challenge of safe mechanical design of polymer coated stent systems. Experimental images of stent coatings undergoing significant damage during deployment have been reported; such coating damage and delamination can lead to complications such as restenosis and increased thrombogenicity. In the current study a cohesive zone modeling framework is developed to predict coating delamination and buckling due to hinge deformation during stent deployment. Models are then extended to analyze, for the first time, stent-coating damage due to webbing defects. Webbing defects occur when a bond forms between coating layers on adjacent struts, resulting in extensive delamination of the coating from the strut surfaces. The analyzes presented in this paper uncover the mechanical factors that govern webbing induced coating damage. Finally, an experimental fracture test of a commercially available stent coating material is performed and results demonstrate that the high cohesive strength of the coating material will prevent web fracture, resulting in significant coating delamination during stent deployment.

  8. Drug-eluting Stents - Grundlagen, Indikationen und klinische Ergebnisse

    Directory of Open Access Journals (Sweden)

    Vogt AM

    2003-01-01

    Full Text Available Die Wiederverengung eines Koronargefäßes nach zunächst erfolgreicher Ballondilatation (Restenose ist ein häufiges, bislang unzureichend gelöstes Problem der interventionellen Kardiologie mit bedeutenden gesundheitsökonomischen Auswirkungen. Die sogenannten drug-eluting Stents (DES stellen diesbezüglich ein erfolgversprechendes Therapiekonzept dar: Solche meist mit einer Polymermatrix überzogenen endovaskulären Prothesen setzen nach ihrer Implantation Substanzen frei, die bekannte Mechanismen der Restenoseentstehung - zelluläre Proliferation, Migration, Inflammation und Zellteilung - hemmen und somit einer Wiederverengung des Interventionsbereiches entgegenwirken. Mit Taxol und seinen Derivaten sowie mit dem Immunsuppressivum Rapamycin (Sirolimus und Analoga stehen heute bereits zwei Substanzgruppen zur Auswahl, deren Nutzen hinsichtlich angiographischer Restenoserate und klinischem Verlauf für ausgewählte Indikationen im Rahmen kontrollierter klinischer Studien nachgewiesen werden konnte. Weitere, z. T. bereits laufende Studien werden zeigen, welcher Stellenwert dieser erfolgversprechenden neuen Technologie tatsächlich zukommt und ob die therapeutischen Vorteile der DES - angesichts limitierter finanzieller Ressourcen - ihren höheren Preis rechtfertigen.

  9. Clinicians' perspectives on the use of drug-eluting contact lenses for the treatment of glaucoma.

    Science.gov (United States)

    Taniguchi, Elise V; Kalout, Patricia; Pasquale, Louis R; Kohane, Daniel S; Ciolino, Joseph B

    2014-10-01

    Glaucoma is the leading cause of irreversible blindness worldwide. The perspective of clinicians who treat the disease is important and may ultimately dictate the adoption of new treatment modalities, such as drug-eluting contact lenses. Recent advances have enabled contact lenses to serve as a sustained-release drug-delivery platform capable of treating glaucoma. This review covers the medical treatment of glaucoma, suboptimal adherence rates to treatment, and factors that may influence the clinical applicability of drug-eluting contact lenses. Ophthalmologists who treat glaucoma were surveyed to determine their perspective on treatment adherence, bandage contact lens use and the use of a drug-eluting contact lens to treat glaucoma. Given the challenge of treating glaucoma and the clinical need for improved drug delivery, drug-eluting contact lenses appear to be a promising treatment option.

  10. Injectable Drug Eluting Elastomeric Polymer: A Novel Submucosal Injection Material

    Science.gov (United States)

    Tran, Richard T.; Palmer, Michael; Tang, Shou-Jiang; Abell, Thomas L.; Yang, Jian

    2011-01-01

    Background Biodegradable hydrogels can deliver therapeutic payloads with great potentials in endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) to yield improvements in efficacy and foster mucosal regeneration. Objective To assess the efficacy of an injectable drug eluting elastomeric polymer (iDEEP) as a submucosal injection material. Design Comparative study among 3 different solutions using material characterization tests, ex vivo and in vivo porcine models. Setting Academic hospital. Interventions 30 gastric submucosal cushions were achieved with saline (0.9%), sodium hyaluronate (0.4%), and iDEEP (n = 10) in ex vivo porcine stomachs. Four porcine gastric submucosal cushions were then performed in vivo using iDEEP. Main outcome measurements Maximum injection pressure, Rebamipide release rate, submucosal elevation duration, and assessment of in vivo efficacy by en bloc resection. Results No significant difference in injection pressures between iDEEP (28.9 ± 0.3 PSI) and sodium hyaluronate (29.5 ± 0.4 PSI, P > .05) was observed. iDEEP gels displayed a controlled release of Rebamipide up to 2 weeks in vitro. The elevation height of iDEEP (5.7 ± 0.5 mm) was higher than saline (2.8 ± 0.2 mm, P < .01) and SH (4.2 ± 0.2 mm, P < .05). All EMR procedures were successfully performed after injection of iDEEP, and a large gel cushion was noted after the resection procedure. Limitations Benchtop, ex vivo, and non-survival pig study. Conclusions A novel injection solution was evaluated for endoscopic resection. These results suggest that iDEEP may provide a significant step towards the realization of an ideal EMR and ESD injection material. PMID:22301346

  11. 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

    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...... with BMS in patients with diabetes who undergo primary percutaneous coronary intervention for STEMI. Published reports were scanned by formal searches of electronic databases (MEDLINE and CENTRAL). All completed randomized trials of DES for STEMI were examined. No language restrictions were enforced...... 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...

  12. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial

    NARCIS (Netherlands)

    von Birgelen, Clemens; Sen, Hanim; Sen, Hanim; Lam, Ming Kai; Danse, Peter W.; Jessurun, Gillian A.J.; Hautvast, Raymond W.M.; van Houwelingen, Gert K.; Schramm, Alexander R.; Gin, R. Melvyn Tjon Joe; Louwerenburg, Johannes W.; de Man, Frits H.A.F.; Stoel, Martin G.; Löwik, Marije M.; Linssen, Gerard C.M.; Saïd, Salla A.M.; Nienhuis, Mark B.; Verhorst, Patrick M.J.; Basalus, Mounir W.Z.; Doggen, Catharina Jacoba Maria; Tandjung, K.; Tandjung, K.

    2014-01-01

    Background Third-generation, permanent-polymer-based drug-eluting stents with novel, flexible designs might be more easily delivered than previous generations of stents in complex coronary lesions, but might be less longitudinally stable. We aimed to assess the safety and efficacy in all-comer

  13. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial

    NARCIS (Netherlands)

    Birgelen, von Clemens; Sen, Hanim; Lam, Ming Kai; Danse, Peter W.; Jessurun, Gillian A.J.; Hautvast, Raymond W.M.; Houwelingen, van Gert K.; Schramm, Alexander R.; Gin, R. Melvyn Tjon Joe; Louwerenburg, Johannes W.; Man, de Frits H.A.F.; Stoel, Martin G.; Löwik, Marije M.; Linssen, Gerard C.M.; Saïd, Salla A.M.; Nienhuis, Mark B.; Verhorst, Patrick M.J.; Basalus, Mounir W. Z.; Doggen, Carine J.M.; Tandjung, K.

    2014-01-01

    Background Third-generation, permanent-polymer-based drug-eluting stents with novel, flexible designs might be more easily delivered than previous generations of stents in complex coronary lesions, but might be less longitudinally stable. We aimed to assess the safety and efficacy in all-comer patie

  14. Studies of post-elution concentration of {sup 99m}-Tc eluted from a gel type chromatographic generator

    Energy Technology Data Exchange (ETDEWEB)

    Suzuki, Katia N.; Osso Junior, Joao Alberto [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)]. E-mail: norisuzuki6@yahoo.com.br; jaosso@ipen.br

    2007-07-01

    The radiopharmaceuticals most used in Diagnostic Nuclear Medicine are those labeled with the metastable technetium ({sup 99m}Tc) due to its ideal physical properties of decay (t{sub 1/2} 6.01 h, E{gamma} 140 keV), low cost and availability facilitated through the commercial generator {sup 99}Mo /{sup 99m}Tc. This radionuclide is formed by the {beta}{sup -} decay of {sup 99}Mo adsorbed on an alumina column of the generator and collected in the form of sodium pertechnetate (Na{sup 99m}TcO{sub 4}) by elution with saline solution (0.9%). The Radiopharmacy Center (CR) of the IPEN-CNEN/SP developed a gel type chromatographic generator of MoZr with {sup 99}Mo produced by {sup 98}Mo(n, {gamma}){sup 99}Mo reaction that occurs in IEA-R1 Nuclear Reactor. The gel is composed of zirconium molybdate with elution volume of 12 ml with an activity of 11100 MBq (300 mCi) producing a radioactive concentration of 925 MBq (34 mCi) / ml. The fission generator gives a higher radioactive concentration around 1850 MBq (69 mCi) / ml. The aim of this work is to study a system of post-elution concentration using ion exchange cartridges in tandem (cation - anion) for the attainment of a high enough radioactive concentration to meet the demand of market, with a proved quality. This system of concentration will be made based in the technique of solid phase extraction (SPE) using commercial cartridges of extraction, which contains the solid phase and eluent saline solution (0.9%). As the eluent results of this system used in the gel generator of MoZr will be compared with the fission generator currently produced by IPEN-CNEN/SP. (author)

  15. Drug release kinetics from a drug-eluting stent with asymmetrical coat

    DEFF Research Database (Denmark)

    Zhang, Haijun; Li, Xiaodong; Deng, Wei

    2017-01-01

    The aim of this study was to investigate the drug release profiles of biodegradable polymer sirolimus- or paclitaxel-eluting stents with asymmetrical coating (BPSES-A or BPPES-A) both in vitro and in vivo. In vitro, the drug release profile was characterized by measuring the drug concentration...... by HPLC over a time-course. In vivo, a porcine aorta stenting model was employed. The results showed that the drug release rates of BPSES-A and BPPES-A were slower, more stable and less burst releasing than those of conventionally coated stents (BPSES-C and BPPES-C respectively), both in vitro and in vivo...... demonstrated the effectiveness of both sirolimus and paclitaxel as stent coating agents, and revealed the favorable drug release kinetics and pharmacokinetics of asymmetrical coated stents compared with conventional coated stents....

  16. 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 imme

  17. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial.

    Science.gov (United States)

    von Birgelen, Clemens; Sen, Hanim; Lam, Ming Kai; Danse, Peter W; Jessurun, Gillian A J; Hautvast, Raymond W M; van Houwelingen, Gert K; Schramm, Alexander R; Gin, R Melvyn Tjon Joe; Louwerenburg, Johannes W; de Man, Frits H A F; Stoel, Martin G; Löwik, Marije M; Linssen, Gerard C M; Saïd, Salah A M; Nienhuis, Mark B; Verhorst, Patrick M J; Basalus, Mounir W Z; Doggen, Carine J M; Tandjung, Kenneth

    2014-02-01

    Third-generation, permanent-polymer-based drug-eluting stents with novel, flexible designs might be more easily delivered than previous generations of stents in complex coronary lesions, but might be less longitudinally stable. We aimed to assess the safety and efficacy in all-comer patients of two third-generation stents that are often used clinically, but that have not yet been compared, and one of which has not previously been assessed in a randomised trial. In this investigator-initiated, single-blind, multicentre, randomised, two-arm, non-inferiority trial, patients aged 18 years and older who required a percutaneous coronary intervention with implantation of a drug-eluting stent were recruited from four study sites in the Netherlands. We randomly assigned patients by independently managed computer-generated allocation sequences in a 1:1 ratio to receive either cobalt-chromium-based zotarolimus-eluting stents (Resolute Integrity, Medtronic, Santa Rosa, CA, USA) or platinum-chromium-based everolimus-eluting stents (Promus Element, Boston Scientific, Natick, MA, USA). Patients and analysts were masked to the allocated stent, but treating clinicians were not. The primary endpoint of target-vessel failure was a composite of safety (cardiac death or target-vessel-related myocardial infarction) and efficacy (target-vessel revascularisation) at 12 months, analysed by intention to treat (with a non-inferiority margin of 3·6%). This trial is registered with ClinicalTrials.gov, number NCT01331707. Between Nov 25, 2010, and May 24, 2012, 1811 eligible all-comer patients, with 2371 target lesions, were enrolled in the study. 370 (20%) patients presented with ST-elevation myocardial infarction and 447 (25%) with non-ST-elevation myocardial infarction. 906 patients were assigned to receive zotarolimus-eluting stents and 905 to receive everolimus-eluting stents. Ease of stent delivery was shown by very low numbers of patients requiring treatment other than their assigned

  18. Multiple coronary micro-aneurysm formation after drug-eluting stent implantation

    Directory of Open Access Journals (Sweden)

    Apostolos H. Christou

    2016-05-01

    Full Text Available Although there are limited data regarding the formation of coronary artery aneurysms (CAAs after drug-eluting stent (DES implantation, CAAs appear to be a rare complication of coronary stenting. The exact mechanism of CAA formation is unknown, but several hypotheses have been proposed. As the use of DES increases, the clinical significance of these findings will become clearer. We report on a patient who developed multiple CAAs in 2 different locations after sirolimus-eluting stent implantation.

  19. Drug eluting biliary stents to decrease stent failure rates: Areview of the literature

    Institute of Scientific and Technical Information of China (English)

    2016-01-01

    Biliary stenting is clinically effective in relieving bothmalignant and non-malignant obstructions. However, thereare high failure rates associated with tumor ingrowth andepithelial overgrowth as well as internally from biofilmdevelopment and subsequent clogging. Within the lastdecade, the use of prophylactic drug eluting stents as ameans to reduce stent failure has been investigated. Inthis review we provide an overview of the current researchon drug eluting biliary stents. While there is limited humantrial data regarding the clinical benefit of drug elutingbiliary stents in preventing stent obstruction, recentresearch suggests promise regarding their safety andpotential efficacy.

  20. Drug-eluting stents in the management of peripheral arterial disease

    Directory of Open Access Journals (Sweden)

    Marc Bosiers

    2008-06-01

    Full Text Available Marc Bosiers1, Catherine Cagiannos1, Koen Deloose1, Jürgen Verbist2, Patrick Peeters21Department of Vascular Surgery, AZ St-Blasius, Dendermonde, Belgium; 2Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, BelgiumAbstract: Since major meta-analyses of randomized controlled trials in interventional cardiology showed the potential of drug-eluting stents in decreasing restenosis and reintervention rates after coronary artery stenting, one of the next steps in the treatment of arterial occlusive disease is the transfer of the active coating technology towards peripheral arterial interventions. In this manuscript, we aim to provide a literature overview on available peripheral (lower limb, renal, and supra-aortic drug-eluting stent applications, debate the cost implications, and give recommendations for future treatment strategies.Keywords: critical limb ischemia, drug-eluting stent, below the knee, infrapopliteal, crural, limb salvage

  1. Drug-eluting stents in the management of peripheral arterial disease.

    Science.gov (United States)

    Bosiers, Marc; Cagiannos, Catherine; Deloose, Koen; Verbist, Jürgen; Peeters, Patrick

    2008-01-01

    Since major meta-analyses of randomized controlled trials in interventional cardiology showed the potential of drug-eluting stents in decreasing restenosis and reintervention rates after coronary artery stenting, one of the next steps in the treatment of arterial occlusive disease is the transfer of the active coating technology towards peripheral arterial interventions. In this manuscript, we aim to provide a literature overview on available peripheral (lower limb, renal, and supra-aortic) drug-eluting stent applications, debate the cost implications, and give recommendations for future treatment strategies.

  2. Very late coronary aneurysm formation with subsequent stent thrombosis secondary to drug-eluting stent

    Institute of Scientific and Technical Information of China (English)

    Ibrahim Akin,; Stephan Kische; Tim C Rehders; Henrik Schneider; G(o)kmen R Turan; Tilo Kleinfeldt; Jasmin Ortak; Christoph A. Nienaber; Hüseyin Ince

    2011-01-01

    Drug-eluting stents have changed the practice in interventional cardiology.With the widespread use of these stents important safety concerns regarding stent thrombosis and formation of coronary artery aneurysm have been expressed.While the majority of attention was focused on stent thrombosis,the formation of coronary aneurysm was only described in anecdotal reports.We report on a patient who suffered from very late stent thrombosis in association with coronary artery aneurysm formation secondary to drug-eluting stent but not to bare-metal stent.

  3. Balloon Angioplasty and Drug Eluting Stenting for Treatment of Peripheral Arterial Occlusive Disease

    Directory of Open Access Journals (Sweden)

    Akın İzgi

    2010-08-01

    Full Text Available Peripheral arterial disease is one of the manifestations of systemic atherosclerosis. In the last decade, remarkable technological advances, especially in the stent area, have shifted revascularization strategies from traditional open surgical approaches toward less morbide percutaneous endovascular treatments. However, even with new designed nitinol bare stents, restenosis remains as the major obstacle of this procedures. More recently, drug eluting stent platforms have been used to treat atherosclerotic peripheral arterial disease. In this article, we reviewed new studies relevant to drug eluting stents for lower extremity peripheral arterial occlusive disease.

  4. Bare metal or drug-eluting stent implantation in last remaining vessel PCI? A serious dilemma.

    Science.gov (United States)

    Zhang, Lei; Zhu, Jianhua; Kiemeneij, Ferdinand

    2009-04-01

    This case report describes the treatment of an old male diabetic patient with last remaining vessel coronary artery disease and poor left ventricular function. In presence of an old occlusion of the left main coronary artery, a subtotal stenosis of a dominant right coronary artery required angioplasty. After ample consideration it was decided to implant a bare metal stent (BMS) instead of a drug-eluting stent (DES). The major reason was the fear for early discontinuation of clopidogrel in case a drug-eluting stent was placed. The procedure and follow-up are described followed by an overview of current literature concerning similar pathology.

  5. 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

  6. Antiplatelet therapy in the era of percutaneous coronary intervention with drug-eluting balloons.

    Science.gov (United States)

    Bonaventura, Klaus; Sonntag, Steffen; Kleber, Franz X

    2011-05-01

    The high rate of restenosis associated with percutaneous coronary intervention (PCI) procedures can be reduced with the implantation of metallic stents into the stenotic vessels. The knowledge that neointimal formation can result in restenosis after stent implantation led to the development of drug-eluting stents (DES) which require long lasting antiplatelet therapy to avoid thrombotic complications. In the last years, the drug-eluting balloon (DEB) technology has emerged as an alternative option for the treatment of coronary and peripheral arteries. Clinical studies demonstrated the safety and effectiveness of DEB in various clinical scenarios and support the use of paclitaxel-eluting balloons for the treatment of in-stent restenosis, of small coronary arteries and bifurcations lesions. The protocols of DEB studies suggest that the dual antiplatelet therapy with aspirin and clopidogrel of four weeks after DEB is safe and effective.

  7. Usefulness of Drug-Eluting Balloons for Bare-Metal and Drug-Eluting In-Stent Restenosis (from the RIBS IV and V Randomized Trials).

    Science.gov (United States)

    Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; García-Touchard, Arturo; López-Mínguez, José-Ramón; Sabaté, Manel; Zueco, Javier; Melgares, Rafael; Hernández, Rosana; Moreno, Raul; Domínguez, Antonio; Sanchís, Juan; Moris, Cesar; Moreu, José; Cequier, Angel; Romaguera, Rafael; Rivero, Fernando; Cuesta, Javier; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Cárdenas, Alberto; Fernández, Cristina

    2017-01-05

    Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is particularly challenging. We sought to compare results of drug-eluting balloons in patients with DES-ISR with those in patients with bare-metal stent (BMS) ISR. A pooled analysis of the Restenosis Intra-Stent: Drug-Eluting Balloon versus Everolimus-Eluting Stent IV and V randomized trials was performed. Both trials had identical inclusion and exclusion criteria. Results of drug-eluting balloons in 95 patients with BMS-ISR and 154 patients with DES-ISR were compared. Patients with DES-ISR were more frequently diabetics, presented more often as an acute coronary syndrome and had more severe lesions and more frequently a focal pattern, including edge-ISR. Late angiographic findings (92% of eligible patients), including minimal lumen diameter (1.80 ± 0.6 vs 2.01 ± 0.6 mm, p = 0.001; absolute mean difference 0.21 mm; 95% confidence interval 0.04 to 0.38; p = 0.014) and restenosis rate (19% vs 9.5%, p ISR. Results were consistent across 10 prespecified subgroups. Moreover, on multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR after adjusting for potential confounders (adjusted absolute mean difference 0.17 mm; 95% confidence interval 0.04 to 0.41; p = 0.019). Finally, at 1-year clinical follow-up (100% of patients), rates of target vessel revascularization (16% vs 6%, p = 0.02) and of the main combined clinical end point (18% vs 8%, p = 0.03) were significantly higher in patients treated for DES-ISR. In conclusion, this study confirms the efficacy of DEB for patients with ISR. However, the long-term clinical and angiographic results of DEB are poorer in patients with DES-ISR than in those with BMS-ISR. (ClinicalTrials.govIdentifier:NCT01239953&NCT01239940).

  8. Hypersensitivity to drug-eluting stent and stent thrombosis: Kounis or not Kounis syndrome?

    Institute of Scientific and Technical Information of China (English)

    TAN Wei; CHENG Kang-lin; CHEN Qiu-xiong

    2009-01-01

    @@ With the utilization of coronary-stents, coronary remodeling and restenosis were reduced compared with balloon angioplasty alone.~1 However, the risk of restenosis is still in the range of 15% to 20%. Drug-eluting stents (DES), which could release antiproliferative pharmacological agents after deployment. were designed to inhibit the response to injury reaction after bare-metal stent (BMS) implantation.

  9. Bioresorbable drug-eluting magnesium-alloy scaffold for treatment of coronary artery disease

    NARCIS (Netherlands)

    C.A.M. Campos (Carlos); T. Muramatsu (Takashi); A. Iqbal (Anwarul); Y.-J. Zhang (Ya-Jun); Y. Onuma (Yoshinobu); H.M. Garcia-Garcia (Hector); M. Haude; P.A. Lemos Neto (Pedro); B. Warnack (Boris); P.W.J.C. Serruys (Patrick)

    2013-01-01

    textabstractThe introduction of metallic drug-eluting stents has reduced the risk of restenosis and widened the indications of percutaneous coronary intervention in treatment of coronary artery disease. However, this medical device can induce hypersensitive reaction that interferes with the endothel

  10. A bioengineered drug-Eluting scaffold accelerated cutaneous wound healing In diabetic mice.

    Science.gov (United States)

    Yin, Hao; Ding, Guoshan; Shi, Xiaoming; Guo, Wenyuan; Ni, Zhijia; Fu, Hong; Fu, Zhiren

    2016-09-01

    Hyperglycemia in diabetic patients can greatly hinder the wound healing process. In this study we investigated if the engagement of F4/80(+) murine macrophages could accelerate the cutaneous wound healing in streptozotocin induced diabetic mice. To facilitate the engagement of macrophages, we engineered a drug-eluting electrospun scaffold with a payload of monocyte chemoattractant protein-1 (MCP-1). MCP-1 could be readily released from the scaffold within 3 days. The electrospun scaffold showed no cytotoxic effects on human keratinocytes in vitro. Full-thickness excisional cutaneous wound was created in diabetic mice. The wound fully recovered within 10 days in mice treated with the drug-eluting scaffold. In contrast, the wound took 14 days to fully recover in control groups. The use of drug-eluting scaffold also improved the re-epithelialization. Furthermore, we observed a larger population of F4/80(+) macrophages in the wound bed of mice treated with drug-eluting scaffolds on day 3. This marked increase of macrophages in the wound bed could have contributed to the accelerated wound healing. Our study shed new light on an immuno-engineering solution for wound healing management in diabetic patients.

  11. 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

    Aims: The use of drug-eluting stents (DES) in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) is controversial and not yet endorsed in clinical guidelines. Methods and results: This was an a priori planned post hoc analysis involving 754 NSTE-ACS patients from the random...

  12. Late stent thrombosis: a not negligible issue after drug-eluting stent implantation

    Institute of Scientific and Technical Information of China (English)

    GAO Run-lin

    2007-01-01

    @@ Drug-eluting stent (DES) has markedly reduced restenosis and the need for target lesion revascularization (TLR). The safety profile of DES does not seem to differ from that of bare metal stent in the acute and subacute phases following coronary intervention.

  13. 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 safe...

  14. 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

    not included all relevant randomised clinical trials. OBJECTIVES: To assess the benefits and harms of drug-eluting stents versus bare-metal stents in people with acute coronary syndrome. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, SCI-EXPANDED...

  15. 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 ...

  16. A thermal analogy for modelling drug elution from cardiovascular stents.

    Science.gov (United States)

    Hose, D R; Narracott, A J; Griffiths, B; Mahmood, S; Gunn, J; Sweeney, D; Lawford, P V

    2004-10-01

    Restriction of blood flow by the narrowing or occlusion of arteries is one of the most common presentations of cardiovascular disease. One treatment involves the introduction of a metal scaffold, or stent, designed to prevent recoil and to provide structural stability to the vessel. On the occasions that this treatment is ineffective, failure is usually associated with re-invasion of tissue. This can be prevented by local delivery of drugs which inhibit tissue growth. The drug might be delivered locally in a polymer coating on the stent. This paper develops and explores the use of a thermal analogue of the drug delivery process and the associated three-dimensional convection-diffusion equation to model the spatial and temporal distribution of drug concentration within the vessel wall. This allows the routine use of commercial finite element analysis software to investigate the dynamics of drug distribution, assist in the understanding of the treatment process and develop improved delivery systems. Two applications illustrate how the model might be used to investigate the effects of controllable or measurable parameters on the progression of the process. It is demonstrated that the geometric characteristics of the stent can have significant impact on the homogeneity of the dosing in the vessel wall.

  17. Inflammatory response, drug-eluting stent and restenosis

    Institute of Scientific and Technical Information of China (English)

    LI Jian-jun

    2008-01-01

    @@ Cardiovascular diseases are the major cause of mortality in the Western world and it is expected that this will remain so during the foreseeable future.1Among them,coronary artery disease(CAD)is the most important underlying cause of death due to cardiovascular disease.2Current treatment of patients with CAD includes mainly risk factor management,drug therapy and revascularization techniques.

  18. 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....

  19. Prime time for drug eluting balloons in SFA interventions?

    Science.gov (United States)

    Brodmann, M

    2014-08-01

    Peripheral arterial disease most commonly affects the femoropopliteal segment. Despite enormous improvements in device and treatment technology the long-term patency rate and clinical benefit of endovascular treatment in the respective vascular bed is not satisfying. Drug coated balloon technology as a treatment option in femoropopliteal disease has shown encouraging results in first-in-man trials, which have now been proven in large randomized controlled trials.

  20. Efficacy and safety of drug-eluting stent implantation for the treatment of in-stent restenosis occurring within bare-metal stent and drug-eluting stent*

    OpenAIRE

    Ge, Heng; Zhang, Qing; Zhou, Wei; He, Qing; Han, Zhi-hua; He, Ben

    2010-01-01

    Objective: Although drug-eluting stent (DES) implantation is the primary treatment modality for bare-metal stent (BMS) in-stent restenosis (ISR), little is known about the efficacy and safety profile of DES in the treatment of DES-ISR. The goal of this study was to compare the clinical outcomes following DES treatment for BMS-ISR and DES-ISR. Methods: Rates of major adverse cardiac events (MACE) were compared in 97 consecutive patients who underwent DES implantation for the treatment of ISR (...

  1. Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design

    DEFF Research Database (Denmark)

    Pfisterer, M.; Bertel, O.; Bonetti, P.O.;

    2008-01-01

    Background Based on a subgroup analysis of 18-month BAsel Stent Kosten Effektivitats Trial (BASKET) outcome data, we hypothesized that very late (>12 months) stent thrombosis occurs predominantly after drug-eluting stent implantation in large native coronary vessel stenting. Methods To prove...... stent use in patients with large native vessel stenting. The 2-year death/myocardial infarction-as well as target vessel revascularization-and bleeding rates in these patients with a first-versus second-generation drug-eluting stent should demonstrate the benefit or harm of these stents compared...

  2. Precision-controlled elution of a 82Sr/82Rb generator for cardiac perfusion imaging with positron emission tomography

    Science.gov (United States)

    Klein, R.; Adler, A.; Beanlands, R. S.; de Kemp, R. A.

    2007-02-01

    A rubidium-82 (82Rb) elution system is described for use with positron emission tomography. Due to the short half-life of 82Rb (76 s), the system physics must be modelled precisely to account for transport delay and the associated activity decay and dispersion. Saline flow is switched between a 82Sr/82Rb generator and a bypass line to achieve a constant-activity elution of 82Rb. Pulse width modulation (PWM) of a solenoid valve is compared to simple threshold control as a means to simulate a proportional valve. A predictive-corrective control (PCC) algorithm is developed which produces a constant-activity elution within the constraints of long feedback delay and short elution time. The system model parameters are adjusted through a self-tuning algorithm to minimize error versus the requested time-activity profile. The system is self-calibrating with 2.5% repeatability, independent of generator activity and elution flow rate. Accurate 30 s constant-activity elutions of 10-70% of the total generator activity are achieved using both control methods. The combined PWM-PCC method provides significant improvement in precision and accuracy of the requested elution profiles. The 82Rb elution system produces accurate and reproducible constant-activity elution profiles of 82Rb activity, independent of parent 82Sr activity in the generator. More reproducible elution profiles may improve the quality of clinical and research PET perfusion studies using 82Rb.

  3. Modeling the transport of drugs eluted from stents: physical phenomena driving drug distribution in the arterial wall.

    Science.gov (United States)

    Bozsak, Franz; Chomaz, Jean-Marc; Barakat, Abdul I

    2014-04-01

    Despite recent data that suggest that the overall performance of drug-eluting stents (DES) is superior to that of bare-metal stents, the long-term safety and efficacy of DES remain controversial. The risk of late stent thrombosis associated with the use of DES has also motivated the development of a new and promising treatment option in recent years, namely drug-coated balloons (DCB). Contrary to DES where the drug of choice is typically sirolimus and its derivatives, DCB use paclitaxel since the use of sirolimus does not appear to lead to satisfactory results. Since both sirolimus and paclitaxel are highly lipophilic drugs with similar transport properties, the reason for the success of paclitaxel but not sirolimus in DCB remains unclear. Computational models of the transport of drugs eluted from DES or DCB within the arterial wall promise to enhance our understanding of the performance of these devices. The present study develops a computational model of the transport of the two drugs paclitaxel and sirolimus eluted from DES in the arterial wall. The model takes into account the multilayered structure of the arterial wall and incorporates a reversible binding model to describe drug interactions with the constituents of the arterial wall. The present results demonstrate that the transport of paclitaxel in the arterial wall is dominated by convection while the transport of sirolimus is dominated by the binding process. These marked differences suggest that drug release kinetics of DES should be tailored to the type of drug used.

  4. Paclitaxel Drug-eluting Tracheal Stent Could Reduce Granulation Tissue Formation in a Canine Model

    Institute of Scientific and Technical Information of China (English)

    Ting Wang; Jie Zhang; Juan Wang; Ying-Hua Pei; Xiao-Jian Qiu; Yu-Ling Wang

    2016-01-01

    Background:Currently available silicone and metallic stents for tracheal stenosis are associated with many problems.Granulation proliferation is one of the main complications.The present study aimed to evaluate the efficacy of paclitaxel drug-eluting tracheal stent in reducing granulation tissue formation in a canine model,as well as the pharmacokinetic features and safety profiles of the coated drug.Methods:Eight beagles were randomly divided into a control group (bare-metal stent group,n =4) and an experimental group (paclitaxel-eluting stent group,n =4).The observation period was 5 months.One beagle in both groups was sacrificed at the end of the 1st and 3rd months,respectively.The last two beagles in both groups were sacrificed at the end of 5th month.The proliferation of granulation tissue and changes in tracheal mucosa were compared between the two groups.Blood routine and liver and kidney function were monitored to evaluate the safety of the paclitaxel-eluting stent.The elution method and high-performance liquid chromatography were used to characterize the rate of in vivo release of paclitaxel from the stent.Results:Compared with the control group,the proliferation of granulation tissue in the experimental group was significantly reduced.The drug release of paclitaxel-eluting stent was the fastest in the 1st month after implantation (up to 70.9%).Then,the release slowed down gradually.By the 54 month,the release reached up to 98.5%.During the observation period,a high concentration of the drug in the trachea (in the stented and adjacent unstented areas) and lung tissue was not noted,and the blood test showed no side effect.Conclusions:The paclitaxel-eluting stent could safely reduce the granulation tissue formation after stent implantation in vivo,suggesting that the paclitaxel-eluting tracheal stent might be considered for potential use in humans in the future.

  5. Clinical outcomes and prognosis of patients with stent fracture after successful drug-eluting stent implantation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, In Soo [Cadiovascular center, Chonnam National University Hospital, Gwangju (Korea, Republic of); Han, Jae Bok; Jang, Seong Joo [Dept. of Radiology, Dongshin University, Naju (Korea, Republic of)

    2014-06-15

    Many studies have suggested that in the era of Drug Eluting Stents (DES) are one of the causes of In-Stent Restenosis (ISR) of Stent Fracture (SF). The present study sought to evaluate clinical characteristics of patients with stent fracture after successful DES implantation. The 4,701 patients were selected for analysis who underwent a follow-up coronary angiography irrespective of ischemic symptoms. The overall incidence of SF was 32 patients(male:female=19:13, Av. age 62.44±9.8 year, 0.68%). Fractures of Sirolimus-Eluting Stents (SES), Paclitaxel-Eluting Stents (PES), Biolimus A9-Eluting Stents (BES), Everolimus-Eluting Etents (EES), Endothelial Progenitor Cell Capture Stent (EPC) and Zotarolimus-Eluting Stents (ZES) are accounted for 19 (59.4%), 9 (28.1%), 2 (6.3%), 1 (3.1%), 1 (3.1%) and 0 (0%) respectively. SF developed in the left Anterior Dscending (LAD) artery in 16 patients (50%) and in complex(type B2, C) lesions in 25 patients (69.4%). Ten patients were treated with heterogenous DES, the rest being treated with either homogenous DES (3 patients), plain old balloon angioplasty (3 patients), or conservative medical treatment (17 patients). None of the patients with SF suffered from cardiac death during a follow-up period of 32.9±12.4 months. The overall rate of DES fracture over up to 3.7 years of follow-up was 0.68% with higher incidence in SES than in PES. SF frequently occurred in the LAD artery and in complex lesions. Of the patients with SF, coronary intervention was performed only when the binary restenosis lesion was significant. During the follow-up, patients with SF have continued on combination antiplatelet therapy. There is a very low rate of major adverse cardiac events(post-detection of SF), especially cardiac death associated with SF.

  6. Efficacy and safety of biodegradable polymer biolimus-eluting stents versus durable polymer drug-eluting stents: a meta-analysis.

    Directory of Open Access Journals (Sweden)

    Yicong Ye

    Full Text Available BACKGROUNDS: Drug-eluting stents (DES with biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation DES. We aimed to determine the efficacy and safety of biodegradable polymer biolimus-eluting stents (BES versus durable polymer DES. METHODS: Systematic database searches of MEDLINE (1950 to June 2013, EMBASE (1966 to June 2013, the Cochrane Central Register of Controlled Trials (Issue 6 of 12, June 2013, and a review of related literature were conducted. All randomized controlled trials comparing biodegradable polymer BES versus durable polymer DES were included. RESULTS: Eight randomized controlled trials investigating 11,015 patients undergoing percutaneous coronary interventions were included in the meta-analysis. The risk of major adverse cardiac events did not differ significantly between the patients treated with the biodegradable polymer BES and the durable polymer DES (Relative risk [RR], 0.970; 95% CI, 0.848-1.111; p = 0.662. However, biodegradable polymer BES was associated with reduced risk of very late ST compared with the durable polymer DES, while the risk of early or late ST was similar (RR for early or late ST, 1.167; 95% CI 0.755-1.802; p = 0.487; RR 0.273; 95% CI 0.115-0.652; p = 0.003; p for interaction = 0.003. CONCLUSIONS: In this meta-analysis of randomized controlled trials, treatments with biodegradable polymer BES did not significantly reduce the risk of major adverse cardiac events, but demonstrated a significantly lower risk of very late ST when compared to durable polymer DES. This conclusion requires confirmation by further studies with long-term follow-up. PROSPERO REGISTER NUMBER: http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013004364#.UnM2lfmsj6J.

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

    Science.gov (United States)

    Feinberg, Joshua; Nielsen, Emil Eik; Greenhalgh, Janette; Hounsome, Juliet; Sethi, Naqash J; Safi, Sanam; Gluud, Christian; Jakobsen, Janus C

    2017-08-23

    Approximately 3.7 million people died from acute coronary syndrome worldwide in 2012. Acute coronary syndrome, also known as myocardial infarction or unstable angina pectoris, is caused by a sudden blockage of the blood supplied to the heart muscle. Percutaneous coronary intervention is often used for acute coronary syndrome, but previous systematic reviews on the effects of drug-eluting stents compared with bare-metal stents have shown conflicting results with regard to myocardial infarction; have not fully taken account of the risk of random and systematic errors; and have not included all relevant randomised clinical trials. To assess the benefits and harms of drug-eluting stents versus bare-metal stents in people with acute coronary syndrome. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, SCI-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. 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. We followed our published protocol and the methodological recommendations of Cochrane. Two review authors independently extracted data. We assessed the risks of systematic error by bias domains. We conducted Trial Sequential Analyses to control the risks of random errors. Our primary outcomes were all-cause mortality, major cardiovascular events, serious adverse events, and quality of life. Our secondary outcomes were angina, cardiovascular mortality, and myocardial infarction. Our primary assessment time point was at maximum follow-up. We assessed the quality of the evidence by the GRADE approach. We included 25

  8. Long-term effectiveness and safety of sirolimus drug-eluting stents

    OpenAIRE

    Bikkina, Mahesh; Koneru, Jayanth

    2011-01-01

    Mahesh Bikkina, Jayanth KoneruSt Joseph Regional Medical Center, Paterson, Seton Hall University, NJ, USAAbstract: The root cause of coronary artery disease is atherosclerosis, ie, intraluminal narrowing (stenosis) of the arteries that supply blood to tissues of the heart. The introduction of the drug-eluting stent over the past decade has revolutionized the field of interventional cardiology. It is used extensively in clinical practice for the treatment of coronary artery disease. The first ...

  9. Study of restenosis in drug eluting stents: new insights from greyscale intravascular ultrasound and virtual histology.

    Science.gov (United States)

    Garcia-Garcia, Hector M; Shen, Zhujun; Piazza, Nicolo

    2009-05-01

    In current cardiology practice, many patients undergo secondary revascularisation due to reduced long-term vein graft patency or in-stent restenosis. In this report, we describe causes of drug-eluting stent restenosis identifiable by intravascular ultrasound imaging (IVUS) and variables related to restenosis used for reporting greyscale IVUS. In addition, IVUS findings in bypass grafts and the long-term results after stent implantation are provided. Finally, the usefulness of IVUS virtual histology for the study of restenosis is described.

  10. Bioresorbable Drug-Eluting Magnesium-Alloy Scaffold for Treatment of Coronary Artery Disease

    OpenAIRE

    Campos, Carlos M.; Takashi Muramatsu; Javaid Iqbal; Ya-Jun Zhang; Yoshinobu Onuma; Garcia-Garcia, Hector M.; Michael Haude; Lemos, Pedro A.; Boris Warnack; Serruys, Patrick W.

    2013-01-01

    The introduction of metallic drug-eluting stents has reduced the risk of restenosis and widened the indications of percutaneous coronary intervention in treatment of coronary artery disease. However, this medical device can induce hypersensitive reaction that interferes with the endothelialization and healing process resulting in late persistent or acquired malapposition of the permanent metallic implant. Delayed endotheliaization and malapposition may lead to late and very late stent thrombo...

  11. 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.

  12. Blood compatibility assessment of polymers used in drug eluting stent coatings.

    Science.gov (United States)

    Szott, Luisa Mayorga; Irvin, Colleen A; Trollsas, Mikael; Hossainy, Syed; Ratner, Buddy D

    2016-06-15

    Differences in thrombosis rates have been observed clinically between different drug eluting stents. Such differences have been attributed to numerous factors, including stent design, injury created by the catheter delivery system, coating application technologies, and the degree of thrombogenicity of the polymer. The relative contributions of these factors are generally unknown. This work focuses on understanding the thrombogenicity of the polymer by examining mechanistic interactions with proteins, human platelets, and human monocytes of a number of polymers used in drug eluting stent coatings, in vitro. The importance for blood interactions of adsorbed albumin and the retention of albumin was suggested by the data. Microscopic imaging and immunostaining enhanced the interpretation of results from the lactate dehydrogenase cell counting assay and provided insight into platelet interactions, total quantification, and morphometry. In particular, highly spread platelets may be surface-passivating, possibly inhibiting ongoing thrombotic events. In many of the assays used here, poly(vinylidene fluoride-co-hexafluoropropylene) (PVDF-HFP) showed a differentiated protein deposition pattern that may contribute to the explanation of the consistently thromboresistant blood-materials interaction for fluororpolymers cited in literature. These results are supportive of one of several possible factors contributing to the good thromboresistant clinical safety performance of PVDF-HFP coated drug eluting stents.

  13. Efficacy of drug-eluting stents for treating in-stent restenosis of drug-eluting stents (from the Korean DES ISR multicenter registry study [KISS]).

    Science.gov (United States)

    Ko, Young-Guk; Kim, Jung-Sun; Kim, Byeong-Keuk; Choi, Donghoon; Hong, Myeong-Ki; Jeon, Dong Woon; Yang, Joo-Young; Ahn, Young Keun; Jeong, Myung Ho; Yu, Cheol Woong; Yun, Kyeong-Ho; Lim, Do-Sun; Jang, Yangsoo

    2012-03-01

    There is currently no established standard treatment for in-stent restenosis (ISR) after the implantation of a drug-eluting stent (DES). The aim of this study was to investigate the efficacy of DES versus balloon angioplasty (BA) for the treatment of DES ISR in a multicenter registry cohort. After matching propensity scores of 805 patients with DES ISR treated with either DES (n = 422) or BA (n = 383), 268 matched pairs were selected and analyzed for major adverse cardiac events, a composite of death, myocardial infarction, and target-vessel revascularization, as the primary end point. Baseline clinical and lesion characteristics of the matched pairs were similar. Survival free of major adverse cardiac events at 2 years was higher with DES compared to BA (88.9% vs 78.7%, p ISR, and previous implantation of a sirolimus-eluting stent. Survival free of death, myocardial infarction, or stent thrombosis did not differ between the 2 groups. Whereas there was no significant difference in survival free of target vessel revascularization between DES and BA for focal ISR lesions, DES was superior to BA in diffuse ISR lesions (94.3% vs 75.2% at 2 years, p ISR.

  14. Drug-eluting balloon catheters for lower limb peripheral arterial disease: the evidence to date

    Directory of Open Access Journals (Sweden)

    Barkat M

    2016-05-01

    Full Text Available Mohamed Barkat,1 Francesco Torella,1 George A Antoniou2 1Liverpool Vascular and Endovascular Service, Royal Liverpool University Hospital, Liverpool, 2Department of Vascular and Endovascular Surgery, The Royal Oldham Hospital, Pennine Acute Hospitals NHS Trust, Manchester, UK Abstract: A significant proportion of patients with severe lower limb peripheral arterial disease require revascularization. Over the past decade, an endovascular-first approach even for complex disease has gained widespread use among vascular specialists. An important limitation of percutaneous transluminal balloon angioplasty or stenting remains the occurrence of restenosis. Drug-coated balloons have emerged as an exciting technology developed to overcome the limitations of standard balloon angioplasty and stenting. Drug-eluting devices inhibit neointimal growth of vascular smooth muscle cells with the potential of preventing restenosis. This review provides a synopsis of the up-to-date evidence on the role of drug-coated balloons in the treatment of lower limb peripheral arterial disease. Bibliographic searches were conducted using MEDLINE, EMBASE, and the Cochrane Library electronic database. Eleven randomized clinical trials, two systematic reviews, and a published registry providing the best available evidence were identified. Current evidence suggests that angioplasty with drug-coated balloon is reliable, safe, and efficient in increasing patency rates and reducing target lesion revascularization and restenosis. However, it remains unknown whether these improved results can translate into beneficial clinical outcomes, as current randomized clinical trials have failed to demonstrate a significant benefit in limb salvage and mortality. Further randomized trials focusing on clinical and functional outcomes of drug-eluting balloons and on cost versus clinical benefit are required. Keywords: drug-eluting balloon, drug-coated balloon, angioplasty, peripheral arterial

  15. The benefits of drug-eluting stents in the treatment of coronary artery disease

    Directory of Open Access Journals (Sweden)

    Kiramijyan S

    2016-03-01

    Full Text Available Sarkis Kiramijyan,1 Ming W Liu2 1Division of Cardiology, Department of Medicine, Harbor-UCLA Medical Center, Torrance, CA, USA; 2Heart and Vascular Care Center, White Memorial Medical Center, Los Angeles, CA, USA Abstract: The advent of coronary stents has been a landmark development in the treatment of coronary artery disease with percutaneous coronary intervention. Initial percutaneous treatment using balloon angioplasty alone had limited clinical efficacy due to immediate vascular elastic recoil and dissection, in addition to late negative vascular remodeling and neointimal hyperplasia. With the introduction of coronary stents, initially bare-metal stents (BMS, the problems of dissection and negative remodeling due to injury in addition to vascular elastic recoil were eliminated; however, neointimal hyperplasia remained an ongoing obstacle in the long-term efficacy of stents. Neointimal hyperplasia resulted in in-stent restenosis in 20%–30% of cases after intervention with BMS, which led to high rates of target lesion revascularization. Subsequently, drug-eluting stents (DES were introduced, which had the added advantage of releasing an anti-proliferative drug from the stent to reduce the neointimal proliferation, thus resulting in the reduction of the rates of in-stent restenosis. Although the first-generation DES had significantly improved outcomes over its predecessor, the BMS, several challenges including stent thrombosis and delayed endothelialization of the stent remained. The second-generation DES have been significantly improved over their first-generation predecessors in regard to efficacy and safety, ie, improved long-term outcomes and significant reductions in stent thrombosis. The duration of dual antiplatelet therapy after DES has also been studied extensively in multiple large trials. A newer generation of stents, including those with bioresorbable polymers, polymer-free, and fully bioresorbable scaffolds is still in the early

  16. On the role of specific drug binding in modelling arterial eluting stents

    OpenAIRE

    McGinty, Sean; Pontrelli, Giuseppe

    2016-01-01

    In this paper we consider drug binding in the arterial wall following\\ud delivery by a drug-eluting stent. Whilst it is now generally accepted that a\\ud non-linear saturable reversible binding model is required to properly describe\\ud the binding process, the precise form of the binding model varies between authors.\\ud Our particular interest in this manuscript is in assessing to what extent\\ud modelling specific and non-specific binding in the arterial wall as separate\\ud phases is important...

  17. Drug-eluting balloon catheters for lower limb peripheral arterial disease: the evidence to date

    Science.gov (United States)

    Barkat, Mohamed; Torella, Francesco; Antoniou, George A

    2016-01-01

    A significant proportion of patients with severe lower limb peripheral arterial disease require revascularization. Over the past decade, an endovascular-first approach even for complex disease has gained widespread use among vascular specialists. An important limitation of percutaneous transluminal balloon angioplasty or stenting remains the occurrence of restenosis. Drug-coated balloons have emerged as an exciting technology developed to overcome the limitations of standard balloon angioplasty and stenting. Drug-eluting devices inhibit neointimal growth of vascular smooth muscle cells with the potential of preventing restenosis. This review provides a synopsis of the up-to-date evidence on the role of drug-coated balloons in the treatment of lower limb peripheral arterial disease. Bibliographic searches were conducted using MEDLINE, EMBASE, and the Cochrane Library electronic database. Eleven randomized clinical trials, two systematic reviews, and a published registry providing the best available evidence were identified. Current evidence suggests that angioplasty with drug-coated balloon is reliable, safe, and efficient in increasing patency rates and reducing target lesion revascularization and restenosis. However, it remains unknown whether these improved results can translate into beneficial clinical outcomes, as current randomized clinical trials have failed to demonstrate a significant benefit in limb salvage and mortality. Further randomized trials focusing on clinical and functional outcomes of drug-eluting balloons and on cost versus clinical benefit are required. PMID:27274265

  18. 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....

  19. 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

    -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...... with coronary drug-eluting stent implantation. FUNDING: Cordis and Medtronic....

  20. Application of quality by design (QbD) approach to ultrasonic atomization spray coating of drug-eluting stents.

    Science.gov (United States)

    McDermott, Martin; Chatterjee, Sharmista; Hu, Xiaoli; Ash-Shakoor, Ariel; Avery, Reginald; Belyaeva, Anastasiya; Cruz, Celia; Hughes, Minerva; Leadbetter, Joanne; Merkle, Conrad; Moot, Taylor; Parvinian, Sepideh; Patwardhan, Dinesh; Saylor, David; Tang, Nancy; Zhang, Tina

    2015-08-01

    The drug coating process for coated drug-eluting stents (DES) has been identified as a key source of inter- and intra-batch variability in drug elution rates. Quality-by-design (QbD) principles were applied to gain an understanding of the ultrasonic spray coating process of DES. Statistically based design of experiments (DOE) were used to understand the relationship between ultrasonic atomization spray coating parameters and dependent variables such as coating mass ratio, roughness, drug solid state composite microstructure, and elution kinetics. Defect-free DES coatings composed of 70% 85:15 poly(DL-lactide-co-glycolide) and 30% everolimus were fabricated with a constant coating mass. The drug elution profile was characterized by a mathematical model describing biphasic release kinetics. Model coefficients were analyzed as a DOE response. Changes in ultrasonic coating processing conditions resulted in substantial changes in roughness and elution kinetics. Based on the outcome from the DOE study, a design space was defined in terms of the critical coating process parameters resulting in optimum coating roughness and drug elution. This QbD methodology can be useful to enhance the quality of coated DES.

  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...

  2. 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

  3. 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

    1992-01-01

    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 Ce

  4. 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.

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

    Directory of Open Access Journals (Sweden)

    Rose Mary Ferreira Lisboa da Silva

    2014-08-01

    Full Text Available Background: The autonomic nervous system plays a central role in cardiovascular regulation; sympathetic activation occurs during myocardial ischemia. Objective: To assess the spectral analysis of heart rate variability during stent implantation, comparing the types of stent. Methods: 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. Results: 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. Conclusions: 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.

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

    Institute of Scientific and Technical Information of China (English)

    Chun-Chi Chen; I-Chang Hsieh

    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.

  7. Effects of diffusion coefficients and struts apposition using numerical simulations for drug eluting coronary stents.

    Science.gov (United States)

    Mongrain, Rosaire; Faik, Isam; Leask, Richard L; Rodés-Cabau, Josep; Larose, Eric; Bertrand, Olivier F

    2007-10-01

    In the context of drug eluting stent, we present two-dimensional numerical models of mass transport of the drug in the wall and in the lumen to study the effect of the drug diffusion coefficients in the three principal media (blood, vascular wall, and polymer coating treated as a three-compartment problem) and the impact of different strut apposition configurations (fully embedded, half embedded, and not embedded). The different conditions were analyzed in terms of their consequence on the drug concentration distribution in the arterial wall. We apply the concept of the therapeutic window to the targeted vascular wall region and derive simple metrics to assess the efficiency of the various stent configurations. Although most of the drug is dispersed in the lumen, variations in the blood flow rate within the physiological range of coronary blood flow and the diffusivity of the drug molecule in the blood were shown to have a negligible effect on the amount of drug in the wall. Our results reveal that the amount of drug cumulated in the wall depends essentially on the relative values of the diffusion coefficients in the polymer coating and in the wall. Concerning the strut apposition, it is shown that the fully embedded strut configuration would provide a better concentration distribution.

  8. Pulsed laser deposition of hydroxyapatite on nanostructured titanium towards drug eluting implants.

    Science.gov (United States)

    Rajesh P; Mohan, Nimmy; Yokogawa, Y; Varma, Harikrishna

    2013-07-01

    Titania nanotubes grown on titanium substrates by electrochemical anodization in glycerol-ammonium fluoride-water system were used to develop efficient drug carrying implants upon coating hydroxyapatite (HA) ceramic. The nanostructured surfaces achieved by anodization were caped with HA crystallites by pulsed laser deposition. The implant substrates were studied for their drug carrying capacity using gentamicin as a model. The nano-tubular surface with HA coating had better drug loading capacity of about 800 μg/cm(2) gentamicin while the bare anodized substrate carried less than 660 μg/cm(2). The HA coating alone stored as low as 68 μg/cm(2) and released the drug within the initial burst period itself. The ceramic coated anodized substrates were found to be more efficient in controlled delivery for longer than 160 h with a drug release of 0.5 μg/cm(2) even towards the end. The substrate with nanostructuring alone delivered the whole drug within 140 h. This study proposes the application of laser deposition of HA over nanostructured titanium, which proves to be promising towards controlled drug eluting bioceramic coated metallic prostheses.

  9. Impact of metabolic syndrome on re-stenosis development: role of drug-eluting stents.

    Science.gov (United States)

    Goyal, S N; Bharti, S; Krishnamurthy, B; Agrawal, Y; Ojha, S K; Arya, D S

    2012-07-01

    Metabolic syndrome (MetS) is defined as a cluster of numerous cardiovascular risk factors, which encompasses obesity, dyslipidaemia, insulin resistance and hypertension. Patients with MetS are more prone to developing cardiovascular events than other patients. To date, several approaches such as physical exercise, dietary control and invasive and non-invasive therapeutic interventions for dyslipidaemia, hypertension and insulin resistance have been used to manage MetS. However, there is a progressive elevation in the incidence of fatal and non-fatal cardiovascular events due to the increased prevalence of obesity and diabetes. Percutaneous coronary intervention has emerged over the last few years as an effective revascularisation strategy for those with coronary artery disease, in parallel with the development of effective anti-platelet medications and newer drug-eluting stents. In recent years, considerable research efforts have been undertaken to elucidate the pathophysiology of re-stenosis and develop strategies to prevent re-stenosis following percutaneous transluminal coronary angioplasty and stent implantation. Although the rate of stent re-stenosis and target-lesion revascularisation has been reduced, there is little information in the literature on the outcome of MetS in the pathophysiology of re-stenosis. In this review article, we summarise the recent development and progress on re-stenosis and the role of drug-eluting stents, particularly in MetS.

  10. Perioperative management of a patient with recently placed drug-eluting stents requiring urgent spinal surgery.

    Science.gov (United States)

    Roth, Eira; Purnell, Chad; Shabalov, Olga; Moguillansky, Diego; Hernandez, Caridad A; Elnicki, Michael

    2012-08-01

    Patients receiving drug-eluting coronary stents (DES) require antiplatelet therapy for at least 12 months to prevent stent thrombosis (ST), a potentially calamitous event. Since interruption of antiplatelet therapy is the greatest risk factor for ST, it is imperative that the decision to discontinue these agents be based on an accurate assessment of the patient's risk for bleeding complications. Individuals who are regarded as being at a high risk are those undergoing intracranial, spinal or intraocular surgeries. These patients require alternative agents during the perioperative period to minimize both their risk of perioperative thrombosis and intraoperative hemorrhage. We report the case of a woman who required spinal surgery 3 months after she underwent placement of two drug-eluting stents. The patient's clopidogrel was stopped 5 days prior to surgery and an infusion of eptifibatide was used to "bridge" antiplatelet therapy during the perioperative period. Postoperatively, anticoagulation therapy was reinstituted using aspirin with clopidogrel. This case serves as a successful example of bridging therapy using a short acting and gycoprotein (GP) IIb/IIIa inhibitor as a means of maintaining antiplatelet therapy during the perioperative period to minimize the risk of stent thrombosis and the risk of intraoperative bleeding.

  11. New drug-eluting lenses to be applied as bandages after keratoprosthesis implantation.

    Science.gov (United States)

    Carreira, A S; Ferreira, P; Ribeiro, M P; Correia, T R; Coutinho, P; Correia, I J; Gil, M H

    2014-12-30

    Corneal tissue is the most commonly transplanted tissue worldwide. This work aimed to develop a new drug-eluting contact lens that may be used as a bandage after keratoprosthesis. During this work, films were produced using poly(vinyl alcohol) (PVA) and chitosan (CS) crosslinked with glyoxal (GL). Vancomycin chlorhydrate (VA) was impregnated in these systems by soaking. Attenuated total reflectance - Fourier transform infrared spectroscopy was used to confirm crosslinking. The cytotoxic and drug release profile, hydrophilicity, thermal and biodegradation as well as swelling capacity of the samples were assessed through in vitro studies. PVA and PVA/CS films were obtained by crosslinking with GL. The films were transparent, flexible with smooth surfaces, hydrophilic and able to load and release vancomycin for more than 8h. Biodegradation in artificial lachrymal fluid (ALF) with lysozyme at 37°C showed that mass loss was higher for the samples containing CS. Also, the samples prepared with CS showed the formation of pores which were visualized by SEM. All samples revealed a biocompatible character after 24h in contact with cornea endothelial cells. As a general conclusion it was possible to determine that the 70PVA/30CS film showed to combine the necessary features to prepare vancomycin-eluting contact lenses to prevent inflammation after corneal substitution.

  12. Use of Drug-Eluting Stents in Patients With Coronary Artery Disease and Renal Insufficiency

    Science.gov (United States)

    El-Menyar, Ayman A.; Al Suwaidi, Jassim; Holmes, David R.

    2010-01-01

    Renal insufficiency (RI) has been shown to be associated with increased major adverse cardiovascular events after percutaneous coronary intervention. We reviewed the impact of RI on the pathogenesis of coronary artery disease and outcomes after percutaneous coronary intervention in the form of drug-eluting stent (DES) implantation in these high-risk patients. We searched the English-language literature indexed in MEDLINE, Scopus, and EBSCO Host research databases from 1990 through January 2009, using as search terms coronary revascularization, drug-eluting stent, and renal insufficiency. Studies that assessed DES implantation in patients with various degrees of RI were selected for review. Most of the available data were extracted from observational studies, and data from randomized trials formed the basis of a post hoc analysis. The outcomes after coronary revascularization were less favorable in patients with RI than in those with normal renal function. In patients with RI, DES implantation yielded better outcomes than did use of bare-metal stents. Randomized trials are needed to define optimal treatment of these high-risk patients with coronary artery disease. PMID:20118392

  13. 药物洗脱支架的研究进展%Progress in Reserch of Drug-eluting Stents

    Institute of Scientific and Technical Information of China (English)

    侯小丽; 张家梁

    2014-01-01

    药物洗脱支架的出现是冠心病患者介入治疗的新的里程碑,具有重要的临床应用价值。本文主要阐述了药物洗脱支架出现的背景、雷帕霉素洗脱支架和紫杉醇洗脱支架的作用机制及临床应用;同时对于新型的药物洗脱支架及其作用机制进行了论述,进一步指出了药物洗脱支架在临床应用中出现的问题及进一步研发的方向。%The review expounds the background of drug eluting stents, the mechanism of action and clinical application of sirolimus-eluting stents and paclitaxel-eluting stents, and discusses at the same time some neotypes of eluting stents and their mechanism of action, and points out the problems of drug eluting stents in clinicaluse and the direction of further research. It also reviews the progress in drug eluting stent study and research in treatment of coronary artery disease.

  14. MRI visible drug eluting magnetic microspheres for transcatheter intra-arterial delivery to liver tumors.

    Science.gov (United States)

    Kim, Dong-Hyun; Chen, Jeane; Omary, Reed A; Larson, Andrew C

    2015-01-01

    Magnetic resonance imaging (MRI)-visible amonafide-eluting alginate microspheres were developed for targeted arterial-infusion chemotherapy. These alginate microspheres were synthesized using a highly efficient microfluidic gelation process. The microspheres included magnetic clusters formed by USPIO nanoparticles to permit MRI and a sustained drug-release profile. The biocompatibility, MR imaging properties and amonafide release kinetics of these microspheres were investigated during in vitro studies. A xenograft rodent model was used to demonstrate the feasibility to deliver these microspheres to liver tumors using hepatic transcatheter intra-arterial infusions and potential to visualize the intra-hepatic delivery of these microspheres to both liver tumor and normal tissues with MRI immediately after infusion. This approach offer the potential for catheter-directed drug delivery to liver tumors for reduced systemic toxicity and superior therapeutic outcomes.

  15. Silica xerogel-chitosan nano-hybrids for use as drug eluting bone replacement.

    Science.gov (United States)

    Lee, Eun-Jung; Jun, Shin-Hee; Kim, Hyoun-Ee; Kim, Hae-Won; Koh, Young-Hag; Jang, Jun-Hyeog

    2010-01-01

    Silica xerogel-chitosan hybrids containing vancomycin were fabricated by the sol-gel process at room temperature and their potential as a drug eluting bone replacement was evaluated in terms of their mechanical properties and drug release behaviors. Regardless of the content of chitosan, all of the prepared hybrids had a uniform mesoporous structure, which would allow the effectual loading of vancomycin. As the content of chitosan was increased, the strength, strain to failure, and work of fracture of the hybrids were significantly enhanced, while the elastic modulus was decreased. These changes in the mechanical properties were mainly attributed to the mitigation of the brittleness of the silica xerogel through its hybridization with the flexible chitosan phase. In addition, the initial burst-effect was remarkably reduced by increasing the content of chitosan. The hybrids with more than 30% chitosan could release the vancomycin for an extended period of time in a controlled manner.

  16. Paclitaxel Drug-eluting Tracheal Stent Could Reduce Granulation Tissue Formation in a Canine Model

    Directory of Open Access Journals (Sweden)

    Ting Wang

    2016-01-01

    Conclusions: The paclitaxel-eluting stent could safely reduce the granulation tissue formation after stent implantation in vivo, suggesting that the paclitaxel-eluting tracheal stent might be considered for potential use in humans in the future.

  17. Generation of aerosolized drugs.

    Science.gov (United States)

    Wolff, R K; Niven, R W

    1994-01-01

    The expanding use of inhalation therapy has placed demands on current aerosol generation systems that are difficult to meet with current inhalers. The desire to deliver novel drug entities such as proteins and peptides, as well as complex formulations including liposomes and microspheres, requires delivery systems of improved efficiency that will target the lung in a reproducible manner. These efforts have also been spurred by the phase out of chlorofluorocarbons (CFCs) and this has included a directed search for alternative propellants. Consequently, a variety of new aerosol devices and methods of generating aerosols are being studied. This includes the use of freon replacement propellants, dry powder generation systems, aqueous unit spray systems and microprocessor controlled technologies. Each approach has advantages and disadvantages depending upon each principle of action and set of design variables. In addition, specific drugs may be better suited for one type of inhaler device vs. another. The extent to which aerosol generation systems achieve their goals is discussed together with a summary of selected papers presented at the recent International Congress of Aerosols in Medicine.

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

    Energy Technology Data Exchange (ETDEWEB)

    Asmis, Lars [Institute for Clinical Hematology, University Hospital Zuerich, Zuerich (Switzerland); Tanner, Felix C. [Cardiovascular Research, Physiology Institute, University of Zuerich, Zuerich (Switzerland); Center for Integrative Human Physiology, University of Zuerich, Zuerich (Switzerland); Cardiology, Cardiovascular Center, University Hospital Zuerich, Zuerich (Switzerland); Sudano, Isabella [Cardiology, Cardiovascular Center, University Hospital Zuerich, Zuerich (Switzerland); Luescher, Thomas F. [Cardiovascular Research, Physiology Institute, University of Zuerich, Zuerich (Switzerland); Center for Integrative Human Physiology, University of Zuerich, Zuerich (Switzerland); Cardiology, Cardiovascular Center, University Hospital Zuerich, Zuerich (Switzerland); Camici, Giovanni G., E-mail: giovannic@access.uzh.ch [Cardiovascular Research, Physiology Institute, University of Zuerich, Zuerich (Switzerland); Center for Integrative Human Physiology, University of Zuerich, Zuerich (Switzerland)

    2010-01-22

    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.

  19. 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.

  20. 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.

  1. Comparison of Bare metal Vs Drug eluting stents for in-stent Restenosis among Diabetics

    Directory of Open Access Journals (Sweden)

    Kakhaber Etsadashvili

    2011-06-01

    Full Text Available Background: Diabetes mellitus is associated with an increased risk of restenosis, stent thrombosis, and death afterpercutaneous coronary interventions. Little is known about the late outcome of patients with diabetes mellitus whoreceive drug-eluting stents (DES or bare metal stents (BMS.Methods: From January 2008 to January 2010, six patients with DES and 20 with BMS, ISR were identified at ourinstitution.Results: The median age of our diabetic cohort was 63 years, and 87 of the patients were male. For two years, ratesof repeat target-vessel revascularization were significantly lower among diabetic patients treated with DEScompared with those treated with BMS (5.8% vs. 17.0%, p=0.003.Conclusions: DES is effective among diabetic patients in substantially reducing the need for repeat TVR.

  2. Bioresorbable drug-eluting magnesium-alloy scaffold for treatment of coronary artery disease.

    Science.gov (United States)

    Campos, Carlos M; Muramatsu, Takashi; Iqbal, Javaid; Zhang, Ya-Jun; Onuma, Yoshinobu; Garcia-Garcia, Hector M; Haude, Michael; Lemos, Pedro A; Warnack, Boris; Serruys, Patrick W

    2013-12-16

    The introduction of metallic drug-eluting stents has reduced the risk of restenosis and widened the indications of percutaneous coronary intervention in treatment of coronary artery disease. However, this medical device can induce hypersensitive reaction that interferes with the endothelialization and healing process resulting in late persistent or acquired malapposition of the permanent metallic implant. Delayed endotheliaization and malapposition may lead to late and very late stent thrombosis. Bioresorbable scaffolds (BRS) have been introduced to potentially overcome these limitations, as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. Magnesium is an essential mineral needed for a variety of physiological functions in the human body and its bioresorbable alloy has the strength-to-weight ratio comparable with that of strong aluminum alloys and alloy steels. The aim of this review is to present the new developments in Magnesium BRS technology, to describe its clinical application and to discuss the future prospects of this innovative therapy.

  3. Initial impact of drug-eluting stents on coronary artery bypass graft surgery.

    Science.gov (United States)

    Liddicoat, John R; De La Torre, Ralph; Ho, Kalon K L; Nathan, Senthil; Levitsky, Sidney; Krempin, Judy; Sellke, Frank

    2006-04-01

    Drug-eluting stents (DES) reduce the incidence of restenosis after percutaneous coronary intervention and have been predicted to decrease the number of patients referred for coronary artery bypass grafting (CABG). The purpose of this study was to determine the impact of DES on the number and characteristics of patients referred for CABG. Drug-eluting stents were introduced at our hospital in April 2003 and reached maturity by June 2003. We compared our isolated CABG patients from the 12 months before the introduction of DES (year 1) with those from the 12 months after full implementation of DES (year 2). In year 1, of 4,348 cardiac catheterization patients, 2,144 (49.3%) underwent percutaneous coronary intervention, and 432 (9.9%) had CABG. In year 2, of 3,986 cardiac catheterization patients, 2,027 (50.9%) had percutaneous coronary intervention, and 337 (8.5%) had CABG, representing a 14% reduction in proportion of cardiac catheterization patients referred for CABG (p = 0.021). Among CABG patients, there was no change in age, prevalence of diabetes, or prevalence of three-vessel disease; however, patients in year 2 were more likely to have left main coronary artery disease (year 1, 36% versus year 2, 44.5%; p < 0.02) and left ventricular ejection fraction greater than 0.50 (year 1, 45% versus year 2, 52%; p < 0.02). The clinical introduction of DES was associated with a modest decrease in the percentage of cardiac catheterization patients referred for CABG. Of those referred for surgery, an increasing proportion had left main coronary artery disease and preserved left ventricular systolic function. Defining the role of DES versus CABG for coronary revascularization will require elucidation of the long-term outcomes of DES compared with CABG.

  4. Stent selection in patients with myocardial infarction: drug eluting, biodegradable polymers or bare metal stents?

    Science.gov (United States)

    Mieres, Juan; Rodríguez, Alfredo E

    2012-08-01

    Percutaneous coronary intervention (PCI) has been increasingly used in the last years during interventional procedures in patients with acute coronary syndromes (ACS) including ST elevation myocardial infarction (STEMI) and non-ST elevation myocardial infarction (NSTEMI). In patients with either STEMI, NSTEMI, high risk ACS with EKG changes or cardiac enzymes rises; PCI with bare metal stent (BMS) implantation has been associated with a significant improvement in clinical outcome. Therefore, BMS implantation during primary PCI in STEMI has become a standard of practice. With the introduction of drug eluting stents (DESs) in this decade, the use of these new devices instead of BMSs in patients with STEMI has emerged as a rational PCI alternative in this particular subgroup of patients. In spite of the unquestionable benefits of DESs in terms of reduction of restenosis and TVR, specific concerns have arisen with regard to their long-term safety. High incidence of very late stent thrombosis has been described with these devices, and special attention should be paid in patients with unstable coronary lesions, in which plaque composition and remodeling may play a main role in their safety and long-term outcome. Intraluminal thrombus caused by plaque rupture is the most frequent mechanism of STEMI, in which the necrotic core and thin fibrous cap play a major role. In this context, the use of first DESs designs may be futile or even unsafe because delayed healing may further contribute to plaque instability. Adjunctive invasive imaging tools can improve stent deployment and safety outcome in these lesions with intravascular findings of plaque instability. Recently, other players such as new dedicated antithrombotic BMS designs, including selfexpanding stents or drug-eluting coated balloons, are exploring their potential indications in patients with ACS and myocardial infarction. This paper reports and discusses new stent devices and adjunctive pharmacologic agents. It

  5. Fabrication of drug eluting implants: study of drug release mechanism from titanium dioxide nanotubes

    Science.gov (United States)

    Hamlekhan, Azhang; Sinha-Ray, Suman; Takoudis, Christos; Mathew, Mathew T.; Sukotjo, Cortino; Yarin, Alexander L.; Shokuhfar, Tolou

    2015-06-01

    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.

  6. Characterization of drug-eluting stent (DES) materials with cluster secondary ion mass spectrometry (SIMS)

    Science.gov (United States)

    Mahoney, Christine M.; Patwardhan, Dinesh V.; Ken McDermott, M.

    2006-07-01

    Secondary ion mass spectrometry (SIMS) employing an SF 5+ polyatomic primary ion source was utilized to analyze several materials commonly used in drug-eluting stents (DES). Poly(ethylene- co-vinyl acetate) (PEVA), poly(lactic- co-glycolic acid) (PLGA) and various poly(urethanes) were successfully depth profiled using SF 5+ bombardment. The resultant molecular depth profiles obtained from these polymeric films showed very little degradation in molecular signal as a function of increasing SF 5+ primary ion dose when experiments were performed at low temperatures (signal was maintained for doses up to ˜5 × 10 15 ions/cm 2). Temperature was determined to be an important parameter in both the success of the depth profiles and the mass spectral analysis of the polymers. In addition to the pristine polymer films, paclitaxel (drug released in Taxus™ stent) containing PLGA films were also characterized, where it was confirmed that both drug and polymer signals could be monitored as a function of depth at lower paclitaxel concentrations (10 wt%).

  7. Mid-Term Follow-Up of Drug-Eluting Stenting for In-Stent Restenosis: Bare-Metal Stents versus Drug- Eluting Stents

    Directory of Open Access Journals (Sweden)

    Negar Faramarzi

    2015-10-01

    Full Text Available Background: Despite major advances in percutaneous coronary intervention (PCI, in-stent restenosis (ISR remains a therapeutic challenge. We sought to compare the mid-term clinical outcomes after treatment with repeat drug-eluting stent (DES implantation (“DES sandwich” technique with DES placement in the bare-metal stent (DES-in-BMS in a "real world" setting.Methods: We retrospectively identified and analyzed clinical and angiographic data on 194 patients previously treated with the DES who underwent repeat PCI for ISR with a DES or a BMS. ISR was defined, by visual assessment, as a luminal stenosis greater than 50% within the stent or within 5 mm of its edges. We recorded the occurrence of major adverse cardiac events (MACE, defined as cardiac death, non-fatal myocardial infarction, and the need for target vessel revascularization (TVR.Results: Of the 194 study participants, 130 were men (67.0% and the mean ± SD of age was 57.0 ± 10.4 years, ranging from37 to 80 years. In-hospital events (death and Q-wave myocardial infarction occurred at a similar frequency in both groups. Outcomes at twelve months were also similar between the groups with cumulative clinical MACE at one-year follow-up of 9.6% and 11.3% in the DES-in-BMS and the DES-in-DES groups, respectively (p value = 0.702. Although not significant, there was a trend toward a higher TVR rate in the intra-DES ISR group as compared to the intra-BMS ISR group (0.9% BMS vs. 5.2% DES; p value = 0.16.Conclusion: Our study suggests that the outcome of the patients presenting with ISR did not seem to be different between the two groups of DES-in-DES and DES-in-BMS at one-year follow-up, except for a trend toward more frequent TVR in the DES-in-DES group. Repeat DES implantation for DES restenosis could be feasible and safe with a relatively low incidence of MACE at mid-term follow-up.

  8. 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 ...

  9. Safety and efficacy of drug-eluting stent for ST-segment elevation myocardial infarction in an unselected consecutive cohort

    NARCIS (Netherlands)

    Vlaar, Pieter J.; Rihal, Charanjit S.; Singh, Mandeep; Lennon, Ryan; Ting, Henry H.; Bresnahan, John F.; Holmes, David R.

    2008-01-01

    (Objective) under bar: The objective of this study is to investigate the clinical outcome of a large cohort of patients with ST-segment elevation myocardial infarction (STEMI) treated with drug-eluting stents (DES) compared to bare metal stents (BMS). (Background) under bar: Several randomized contr

  10. Vascular brachytherapy revisited for in-stent restenosis in the drug-eluting stent era: current status and future perspective

    Institute of Scientific and Technical Information of China (English)

    LI Xiong-jie; Seung-Woon Rha; Sunil-P Wani; WANG Lin; Kanhaiya-L Poddar; Dong-Joo Oh

    2009-01-01

    @@ Percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) has revolutionized the management of atherosclerotic coronary artery disease. However, in-stent restenosis (ISR) has been the downside of all coronary interventions with the devices that have been tested so far, even in the DES era.

  11. 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.

  12. Comparison of the Efficacy of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With In-Stent Restenosis (from the RIBS IV and V Randomized Clinical Trials).

    Science.gov (United States)

    Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; García-Touchard, Arturo; Masotti, Mónica; López-Minguez, José R; Iñiguez, Andrés; Zueco, Javier; Velazquez, Maite; Cequier, Angel; Lázaro-García, Rosa; Martí, Vicens; Moris, César; Urbano-Carrillo, Cristobal; Bastante, Teresa; Rivero, Fernando; Cárdenas, Alberto; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Fernández, Cristina

    2016-02-15

    Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study sought to compare the efficacy of everolimus-eluting stents (EESs) and drug-eluting balloons (DEBs) with paclitaxel in patients with ISR. A pooled analysis of the Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS IV) and Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS V) randomized trials was performed using patient-level data. In both trials, EESs were compared with DEBs in patients with ISR (RIBS V included 189 patients with bare-metal ISR; RIBS IV included 309 patients with drug-eluting ISR). Inclusion and exclusion criteria were identical in both trials. A total of 249 patients were allocated to EES and 249 to DEB. Clinical follow-up at 1 year was obtained in all (100%) patients and late angiography (median 249 days) in 91% of eligible patients. Compared with patients treated with DEBs, patients treated with EESs obtained better short-term results (postprocedural minimal lumen diameter 2.28 ± 0.5 vs 2.12 ± 0.4 mm, p stent type and treatment effects. At 1-year clinical follow-up, the composite of cardiac death, myocardial infarction, and target vessel revascularization was significantly reduced in the EES arm (8.8% vs 14.5%, p = 0.03; hazard ratio 0.59, 95% CI 0.31 to 0.94) mainly driven by a lower need for target vessel revascularization (6% vs 12.4%, p = 0.01, hazard ratio 0.46, 95% CI 0.25 to 0.86). This pooled analysis of the RIBS IV and RIBS V randomized trials demonstrates the superiority of EES over DEB in the treatment of patients with ISR.

  13. Sirolimus-loaded CaP coating on Co-Cr alloy for drug-eluting stent.

    Science.gov (United States)

    Yang, Jingxin; Lee, In-Seop; Cui, Fuzhai

    2016-09-01

    To achieve polymer-free and controllable drug-eluting system, there have been many efforts to modify the surface composition and topography of metal stent. Recently, calcium phosphate is commonly applied to metallic implants as a coating material for fast fixation and firm-implant bone attachment on the account of its demonstrated bioactive and osteoconductive properties. In the present study, the release of sirolimus could be controllable because of immobilization of sirolimus during the process of biomimetic CaP coating forming. A completely new concept is the drug carrier of biomimetic CaP coating with sirolimus for an absorbable drug eluting system, which in turn can serve as a drug reservoir. We here describe the characteristic, mechanisms and drug release in vitro of new drug-eluting system in comparison to conventional system equivalent. Nano-structured calcium phosphate (CaP) coating was formed on the cobalt-chromium (Co-Cr) alloy substrate. By immersing coated sample in solution with sirolimus (rapamycin), the sirolimus could be immobilized in the newly formed CaP layer. The morphology, composition and formation process of the coating were studied with scanning electron microscopy, energy dispersive spectrometer, X-ray diffraction and X-ray photoelectron spectroscopy. The results showed that a uniform CaP coating incorporated with sirolimus was observed on Co-Cr alloy.

  14. Bioresorbable Drug-Eluting Magnesium-Alloy Scaffold for Treatment of Coronary Artery Disease

    Directory of Open Access Journals (Sweden)

    Carlos M. Campos

    2013-12-01

    Full Text Available The introduction of metallic drug-eluting stents has reduced the risk of restenosis and widened the indications of percutaneous coronary intervention in treatment of coronary artery disease. However, this medical device can induce hypersensitive reaction that interferes with the endothelialization and healing process resulting in late persistent or acquired malapposition of the permanent metallic implant. Delayed endotheliaization and malapposition may lead to late and very late stent thrombosis. Bioresorbable scaffolds (BRS have been introduced to potentially overcome these limitations, as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. Magnesium is an essential mineral needed for a variety of physiological functions in the human body and its bioresorbable alloy has the strength-to-weight ratio comparable with that of strong aluminum alloys and alloy steels. The aim of this review is to present the new developments in Magnesium BRS technology, to describe its clinical application and to discuss the future prospects of this innovative therapy.

  15. Optical coherence tomography assessment of edge dissections after drug-eluting stent implantation in coronary artery

    Institute of Scientific and Technical Information of China (English)

    GUO Jun; HAN Bao-shi; GAI Lu-yue; YANG Ting-shu; CHEN Yun-dai; TIAN Feng; LIU Hong-bin; CHEN Lian; SUN Zhi-jun; REN Yi-hong; JIN Qin-hua; LIU Chang-fu

    2012-01-01

    Background Edge dissections after coronary stent implantation are associated with increased short-term risk of major adverse cardiovascular events.The incidence and outcome of edge dissections after coronary stent implantation were reportedly different using different imaging techniques.We used optical coherence tomography (OCT) to assess the incidence,morphological findings and related factors of edge dissections after drug-eluting stent (DES) implantation.Methods Totally 42 patients with 43 de novo lesions in 43 native arteries undergoing DES implantation with OCT imaging were enrolled in this study.Results Nine edge dissections were detected in 43 arteries after DES implantation.There were four morphological patterns of stent edge dissections indentified in this study:(1) superficial intimal tears (n=3),(2) subintimal dissections (n=4),(3) split of media (n=1),(4) disruption of the fibrotic cap of plaque (n=1).Stent edge expansion and stent expansion were both higher in the group with dissections than those in the group without dissections (1.682±0.425 vs.1.229±0.285,P=0.0290; 1.507±0.445 vs.1.174±0.265,P=0.0072).Conclusions The incidence of stent edge dissections detected by OCT was 21%.Stent edge dissection is related with stent edge expansion and stent expansion.

  16. Safety and efficacy of coronary drug eluting stent for atherosclerotic stenosis of the small renal artery

    Institute of Scientific and Technical Information of China (English)

    LI Chun-jie; WU Zheng; YAN Hong-bing; WANG Jian; ZHAO Han-jun

    2009-01-01

    @@ Small diameter renal artery refers to the renal artery with the cross-section diameter less than 5 mm, the incidence of which is approximately 8%.1 Small diameter renal artery is common in patients with congenital multi-branch renal arteries, diabetes and multi-coronary artery lesions. Renal artery bare-mental stent (BMS) implantation is the standard treatment for ostial renal artery stenosis.2,3 However, the restenosis rate4-6 is too high and becomes one of the relative contraindications for small diameter renal artery stent implantation. Clinical trials (e.g. RAVEL,7,8 SIRIUS9 and TAXUS-IV10) have proved that drug eluting stent (DES), compared with BMS, can reduce the restenosis rate after the percutanous coronary intervention (PCI). And Huda et al11 claimed that DES had the better results than BMS in the treatment of obstructive superficial femoral artery disease. However,there are few studies involved restenosis after the renal artery intervention. We hypothesized that coronary DES applied in renal artery stenosis might inhibit intimal proliferation effectively as in coronary artery disease;therefore we evaluated the results of 25 patients with atherosclerotic renal artery stenosis treated using coronary DES to assess the safety and efficacy of coronary DES in patients with small renal artery stenotic lesions.

  17. Sirolimus-eluting stents for treatment of drug-eluting versus bare-metal stents restenosis: 42-month clinical outcomes from a Chinese single center

    Institute of Scientific and Technical Information of China (English)

    YAN Rong-qiang; LIU Hai-bo; WU Yong-jian; YUAN Jin-qing; CHEN Jue; YOU Shi-jie; DAI Jun; GAO Run-lin; CHEN Ji-lin; GAO Li-jian; YANG Yue-jin; LI Jian-jun; QIAO Shu-bin; XU Bo; YAO Min; QIN Xue-wen

    2012-01-01

    Background Restenosis of bare-metal stents (BMS) and drug-eluting stents (DES) has been increasingly treated with sirolimus-eluting stents (SES),but the long-term outcomes are unknown.Methods In our study,388 consecutive patients (144 DES restenosis and 244 BMS restenosis) with 400 lesions (147 DES restenosis and 253 BMS restenosis) treated with SES were included.The rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE) at 42 months were analyzed.Results At the mean follow-up of 42 months,the rates of death (3.5% vs.3.3%,P=1.000) and myocardial infarction (2.8% vs.1.2%,P=0.431) in the DES group and BMS group were comparable.Compared with the BMS group,ischemia-driven TLR occurred with a higher frequency in the DES group (18.8% vs.10.7%,P=0.024).This translated into an increased rate of MACE in the DES group (22.2% vs.14.0%,P=0.034).Stent thrombosis occurred with a similar frequency in both groups (2.8% vs.1.6%,P=0.475).Multivariate analysis showed that DES restenosis (OR=1.907,95%Cl 1.108-3.285,P=0.020) and smoking (OR=2.069; 95% C/ 1.188-3.605; P=0.010) were independent predictors of MACE.Conclusions Although SES implantation appears to be safe and effective,it was associated with higher TLR recurrence for DES than BMS restenosis.

  18. 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.

  19. [Cardiovascular diseases in the focus of health economics. The example of drug-eluting vascular stents in coronary heart disease].

    Science.gov (United States)

    Reinhold, T; Müller-Riemenschneider, F; McBride, D; Brüggenjürgen, B; Willich, S N

    2012-05-01

    Coronary heart disease is an important disorder in Western industrialized societies, with regard to both the epidemiologic and economic burden of illness. A modern therapeutic strategy consists of coronary interventions and the implantation of drug-eluting vascular stents. The cost-effectiveness of such drug-eluting stents has been an important subject of health-economic evaluation research in recent years. This article presents two examples of such studies and deals with the question whether existing study projects are able to provide sufficient evidence for allocation decisions in health care. On this basis we discuss important challenges for future health economic analysis. A key conclusion is the need for long-term and cross-sectoral evaluation strategies that could be based on routinely collected health care data. Supplemented by health economic results from clinical trials, the use of such data would lead to a broader data basis for allocation decisions in health care.

  20. Lesion length impacts long term outcomes of drug-eluting stents and bare metal stents differently.

    Directory of Open Access Journals (Sweden)

    Shang-Hung Chang

    Full Text Available BACKGROUND: Long lesions have been associated with adverse outcomes in percutaneous coronary interventions with bare metal stents (BMS. However, the exact impact of lesion length on the short- and long-term outcomes of drug-eluting stent (DES implantations is not as clear. METHODS AND RESULTS: This study compared the impact of lesion length on angiographic and clinical outcomes of BMS and DES in a single-center prospective registry. Lesion length was divided into tertiles. The primary endpoints were angiographically defined binary in-stent restenosis (ISR rate and major adverse cardiac event (MACE. Of the 4,312 de novo lesions in 3,447 consecutive patients in the CAPTAIN registry, 2,791 lesions (of 2,246 patients received BMS, and the remaining 1,521 lesions (of 1,201 patients received DES. The mean follow-up duration was 4.5 years. The longer the lesion, the higher the ISR rate (14%, 18%, and 29%, p<0.001 and the lower the MACE-free survivals (p = 0.007 in the BMS group. However, lesion length showed no such correlation with ISR rates (4.7%, 3.3%, and 7.8%, p = 0.67 or MACE-free survivals (p = 0.19 in the DES group. CONCLUSIONS: In our single-center prospective registry, lesion length defined in tertiles has no impact on the short-term (ISR or long-term (MACE outcomes of patients implanted with DES. In contrast, longer lesion correlates with higher ISR and MACE rates in BMS group.

  1. 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.

  2. Early local intracoronary platelet activation after drug-eluting stent placement

    Institute of Scientific and Technical Information of China (English)

    Ailiman Mahemuti; Nicolas Meneveau; Marie-France Seronde; Francois Schiele; Mariette Mercier; Evelyne Racadot; Jean-Pierre Bassand

    2007-01-01

    Background Early local platelet activation after coronary intervention identifies patients at increased risk of acute stent thrombosis (AST). However, early changes in platelet activation in coronary circulation following drug-eluting stent (DES) implantation have never been reported.Methods In a prospective study of 26 consecutive elective stable angina patients, platelet activation was analyzed by measuring soluble glycoprotein V (sGPV) and P-selectin (CD62P) before and after implantation of either DES or bare metal stent (BMS). All patients were pretreated with clopidogrel (300 mg loading dose) and aspirin (75 mg orally) the day before the procedure. Blood samples were drawn from the coronary ostium and 10 - 20 mm distal to the lesion site.Results Consistent with the lower baseline clinical risk, the levels of CD62P and sGPV were within normal reference range, both in the coronary ostium and distal to the lesion before percutaneous coronary intervention (PCl) procedure.The levels of CD62P and sGPV did not change significantly (CD62P: (31.1 ± 9.86) ng/ml vs (29.5 ± 9.02) ng/ml, P=0.319and sGPV: (52.4 ± 13.5) ng/ml vs (51.8 ± 11.7) ng/ml, P=0.674, respectively) after stent implantation when compared with baseline. Changes in these platelet activation markers did not differ between stent types.Conclusions Intracoronary local platelet activation does not occur in stable angina patients before and immediately following DES implantation when dual anti-platelet is administered.

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

    Science.gov (United States)

    Tang, Jing; Liu, Yongjia; Zhu, Bangshang; Su, Yue; Zhu, Xinyuan

    2017-01-01

    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.

  4. 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

    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 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. Results 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. Conclusions 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. PMID:27621830

  5. Improved outcomes of elderly patients treated with drug-eluting versus bare metal stents in large coronary arteries

    DEFF Research Database (Denmark)

    Kurz, David J; Bernheim, Alain M; Tüller, David

    2015-01-01

    BACKGROUND: Drug-eluting stents (DES) improve outcomes in elderly patients with small coronary artery disease compared with bare-metal stents (BMS), but randomized data in elderly patients in need of large coronary stents are not available. METHODS: Planned secondary analysis of patients ≥75 years...... recruited to the "BASKET-PROVE" trial, in which 2,314 patients undergoing percutaneous coronary intervention for large (≥3.0 mm) native vessel disease were randomized 2:1 to DES (everolimus- vs sirolimus-eluting stents 1:1) versus BMS. All patients received 12 months of dual antiplatelet therapy....... The primary end point was a composite of cardiac death or nonfatal myocardial infarction at 2 years. RESULTS: Comparison of DES versus BMS among 405 patients ≥75 years showed significantly lower rates of the primary end point for DES (5.0% vs 11.6%; hazard ration (HR) 0.64 [0.44-0.91]; P = .014). Rates...

  6. 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 Skov; Kaltoft, Anne

    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....

  7. 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....

  8. 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

  9. Five-Year Clinical Outcomes After Drug-Eluting Stent Implantation Following Rotational Atherectomy for Heavily Calcified Lesions.

    Science.gov (United States)

    Jinnouchi, Hiroyuki; Kuramitsu, Shoichi; Shinozaki, Tomohiro; Hiromasa, Takashi; Kobayashi, Yohei; Takeji, Yasuaki; Miura, Mizuki; Masuda, Hisaki; Matsumura, Yukiko; Yamaji, Yuhei; Sakakura, Kenichi; Domei, Takenori; Soga, Yoshimitsu; Hyodo, Makoto; Shirai, Shinichi; Ando, Kenji

    2017-09-09

    Percutaneous coronary intervention for heavily calcified lesions requires rotational atherectomy (RA). Long-term clinical outcomes after drug-eluting stent (DES) implantation following (RA) for heavily calcified lesions remain unclear. We assessed 5-year clinical outcomes after DES implantation following RA.Methods and Results:Between March 2006 and September 2011, 219 consecutive patients with 219 lesions treated with DES following RA, were retrospectively enrolled. The cumulative 5-year incidence of target-lesion revascularization (TLR) and definite stent thrombosis (ST) were assessed. The cumulative incidence of TLR within (≤) the first year was 18.6%. Late TLR beyond (>) 1 year continued to occur at 1.9% per year without a decrease in the rate (5-year incidence, 26.0%). The cumulative incidence of definite ST at 30 days, 1 and 5 years was 0.9%, 2.3% and 2.9%, respectively. The annual rate of definite ST beyond 1 year was 0.15%. On multivariate analysis, the significant predictor of TLR within 1 year was use of first-generation DES (hazard ratio [HR], 2.09; 95% CI: 1.10-4.03, P=0.02) and that of TLR beyond 1 year was hemodialysis (HR, 3.29; 95% CI: 1.06-10.55, P=0.04). Late TLR beyond 1 year continued to occur up to 5 years at a constant annual incidence, whereas very late ST was rare. Careful long-term clinical follow-up is continually needed in patients who have already received DES following RA for heavily calcified lesions.

  10. 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.

  11. 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...

  12. Gender difference in patients with acute myocardial infarction treated by primary percutaneous coronary intervention in drug-eluting stent era

    Institute of Scientific and Technical Information of China (English)

    GE Jun-bo

    2010-01-01

    @@ Primary percutaneous coronary intervention (PCI) has been the standard of care for patients with acuteST-elevation myocardial infarction (STEMI) within 12 hours of symptom onset in modern era.~(1,2) The advances and applications of robust anti-platelet and anti-coagulation medicines further improve the outcome of STEMI patients undergoing primary PCI,~3 and drug-eluting stent (DES) has also been proven to be effective and safe when applying in primary PCI.~4 Historical data indicated that women undergoing PCI exerted worse outcomes than male patients, and the gender differences in outcome after PCI are still topical and of interest, especially the outcome after primary PCI.

  13. 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

  14. Drug-eluting versus bare metal stents in patients with st-segment-elevation myocardial infarction: eight-month follow-up in the Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION) trial

    DEFF Research Database (Denmark)

    Kelbaek, Henning; Thuesen, Leif; Helqvist, Steffen

    2008-01-01

    BACKGROUND: Implantation of drug-eluting stents (DES) limits the rate of coronary restenosis in most patients with coronary artery disease, but data are scarce with regard to their use in patients with ST-segment-elevation myocardial infarction and in connection with distal protection of the micr......BACKGROUND: Implantation of drug-eluting stents (DES) limits the rate of coronary restenosis in most patients with coronary artery disease, but data are scarce with regard to their use in patients with ST-segment-elevation myocardial infarction and in connection with distal protection...... of the microvascular perfusion during primary percutaneous coronary intervention. METHODS AND RESULTS: We randomly assigned 626 patients referred within 12 hours from symptom onset of an ST-elevation myocardial infarction to have a DES or a bare metal stent implanted in the infarct-related lesion with or without...... distal protection during primary percutaneous coronary intervention. Quantitative coronary angiography was performed during the index treatment and 8 months later. The primary end point was loss of the lumen diameter in the infarct-related lesion induced by neointimal proliferation. Patients were...

  15. Molecular Mechanism of Local Drug Delivery with Paclitaxel-Eluting Membranes in Biliary and Pancreatic Cancer: New Application for an Old Drug

    Directory of Open Access Journals (Sweden)

    Sookhee Bang

    2015-01-01

    Full Text Available Implantation of self-expanding metal stents (SEMS is palliation for patients suffering from inoperable malignant obstructions associated with biliary and pancreatic cancers. Chemotherapeutic agent-eluting stents have been developed because SEMS are susceptible to occlusion by tumor in-growth. We reported recently that paclitaxel-eluting SEMS provide enhanced local drug delivery in an animal model. However, little is known about the molecular mechanisms by which paclitaxel-eluting stents attenuate tumor growth. We investigated the signal transduction pathways underlying the antiproliferative effects of a paclitaxel-eluting membrane (PEM implanted in pancreatic/cholangiocarcinoma tumor bearing nude mice. Molecular and cellular alterations were analyzed in the PEM-implanted pancreatic/cholangiocarcinoma xenograft tumors by Western blot, immunoprecipitation, and immunofluorescence. The quantities of paclitaxel released into the tumor and plasma were determined by liquid chromatography-tandem mass spectroscopy. Paclitaxel from the PEM and its diffusion into the tumor inhibited angiogenesis, which involved suppression of mammalian target of rapamycin (mTOR through regulation of hypoxia inducible factor (HIF-1 and increased apoptosis. Moreover, implantation of the PEM inhibited tumor-stromal interaction-related expression of proteins such as CD44, SPARC, matrix metalloproteinase-2, and vimentin. Local delivery of paclitaxel from a PEM inhibited growth of pancreatic/cholangiocarcinoma tumors in nude mice by suppressing angiogenesis via the mTOR and inducing apoptosis signal pathway.

  16. 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

    -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...... associated with smaller, not statistically significant, increases in MACE rates. Among patients who discontinued clopidogrel, MACE rates were highest within the first 2 months after discontinuation. CONCLUSIONS: Discontinuation of clopidogrel was associated with an increased rate of MACE among patients...

  17. Effect of Optimal Medical Therapy Before Procedures on Outcomes in Coronary Patients Treated With Drug-Eluting Stents.

    Science.gov (United States)

    Iijima, Raisuke; Nakamura, Masato; Matsuyama, Yutaka; Muramatsu, Toshiya; Yokoi, Hiroyoshi; Hara, Hidehiko; Okada, Hisayuki; Ochiai, Masahiko; Suwa, Satoru; Hozawa, Hidenari; Kawai, Kazuya; Awata, Masaki; Mukawa, Hiroaki; Fujita, Hiroshi; Nanto, Shinsuke

    2016-09-15

    It has not been established whether the achievement of optimal medical therapy (OMT) before implantation of a drug-eluting stent has a clinical benefit for patients with stable coronary artery disease (CAD). This study included 3,004 patients with CAD treated with drug-eluting stent from 123 Japanese participating centers. The achievement of OMT was defined as control of blood pressure OMT group), whereas the remaining 2,456 patients failed to achieve one or more criteria (the non-OMT group). At 24 months, the incidence of target vessel failure was 7.0% in the achieved OMT group versus 10.0% in the non-OMT group (hazard ratio 0.68, 95% CI 0.48 to 0.96, p = 0.03). The incidence of non-Q-wave myocardial infarction was also lower in the achieved OMT group than in the non-OMT group (0.5% vs 1.5%, p = 0.08). Multivariate logistic regression analysis identified that hemoglobin A1c OMT before percutaneous coronary intervention significantly reduced subsequent cardiac events. Achievement of OMT is still insufficient in modern clinical practice.

  18. Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (The SORT OUT IV Trial)

    DEFF Research Database (Denmark)

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

    2012-01-01

    BACKGROUND: Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent. METHODS AND RESULTS: The Scandinavian Organi.......9%]; hazard ratio, 0.25; 95% confidence interval, 0.07-0.88). CONCLUSION: The everolimus-eluting stent was found to be noninferior to the sirolimus-eluting stent. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00552877....

  19. Drug-eluting coating of ginsenoside Rg1 and Re incorporated poly(lactic-co-glycolic acid) on stainless steel 316L: Physicochemical and drug release analyses.

    Science.gov (United States)

    Miswan, Zulaika; Lukman, Siti Khadijah; Abd Majid, Fadzilah Adibah; Loke, Mun Fai; Saidin, Syafiqah; Hermawan, Hendra

    2016-12-30

    Active ingredients of ginsenoside, Rg1 and Re, are able to inhibit the proliferation of vascular smooth muscle cells and promote the growth of vascular endothelial cells. These capabilities are of interest for developing a novel drug-eluting stent to potentially solve the current problem of late-stent thrombosis and poor endotheliazation. Therefore, this study was aimed to incorporate ginsenoside into degradable coating of poly(lactic-co-glycolic acid) (PLGA). Drug mixture composed of ginseng extract and 10% to 50% of PLGA (xPLGA/g) was coated on electropolished stainless steel 316L substrate by using a dip coating technique. The coating was characterized principally by using attenuated total reflectance-Fourier transform infrared spectroscopy, scanning electron microscopy and contact angle analysis, while the drug release profile of ginsenosides Rg1 and Re was determined by using mass spectrometry at a one month immersion period. Full and homogenous coating coverage with acceptable wettability was found on the 30PLGA/g specimen. All specimens underwent initial burst release dependent on their composition. The 30PLGA/g and 50PLGA/g specimens demonstrated a controlled drug release profile having a combination of diffusion- and swelling-controlled mechanisms of PLGA. The study suggests that the 30PLGA/g coated specimen expresses an optimum composition which is seen as practicable for developing a controlled release drug-eluting stent.

  20. 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)....

  1. 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)....

  2. Prevalence and Predictors of Early Discontinuation of Dual-Antiplatelet Therapy After Drug-Eluting Stent Implantation in Korean Population.

    Science.gov (United States)

    Cho, Mi Hee; Shin, Dong Wook; Yun, Jae Moon; Shin, Joong Hyun; Lee, Seung Pyo; Lee, Hyejin; Lim, Yoo Kyoung; Kim, Eun Ha; Kim, Hyun Kyoung

    2016-11-15

    The administration of antiplatelet drugs for months after a drug-eluting stent implantation is critical in decreasing the risk of complications, and premature discontinuation of antiplatelet therapy before the recommended period is the most important predictor for late complications. Therefore, we investigated the prevalence and associated factors of premature discontinuation of antiplatelet therapy in patients in Korea. This retrospective cohort study was conducted using the Korean National Health Insurance Service-National Sample Cohort data. Patients who were treated with dual-antiplatelet therapy (DAPT) were identified with medication prescription data. The Kaplan-Meier failure time plot was used to illustrate the cumulative probability of treatment discontinuation. Cox regression analysis was conducted to compare predictors of early discontinuation of DAPT. The characteristics of the early discontinuation group were not significantly different from the guideline concordance group, except for a higher prevalence of disability and a lower rate of chronic kidney disease. In a Cox regression model, the presence of hypertension was identified as a negative predictor of early discontinuation, and disability was not a statistically significant predictor. The prevalence of early discontinuation was 31.0% and seems to be significantly higher than those reported from prospective studies, which may more accurately reflect the real-world situation. In conclusion, physicians should make more effort to educate patients on the risk associated with premature discontinuation of antiplatelet therapy after percutaneous coronary intervention with drug-eluting stent, and further studies investigating the reasons for nonadherence of DAPT are needed to improve DAPT compliance. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Acidic pH-Triggered Drug-Eluting Nanocomposites for Magnetic Resonance Imaging-Monitored Intra-arterial Drug Delivery to Hepatocellular Carcinoma.

    Science.gov (United States)

    Park, Wooram; Chen, Jeane; Cho, Soojeong; Park, Sin-Jung; Larson, Andrew C; Na, Kun; Kim, Dong-Hyun

    2016-05-25

    Transcatheter hepatic intra-arterial (IA) injection has been considered as an effective targeted delivery technique for hepatocellular carcinoma (HCC). Recently, drug-eluting beads (DEB) were developed for transcatheter IA delivery to HCC. However, the conventional DEB has offered relatively modest survival benefits. It can be difficult to control drug loading/release from DEB and to monitor selective delivery to the targeted tumors. Embolized DEBs in hepatic arteries frequently induce hypoxic and low pH conditions, promoting cancer cell growth. In this study, an acidic pH-triggered drug-eluting nanocomposite (pH-DEN) including superparamagnetic iron oxide nanocubes and pH-responsive synthetic peptides with lipid tails [octadecylamine-p(API-l-Asp)10] was developed for magnetic resonance imaging (MRI)-monitored transcatheter delivery of sorafenib (the only FDA-approved systemic therapy for liver cancer) to HCC. The synthesized sorafenib-loaded pH-DENs exhibited distinct pH-triggered drug release behavior at acidic pH levels and highly sensitive MR contrast effects. In an orthotopic HCC rat model, successful hepatic IA delivery and distribution of sorafenib-loaded pH-DEN was confirmed with MRI. IA-delivered sorafenib-loaded pH-DENs elicited significant tumor growth inhibition in a rodent HCC model. These results indicate that the sorafenib-pH-DENs platform has the potential to be used as an advanced tool for liver-directed IA treatment of unresectable HCC.

  4. Antileukemic HLA-restricted T-cell clones generated with naturally processed peptides eluted from acute myeloblastic leukemia blasts.

    Science.gov (United States)

    Ostankovitch, M; Buzyn, A; Bonhomme, D; Connan, F; Bouscary, D; Heshmati, F; Dreyfus, F; Choppin, J; Guillet, J G

    1998-07-01

    Recent studies have shown that transfusions of HLA-compatible donor lymphocytes may induce complete remission in marrow-grafted patients with relapses of acute myeloblastic leukemia (AML). We investigated the in vitro generation of antileukemia T-cell clones obtained from the peripheral blood mononuclear cells of a partially HLA-compatible donor (HLA-A2 and B7 molecules in common with the leukemic blasts) after stimulation with a pool of naturally processed peptides extracted from leukemic blast cells collected at diagnosis from a patient with hyperleucocytosis AML. We recovered a significant quantity of peptides that bound to the HLA-A2 or HLA-B7 molecules that were able to induce cytolytic T-lymphocyte (CTL) lines and clones specific for the eluted AML peptides and restricted to the HLA-A2 or B7 molecules. Such CTL line did not recognize the patient's nonleukemic cells, and one clone was able to interact with the leukemic blasts from which the naturally processed peptides had been eluted. Such T-cell clones might provide a rationale for the development of adoptive immunotherapy and could be used to improve the efficiency of HLA-compatible T-lymphocyte transfusions and the graft-versus-leukemia response in patients with AML.

  5. 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...... in women undergoing percutaneous coronary intervention with DES remain unclear. METHODS: Patient-level data from female participants in 26 randomized trials of DES were pooled. Study population was categorized according to the presence of moderate or severe versus mild or no target lesion CAC, assessed......,371 women. Of these, 1,622 (25.5%) had moderate or severe CAC. In fully adjusted models, independent correlates of CAC were age, hypertension, hypercholesterolemia, smoking, previous coronary artery bypass graft surgery, and worse left ventricular and renal function. At 3 years, women with CAC were...

  6. 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.

  7. Three-dimensional printing of drug-eluting implants: preparation of an antimicrobial polylactide feedstock material.

    Science.gov (United States)

    Water, Jorrit Jeroen; Bohr, Adam; Boetker, Johan; Aho, Johanna; Sandler, Niklas; Nielsen, Hanne Mørck; Rantanen, Jukka

    2015-03-01

    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 the processing. Release of NF from the disks was dependent on the drug loading in a concentration-dependent manner as a higher level of released drug was observed from disks with higher drug loads. Disks with 30% drug loading were able to prevent surface-associated and planktonic growth of Staphylococcus aureus over a period of 7 days. At 10% drug loading, the disks did not inhibit planktonic growth, but still inhibited surface-associated growth. Elemental analysis indicated the presence of microdomains of solid drug supporting the observed slow and partial drug release. This work demonstrates the potential of custom-made, drug-loaded feedstock materials for 3D printing of pharmaceutical products for controlled release. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  8. Neointimal hyperplasia after sirolimus-eluting and paclitaxel-eluting stent implantation in diabetic patients: the Randomized Diabetes and Drug-Eluting Stent (DiabeDES) Intravascular Ultrasound Trial

    DEFF Research Database (Denmark)

    Jensen, L.O.; Maeng, M.; Thayssen, P.;

    2008-01-01

    AIMS: Patients with diabetes have increased risk of in-stent restenosis after coronary stent implantation owing to neointimal hyperplasia (NIH). The aim of the study was to evaluate the extent and distribution of NIH with intravascular ultrasound (IVUS) after coronary artery stenting with sirolimus......-eluting (Cypher) or paclitaxel-eluting (Taxus) stents in diabetic patients. METHODS AND RESULTS: One hundred and thirty diabetic patients were randomized to Cypher or Taxus stent implantation. IVUS was performed at 8 month follow-up. NIH volume was significantly reduced in the Cypher group when compared...... with the Taxus group: median (inter-quartile range) 0.0 (0.0-0.0) vs. 8.0 mm(3) (0.1-33.0), P stents compared with Taxus stents: median (inter-quartile range) 0.0 (0.0-0.0) vs. 7.5% (0.1-27.0), P stent...

  9. 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

    The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients...... with diabetes with coronary artery disease were randomized to Cypher (n = 76) or Taxus (n = 77) stent implantation. All patients were followed for 8 months. The primary end point was 8-month angiographic in-stent late luminal loss. This primary end point was reduced in the Cypher group compared with the Taxus.......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...

  10. Late and very late stent thrombosis following drug-eluting stent implantation in unprotected left main coronary artery: A multicentre registry

    NARCIS (Netherlands)

    A. Chieffo (Alaide); S.-J. Park (Seung-Jung); E. Meliga (Emanuele); I. Sheiban (Imad); M.S. Lee (Michael); A. Latib (Azeem); Y.-H. Kim (Young-Hak); M. Valgimigli (Marco); D. Sillano (Dario); V. Magni (Valeria); G.G. Biondi-Zoccai (Giuseppe); M. Montorfano (Matteo); F. Airoldi (Flavio); R. Rogacka (Renata); M. Carlino (Mauro); I. Michev (Iassen); M.K. Hong (Myeong); C. Moretti (Claudio); E. Bonizzoni (Erminio); G.M. Sangiorgi (Giuseppe); J. Tobis (Jonathan); P.W.J.C. Serruys (Patrick); A. Colombo (Antonio)

    2008-01-01

    textabstractAims: To evaluate the occurrence of late and very late stent thrombosis (ST) following elective drug-eluting stent (DES) implantation in unprotected left main coronary artery (LMCA) stenosis in a large multicentre registry. Methods and results: All 731 consecutive patients who had siroli

  11. Effect of Oversized Partial Postdilatation on Coatings of Contemporary Durable Polymer-Based Drug-Eluting Stents: A Scanning Electron Microscopy Study

    NARCIS (Netherlands)

    Basalus, Mounir W.Z.; Tandjung, Kenneth; Apeldoorn, van Aart A.; Ankone, Marc J.K.; Birgelen, von Clemens

    2011-01-01

    Background: Oversized postdilation of drug-eluting stents (DES) is often performed to avoid stent malapposition. In stents implanted in long lesion or major bifurcations, extremely oversized partial postdilation may be required, which exposes DES coating to extreme forces. This study aims to assess

  12. Long-term benefits and risks of drug-eluting compared to bare-metal stents in patients with versus without chronic kidney disease

    DEFF Research Database (Denmark)

    Wanitschek, Maria; Pfisterer, Matthias; Hvelplund, Anders;

    2013-01-01

    AIMS: Chronic kidney disease (CKD) is associated with worse outcomes in patients with coronary artery disease (CAD). How CKD influences the benefit-risk balance of drug-eluting stents (DES) versus bare-metal stents (BMS) is less known. METHODS AND RESULTS: In the multicentre BASKET-PROVE trial, 2...

  13. 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;

    2013-01-01

    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....

  14. Incidence of definite stent thrombosis or in-stent restenosis after drug-eluting stent implantation for treatment of coronary in-stent restenosis

    DEFF Research Database (Denmark)

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

    2013-01-01

    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...

  15. Long-term outcome following percutaneous coronary intervention with drug-eluting stents compared with bare-metal stents in saphenous vein graft lesions

    DEFF Research Database (Denmark)

    Hougaard, Mikkel; Thayssen, Per; Kaltoft, Anne

    2013-01-01

    OBJECTIVES: We used the Western Denmark Heart Registry to assess one-year and long-term all-cause mortality and stent failure following Percutaneous Coronary Intervention (PCI) with drug-eluting stents (DES) or bare-metal stents (BMS). BACKGROUND: The use of DES compared with BMS during PCI has...

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

    Science.gov (United States)

    Hsu, Yung-Heng; Chen, Dave Wei-Chih; Tai, Chun-Der; Chou, Ying-Chao; Liu, Shih-Jung; Ueng, Steve Wen-Neng; Chan, Err-Cheng

    2014-01-01

    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.

  17. 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....

  18. Effect of Oversized Partial Postdilatation on Coatings of Contemporary Durable Polymer-Based Drug-Eluting Stents: A Scanning Electron Microscopy Study

    NARCIS (Netherlands)

    Basalus, Mounir W.Z.; Tandjung, Kenneth; Tandjung, K.; van Apeldoorn, Aart A.; Ankone, Martinus J.K.; von Birgelen, Clemens

    2011-01-01

    Background: Oversized postdilation of drug-eluting stents (DES) is often performed to avoid stent malapposition. In stents implanted in long lesion or major bifurcations, extremely oversized partial postdilation may be required, which exposes DES coating to extreme forces. This study aims to assess

  19. In vitro and in vivo evaluation of drug-eluting microspheres designed for transarterial chemoembolization therapy.

    Science.gov (United States)

    Wang, Yujing; Molin, Daniël G M; Sevrin, Chantal; Grandfils, Christian; van den Akker, Nynke M S; Gagliardi, Mick; Knetsch, Menno L; Delhaas, Tammo; Koole, Leo H

    2016-04-30

    Poly(D,L-lactic acid) biodegradable microspheres, loaded with the drugs cisplatin and/or sorafenib tosylate, were prepared, characterized and studied. Degradation of the microspheres, and release of cisplatin and/or sorafenib tosylate from them, were investigated in detail. Incubation of the drug-carrying microspheres in phosphate buffered saline (pH=7.4) revealed slow degradation. Nevertheless, significant release of cisplatin and sorafenib tosylate from microspheres loaded with both drugs was apparent in vitro; this can be attributed to their porous structure. Supernatants from microspheres loaded with both drugs showed strong toxic effects on cells (i.e. endothelial cells, fibroblast cells and Renca tumor cells) and potent anti-angiogenic effect in the matrigel endothelial tube assay. In vivo anti-tumor effects of the microspheres were also observed, in a Renca tumor mouse model. The poly(D,L-lactic acid) microspheres containing both cisplatin and sorafenib tosylate revealed highest therapeutic efficacy, probably demonstrating that combined local administration of cisplatin and sorafenib tosylate synergistically inhibits tumor growth in situ. In conclusion, this study demonstrates the applicability of biodegradable poly(D,L-lactic acid) microspheres loaded with cisplatin and sorafenib tosylate for local drug delivery as well as the potential of these microspheres for future use in transarterial chemoembolization.

  20. 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.

  1. STUDY OF LOT-TO-LOT REPRODUCIBILITIES OF BOND ELUT CERTIFY AND CLEAN SCREEN DAU MIXED-MODE SOLID-PHASE EXTRACTION COLUMNS IN THE EXTRACTION OF DRUGS FROM WHOLE-BLOOD

    NARCIS (Netherlands)

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

    1993-01-01

    The lot-to-lot reproducibilities of Bond Elut Certify and Clean Screen DAU columns are described. The recoveries of five test drugs obtained from twelve lots of Bond Elut Certify columns ranged from 84 to 104% with standard deviations of less than 9%. The recoveries of five test drugs obtained from

  2. 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....

  3. Drug-eluting stent coatings for the treatment of bronchotracheal cancer

    NARCIS (Netherlands)

    Chen, Weiluan

    2017-01-01

    One of the complications of bronchotracheal cancer is obstruction of the upper airways. Local tumor resection in combination with an airway stent can suppress intraluminal tumor (re)growth. We have investigated a novel PulmoStent for local release of the anticancer drug gefitinib. We evaluated diffe

  4. Drug-eluting stent coatings for the treatment of bronchotracheal cancer

    NARCIS (Netherlands)

    Chen, W.|info:eu-repo/dai/nl/371747198

    2017-01-01

    One of the complications of bronchotracheal cancer is obstruction of the upper airways. Local tumor resection in combination with an airway stent can suppress intraluminal tumor (re)growth. We have investigated a novel PulmoStent for local release of the anticancer drug gefitinib. We evaluated

  5. Cost-effectiveness of paclitaxel-coated balloon angioplasty in patients with drug-eluting stent restenosis.

    Science.gov (United States)

    Dorenkamp, Marc; Boldt, Julia; Leber, Alexander W; Sohns, Christian; Roser, Mattias; Boldt, Leif-Hendrik; Haverkamp, Wilhelm; Bonaventura, Klaus

    2013-07-01

    The economic impact of drug-eluting stent (DES) in-stent restenosis (ISR) is substantial, highlighting the need for cost-effective treatment strategies. Compared to plain old balloon angioplasty (POBA) or repeat DES implantation, drug-coated balloon (DCB) angioplasty is a cost-effective therapy for DES-ISR. A Markov state-transition model was used to compare DCB angioplasty with POBA and repeat DES implantation. Model input parameters were obtained from the literature, and the cost analysis was conducted from a German healthcare payer's perspective. Extensive sensitivity analyses were performed. Initial procedure costs amounted to €3488 for DCB angioplasty and to €2782 for POBA. Over a 6-month time horizon, the DCB strategy was less costly (€4028 vs €4169) and more effective in terms of life-years (LYs) gained (0.497 versus 0.489) than POBA. The DES strategy incurred initial costs of €3167 and resulted in 0.494 LYs gained, at total costs of €4101 after a 6-month follow-up. Thus, DCB angioplasty was the least costly and most effective strategy. Base-case results were influenced mostly by initial procedure costs, target lesion revascularization rates, and the costs of dual antiplatelet therapy. DCB angioplasty is a cost-effective treatment option for coronary DES-ISR. The higher initial costs of the DCB strategy compared to POBA or repeat DES implantation are offset by later cost savings. © 2013 Wiley Periodicals, Inc.

  6. Simultaneous occlusion of left anterior descending and left circumflex arteries by very late stent thrombosis: vascular response to drug-eluting stents assessed by intravascular ultrasound.

    Science.gov (United States)

    Yamawaki, Masahiro; Onuma, Yoshinobu; Nakano, Masatsugu; Muramatsu, Takashi; Nakatani, Shimpei; Ishibashi, Yuki; Ishimori, Hiroshi; Hirano, Keisuke; Ito, Yoshiaki; Tsukahara, Reiko; Muramatsu, Toshiya

    2015-11-01

    Very late stent thrombosis (VLST) is a catastrophic complication after implantation of a drug-eluting stent (DES). It has been reported that VLST is associated with pathological changes, which often include late acquired incomplete stent apposition (LAISA) with thrombus formation. In addition, the vascular response to the stent (evaginations, neointimal growth, and thrombosis) and the incidence of LAISA are reported to vary among the different types of DES. We experienced a patient with cardiogenic shock induced by simultaneous VLST of both the left anterior descending artery (LAD) and the left circumflex artery (LCX) at 3 years after implantation of two sirolimus-eluting stents. Intravascular ultrasound (IVUS) showed LAISA of both arteries. A paclitaxel-eluting stent, which had been implanted in the right coronary artery 3 years earlier, did not show such a finding. IVUS revealed "different vascular reactions" to "different types of DES" in this patient.

  7. Aspiration Thrombectomy and Drug-Eluting Stent Implantation Decrease the Occurrence of Angina Pectoris One Year After Acute Myocardial Infarction.

    Science.gov (United States)

    Lee, Wei-Chieh; Fang, Chih-Yuan; Chen, Huang-Chung; Hsueh, Shu-Kai; Chen, Chien-Jen; Yang, Cheng-Hsu; Yip, Hon-Kan; Hang, Chi-Ling; Wu, Chiung-Jen; Fang, Hsiu-Yu

    2016-04-01

    Angina pectoris is a treatable symptom that is associated with mortality and decreased quality of life. Angina eradication is a primary care goal of care after an acute myocardial infarction (AMI). Our aim was to evaluate factors influencing angina pectoris 1 year after an AMI.From January 2005 to December 2013, 1547 patient received primary percutaneous intervention in our hospital for an acute ST-segment elevation myocardial infarction (MI). Of these patients, 1336 patients did not experience post-MI angina during a 1-year follow-up, and 211 patients did. Univariate and multivariate logistic regression analyses were performed to identify the factors influencing angina pectoris 1 year after an AMI. Propensity score matched analyses were performed for subgroups analyses.The average age of the patients was 61.08 ± 12.77 years, with a range of 25 to 97 years, and 82.9% of the patients were male. During 1-year follow-up, 13.6% of the patients experienced post-MI angina. There was a longer chest pain-to-reperfusion time in the post-MI angina group (P = 0.01), as well as a higher fasting sugar level, glycohemoglobin (HbA1C), serum creatinine, troponin-I and creatine kinase MB (CK-MB). The post-MI angina group also had a higher prevalence of multiple-vessel disease. Manual thrombectomy, and distal protective device and intracoronary glycoprotein IIb/IIIa inhibitor injection were used frequently in the no post-MI angina group. Antiplatelet agents and post-MI medication usage were similar between the 2 groups. Multivariate logistic regression analyses demonstrated that prior MI was a positive independent predictor of occurrence of post-MI angina. Manual thrombectomy use and drug-eluting stent implantation were negative independent predictors of post-MI angina. Higher troponin-I and longer chest pain-to-reperfusion time exhibited a trend toward predicting post-MI angina.Prior MIs were strong, independent predictors of post-MI angina. Manual thrombectomy and drug-eluting

  8. Angiographic and clinical outcomes after implantation of drug eluting stents in bifurcation lesions with crush or kissing stent technique.

    Science.gov (United States)

    Cheema, Asim N; Jolly, Sanjit S; Burstein, Jason M; Sharieff, Waseem; Mohammad, Atif; Yeoh, Eunice; Mancini, G B John; Cantor, Warren J; Kutryk, Michael J B; Strauss, Bradley H; Chisholm, Robert J

    2013-04-01

    Long-term outcome after bifurcation stenting with drug-eluting stents (DES) for obstructive coronary artery disease is poorly understood. In this study, we report 6-9-month angiographic follow-up and long-term clinical outcomes after implantation of drug-eluting stents by crush and kissing stent technique for coronary bifurcation lesions. Consecutive patients undergoing bifurcation stenting with DES by crush or kissing stent technique were enrolled in a prospective registry. Angiographic follow-up was obtained at 6-9 months and clinical follow-up completed for a median of 38 months. A total of 86 patients participated in the study. Bifurcation stenting by crush technique was performed in 73 (85%) and by kissing stent in 13 (15%) patients. Stenting of left main bifurcation was applied in 24 (28%) patients. Angiographic follow-up was completed in 75 (87%) patients and showed restenosis in the main for 8 (11%) and side branch for 20 (27%) patients. Clinical follow-up was available for a median duration of 38 months. During follow-up, 2 (2%) patients died, 4 (5%) experienced myocardial infarction (MI), and 11 (13%) underwent target vessel revascularization (TVR) with an overall major adverse cardiac event (MACE) rate of 16%. In left main cohort, angiographic restenosis occurred in 9 (37%) patients, and 3 (12%) patients required TVR. There were no deaths or stent thrombosis. A comparison of crush and kissing stent technique showed significantly higher angiographic restenosis with crush (26% vs 13% in kissing stent patients, P = 0.046) and 95% of restenosis in crush group involved ostium of the side branch. There was no difference in clinical outcomes between the crush and kissing stent groups. Final kissing balloon dilatation (FKB) was successful in 65 (89%) patients in the crush group and associated with a significant reduction in MACE (8% in FKB successful vs 37% in FKB unsuccessful, P = 0.04) during follow-up. Bifurcation stenting with crush or kissing stent

  9. Modifying release characteristics from 3D printed drug-eluting products

    DEFF Research Database (Denmark)

    Boetker, Johan; Water, Jorrit; Aho, Johanna

    2016-01-01

    Abstract This work describes an approach to modify the release of active compound from a 3D printed model drug product geometry intended for flexible dosing and precision medication. The production of novel polylactic acid and hydroxypropyl methylcellulose based feed materials containing...... nitrofurantoin for 3D printing purposes is demonstrated. Nitrofurantoin, Metolose® and polylactic acid were successfully co-extruded with up to 40% Metolose® content, and subsequently 3D printed into model disk geometries (ø10 mm, h = 2 mm). Thermal analysis with differential scanning calorimetry and solid phase...... identification with Raman spectroscopy showed that nitrofurantoin remained in its original solid form during both hot-melt extrusion and subsequent 3D printing. Rheological measurements of the different compositions showed that the flow properties were sensitive to the amount of undissolved particles present...

  10. Drug Eluting Stents for Malignant Airway Obstruction: A Critical Review of the Literature

    Science.gov (United States)

    Hohenforst-Schmidt, Wolfgang; Zarogoulidis, Paul; Pitsiou, Georgia; Linsmeier, Bernd; Tsavlis, Drosos; Kioumis, Ioannis; Papadaki, Eleni; Freitag, Lutz; Tsiouda, Theodora; Turner, J Francis; Browning, Robert; Simoff, Michael; Sachpekidis, Nikolaos; Tsakiridis, Kosmas; Zaric, Bojan; Yarmus, Lonny; Baka, Sofia; Stratakos, Grigoris; Rittger, Harald

    2016-01-01

    Lung cancer being the most prevalent malignancy in men and the 3rd most frequent in women is still associated with dismal prognosis due to advanced disease at the time of diagnosis. Novel targeted therapies are already on the market and several others are under investigation. However non-specific cytotoxic agents still remain the cornerstone of treatment for many patients. Central airways stenosis or obstruction may often complicate and decrease quality of life and survival of these patients. Interventional pulmonology modalities (mainly debulking and stent placement) can alleviate symptoms related to airways stenosis and improve the quality of life of patients. Mitomycin C and sirolimus have been observed to assist a successful stent placement by reducing granuloma tissue formation. Additionally, these drugs enhance the normal tissue ability against cancer cell infiltration. In this mini review we will concentrate on mitomycin C and sirolimus and their use in stent placement. PMID:26918052

  11. 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.

  12. Development of novel drug-eluting biodegradable nano-fiber for prevention of postoperative pulmonary venous obstruction.

    Science.gov (United States)

    Mutsuga, Masato; Narita, Yuji; Yamawaki, Aika; Satake, Makoto; Kaneko, Hiroaki; Usui, Akihiko; Ueda, Yuichi

    2009-04-01

    Pulmonary venous obstruction (PVO) after correction of total anomalous pulmonary venous connection (TAPVC) frequently occurs due to intimal-hyperplasia and the required re-operation. We have developed a novel sustained-release drug delivery system, using Tacrolimus-eluting biodegradable nano-fiber (TEBN). It consists of nano-scale fiber composed of biodegradable polymer and Tacrolimus. This study evaluated the effects of TEBN for prevention of venous anastomotic stricture in a rat model to apply to PVO operation. Tacrolimus was incorporated into poly (L-lactide-co-glycolide). The venous stricture model was made by rat inferior vena cava anastomosis. The IVC anastomosis was covered with TEBN with 1.0 wt% Tacrolimus (n=12) or without TEBN as a control (n=12), and evaluated histologically at 1, 2, and 4 weeks after operation. The ratio of intimal area was significantly reduced in the TEBN group compared with the control group (ratio; 1 week: 0.43+/-0.26 vs. 0.07+/-0.04, P=0.04, 2 weeks: 0.39+/-0.19 vs. 0.05+/-0.02, P=0.01, 4 weeks: 0.31+/-0.15 vs. 0.09+/-0.04, P=0.03, control vs. TEBN, respectively). Histological findings showed endothelialization along the inner surface of the vein even in TEBN. The TEBN reduced intimal hyperplasia and preserved endothelialization even in a venous stricture. These results suggested that this strategy might be useful for prevention of recurrent PVO after TAPVC correction.

  13. Meta-analysis of stent thrombosis after drug-eluting stent implantation: 4-year follow-up

    Institute of Scientific and Technical Information of China (English)

    Nata(s)a M Mili(c); Biljana J Parapid; Miodrag (C) Ostoji(c); Milan A Nedeljkovi(c); Jelena M Marinkovi(c)

    2010-01-01

    Background Drug-eluting stents (DES) are the most common device used in percutaneous treatment of coronary artery disease. Recently, there has been an increased concern regarding their safety profile, in particular the late and very late stent thrombosis rate compared to bare metal stents (BMS). The aim of the study was to compare the reported incidence of late and very late stent thrombosis of DES and BMS in patients from published clinical studies with an extended follow-up period to four years.Methods A search strategy was developed to identify publications reporting on late or very late thrombosis of BMS and DES available through MEDLINE and Cochrane Library databases. Two independent reviewers appraised eligible studies and extracted data. Odds ratios (OR) were calculated for each outcome and presented with 95% confidence intervals (CI).Results Fourteen randomized controlled trials, which were at least single blinded, were identified. There was no difference in the incidence of late and very late stent thrombosis in patients treated with DES compared with patients treated with BMS (late OR 0.55, 95%Cl 0.23-1.31 and late/very late OR=1.08, 95%CI 0.61-1.91).Conclusions The safety profile of DES was similar to BMS in terms of stent thrombosis. We found no evidence of increased risk of late and very late thrombosis for DES.

  14. Low Resolution Limits and Inaccurate Algorithms Decrease Significantly the Value of Late Loss in Current Drug-Eluting Stent Trials

    Directory of Open Access Journals (Sweden)

    Johannes B. Dahm

    2012-01-01

    Full Text Available Quantitative coronary and vascular angiography (QCA resp., QVA remains the current gold standard for evaluation of restenosis. Late loss as one of the most commonly accepted parameters to highlight efficacy of the various devices has shown high correlation to clinical parameters but, surprisingly, has no impact on the evaluation of the remaining amount of restenostic tissue. The current clinical practice leads to unrealistic late loss calculations. Smaller late loss differences are usually not greater than the inherited resolution limits of QCA, which is especially the case in small differences between the various stents in the drug-eluting stent era. Late loss include additional systematic and random errors, due to the fact that measurements were taken at two different time points including the inherited resolution and calibration limits of QCA on two occasions. Due to the limited value of late loss in discriminating the small differences between the one and other DES, late lumen area loss and clearly defined calculation algorithms (e.g., MLD-relocation should be used in future DES studies also to fulfill the more stringent regulatory requirements.

  15. Diphenylalanine peptide nanotubes self-assembled on functionalized metal surfaces for potential application in drug-eluting stent.

    Science.gov (United States)

    Zohrabi, Tayebeh; Habibi, Neda; Zarrabi, Ali; Fanaei, Maryam; Lee, Lai Yeng

    2016-09-01

    This study focuses on the potential of diphenylalanine self-assembled peptide nanotubes (FF Nts) for delivery of flufenamic acid (FA) from metal implants. Self-assembly of FF Nts was studied in solution and on surfaces of glass, silicone and gold substrates. FA was loaded inside the shell of FF Nts and subsequently FF/FA Nts were attached to gold surfaces. The substrate were characterized by Field Emission Scanning Electron Microscopy (FESEM), fluorescence microscopy, confocal microscopy, and UV-vis spectroscopy. Release of FA from FF Nts were investigated by immersing coated metal substrates in phosphate-buffered saline for 12 days. Self-assembly of FF in water and solvent resulted in formation of nanotubes, which efficiently loaded 98% of FA with concentration of 20 µg/mL. FESEM images confirmed successful attachment of FF/FA Nts to functionalized gold substrates. In vitro release studies indicated using FF Nts has prolonged the release rate of FA for several days. Biocompatibility studied confirmed more than 50% of the cells were alive in concentration of 250-1000 µg/mL of FF Nts thus suggesting the potential of peptide based self-assemble nanostructures as an alternate system for polymer coating in drugs eluting stents. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 104A: 2280-2290, 2016.

  16. 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....... The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0·025. This trial is registered with ClinicalTrials.gov, number NCT01956448. FINDINGS: Of 7103 screened...

  17. Association between Low Serum Magnesium Level and Major Adverse Cardiac Events in Patients Treated with Drug-Eluting Stents for Acute Myocardial Infarction

    OpenAIRE

    Guipeng An; Zhongqi Du; Xiao Meng; Tao Guo; Rui Shang; Jifu Li; Fengshuang An; Wenjing Li; Cheng Zhang

    2014-01-01

    OBJECTIVES: We investigated the association of serum magnesium (Mg) levels and major adverse cardiac events (MACEs) after drug-eluting stent (DES) implantation. BACKGROUND: Mg depletion plays a key role in the pathphysiologic features of diabetes mellitus, hypertension, thrombosis, arrhythmias and coronary artery disease. Whether the depletion is related to the long-term prognosis of DES implantation is not known. METHODS: From 2008 to 2011, we enrolled 414 consecutive patients

  18. Impact of the introduction of drug eluting stents on clinical outcomes in patients undergoing percutaneous and surgical coronary artery revascularisation procedures in Western Australia

    OpenAIRE

    Sanfilippo, Frank M; Rankin, Jamie M.; Hobbs, Michael ST; Nguyen, Michael; Knuiman, Matthew W; Berg, Patricia; Whitford, Eric G; Hendriks, Randall; Hockings, Bernard E; Muhlmann, Michael; Newman, Mark; Larbalestier, Robert; Gilfillan, Ian; Briffa, Thomas G

    2013-01-01

    Background Increasing rates of percutaneous coronary intervention (PCI) and decreasing rates of coronary artery bypass graft (CABG) surgery followed the introduction of drug eluting stents in Western Australia in 2002. We assessed the impact of these changes on one-year outcomes for the total population of patients undergoing coronary artery revascularisation procedures (CARP) in Western Australia between 2000-2004. Methods Clinical and linked administrative data (inpatient admissions and dea...

  19. Fabrication of balloon-expandable self-lock drug-eluting polycaprolactone stents using micro-injection molding and spray coating techniques.

    Science.gov (United States)

    Liu, Shih-Jung; Chiang, Fu-Jun; Hsiao, Chao-Ying; Kau, Yi-Chuan; Liu, Kuo-Sheng

    2010-10-01

    The purpose of this report was to develop novel balloon-expandable self-lock drug-eluting poly(ε-caprolactone) stents. To fabricate the biodegradable stents, polycaprolactone (PCL) components were first fabricated by a lab-scale micro-injection molded machine. They were then assembled and hot-spot welded into mesh-like stents of 3 and 5 mm in diameters. A special geometry of the components was designed to self-lock the assembled stents and to resist the external pressure of the blood vessels after being expanded by balloons. Characterization of the biodegradable PCL stents was carried out. PCL stents exhibited comparable mechanical property to that of metallic stents. No significant collapse pressure reduction and weight loss of the stents were observed after being submerged in PBS for 12 weeks. In addition, the developed stent was coated with paclitaxel by a spray coating technique and the release characteristic of the drug was determined by an in vitro elution method. The high-performance liquid chromatography analysis showed that the biodegradable stents could release a high concentration of paclitaxel for more than 60 days. By adopting the novel techniques, we will be able to fabricate biodegradable drug-eluting PCL stents of different sizes for various cardiovascular applications.

  20. Comparison of Bare Metal and Drug-Eluting Stents in Patients with Chronic Kidney Disease (From the NHLBI Dynamic Registry)

    Science.gov (United States)

    Green, Sandy M.; Selzer, Faith; Mulukutla, Suresh R.; Tadajweski, Edward J.; Green, Jamie A.; Wilensky, Robert L.; Laskey, Warren K.; Cohen, Howard A.; Rao, Sunil V.; Weisbord, Steven D.; Lee, Joon S.; Reis, Steven E.; Kip, Kevin E.; Kelsey, Sheryl F.; Williams, David O.; Marroquin, Oscar C.

    2011-01-01

    Patients with chronic kidney disease (CKD) have a disproportionate burden of coronary artery disease and commonly undergo revascularization. The role and safety of percutaneous coronary intervention (PCI) using drug eluting stents (DES) verses bare metal stents (BMS) in CKD patients not on renal replacement therapy has not been fully evaluated. This study investigated the efficacy and safety of DES in patients with CKD not on renal replacement therapy. Patients where drawn from the National Heart, Lung, and Blood Institute Dynamic Registry and were stratified by renal function based on estimated glomerular filtration rate (GFR). Of the 4157 participants, 1108 had CKD (“low-GFR” <60 ml/min/1.73m2), while 3049 patients had normal renal function (“normal-GFR”≥60 ml/min/1.73m2). For each strata of renal function, we compared the risk of death, myocardial infarction (MI), or repeat revascularization between subjects who received DES and BMS at the index procedure. Patients with low-GFR had higher one-year rates of death and MI and a decreased rate of repeat revascularization when compared to patients with a normal-GFR. The use of DES was associated with a decreased need for repeat revascularization in the normal-GFR group (adjusted hazard ratio [HR] 0.63, 95% CI 0.50–0.79, p<0.001) but not in the low-GFR group (HR 0.69, 95% CI 0.45–1.06, p=0.09). The risks of death and MI were not different between the two stents in either patient population. In conclusion, the presence of CKD predicted poor outcomes after PCI with high rates of mortality regardless of stent type. The effect of DES in reducing repeat revascularization appeared to be attenuated in these patients. PMID:21890077

  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. 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.

  3. Clinical outcome after management of unprotected left main in-stent restenosis after bare metal or drug-eluting stents

    Institute of Scientific and Technical Information of China (English)

    CHEN Shao-liang; QIAN Jun; Kwan Tak W; XU Bo; Gary Mintz; YE Fei; ZHANG Jun-jie; KAN Jing; SUN Xue-wen; ZHANG Ai-ping; CHEN Jin-guo

    2010-01-01

    Background Implantation of either bare metal stent (BMS) or drug-eluting stent (DES) has been used in every day practice for patients with unprotected left main stenosis (UPLMS). There are still a lack of data regading the subsequent results of UPLMS in-stent restenosis (ISR). The present study aimed at determing the clinical outcome of UPLMS ISR patients after implantation of either BMS or DES.Methods Patients with UPLMS ISR after stenting were included. The primary endpoint was the cumulative major adverse cardiac events (MACE), including cardiac death, myocardial infarction (Ml), and target vessel revascularization (TVR).Results UPLMS ISR rate was 14.8% (n=73, 15.7% after BMS, 14.5% for DES) after average of (3.89±2.01) years (range from 1 to 10.5 years) follow-up. Angiographic follow-up between 6-8 months was available in 85.3%. Of these,repeat percutaneous coronary intervention (PCI) was used in 62 (84.9%) patients, with medicine only in 9 (12.4%) and coronary artery bypass graft (CABG) in 2 (2.7%). Most repeat PCI patients were with unstable angina (87.0%), and had decreased left ventricular ejection fraction ((42.58±5.12)%), fewer focal/ostial left circumflex branch (LCX) lesions, in relative to medicine only group. After (31.9±23.3) months, the MACE, Ml, TVR and cardiac death were 31.5%, 1.4%, 24.1% and 8.2%, respectively. Definite and possible stent thrombosis occurred in 1 (1.4%) patient.Conclusions Medical therapy for asymptomatic isolated ostial LCX was safe. Repeat PCI for UPLMS ISR was associated with acceptable early and short-term clinical outcome. Further study was needed to elucidate the role of CABG in treating UPLMS ISR.

  4. Duration of dual antiplatelet therapy after drug-eluting stent implantation: Meta-analysis of large randomised controlled trials

    Science.gov (United States)

    Tsoi, Man-Fung; Cheung, Ching-Lung; Cheung, Tommy Tsang; Wong, Ian Chi-Kei; Kumana, Cyrus Rustam; Tse, Hung-Fat; Cheung, Bernard Man-Yung

    2015-01-01

    Patients receive dual antiplatelet therapy (DAPT) for 6–12 months after drug-eluting stents (DES) implantation. The efficacy and safety of prolonged DAPT has been questioned. Therefore, we performed a meta-analysis on randomised trials comparing different DAPT durations. Literature was searched on trials comparing different DAPT durations. For inclusion, reports must report frequency of cardiovascular and bleeding events. Ten trials were included. Compared to 12 months, DAPT beyond 12 months was associated with fewer myocardial infarctions (OR 0.58 95%CI: 0.40–0.84) and stent thrombosis (OR 0.35 95%CI: 0.20–0.62), but more major bleeds (OR 1.60 95%CI: 1.22–2.11) and all-cause (OR 1.30 95%CI: 1.02–1.66) mortality. There was no significant alteration in risk of stroke (OR 0.93 95%CI: 0.66–1.31) or cardiac (OR 1.12 95%CI: 0.73–1.71) mortality. Compared to less than 12 months DAPT, 12 months DAPT did not reduce risk of myocardial infarction, stent thrombosis, strokes, cardiac or all-cause mortality, but increased the risk of major bleeds (OR 1.60 95%CI: 1.22–2.11). DAPT beyond 12 months reduce risk of myocardial infarction and stent thrombosis, but there is substantial increase in major bleeding risk and all-cause mortality which need to be addressed. DAPT beyond 12 months does not appear to alter the risk of stroke. PMID:26278959

  5. Late-term clinical outcomes with zotarolimus- and sirolimus-eluting stents. 5-year follow-up of the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions).

    Science.gov (United States)

    Kandzari, David E; Mauri, Laura; Popma, Jeffrey J; Turco, Mark A; Gurbel, Paul A; Fitzgerald, Peter J; Leon, Martin B

    2011-05-01

    This study sought to compare late safety and efficacy outcomes following percutaneous coronary revascularization with zotarolimus-eluting stents (ZES) and sirolimus-eluting stents (SES). Despite higher late lumen loss and binary restenosis with ZES compared with SES, it is uncertain whether differences in early angiographic measures translate into more disparate late clinical events. Clinical outcomes were prospectively evaluated through 5 years in the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) that randomized 436 patients of relatively low anatomic and clinical risk to treatment with ZES (n = 323) or SES (n = 113) and evaluated a primary endpoint of 8-month angiographic late lumen loss. At 5 years (completeness of follow-up: 95.2%), pre-specified endpoints of all-cause mortality (5.2% vs. 13.0%, p = 0.02), myocardial infarction (1.0% vs. 4.6%, p = 0.03), and the composite event rates of cardiac death/myocardial infarction (1.3% vs. 6.5%, p = 0.009) and major adverse cardiac events (14.0% vs. 22.2%, p = 0.05) were significantly lower among patients treated with ZES. Rates of target lesion (8.1% ZES vs. 6.5% SES, p = 0.68) and target vessel revascularization were similar between treatment groups. Stent thrombosis was infrequent and similar in both groups (0.7% ZES vs. 0.9% SES, p = 1.0). Between 9 months and 5 years, progression of major adverse cardiac events was significantly more common with SES than with ZES (16.7% vs. 7.8%, p = 0.015). Despite initially higher angiographic late lumen loss, rates of clinical restenosis beyond the protocol-specified angiographic follow-up period remain stable with ZES compared with the rates for SES, resulting in similar late-term efficacy. Over 5 years, significant differences in death, myocardial infarction, and composite endpoints favored treatment with ZES

  6. Association of Coronary Perivascular Adipose Tissue Inflammation and Drug-Eluting Stent-Induced Coronary Hyperconstricting Responses in Pigs: (18)F-Fluorodeoxyglucose Positron Emission Tomography Imaging Study.

    Science.gov (United States)

    Ohyama, Kazuma; Matsumoto, Yasuharu; Amamizu, Hirokazu; Uzuka, Hironori; Nishimiya, Kensuke; Morosawa, Susumu; Hirano, Michinori; Watabe, Hiroshi; Funaki, Yoshihito; Miyata, Satoshi; Takahashi, Jun; Ito, Kenta; Shimokawa, Hiroaki

    2017-09-01

    Although coronary perivascular adipose tissue (PVAT) may play important roles as a source of inflammation, the association of coronary PVAT inflammation and coronary hyperconstricting responses remains to be examined. We addressed this important issue in a porcine model of coronary hyperconstricting responses after drug-eluting stent implantation with (18)F-fluorodeoxyglucose ((18)F-FDG) positron emission tomographic imaging. An everolimus-eluting stent (EES) was randomly implanted in pigs into the left anterior descending or the left circumflex coronary artery while nonstented coronary artery was used as a control. After 1 month, coronary vasoconstricting responses to intracoronary serotonin (10 and 100 μg/kg) were examined by coronary angiography in vivo, followed by in vivo and ex vivo (18)F-FDG positron emission tomographic/computed tomographic imaging. Coronary vasoconstricting responses to serotonin were significantly enhanced at the EES edges compared with the control site (Pinflammation. © 2017 American Heart Association, Inc.

  7. Long-term predictors of mortality after percutaneous coronary intervention in the era of drug-eluting stents.

    Science.gov (United States)

    Wilson, William McLeish; Andrianopoulos, Nick; Clark, David; Duffy, Stephen James; Brennan, Angela; Harries, Iwan; New, Gishel; Sebastian, Martin; Loane, Philippa; Reid, Christopher; Ajani, Andrew Edward

    2011-10-01

    The aim was to examine timing, causes, and predictors of death during long-term follow-up after contemporary percutaneous coronary intervention (PCI) using a large multicenter Australian registry. The cohort consisted of 10,682 consecutive patients from the Melbourne Interventional Group registry undergoing PCI (February 2004 through November 2009). For the first time in Australia, long-term mortality rates of a PCI cohort were defined by linkage to the National Death Index database. The cohort (mean age 64 ± 12 years) comprised 75% men, 24% diabetics, 59% with multivessel disease, 4.4% with renal failure, 25% with ST-elevation myocardial infarction (STEMI), 2.5% with cardiogenic shock, and 5.1% with heart failure. Drug-eluting stents (DES) were used in 43% of cases. Mean follow-up was 3.2 ± 0.5 years. In-hospital, 30-day, 12-month, and long-term (3.2 ± 0.5 years) mortalities were 1.6% (80% cardiac), 2.1% (79%), 3.9% (61%), and 8.2% (50%), respectively. Independent predictors of long-term mortality included age (hazard ratio 1.05, 95% confidence interval 1.04 to 1.06), cardiogenic shock (4.58, 3.60 to 5.83), renal failure (3.14, 2.58 to 3.82), previous heart failure (1.97, 1.60 to 2.41), STEMI (1.79, 1.47 to 2.18), peripheral vascular disease (1.72, 1.4 to 2.11), non-STEMI (1.58, 1.32 to 1.90), multivessel disease (1.47, 1.24 to 1.74), current smoking (1.39, 1.12 to 1.71), diabetes (1.36, 1.16 to 1.59), and cerebrovascular disease (1.33, 1.06 to 1.60, p long-term mortality after PCI, whereas DES use in this large registry was not associated with late mortality risk.

  8. Qualitative and quantitative assessment of stent restenosis by optical coherence tomography: comparison between drug-eluting and bare-metal stents.

    Science.gov (United States)

    Nagoshi, Ryoji; Shinke, Toshiro; Otake, Hiromasa; Shite, Junya; Matsumoto, Daisuke; Kawamori, Hiroyuki; Nakagawa, Masayuki; Kozuki, Amane; Hariki, Hirotoshi; Inoue, Takumi; Ohsue, Tsuyoshi; Taniguchi, Yu; Iwasaki, Masamichi; Nishio, Ryo; Hiranuma, Noritoshi; Konishi, Akihide; Kinutani, Hiroto; Miyoshi, Naoki; Takaya, Tomofumi; Yamada, Shinichiro; Yasaka, Yoshinori; Hayashi, Takatoshi; Yokoyama, Mitsuhiro; Kato, Hiroki; Kadotani, Makoto; Ohnishi, Yoshio; Hirata, Ken-ichi

    2013-01-01

    We hypothesized that the tissue components of in-stent restenosis (ISR) might differ between drug-eluting stents (DES) and bare-metal stents (BMS) and that these differences could be distinguished by qualitative and quantitative optical coherence tomography (OCT) analyses. One-hundred and twenty-two initial ISR lesions (sirolimus-eluting stents: n=28; paclitaxel-eluting stents: n=51; BMS: n=43) were evaluated with OCT. Based on their OCT appearance, the lesions were classified as homogeneous, layered or heterogeneous. The optical properties of backscatter, attenuation and signal intensity of the neointimal tissue (NIT) were quantified. To evaluate the vascular response after balloon angioplasty (BA), the rate of reduction of the NIT area (NITA) was calculated (NITA before - after BA/NITA before BA at the minimum lumen cross-sectional area). Among the morphologic OCT patterns, the layered type was predominant with DES, whereas lesions were homogeneous with BMS (P<0.001). Backscatter and signal intensity were significantly higher with BMS (P<0.05 and P<0.001 respectively). The NITA reduction rate was significantly greater in the layered and heterogeneous groups than in the homogeneous group (P<0.01). The morphologic OCT patterns of the NIT in ISR differed significantly between DES and BMS, probably reflecting pathologic differences. Layered and heterogeneous tissues might respond better than homogeneous tissue to simple balloon dilatation, suggesting a possible direction for OCT-based ISR treatment strategies. 

  9. Five-year clinical outcomes of a polymer-free sirolimus-eluting stent versus a permanent polymer paclitaxel-eluting stent: final results of the intracoronary stenting and angiographic restenosis - test equivalence between two drug-eluting stents (ISAR-TEST) trial.

    Science.gov (United States)

    King, Lamin; Byrne, Robert A; Mehilli, Julinda; Schömig, Albert; Kastrati, Adnan; Pache, Jurgen

    2013-01-01

    Limited evidence exists regarding the long-term performance of polymer-free (PF) drug-eluting stents (DES) in comparison to permanent polymer DES. This study investigated the 5-year efficacy and safety of a PF sirolimus-eluting stent (PF-SES) versus a permanent polymer paclitaxel-eluting stent (PES) in the setting of the Intracoronary Stenting and Angiographic Restenosis-Test Equivalence Between Two Drug-Eluting Stents (ISAR-TEST) randomized trial. A total of 450 patients undergoing percutaneous coronary intervention were randomized to receive either PF-SES (Yukon, Translumina; n = 225) or PES (Taxus, Boston Scientific; n = 225). Clinical follow-up was performed to 5 years after enrollment. The endpoints were major adverse cardiac events (MACE), target lesion revascularization (TLR), the composite of death or any myocardial infarction (MI) and stent thrombosis (ST). The incidence of MACE at 5 years was 27.3% (57 patients) in the PF-SES group and 31.7% (65 patients) in the PES group [hazard ratio (HR) = 0.87 [95% confidence interval (95% CI) = 0.61-1.24]; P = 0.40]. The combined incidence of death or MI was 16.6% (34 patients) in the PF-SES group and 20.0% (39 patients) in the PES group (HR = 0.86 [95% CI = 0.54-1.36]; P = 0.52). The incidence of TLR was 16.5% (34 patients) in the PF-SES group and 16.4% (33 patients) in the PES group (HR = 1.03 [95% CI = 0.64-1.66]; P = 0.89). ST occurred in 0.5% (one patient) in the PF-SES group and 1.6% (three patients) in the PES group (HR = 0.33 [95% CI = 0.03-3.14]; P = 0.32). Overall there was no significant difference in clinical outcomes between PF-SES and PES to 5 years. Extended follow-up supports the durability of efficacy and safety of PF-SES. Copyright © 2012 Wiley Periodicals, Inc.

  10. 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

  11. 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...... stent thrombosis, which may be more pronounced in elderly patients. Therefore, the aim of this study was to evaluate the impact of age on outcome in patients with STEMI who underwent primary angioplasty with bare-metal stents (BMS) or DES. Our population comprised 6,298 patients who underwent primary...

  12. Outcomes after primary coronary intervention with drug eluting stent implantation in diabetic patients with acute ST elevation myocardial infarction

    Institute of Scientific and Technical Information of China (English)

    ZHANG Qi; HU Jian; YANG Zhen-kun; ZHENG Ai-fang; ZHANG Xian; SHEN Wei-feng; SHEN Jie; ZHANG Rui-yan; QIU Jian-ping; LU Ji-de; ZHANG Yu; CHEN Yue-hua; ZHANG Jun-feng; ZHANG Jian-sheng

    2007-01-01

    Background Drug-eluting stent (DES) has been used widely for the treatment of patients with acute coronary syndrome with or without diabetes mellitus during percutaneous coronary intervention (PCI), but its long-term safety and efficacy in diabetic patients with acute ST elevation myocardial infarction (STEMI) remain uncertain. This study aimed to investigate the clinical outcomes after primary coronary intervention with DES implantation for diabetic patients with acute STEMI, compared with non-diabetic counterparts.Methods From December 2004 to March 2006, 56 consecutive diabetic patients (diabetic group) and 170 non-diabetic patients (non-diabetic group) with acute STEMI who underwent primary PCI with DES implantation in 3 hospitals were enrolled. Baseline clinical, angiographic, and procedural characteristics, as well as occurrence of major adverse cardiac event (MACE) including cardiac death, non-fatal recurrent myocardial infarction (re-MI) and target vessel revascularization (TVR) during hospitalization and one-year clinical follow-up were compared between the two groups.Results Patients in diabetic group were more hyperlipidemic (69.6% and 51.8%, P=0.03) and had longer time delay from symptom onset to admission ((364±219) minutes and (309±223) minutes,P=0.02) than those in non-diabetic group.The culprit vessel distribution, reference vessel diameter, and baseline TIMI flow grade were similar between the two groups, but multi-vessel disease was more common in diabetic than in non-diabetic group (82.1% and 51.2%, P<0.001).Despite similar TIMI flow grades between the two groups after stenting, the occurrence of TIMI myocardial perfusion grade (TMPG)≥2 was lower in diabetic group (75.0% vs 88.8% in non-diabetic groups, P=0.02). The MACE rate was similar during hospitalization between the two groups (5.4% vs 3.5%, P=0.72), but it was significantly higher in diabetic group (16.1%) during one-year follow-up, as compared with non-diabetic group (6.5%, P=0

  13. Effect of solvent on drug release and a spray-coated matrix of a sirolimus-eluting stent coated with poly(lactic-co-glycolic acid).

    Science.gov (United States)

    Choi, Jiyeon; Jang, Bu Nam; Park, Bang Ju; Joung, Yoon Ki; Han, Dong Keun

    2014-08-26

    Sirolimus (SRL) release from the biodegradable poly(l-lactic-co-glycolic acid) (PLGA) matrix was investigated for the application of drug-eluting stents (DES). In particular, this study focused on whether various organic solvents affect the interaction between SRL and PLGA and the formation of microstructures during ultrasonic coating. The SRL-loaded PLGA coated by tetrahydrofuran or acetone showed a significant initial burst, whereas that from acetonitrile was constantly released during a period of 21 days. On the basis of these results, the interactions at the molecular level of SRL with the polymer matrix were estimated according to various organic solvents. Although the topographies of the coated surface were obviously different, the correlation between surface roughness and SRL release was very poor. Irrespective of organic solvents, FT-IR data showed significantly weak SRL-PLGA interactions. From the result of wide-angle X-ray diffraction, it was confirmed that SRL was dispersed in an amorphous state in the polymer matrix after ultrasonic coating. The glass-transition temperature was also influenced by organic solvents, resulting in a plasticizing effect. The particle size of SRL appeared to determine the release profile from the PLGA matrix, which was the combination of diffusion and polymer degradation at an SRL size of more than 800 nm and the Fickian release at that of less than 300 nm. Therefore, organic solvents can lead to a heterogeneous microstructure in the SRL-loaded PLGA matrix, which is at or near the surface, consisting of aggregated drug- and polymer-rich regions. It is expected that the drug release can be controlled by physicochemical properties of organic solvents, and this study can be used effectively for localized drug release in biomedical devices such as drug-eluting stents.

  14. COMPARISON OF SHORT- AND LONG-TERM OUTCOMES BETWEEN CYPHER AND TAXUS DRUG-ELUTING STENTS FOR IN-STENT RESTENOSIS

    Institute of Scientific and Technical Information of China (English)

    Ji-lin Chen; Jue Chen; Shi-jie You; Jun Dai; Jian-jun Li; Run-lin Gao; Yue-jin Yang; Shu-bin Qiao; Min Yao; Xue-wen Qin; Bo Xu; Hai-bo Liu; Yong-jian Wu; Jin-qing Yuan

    2007-01-01

    Objective To compare the short- and long-term clinical outcomes between sirolimus-eluting stent (Cypher stent) and paclitaxel-eluting stent (TAXUS stent) in patients with in-stent restenosis (ISR) lesions of the coronary arteries.Methods From December 2002 to March 2005, 253 patients with ISR lesions of the coronary arteries were selected and divided into two groups. Cypher group (152 cases) was treated with Cypher or Cypher Select stents, and TAX-US group (101 cases) with TAXUS stents. A total of 262 ISR lesions in these patients were treated with 308 drug-eluting stents (DESs), including 176 Cypher or Cypher Select stents and 132 TAXUS stents. All patients were followed up for 10 months. Procedure success rates of DES implantation in both groups were observed. Major adverse cardiac events (MACE) rates in hospital and at 10 months follow-up, as well as in-DES restenosis observed using coronary angiogra-phy at follow-up were compared between two groups.Results Success rate of DES implantation was 100% in both groups. No significant difference in MACE rate during hospitalization was found between the two groups. However, at 10 months follow-up, MACE rate was higher in TAXUS group than in Cypher group (16.00% vs. 6.67% , P = 0.031). As for coronary angiography at 10 months follow-up, we observed an increasing tendency of in-DES restenosis rate in TAXUS group compared with Cypher group (29.41% vs. 14.04%, P= 0.075).Conclusions Cypher and TAXUS DESs both have good short- and long-term outcomes in treating ISR. Cypher DES proved better long-term clinical outcome than TAXUS DES.

  15. Development of a Composite Electrospun Polyethylene Terephthalate-Polyglycolic Acid Material: Potential Use as a Drug-Eluting Vascular Graft

    Directory of Open Access Journals (Sweden)

    Christoph S. Nabzdyk

    2015-01-01

    Full Text Available Intimal hyperplasia (IH, an excessive wound healing response of an injured vessel wall after bypass grafting, typically leads to prosthetic bypass graft failure. In an approach to ameliorate IH, nondegradable poly(ethylene terephthalate or PET, which has been used in prosthetic vascular grafts for over 60 years, and biodegradable poly(glycolic acid or PGA were electrospun using different techniques to generate a material that may serve as permanent scaffold and as a drug/biologic delivery device. PET and PGA polymers were electrospun from either a single-blended solution (ePET/ePGA-s or two separate polymer solutions (ePET/ePGA-d. ePET/ePGA-d material revealed two distinct fibers and was significantly stronger than the single fiber ePET/ePGA-s material. After 21 days of incubation in PBS, ePET-PGA-s showed fiber strand breaks likely due to the degradation of the PGA within the ePET-ePGA-s fiber, while the ePET/ePGA-d material showed intact ePET fibers even after ePGA fiber degradation. The ePET/ePGA- material was able to release red fluorescent dye for at least 14 days. Attachment of human aortic smooth muscle cells (AoSMCs was similar to both materials. ePET/ePGA-d materials maybe a step towards bypass graft materials that can be custom-designed to promote cellular attachment while serving as a drug delivery platform for IH prevention.

  16. The Mid-Term Clinical Follow-Up Using Drug-Eluting Balloons on Tibial Artery "De Novo" Lesions in Patients With Critical Limb Ischemia: A Cohort Study.

    Science.gov (United States)

    Tolva, Valerio; Casana, Renato; Huibers, Anne; Parati, Gianfranco; Bianchi, Paolo; Cireni, Lea; Ferrero, Emanuele; Halliday, Allison

    2016-07-01

    Restenosis due to intimal hyperplasia (IH) is a major clinical issue that affects the success of lower limb endovascular surgery. After 1 year, restenosis occurs in 40% to 60% of the treated vessels. The possibility to reduce IH using local antiproliferative drugs, such as taxols, has been the rationale for the clinical applications of drug-eluting stents and drug-eluting balloons (DEBs). The purpose of this study was to evaluate the clinical and instrumental efficacy of DEBs versus simple percutaneous transluminal angioplasty (PTA) in patients affected by chronic limb ischemia (CLI) with tibial artery "de novo" lesions. A retrospective analysis was performed and included all consecutive patients who underwent endovascular treatment for CLI in our centers between January 2011 and March 2013. Inclusion criteria were (1) "de novo" tibial artery stenosis and (2) Rutherford class >4. Lesions were further divided by TransAtlantic Inter-Societal Consensus (TASC) classification into groups A, B, C, and D. Between January 2010 and March 2013, a total of 138 patients underwent simple PTA or DEB for CLI, and the groups were clinically and demographically homogenous. We decided to use DEBs in 70 cases. An improvement in the Rutherford Scale in cumulative and single TASC lesions classification was better in the DEB group (74% vs 51%; P = .024) at 24 months than in the PTA group. In the DEB group, the increase in ankle-brachial index was significantly higher than in the PTA group (P = .039). Our experience in addition to the existing literature supports the use of DEB in patients with CLI Rutherford class >3. © The Author(s) 2016.

  17. Bioinspired Titanium Drug Eluting Platforms Based on a Poly-β-cyclodextrin-Chitosan Layer-by-Layer Self-Assembly Targeting Infections.

    Science.gov (United States)

    Pérez-Anes, Alexandra; Gargouri, Myriem; Laure, William; Van Den Berghe, Hélène; Courcot, Elisabeth; Sobocinski, Jonathan; Tabary, Nicolas; Chai, Feng; Blach, Jean-François; Addad, Ahmed; Woisel, Patrice; Douroumis, Dennis; Martel, Bernard; Blanchemain, Nicolas; Lyskawa, Joël

    2015-06-17

    In the field of implantable titanium-based biomaterials, infections and inflammations are the most common forms of postoperative complications. The controlled local delivery of therapeutics from implants through polyelectrolyte multilayers (PEMs) has recently emerged as a versatile technique that has shown great promise in the transformation of a classical medical implant into a drug delivery system. Herein, we report the design and the elaboration of new biodegradable multidrug-eluting titanium platforms based on a polyelectrolyte multilayer bioactive coating that target infections. These systems were built up in mild conditions according to the layer-by-layer (L-b-L) assembly and incorporate two biocompatible polysaccharides held together through electrostatic interactions. A synthetic, negatively charged β-cyclodextrin-based polymer (PCD), well-known for forming stable and reversible complexes with hydrophobic therapeutic agents, was exploited as a multidrug reservoir, and chitosan (CHT), a naturally occurring, positively charged polyelectrolyte, was used as a barrier for controlling the drug delivery rate. These polyelectrolyte multilayer films were strongly attached to the titanium surface through a bioinspired polydopamine (PDA) film acting as an adhesive first layer and promoting the robust anchorage of PEMs onto the biomaterials. Prior to the multilayer film deposition, the interactions between both oppositely charged polyelectrolytes, as well the multilayer growth, were monitored by employing surface plasmon resonance (SPR). Several PEMs integrating 5, 10, and 15 bilayers were engineered using the dip coating strategy, and the polyelectrolyte surface densities were estimated by colorimetric titrations and gravimetric analyses. The morphologies of these multilayer systems, as well as their naturally occurring degradation in a physiological medium, were investigated by scanning electron microscopy (SEM), and their thicknesses were measured by means of

  18. Two-year clinical outcomes after coronary drug-eluting stent placement in Chinese men and women: a multicenter, prospective registry study

    Directory of Open Access Journals (Sweden)

    Shrestha R

    2013-07-01

    Full Text Available Rajiv Shrestha,1 Sandeep Gami,1 Jing Xu,2 Du-Jiang Xie,2 Zhi-Zhong Liu,2 Tian Xu,1 Fei Ye,2 Shi-Qing Din,3 Xue-Song Qian,4 Song Yang,5 Yue-Qiang Liu,6 Feng Li,7 Ai-Ping Zhang,8 Shao-Liang Chen2 1Nanjing Medical University, Nanjing, 2Nanjing First Hospital, Nanjing Medical University, Nanjing, 3Huainan Xinhua Hospital, Huainan, 4Zhangjiagang People's Hospital, Zhangjiagang, 5Yixin People's Hospital, Yixin, 6Jintan People's Hospital, Jintan, 7Huainan Oriental General Hospital, Huainan, 8Huainan People's Hospital, Huainan, People's Republic of China Background: Previous studies have reported a discrepancy in baseline characteristics and outcomes after percutaneous coronary intervention between men and women. However, this finding has never been verified in the Chinese population. The present study analyzed two-year clinical outcomes after placement of coronary drug-eluting stents in Chinese men and women. Methods: From January 2005 to December 2010, a total of 3804 Chinese patients (2776 men, 1028 women who underwent drug-eluting stent implantation were studied prospectively. The primary endpoint was the composite major adverse cardiac event (MACE rate, including myocardial infarction, cardiac death, and target vessel revascularization at two years. Stent thrombosis served as the safety endpoint. Propensity score matching was used to compare the adjusted MACE rate between the two groups. Results: At two-year follow-up, unadjusted rates of myocardial infarction, non-ST segment elevation myocardial infarction, target vessel revascularization, and MACE were significantly different between men (6.84%, 4.6%, 13.1%, and 21.7%, respectively and women (3.8% [P = 0.001], 2.0% [P < 0.001] 10.3% [P = 0.025], and 16.3% [P < 0.001], respectively. After propensity score matching, there were no significant differences in composite MACE and individual endpoints at two years between the genders. Conclusion: Despite all the unfavorable risk factor clustering in

  19. Everolimus-eluting stents: update on current clinical studies

    Directory of Open Access Journals (Sweden)

    Allocco DJ

    2011-07-01

    Full Text Available Dominic J Allocco, Anita A Joshi, Keith D DawkinsBoston Scientific Corporation, Natick, MA, USAAbstract: Everolimus-eluting stents (EES have become the most commonly implanted coronary stents worldwide. This review describes and analyzes the clinical data supporting the use of EES, focusing primarily on published, randomized, controlled trials. Everolimuseluting stents have been shown to have less restenosis, stent thrombosis, and periprocedural myocardial infarction compared with earlier generation paclitaxel-eluting stents (PES. Lower rates of adverse events for EES compared with PES were generally seen in all subgroups, with the notable exception of patients with diabetes mellitus. There have been fewer, randomized, clinical trials comparing EES with either sirolimus-eluting stents or zotarolimus-eluting stents, although very good results with EES have been observed in the trials that have been performed. Recent clinical trial data suggest that this excellent safety and efficacy profile is maintained in a next-generation EES designed to have improved mechanical properties and radiopacity.Keywords: drug-eluting stents, everolimus, Xience V, Promus, Promus ElementVideo Abstract:  http://dvpr.es/allocco  

  20. Study design and rationale of 'Influence of Cilostazol-based triple anti-platelet therapy on ischemic complication after drug-eluting stent implantation (CILON-T' study: A multicenter randomized trial evaluating the efficacy of Cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease

    Directory of Open Access Journals (Sweden)

    Lee Seung-Pyo

    2010-08-01

    Full Text Available Abstract Background Current guidelines recommend dual anti-platelet therapy, aspirin and clopidogrel, for patients treated with drug-eluting stent for coronary heart disease. In a few small trials, addition of cilostazol on dual anti-platelet therapy (triple anti-platelet therapy showed better late luminal loss. In the real-world unselected patients with coronary heart disease, however, the effect of cilostazol on platelet reactivity and ischemic vascular events after drug-eluting stent implantation has not been tested. It is also controversial whether there is a significant interaction between lipophilic statin and clopidogrel. Methods/Design CILON-T trial was a prospective, randomized, open-label, multi-center, near-all-comer trial to demonstrate the superiority of triple anti-platelet therapy to dual anti-platelet therapy in reducing 6 months' major adverse cardiovascular/cerebrovascular events, composite of cardiac death, nonfatal myocardial infarction, target lesion revascularization and ischemic stroke. It also tested whether triple anti-platelet therapy is superior to dual anti-platelet therapy in inhibiting platelet reactivity in patients receiving percutaneous coronary intervention with drug-eluting stent. Total 960 patients were randomized to receive either dual anti-platelet therapy or triple anti-platelet therapy for 6 months and also, randomly stratified to either lipophilic statin (atorvastatin or non-lipophilic statin (rosuvastatin indefinitely. Secondary endpoints included all components of major adverse cardiovascular/cerebrovascular events, platelet reactivity as assessed by VerifyNow P2Y12 assay, effect of statin on major adverse cardiovascular/cerebrovascular events, bleeding complications, and albumin-to-creatinine ratio to test the nephroprotective effect of cilostazol. Major adverse cardiovascular/cerebrovascular events will also be checked at 1, 2, and 3 years to test the 'legacy' effect of triple anti-platelet therapy

  1. Stent Fracture after Everolimus-Eluting Stent Implantation

    Directory of Open Access Journals (Sweden)

    Ali S. Almasood

    2011-01-01

    Full Text Available Compared with bare-metal stents, drug-eluting stents (DES have greatly reduced the risk of in-stent restenosis (ISR by inhibiting neointimal growth. Nevertheless, DES are still prone to device failure, which may lead to cardiac events. Recently, stent fracture (SF has emerged as a potential mechanism of DES failure that is associated with ISR. Stent fracture is strongly related to stent type, and prior reports suggest that deployment of sirolimus eluting stents (SES may be associated with a higher risk of SF compared to other DES. Everolimus eluting stents (EESs represent a new generation of DES with promising results. The occurrence of SF with EES has not been well established. The present paper describes two cases of EES fracture associated with ISR.

  2. Clinical Outcomes After Drug-Eluting Stents Versus Coronary Artery Bypass Surgery in High Surgical Risk Patients With Left Main or Three-Vessel Coronary Artery Disease

    Directory of Open Access Journals (Sweden)

    Tonga Nfor

    2015-08-01

    Full Text Available Purpose: Previous studies comparing percutaneous coronary intervention (PCI with coronary artery bypass graft surgery (CABG in patients with unprotected left main or three-vessel coronary artery disease (LM-3VD have excluded patients at high surgical risk. We compared clinical outcomes after PCI with drug-eluting stents to CABG in high surgical risk patients with LM-3VD. Methods: Patients with symptomatic LM-3VD who had Society of Thoracic Surgeons (STS-predicted operative mortality > 5% and were undergoing either PCI with drug-eluting stents or CABG at a tertiary care center from January 2009 to December 2010 were enrolled in this nonrandomized prospective study. Results: Mean STS score was 14.5 ± 5.8% for PCI (n=83 vs. 13.6 ± 7.1% for CABG (n=187 (P=0.31. After mean follow-up of 37 months, incidence of the composite primary endpoint (death, myocardial infarction or stroke was 42.2% for PCI and 39.6% for CABG (P=0.69, hazard ratio 1.3, 95% confidence interval 0.5-2.8. There were no differences in the individual components of the primary endpoint between PCI and CABG. Repeat revascularization was 30.1% for PCI vs. 9.6% for CABG (P=0.001. Major adverse cardiac and cerebrovascular event rates were similar between PCI and CABG, 50.6% vs. 42.2%, respectively (P=0.23. Patients in the PCI group were less likely than those in the CABG group to be discharged to a nursing home (12.1% vs. 47.1%, P 5%.

  3. Effects of amphiphilic chitosan-g-poly(ε-caprolactone) polymer additives on paclitaxel release from drug eluting implants

    Energy Technology Data Exchange (ETDEWEB)

    Shi, Weibin [Department of General Surgery, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200092 (China); Gu, Chunhua [Key Laboratory for Ultrafine Materials of Ministry of Education, School of Materials Science and Engineering, East China University of Science and Technology, Shanghai 200237 (China); Jiang, Han [Department of General Surgery, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200092 (China); Zhang, Mengru [Key Laboratory for Ultrafine Materials of Ministry of Education, School of Materials Science and Engineering, East China University of Science and Technology, Shanghai 200237 (China); Lang, Meidong, E-mail: mdlang@ecust.edu.cn [Key Laboratory for Ultrafine Materials of Ministry of Education, School of Materials Science and Engineering, East China University of Science and Technology, Shanghai 200237 (China)

    2014-12-01

    Bioresorbable polymer stents have been proposed as promising medical implants to avoid long-term safety concerns and other potential issues caused by traditional materials. As an important member, poly(ε-caprolactone) (PCL) was used as the implant matrix with different drug loadings. To better regulate drug release rate, the hydrophilicity of PCL was adjusted by addition of amphiphilic graft copolymers, chitosan-g-poly(ε-caprolactone) (CP). The in vitro release results indicated that the improvement of bulk hydrophilicity could accelerate drug release better than that of surface coating. The optimum additive amount was 25% with CP9. Further study showed that the effect of aspirin molecules displayed no obvious difference to that of CP macromolecules on drug release rate. Moreover, these release profiles were fitted with mathematical models. The similarities were evaluated with similarity factors. Scanning electron microscopy (SEM) images displayed surface/cross-section morphologies of pure PCL and modified implants before and after release. - Highlights: • The improvement of bulk hydrophilicity better accelerated drug release. • The higher weight ratio of CP implants had, the faster the drug released. • The shorter PCL chain in CP graft coploymers, the faster the drug released. • The optimum additive amount was 25% with CP9. • Drug release profile conformed to controllable Fick diffusional release mechanism.

  4. 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.

  5. Long-term clinical and economic analysis of the Endeavor drug-eluting stent versus the Driver bare-metal stent: 4-year results from the ENDEAVOR II trial (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).

    Science.gov (United States)

    Eisenstein, Eric L; Wijns, William; Fajadet, Jean; Mauri, Laura; Edwards, Rex; Cowper, Patricia A; Kong, David F; Anstrom, Kevin J

    2009-12-01

    This study was designed to evaluate long-term clinical and economic outcomes for subjects receiving Endeavor drug-eluting versus Driver bare-metal stents (both Medtronic CardioVascular, Santa Rosa, California). Early studies found that the drug-eluting stent (DES) was a clinically and economically attractive alternative to the bare-metal stent; however, associations between DES and very late stent thrombosis suggest that longer follow-up is required. We used clinical, resource use and follow-up data from 1,197 subjects randomized to receive Endeavor (n = 598) versus Driver (n = 599) stents in ENDEAVOR II (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) study with Medicare cost weights and quality of life adjustments applied from secondary sources. We compared differences through 4-year follow-up (1,440 days). Patients in both treatment groups had similar baseline characteristics. The use of Endeavor versus Driver reduced 4-year target vessel revascularization rates per 100 subjects (10.4 vs. 21.5; difference: -11.1; 95% confidence interval [CI]: -16.0 to -6.1; p Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions [ENDEAVOR II]; NCT00614848).

  6. Everolimus-eluting coronary stents

    Directory of Open Access Journals (Sweden)

    Alejandro Saez

    2010-09-01

    Full Text Available Alejandro Saez, Raul MorenoDivision of Interventional Cardiology, University Hospital La Paz, Madrid, SpainAbstract: Bare metal stents enabled a reduction in the risk of early procedural complications and restenosis in comparison with balloon angioplasty alone, but introduced a new and device-specific iatrogenic condition, ie, in-stent restenosis due to increased neointimal hyperplasia. Sirolimus- and paclitaxel-eluting stents reduce restenosis and the need for new revascularizations in comparison with bare metal stents, although at the cost of a slight increase in the risk of late stent thrombosis and a need for prolonged dual antiplatelet therapy. Everolimus is an analog of sirolimus with an increased solubility. In this review, the currently available evidence for everolimus-eluting stents is revised, including randomized trials against bare metal stents, and head-to-head trials comparing this stent with other drug-eluting stents.Keywords: coronary stents, restenosis, everolimus, review

  7. INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Burzotta Francesco

    2012-05-01

    Full Text Available Abstract Background Neointimal hyperplasia plays a pivotal role in the pathogenesis of in-stent restenosis in patients undergoing percutaneous coronary interventions. Drug-eluting balloons are a promising tool to prevent restenosis after coronary angioplasty. Moreover, an increased knowledge of the pathophysiology of restenosis my help improve therapeutic strategies. Methods/Design We present the design of an open-label, randomized three-arm clinical trial aimed to assess whether a strategy of bare-metal stent implantation with additional use of drug-eluting balloons, either before (pre-dilation or after stenting (post-dilation, reduces the primary endpoint of in-stent neointimal hyperplasia area as compared with a strategy of bare-metal stent implantation alone. This primary endpoint will be assessed by optical coherence tomography at follow-up. Secondary endpoints will be the percentage of uncovered struts, and the percentage of struts with incomplete apposition. An ancillary study investigating the relation between systemic levels of endothelial progenitors cells and neointimal hyperplasia, and the interaction between endothelial progenitors cell levels and drug-eluting balloons has been planned. Thirty consecutive patients undergoing percutaneous coronary intervention will be randomized with a 1:1:1 design to bare-metal stent implantation alone (n = 10; bare-metal stent implantation after pre-dilation with a drug-eluting balloon (n = 10; or bare-metal stent implantation followed by post-dilation with a drug-eluting balloon (n = 10. Six-month follow-up coronary angiography with optical coherence tomography imaging of the stented segment will be performed in all patients. Blood samples for the assessment of endothelial progenitors cell levels will be collected on admission and at 6 months. Discussion Experimental and early clinical data showed that inhibition of neointimal hyperplasia may be obtained by local administration of

  8. 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.

  9. Direct drug-eluting stenting to reduce stent restenosis : a randomized comparison of direct stent implantation to conventional stenting with pre-dilation or provisional stenting in elective PCI patients

    NARCIS (Netherlands)

    Remkes, Wouter S; Somi, Samer; Roolvink, Vincent; Rasoul, Saman; Ottervanger, Jan Paul; Gosselink, A T Marcel; Hoorntje, Jan C A; Dambrink, Jan-Henk E; de Boer, Menko-Jan; Suryapranata, Harry; van 't Hof, Arnoud W J

    2014-01-01

    OBJECTIVES: The aim was to investigate whether a strategy of direct drug-eluting stent (DES) implantation without pre-dilation is associated with a reduced incidence of restenosis compared with CS with pre-dilation or provisional stenting (PS). BACKGROUND: Previous studies were performed comparing d

  10. Post-elution processing of {sup 44}Ti/{sup 44}Sc generator-derived {sup 44}Sc for clinical application

    Energy Technology Data Exchange (ETDEWEB)

    Pruszynski, M. [Institute of Nuclear Chemistry and Technology, 03-195 Warszawa (Poland); Loktionova, N.S. [Institute of Nuclear Chemistry, Johannes Gutenberg-University of Mainz, D-55128 Mainz (Germany); Filosofov, D.V. [Joint Institute of Nuclear Research, DLNP, 141980 Dubna (Russian Federation); Roesch, F., E-mail: frank.roesch@uni-mainz.d [Institute of Nuclear Chemistry, Johannes Gutenberg-University of Mainz, D-55128 Mainz (Germany)

    2010-09-15

    The {sup 44}Ti/{sup 44}Sc (T{sub 1/2}{sup 44}Ti=60 a) generator provides cyclotron-independent access to positron-emitting {sup 44}Sc (T{sub 1/2}=3.97 d) for PET imaging. This work aims to post-elution processing of initial {sup 44}Sc generator eluates in order to reduce its volume, HCl concentration and remove the oxalate anions. The on-line adsorption of {sup 44}Sc on cationic resin AG 50W-X8 (200-400 mesh, H{sup +}-form) is achieved with >98% efficacy. Subsequently, the purified {sup 44}Sc is desorbed by using 3 ml of 0.25 M ammonium acetate (pH=4.0). The post-processing takes 10 min. The overall yield of the post-processing reached 90%, which is referred to the {sup 44}Sc obtained from the {sup 44}Ti/{sup 44}Sc generator. In addition to the chemical purification, the content of {sup 44}Ti breakthrough was further reduced by one order of magnitude. The 185 MBq generator finally provides 150 MBq of {sup 44}Sc containing <10 Bq of {sup 44}Ti ready for labeling.

  11. Impact of Aspirin and Clopidogrel Hyporesponsiveness in Patients Treated With Drug-Eluting Stents: 2-Year Results of a Prospective, Multicenter Registry Study.

    Science.gov (United States)

    Stuckey, Thomas D; Kirtane, Ajay J; Brodie, Bruce R; Witzenbichler, Bernhard; Litherland, Claire; Weisz, Giora; Rinaldi, Michael J; Neumann, Franz-Josef; Metzger, D Christopher; Henry, Timothy D; Cox, David A; Duffy, Peter L; Mazzaferri, Ernest L; Gurbel, Paul A; Mehran, Roxana; Généreux, Philippe; Ben-Yehuda, Ori; Simonton, Charles A; Stone, Gregg W

    2017-08-28

    In this analysis of 2-year outcomes in the ADAPT-DES (Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents) study, the authors sought to examine the independent associations between platelet reactivity to both aspirin and clopidogrel and subsequent outcomes. The relationship between platelet reactivity and long-term adverse events following implantation of drug-eluting stents (DES) has been incompletely characterized. The ADAPT-DES study was a multicenter registry of patients undergoing routine platelet function testing following percutaneous coronary intervention with DES. The primary study endpoint was definite or probable stent thrombosis (ST); other endpoints were all-cause mortality, myocardial infarction, and clinically relevant bleeding. A total of 8,582 patients were enrolled between 2008 and 2010; 46.3% of patients were on dual antiplatelet therapy at 2 years without discontinuation. At 2 years, definite or probable ST occurred in 92 patients (1.07%). In patients treated with dual antiplatelet therapy continuously for 2 years, high platelet reactivity on clopidogrel was independently associated with definite or probable ST (adjusted hazard ratio [HR]: 2.16; 95% confidence interval [CI]: 1.27 to 3.67; p = 0.003), myocardial infarction (adjusted HR: 1.35; 95% CI: 1.05 to 1.74; p = 0.02), freedom from clinically relevant bleeding (adjusted HR: 0.74; 95% CI: 0.62 to 0.90; p = 0.002), and all-cause mortality (adjusted HR: 1.36; 95% CI: 1.01 to 1.85; p = 0.04). Between years 1 and 2, high platelet reactivity was not associated with the very late ST and in patients on aspirin monotherapy, aspirin hyporesponsiveness was not associated with adverse outcomes. The present study confirms the strong relationship of high platelet reactivity on clopidogrel to 2-year ischemic and bleeding outcomes after DES. The majority of stent-related events occurred within the first year. Copyright © 2017 American College of Cardiology Foundation. Published by

  12. Two-year clinical outcome after successful implantation of drug-eluting and bare metal stents in diabetic patients: results from a real-world single center registry

    Institute of Scientific and Technical Information of China (English)

    DOU Ke-fei; XU Bo; YANG Yue-jin; CHEN Ji-lin; QIAO Shu-bin; LI Jian-jun; QIN Xue-wen; LIU Hai-bo; WU Yong-jian; CHEN Jue; YAO Min; YOU Shi-jie; YUAN Jin-qing; DAI Jun; GAO Run-lin

    2009-01-01

    Background Drug-eluting stents (DES) have revolutionized the field of interventional cardiology by dramatically improving clinical and angiographic outcomes. Patients with diabetes mellitus (DM) are associated with an increased risk of adverse clinical outcomes after a percutaneous coronary intervention (PCI). Available information on the efficacy and safety of DES and bare metal stent (BMS) in diabetic patients remains scarce.Methods From April 2004 to October 2006, 1565 patients with diabetes, who successfully underwent elective stenting at Fu Wai Hospital in Beijing, China, were enrolled in this study. All enrolled patients were assigned to a drug eluting stent group and a bare metal stent group. We obtained follow-up data: death, myocardial infarction (MI), thrombus, target lesion revascularization (TLR), and target vessel revascularization (TVR) at 30 days and 12 and 24 months, as defined by the Academic Research Consortium (ARC). We calculated and compared all the unadjusted cumulative frequencies of the various adverse events in the two groups. Cox's proportional-hazards models adjusted with the propensity score were used to assess the relative risks of all the outcome measures at 24 months.Results At 24 months, all ARC defined stent thrombosis in the two groups were similar; at 30 days, a more definite thrombosis was found in the BES group (0.08% vs 0.81%, P=0.016). Patients treated with DES showed a significant lower risk of TLR (3.88% vs 10.89%; hazard ratio (HR) 0.159 (95% CI: 0.151-0.444), P<0.001), TVR (5.48% vs 11.69%; HR 0.383 (95% CI: 0.232-0.633), P <0.001), and any revascularization (12.47% vs 18.55%; HR 0.555 (95% CI: 0.370-0.831), P=0.0004) at 24 months. No significant difference was apparent in terms of all-cause mortality, MI, and all-cause mortality/MI.Conclusions In contemporary society's large, diabetic population, the use of DES is associated with long-term significant reductions in the risks of TLR, TVR, and any revascularization. There

  13. Delayed coverage of drug-eluting stents after interventional revascularisation of chronic total occlusions assessed by optical coherence tomography: the ALSTER-OCT-CTO registry.

    Science.gov (United States)

    Heeger, Christian-Hendrik; Busjahn, Andreas; Hildebrand, Laura; Fenski, Maximillian; Lesche, Felix; Meincke, Felix; Kuck, Karl-Heinz; Bergmann, Martin Walter

    2016-01-22

    Following percutaneous coronary interventions (PCI) for revascularisation of chronic total occlusions (CTO) patients are at increased risk for stent thrombosis (ST). Delayed drug-eluting stent (DES) coverage has previously been shown to be related to ST. Using optical coherence tomography (OCT), we tested the hypothesis that CTO-PCI is associated with delayed DES coverage compared to non-CTO lesions. From 06/2010 to 11/2013, 105 patients (111 lesions) with clinically driven follow-up angiography after PCI with DES received an OCT analysis. Patients with successful CTO-PCI (19 patients/20 lesions, 6.5±2.1 months post PCI) were included in the CTO group, and patients with non-CTO lesions and total stent length >24 mm (28 patients/28 lesions, 4.9±2.2 months post PCI) were used as a control group. Struts were analysed by OCT (CTO vs. control, mean±SD): covered: 68.9±21.9% vs. 89.6±10.4%, pCTO-PCI approaches were found. A significantly delayed DES coverage after CTO-PCI was observed. Given the known increased rate of ST following CTO-PCI and the known association between delayed DES coverage and ST, OCT may aid in determining the optimal duration of dual antiplatelet therapy after CTO-PCI.

  14. Effect of pioglitazone on in-stent restenosis after coronary drug-eluting stent implantation: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Ming-duo Zhang

    Full Text Available In-stent restenosis (ISR remains a common life-threatening complication and some studies have shown that pioglitazone can reduce the incidence of ISR in patients with drug-eluting stents (DES implantation. We conducted a meta-analysis to assess the effect of pioglitazone in preventing ISR after DES implantation.Randomized controlled trials (RCTs investigating the effects of pioglitazone for ISR after DES implantation were identified by systematic searches of multiple online databases and manual searches of related reference lists of identified trials through May 2014. The primary endpoint was the rate of ISR. Secondary endpoints included minimum lumen diameter, percentage stenosis of stented vessels, late loss, in-stent neointimal volume, target vessel revascularization (TVR, target lesion revascularization, myocardial infarction, stent thrombosis and death.Five studies, comprising 255 pioglitazone-treated patients and 245 controls, were identified in the current meta-analysis. Pioglitazone did not significantly reduce the rate of ISR (P = 0.20 with low heterogeneity (I2 = 13.3%, P = 0.32. For the secondary outcomes, pioglitazone did not substantially affect the pooled estimates of these endpoints except late loss (P = 0.01 and TVR (P = 0.04.The limited evidence indicates that pioglitazone does not demonstrate markedly beneficial effect in patients subjected to coronary DES implantation. However, the results should be interpreted with care given the small sample size. Further large-scale RCTs are needed.

  15. Optimal duration of dual antiplatelet therapy after percutaneous coronary intervention with drug eluting stents: meta-analysis of randomised controlled trials

    Science.gov (United States)

    Andreotti, Felicita; Schulze, Volker; Kołodziejczak, Michalina; Buffon, Antonino; Brouwer, Marc; Costa, Francesco; Kowalewski, Mariusz; Parati, Gianfranco; Lip, Gregory Y H; Kelm, Malte; Valgimigli, Marco

    2015-01-01

    Objective To assess the benefits and risks of short term (12 months) dual antiplatelet therapy (DAPT) versus standard 12 month therapy, following percutaneous coronary intervention with drug eluting stents. Design Meta-analysis of randomised controlled trials. Data sources PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Scopus, Web of Science, Cochrane Library, and major congress proceedings, searched from 1 January 2002 to 16 February 2015. Review methods Trials comparing short term (12 months) DAPT regimens with standard 12 month duration of therapy. Primary outcomes were cardiovascular mortality, myocardial infarction, stent thrombosis, major bleeding, and all cause mortality. Results 10 randomised controlled trials (n=32 287) were included. Compared to 12 month DAPT, a short term course of therapy was associated with a significant reduction in major bleeding (odds ratio 0.58 (95% confidence interval 0.36 to 0.92); P=0.02) with no significant differences in ischaemic or thrombotic outcomes. Extended versus 12 month DAPT yielded a significant reduction in the odds of myocardial infarction (0.53 (0.42 to 0.66); P12 months) could be considered. The increase in all cause but not cardiovascular death with extended DAPT requires further investigation. PMID:25883067

  16. A novel platinum chromium everolimus-eluting stent for the treatment of coronary artery disease

    Directory of Open Access Journals (Sweden)

    Bennett J

    2013-06-01

    Full Text Available Johan Bennett, Christophe DuboisDepartment of Cardiovascular Diseases, University Hospitals Leuven, Leuven, BelgiumAbstract: The development of coronary stents represents a major step forward in the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. The initial enthusiasm for bare metal stents was, however, tempered by a significant incidence of in-stent restenosis, the manifestation of excessive neointima hyperplasia within the stented vessel segment, ultimately leading to target vessel revascularization. Later, drug-eluting stents, with controlled local release of antiproliferative agents, consistently reduced this need for repeat revascularization. In turn, the long-term safety of first-generation drug-eluting stents was brought into question with the observation of an increased incidence of late stent thrombosis, often presenting as myocardial infarction or sudden death. Since then, new drugs, polymers, and platforms for drug elution have been developed to improve stent safety and preserve efficacy. Development of a novel platinum chromium alloy with high radial strength and high radiopacity has enabled the design of a new, thin-strut, flexible, and highly trackable stent platform, while simultaneously improving stent visibility. Significant advances in polymer coating, serving as a drug carrier on the stent surface, and in antiproliferative agent technology have further improved the safety and clinical performance of newer-generation drug-eluting stents. This review will provide an overview of the novel platinum chromium everolimus-eluting stents that are currently available. The clinical data from major clinical trials with these devices will be summarized and put into perspective.Keywords: drug-eluting stent, restenosis, Promus Element, Synergy

  17. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery.

    Science.gov (United States)

    Katsanos, Konstantinos; Spiliopoulos, Stavros; Karunanithy, Narayan; Krokidis, Miltiadis; Sabharwal, Tarun; Taylor, Peter

    2014-04-01

    Several randomized controlled trials (RCTs) have shown the superiority of some of these technologies over balloon angioplasty, but direct comparisons between these treatment options are lacking. The authors conducted a network meta-analysis of RCTs comparing bare nitinol stents, covered nitinol stents, paclitaxel- or sirolimus-eluting stents (PES or SES), and paclitaxel-coated balloons (PCB) with plain balloon angioplasty or with each other in the femoropopliteal artery (PROSPERO registry: CRD42013004845). Sixteen RCTs comprising 2532 patients with 4227 person-years of follow-up were analyzed on an intention-to-treat basis. Bayesian random effects Poisson and binomial models were used for mixed treatment comparisons (WinBUGS). Clinical heterogeneity was accounted for by incorporating a meta-regression model on trial-specific baseline risk. End points included technical success, vascular restenosis, target lesion revascularization, and major amputations. Pairwise odds ratios and rate ratios (ORs and RRs) of absolute treatment effects were calculated, and the probabilities of each treatment being best are reported. Summary estimates are reported as the posterior median and associated credible intervals (CrIs) that serve the same purpose as confidence intervals in the context of the Bayesian framework. Extensive sensitivity, meta-regression, and network consistency analyses were performed to evaluate heterogeneity. Technical success was highest with covered stents (pooled OR, 13.6; 95% CrI, 3.3-31.1, probability best 82%) followed by uncovered stents (pooled OR, 7.0; 95% CrI, 2.6-129, probability best 18%) when compared with balloon angioplasty (reference treatment). Vascular restenosis was lowest with PES (RR, 0.43; 95% CrI, 0.16-1.18, probability best 45%) followed by PCB (RR, 0.43; 95% CrI, 0.26-0.67, probability best 42%). Target lesion revascularization was lowest with PCB (RR, 0.36; 95% CrI, 0.23-0.55, probability best 56%) followed by PES (RR, 0.42; 95% CrI, 0

  18. 国产Firebird2TM与进口Endeavor-Sprint药物洗脱支架临床应用比较%Comparison of home-made Firebird 2TM drug-eluting stent and imported Endeavor-Sprint drug-eluting stent

    Institute of Scientific and Technical Information of China (English)

    李平; 姚光; 陈坚; 王正东; 甘剑挺; 梁祥文

    2012-01-01

    目的 对比研究国产Firebird 2TM雷帕霉素药物洗脱钴基合金支架与进口Endeavor-Sprint药物洗脱支架临床应用的安全性及疗效.方法 对100例冠心病患者进行介入治疗,随机分为Firebird组和Endeavor组,每组50例,比较两组支架植入后效果.结果 两组患者血管病变单支、双支、三支、分叉、慢性闭塞、左主干数比较差异无统计学意义(P>0.05),平均血管直径和平均靶病变长度比较差异无统计学意义(P>0.05);两组手术成功率为100%.Firebird组无血栓形成事件发生,Endeavor组发生1例亚急性血栓形成事件,且进行血运重建.Firebird组28例复查冠状动脉造影,1例再狭窄;Endeavor组19例复查冠状动脉造影,2例有再狭窄,两组比较差异无统计学意义(P>0.05).结论 Firebird 2TM雷帕霉素药物洗脱钴基合金支架具有良好的安全性和满意的近、中期疗效.其与进口Endeavor-Sprint药物洗脱支架比较无明显差别.%Objective To compare the safety and efficacy between home - made Firebird 2 sirolimus drug - e-luting Co - based alloy stent and imported Endeavor - Sprint drug - eluting stent. Methods One hundred patients with coronary artery disease , who were to received percutaneous coronary intervention therapy , were randomly divided into Fire -bird Group (50 cases) and Endeavor Group(50 cases). The efficacy and safety were compared. Results There was no significant difference was revealed in age , sex ratio, hypertension , diabetes mellitus, or myocardial infarction history be -tween the two groups ; neither was the number or location of the affected vessels , nor the vascular diameter or target lesion length. The operation success rates were 100% in both groups. No thrombosis was reported in Firebird Group , while re-vascularization was performed for one sub - acute thrombosis event in Endeavor Group . In 28 and 19 cases received coronary angiography in Firebird Group and Endeavor Group , respectively, 1 and

  19. Enhanced in Vitro and in Vivo Performance of Mg-Zn-Y-Nd Alloy Achieved with APTES Pretreatment for Drug-Eluting Vascular Stent Application.

    Science.gov (United States)

    Liu, Jing; Zheng, Bo; Wang, Pei; Wang, Xingang; Zhang, Bin; Shi, Qiuping; Xi, Tingfei; Chen, Ming; Guan, Shaokang

    2016-07-20

    Bioabsorbable magnesium alloys are becoming prominent as temporary functional implants, as they avoid the risks generated by permanent metallic implants such as persistent inflammation and late restenosis. Nevertheless, the overfast corrosion of Mg alloys under physiological conditions hinders their wider application as medical implant materials. Here we investigate a simple one-step process to introduce a cross-linked 3-amino-propyltrimethoxysilane (APTES) silane physical barrier layer on the surface of Mg-Zn-Y-Nd alloys prior to electrostatic spraying with rapamycin-eluting poly(lactic-co-glycolic acid) (PLGA) layer. Surface microstructure was characterized by scanning electron microscope and Fourier transform infrared spectroscopy. Nanoscratch test verified the superior adhesion strength of PLGA coating in the group pretreated with APTES. Electrochemical tests combined with long-term immersion results suggested that the preferable in vitro anticorrosion behavior could be achieved by dense APTES barrier. Cell morphology and proliferation data demonstrated that APTES pretreated group resulted in remarkably preferable compatibility for both human umbilical vein endothelial cells and vascular smooth muscle cells. On the basis of excellent in vitro mechenical property, the animal study on the APTES pretreated Mg-Zn-Y-Nd stent implanted into porcine coronary arteries confirmed benign tissue compatibility as well as re-endothelialization without thrombogenesis or in-stent restenosis at six-month followup.

  20. The Pharmacology and Toxicology of Third-Generation Anticonvulsant Drugs.

    Science.gov (United States)

    LaPenna, Paul; Tormoehlen, Laura M

    2017-08-16

    Epilepsy is a neurologic disorder affecting approximately 50 million people worldwide, or about 0.7% of the population [1]. Thus, the use of anticonvulsant drugs in the treatment of epilepsy is common and widespread. There are three generations of anticonvulsant drugs, categorized by the year in which they were developed and released. The aim of this review is to discuss the pharmacokinetics, drug-drug interactions, and adverse events of the third generation of anticonvulsant drugs. Where available, overdose data will be included. The pharmacokinetic properties of third-generation anticonvulsant drugs include relatively fewer drug-drug interactions, as well as several unique and life-threatening adverse events. Overdose data are limited, so thorough review of adverse events and knowledge of drug mechanism will guide expectant management of future overdose cases. Reporting of these cases as they occur will be necessary to further clarify toxicity of these drugs.

  1. Peri-stent contrast staining, major evaginations and severe malapposition after biolimus-eluting stent implantation

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Thayssen, Per; Jensen, Lisette Okkels

    2014-01-01

    Peri-stent contrast staining and late acquired malapposition represent pathological vessel wall healing patterns following percutaneous coronary intervention with stent implantation. Earlier studies have described these abnormal vessel wall responses commonly present after implantation of first......-generation drug-eluting stents. These coronary vascular changes can cause flow disturbance and thereby dispose for later thrombotic events. This case report, based on coronary optical frequency domain imaging, describes peri-stent contrast staining, major evaginations and severe malapposition occurring 18months...... after third-generation biolimus-eluting stent implantation....

  2. Endovascular Gene Delivery from a Stent Platform: Gene- Eluting Stents.

    Science.gov (United States)

    Fishbein, Ilia; Chorny, Michael; Adamo, Richard F; Forbes, Scott P; Corrales, Ricardo A; Alferiev, Ivan S; Levy, Robert J

    A synergistic impact of research in the fields of post-angioplasty restenosis, drug-eluting stents and vascular gene therapy over the past 15 years has shaped the concept of gene-eluting stents. Gene-eluting stents hold promise of overcoming some biological and technical problems inherent to drug-eluting stent technology. As the field of gene-eluting stents matures it becomes evident that all three main design modules of a gene-eluting stent: a therapeutic transgene, a vector and a delivery system are equally important for accomplishing sustained inhibition of neointimal formation in arteries treated with gene delivery stents. This review summarizes prior work on stent-based gene delivery and discusses the main optimization strategies required to move the field of gene-eluting stents to clinical translation.

  3. 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 <0.01). Conversely, no differences in crude mortality rates were observed between 1 and 3 years across 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 <0.01), whereas no differences were observed between UAP or NSTEMI and SAP (HR 0.99; 95% CI 0.73 to 1.34; p = 0.94). In women with ACS, use of new-generation DES was associated with reduced risk of major adverse cardiac events (HR 0.58; 95% CI 0.34 to 0.98). The magnitude and direction of the effect with new-generation DES was uniform between women with or without ACS (pinteraction = 0.66). In conclusion, in women across the 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.

  4. Comparison of bare-metal and drug-eluting stents in patients with chronic kidney disease (from the NHLBI Dynamic Registry).

    Science.gov (United States)

    Green, Sandy M; Selzer, Faith; Mulukutla, Suresh R; Tadajweski, Edward J; Green, Jamie A; Wilensky, Robert L; Laskey, Warren K; Cohen, Howard A; Rao, Sunil V; Weisbord, Steven D; Lee, Joon S; Reis, Steven E; Kip, Kevin E; Kelsey, Sheryl F; Williams, David O; Marroquin, Oscar C

    2011-12-01

    Patients with chronic kidney disease (CKD) have a disproportionate burden of coronary artery disease and commonly undergo revascularization. The role and safety of percutaneous coronary intervention (PCI) using drug-eluting stents (DESs) verses bare-metal stents in patients with CKD not on renal replacement therapy has not been fully evaluated. This study investigated the efficacy and safety of DES in patients with CKD not on renal replacement therapy. Patients were drawn from the National Heart, Lung, and Blood Institute Dynamic Registry and were stratified by renal function based on estimated glomerular filtration rate (GFR). Of the 4,157 participants, 1,108 had CKD ("low GFR" <60 ml/min/1.73 m(2)), whereas 3,049 patients had normal renal function ("normal GFR" ≥60 ml/min/1.73 m(2)). For each stratum of renal function we compared risk of death, myocardial infarction, or repeat revascularization between subjects who received DESs and bare-metal stents at the index procedure. Patients with low GFR had higher 1-year rates of death and myocardial infarction and a decreased rate of repeat revascularization compared to patients with normal GFR. Use of DESs was associated with a decreased need for repeat revascularization in the normal-GFR group (adjusted hazard ratio 0.63, 95% confidence interval 0.50 to 0.79, p <0.001) but not in the low-GFR group (hazard ratio 0.69, 95% confidence interval 0.45 to 1.06, p = 0.09). Risks of death and myocardial infarction were not different between the 2 stents in either patient population. In conclusion, presence of CKD predicted poor outcomes after PCI with high rates of mortality regardless of stent type. The effect of DES in decreasing repeat revascularization appeared to be attenuated in these patients. Copyright © 2011 Elsevier Inc. All rights reserved.

  5. 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.

  6. 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.)

  7. Dialysis Patients with Implanted Drug-Eluting Stents Have Lower Major Cardiac Events and Mortality than Those with Implanted Bare-Metal Stents: A Taiwanese Nationwide Cohort Study.

    Directory of Open Access Journals (Sweden)

    Hsin-Fu Lee

    Full Text Available To investigate the efficacy and long-term clinical benefits of DES for dialysis patients.It is unclear whether percutaneous coronary intervention (PCI with drug-eluting stent (DES implantation is associated with lower rates of major adverse cardiovascular events (MACE or mortality compared to bare-metal stents (BMS.From a nationwide cohort selected from Taiwan's National Health Insurance Research Database, we enrolled 2,835 dialysis patients who were hospitalized for PCI treatment with stent implantation from Dec 1, 2006. Follow-up was from the date of index hospitalization for PCI until the first MACE, date of death, or December 31, 2011, whichever came first.A total of 738 patients (26.0% had DES implanted, and 2,097 (74% had BMS implanted. The medium time to the first MACE was 0.53 years (interquartile range: 0.89 years; range: 0-4.62 years. At 1-year follow-up, patients treated with BMS had significantly, non-fatal myocardial infarction (MI, all-cause mortality, and composite MACE compared to those treated with DES. The overall repeat revascularization with coronary artery bypass graft (CABG, non-fatal MI, all-cause mortality, and composite MACE were significantly lower in patients treated with DES than those treated with BMS. Multivariate cox regression analysis showed that older age, history of diabetes, history of heart failure, history of stroke, and DES vs. BMS were independent significant predictors of MACE.DES implantation conferred survival benefits in dialysis patients compared with BMS implantation.

  8. Drug-eluting cements for hard tissue repair: a comparative study using vancomycin and RNPA1000 to inhibit growth of Staphylococcus aureus.

    Science.gov (United States)

    Eidem, Tess M; Coughlan, Aisling; Towler, Mark R; Dunman, Paul M; Wren, Anthony William

    2014-04-01

    Bone cement used in orthopaedic applications can become colonized with bacterial biofilms, resulting in severe medical complications. Consequently, bone cements are often loaded with antibiotics in an effort to prevent bacterial colonization. However, current formulations may not release antibiotics into the environment at sufficient and sustained concentrations required to impede bacterial growth or may be incompatible with antibiotics that are effective against the colonizing organism. Thus, new cement formulation options are needed. This report describes the performance of a novel SiO2-TiO2-ZnO-CaO-SrO-based glass polyalkenoate cement as a carrier of antimicrobials active against Staphylococcus aureus, the predominant cause of orthopaedic biofilm-associated infections. The antibiotic vancomycin and a novel Staphylococcus aureus RnpA inhibitor under pre-clinical development, RNPA1000, were included in these studies. Rheological testing characterized the workability of the glass polyalkenoate cement over a range of powder-to-liquid ratios and polyacrylic acid concentrations and revealed that the most suitable powder-to-liquid ratio was 2/1.25 with 40 wt% polyacrylic acid. Loading glass polyalkenoate cement with either 20-30% RNPA1000 or vancomycin prevented bacterial growth. However, longer incubations allowed for Staphylococcus aureus colonies to form near the vancomycin-infused cement, indicating that vancomycin may not be suitable for long-term biofilm inhibition in comparison to RNPA1000. Scanning electron microscopy and energy-dispersive X-ray analyses confirmed successful incorporation RNPA1000 into the cement matrix and were indicative of its slow release. These studies establish a drug-eluting formulation of glass polyalkenoate cement with great potential in orthopaedic implants that incorporates known antibiotics as well as RNPA1000 to prevent growth of the dangerous pathogen Staphylococcus aureus.

  9. Association between low serum magnesium level and major adverse cardiac events in patients treated with drug-eluting stents for acute myocardial infarction.

    Directory of Open Access Journals (Sweden)

    Guipeng An

    Full Text Available OBJECTIVES: We investigated the association of serum magnesium (Mg levels and major adverse cardiac events (MACEs after drug-eluting stent (DES implantation. BACKGROUND: Mg depletion plays a key role in the pathphysiologic features of diabetes mellitus, hypertension, thrombosis, arrhythmias and coronary artery disease. Whether the depletion is related to the long-term prognosis of DES implantation is not known. METHODS: From 2008 to 2011, we enrolled 414 consecutive patients <50 years old who underwent DES implantation for acute coronary syndrome. Serum Mg level was analyzed and patients were followed up for a median of 24 months (interquartile range 14-32 months for the occurrence of MACEs defined as death, myocardial infarction, stroke, and any revascularization. RESULTS: For patients with unstable angina, no significant association between serum Mg level and MACEs was found in the multivariate model. For patients with myocardial infarction, after adjusting for age, positive family history, smoking status, hypertension, hypercholesterolemia, and diabetes at baseline, the risk was 8.11-fold higher for patients with quartile 1 than 4 Mg level (95% confidence interval 1.7-38.75; P<0.01. In addition, when tested as a continuous variable, serum magnesium was a significant predictor for MACEs of acute myocardial infarction (HR [per 0.1 mM increase], 0.35 [95% CI, 0.19-0.63], p< 0.01, after adjustment for other confounders. CONCLUSIONS: Low serum level of Mg may be an important predictor of MACEs with DES implantation for acute myocardial infarction. Further research into the effectiveness of Mg supplementation for these patients is warranted.

  10. High-intensity Statin Treatments in Clinically Stable Patients on Aspirin Monotherapy 12 Months After Drug-eluting Stent Implantation: A Randomized Study.

    Science.gov (United States)

    Im, Eui; Cho, Yun-Hyeong; Suh, Yongsung; Cho, Deok-Kyu; Her, Ae-Young; Kim, Yong Hoon; Lee, Kyounghoon; Kang, Woong Chol; Yun, Kyeong Ho; Yoo, Sang-Yong; Cheong, Sang-Sig; Shin, Dong-Ho; Ahn, Chul-Min; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

    2017-07-14

    Current guidelines on the treatment of blood cholesterol recommend continuous maintenance of high-intensity statin treatment in drug-eluting stent (DES)-treated patients. However, high-intensity statin treatment is frequently underused in clinical practice after stabilization of DES-treated patients. Currently, the impact of continuous high-intensity statin treatment on the incidence of late adverse events in these patients is unknown. We investigated whether high-intensity statin treatment reduces late adverse events in clinically stable patients on aspirin monotherapy 12 months after DES implantation. Clinically stable patients who underwent DES implantation 12 months previously and received aspirin monotherapy were randomly assigned to receive either high-intensity (40mg atorvastatin, n = 1000) or low-intensity (20mg pravastatin, n = 1000) statin treatment. The primary endpoint was adverse clinical events at 12-month follow-up (a composite of all death, myocardial infarction, revascularization, stent thrombosis, stroke, renal deterioration, intervention for peripheral artery disease, and admission for cardiac events). The primary endpoint at 12-month follow-up occurred in 25 patients (2.5%) receiving high-intensity statin treatment and in 40 patients (4.1%) receiving low-intensity statin treatment (HR, 0.58; 95%CI, 0.36-0.92; P = .018). This difference was mainly driven by a lower rate of cardiac death (0 vs 0.4%, P = .025) and nontarget vessel myocardial infarction (0.1 vs 0.7%, P = .033) in the high-intensity statin treatment group. Among clinically stable DES-treated patients on aspirin monotherapy, high-intensity statin treatment significantly reduced late adverse events compared with low-intensity statin treatment. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01557075. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  11. Comparison of drug eluting stent implantation with coronary artery bypass surgery in the treatment of patients with chronic total occlusion and multiple vessel disease

    Institute of Scientific and Technical Information of China (English)

    LIU Wei; ZHU Xiao-Ling; MA Chang-sheng; KANG Jun-ping; DU Xin; CHEN Fang; ZHOU Yu-jie; L(U) Shu-zheng; HUANG Fang-jiong; GU Cheng-xiong

    2011-01-01

    Background In patients with chronic total occlusion (CTO) and multivessel coronary artery disease, the comparison of surgical and the percutaneous revascularization strategies has rarely been conducted. The aim of this study was to compare long term clinical outcomes of drug eluting stent (DES) implantation with coronary artery bypass surgery (CABG)in the patients with CTO and multivessel disease.Methods From a prospective registry of 6000 patients in our institution, we included patients with CTO and multivessel coronary artery disease who underwent either CABG (n=679) or DES (n=267) treatment. Their propensity risk score was used for adjusting baseline differences.Results At a median follow-up of three years, propensity score adjusted Cox regression analysis showed that the rate of major adverse cardiac cerebrovascular events (MACCE) was lower in CABG group (12.7% vs. 24.3%, hazard ratio (HR) 1.969, 95% Cl 1.219-3.179, P=0.006) mainly due to lower rate of target vessel revascularization in CABG group than in DES group (3.1% vs. 17.2%, HR 16.14, 95% CI 5.739-45.391, P <0.001). The incidence of cardiac death or myocardial infarction (composite end point) was not significantly different between these two groups. On multivariate analysis, the significant predictors of MACCE were only the type of revascularization. Age, left ventricular ejection fraction (LVEF), and complete revascularization were identified as significant predictors of composite end points.Conclusions Our study shows that in patients with CTO and multivessel coronary disease, DES can offer comparable long term outcomes in cardiac death and myocardial infraction free survival in comparison with CABG. However, there is an increased rate of MACCE which results from more repeat revascularizations. Obtaining a complete revascularization is crucial for decreasing adverse cardiac events.

  12. Impact of cardiac rehabilitation on angiographic outcomes after drug-eluting stents in patients with de novo long coronary artery lesions.

    Science.gov (United States)

    Lee, Jong-Young; Yun, Sung-Cheol; Ahn, Jung-Min; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Lee, Cheol Whan; Park, Seong-Wook; Yoo, Yeong Sook; Park, Eun-Kyung; Jin, Young-Soo; Kim, Jeongsoon; Nam, Hyo-Jung; Min, Sun-Yang; Park, Seung-Jung

    2014-06-15

    Cardiac rehabilitation (CR) can reduce cardiovascular mortality and morbidity in coronary artery disease. Long coronary artery lesions may be associated with adverse outcomes after drug-eluting stent (DES) implantation. The purpose of this study was to evaluate angiographic outcomes after a comprehensive CR program in patients with DESs for long coronary artery lesions. A total of 576 patients treated with DESs for long (≥25 mm) coronary lesions were enrolled in this prospective CR registry. Comprehensive CR programs were successfully performed in 288 patients (50%). The primary end point was in-stent late luminal loss at the 9-month angiographic follow-up. There were few significant differences between the CR and non-CR groups in terms of baseline characteristics, including clinical, angiographic, and procedural variables. The rate of in-stent late luminal loss in the CR group was 35% less than in the usual care group (0.19 ± 0.33 mm in CR vs 0.29 ± 0.45 mm in non-CR, difference 0.08 mm, 95% confidence interval 0.01 to 0.16, p = 0.02) at the 9-month follow-up. After propensity-matched analysis (224 pairs), the results were consistent (0.18 ± 0.31 mm in CR vs 0.28 ± 0.41 mm in non-CR, difference 0.10 mm, 95% confidence interval 0.02 to 0.18, p = 0.02). The CR group showed a significant improvement in the overall risk profile compared with the non-CR group, including current smoking, biochemical profiles, depression, obesity, and exercise capacity. In conclusion, the comprehensive CR program significantly reduced late luminal loss after DES implantation for long coronary lesions. This may be associated with significant improvements in exercise capacity and overall risk profile.

  13. 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 Antiplatelet Therapy Study [DAPT study]; NCT00977938). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  14. Point-of-care platelet function assays demonstrate reduced responsiveness to clopidogrel, but not aspirin, in patients with Drug-Eluting Stent Thrombosis whilst on dual antiplatelet therapy

    Directory of Open Access Journals (Sweden)

    Dawkins Keith D

    2008-02-01

    Full Text Available Abstract Background To test the hypothesis that point-of-care assays of platelet reactivity would demonstrate reduced response to antiplatelet therapy in patients who experienced Drug Eluting Stent (DES ST whilst on dual antiplatelet therapy compared to matched DES controls. Whilst the aetiology of stent thrombosis (ST is multifactorial there is increasing evidence from laboratory-based assays that hyporesponsiveness to antiplatelet therapy is a factor in some cases. Methods From 3004 PCI patients, seven survivors of DES ST whilst on dual antiplatelet therapy were identified and each matched with two patients without ST. Analysis was performed using (a short Thrombelastogram PlateletMapping™ (TEG and (b VerifyNow Aspirin and P2Y12 assays. TEG analysis was performed using the Area Under the Curve at 15 minutes (AUC15 as previously described. Results There were no differences in responses to aspirin. There was significantly greater platelet reactivity on clopidogrel in the ST group using the Accumetrics P2Y12 assay (183 ± 51 vs. 108 ± 31, p = 0.02 and a trend towards greater reactivity using TEG AUC15 (910 ± 328 vs. 618 ± 129, p = 0.07. 57% of the ST group by TEG and 43% of the ST cases by Accumetrics PRU had results > two standard deviations above the expected mean in the control group. Conclusion This study demonstrates reduced platelet response to clopidogrel in some patients with DES ST compared to matched controls. The availability of point-of-care assays that can detect these responses raises the possibility of prospectively identifying DES patients at risk of ST and manipulating their subsequent risk.

  15. Clinical outcomes of biodegradable polymer drug-eluting stents for percutaneous coronary intervention: an updated meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Kwong, Joey S W; Yu, Cheuk-Man

    2014-07-01

    Biodegradable polymer drug-eluting stents (DES) are innovative concepts in the era of percutaneous coronary intervention. We systematically reviewed the latest randomized evidence on the efficacy and safety of biodegradable polymer DES as compared to durable polymer DES. MEDLINE, Embase, and the Cochrane database were searched in August 2013 for eligible randomized controlled trials (RCTs) comparing biodegradable polymer DES with durable polymer DES. Clinical outcomes of interest were mortality, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis. A total of 20 RCTs randomizing 20 021 participants were included, of whom 11 045 were allocated to biodegradable polymer DES and 8976 to durable polymer DES. Treatment of biodegradable polymer DES was not associated with a significant reduction of any of the clinical outcomes (all-cause mortality, odds ratio [OR]: 0.94, 95% confidence interval [CI]: 0.80 to 1.10, P = 0.42; cardiovascular mortality, OR: 0.97, 95% CI: 0.79 to 1.19, P = 0.74; MI, OR: 1.07, 95% CI: 0.91 to 1.26, P = 0.41; TLR, OR: 0.87, 95% CI: 0.69 to 1.08, P = 0.20; TVR, OR: 1.05, 95% CI: 0.85 to 1.28, P = 0.67; definite/probable stent thrombosis, OR: 0.80, 95% CI: 0.59 to 1.07, P = 0.14). Current randomized data indicate that clinical efficacy and safety profiles of biodegradable polymer DES are comparable to those of durable polymer DES. Findings from large-scale studies with rigorous methodology and long follow-up duration are needed.

  16. Polymer-free versus permanent polymer drug eluting stents in coronary artery disease: A meta-analysis of 10 RCTs with 6575 patients

    Institute of Scientific and Technical Information of China (English)

    De-Wei Wu; Meng-Yue Yu; Hai-Yang Gao; Li Zhang; Fei Song; Xin-Yue Zhang; Yong-Jian Wu

    2015-01-01

    Background:Permanent polymer drug eluting stents (PP-DES) may induce inflammation of the vessel wall due to the existence of the polymer,which may delay intimal healing.Polymer-free DES (PF-DES) that eliminate the polymeric carrier may potentially lead to safer DES.However,the safety and efficacy of PF-DES remains controversial.Methods:Randomized controlled trials comparing PF-DES with PP-DES were searched in online database including MEDLINE,Excerpta Medica Database (EMBASE) and Cochrane Library.Studies reporting late lumen loss (LLL),all-cause death,myocardial infarction (MI),target lesion revascularization (TLR) and late stent thrombosis (LST) were enrolled and quantitatively analyzed.Results:Ten studies enrolling 6575 patients were included in this meta-analysis.The PF-DES showed a benefit in reducing all-cause death (OR =0.77,95% CI:0.61 to 0.98,P =0.03) and long-term LLL (weighted mean difference (WMD)-0.16 mm,95% CI:-0.22 to -0.11 mm,P < 0.001),while no superiority was found in reducing short-term LLL (WMD 0.03 mm,95% CI:-0.07-0.13 mm,P =0.57),MI (OR =1.12,95% CI:0.19 to 23.18,P=0.39),TLR (OR =1.19,95% CI:0.42 to 3.38,P=0.83)and LST (OR =0.92,95%CI:0.05 to 5.71,P =0.74).Conclusion:PF-DES showed benefits in reducing long-term LLL and mortality compared with PP-DES,but no superiority was found in short-term LLL,MI,TLR and LST.These findings provide a sound basis for the wide application of PF-DES in the future.

  17. Meta-analysis of randomized controlled trials on efficacy and safety of extended thienopyridine therapy after drug-eluting stent implantation

    Science.gov (United States)

    Tang, Wenyi; Yeh, James; Chen, Jian; Liu, Mao; Ke, Jianting; Tan, Guangyi; Lin, Xiufang

    2016-01-01

    Background The potential benefits and risks of extended thienopyridine therapy beyond 12 months after drug-eluting stent (DES) implantation remain unclear. Methods Randomized controlled trials (RCTs) were searched in PubMed, EMBASE, the Cochrane Library and China National Knowledge Infrastructure databases. The adverse clinical endpoints were compared between 12 months group (aspirin alone) and >12 months group (additional thienopyridine plus aspirin after 12-month dual antiplatelet therapy). Odds ratios (ORs) with 95% confidence intervals (95% CIs) were used as summary statistics. A random-effect model was used in the meta-analysis process. Results Finally, three RCTs incorporating 16,265 participants were included in this meta-analysis. The results indicated that the incidences of myocardial infarction (1.55% vs. 2.90%; OR =0.58; 95% CI, 0.40–0.84; P=0.004) and stent thrombosis (0.32% vs. 0.98%; OR =0.35; 95% CI, 0.20–0.62; P12 months group were significantly lower than the 12 months group. However, compared to the 12 months group, the extended thienopyridine therapy markedly increased the risk of bleeding events (2.09% vs. 1.28%; OR =1.64; 95% CI, 1.23–2.17; P<0.001). The risks of stroke (0.78% vs. 0.84%; P=0.67) and cardiac death (0.94% vs. 0.89%; P=0.61) were similar between the two groups. Conclusions The synthesis of available evidence indicates that a regimen of extended thienopyridine therapy beyond 12 months may significantly reduce the risks of myocardial infarction and stent thrombosis but increase the risk of bleeding events in the patients who have received DESs implantation. PMID:27747163

  18. 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.

  19. 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.)

  20. Temporal variability in the antiplatelet effects of clopidogrel and aspirin after elective drug-eluting stent implantation. An ADAPT-DES substudy.

    Science.gov (United States)

    Nührenberg, Thomas G; Stratz, Christian; Leggewie, Stefan; Hochholzer, Willibald; Valina, Christian M; Gick, Michael; Kirtane, Ajay J; Stone, Gregg W; Neumann, Franz-Josef; Trenk, Dietmar

    2015-11-01

    Given conflicting data on temporal variability in pharmacodynamic platelet responses to clopidogrel, we investigated platelet reactivity on clopidogrel and aspirin for up to six months after elective percutaneous coronary intervention (PCI) with drug-eluting stents. Platelet reactivity was determined in 102 patients before loading with clopidogrel and aspirin, and on maintenance therapy after PCI on day 1, at one month and six months by VerifyNow™ P2Y12 and Aspirin assays and by residual platelet aggregation (RPA) on light transmission aggregometry using adenosine diphosphate and arachidonic acid. By VerifyNow testing, median (interquartile range) P2Y12 reaction units (PRU) on clopidogrel were 166 (90-234), 195 (124-257), and 198 (141-252) on day 1, one month and six months after PCI, respectively (p=0.005 day 1 to 1 month, and p=0.86 1 month to 6 months). Using a cut-off of > 208 PRU, 35 % of patients had high platelet reactivity (HPR) to clopidogrel on day 1, 43 % at one month, and 46 % at six months after PCI. Between day 1 and six months after PCI, 38.2 % of patients changed clopidogrel responder status at least once. Other cut-offs and RPA yielded similar results. Platelet inhibition by aspirin was consistent over time with only five patients being characterised as having HPR. Considerable variation in individual on-clopidogrel platelet reactivity was present during both the subacute and the late phases of maintenance therapy after elective PCI. Hence, the utility of contemporary platelet function testing to guide antiplatelet therapy may be limited.

  1. Association of morphologic characteristics on optical coherence tomography and angiographic progression patterns of late restenosis after drug-eluting stent implantation

    Energy Technology Data Exchange (ETDEWEB)

    Yamaguchi, Hiroshi, E-mail: yhclinic@po5.synapse.ne.jp [Division of Cardiology, Tenyoukai Central Hospital, Izumi-cho, Kagoshima city, Kagoshima (Japan); Arikawa, Ryo; 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); Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe (Japan)

    2015-01-15

    Objectives: To gain insight into the pathophysiology of late drug-eluting stent (DES) restenosis. Background: Restenosis of DES has a different time course from that of bare metal stents. Methods: Patients who underwent follow-up coronary angiography (CAG) twice (six to nine months and 18 to 24 months) after DES implantation were examined using optical coherence tomography (OCT). All lesions with target lesion revascularization at first follow-up were excluded. Late catch-up was defined as lesions that progressed from less than 50% diameter stenosis (DS) at the first CAG to more than 50% DS at the second CAG. Lesions with the late catch-up were further divided into two groups; lesions with jump-up (less than 25% DS at the first CAG) and lesions with gradual progression (25–50% DS at the first CAG). Results: Of the 25 patients who had late ISR, 23 patients (10 jump-up/13 gradual progression) were examined with OCT at late follow-up and enrolled in this study. In the qualitative OCT assessment, each ratio of homogeneous, layered, heterogeneous with or without attenuation tissue morphologies were in jump-up group, and gradual progression group were 0% and 15%, 0% and 23%, and 60% and 8%, and 40% and 54%, respectively. All of jump-up group showed heterogeneous restenotic tissue, while 62% of gradual progression group showed heterogeneous restenotic tissue (P = .04). Conclusions: These findings suggest different pathophysiology of the late catch-up after DES implantation between the jump-up and gradual progression groups.

  2. Change in enrollment patterns, patient selection, and clinical outcomes with the availability of drug-eluting stents in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial

    Science.gov (United States)

    Shah, Binita; Srinivas, Vankeepuram S.; Lu, Jiang; Brooks, Maria M.; Bates, Eric R.; Nedeljkovic, Zoran S.; Escobedo, Jorge; Das, Gladwin S.; Lopez, John J.; Feit, Frederick

    2013-01-01

    Background In the BARI 2D trial, patients with type 2 diabetes and stable coronary artery disease were randomized to prompt revascularization versus intensive medical therapy (IMT). This analysis sought to evaluate how the availability of drug-eluting stents (DESs) has changed practice and outcomes. Methods In BARI 2D, 1,605 patients were in the percutaneous coronary intervention (PCI)–intended stratum. As DES became available midway through recruitment, we report clinical outcomes among patients who underwent IMT versus prompt PCI with bare-metal stents (BMSs) or DES up to 4 years. Results In North America, after DES became available, selection for the PCI-intended stratum increased from 73% to 79% (P = .003). Fewer BMS than DES patients had total occlusions treated or underwent rotational atherectomy (5.6% vs 9.7%, P = .02, and 1.2% vs 3.7%, P < .01, respectively). Subsequent revascularization (IMT 39%, BMS 29%, DES 21%, P < .01) and target vessel revascularization (BMS 16.1% vs DES 9.6%, P = .03) were lower with DES. Angina at 2 years tended to be less common with DES (IMT 39%, BMS 37%, DES 29%, P = .04, for 3 groups, P = .07 for DES vs BMS). The composite of death, myocardial infarction, or stroke was IMT 16.0%, BMS 20.5%, DES 17.5%; P = .80. Conclusions When DES became available in North America, patients were more likely to be selected into the PCI-intended stratum. Compared with patients receiving BMS, those receiving DES tended to have less target vessel revascularization and angina. PMID:24016502

  3. Three-year follow-up of patients with bifurcation lesions treated with sirolimus- or everolimus-eluting stents: SEAside and CORpal cooperative study.

    Science.gov (United States)

    Pan, Manuel; Burzotta, Francesco; Trani, Carlo; Medina, Alfonso; Suárez de Lezo, Jose; Niccoli, Giampaolo; Romero, Miguel; Porto, Italo; Mazuelos, Francisco; Leone, Antonio Maria; Martín, Pedro; Coluccia, Valentina; Suárez de Lezo, Javier; Ojeda, Soledad; Crea, Filippo

    2014-10-01

    To compare the 3-year incidence of major events in patients with bifurcation lesions treated with provisional sirolimus-eluting stents vs everolimus-eluting stents. A pooled analysis of 2 prospective randomized trials with similar methodology (SEAside and CORpal) was performed. In these trials, 443 patients with bifurcation lesions were randomly assigned to treatment with either sirolimus-eluting stents or everolimus-eluting stents. The clinical follow-up was extended up to 3 years to assess major adverse cardiovascular events (death or acute myocardial infarction or target vessel revascularization). At 3 years, survival free of major adverse cardiovascular events was 93.2% vs 91.3% in the everolimus-eluting stent group vs the sirolimus-eluting stent group (P = .16). Exploratory land-mark analysis for late events (occurring after 12 months) showed significantly fewer major adverse cardiovascular events in the everolimus-eluting stent group: 1.4% vs 5.4% in the sirolimus-eluting stent group (P = .02). Provisional stenting with either sirolimus-eluting stents or everolimus-eluting stents in bifurcation lesions is associated with low rates of major adverse events at 3-years' follow-up. The results of a subanalysis of events beyond 1 year, showing a lower event rate with everolimus-eluting stents than with sirolimus-eluting stents, suggest that studies exploring the long-term clinical benefit of the latest generation of drug-eluting stents are warranted. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  4. Comparison of the incidence of late stent thrombosis after implantation of different drug-eluting stents in the real world coronary heart disease patients: three-year follow-up results

    Institute of Scientific and Technical Information of China (English)

    CHEN Ji-lin; LIU Hai-bo; WU Yong-jian; YUAN Jin-qing; CHEN Jue; YOU Shi-jie; DAI Jun; GAO Run-lin; GAO Li-jian; YANG Yue-jin; LI Jian-jun; QIAO Shu-bin; XU Bo; HUANG Jing-han; YAO Min; QIN Xue-wen

    2010-01-01

    Background Late stent thrombosis (LST) is still concerned by interventions cardiologists in daily clinical practice. This study aimed to compare the incidence of LST after implantation of different drug-eluting stents (DES) in coronary heart disease (CHD) patients in the real world.Methods From December 2001 to February 2009, a total of 11 875 consecutive CHD patients undergone DES implantation were enrolled in this single-center registery study. Patients with acute ST-segment elevation myocardial infarction, mixed DES implantation, restenosis lesions, and patients who could not take dual antiplatlet medication and those who were contraindicated for coronary interventional treatment were excluded. All patients were treated with completed dual antiplatelet medications for at least 9 months after DES deployment. The follow-up was completed by outpatient visits, letter correspondence, phone calls and coronary angiography. Definite LST was diagnosed auording to the Academic Research Consortium (ARC) definition.Results Cypher or Cypher Select stents were implanted in 4104 cases, Taxus or Taxus Liberty stents in 2271 cases and Firebird stents (Chinese rapamycin-eluting stents) in 5500 cases. One-year follow-up was completed in 9693 patients, including 3346 cases with Cypher or Cypher Select stents, 1529 cases with Taxus or Taxus Liberty stents and 4818 cases with Firebird stents. Two- and three-year follow-up results were obtained in 7133 and 4353 patients, respectively, including 2410 and 1760 cases with Cypher or Cypher Select stents, 1285 and 900 cases with Taxus or Taxus Liberty stents as well as 3438 and 1693 cases with Firebird stents. One-year follow-up results showed that the incidence of LST was 1.08% in patients with Cypher or Cypher Select stents, 1.24% in those with Taxus or Taxus Liberty stents and 0.71% in those with Firebird stents; there was no significant difference between those with Cypher or Cypher Select and Firebird stents, but there was significant

  5. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial.

    Science.gov (United States)

    Kandzari, David E; Mauri, Laura; Koolen, Jacques J; Massaro, Joseph M; Doros, Gheorghe; Garcia-Garcia, Hector M; Bennett, Johan; Roguin, Ariel; Gharib, Elie G; Cutlip, Donald E; Waksman, Ron

    2017-08-25

    427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI -6·84 to -0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency -2·6% [95% credible interval -5·5 to 0·1], non-inferiority margin 3·85%, n=2208). The outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology. BIOTRONIK. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. Evaluation of neointimal coverage in patients with coronary artery aneurysm formation after drug-eluting stent implantation by optical coherence tomography

    Institute of Scientific and Technical Information of China (English)

    TIAN Feng; CHEN Yun-dai; CHEN Lian; SUN Zhi-jun; GUO Jun; JIN Qin-hua; LIU Chang-fu

    2013-01-01

    Background The vessel healing in patients with coronary artery aneurysms (CAA) that form after drug-eluting stent (DES) implantation is not clear.This study aims to assess the vessel healing in patients with CAA formation after DES implanation.Methods From June 2008 to August 2011,follow-up coronary angiography was conducted on 1160 patients who underwent percutaneous coronary intervention (PCI).The average period of follow-up was about (18.95+13.05) months.A total of 175 patients who underwent DES implantation into de novo lesions and who underwent coronary angiography and optical coherence tomography (OCT) examination during follow-up were identified.Patients were divided into the CAA group (n=31) and non-CAA group (n=144) based on the results of the coronary angiography.The cardiac events including angina and acute myocardial infarction were noted; in addition,the neointimal thickness and the frequency of strut malapposition and strut uncoverage were also noted.Results A greater proportion of incomplete neointimal coverage (17.17% vs.1.90%,P <0.001) and strut malapposition (18.20% vs.1.38%,P <0.001) were observed in the CAA group.The neointimal thickness in the CAA group was significantly thinner than that in the non-CAA group ((146.6+94.8) μm vs.(192.5+97.1) μm,P <0.001),as detected via OCT.Patients with CAA formation had a higher frequency of cardiac events including angina pectoris (25.81% vs.6.25%,P=0.001) and acute myocardial infarction (9.68% vs.0.13%,P=0.002) and thrombosis (16.13% vs.0.69%,P <0.001).The longitudinal length of the CAA in the cardiac event group was significantly longer than in the no cardiac event group ((20.0+9.07) mm vs.(12.05+5.38) mm,P=-0.005).Conclusion CAA formation after DES implantation is frequently associated with cardiac events as a result of stent malapposition and incomplete neointimal coverage.

  7. Favorable effect of optimal lipid-lowering therapy on neointimal tissue characteristics after drug-eluting stent implantation: qualitative optical coherence tomographic analysis.

    Science.gov (United States)

    Jang, Ji-Yong; Kim, Jung-Sun; Shin, Dong-Ho; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

    2015-10-01

    Serial follow-up optical coherence tomography (OCT) was used to evaluate the effect of optimal lipid-lowering therapy on qualitative changes in neointimal tissue characteristics after drug-eluting stent (DES) implantation. DES-treated patients (n = 218) who received statin therapy were examined with serial follow-up OCT. First and second follow-up OCT evaluations were performed approximately 6 and 18 months after the index procedure, respectively. Patients were divided into two groups, based on the level of low-density lipoprotein-cholesterol (LDL-C), which was measured at the second follow-up. The optimal lipid-lowering group (n = 121) had an LDL-C reduction of ≥50% or an LDL-C level ≤70 mg/dL, and the conventional group (n = 97). Neointimal characteristics were qualitatively categorized as homogeneous or non-homogeneous patterns using OCT. The non-homogeneous group included heterogeneous, layered, or neoatherosclerosis patterns. Qualitative changes in neointimal tissue characteristics between the first and second follow-up OCT examinations were assessed. Between the first and second follow-up OCT procedures, the neointimal cross-sectional area increased more substantially in the conventional group (0.4 mm(2) vs. 0.2 mm(2) in the optimal lipid-lowering group, p = 0.01). The neointimal pattern changed from homogeneous to non-homogeneous less often in the optimal lipid-lowering group (1.3%, 1/77, p < 0.001) than in the conventional group (15.3%, 11/72, p = 0.44). Optimal LDL-C reduction was an independent predictor for the prevention of neointimal pattern change from homogeneous to non-homogeneous (odds ratio: 0.05, 95% confidence interval: 0.01∼0.46, p = 0.008). Our findings suggest that an intensive reduction in LDL-C levels can prevent non-homogeneous changes in the neointima and increases in neointimal cross-sectional area compared with conventional LDL-C controls. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  8. Socioeconomic Inequalities in Quality of Care and Outcomes Among Patients With Acute Coronary Syndrome in the Modern Era of Drug Eluting Stents

    Science.gov (United States)

    Yong, Celina M.; Abnousi, Freddy; Asch, Steven M.; Heidenreich, Paul A.

    2014-01-01

    Background The rapidly changing landscape of percutaneous coronary intervention provides a unique model for examining disparities over time. Previous studies have not examined socioeconomic inequalities in the current era of drug eluting stents (DES). Methods and Results We analyzed 835 070 hospitalizations for acute coronary syndrome (ACS) from the Healthcare Cost and Utilization Project across all insurance types from 2008 to 2011, examining whether quality of care and outcomes for patients with ACS differed by income (based on zip code of residence) with adjustment for patient characteristics and clustering by hospital. We found that lower‐income patients were less likely to receive an angiogram within 24 hours of a ST elevation myocardial infarction (STEMI) (69.5% for IQ1 versus 73.7% for IQ4, P<0.0001, OR 0.79 [0.68 to 0.91]) or within 48 hours of a Non‐STEMI (47.6% for IQ1 versus 51.8% for IQ4, P<0.0001, OR 0.86 [0.75 to 0.99]). Lower income was associated with less use of a DES (64.7% for IQ1 versus 71.2% for IQ4, P<0.0001, OR 0.83 [0.74 to 0.93]). However, no differences were found for coronary artery bypass surgery. Among STEMI patients, lower‐income patients also had slightly increased adjusted mortality rates (10.8% for IQ1 versus 9.4% for IQ4, P<0.0001, OR 1.17 [1.11 to 1.25]). After further adjusting for time to reperfusion among STEMI patients, mortality differences across income groups decreased. Conclusions For the most well accepted procedural treatments for ACS, income inequalities have faded. However, such inequalities have persisted for DES use, a relatively expensive and until recently, controversial revascularization procedure. Differences in mortality are significantly associated with differences in time to primary PCI, suggesting an important target for understanding why these inequalities persist. PMID:25398888

  9. Short- versus standard-term dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stent implantation: A meta-analysis.

    Science.gov (United States)

    Basaraba, Jade E; Barry, Arden R

    2017-01-01

    Twelve months of dual antiplatelet therapy (DAPT) is recommended after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. However, certain clinical scenarios may require premature discontinuation of therapy (e.g. urgent surgical procedure, major bleeding). The objective of this systematic review and meta-analysis was to investigate clinically relevant outcomes associated with a shorter duration of DAPT after PCI with DES implantation. A systematic search of Medline and Embase (inception to December 2015) was conducted. Included were randomized controlled trials that compared 6 months (or less) of DAPT (defined as acetylsalicylic acid 75-200mg daily and a P2Y12 inhibitor) to the standard of 12 months. Outcomes of interest included death (all-cause and cardiac), myocardial infarction (MI), definite/probable stent thrombosis, and bleeding (major and overall). An odds ratio (OR) and 95% confidence interval (CI) were calculated for each outcome using a random effects model. Six trials (five open-label, one double-blind) were included (N=13,900). Four studies investigated 6 months of DAPT, and two studies investigated 3 months. Median follow-up was 12 months. There was no statistically significantly difference between groups regarding all-cause death (OR 0.88, 95% CI 0.64-1.20), cardiac death (OR 1.00, 95% CI 0.64-1.55), MI (OR 1.16, 95% CI 0.87-1.56), and stent thrombosis (OR 1.22, 95% CI 0.70-2.15). Both major and any bleeding were significantly decreased with shorter-term DAPT (OR 0.58, 95% CI 0.34-0.98, and OR 0.62, 95% CI 0.47-0.81, respectively). Shorter duration (3-6 months) of DAPT, as compared to 12 months, was not associated with a higher risk of death, MI, or stent thrombosis, but a lower rate of major and overall bleeding. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  10. 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

  11. Impact of biodegradable versus durable polymer drug-eluting stents on clinical outcomes in patients with coronary artery disease: a meta-analysis of 15 randomized trials

    Institute of Scientific and Technical Information of China (English)

    Zhang Yaojun; Tian Nailiang; Dong Shengjie; Ye Fei; Li Minghui; Christos V.Bourantas; Javaid Iqbal

    2014-01-01

    Background Drug eluting stents (DESs) made with biodegradable polymer have been developed in an attempt to improve clinical outcomes.However,the impact of biodegradable polymers on clinical events and stent thrombosis (ST) remains controversial.Methods We searched Medline,the Cochrane Library and other internet sources,without language or date restrictions for articles comparing clinical outcomes between biodegradable polymer DES and durable polymer DES.Safety endpoints were ST (definite,definite/probable),mortality,and myocardial infarction (MI).Efficacy endpoints were major adverse cardiac event (MACE) and target lesion revascularization (TLR).Results We identified 15 randomized controlled trials (n=17 068) with a weighted mean follow-up of 20.6 months.There was no statistical difference in the incidence of definite/probable ST between durable polymer-and biodegradable polymerDES; relative risk (RR) 0.83; 95% confidence interval (CI) 0.62-1.11; P=0.22.Biodegradable polymer DES had similar rates of definite ST (RR 0.94,95% CI 0.66-1.33,P=0.72),mortality (RR 0.94,95% C/0.82-1.09,P=0.43),MI (RR 1.08,95% CI 0.92-1.26.P=0.35),MACE (RR 0.99,95% CI 0.91-1.09,P=0.85),and TLR (RR,0.94,95% CI 0.83-1.06,P=0.30) compared with durable polymer DES.Based on the stratified analysis of the included trials,the treatment effect on definite ST was different at different follow-up times:≤1 year favoring durable polymer DES and >1 year favoring biodegradable polymer DES.Conclusions Biodegradable polymer DES has similar safety and efficacy for treating patients with coronary artery disease compared with durable polymer DES.Further data with longer term follow-up are warranted to confirm the potential benefits of biodegradable polymer DES.

  12. Impact of admission creatinine level on clinical outcomes of patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention with drug-eluting stent implantation

    Institute of Scientific and Technical Information of China (English)

    ZHANG Qi; ZHANG Rui-yan; SHEN Jie; ZHANG Jian-sheng; HU Jian; YANG Zheng-kun; ZHANG Xian; ZHENG Ai-fang; SHEN Wei-feng

    2008-01-01

    Background Prognosis of patients with acute ST-elevation myocardial infarction (STEMI) and renal dysfunction (RD) who received primary percutaneous coronary intervention (PCI) has not been fully investigated in the drug-eluting stent (DES) era.This study aimed to evaluate the impact of admission serum creatinine level on short-term outcomes in patients with acute STEMI undergoing DES-based primary PCI.Methods Primary PCI with DES implantation was attempted in 619 consecutive STEMI patients within 12 hours of symptom onset.Among them,86 patients had a serum creatinine level >115 μmol/L on admission (RD group),and the remaining 533 patients had normal renal function (non-RD group).The primary endpoint was 30-day major adverse cardiac events (MACE,including death,non-fatal reinfarction,and target vessel revascularization),and the secondary endpoint was subacute stent thrombosis.Results Patients in the RD group were older than those in the non-RD group.There are more female patients in the RD group and they had a history of hypertension,myocardial infarction and revascularization.The occurrence rates of Killip class ≥2 (29.1% vs 18.6%,P=0.02) and multi-vessel (62.8% vs 44.5%,P=0.001) and triple vessel disease (32.6% vs 18.2%,P=0.002),in-hospital mortality (9.3% vs 3.8%,P=0.03),and MACE rate during hospitalization (17.4% vs 7.7%,P=0.006) were higher in the RD group than those in the non-RD group.At a 30-day clinical follow-up,the MACE-free survival rate was significantly reduced in the RD group (76.7% vs 89.9%,P=0.0003).Angiographic stent thrombosis occurred in 3 (3.5%) and 7 (1.3%) of patients in the RD group and non-RD group,respectively (P=0.15).Multivariate analysis revealed that the serum creatinine level≥115 μmol/L on admission was an independent predictor for MACE rate at a 30-day follow-up (Hazard ratio (HR) 3.31,95% CI 1.19-9.18,P<0.001).Conclusion Despite similar prevalence of stent thrombosis at a 30-day clinical follow-up,the short-term prognosis of

  13. A high maintenance dose of clopidogrel improves short-term clinical outcomes in patients with acute coronary syndrome undergoing drug-eluting stent implantation

    Institute of Scientific and Technical Information of China (English)

    HAN Ya-ling; WANG Bin; LI Yi; XU Kai; WANG Shou-li; JING Quan-min; WANG Zu-lu; WANG Dong-mei; MA Ying-yan; WANG Geng

    2009-01-01

    Background Recurrent ischemic events occurred even during routine use of 75 mg clopidogrel in addition to aspirin,that indicated a potentially insufficient maintenance dosage of clopidogrel.The aim of the present study was to evaluate the short-term efficacy and safety of a 150 mg maintenance dose of clopidogrel following a 600 mg loading dose in patients with an acute coronary syndrome (ACS) undergoing drug eluting stent (DES) implantation.Methods Between November 2005 and November 2006,a total of 813 consecutive ACS patients undergoing DES implantation were enrolled.A 600 mg loading dose was administered before percutaneous coronary intervention (PCI) nd patients were randomized to receive clopidogrel 75 mg or 150 mg for 30 days in addition to 300 mg aspidn daily.Primary end points were the composite of cardiac death,non-fatal myocardial infarction (MI) and urgent target vessel revascularization (UTVR).Secondary end points included stent thrombosis (ST),major and minor bleeding events at 30days.Results At a follow-up period of 30 days,4 (1.0%) patients in the 150 mg group and 9 (2.2%) patients in the 75 mg group (P >0.05) reached the primary end points.There was no significant difference in the incidences of MI (0.5% vs1.2%,P >0.05),UTVR (0.7% vs 2.0%,P >0.05),and cardiac death (0.2% vs 0.2%,P >0.05) between the two groups.The incidence of ST (0 vs 1.5%,P <0.05) was significantly lower in the 150 mg group than that in the 75 mg group.There were no significant differences between both groups regarding the risk of major (0.2% vs 0,P >0.05) or minor (0.5% vs 0.2%,P >0.05) bleedings.Conclusion A high clopidogrel maintenance dose of 150 mg daily following a 600 mg loading dose for the first month after PCI procedure reduces the risk of ST and appears to be safe in patients with ACS undergoing DES implantation.

  14. Ultrasonic atomization and subsequent desolvation for monoclonal antibody (mAb) to the glycoprotein (GP) IIIa receptor into drug eluting stent.

    Science.gov (United States)

    Wang, G X; Luo, L L; Yin, T Y; Li, Y; Jiang, T; Ruan, C G; Guidoin, R; Chen, Y P; Guzman, R

    2010-01-01

    An eluting-stent system with mAb dispersed in the PLLA (poly (L-lactic acid)) was validated in vitro. Specifically designed spray equipment based on the principle of ultrasonic atomization was used to produce a thin continuous PLLA (poly (L-lactic acid)) polymer coating incorporating monoclonal antibody (mAb). This PLLA coating was observed in light microscopy (LM) and scanning electron microscopy (SEM). The concentration of the monoclonal antibody (mAb) to the platelet glycoprotein (GP) IIIa receptor and the eluting rate were then measured by a radioisotope technique with (125)I-labelled GP IIIa mAb. An in vitro perfusion circuit was designed to evaluate the release rates at different velocities (10 or 20 ml min(-1)). The PLLA coating was thin and transparent, uniformly distributed on the surface of the stent. Three factors influenced its thickness: PLLA concentration, duration and gas pressure. The concentration of mAb was influenced by the duration of absorption and the concentration of the mAb solution; the maximum was 1662.23 + or - 38.83 ng. The eluting rate was fast for the first 2 h, then decreased slowly and attained 80% after 2 weeks. This ultrasonic atomization spray equipment and technological process to prepare protein eluting-stents were proved to be effective and reliable.

  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. 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.

  17. 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.

  18. 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.

    Science.gov (United States)

    Lai, Chao-Lun; Wu, Ching-Fen; Kuo, Raymond Nien-Chen; Yang, Yen-Yun; Chen, Ming-Fong; Chan, K Arnold; Lai, Mei-Shu

    2015-01-01

    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.

  19. Progress with Drug-Eluting Stent Technology from Early to New Generation Devices : A comprehensive clinical and intravascular imaging evaluation

    NARCIS (Netherlands)

    L. Räber (Lorenz)

    2014-01-01

    markdownabstract__Abstract__ Percutaneous coronary interventions (PCI) are among the most frequently performed medical interventions worldwide reflecting the large burden of coronary atherosclerosis. Bare metal stents were associated with a high rate of repeat revascularization due to clinical

  20. Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial.

    Science.gov (United States)

    Raungaard, Bent; Jensen, Lisette Okkels; Tilsted, Hans-Henrik; Christiansen, Evald Høj; Maeng, Michael; Terkelsen, Christian Juhl; Krusell, Lars Romer; Kaltoft, Anne; Kristensen, Steen Dalby; Bøtker, Hans Erik; Thuesen, Leif; Aarøe, Jens; Jensen, Svend Eggert; Villadsen, Anton Boel; Thayssen, Per; Veien, Karsten Tange; Hansen, Knud Nørregaard; Junker, Anders; Madsen, Morten; Ravkilde, Jan; Lassen, Jens Flensted

    2015-04-18

    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. This open-label, randomised, multicentre, non-inferiority trial was done at three sites across western Denmark. All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion (more than 50% stenosis) from March, 2011, to August, 2012, were assessed for eligibility. Patients were randomly assigned in a 1:1 ratio to receive either the durable-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. The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of 0·025. This trial is registered with ClinicalTrials.gov, number NCT01956448. Of 7103 screened, 1502 patients with 1883 lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and 1497 patients with 1791 lesions to receive the biodegradable-polymer biolimus-eluting stent. 79 (5·3%) and 75 (5·0%) patients, respectively, met the primary endpoint (absolute risk difference 0·0025, upper limit of one-sided 95% CI 0·016%; p=0·004). The individual components of the primary endpoint did not differ significantly between stent types at 12 months. The durable

  1. Third Generation Sequencing Techniques and Applications to Drug Discovery

    Science.gov (United States)

    Ozsolak, Fatih

    2012-01-01

    Introduction There is an immediate need for functional and molecular studies to decipher differences between disease and “normal” settings to identify large quantities of validated targets with the highest therapeutic utilities. Furthermore, drug mechanism of action and biomarkers to predict drug efficacy and safety need to be identified for effective design of clinical trials, decreasing attrition rates, regulatory agency approval process and drug repositioning. By expanding the power of genetics and pharmacogenetics studies, next generation nucleic acid sequencing technologies have started to play an important role in all stages of drug discovery. Areas covered This article reviews the first and second generation sequencing technologies (SGSTs) and challenges they pose to biomedicine. The article then focuses on the emerging third generation sequencing technologies (TGSTs), their technological foundations and potential contributions to drug discovery. Expert Opinion Despite the scientific and commercial success of SGSTs, the goal of rapid, comprehensive and unbiased sequencing of nucleic acids has not been achieved. TGSTs promise to increase sequencing throughput and read lengths, decrease costs, run times and error rates, eliminate biases inherent in SGSTs, and offer capabilities beyond nucleic acid sequencing. Such changes will have positive impact in all sequencing applications to drug discovery. PMID:22468954

  2. Análise de impacto do stent farmacológico no orçamento do sistema único de saúde Impact analysis of drug-eluting stent in the unified health system budget

    Directory of Open Access Journals (Sweden)

    Denizar Vianna Araújo

    2007-04-01

    Full Text Available FUNDAMENTO: Stents farmacológicos representam opção adicional para o tratamento da doença arterial coronariana. Essa tecnologia representa importante inovação, para a qual pode ser necessário financiamento adicional, no curto prazo, para permitir incorporação no Sistema Único de Saúde brasileiro. OBJETIVOS: Estimar o impacto da incorporação do stent farmacológico no orçamento do Sistema Único de Saúde, no primeiro ano de utilização. MÉTODOS: Foi elaborado um modelo de impacto no orçamento para prever o impacto econômico da incorporação dos stents farmacológicos no orçamento do Sistema Único de Saúde. Foram coletados dados de custo e procedimentos locais de várias fontes, mais especificamente: dados de volume de procedimentos, custos hospitalares, custos dos stents, custos de medicamentos e número de stents utilizados por procedimentos uni e multivasculares. RESULTADOS: Os resultados no primeiro ano indicam que o impacto no Sistema Único de Saúde é de 12,8% no cenário conservador e de 24,4% no pior cenário, representando aumento de R$ 24 milhões a R$ 44 milhões no orçamento total projetado. CONCLUSÃO: O uso de stent farmacológico tem custo adicional comparativamente ao uso de stent convencional, no primeiro ano de utilização, no Sistema Único de Saúde.BACKGROUND: Drug-eluting stents represent an additional option to treat coronary artery disease. This technology represents a major breakthrough that may require additional funding in the short-term to enable its inclusion in procedures of the Unified Health System. OBJECTIVE: To estimate the impact on the Unified Health System budget in the first year of use of drug-eluting stents. METHODS: A Budget Impact Model was designed to predict the economic impact of the inclusion of drug-eluting stents in the Unified Health System budget. Data about costs and local procedures were collected in multiple sources, specifically procedure volume data, hospital costs

  3. Study on tacrolimus-loaded poly(1,3-trimethylene carbonate) as drug-eluting stent coating%他克莫司-聚三亚甲基碳酸酯药物洗脱支架涂层研究

    Institute of Scientific and Technical Information of China (English)

    吴雷刚; 吴婧; 侯瑞霞; 王进; 黄楠

    2011-01-01

    One kind of tacrolimus eluting stent coated with biodegradable poly(1,3-trimethylene carbonate)(PTMC) was developed.The results of Fourier transform infrared spectroscopy(FT-IR) and X-ray diffraction(XRD) analysis proved the chemical stability of tacrolimus loaded in PTMC matrix.Stent coating were examined by scanning electron microscopy(SEM),indicating that the coating not only was very smooth and uniform but also had the ability to withstand the compressive and tensile strains.In vitro drug release of tacrolimus-eluting stents was similar to the Weibull's release mode.The result of in vitro platelets adhesion and human umbilical cord artery smooth muscle cells(HUCASMCs) culture showed the PTMC loaded by tacrolimus could significantly prohibit the adhesion of platelets and the proliferation of HUCASMCs.This work aims to find a better biodegradable polymer which is surface erosion and can be applied as drug-eluting stent coatings.%以表面溶蚀性可降解聚合物聚三亚甲基碳酸酯(PTMC)为载体,分别采用超声雾化喷涂技术和溶液浇注法制备了以PTMC为涂层载体的他克莫司药物洗脱支架和载药薄膜。傅里叶红外光谱(FT-IR)结果显示他克莫司分散在PTMC中。扫描电子显微镜观察支架撑开后的药物涂层保持连续均匀,没有开裂和剥落。他克莫司洗脱支架的药物释放行为与Weibull模型的相关性最高。体外血小板粘附和平滑肌粘附、增殖实验表明包载他克莫司的PTMC表面具有显著地抑制血小板粘附和平滑肌增生的作用。

  4. Determinants of neointimal proliferation and stent coverage after intracoronary therapy with drug-eluting devices in stable coronary artery disease: role of endothelial progenitor cells and interleukin-1 family cytokines.

    Science.gov (United States)

    Otto, Sylvia; Nitsche, Kristina; Jung, Christian; Gassdorf, Johannes; Janiak, Florian; Goebel, Björn; Figulla, Hans R; Poerner, Tudor C

    2014-12-01

    Endothelial progenitor cells (EPCs) and cytokines seem to play a pivotal role in arterial healing after stent implantation. Using optical coherence tomography (OCT) as a high-resolution imaging technique, we aimed to assess the influence of circulating EPCs and levels of Il-1 cytokines on stent coverage and in-stent proliferation. Eighty-nine patients were randomly treated with either Xience V drug-eluting stent (DES; n = 48) or bare-metal stent (BMS) postdilated with the SeQuent Please drug-eluting balloon (DEB; n = 41). EPC populations (CD34+/CD133+ and CD34+/CD133+/KDR+ EPC) and cytokines (Il-1ra, Il-18, and Il-1α) were measured before percutaneous coronary intervention using flow cytometry or immunoassay. Vessel remodeling was analyzed using coronary angiography and OCT at 6-month follow-up. Indexed neointimal volume and maximal proliferation thickness correlated inversely with EPC levels in the entire study population (r = -0.220; P=.04 and r = -0.253; P=.02) and the BMS + DEB subgroup (r = -0.344; P=.03 and r = -0.374; P=.02). Late lumen loss (LLL) was associated with the proatherogenic Il-18 concentration in the main population (r = 0.342; P=.01) and the BMS + DEB group (r = 0.471; P=.01). In the DES subgroup, associations with proliferation and LLL were lacking. Associations for stent strut coverage were not observed. A high EPC count seems to be a favorable individual patient factor, since it was associated with less instent proliferation. Contrarily, high Il-18 levels lead to more LLL, which emphasizes its proatherogenic properties.

  5. Salvage Therapy of Multiple Myeloma: The New Generation Drugs

    Directory of Open Access Journals (Sweden)

    Alessandra Romano

    2014-01-01

    Full Text Available During the past decade, overall results of treatment of multiple myeloma (MM have been improved and survival curves are now significantly better with respect to those obtained with historical treatment. These improvements are linked to a deeper knowledge of the biology of disease and to the introduction in clinical practice of drugs with different mechanism of action such as proteasome inhibitors and immunomodulatory drugs (IMiDs. However, MM remains in most cases an incurable disease. For patients who relapse after treatment with novel agents, the prognosis is dismal and new drugs and therapeutic strategies are required for continued disease control. In this review, we summarize new insights in salvage therapy for relapsed/refractory MM as emerging from recent clinical trials exploring the activity of bendamustine, new generation proteasome inhibitors, novel IMiDs, monoclonal antibodies, and drugs interfering with growth pathways.

  6. Methods of increasing the performance of radionuclide generators used in nuclear medicine: daughter nuclide build-up optimisation, elution-purification-concentration integration, and effective control of radionuclidic purity.

    Science.gov (United States)

    Le, Van So; Do, Zoe Phuc-Hien; Le, Minh Khoi; Le, Vicki; Le, Natalie Nha-Truc

    2014-06-10

    Methods of increasing the performance of radionuclide generators used in nuclear medicine radiotherapy and SPECT/PET imaging were developed and detailed for 99Mo/99mTc and 68Ge/68Ga radionuclide generators as the cases. Optimisation methods of the daughter nuclide build-up versus stand-by time and/or specific activity using mean progress functions were developed for increasing the performance of radionuclide generators. As a result of this optimisation, the separation of the daughter nuclide from its parent one should be performed at a defined optimal time to avoid the deterioration in specific activity of the daughter nuclide and wasting stand-by time of the generator, while the daughter nuclide yield is maintained to a reasonably high extent. A new characteristic parameter of the formation-decay kinetics of parent/daughter nuclide system was found and effectively used in the practice of the generator production and utilisation. A method of "early elution schedule" was also developed for increasing the daughter nuclide production yield and specific radioactivity, thus saving the cost of the generator and improving the quality of the daughter radionuclide solution. These newly developed optimisation methods in combination with an integrated elution-purification-concentration system of radionuclide generators recently developed is the most suitable way to operate the generator effectively on the basis of economic use and improvement of purposely suitable quality and specific activity of the produced daughter radionuclides. All these features benefit the economic use of the generator, the improved quality of labelling/scan, and the lowered cost of nuclear medicine procedure. Besides, a new method of quality control protocol set-up for post-delivery test of radionuclidic purity has been developed based on the relationship between gamma ray spectrometric detection limit, required limit of impure radionuclide activity and its measurement certainty with respect to

  7. 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.

  8. Virtual Screening and Structure Generation Applied to Drug Design

    Institute of Scientific and Technical Information of China (English)

    FAN B.T.; CHEN H. F.; XIE L.; YUAN S. G.; A. PANAYE; J-P. DOUCET

    2004-01-01

    The methods of computer-aided drug design can be divided into two categories according to whether or not the structures of receptors are known1, corresponding to two principal strategies:(1) searching the bio-active ligands against virtual combinatorial libraries and calculating the affinity energy between ligand and receptor by docking ; (2) QSAR and 3D-structure data-mining.3D-QSAR method is now applied widely to drug discovery, but this method is generally limited to refine the structures of known bio-active compounds. During the process of drug design, we have usually the prejudice that certain groups or structural fragments will play or not important roles on the activity. This will sometimes be misleading, and prevent us from obtaining expected results.The method of generating firstly diverse structures, then screening out the promising structures by means of a computational method or QSAR model, is an efficient way for drug discovery. We developed an efficient virtual and rational drag design method. It combines virtual bioactive compound generation using genetic algorithms with 3D-QSAR model and docking. Using this method can generate a lot of highly diverse molecules and find virtual active lead compounds. The method was validated by the study on a set of anti-tumor drugs, colchicine analogs2. With the constraints of pharmacophore obtained determined by DISCO, 97 virtual bioactive compounds were generated,and their anti-tumor activities were predicted by CoMFA. 8 structures with high activity were selected and screened by 3D-QSAR model. The most active generated structure was further investigated by modifying its structure in order to increase the activity (see fig.1). This drug design method could also avoid the conflict between the insufficiency of active structures and the great quantity of compounds needed for high-throughput screening. This method has been also applied to anti-HIV drug design.We have developed equally another approach of virtual

  9. Comparison of biolimus eluted from an erodible stent coating with bare metal stents in acute ST-elevation myocardial infarction (COMFORTABLE AMI trial): rationale and design

    NARCIS (Netherlands)

    Räber, L.; von Birgelen, Clemens

    2012-01-01

    Aims: Compared with bare metal stents (BMS), early generation drug-eluting stents (DES) reduce the risk of revascularisation in patients with ST-elevation myocardial infarction (STEMI) at the expense of an increased risk of very late stent thrombosis (ST). Durable polymer coatings for controlled

  10. 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.

  11. Usefulness of preprocedure high-sensitivity C-reactive protein to predict death, recurrent myocardial infarction, and stent thrombosis according to stent type in patients with ST-segment elevation myocardial infarction randomized to bare metal or drug-eluting stenting during primary percutaneous

    DEFF Research Database (Denmark)

    Schoos, Mikkel Malby; Kelbæk, Henning; Kofoed, Klaus F

    2011-01-01

    primary percutaneous coronary intervention (pPCI), 301 patients had blood drawn. Patients were categorized according to hs-CRP levels and combination of hs-CRP (=2 vs >2 mg/L) and stent type (bare metal stent [BMS] vs drug-eluting stent [DES]). Hs-CRP >2 mg/L (median, hazard ratio 2.7, 95% confidence...

  12. 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

  13. The mid-term clinical follow-up using drug-eluting balloons on tibial artery "de novo" lesions in patients with critical limb ischemia : A cohort study

    NARCIS (Netherlands)

    Tolva, Valerio; Casana, Renato; Huibers, Anne; Parati, Gianfranco; Bianchi, Paolo; Cireni, Lea; Ferrero, Emanuele; Halliday, Allison

    2016-01-01

    Rationale: Restenosis due to intimal hyperplasia (IH) is a major clinical issue that affects the success of lower limb endovascular surgery. After 1 year, restenosis occurs in 40% to 60% of the treated vessels. The possibility to reduce IH using local antiproliferative drugs, such as taxols, has

  14. 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

  15. 再次置入药物洗脱支架治疗经皮冠状动脉支架置入术后早期与晚期支架内再狭窄的对比研究%Comparison of repeated drug eluting stent for treatment of early and late in-stent restenosis after drug eluting stent implantation

    Institute of Scientific and Technical Information of China (English)

    朱玮玮; 赵林; 郭成军; 方冬平; 何东方; 张晓江; 迟云鹏; 刘梅颜; 吴小凡

    2014-01-01

    目的 比较再次置入药物洗脱支架(DES)治疗置入DES后早期(≤1年)与晚期(>1年)支架内再狭窄(ISR)患者的临床疗效.方法 收集2008年10月至2011年12月在北京安贞医院因DES置入术后ISR接受再次DES置人治疗并完成临床随访的患者资料.根据DES置入术后发生ISR的时间分为早期ISR组和晚期ISR组.对比2组随访期间的主要不良心血管事件(MACE)[包括全因死亡、心肌梗死和靶病变血运重建(TLR)].结果 总计107例患者入选本研究,其中早期ISR组43例,晚期ISR组64例.2组的患者基线资料、靶病变部位、类型、长度、置入支架特征及ISR类型、再次置入支架特征差异均无统计学意义(P>0.05).早期ISR组糖尿病患病率明显低于晚期ISR组[22.7% (10/44)比42.9% (27/63),P<0.01].晚期ISR组MACE发生率明显低于早期ISR组[15.9% (10/63)比47.7% (21/44),P<0.01];晚期ISR组TLR率明显低于早期ISR组[12.7% (8/63))比43.2% (19/44),P<0.01].Logistic回归分析显示,DES术后早期ISR(OR=6.47,95% CI:2.26~18.50,P<0.01)是DES治疗ISR后再次TLR的唯一预测因素.结论 再次DES置入治疗DES置入后ISR安全有效,但治疗早期ISR时TLR明显升高.%Objective To compare the efficiency and safety of repeated drug eluting stent (DES) for treatment of early and late DES in-stent restenosis(ISR).Methods Patients treated with repeated DES for DES ISR in Beijing anzhen hospital between October 2008 and December 2011 were followed up.All lesions were divided into early ISR group(within 1 year) (43 cases)and late ISR group (in > 1 year) (64 cases) by the period ISR occurring after initial DES implantation.Major adverse cardiovascular events (MACE) including all-cause death,myocardial infarction and clinical target lesion revascularization (TLR) were the primary endpoints.Results There were not differences between early ISR group and late ISR group in clinical and angiographic characteristics(P >0

  16. 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) .../min was independently associated with a higher risk of MACE (adjusted hazard ratio: 1.56; 95% confidence interval: 1.23 to 1.98) and all-cause mortality (adjusted hazard ratio: 2.67; 95% confidence interval: 1.85 to 3.85). Compared with older-generation DES, the use of newer-generation DES was associated...... with a reduction in the risk of cardiac death, myocardial infarction, or stent thrombosis in women with CKD. The effect of new-generation DES on outcomes was uniform, between women with or without CKD, without evidence of interaction. CONCLUSIONS: Among women undergoing PCI with DES, CKD is a common comorbidity...

  17. Studies of techniques for the post-elution concentration of {sup 99}mTc obtained from gel type {sup 99}Mo/{sup 99}mTc generators; Estudos de tecnicas de concentracao da atividade de {sup 99}mTc eluido de geradores de {sup 99}Mo/{sup 99}mTc tipo gel

    Energy Technology Data Exchange (ETDEWEB)

    Suzuki, Katia Noriko

    2009-07-01

    On average 80% of the radiopharmaceuticals used in Nuclear Medicine are labeled with {sup 99}mTc due to its physical properties and easy attainment through of {sup 99}Mo/{sup 99}mTc generators. The Directory of Radiopharmacy (DIRF) of IPEN-CNEN/SP developed a gel type chromatographic generator of MoZr with {sup 99}Mo produced by {sup 98}Mo(n,{gamma}){sup 99}Mo reaction that occurs at the IEA-R1 Nuclear Reactor. The gel is composed of zirconium molybdate with elution volume of 12 mL with an activity of 11100 MBq (300 mCi) producing a radioactive concentration of 925 MBq (25 mCi)/mL. The fission generator gives a higher radioactive concentration around 1850 MBq (50 mCi)/mL. The aim of this work is to study a system of post-elution concentration of {sup 99}mTc for the attainment of a high enough radioactive concentration to meet the demands of the market, with a proved quality. Two types of systems of post-elution concentration were developed: the single and the tandem. The most appropriate system for the gel generator of {sup 99}Mo/{sup 99}mTc, being at the same time sterile and vacuum automated, was the tandem system using Dionex 2.5 cc/QMA cartridges. The gel generator is eluted with 10 mL of solution of 0.1% NaCl and the pertechnetate anion is retained in the QMA cartridge and further eluted with 4 mL of saline. The process takes no more than 30 minutes. The elution efficiency of the system of concentration was 90 %. At the beginning of 2009 a global crisis in the supply of {sup 99}Mo took place making it necessary the development of alternative technologies for the production of {sup 99}Mo/{sup 99}mTc generators using fission produced {sup 99}Mo and the development of an appropriate method to extend the useful life of this generator. The results of this study showed that the same system developed for the post- concentration of the gel generator can be employed for the fission generator, using the tandem system, giving a concentration factor of 3 for the elution

  18. 两类药物洗脱支架药物释放曲线对血管壁内药物浓度影响的数值研究%Numerical Study on the Effects of Drug Release Profile of Two Drug -eluting Stents on the Drug Concentration within the Vessel Wall

    Institute of Scientific and Technical Information of China (English)

    吴昊; 蒋文涛; 晏菲; 陈宇; 樊瑜波

    2013-01-01

    研究两类药物释放曲线对血管壁中药物浓度分布的影响,为药物洗脱支架(DES)的优化设计提供依据;建立三维支架-血管模型,采用数值方法分析了雷帕霉素和紫杉醇两种药物释放曲线下血管壁中药物的浓度分布;初始药物释放率的增大会导致初始血管壁内药物浓度的增大,但随着时间的增加,血管壁中的药物浓度均趋于平稳。两种药物释放曲线下血管壁中的药物浓度均是随着时间的变化先增加后减少的,相比来说,雷帕霉素血管壁中的药物浓度随着时间变化的趋势要比紫杉醇血管壁中的药物浓度随着时间变化的趋势平稳,并且雷帕霉素血管壁中的药物浓度分布要比紫杉醇中血管壁中的药物浓度分布均匀。血管壁中药物浓度变化趋势的平稳性以及药物浓度分布的均匀性表明,雷帕霉素药物释放曲线要优于紫杉醇药物释放曲线。%To study the effects of two drug release profiles on the drug concentration for better design of drug -eluting stents (DES).A 3D virtual drug -eluting -vessel stent was modeled,and numerical simulation was used to investigate the drug concentration within the vessel wall at the drug release profile of rapamycin and paclitaxel,The initial drug concentration was increased with initial drug release rate increasing,but over time the drug concentration in the vessel wall would be stabilized.The drug concentrations pro-duced by both drug release profiles were first increased and then decreased with time,and compared with the concentration variation trend of paclitaxel,the concentration variation trend of rapamycin was steadier.In addition,the rapamycin concentration distribution in the vessel wall was more uniform than the paclitaxel concentration distribution.The stability of the drug concentration variation trend and the uniformity of drug concentration within the vessel wall show that rapamycin release profile is

  19. Rapid determination of {sup 90}Sr impurities in freshly 'generator eluted'{sup 90}Y for radiopharmaceutical preparation

    Energy Technology Data Exchange (ETDEWEB)

    Bonardi, Mauro L. [LASA, Universita degli Studi di Milano and INFN-Milano, via F.lli Cervi 201, I-20090 Segrate, Milano (Italy); Martano, Luigi [Division of Nuclear Medicine, European Institute of Oncology, via G. Ripamonti 435, I-20141 Milano (Italy); Groppi, Flavia [LASA, Universita degli Studi di Milano and INFN-Milano, via F.lli Cervi 201, I-20090 Segrate, Milano (Italy); Chinol, Marco [Division of Nuclear Medicine, European Institute of Oncology, via G. Ripamonti 435, I-20141 Milano (Italy)], E-mail: marco.chinol@ieo.it

    2009-10-15

    {sup 90}Y is one of the most useful radionuclides for radioimmunotherapeutic applications and has a half-life (t{sub 1/2}=64.14 h) suitable for most therapeutic applications, beta particles of high energy and decays to a stable daughter. It is significant that {sup 90}Y is available conveniently and inexpensively from a radionuclide 'generator' by decay of its parent, {sup 90}Sr. Nevertheless, current and planned clinical applications with [{sup 90}Y] labelled compounds employ activity levels that cannot be readily obtained from an in-house generator, but from commercial sources. We have evaluated Eichrom's Sr-resin, either as an 'in-house' generator or as a fast QC method for analysis of {sup 90}Y solutions. In particular, for the development as a generator, we investigated the percentage of the radio-Sr in the first 8 M HNO{sub 3} eluate: in this fraction the concentration of {sup 90}Sr must be smaller than 10{sup -5}% (recommendations of the International Commission on Radiological Protection). For evaluation as a rapid QC method, we analyzed the concentration of {sup 90}Y in all the fractions containing 'only' radio-Sr: {sup 90}Y should not be present in these eluates. After the collection of {beta}{sup -} and {gamma} spectra and analysis of them, we concluded that commercial Sr-resin minicolumn cannot give us the results expected; we developed an in-house system loaded with 4 mL of Sr-resin which gave better results as a generator and a rapid QC method.

  20. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents

    NARCIS (Netherlands)

    C.M. Spaulding (Christian); J. Daemen (Joost); H. Boersma (Eric); D.E. Cutlip (Donald); P.W.J.C. Serruys (Patrick)

    2007-01-01

    textabstractBACKGROUND: Although randomized studies have shown a beneficial effect of drug-eluting stents in reducing the risk of repeated revascularization, these trials were underpowered to compare rates of death and myocardial infarction. The long-term safety of drug-eluting stents has been

  1. Effects of cigarette smoking on platelet reactivity during P2Y12 inhibition in patients with myocardial infarction undergoing drug-eluting stent implantation: results from the prospective cigarette smoking on platelet reactivity (COPTER) study.

    Science.gov (United States)

    Patti, Giuseppe; Polacco, Marina; Taurino, Ester; Gaudio, Carlo; Greco, Cesare

    2016-05-01

    Interaction between cigarette smoking and efficacy of oral antiplatelet drugs is not definitely elucidated. We evaluated the effects of cigarette smoking on platelet reactivity in patients receiving different oral P2Y12 antagonists after myocardial infarction (MI) and drug-eluting stent (DES) implantation. Two-hundred-five consecutive current smokers receiving DES implantation after ST-segment elevation MI were enrolled. All patients were aspirin-treated and were on chronic therapy with clopidogrel (N = 59), prasugrel (N = 71) or ticagrelor (N = 75); by protocol, all patients at baseline had no high on-treatment platelet reactivity by the VerifyNow P2Y12 assay. Platelet reactivity, expressed by P2Y12 reaction units (PRU), was measured in all patients at baseline (T0), after a 15-day period of smoking cessation (T1) and after further 15 days of smoking resumption (T2). In the overall population there was a modest, albeit significant, reduction of PRU values from T0 to T1 (from 173 ± 14 to 165 ± 17, P smoking was associated with re-increase of platelet reactivity (from 165 ± 17 at T1 to 170 ± 17 at T2, P = 0.0002). These variations were consistent in the subgroups receiving clopidogrel, prasugrel or ticagrelor and were irrespective of the number of cigarettes smoked. In conclusion, cigarette smoking weakly influences antiplatelet effects of oral P2Y12 inhibition and this was irrespective of the type of antiplatelet agent; thus, interaction between cigarette smoking and efficacy of oral antiplatelet drugs is modest and unlikely translates into clinical effects (ClinicalTrials.gov Identifier: NCT02026713).

  2. The Ultimaster Biodegradable-Polymer Sirolimus-Eluting Stent: An Updated Review of Clinical Evidence.

    Science.gov (United States)

    Chisari, Alberto; Pistritto, Anna Maria; Piccolo, Raffaele; La Manna, Alessio; Danzi, Gian Battista

    2016-09-06

    The Ultimaster coronary stent system (Terumo Corporation, Tokyo, Japan) represents a new iteration in drug-eluting stent (DES) technology that has recently received the Conformité Européenne (CE) mark approval for clinical use. The Ultimaster is a thin-strut, cobalt chromium, biodegradable-polymer, sirolimus-eluting coronary stent. The high elasticity of the biodegradable-polymer (PDLLA-PCL) and the abluminal gradient coating technology are additional novel features of this coronary device. The Ultimaster DES has undergone extensive clinical evaluation in two studies: The CENTURY I and II trials. Results from these two landmark studies suggested an excellent efficacy and safety profile of the Ultimaster DES across several lesion and patient subsets, with similar clinical outcomes to contemporary, new-generation DES. The aim of this review is to summarize the rationale behind this novel DES technology and to provide an update of available evidence about the clinical performance of the Ultimaster DES.

  3. Five-year outcomes of chronic total occlusion treatment with a biolimus A9-eluting biodegradable polymer stent versus a sirolimus-eluting permanent polymer stent in the LEADERS all-comers trial

    NARCIS (Netherlands)

    M. Ghione (Matteo); J.J. Wykrzykowska (Joanna); S. Windecker (Stephan); P.W.J.C. Serruys (Patrick); P.E. Buszman (Pawel); A. Linke (Axel); H.Y. Sohn (Hae Y); R. Corti (Roberto); M.L. Antoni (Louisa); W. Wijns (William); Estevez-Loureiro, R. (Rodrigo); M-C. Morice (Marie-Claude); G.A. van Es (Gerrit Anne); R.J.M. van Geuns (Robert Jan); P. Jùni (Peter); P. Eerdmans (Pedro); T. de Vries (Ton); Konik, S. (Stéphanie); C. di Mario (Carlo)

    2016-01-01

    textabstractBackground: Few data are available on long-term follow-up of drug-eluting stents in the treatment of chronic total occlusion (CTO). The LEADERS CTO sub-study compared the long-term results in CTO and non-CTO lesions of a Biolimus A9™-eluting stent (BES) with a sirolimus-eluting stent (SE

  4. Five-year outcomes of chronic total occlusion treatment with a biolimus A9-eluting biodegradable polymer stent versus a sirolimus-eluting permanent polymer stent in the LEADERS all-comers trial

    NARCIS (Netherlands)

    M. Ghione (Matteo); J.J. Wykrzykowska (Joanna); S. Windecker (Stephan); P.W.J.C. Serruys (Patrick); P.E. Buszman (Pawel); A. Linke (Axel); H.Y. Sohn (Hae Y); R. Corti (Roberto); M.L. Antoni (Louisa); W. Wijns (William); Estevez-Loureiro, R. (Rodrigo); M-C. Morice (Marie-Claude); G.A. van Es (Gerrit Anne); R.J.M. van Geuns (Robert Jan); P. Jùni (Peter); P. Eerdmans (Pedro); T. de Vries (Ton); Konik, S. (Stéphanie); C. di Mario (Carlo)

    2016-01-01

    textabstractBackground: Few data are available on long-term follow-up of drug-eluting stents in the treatment of chronic total occlusion (CTO). The LEADERS CTO sub-study compared the long-term results in CTO and non-CTO lesions of a Biolimus A9™-eluting stent (BES) with a sirolimus-eluting stent (SE

  5. Trans-arterial chemo-embolization (TACE, with either lipiodol (traditional TACE or drug-eluting microspheres (precision TACE, pTACE in the treatment of hepatocellular carcinoma: efficacy and safety results from a large mono-institutional analysis

    Directory of Open Access Journals (Sweden)

    Marmorale Cristina

    2010-12-01

    Full Text Available Abstract More data about TACE and pTACE seem necessary to better define the global treatment strategy for HCC. Aim of our analysis was to evaluate the role of TACE, either with lipiodol (traditional or drug-eluting microspheres in terms of response rate (RR, time to progression (TTP, overall survival (OS and toxicity in HCC. Patients with HCC undergoing traditional TACE or pTACE (either alone or in combination with other treatment options were eligible One hundred and fifty patients were analyzed. In the global patient population median OS was 46 months for lipiodol TACE and 19 months for pTACE (p At multivariate analysis, age, the Okuda stage, type of TACE and number of TACE proved to be independent prognostic factors influencing overall survival. In our experience, lipiodol TACE showed a better OS and TTP over pTACE, without difference in toxicity profile and RR. Among the staging systems analyzed only the Okuda stage seemed able to reliably predict patients outcome.

  6. Impact of high lipoprotein(a) levels on in-stent restenosis and long-term clinical outcomes of angina pectoris patients undergoing percutaneous coronary intervention with drug-eluting stents in Asian population.

    Science.gov (United States)

    Park, Sang-Ho; Rha, Seung-Woon; Choi, Byoung-Geol; Park, Ji-Young; Jeon, Ung; Seo, Hong-Seog; Kim, Eung-Ju; Na, Jin-Oh; Choi, Cheol-Ung; Kim, Jin-Won; Lim, Hong-Euy; Park, Chang-Gyu; Oh, Dong-Joo

    2015-06-01

    Lipoprotein(a) (Lp(a)) is known to be associated with cardiovascular complications and atherothrombotic properties in general populations. However, it has not been examined whether Lp(a) levels are able to predict adverse cardiovascular outcomes in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). A total of 595 consecutive patients with angina pectoris who underwent elective PCI with DES were enrolled from 2004 to 2010. The patients were divided into two groups according to the levels of Lp(a): Lp(a) 50 mg/dL was significantly associated with the 3-year adverse clinical outcomes including any myocardial infarction, revascularization (target lesion revascularization (TLR) and target vessel revascularization (TVR)), TLR-major adverse cardiac events (MACEs), TVR-MACE, and All-MACEs. In our study, high Lp(a) level ≥ 50 mg/dL in angina pectoris patients undergoing elective PCI with DES was significantly associated with binary restenosis and 3-year adverse clinical outcomes in an Asian population.

  7. 药物洗脱支架治疗冠状动脉疾病疗效优势的研究进展%Research Progress in the Therapeutic Advantages of Drug-eluting Stent Implantation for Coronary Artery Disease

    Institute of Scientific and Technical Information of China (English)

    郭冠兰; 黄胜堂

    2015-01-01

    药物洗脱支架(DES)取代裸金属支架(BMS)应用于临床是心脏病介入治疗领域的突破性进展. DES的介入治疗可与冠状动脉旁路移植术(CABG)媲美,后者是目前临床上治疗冠状动脉疾病的标准方法. DES可较好控制再狭窄率的效果. 此外,复杂程度较低的冠心病患者用DES进行经皮冠状动脉介入(PCI)的疗效好. 但是CABG依然是左前降支或左主干冠状动脉病以及复杂的多血管病变患者优先选择的治疗方案.%Bare-metal stents have been replaced by drug-eluting stents( DES) , which is considered as a breakthrough therapy that might compete with coronary artery bypass grafting(CABG) as the standard treat-ment for coronary artery disease.DES can control the effect of restenosis rate.In addition,less complex coro-nary heart disease patients treated by percutaneous coronary intervention with DES have better therapeutic effect.However,CABG is still the priority option for patients with left anterior descending coronary artery involvement, left main involvement, or multivessel disease.

  8. Everolimus-eluting stent platforms in percutaneous coronary intervention: comparative effectiveness and outcomes

    Directory of Open Access Journals (Sweden)

    Panoulas VF

    2015-07-01

    Full Text Available Vasileios F Panoulas,1 Ioannis Mastoris,2 Klio Konstantinou,1 Maurizio Tespili,3 Alfonso Ielasi3 1National Heart and Lung Institute, Imperial College London, London, UK; 2Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A Wiener Cardiovascular Institute, The Icahn School of Medicine at Mount Sinai, New York NY, USA; 3Cardiology Department, Bolognini Hospital Seriate, Seriate (BG, Italy Abstract: Despite the remarkable benefits obtained following the introduction of the first-generation drug-eluting stent (DES, concerns were raised over its long-term safety, particularly with regard to very late (beyond 1 year stent thrombosis. Newer-generation DESs have been developed to overcome this limitation using novel stent platforms, new drugs, more biocompatible durable polymers, and bioabsorbable polymers or backbones. To date, new-generation DESs have virtually replaced the use of first-generation DESs worldwide. In this review article, we discuss in detail the design, pharmacology, and mechanism of action of the newer-generation permanent and bioresorbable everolimus-eluting platforms. Furthermore, we present and evaluate the current evidence on the performance and safety of these devices compared to those of other available stent platforms. Keywords: PCI, angioplasty, stent, outcome 

  9. Drug-Eluting Beads Loaded With Doxorubicin (DEBDOX) Chemoembolisation Before Liver Transplantation for Hepatocellular Carcinoma: An Imaging/Histologic Correlation Study

    Energy Technology Data Exchange (ETDEWEB)

    Pauwels, Xavier, E-mail: xpauwels@hotmail.com; Azahaf, Mustapha, E-mail: mustapha.azahaf@chru-lille.fr [CHRU Lille, Hôpital Claude Huriez, Department of Digestive Diagnostic and Interventional Radiology (France); Lassailly, Guillaume, E-mail: guillaume.lassailly@chru-lille.fr [CHRU Lille, Hôpital Claude Huriez, Department of Digestive Diseases and Nutrition (France); Sergent, Géraldine, E-mail: geraldine.sergent@chru-lille.fr [CHRU Lille, Hôpital Claude Huriez, Department of Digestive Diagnostic and Interventional Radiology (France); Buob, David, E-mail: david.buob@chru-lille.fr [CHRU Lille, Department of Pathology (France); Truant, Stéphanie, E-mail: stephanie.truant@chru-lille.fr; Boleslawski, Emmanuel, E-mail: emmanuel.boleslawski@gmail.com [CHRU Lille, Hôpital Claude Huriez, Department of Digestive Surgery and Transplantation (France); Louvet, Alexandre, E-mail: alexandre.louvet@chru-lille.fr [CHRU Lille, Hôpital Claude Huriez, Department of Digestive Diseases and Nutrition (France); Gnemmi, Vivianne, E-mail: viviane.gnemmi@chru-lille.fr [CHRU Lille, Department of Pathology (France); Canva, Valérie, E-mail: valerie.canva@chru-lille.fr; Mathurin, Philippe, E-mail: philippe.mathurin@chru-lille.fr [CHRU Lille, Hôpital Claude Huriez, Department of Digestive Diseases and Nutrition (France); Pruvot, François-René, E-mail: francois-rene.pruvot@chru-lille.fr [CHRU Lille, Hôpital Claude Huriez, Department of Digestive Surgery and Transplantation (France); Leteurtre, Emmanuelle, E-mail: emmanuelle.leteurtre@chru-lille.fr [CHRU Lille, Department of Pathology (France); and others

    2015-06-15

    Purpose Most transplant centers use chemoembolisation as locoregional bridge therapy for hepatocellular carcinoma (HCC) before liver transplantation (LT). Chemoembolisation using beads loaded with doxorubicin (DEBDOX) is a promising technique that enables delivery of a large quantity of drugs against HCC. We sought to assess the imaging–histologic correlation after DEBDOX chemoembolisation.Materials and Methods All consecutive patients who had undergone DEBDOX chemoembolisation before receiving liver graft for HCC were included. Tumour response was evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST) and modified RECIST (mRECIST) criteria. The result of final imaging made before LT was correlated with histological data to predict tumour necrosis.ResultsTwenty-eight patients underwent 43 DEBDOX procedures for 45 HCC. Therapy had a significant effect as shown by a decrease in the mean size of the largest nodule (p = 0.02) and the sum of viable part of tumour sizes according to mRECIST criteria (p < 0.001). An objective response using mRECIST criteria was significantly correlated with mean tumour necrosis ≥90 % (p = 0.03). A complete response using mRECIST criteria enabled accurate prediction of complete tumour necrosis (p = 0.01). Correlations using RECIST criteria were not significant.ConclusionOur data confirm the potential benefit of DEBDOX chemoembolisation as bridge therapy before LT, and they provide a rational basis for new studies focusing on recurrence-free survival after LT. Radiologic evaluation according to mRECIST criteria enables accurate prediction of tumour necrosis, whereas RECIST criteria do not.

  10. Labeling of ceftriaxone for infective inflammation imaging using {sup 99m}Tc eluted from {sup 99}Mo/{sup 99m}Tc generator based on zirconium molybdate

    Energy Technology Data Exchange (ETDEWEB)

    Mostafa, M., E-mail: mmostafa95@yahoo.co [Radioactive Isotopes and Generators Department, Hot Labs Center, Atomic Energy Authority, P.O. Box 13759, Cairo (Egypt); Motaleb, M.A. [Labeled Compounds Department, Hot Labs Center, Atomic Energy Authority, P.O. Box 13759, Cairo (Egypt); Sakr, T.M. [Radioactive Isotopes and Generators Department, Hot Labs Center, Atomic Energy Authority, P.O. Box 13759, Cairo (Egypt)

    2010-10-15

    Zirconium molybdate gel was prepared by mixing {sup 99}Mo, produced from {sup 98}Mo(n,{gamma}) reaction and Zr solutions in nitrate media with excess H{sub 2}O{sub 2}, and used as the base material for {sup 99}Mo/{sup 99m}Tc generator. The prepared generator showed a good performance. {sup 99m}Tc eluted from the prepared generator passed the quality control tests with specifications meeting the requirements of European and US Pharmacopeias. The {sup 99m}Tc eluate was used for labeling of cephalosporin analogue, ceftriaxone, which was then assessed for infection imaging in a mouse model. {sup 99m}Tc-ceftriaxone was prepared at pH 9 with a radiochemical yield of 95{+-}2% by adding {sup 99m}Tc to 30 mg ceftriaxone in the presence of 50 {mu}g SnCl{sub 2}.2H{sub 2}O. Biodistribution studies in mice were carried out using experimentally induced infection in the left thigh using E. coli. Both thighs of the mice were dissected and counted to evaluate the ratio of bacterial infected thigh/contralateral thigh. {sup 99m}Tc-ceftriaxone showed high uptake in the infectious lesion (T/NT =5.6{+-}0.6 at 4 h post injection). The abscess to normal muscle ratio indicated that {sup 99m}Tc-ceftriaxone could be used for infection imaging. Besides, in vitro studies showed that {sup 99m}Tc-ceftriaxone can differentiate between bacterial infection and sterile inflammation.

  11. Solving the Issue of Restenosis After Stenting of Intracranial Stenoses: Experience with Two Thin-Strut Drug-Eluting Stents (DES)—Taxus Element™ and Resolute Integrity™

    Energy Technology Data Exchange (ETDEWEB)

    Kurre, Wiebke, E-mail: wiebke.kurre@gmx.de; Aguilar-Pérez, Marta [Klinikum Stuttgart, Klinik für Diagnostische und Interventionelle Neuroradiologie (Germany); Fischer, Sebastian [Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin (Germany); Arnold, Guy [Klinikverbund Südwest, Klinikum Sindelfingen, Klinik für Neurologie (Germany); Schmid, Elisabeth; Bäzner, Hansjörg [Klinikum Stuttgart, Klinik für Neurologie (Germany); Henkes, Hans [Klinikum Stuttgart, Klinik für Diagnostische und Interventionelle Neuroradiologie (Germany)

    2015-06-15

    PurposeThin-strut, flexible DES are suitable for intracranial stenting and may improve long-term vessel patency. The purpose of this study was to report our experience with two new-generation DES for the treatment of intracranial atherosclerotic disease.Patients and MethodsWe retrospectively reviewed all patients treated with Taxus Element™ or Resolute Integrity™ stent for an intracranial atherosclerotic stenosis between March 2011 and August 2013. Technical success was defined as the ability to deploy the device at the desired location and reduce the degree of stenosis below 50 %. All procedure-related strokes were recorded. Control angiography was scheduled after 6 weeks, 3, 6, and 12 months and yearly thereafter. A luminal narrowing ≥50 % was regarded as a restenosis. Stroke recurrence in the territory of the treated artery was reported.ResultsIn the defined period we treated 101 patients harboring 117 intracranial stenoses. The procedure was successful in 100 (85.5 %) lesions. Procedure-related strokes occurred in 10 (9.9 %) patients with a permanent morbidity in 3 (3.0 %). Follow-up angiography was available for 83 of 100 (83.0 %) successfully treated lesions with an average of 355 days (IQR 153–482 days). Three (3.6 %) asymptomatic restenoses were detected. All occurred after treatment with Resolute Integrity™, none after Taxus Element™ (p = 0.059). New strokes in the territory of the treated artery were encountered in 2 (2.6 %) occasions.ConclusionThin-strut DES improve long-term patency and reduce the risk of subsequent stroke. Differences between devices may exist. Feasibility is comparable to bare-metal balloon-mounted stents and procedure-related strokes occurred within the expected range.

  12. The Supralimus sirolimus-eluting stent.

    Science.gov (United States)

    Lemos, Pedro A; Bienert, Igor

    2013-05-01

    The use of biodegradable polymeric coatings has emerged as a potential bioengineering target to improve the vascular compatibility of coronary drug-eluting stents (DESs). This review summarizes the main features and scientific facts about the Supralimus sirolimus-eluting stent (Sahajanand Medical Technologies Ltd, Surat, India), which is a biodegradable polymer-based, sirolimus-eluting metallic stent that was recently introduced for routine use in Europe. The novel stent is built on a stainless steel platform, coated with a blend of biodegradable polymers (poly-l-lactide, poly-dl-lactide-co-glycolide and polyvinyl pyrrolidone; coating thickness is 4-5 µm). The active agent is the antiproliferative sirolimus in a dose load of 1.4 µg/mm(2), which is released within 48 days. The Supralimus stent was initially evaluated in the single-arm SERIES-I study, which showed binary angiographic restenosis rates of 0% (in-stent) and 1.7% (in-segment) and an in-stent late lumen loss of 0.09 ± 0.28 mm. The multicenter randomized PAINT trial compared two DESs with identical metallic platforms and biodegradable polymer carriers, but different agents (Infinnium [Sahajanand Medical Technologies Pvt Ltd] paclitaxel-eluting stent or Supralimus sirolimus-eluting stent) against bare stents. After 3 years, the pooled DES population had similar rates of cardiac death or myocardial infarction (9 vs 7.1%; p = 0.6), but a lower risk of repeat interventions (10 vs 29.9%; p < 0.01) than controls with bare stents. The incidence of definite or probable stent thrombosis in the pooled DES group was 2.3% (1st year: 1.8%; 2nd year: 0.4% and 3rd year: 0%). These results demonstrate that the novel Supralimus stents are effective in reducing reintervention, while potentially improving the safety profile by decreasing the risk of late-term thrombosis, even though further studies would be necessary to confirm these findings.

  13. Angiographic and clinical comparisons of intravascular ultrasound- versus angiography-guided drug-eluting stent implantation for patients with chronic total occlusion lesions: two-year results from a randomised AIR-CTO study.

    Science.gov (United States)

    Tian, Nai-Liang; Gami, Sandeep-Kumar; Ye, Fei; Zhang, Jun-Jie; Liu, Zhi-Zhong; Lin, Song; Ge, Zhen; Shan, Shou-Jie; You, Wei; Chen, Liang; Zhang, Yao-Jun; Mintz, Gary; Chen, Shao-Liang

    2015-04-01

    This study sought to compare angiographic endpoints at one-year follow-up after a drug-eluting stent implantation guided by either intravascular ultrasound (IVUS) or angiography in patients with chronic total occlusion (CTO) lesions. Patients with at least one CTO lesion recanalised successfully were randomly assigned to the IVUS-guided or the angiography-guided group. The use of IVUS for penetration of the true lumen and optimisation of stent expansion was only done in the IVUS-guided group. The primary endpoint was in-stent late lumen loss (LLL) at one-year follow-up. A total of 230 patients with CTO lesions after successful recanalisation were enrolled and followed with office visits or telephone contact up to 24 months. In-stent LLL in the IVUS-guided group was significantly lower compared to the angiography-guided group at one-year follow-up (0.28±0.48 mm vs. 0.46±0.68 mm, p=0.025), with a significant difference in restenosis of the "in-true-lumen" stent between the two groups (3.9% vs.13.7%, p=0.021). The minimal lumen diameter and minimal stent cross-section area significantly and negatively correlated with LLL (all pCTO lesion was associated with less LLL and a lower incidence of "in-true-lumen" stent restenosis. Additional study is required to identify the clinical benefit of the IVUS-guided procedure for CTO lesions. [ChiCTR-TRC-10000996].

  14. Prognostic Impact of 9-Month High-Sensitivity C-Reactive Protein Levels on Long-Term Clinical Outcomes and In-Stent Restenosis in Patients at 9 Months after Drug-Eluting Stent Implantation.

    Directory of Open Access Journals (Sweden)

    I-Chang Hsieh

    Full Text Available The level of 9-month high-sensitivity C-reactive protein (hsCRP in predicting cardiovascular outcomes is scanty in patients at 9 months after receiving drug-eluting stent (DES implantations. This study aims to evaluate the relationship between 9-month follow-up hsCRP levels and long-term clinical outcomes in patients at 9 months after receiving DES.A total of 1,763 patients who received 9-month follow-up angiography were enrolled and grouped according to hsCRP level 9 months after the DES implantation: group I (718 patients, hsCRP3.0 mg/L.Group III patients had a lower cardiovascular event-free survival rate than group I or II patients during a follow-up of 64 ± 45 months (64.5% vs. 71.6% vs. 72.8%, respectively, p = 0.012. Multivariate analysis showed that a follow-up hsCRP level <3.0 mg/L was an independent predictor of a major adverse cardiovascular event (cardiac death, reinfarction, target lesion revascularization, stenting in a new lesion, or coronary bypass surgery. Group III patients had a higher restenosis rate (11.3% vs. 5.8% vs. 6.6%, respectively, p = 0.002 and loss index (0.21 ± 0.32 vs. 0.16 ± 0.24 vs. 0.18 ± 0.28, respectively, p = 0.001 than group I or II patients in 9-month follow-up angiography.A high 9-month follow-up hsCRP level is an independent predictor of long-term clinical cardiovascular outcomes in patients at 9 months after DES implantation. It is also associated with a higher restenosis rate, larger late loss and loss index at 9 months after DES implantation.

  15. Randomized comparison of cost-saving and effectiveness of oral rapamycin plus bare-metal stents with drug-eluting stents: three-year outcome from the randomized oral rapamycin in Argentina (ORAR) III trial.

    Science.gov (United States)

    Rodriguez, Alfredo E; Rodriguez-Granillo, Alfredo M; Antoniucci, David; Mieres, Juan; Fernandez-Pereira, Carlos; Rodriguez-Granillo, Gaston A; Santaera, Omar; Rubilar, Bibiana; Palacios, Igor F; Serruys, Patrick W

    2012-09-01

    The Oral Rapamycin in ARgentina (ORAR) III trial is a randomized study comparing a strategy of oral rapamycin (OR) plus bare-metal stent (BMS) versus a strategy of drug-eluting stents (DES) in patients with de novo coronary lesions. The purpose of this study was to assess the 3 years cost-effectiveness outcome of each strategy. OR after BMS has been associated with reduction of target vessel revascularization (TVR) although its value in long-term efficacy in comparison with DES is unknown. In three hospitals in Buenos Aires, Argentina, 200 patients were randomized to OR plus BMS (n = 100) or DES (n = 100). Primary objectives were costs and effectiveness. Cost analysis included in-hospital and follow-up costs. Safety was defined as the composite of death, myocardial infarction (MI), and stroke. Efficacy was defined as TVR. Baseline characteristics between groups were similar. The 3-year follow-up rate was 99%. Cardiac mortality was 2% and 5% in OR group and DES group, respectively (P = 0.44). The composite of death, MI and stroke rate was 11% in OR group and 20% in DES group (P = 0.078). TVR rate was 14.5% in OR group and 17.6% in DES group (P = 0.50), respectively. Three year cumulative costs were significantly lower in the OR arm as compared to the DES arm (P = 0.0001) and DES strategy did not result cost-effective according to the non-inferiority test. At 3 years follow-up, there were no differences in effectiveness between the two strategies, and DES strategy was not more cost-effective as compared to OR plus BMS. Copyright © 2011 Wiley Periodicals, Inc.

  16. Cyclic strain amplitude dictates the growth response of vascular smooth muscle cells in vitro: role in in-stent restenosis and inhibition with a sirolimus drug-eluting stent.

    Science.gov (United States)

    Colombo, Alberto; Guha, Shaunta; Mackle, Joseph N; Cahill, Paul A; Lally, Caitríona

    2013-08-01

    The putative effects of changes in mean strain and cyclic strain amplitude on vascular smooth muscle cell (vSMC) growth (proliferation and apoptosis) were examined. Subsequently, a quantitative measure of vSMC growth was obtained to determine the prolonged effect of changes in mechanical burden following bare-metal stent (BMS) and sirolimus drug-eluting stent (DES) deployment in vitro. Bovine aortic vSMCs were exposed to prolonged cyclic strain using a Flexercell(TM) Tension system and a novel Sylgard(TM) phantom vessel following stent implantation before the level of vSMC proliferation and apoptosis was assessed by FACS analysis, cell counting, and immunocytochemistry. Physiological cyclic strain (5%) decreased vSMC proliferation and increased apoptosis in a temporal manner. There was no significant difference in cell growth following exposure to varying mean strains with similar amplitude. In contrast, exposure to varying strain amplitudes with similar mean strains resulted in significant differences in cell proliferation and apoptosis. In parallel studies, the level of vSMC proliferation and cell survival was significantly increased within low amplitude, high mean strain regions of a phantom vessel following BMS implantation when compared to regions of higher strain amplitude upstream and downstream of the stent, respectively. Moreover, the level of vSMC growth within the stented region was significantly attenuated following implantation of a sirolimus-coated DES independent of significant changes in cell survival. Cyclic strain amplitude is an important regulator of vSMC growth capacity within a stent and is a target for inhibition using a sirolimus-coated DES.

  17. Impact of six versus 12 months of dual antiplatelet therapy in patients with drug-eluting stent implantation after risk stratification with the residual SYNTAX score: Results from a secondary analysis of the I-LOVE-IT 2 trial.

    Science.gov (United States)

    Qiu, Miaohan; Li, Yi; Li, Jing; Xu, Kai; Jing, Quanmin; Dong, Shaohong; Jin, Zhe; Zhao, Pitian; Xu, Bo; Han, Yaling

    2017-03-01

    The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation remains undetermined, especially for those at high risk of cardiac events postprocedure. This study was aimed to investigate the impact of 6 versus 12 months of DAPT after DES implantation based on risk stratification with the residual SYNTAX score (rSS). A total of 2737 patients in the I-LOVE-IT 2 trial were grouped according to rSS status (low rSS [rSS = 0, n = 1474] versus high rSS [rSS > 0, n = 1263]) and DAPT duration (6 months vs. 12 months). The primary endpoint was 12-month target lesion failure (TLF), and the major secondary endpoints were 12-month net adverse clinical events (NACE) and major bleeding. Incidences of TLF (5.2 vs. 7.4%, P = 0.01) and NACE (9.2 vs. 13.4%, P rSSs compared with patients with low rSSs. Landmark analysis showed that, in patients with high rSS, 12-month DAPT was associated with slightly lower risks of TLF (3.0% vs. 1.6%, P = 0.08) and NACE (7.0 vs. 4.4%, P = 0.054) compared with 6-month DAPT within 6 to 12 months after PCI. Patients with different DAPT durations had similar risks of bleeding both in the low and high rSS groups. Patients with high rSSs have an increased risk of TLF and NACE at 12 months after DES implantation. Twelve-month DAPT might be superior to 6-month DAPT in patients with high rSS for reducing adverse events within 6 to 12 months after PCI without excessive risk of bleeding. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  18. Exploiting Specific Interactions toward Next-Generation Polymeric Drug Transporters

    NARCIS (Netherlands)

    Wieczorek, Sebastian; Krause, Eberhard; Hackbarth, Steffen; Roeder, Beate; Hirsch, Anna K. H.; Boerner, Hans G.

    2013-01-01

    A generic method describes advanced tailoring of polymer drug carriers based on polymer-block-peptides. Combinatorial means are used to select suitable peptide segments to specifically complex small-molecule drugs. The resulting specific drug formulation agents render insoluble drugs water-soluble a

  19. The late acute thrombosis in coronary drug-eluting stent-cases pooled analysis%冠状动脉药物洗脱支架晚发支架内急性血栓形成分析

    Institute of Scientific and Technical Information of China (English)

    王禹; 盖鲁粤; Sueselbeck T; Remppis A; 杨庭树; 陈练; 刘宏斌; 金琴花; 李丽

    2006-01-01

    目的分析近期临床应用冠脉药物洗脱支架(drug-eluting stent,DES)术后,晚发的支架内急性血栓形成病例的发生特点及可能影响因素.方法应用关键词:coronary artery、sirolimus、paclitaxil、drug-elutistent、thrombosis,anuervsm、malapposition等,应用美国国立医学图书馆的PubMed系统和德国海德堡大学的电子期刊系统对临床医学核心期刊进行系统检索.对检索出的12个病例及本中心3例冠状动脉内置入DES后晚发支架内急性血栓形成病例汇总分析.结果共有15例患者,在DES(sirolimus和paclitaxel支架)术后出现晚发的支架内急性血栓形成和(或)同时合并冠脉瘤样扩张、支架与血管壁贴合不良(malapposition).急性血栓发生时间:120~540天.9例患者在停用阿司匹林、氯吡格雷后4~15天发生;3例患者在DES置入部位出现明显冠脉瘤样扩张和(或)瘤腔内血栓形成;4例患者在DES发生急性血栓时、同时置入的6枚普通金属支架完全通畅.结论晚发的DES内急性血栓形成(≥6个月)、支架与血管壁贴合不良、明显的冠脉管壁瘤样扩张造成再次严重的心肌缺血或梗死.

  20. The everolimus-eluting Xience stent in small vessel disease: bench, clinical, and pathology view

    Directory of Open Access Journals (Sweden)

    Sanchez OD

    2014-12-01

    Full Text Available Oscar D Sanchez, Kazuyuki Yahagi, Tobias Koppara, Renu Virmani, Michael Joner CVPath Institute, Inc., Gaithersburg, MD, USA Abstract: Coronary artery disease (CAD is the leading cause of morbidity and mortality worldwide. The pathogenesis of CAD relates to the presence of atherosclerotic plaques in the coronary arteries, which are most frequently treated today by percutaneous coronary intervention. Small vessel disease treatment represents one-third of all percutaneous coronary interventions with higher rates of restenosis and major adverse cardiac events. Initially, drug-eluting stents (DES were developed to reduce in-stent restenosis, improving clinical outcomes and reducing the need for target vessel revascularization. However, late and very late stent thrombosis emerged as a new problem compromising DES's long-term results. The cobalt–chromium everolimus-eluting stent (CoCr-EES represents the results of an evolutionary process in DES technology aimed at improving the shortcomings of first-generation DES. Small vessel CAD has historically been an obstacle to long-term patency following implantation of DES. Antirestenotic efficacy has been shown to be of high relevance in small vessels. Therefore, stent selection may play an important role in determining outcomes in this subgroup of patients. This article will review the performance of CoCr-EES in the treatment of small vessel CAD from preclinical, clinical, and pathology perspectives, and it will highlight the most important findings in this regard. Keywords: small vessel, cobalt–chromiun everolimus-eluting stent, Xience V, pathology

  1. Biodegradable polymer Biolimus-eluting stent (Nobori® for the treatment of coronary artery lesions: review of concept and clinical results

    Directory of Open Access Journals (Sweden)

    Schurtz G

    2014-02-01

    Full Text Available Guillaume Schurtz,1,2 Cédric Delhaye,1 Christopher Hurt,1,2 Henri Thieuleux,1,2 Gilles Lemesle1–3 1Centre Hémodynamique et Unité des Soins Intensifs de Cardiologie, Hôpital Cardiologique, Centre Hospitalier Régional et Universitaire de Lille, Lille, France; 2Faculté de Médecine de Lille, Lille, France; 3Unité INSERM UMR744, Institut Pasteur de Lille, Lille, France Abstract: First-generation drug-eluting stents have raised concerns regarding the risk of late and very late stent thrombosis compared with bare metal stents and require prolonged dual antiplatelet therapy. Despite extensive investigations, the physiopathology of these late events remains incompletely understood. Aside from patient- and lesion-related risk factors, stent polymer has been cited as one of the potential causes. In fact, the persistence of durable polymer after complete drug release has been shown to be responsible for local hypersensitivity and inflammatory reactions. Third-generation drug-eluting stents with more biocompatible or biodegradable polymers have subsequently been developed to address this problem. In this article, we evaluate and discuss the concept and clinical results (safety and efficacy of a third-generation drug-eluting stent with biodegradable polymer: the Nobori® stent. Keywords: percutaneous coronary intervention, stent thrombosis, antiplatelet therapy

  2. 携带缓释药物的生物可降解输尿管支架体内外降解特性研究%Biodegradation characteristics of a new kind of drug-eluting biodegradable ureteral stent in vivo and in vitro

    Institute of Scientific and Technical Information of China (English)

    符伟军; 张旭; 曹磊; 徐福强; 李钢; 王忠新; 洪宝发; 王晓雄; 胡堃; 崔福斋

    2010-01-01

    目的 观察携带缓释药物的生物可降解输尿管支架的体内外降解特性,比较输尿管裸支架与输尿管药物支架的生物相容性等差异.方法 将输尿管裸支架与输尿管药物支架分别浸泡于新鲜人体尿液中,观察体外支架降解.将两种输尿管支架分别包埋于18只Wistar大鼠脊柱两侧肌肉内.通过组织切片染色、扫描电镜、相对分子质量测定及质量变化分析体内生物可降解特性差异.结果 输尿管药物支架体外人体尿液浸泡10周时,支架失重率已达35%.切片染色发现组织反应较轻,纤维增生不明显.扫描电镜支架表面失去原有形态,出现大块状脱落物.12周时,降解为细小泥沙样颗粒输尿管裸支架组纤维膜厚(21.24±3.27)μm,输尿管药物支架组纤维膜厚(10.75±3.69)μm,两组比较差异有统计学意义(P<0.01).结论 与输尿管裸支架比较,输尿管药物支架的降解特性相似,但炎症反应轻,包裹纤维膜厚度更薄,具有良好的组织相容性.%Objective To observe the degradation characteristics of the novel drug-eluting biodegradable polylactide ureteral stents in vivo and in vitro, and to compare biocompatibility differences of the pure biodegradable ureteral stents with paclitaxel-eluting biodegradable ureteral stent. Methods The polylactide ureteral stents were dipped into fresh urine specimen and urinary environment simulated in vivo by shocks. And in vivo these two kinds of ureteral stents were implanted in the dorsal muscle of 16 Wistar rats. Histological study was used to investigate the tissue reaction of the material and the differeces of these two kind of ureteral stents were evaluated. Scanning election microscopy (SEM) and measurement of gravity and molecular weight were performed to make out the biodegradation characteristics of stents in vitro and in vivo. Results After being soaked in human urine for 10 weeks, weight of the novel drug-eluting stents was decreased by 35

  3. Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: Final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472)

    Energy Technology Data Exchange (ETDEWEB)

    Kitrou, Panagiotis M., E-mail: panoskitrou@gmail.com [Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion 26504 (Greece); Katsanos, Konstantinos [Department of Interventional Radiology, Guy' s and St. Thomas’ Hospitals, NHS Foundation Trust, King' s Health Partners, London SE1 7EH (United Kingdom); Spiliopoulos, Stavros; Karnabatidis, Dimitris; Siablis, Dimitris [Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion 26504 (Greece)

    2015-03-15

    Highlights: •1-Year target lesion primary patency significantly higher after PCB application compared to plain balloon angioplasty in the failing dialysis access. •Significant difference in favor of PCB in cumulative primary patency of AVGs at 1 year. •No significant difference in cumulative primary patency of AVFs treated with PCB at 1 year. •Cost effectiveness analysis performed. •Paclitaxel-coated balloon angioplasty proves to be a cost-effective option for treating dialysis access. -- Abstract: Objective: To report the final results and cost-effectiveness analysis of a prospective randomized controlled trial investigating drug-eluting balloon (DEB) versus plain balloon angioplasty (BA) for the treatment of failing dialysis access ( (NCT01174472)). Methods: 40 patients were randomized to angioplasty with either DEB (n = 20) or BA (n = 20) for treatment of significant venous stenosis causing a failing dialysis access. Both arteriovenous fistulas (AVF) and synthetic arteriovenous grafts (AVG) were included. Angiographic follow up was scheduled every two months. Primary endpoints were technical success and target lesion primary patency at 1 year. Cumulative and survival analysis was performed. Incremental net benefit (INB) and incremental cost effectiveness ratio (ICER) were calculated and the cost-effectiveness acceptability curve (CEAC) was drawn. Results: Baseline variables were equally distributed between the two groups. At 1 year, cumulative target lesion primary patency was significantly higher after DEB application (35% vs. 5% after BA, p < 0.001). Overall, median primary patency was 0.64 years in case of DEB vs. 0.36 years in case of BA (p = 0.0007; unadjusted HR = 0.27 [95%CI: 0.13–0.58]; Cox adjusted HR = 0.23 [95%CI: 0.10–0.50]). ICER was 2198 Euros (€) per primary patency year of dialysis access gained. INB was 1068€ (95%CI: 31–2105€) for a willingness-to-pay (WTP) threshold of 5000€ (corresponding acceptability probability >97

  4. Evaluation of myocardial blood flow and coronary flow reserve after implantation of a bioresorbable vascular scaffold versus metal drug-eluting stent: an interim one-month analysis of the VANISH trial.

    Science.gov (United States)

    Stuijfzand, Wijnand J; Raijmakers, Pieter G; Driessen, Roel S; Lammertsma, Adriaan A; van Rossum, Albert C; Nap, Alexander; Appelman, Yolande; Lemkes, Jorrit S; van Leeuwen, Maarten A; van Royen, Niels; Knaapen, Paul

    2016-08-05

    A randomised clinical trial of bioresorbable vascular scaffold (BVS) vs. metal drug-eluting stent (DES) was initiated, using positron emission tomography (PET) perfusion imaging to assess the effects of both treatments on (hyperaemic) myocardial blood flow (MBF) and coronary flow reserve (CFR) over a three-year period (VANISH trial). In the present study, early, i.e., after one month, MBF and CFR are reported. Sixty patients (45 men [75%], 55±7 years) with a documented single-vessel type A or B1 lesion were included in this single-blind randomised clinical trial. Patients were randomised to implantation of a BVS or DES in a one-to-one fashion. Approximately one month after percutaneous coronary intervention, patients underwent [15O]H2O PET to assess (hyperaemic) MBF, cold pressor test MBF, and CFR. One patient refused PET perfusion at one-month follow-up (in the DES arm). MBF of the treated myocardial territory during rest, CPT, and hyperaemia were not different in BVS-treated patients as compared to DES-treated patients (1.02±0.28 vs. 0.96±0.24 mL·min-1·g-1, p=0.38, 1.20±0.38 vs. 1.08±0.23 mL·min-1·g-1, p=0.16, and 3.04±0.80 vs. 3.33±0.77 mL·min-1·g-1, p=0.16, respectively). CFR of the treated myocardial territory was significantly lower in the BVS-treated patients (3.09±0.94 vs. 3.57±0.85, p<0.05). No differences in PET-derived absolute myocardial perfusion were observed between BVS-treated patients as compared to DES-treated patients at one-month follow-up. CFR was attenuated in BVS-treated patients, although still within the normal range.

  5. 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

    Energy Technology Data Exchange (ETDEWEB)

    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, E-mail: ron.waksman@medstar.net

    2014-04-15

    Objective: 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). Background: Neoatherosclerosis in neointima has been reported in BMS and in DES. Methods: Thirty patients with 36 stented lesions [BMS (n = 17) or DES (n = 19)] > 3 years after implantation were prospectively enrolled. OCT and VH-IVUS were performed and analyzed independently. Stents with ≥ 70% diameter stenosis were excluded. Results: The median duration from implantation was 126.0 months in the BMS group and 60.0 months in the DES group (p < 0.001). Lipid-laden intima (58.8% vs. 42.1%, p = 0.317), thrombus (17.6% vs. 5.3%, p = 0.326), and calcification (35.3% vs. 26.3%, p = 0.559) did not show significant differences between BMS and DES. When divided into 3 time periods, the cumulative incidence of lipid-laden neointima from > 3 years to < 9 years was similar between BMS and DES (42.9% vs. 42.1%, p = 1.000). Furthermore, it continued to gradually increase over time in both groups. OCT-derived thin-cap fibroatheroma (TCFA) was observed in 17.6% of BMS- and 5.3% of DES-treated lesions (p = 0.326). No 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. Conclusion: At long-term follow-up beyond 3 years after implantation, the intra-stent neointimal tissue characteristics appeared similar for both BMS and DES.

  6. Long-term outcome of patients of over 85 years old with acute coronary syndrome undergoing percutaneous coronary stenting: a comparison of bare metal stent and drug eluting stent

    Institute of Scientific and Technical Information of China (English)

    MA Han-ying; ZHOU Yu-jie; Ronald J Dick; SHI Dong-mei; LIU Yu-yang; CHENG Wan-jun; GUO Yong-he; WANG Jian-long; GE Hai-long

    2008-01-01

    Background Patients aged over 85 years have been under-represented in percutaneous coronary intervention (PCI)trials despite an increase in referrals for PCI. The long-term safety and efficacy of percutaneous coronary stenting in patients aged over 85 years with acute coronary syndrome (ACS) remain unclear. Moreover it is unknown whether there are differences between bare metal stent (BMS) and drug eluting stent (DES) in this special population.Methods A total of 80 patients with ACS aged over 85 years undergoing stenting (BMS group n=21 vs DES group n=59)were retrospectively studied. In-hospital, one year and overall clinical follow-up (12-36 months) of major adverse cardiac events (MACEs) including cardiac deaths, myocardial infarction, target lesion revascularization (TLR) and target vessel revascularization (TVR) as well as stroke and other major bleeding were compared between the two groups.Results In the entire cohort, the procedure success rate was 93.8% with TIMI-3 coronary flow post-PCI in 93.8% of the vessels and the procedure related complication was 17.5%. The incidence of in-hospital MACEs in BMS group was higher (14.3% vs 6.8%, P=0.30). The 1-year incidence of MACEs in DES group was 7.0% while there was no MACE in the BMS group. Clinical follow-up for 12-36 months showed that the overall survival free from MACE was 82.9% and the incidence of MACE in the BMS group was lower (5.3% vs 21.1%, P=0.20). Multivariate regression analysis showed that the creatinine level (OR:1.013; 95%C1: 1.006-1.020; P=0.004) and hypertension (OR:3.201; 95%C1: 1.000-10.663;P=0.04) are two major factors affecting the long-term MACE.Conclusions Percutaneous coronary stenting in patients aged over 85 years is safe and provides good short and long-term efficacy. Patients with renal dysfunction and hypertension may have a relatively high incidence of MACE.

  7. Short- and long-term outcomes of single bare metal stent versus drug eluting stent in nondiabetic patients with a simple de novo lesion in the middle and large vessel

    Directory of Open Access Journals (Sweden)

    Li Jian-jun

    2008-08-01

    Full Text Available Abstract Objective This study was aimed to investigate the short- and long-term outcomes of percutaneous coronary intervention (PCI between single bare metal stent (BMS and single drug eluting stent (DES in nondiabetic patients with a simple de novo lesion in the middle and large vessel. Methods Two hundred and thirty-five consecutive patients with a simple de novo lesion in the middle and large vessel were treated with BMS or DES in our hospital from Apr. 2004 to Dec. 2004. The inclusion criteria: a simple de novo lesion in the middle and large vessel, stent diameter ≥ 3.0 mm, stent length ≤ 18 mm, the exclusion criteria: diabetes mellitus, left main trunk disease and left ventricular ejection fraction ≤ 30%. Of them, there were 150 patients in BMS group and 85 patients in DES group, and the rates of lost to follow up were 6.7% and 1.2% respectively. Results BMS group had lower hypercholesteremia rate (22.0% vs 38.8% and higher proportion of TIMI grade 0 (12% vs 1.2% than DES group (all P 0.05. No difference was found in TLR (1.3% vs 1.2%, P = 1.00 and recurrent myocardial infarction (Re-MI (0% vs 1.2%, P = 0.36, cardiac death (0.7% vs 1.2%, P = 1.00 between 1- and 3-year. So were TLR (6.0% vs 5.9%, P = 0.97, Re-MI (0% vs 2.4%, P = 0.06, cardiac death (2.0% vs 3.5%, P = 0.48 and major adverse cardiac events (MACE, 8.7% vs 10.6%, P = 0.63, cardiac death-free cumulative survival (98.7% vs 97.7%, P = 0.56, TLR-free cumulative survival (94.0% vs 94.1%, P = 0.98 and Re-MI-free cumulative survival (100% vs 97.7%, P = 0.06 at 3-year follow-up. Conclusion The single BMS has similar efficacy and safety to single DES in nondiabetic patients with a simple de novo lesion in the middle and large vessel at short- and long-term follow-up.

  8. Clinical outcomes of "complete, partially complete, and incomplete" revascularisation at five-year follow-up after percutaneous intervention of unprotected left main coronary artery disease with drug-eluting stents.

    Science.gov (United States)

    Zhang, Yao-Jun; Iqbal, Javaid; Xu, Bo; Ye, Fei; Zhang, Jun-Jie; Bourantas, Christos V; Pan, Dao-Rong; Tian, Nai-Liang; Kan, Jing; Qian, Xue-Song; Ding, Shi-Qing; Li, Feng; Zhang, Ai-Ping; Liu, Yue-Qiang; Muramatsu, Takashi; Onuma, Yoshinobu; Garcia-Garcia, Hector M; Serruys, Patrick W; Chen, Shao-Liang

    2016-10-10

    The study aimed to examine five-year clinical outcomes of complete (CR), partially complete (PCR), and incomplete revascularisation (ICR) in patients with unprotected left main coronary artery (ULMCA) disease treated with drug-eluting stents (DES). Completeness of revascularisation, defined as revascularisation of all vessels ≥1.5 or 2.5 mm in diameter, has been shown to correlate with outcomes after percutaneous coronary intervention (PCI). There are no data to compare revascularisation strategies on long-term clinical outcomes in patients undergoing PCI of ULMCA disease. This prospective registry enrolled 910 consecutive patients with ULMCA disease undergoing PCI with DES implantation. CR included patients who had a successful revascularisation of all diseased segments with diameter ≥1.5 mm. PCR included patients who had successful revascularisation of all diseased segments with diameter ≥2.5 mm. ICR included patients who did not achieve revascularisation for all diseased segments of diameter ≥2.5 mm. The primary endpoint was the incidence of major adverse cardiac events (MACE: a composite of cardiac death, myocardial infarction and repeat revascularisation) at five-year follow-up. CR was achieved in 386 (42.4%), PCR in 227 (25.0%), and ICR in 297 (32.6%) patients. Patients with ICR had a significantly higher rate of MACE (29.6% vs. 22.5% and 15.5%, pfive-year follow-up. After propensity score matching, patients with CR vs. PCR had similar incidences of MACE (hazard ratio [HR]: 1.16, 95% confidence interval [CI]: 0.78-1.74, p=0.46), mortality (HR: 1.27, 95% CI: 0.61-2.63, p=0.53), and cardiac death (1.8% vs. 4.5%; HR: 2.56, 95% CI: 0.80-8.17, p=0.11). On multivariable logistic regression analysis, ICR appears to be an outcome of poor clinical characteristics, comorbidities and complex coronary anatomy. In the treatment of patients with ULMCA disease, ICR was associated with worse long-term clinical outcomes than CR and PCR. PCR has clinical outcomes

  9. The ‘all comer’ Coroflex Please drug-eluting stent registry in Europe and Asia – An overall and transcontinental assessment of the 10-month major adverse cardiac events

    Science.gov (United States)

    Leschke, Matthias; Nhan, Vo Thanh; Waliszewski, Matthias; Palacios, Vicente; Horváth, Iván; Ivanov, Vladimir A.; Tresukosol, Damras; Avraamides, Panicos; Schneider, André; Unverdorben, Martin

    2012-01-01

    Background Randomized trials assess the potential of a medical device in well defined indications while “all comer studies” reveal the device performance in the real clinical environment. Aims This ‘all comers’ registry assessed the 10-month outcome of the Coroflex® Please drug-eluting stent in Europe and Asia by clinically driven major adverse cardiac events. Methods The Coroflex® Please Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease. The primary endpoint was clinically driven target lesion revascularization (TLR) at 9 months. Secondary endpoints were technical success, in-hospital outcomes, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) for subgroup analyses. Results Of the enrolled 1230 patients (63.6 ± 11.2 years, 33.9% diabetics), 339 (27.6%) had an acute coronary syndrome, 148 (12.1%) STEMI and 191 (15.6%) NSTEMI. After 10.5 ± 3.8 months (follow-up rate 92.8%), the target lesion revascularization rate (TLR) was 7.8% overall, 8.3% in STEMI, and 11.3% in NSTEMI patients. Total MACE was 11.1% and significantly higher in ACS with either diabetes mellitus (22.9%, p = 0.017) or age ≥75 years (25.4%, p = 0.026). In European and Asian patients MI rates (5.2% vs 3.1%, p = 0.135) and cardiac death rates (1.6% vs 0.9%, p = 0.414) were similar. The MACE rate was higher in Europe (13.6% vs 4.7%, p < 0.001) driven by a six times higher TLR rate. Conclusions TLR and MACE occurred within the range of previously published data. The incidence of MI and cardiac death were not different between Europe and Asia. MACE were higher in Europe driven by target lesion revascularization. PMID:23102382

  10. First-in-man use of polymer-free valsartan-eluting stents in small coronary vessels: a comparison to polymer-free rapamycin (2%)-eluting stents.

    Science.gov (United States)

    Peters, Stefan; Behnisch, Boris; Heilmann, Torsten; Richter, Christian

    2009-06-01

    Orally administered angiotensin receptor antagonists administered after bare-metal stent implantation and even after drug-eluting stent implantation seem to lower in-stent restenosis rates.Whether valsartan-eluting stents are similarly effective was tested here in a first-in-man trial. The efficacy of a polymer-free drug-eluting stent coated with 300 mcg valsartan was compared to a coating with a 2% rapamycin solution in small (Translumina GmbH, Hechingen, Germany). Fifteen patients (eight males, mean age 64.4+/-7.7 years) were treated with YUKON Choice valsartan-eluting stents and 30 patients (24 males, mean age 65.7+/-8.4 years) received YUKON Choice rapamycin-eluting stents. Clopidogrel was given for six months in all patients. Within the first 30 days, no adverse events occurred in either group. Binary in-stent restenosis rate was 30.8% (four in 13 angiographic controls) in the valsartan-eluting stent group and 35.0% (eight in 20 angiographic controls) in the rapamycin-eluting YUKON Choice stent group. Mean late lumen loss was 0.78+/-0.53 mm and 0.79+/-0.58 mm, respectively. Target lesion and target vessel revascularisation rate was 26.6% and 25.0%, respectively. No restenoses in rapamycin-eluting YUKON Choice stents appeared in 12 patients with adjunct oral valsartan administration. If polymer-free YUKON Choice stents are used in small vessels, valsartan-eluting stents show an identical efficacy as rapamycin-loaded stents. In patients with rapamycin-eluting YUKON Choice stents it seems that the efficacy can be increased by oral valsartan administration.

  11. The efficacy of the drug-eluting stents in the treatment of coronary artery disease in patients with diabetes%药物洗脱支架置入对糖尿病并发冠心病患者不良心血管事件的影响

    Institute of Scientific and Technical Information of China (English)

    黄冰清; 钱菊英

    2009-01-01

    Objective To evaluate the efficacy of the drug-eluting stents in the treatment of coronary artery diseases in patients with diabetes. Methods This study included a retrospective database of 600 consecutive patients with coronary artery disease who underwent drug-eluting stems implantation in Zhong Shan Hospital,including 147 pa-tients with diabetes. The MACE in this study included death of any cause,nonfatal myocardial infarction,target lesion revascularization and target vessel revascularization. All the MACE were recorded. The efficacy of the drug-eluting stents was evaluated by the incidence of MACE and the rate of in-stent restenosis. Results No significant differences were found concerning the incidence of MACE (7. 9% vs 4. 9% ,P = 0. 344) as well as the rate of ISR(6. 0% vs 4.9% ,P =0. 540) between patients with diabetes and patients without diabetes. No significant differences were found concerning the incidence of MACE(7.9% vs 4. 9% ,P = 0. 344) as well as the rate of ISR( 1.4% vs 1.9% ,P = 1. 000) between Cypher stents and TAXUS stents. Conclusion Drug-eluting stents are effective in the treatment of coronary artery disease of patients with diabetes. There was no significant difference in the rate of MACE and in-stent restenosis between the two leading drug-eluting stents of sirolimus eluting Cypher stent and the paclitaxle eluting TAX-US stent.%目的 评价药物洗脱支架置入对糖尿病并发冠心病患者不良事件的影响.方法 对600例行药物洗脱支架植入术的患者进行随访,其中糖尿病患者147例.通过随访术后主要不良心血管事件(包括死亡,非致死性心肌梗死,再次靶病变血运重建和再次靶血管血运重建)和支架内再狭窄的发生率评价药物洗脱支架在糖尿病患者中的疗效.结果 糖尿病患者和非糖尿病患者术后的主要不良心血管事件(7.9%与4.9%,P=0.344)和支架内再狭窄(6.0%与4.9%,P=0.540)发生率之间差异无统计学意义.糖尿病患者植

  12. Late stent malapposition and marked positive vessel remodeling after sirolimus-eluting coronary stent implantation

    Institute of Scientific and Technical Information of China (English)

    ZHANG Feng; QIAN Ju-ying; GE Jun-bo

    2006-01-01

    @@ It has been reported that positive remodeling, regression of neointimal hyperplasia, and late malapposition are associated with brachytherapy, one of the approaches to prevent first-time and recurrent in-stent restenosis.1,2 Recently, some drug-eluting stents have been demonstrated to dramatically reduce restenosis rates.3,4 Despite these promising results, these drug-eluting stents may have the same potential risks as brachytherapy, with some similarities between the 2 technologies in anti- proliferative effects on vascular smooth muscle cells and endothelial cells. We reported a case of late stent malapposition and marked positive vessel remodeling after sirolimus-eluting coronary stent implantation.

  13. Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

    OpenAIRE

    Regan, Kelly; Moosavinasab, Soheil; Payne, Philip; Lin, Simon

    2016-01-01

    The promise of drug repurposing is that existing drugs may be used for new disease indications in order to curb the high costs and time for approval. The goal of computational methods for drug repurposing is to enable solutions for safer, cheaper and faster drug discovery. Towards this end, we developed a novel method that integrates genetic and clinical phenotype data from large-scale GWAS and PheWAS studies with detailed drug information on the concept of transitive Drug-Gene-Disease triads...

  14. Early vascular healing with rapid breakdown biodegradable polymer sirolimus-eluting versus durable polymer everolimus-eluting stents assessed by optical coherence tomography

    Energy Technology Data Exchange (ETDEWEB)

    Tada, Tomohisa, E-mail: tomohisa@dhm.mhn.de [Deutsches Herzzentrum, Technische Universität, München (Germany); Byrne, Robert A. [Deutsches Herzzentrum, Technische Universität, München (Germany); Schuster, Tibor [Institut für Medizinische Statistik und Epidemiologie, München (Germany); Cuni, Rezarta [Deutsches Herzzentrum, Technische Universität, München (Germany); Kitabata, Hironori [Wakayama Medical University, Wakayama (Japan); Tiroch, Klaus [Deutsches Herzzentrum, Technische Universität, München (Germany); Dirninger, Alfred; Gratze, Franz; Kaspar, Klaus; Zenker, Gerald [Landeskrankenhaus Bruck/Mur (Austria); Joner, Michael; Schömig, Albert; Kastrati, Adnan [Deutsches Herzzentrum, Technische Universität, München (Germany)

    2013-03-15

    Background: Differences in early arterial healing patterns after stent implantation between biodegradable and durable polymer based new generation drug-eluting stents are not well understood. The aim of this study was to compare the healing patterns of a novel rapid breakdown (≤ 8 weeks) biodegradable polymer sirolimus-eluting stent (BP-SES) with a durable polymer everolimus-eluting stent (EES) using intravascular optical coherence tomography (OCT) at 4 months. Methods: A total of 20 patients were randomly assigned to stenting with BP-SES (n = 11) or EES (n = 9). Overall intravascular imaging was available for 15 (75%) patients. The primary endpoint was the difference in rate of uncovered struts between BP-SES and EES. To account for strut-level clustering, the results in both treatment groups were compared using a generalized linear mixed model approach. Results: Regarding the primary endpoint, BP-SES as compared to EES showed similar rates of uncovered struts (37 [6.8%] versus 167 [17.5%], odds ratio (OR) 0.45 (95% CI 0.09-2.24), p = 0.33). There were no malapposed struts in BP-SES group and 14 malapposed struts in EES group (p = 0.97). No difference in percent neointimal volume (14.1 ± 8.2% vs. 11.4 ± 6.4%, p = 0.56) was observed. Conclusions: Although rapid-breakdown BP-SES as compared to EES showed signs of improved early tissue coverage, after adjustment for strut-level clustering these differences were not statistically significant. No differences in ability to suppress neointimal hyperplasia after stent implantation between 2 stents were observed.

  15. 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.

  16. Three-year clinical outcome after treatment of chronic total occlusions with second-generation drug-eluting stents in the TWENTE trial

    NARCIS (Netherlands)

    van Houwelingen, K. Gert; Sen, Hanim; Sen, Hanim; Lam, Ming Kai; Tandjung, Kenneth; Tandjung, K.; Löwik, Marije M.; de Man, Frits H.A.F.; Louwerenburg, J. (Hans) W.; Stoel, Martin G.; Hartmann, Marc; Linssen, Gerard C.M.; Doggen, Catharina Jacoba Maria; von Birgelen, Clemens

    2015-01-01

    Objective To compare long-term outcome of patients treated for chronic total occlusion (CTO) lesions versus patients treated for non-CTO lesions only. Background Percutaneous coronary interventions (PCI) for CTO lesions generally have a higher adverse event risk than PCI for non-CTO lesions. However

  17. Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions

    DEFF Research Database (Denmark)

    Haude, Michael; Ince, Hüseyin; Abizaid, Alexandre;

    2016-01-01

    patients (3.4%), consisting of one death of unknown cause, one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional event occurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienced a definite...

  18. Validation of the DAPT score in patients randomized to 6 or 12 months clopidogrel after predominantly second-generation drug-eluting stents

    DEFF Research Database (Denmark)

    Harada, Yukinori; Michel, Jonathan; Lohaus, Raphaela

    2017-01-01

    The DAPT score is a recently-proposed decision tool for guiding optimal duration of dual antiplatelet therapy (DAPT). It showed modest accuracy in prior derivation and validation cohorts of patients with ≥12 months DAPT. This study was aimed to evaluate the validity of the DAPT score in a cohort ...

  19. Three-year clinical outcome after treatment of chronic total occlusions with second-generation drug-eluting stents in the TWENTE trial

    NARCIS (Netherlands)

    Houwelingen, van K. Gert; Sen, Hanim; Lam, Ming Kai; Tandjung, Kenneth; Löwik, Marije M.; Man, de Frits H.A.F.; Louwerenburg, J. (Hans) W.; Stoel, Martin G.; Hartmann, Marc; Linssen, Gerard C.M.; Doggen, C.J.M.; Birgelen, von C.

    2015-01-01

    Objective To compare long-term outcome of patients treated for chronic total occlusion (CTO) lesions versus patients treated for non-CTO lesions only. Background Percutaneous coronary interventions (PCI) for CTO lesions generally have a higher adverse event risk than PCI for non-CTO lesions. Howeve

  20. Lectin-mediated drug delivery: the second generation of bioadhesives.

    Science.gov (United States)

    Lehr, C M

    2000-03-01

    This paper reviews some recent developments in the area of bioadhesive drug delivery systems. The area of bioadhesion in drug delivery had started some 20 years ago by using so-called mucoadhesive polymers. Many of these polymers were already used as excipients in pharmaceutical formulations. This has facilitated the development of the first bioadhesive drug products, which are now commercially available. A major disadvantage of the hitherto known mucoadhesives, however, is their non-specificity with respect to the substrate. In particular for gastro-intestinal applications, this may cause some premature inactivation and moreover limits the duration of mucoadhesive bonds to the relatively fast mucus turnover. Nevertheless, for some mucoadhesive polymers other interesting functionalities were discovered, such as their ability to modulate epithelial permeability and to inhibit proteolytic enzymes. In contrast to the mucoadhesive polymers, lectins and some other adhesion molecules specifically recognize receptor-like structures of the cell membrane and therefore bind directly to the epithelial cells themselves ("cytoadhesion") rather than to the mucus gel layer. Furthermore, when bioadhesion is receptor-mediated, it is not only restricted to mere binding, but may subsequently trigger the active transport of large molecules or nanoscalic drug carrier systems by vesicular transport processes (endo-/transcytosis). Rather than only acting as a platform for controlled release systems, the concept of lectin-mediated bioadhesion therefore bears the potential for the controlled delivery of macromolecular biopharmaceuticals at relevant biological barriers, such as the epithelia of the intestinal or respiratory tract.

  1. Beyond THC: the new generation of cannabinoid designer drugs

    Directory of Open Access Journals (Sweden)

    Liana eFattore

    2011-09-01

    Full Text Available Synthetic cannabinoids are functionally similar to delta9-tetrahydrocannabinol (THC, the psychoactive principle of cannabis, and bind to the same cannabinoid receptors in the brain and peripheral organs. From 2008, synthetic cannabinoids were detected in herbal smoking mixtures sold on websites and in head shops under the brand name of Spice Gold, Yucatan Fire, Aroma, and others. Although these products (also known as Spice drugs or legal highs do not contain tobacco or cannabis, when smoked they produce effects similar to THC. Intoxication, withdrawal, psychosis and death have been recently reported after consumption, posing difficult social, political and health challenges. More than 140 different Spice products have been identified to date. The ability to induce strong cannabis-like psychoactive effects, along with the fact that they are readily available on the Internet, still legal in many countries, marketed as natural safe substances, and undetectable by conventional drug screening tests, has rendered these drugs very popular and particularly appealing to young and drug-naïve individuals seeking new experiences. An escalating number of compounds with cannabinoid receptor activity are currently being found as ingredients of Spice, of which almost nothing is known in terms of pharmacology, toxicology and safety. Since legislation started to control the synthetic cannabinoids identified in these herbal mixtures, many new analogs have appeared on the market. New cannabimimetic compounds are likely to be synthesized in the near future to replace banned synthetic cannabinoids, leading to a dog chasing its tail situation. Spice smokers are exposed to drugs that are extremely variable in composition and potency, and are at risk of serious, if not lethal, outcomes. Social and health professionals should maintain a high degree of alertness for Spice use and its possible psychiatric effects in vulnerable people.

  2. Concentration effects on peptide elution from pendant PEO layers.

    Science.gov (United States)

    Wu, Xiangming; Ryder, Matthew P; McGuire, Joseph; Schilke, Karl F

    2014-06-01

    In earlier work, we have provided direction for development of responsive drug delivery systems based on modulation of structure and amphiphilicity of bioactive peptides entrapped within pendant polyethylene oxide (PEO) brush layers. Amphiphilicity promotes retention of the peptides within the hydrophobic inner region of the PEO brush layer. In this work, we describe the effects of peptide surface density on the conformational changes caused by peptide-peptide interactions, and show that this phenomenon substantially affects the rate and extent of peptide elution from PEO brush layers. Three cationic peptides were used in this study: the arginine-rich amphiphilic peptide WLBU2, the chemically identical but scrambled peptide S-WLBU2, and the non-amphiphilic homopolymer poly-l-arginine (PLR). Circular dichroism (CD) was used to evaluate surface density effects on the structure of these peptides at uncoated (hydrophobic) and PEO-coated silica nanoparticles. UV spectroscopy and a quartz crystal microbalance with dissipation monitoring (QCM-D) were used to quantify changes in the extent of peptide elution caused by those conformational changes. For amphiphilic peptides at sufficiently high surface density, peptide-peptide interactions result in conformational changes which compromise their resistance to elution. In contrast, elution of a non-amphiphilic peptide is substantially independent of its surface density, presumably due to the absence of peptide-peptide interactions. The results presented here provide a strategy to control the rate and extent of release of bioactive peptides from PEO layers, based on modulation of their amphiphilicity and surface density.

  3. Comparison of generation 3 polyamidoamine dendrimer and generation 4 polypropylenimine dendrimer on drug loading, complex structure, release behavior, and cytotoxicity

    Directory of Open Access Journals (Sweden)

    Shao N

    2011-12-01

    Full Text Available Naimin Shao1, Yunzhang Su1, Jingjing Hu2, Jiahai Zhang3, Hongfeng Zhang1, Yiyun Cheng1,41School of Life Sciences, East China Normal University, Shanghai, 2CAS Key Laboratory of Soft Matter Chemistry, Department of Chemistry, University of Science and Technology of China, Hefei,  3School of Life Sciences, University of Science and Technology of China, Hefei, 4Shanghai Key Laboratory of Magnetic Resonance, Department of Physics, East China Normal University, Shanghai, ChinaBackground: Polyamidoamine (PAMAM and polypropylenimine (PPI dendrimers are the commercially available and most widely used dendrimers in pharmaceutical sciences and biomedical engineering. In the present study, the loading and release behaviors of generation 3 PAMAM and generation 4 PPI dendrimers with the same amount of surface amine groups (32 per dendrimer were compared using phenylbutazone as a model drug.Methods: The dendrimer-phenylbutazone complexes were characterized by 1H nuclear magnetic resonance and nuclear Overhauser effect techniques, and the cytotoxicity of each dendrimer was evaluated.Results: Aqueous solubility results suggest that the generation 3 PAMAM dendrimer has a much higher loading ability towards phenylbutazone in comparison with the generation 4 PPI dendrimer at high phenylbutazone-dendrimer feeding ratios. Drug release was much slower from the generation 3 PAMAM matrix than from the generation 4 PPI dendrimer. In addition, the generation 3 PAMAM dendrimer is at least 50-fold less toxic than generation 4 PPI dendrimer on MCF-7 and A549 cell lines.Conclusion: Although the nuclear Overhauser effect nuclear magnetic resonance results reveal that the generation 4 PPI dendrimer with a more hydrophobic interior encapsulates more phenylbutazone, the PPI dendrimer-phenylbutazone inclusion is not stable in aqueous solution, which poses a great challenge during drug development.Keywords: dendrimer, polyamidoamine, polypropylenimine, drug delivery, cytotoxicity

  4. 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

  5. Subcutaneous implants for long-acting drug therapy in laboratory animals may generate unintended drug reservoirs

    Directory of Open Access Journals (Sweden)

    Michael Guarnieri

    2014-01-01

    Full Text Available Background: Long-acting therapy in laboratory animals offers advantages over the current practice of 2-3 daily drug injections. Yet little is known about the disintegration of biodegradable drug implants in rodents. Objective: Compare bioavailability of buprenorphine with the biodegradation of lipid-encapsulated subcutaneous drug pellets. Methods: Pharmacokinetic and histopathology studies were conducted in BALB/c female mice implanted with cholesterol-buprenorphine drug pellets. Results: Drug levels are below the level of detection (0.5 ng/mL plasma within 4-5 days of implant. However, necroscopy revealed that interstitial tissues begin to seal implants within a week. Visual inspection of the implant site revealed no evidence of inflammation or edema associated with the cholesterol-drug residue. Chemical analyses demonstrated that the residues contained 10-13% of the initial opiate dose for at least two weeks post implant. Discussion: The results demonstrate that biodegradable scaffolds can become sequestered in the subcutaneous space. Conclusion: Drug implants can retain significant and unintended reservoirs of drugs.

  6. Improved blood compatibility of rapamycin-eluting stent by incorporating curcumin.

    Science.gov (United States)

    Pan, C J; Tang, J J; Shao, Z Y; Wang, J; Huang, N

    2007-09-01

    This paper dealt with improving the blood compatibility of the rapamycin-eluting stent by incorporating curcumin. The rapamycin- and rapamycin/curcumin-loaded PLGA (poly(d,l-lactic acid-co-glycolic acid)) coatings were fabricated onto the surface of the stainless steel stents using an ultrasonic atomization spray method. The structure of the coating films was characterized by Fourier transform infrared spectroscopy (FTIR). The optical microscopy and scanning electron microscopy (SEM) images of the drug-eluting stents indicated that the surface of all drug-eluting stents was very smooth and uniform, and there were not webbings and "bridges" between struts. There were not any cracks and delaminations on stent surface after expanded by the angioplasty balloon. The in vitro platelet adhesion and activation were investigated by static platelet adhesion test and GMP140 (P-selection), respectively. The clotting time was examined by activated partially prothromplastin time (APTT) test. The fibrinogen adsorption on the drug-loaded PLGA films was evaluated by enzyme-linked immunosorbent assay (ELISA). All obtained data showed that incorporating curcumin in rapamycin-loaded PLGA coating can significantly decrease platelet adhesion and activation, prolong APTT clotting time as well as decrease the fibrinogen adsorption. All results indicated that incorporating curcumin in rapamycin-eluting coating obviously improve the blood compatibility of rapamycin-eluting stents. It was suggested that it may be possible to develop a drug-eluting stent which had the characteristics of not only good anti-proliferation but also improved anticoagulation.

  7. DESyne novolimus-eluting coronary stent is superior to Endeavor zotarolimus-eluting coronary stent at five-year follow-up: final results of the multicentre EXCELLA II randomised controlled trial.

    Science.gov (United States)

    Iqbal, Javaid; Verheye, Stefan; Abizaid, Alexandre; Ormiston, John; de Vries, Ton; Morrison, Lynn; Toyloy, Sara; Fitzgerald, Peter; Windecker, Stephan; Serruys, Patrick W

    2016-12-10

    Newer-generation drug-eluting stents (DES) have been shown to be superior to first-generation DES. Current-generation DES have zotarolimus, everolimus or biolimus as antiproliferative drugs. Novolimus, a metabolite of sirolimus, has been specifically developed to provide efficacy similar to currently available agents at a lower dose and thus requires a lower polymer load. We report the final five-year outcomes of the EXCELLA II trial comparing a zotarolimus-eluting stent (ZES) with a novolimus-eluting stent (NES). EXCELLA II is a prospective, multicentre, single-blind, non-inferiority clinical trial. Patients (n=210) with a maximum of two de novo lesions in two different epicardial vessels were randomised (2:1) to treatment with either NES (n=139) or ZES (n=71). At five-year follow-up, patients in the NES group had a significantly lower incidence of the patient-oriented (HR 0.53, 95% CI: 0.32-0.87, p=0.013) and device-oriented (HR 0.38, 95% CI: 0.17-0.83, p=0.011) composite endpoints. There was no difference in cardiac death and definite/probable stent thrombosis between the two groups; however, there was a trend towards reduction in myocardial infarction and repeat revascularisation in the NES group at five-year follow-up. At five-year follow-up, the incidence of device- and patient-oriented events was significantly lower in the NES group. Further studies, adequately powered for clinical outcomes, are warranted.

  8. HIV entry inhibitors: a new generation of antiretroviral drugs

    Institute of Scientific and Technical Information of China (English)

    Elias KRAMBOVITIS; Filippos PORICHIS; Demetrios A SPANDIDOS

    2005-01-01

    AIDS is presently treatable, and patients can have a good prognosis due to the success of highly active antiretroviral therapy (HAART), but it is still not curable or preventable. High toxicity of HAART, and the emergence of drug resistance add to the imperative to continue research into new strategies and interventions.Considerable progress in the understanding of HIV attachment and entry into host cells has suggested new possibilities for rationally designing agents that interfere with this process. The approval and introduction of the fusion inhibitor enfuvirtide (Fuzeon) for clinical use signals a new era in AIDS therapeutics. Here we review the crucial steps the virus uses to achieve cell entry, which merit attention as potential targets, and the compounds at pre-clinical and clinical development stages, reported to effectively inhibit cell entry.

  9. Research about the relevant factors of late thrombosis in drug-eluting stents ZHANG Hai-jun, CHEN Huixiao,%药物涂层支架晚期血栓形成相关因素的分析

    Institute of Scientific and Technical Information of China (English)

    张海军; 杨静; 李曦; 陈会校; 张强; 李俊峡; 齐书英; 李鑫平; 崔俊玉; 孔令海; 石勇

    2013-01-01

    Objective To investigate the relevant factors of late thrombosis in drug-eluting stents (DES). Methods The patients ( n=30 ) with late thrombosis in stent after DES implantation ( thrombosis group ) and patients ( n=30 ) without thrombosis instent for at least 1 year ( control group ) were chosen from Jan. 2008 to Jan. 2013. and the adherent situation and stent position as well as the length and diameter were all conculated by 64 SCT, meanwhile the history of all the patients were collcted for further analysis. Results Compared with control group, the incidence of DES malapposition ( 60.0% vs. 10.0% ) , ratio of applying squeezing bracket technique ( 36.7% vs. 13.3% ) , incidence of bifurcation lesion ( 43.3% vs. 16.7% ) , and implantation ratio of multiple DES ( >4, 33.3% vs. 0 ) were all higher in thrombosis group, and at the same time, the average stent length was longer [ ( 39.2 ± 20 ) mm vs. ( 21.7 ± 7 ) mm] and average stent diameter was larger [ ( 3.0 ± 0.5 ) mm vs. ( 2.5 ± 0.5 ) mm, P<0.05], The incidences of complicated decrease of left ventricular ejection fraction ( LVEF ) , diabetes, renal insufficiency and premature discontinuation of dual antiplatelet treatment were all higher in thrombosis group than those in control group. Conclusion There're many factors for the thrombosis in DES, including complex lesions, stenting too much or too long, as well as the history of diabetes, renal insufficiency, also lack of anticoagulation.%目的 探讨药物涂层支架(DES)晚期血栓形成的相关因素.方法 分别纳入我院2008年1月~2013年1月DES置入术后发生晚期血栓患者30例(血栓组)和置入DES 1年以上未发生支架内血栓患者30例(对照组),通过64SCT冠状动脉成像观测支架贴壁情况、支架置入部位个数及长度与直径,采集病史分析晚期血栓的危险因素.结果 与对照组相比,血栓组支架贴壁不良发生率(60.0%vs.10.0%)、采用挤压支架技术(crush技术)比例(36.7% vs.13.3%)

  10. NanoCrySP technology for generation of drug nanocrystals: translational aspects and business potential.

    Science.gov (United States)

    Shete, Ganesh; Bansal, Arvind Kumar

    2016-08-01

    Drug nanocrystals have rapidly evolved into a mature drug delivery strategy in the last decade, with almost 16 products currently on the market. Several "top-down" technologies are available in the market for generation of nanocrystals. Despite several advantages, very few bottom-up technologies have been explored for commercial purpose. This short communication highlights a novel, bottom-up, spray drying based technology-NanoCrySP-to generate drug nanocrystals. Nanocrystals are generated in the presence of non-polymeric excipients that act as crystallization inducer for the drug. Excipients encourage crystallization of drug by plasticization, primary heterogeneous nucleation, and imparting physical barrier to crystal growth. Nanocrystals have shown significant improvement in dissolution and thereby oral bioavailability. NanoCrySP technology is protected through patents in India, the USA, and the European Union. NanoCrySP can be utilized for (i) pharmaceutical development of new chemical entities, (ii) differentiated products of existing molecules, and (iii) generic drug products. The aggregation of drug nanocrystals generated using NanoCrySP poses significant challenges in the nanocrystal-based product development. Addition of stabilizers either during spray drying or during dissolution has shown beneficial effects.

  11. Mass spectrometric detection of short-lived drug metabolites generated in an electrochemical microfluidic chip.

    Science.gov (United States)

    van den Brink, Floris T G; Büter, Lars; Odijk, Mathieu; Olthuis, Wouter; Karst, Uwe; van den Berg, Albert

    2015-02-03

    The costs of drug development have been rising exponentially over the last six decades, making it essential to select drug candidates in the early drug discovery phases before proceeding to expensive clinical trials. Here, we present novel screening methods using an electrochemical chip coupled online to mass spectrometry (MS) or liquid chromatography (LC) and MS, to generate phase I and phase II drug metabolites and to demonstrate protein modification by reactive metabolites. The short transit time (∼4.5 s) between electrochemical oxidation and mass spectrometric detection, enabled by an integrated electrospray emitter, allows us to detect a short-lived radical metabolite of chlorpromazine which is too unstable to be detected using established test routines. In addition, a fast way to screen candidate drugs is established by recording real-time mass voltammograms, which allows one to identify the drug metabolites that are expected to be formed upon oxidation by applying a linear potential sweep and simultaneously detect oxidation products. Furthermore, detoxification of electrochemically generated reactive metabolites of paracetamol was mimicked by their adduct formation with the antioxidant glutathione. Finally, the potential toxicity of reactive metabolites can be investigated by the modification of proteins, which was demonstrated by modification of carbonic anhydrase I with electrochemically generated reactive metabolites of paracetamol. With this series of experiments, we demonstrate the potential of this electrochemical chip as a complementary tool for a variety of drug metabolism studies in the early stages of drug discovery.

  12. Nanoporous titanium surfaces for sustained elution of proteins and antibiotics.

    Directory of Open Access Journals (Sweden)

    Amirhossein Ketabchi

    Full Text Available Current medically relevant metals for prosthetic reconstructions enjoy a relatively good success rate, but their performance drops significantly in patients with compromised health status, and post-surgical infections still remain an important challenge. To address these problems, different nanotechnology-based strategies have been exploited to create implantable metals with an enhanced bioactivity and antibacterial capacities. Among these, oxidative nanopatterning has emerged as a very effective approach to engender nanoporous surfaces that stimulate and guide the activity of adhering cells. The resulting nanoporosity is also attractive because it offers nanoconfined volumes that can be exploited to load bioactive compounds and modulate their release over time. Such extended elution is needed since a single exposure to growth factors and/or antibiotics, for instance, may not be adequate to further sustain bone regeneration and/or to counteract bacterial colonization. In this article, we assessed the capacities of nanoporous titanium surfaces generated by oxidative nanopatterning to provide controlled and sustained elution of proteins and antibiotic molecules. To this end, we have selected bovine serum albumin (BSA and vancomycin to reflect commonly used compounds, and investigated their adsorption and elution by Fourier-transform infrared (FT-IR and ultraviolet-visible (UV-VIS spectroscopy. Our results demonstrate that while the elution of albumin is not significantly affected by the nanoporosity, in the case of vancomycin, nanoporous surfaces provided an extended release. These findings were successively correlated to the establishment of interactions with the surface and physical-entrapment effects exerted by the nanopores, ultimately highlighting their synergistic contribution to the release profiles and thus their importance in the design of nanostructured eluting platforms for applications in medicine.

  13. Nanoparticles generated by PEG-Chrysin conjugates for efficient anticancer drug delivery.

    Science.gov (United States)

    Zheng, Hui; Li, Sai; Pu, Yuji; Lai, Yusi; He, Bin; Gu, Zhongwei

    2014-08-01

    Nanoparticle-based drug delivery systems promise the safety and efficacy of anticancer drugs. Herein, we presented a facile approach to fabricate novel nanoparticles generated by PEG-Chrysin conjugates for the delivery of anticancer drug doxorubicin. Chrysin was immobilized on the terminal group of methoxy poly(ethylene glycol) (mPEG) to form mPEG-Chrysin conjugate. The conjugates were self-assembled into nanoparticles. Doxorubicin (DOX) was loaded in the nanoparticles. The self-assembly, drug release profiles, interactions between nanoparticle and drug, cellular uptake and in vitro anticancer activity of the DOX loaded nanoparticles were investigated. The results showed that the mean diameters of drug loaded nanoparticles were below 200 nm. Strong π-π stacking interaction was tested within the drug loaded nanoparticles. The drug release rate was closely related to the chain length of PEG, shorter PEG chain resulted faster release. The mPEG-Chrysin conjugate was non-toxic to both 3T3 fibroblasts and HepG2 cancer cells. The cellular uptake measurements demonstrated that the mPEG1000-Chrysin nanoparticles exhibited higher capability in endocytosis. The IC50 of drug loaded mPEG1000-Chrysin nanoparticles was 4.4 μg/mL, which was much lower than that of drug loaded mPEG2000-Chrysin nanoparticles (6.8 μg/mL). These nanoparticles provided a new strategy for fabricating antitumor drug delivery systems.

  14. Comparison of two biodegradable-polymer-based sirolimus-eluting stents with varying elution and absorption kinetics in patients with acute myocardial infarction: A subgroup analysis of the PANDA III trial.

    Science.gov (United States)

    Guan, Changdong; Xu, Bo; Qiao, Shubin; Qin, Lei; Li, Yi; Li, Zhanquan; Guo, Yong; Sun, Zhongwei; Song, Lei; Gao, Runlin

    2017-03-01

    Implantation of early-generation metallic drug-eluting stents (DES) in patients with acute myocardial infarction (AMI) is associated with poor vessel wall healing. Use of biodegradable polymer (BP) DES might improve safety outcomes; however, the impact of varying drug elution and polymer absorption kinetics of BP-DES on clinical outcomes in the AMI population is unknown. This subgroup analysis of the randomized PANDA III trial included 732 patients (366 in each group) presenting with recent (<1 month) AMI. Primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), or ischemia-driven target lesion revascularization. Secondary endpoints included a patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization; individual TLF and PoCE components; and definite/probable stent thrombosis (ST). There were no significant differences between-groups in baseline clinical, angiographic, or procedural characteristics other than the proportion of post-dilatation, which was performed more frequently with the BuMA stent (53.9% vs. 44.5%; P = 0.004). After 1 year, compared to Excel SES implantation in patients with AMI, BuMA was associated with similar incidences of TLF and PoCE (5.5% vs. 8.3%, P = 0.14; 8.8% vs. 9.9%, P = 0.61, respectively) but lower incidences of MI (2.5% vs. 6.1%, P = 0.02), target vessel MI (2.2% vs. 5.8%, P = 0.01), and definite/probable ST (0.3% vs. 2.2%, P = 0.04). BuMA SES, with faster drug elution rate and polymer absorption kinetics, might improve safety outcomes compared to Excel SES in the high-risk AMI population. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  15. Blood compatibility of a ferulic acid (FA)-eluting PHBHHx system for biodegradable magnesium stent application.

    Science.gov (United States)

    Zhang, Erlin; Shen, Feng

    2015-01-01

    Magnesium stent has shown potential application as a new biodegradable stent. However, the fast degradation of magnesium stent limited its clinic application. Recently, a biodegradable and drug-eluting coating system was designed to prevent magnesium from fast degradation by adding ferulic acid (FA) in poly (3-hydroxybutyrate-co-3-hydroxyhexanoate) (PHBHHx) by a physical method. In vitro study has demonstrated that the FA-eluting system exhibited strong promotion to the endothelialization, which might be a choice for the stent application. In this paper, the hemolysis rate, the plasma recalcification time (PRT), the plasma prothrombin time (PT) and the kinetic clotting time of the FA-eluting films were investigated and the platelet adhesion was observed in order to assess the blood compatibility of the FA-eluting PHBHHx films in comparison with PHBHHx film. The results have shown that the addition of FA had no influence on the hemolysis, but prolonged PRT, PT and the clotting time and reduced the platelet adhesion and activation, displaying that the FA-eluting PHBHHx exhibited better blood compatibility than PHBHHx. In addition, the effect of alkali treatment on the blood compatibility of FA-eluting PHBHHx was also studied. It was indicated that alkali treatment had no effect on the hemolysis and the coagulation time, but enhanced slightly the platelet adhesion. All these demonstrated that FA-eluting PHBHHx film had good blood compatibility and might be a candidate surface coating for the biodegradable magnesium stent.

  16. Inflammation-induced drug release by using a pH-responsive gas-generating hollow-microsphere system for the treatment of osteomyelitis.

    Science.gov (United States)

    Chung, Ming-Fan; Chia, Wei-Tso; Liu, Hung-Yi; Hsiao, Chun-Wen; Hsiao, Hsu-Chan; Yang, Chih-Man; Sung, Hsing-Wen

    2014-11-01

    In the conventional treatment of osteomyelitis, the penetration of antibiotics into the infected bone is commonly poor. To ensure that the local antibiotic concentration is adequate, this work develops an injectable calcium phosphate (CP) cement in which is embedded pH-responsive hollow microspheres (HMs) that can control the release of a drug according to the local pH. The HMs are fabricated using a microfluidic device, with a shell of poly(D,L-lactic-co-glycolic acid) (PLGA) and an aqueous core that contains vancomycin (Van) and NaHCO3. At neutral pH, the CP/HM cement elutes a negligible concentration of the drug. In an acidic environment, the NaHCO3 that is encapsulated in the HMs reacts with the acid rapidly to generate CO2 bubbles, disrupting the PLGA shells and thereby releasing Van locally in excess of a therapeutic threshold. The feasibility of using this CP/HM cement to treat osteomyelitis is studied using a rabbit model. Analytical results reveal that the CP/HM cement provides highly effective local antibacterial activity. Histological examination further verifies the efficacy of the treatment by the CP/HM cement. The above findings suggest that the CP/HM cement is a highly efficient system for the local delivery of antibiotics in the treatment of osteomyelitis.

  17. Duration of dual antiplatelet therapy after implantation of drug-eluting stents%冠心病介入术后双联抗血小板治疗持续时间的研究

    Institute of Scientific and Technical Information of China (English)

    高阅春; 玉献鹏; 何继强; 陈方

    2012-01-01

    Objective:To evaluate the potential benefit of prolonging 12-month dual antiplatelet therapy among patients with coronary artery disease receiving zotarolimus-eluting stents. Methods: From Sep. 2006 to Jue. 2009, patients with coronary artery disease undergoing PCI with zotarolimus-eluting stents in the cardiology department of Beijing Anzhen Hospital were enrolled. Our clinical endpoint focused on major adverse cardiac or cerebrovascular events (MACCE) , death, nonfatal myocardial infarction (Ml), stroke, and repeat revascular-ization. Follow up was carried out by telephone or outpatient interview. To overcome the defect of non-randomized comparisons, multivariable Cox proportional-hazards regression was carried out to adjust for potential confounding factors. Results:The average follow-up was (28. 4 ±7.4) months. A toal of 915 appropriate patients were divided to two groups; 12-month DAPT group (362) and > 12-month DAFT group (553). Rates of MACCE (3.6% VS. 4. 3% , P =0. 87) and TVR (2. 2% VS. 2. 5% , P =0. 97) did not differ between 12-month DAPT group and > 12-month DAPT group. After adjusted by the multivariable Cox proportional-hazards regression, still no significant differences of the endpoints mentioned above were observed between the two groups. Rates of death Ml or stroke were not significantly different between the two groups either. Conclusion; The use of dual antiplatelet therapy for a period longer than 12 months in patients who had received zotarolimus-eluting. stents was not significantly more effective than aspirin monotherapy in reducing adverse cardiac or cerebrovascular event.%[目的]:对置入佐他莫司洗脱支架的冠心病患者双联抗血小板治疗(DAPT)12个月后,继续延长治疗时间能否获益进行分析.[方法]:回顾性分析2006年9月至2009年6月于北京安贞医院心内科置入佐他莫司洗脱支架的患者,按照DAPT的时间分为:DAPT12个月组和DAPT> 12个月组,通过门诊或电话随访,评价术

  18. 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-generation ...

  19. Impact of dual antiplatelet therapy on blood viscosity after treatment with drug-eluting coronary stents%双联抗血小板治疗对药物洗脱支架术后患者血液流变学的影响

    Institute of Scientific and Technical Information of China (English)

    阚静; 陈绍良; 林玲; 徐海梅; 赵莹莹; 刘彦; 陈峰

    2013-01-01

    目的 探讨双联抗血小板治疗对药物洗脱支架术后不同性别患者血液流变学的影响.方法 选择2009年9月至2009年12月接受药物洗脱支架置入术的598例冠心病患者,排除急性心肌梗死、急性脑梗死、肿瘤、肺源性心脏病、血流变学检查异常者,共有444例患者纳入分析.其中214例在术后9个月完成血液流变学检测随访.用ZL9000 PLUS型血流变测定仪测定全血黏度(高切、中切、低切)、血浆黏度、血细胞比容、红细胞变形指数、红细胞聚集指数、红细胞电泳时间.结果 药物洗脱支架术后双联抗血小板治疗9个月时,患者的全血黏度均明显升高,但全血低切还原黏度轻度降低,男性组红细胞沉降率和红细胞沉降率方程K值(除去血细胞比容的影响后的红细胞沉降率校正值)明显减小,但女性组变化不明显.结论 双联抗血小板治疗可以降低男性红细胞聚集,从而减少男性冠心病患者药物洗脱支架术后主要不良心脏事件的发生.%Objective To study the effect of dual antiplatelet therapy on blood viscosity in women and men after drug-eluting stent implantation. Methods 598 consecutive patients with coronary artery disease were treated by drug-eluting stent implantation from May 2009 to December 2010,of which 444 patients were included in the analysis,excluded acute myocardial infarction,acute cerebral infarction,tumor,cor pulmonale,and abnormal hemorrheology. 214 among them completed with hemorrheology follow-up 9 months after the teatment. The hemorheology was measured with hemorrheology tester (ZL9000 PLUS),including whole blood viscosity (high cut,cut,low cut),plasma viscosity,red blood cell deposited,erythrocyte deformation index,red cell aggregation index, and red blood cells electrophoretic time. Results Whole blood viscosity were significantly increased in patients with dual antiplatelet therapy continue 9-months after drug-eluting stent implantation

  20. Comparison of drug substance impurity profiles generated with extended length columns during packed-column SFC.

    Science.gov (United States)

    Roston, D A; Ahmed, S; Williams, D; Catalano, T

    2001-10-01

    The current study assesses the effect of extending column length during gradient packed column sub/supercritical fluid chromatography (PCSFC) experiments on the detection of known and unknown impurities in a drug substance sample. Quantitative drug substance impurity profiles were generated and compared using multiple column PCSFC and HPLC conditions. Also, chromatographic figures of merit were estimated and compared for components of a standard mixture during PCSFC experiments, which used one column, four columns, and six columns in series.

  1. Generation of human pluripotent stem cell-derived hepatocyte-like cells for drug toxicity screening.

    Science.gov (United States)

    Takayama, Kazuo; Mizuguchi, Hiroyuki

    2017-02-01

    Because drug-induced liver injury is one of the main reasons for drug development failures, it is important to perform drug toxicity screening in the early phase of pharmaceutical development. Currently, primary human hepatocytes are most widely used for the prediction of drug-induced liver injury. However, the sources of primary human hepatocytes are limited, making it difficult to supply the abundant quantities required for large-scale drug toxicity screening. Therefore, there is an urgent need for a novel unlimited, efficient, inexpensive, and predictive model which can be applied for large-scale drug toxicity screening. Human embryonic stem (ES) cells and induced pluripotent stem (iPS) cells are able to replicate indefinitely and differentiate into most of the body's cell types, including hepatocytes. It is expected that hepatocyte-like cells generated from human ES/iPS cells (human ES/iPS-HLCs) will be a useful tool for drug toxicity screening. To apply human ES/iPS-HLCs to various applications including drug toxicity screening, homogenous and functional HLCs must be differentiated from human ES/iPS cells. In this review, we will introduce the current status of hepatocyte differentiation technology from human ES/iPS cells and a novel method to predict drug-induced liver injury using human ES/iPS-HLCs.

  2. Preserving the supersaturation generation capability of amorphous drug-polysaccharide nanoparticle complex after freeze drying.

    Science.gov (United States)

    Kiew, Tie Yi; Cheow, Wean Sin; Hadinoto, Kunn

    2015-04-30

    While the supersaturation generation capability of amorphous nanopharmaceuticals (NPs) in their aqueous suspension form has been well established, their supersaturation generation is adversely affected after drying. Herein we investigated the effects of freeze drying on the supersaturation generation capability of a new class of amorphous NPs referred to as drug nanoplex prepared and stabilized by electrostatic complexation of drug molecules with polysaccharides (dextran sulfate). Using ciprofloxacin as the model drug, two types of freeze-drying adjuvants were investigated, i.e., (1) highly water-soluble excipient (trehalose, mannitol), whose role was to prevent irreversible NPs aggregations upon drying, and (2) crystallization inhibitor (hydroxypropylmethylcellulose (HPMC)), whose role was to suppress crystallization of the dissolved drug and the remaining solid phase. The results showed that dual-adjuvant formulations (i.e. trehalose-HPMC and mannitol-HPMC) were required to preserve the supersaturation generation capability of the drug nanoplex suspension after drying. Freeze drying with only one adjuvant type, or incorporating HPMC as physical mixtures with the freeze-dried nanoplex, were ineffective in preserving the supersaturation. The dual-adjuvant formulations produced prolonged supersaturation levels over 240min at ≈6-8× of the saturation solubility with comparable area under the curve (AUC) in the concentration versus time plot as that exhibited by the suspension form. Copyright © 2015 Elsevier B.V. All rights reserved.

  3. One-year clinical outcomes of Chinese sirolimus-eluting stent in the treatment of unselected patients with coronary artery disease

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    @@ The application of drug-eluting stent (DES), either sirolimus-eluting stent (Cypher, Cordis, USA) or paclitaxel-eluting stent (Taxus, Boston Scientific, USA), in treatment of patients with coronary artery disease (CAD) has achieved great success.1-4 The high cost of imported DES (either Cypher or Taxus) gave the birth to a China-made, polymer-based, sirolimus-eluting stent (Firebird, Microport Company, China). In March 2003, China Food and Drug Administration approved the clinical use of Firebird stent. However, the safety and efficacy of Firebird stent in comparison with Cypher and Taxus stents are still underestimated.

  4. Assessment of a micropatterned hepatocyte coculture system to generate major human excretory and circulating drug metabolites.

    Science.gov (United States)

    Wang, Wendy WeiWei; Khetani, Salman R; Krzyzewski, Stacy; Duignan, David B; Obach, R Scott

    2010-10-01

    Metabolism is one of the important determinants of the overall disposition of drugs, and the profile of metabolites can have an impact on efficacy and safety. Predicting which drug metabolites will be quantitatively predominant in humans has become increasingly important in the research and development of new drugs. In this study, a novel micropatterned hepatocyte coculture system was evaluated for its ability to generate human in vivo metabolites. Twenty-seven compounds of diverse chemical structure and subject to a range of drug biotransformation reactions were assessed for metabolite profiles in the micropatterned coculture system using pooled cryopreserved human hepatocytes. The ability of this system to generate metabolites that are >10% of dose in excreta or >10% of total drug-related material in circulation was assessed and compared to previously reported data obtained in human hepatocyte suspensions, liver S-9 fraction, and liver microsomes. The micropatterned coculture system was incubated for up to 7 days without a change in medium, which offered an ability to generate metabolites for slowly metabolized compounds. The micropatterned coculture system generated 82% of the excretory metabolites that exceed 10% of dose and 75% of the circulating metabolites that exceed 10% of total circulating drug-related material, exceeds the performance of hepatocyte suspension incubations and other in vitro systems. Phase 1 and phase 2 metabolites were generated, as well as metabolites that arise via two or more sequential reactions. These results suggest that this in vitro system offers the highest performance among in vitro metabolism systems to predict major human in vivo metabolites.

  5. Nature and frequency of drug therapy alerts generated by clinical decision support in community pharmacy

    NARCIS (Netherlands)

    Heringa, Mette; Floor-Schreudering, Annemieke; Tromp, P. Chris; de Smet, Peter A G M; Bouvy, Marcel L.

    2016-01-01

    Purpose: The purpose of this study is to investigate the nature, frequency, and determinants of drug therapy alerts generated by a clinical decision support system (CDSS) in community pharmacy in order to propose CDSS improvement strategies. Methods: This is a retrospective analysis of dispensed dru

  6. Evaluation of electrochemical ion exchange for cesium elution

    Energy Technology Data Exchange (ETDEWEB)

    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.

  7. Target lesion revascularisation in patients treated with a sirolimus-eluting or paclitaxel-eluting stent

    DEFF Research Database (Denmark)

    Maeng, Michael; Okkels Jensen, Lisette; Rasmussen, Klaus;

    2007-01-01

    OBJECTIVE: To identify risk factors for clinical-driven target lesion revascularisation (TLR) in patients treated with sirolimus-eluting (Cypher) or paclitaxel-eluting (Taxus) stents in a real-world scenario. DESIGN: From 1 January 2003 to 18 May 2005, all patients treated with a Cypher or Taxus ...

  8. Comparison of zotarolimus-eluting and sirolimus-eluting coronary stents

    DEFF Research Database (Denmark)

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

    2012-01-01

    ABSTRACT: BACKGROUND: We evaluated the effectiveness and safety of a zotarolimus-eluting (ZES) versus a sirolimus-eluting (SES) coronary stent in a large cohort of patients treated with one of these stents in Western Denmark. METHODS: A total of 6,122 patients treated with ZES (n = 2,282) or SES (n...

  9. Elution of leachable components from composites.

    Science.gov (United States)

    Ferracane, J L

    1994-07-01

    A significant amount of residual monomer or short chain polymers remain unbound in set composite material. Due to its potential impact on both the biocompatibility and the structural stability of the restoration, many investigators have studied the elution of these unbound molecules into aqueous media. The results of these studies suggest that elution of leachable components from composites is rapid, with the majority being released within a matter of hours. Weight losses of up to 2% of the mass of the composite have been reported under certain conditions. The studies have also shown that the extent and rate of elution of components from composites is dependent upon several factors. The quantity of leachables has been correlated to the degree of cure of the polymer network. The composition and solubility characteristics of the extraction solvent influence the kinetics and mechanism of the elution process. Elution is generally thought to occur via diffusion of molecules through the resin matrix, and is therefore dependent upon the size and chemical characteristics of the leachable species.

  10. 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.

  11. WE-G-BRE-08: Radiosensitization by Olaparib Eluting Nanospheres

    Energy Technology Data Exchange (ETDEWEB)

    Tangutoori, S; Kumar, R; Sridhar, S [Northeastern University, Boston, MA (United States); Korideck, H; Makrigiorgos, G [Dana-Farber Cancer Institute, Boston, MA (United States); Cormack, R [Harvard Medical School, Boston, MA (United States)

    2014-06-15

    Purpose: Permanent prostate brachytherapy often uses inert bio-absorbable spacers to achieve the desired geometric distribution of sources within the prostate. Transforming these spacers into implantable nanoplatforms for chemo-radiation therapy (INCeRT) provides a means of providing sustained in-situ release of radiosensitizers in the prostate to enhance the therapeutic ratio of the procedure. Olaparib, a PARP inhibitor, suppresses DNA repair processes present during low dose rate continuous irradiation. This work investigates the radiosensitizing/DNA damage repair inhibition by NanoOlaparib eluting nanospheres. Methods: Human cell line PC3 (from ATCC), was maintained in F12-k medium supplemented with fetal bovine serum. Clonogenic assay kit (from Fischer Scientific) was used to fix and stain the cells to determine the long term effects of irradiation. Nanoparticle size and zeta potential of nanospheres were determined using a Zeta particle size analyzer. The incorporation of Olaparib in nanospheres was evaluated by HPLC. Irradiation was performed in a small animal irradiator operating at 220 KeV.The long term effects of radio-sensitization with olaparib and nanoolaparib was determined using the clonogenic assay at 2 Gy and 4 Gy doses. The cells were allowed to grow for around 10 doubling cycles, The colonies were fixed and stained using clonogenic assay kit. The excess stain was washed off using DI water and the images were taken using a digital camera. Results: Radiosensitization studies were carried out in prostate cancer cell line, PC3 radiation at 0, 2 and 4Gy doses. Strongest dose response was observed with nanoolaparib treated cells compared to untreated cells. Conclusion: A two stage drug release of drug eluting nanospheres from a biodegradable spacer has been suggested for sustained in-situ release of Olaparib to suppress DNA repair processes during prostate brachytherapy. The Olaparib eluting nanospheres had the same in-vitro radiosensitizing effect as

  12. 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.

  13. Neoclassic drug discovery: the case for lead generation using phenotypic and functional approaches.

    Science.gov (United States)

    Lee, Jonathan A; Berg, Ellen L

    2013-12-01

    Innovation and new molecular entity production by the pharmaceutical industry has been below expectations. Surprisingly, more first-in-class small-molecule drugs approved by the U.S. Food and Drug Administration (FDA) between 1999 and 2008 were identified by functional phenotypic lead generation strategies reminiscent of pre-genomics pharmacology than contemporary molecular targeted strategies that encompass the vast majority of lead generation efforts. This observation, in conjunction with the difficulty in validating molecular targets for drug discovery, has diminished the impact of the "genomics revolution" and has led to a growing grassroots movement and now broader trend in pharma to reconsider the use of modern physiology-based or phenotypic drug discovery (PDD) strategies. This "From the Guest Editors" column provides an introduction and overview of the two-part special issues of Journal of Biomolecular Screening on PDD. Terminology and the business case for use of PDD are defined. Key issues such as assay performance, chemical optimization, target identification, and challenges to the organization and implementation of PDD are discussed. Possible solutions for these challenges and a new neoclassic vision for PDD that combines phenotypic and functional approaches with technology innovations resulting from the genomics-driven era of target-based drug discovery (TDD) are also described. Finally, an overview of the manuscripts in this special edition is provided.

  14. A proposal for a drug information database and text templates for generating package inserts.

    Science.gov (United States)

    Okuya, Ryo; Kimura, Masaomi; Ohkura, Michiko; Tsuchiya, Fumito

    2013-01-01

    To prevent prescription errors caused by information systems, a database to store complete and accurate drug information in a user-friendly format is needed. In previous studies, the primary method for obtaining data stored in a database is to extract drug information from package inserts by employing pattern matching or more sophisticated methods such as text mining. However, it is difficult to obtain a complete database because there is no strict rule concerning expressions used to describe drug information in package inserts. The authors' strategy was to first build a database and then automatically generate package inserts by embedding data in the database using templates. To create this database, the support of pharmaceutical companies to input accurate data is required. It is expected that this system will work, because these companies can earn merit for newly developed drugs to decrease the effort to create package inserts from scratch. This study designed the table schemata for the database and text templates to generate the package inserts. To handle the variety of drug-specific information in the package inserts, this information in drug composition descriptions was replaced with labels and the replacement descriptions utilizing cluster analysis were analyzed. To improve the method by which frequently repeated ingredient information and/or supplementary information are stored, the method was modified by introducing repeat tags in the templates to indicate repetition and improving the insertion of data into the database. The validity of this method was confirmed by inputting the drug information described in existing package inserts and checking that the method could regenerate the descriptions in the original package insert. In future research, the table schemata and text templates will be extended to regenerate other information in the package inserts.

  15. Antithrombotic Therapy for Non-valvular Atrial Fibrillation Patients with Coronary Artery Disease after Percutaneous Coronary Intervention with Drug-eluting Stent%冠心病药物支架术后合并非瓣膜性心房颤动的抗栓治疗

    Institute of Scientific and Technical Information of China (English)

    王洁(综述); 苏立(审校)

    2015-01-01

    Patients with non-valvular atrial fibrillation undergoing percutaneous coronary intervention with drug-eluting stent implanta-tion need dual antiplatelet therapy as well as anticoagulation therapies.Dual antiplatelet therapy and anticoagulation therapy together can re-duce ischemic events, however, it can also increase bleeding events.More research is warranted to find an effective way to reduce ischemic events such as stent thrombosis and systemic embolism without increasing bleeding events through the combination of antiplatelet drugs with either vitamin K antagonist therapy or novel oral anticoagulants.%冠心病合并非瓣膜性心房颤动患者支架植入术后需要抗血小板及口服抗凝药物治疗。抗血小板及抗凝治疗在减少缺血事件的同时也增加了出血风险。抗血小板药物与传统口服抗凝药物维生素K拮抗剂或新型口服抗凝药物如何联合使用以最大程度减少支架内血栓、系统性栓塞等缺血事件,同时又不显著增加出血事件,有待更多研究。

  16. Vascular Response of the Segments Adjacent to the Proximal and Distal Edges of the ABSORB Everolimus-Eluting Bioresorbable Vascular Scaffold

    DEFF Research Database (Denmark)

    Gogas, Bill D; Serruys, Patrick W; Diletti, Roberto

    2012-01-01

    This study sought to investigate in vivo the vascular response at the proximal and distal edges of the second-generation ABSORB everolimus-eluting bioresorbable vascular scaffold (BVS).......This study sought to investigate in vivo the vascular response at the proximal and distal edges of the second-generation ABSORB everolimus-eluting bioresorbable vascular scaffold (BVS)....

  17. Modeling of salt and pH gradient elution in ion-exchange chromatography.

    Science.gov (United States)

    Schmidt, Michael; Hafner, Mathias; Frech, Christian

    2014-01-01

    The separation of proteins by internally and externally generated pH gradients in chromatofocusing on ion-exchange columns is a well-established analytical method with a large number of applications. In this work, a stoichiometric displacement model was used to describe the retention behavior of lysozyme on SP Sepharose FF and a monoclonal antibody on Fractogel SO3 (S) in linear salt and pH gradient elution. The pH dependence of the binding charge B in the linear gradient elution model is introduced using a protein net charge model, while the pH dependence of the equilibrium constant is based on a thermodynamic approach. The model parameter and pH dependences are calculated from linear salt gradient elutions at different pH values as well as from linear pH gradient elutions at different fixed salt concentrations. The application of the model for the well-characterized protein lysozyme resulted in almost identical model parameters based on either linear salt or pH gradient elution data. For the antibody, only the approach based on linear pH gradients is feasible because of the limited pH range useful for salt gradient elution. The application of the model for the separation of an acid variant of the antibody from the major monomeric form is discussed.

  18. Coronary aneurysm and very late stent thrombosis formation associated with sirolimus-eluting stent implantation

    Institute of Scientific and Technical Information of China (English)

    XIE Hong-zhi; ZHANG Shu-yang; ZENG Yong; SHEN Zhu-jun; FANG Quan

    2009-01-01

    @@ Since drug-eluting stents (DES) can significantly reduce the risk of instant restenosis compared with bare-metal stents, they have been widely used in interventional therapy for coronary heart disease. With bare-metal stents being rapidly replaced by DES there is a great concern about the safety of DES due to stent thrombosis.~(1,2)

  19. Softening and elution of monomers in ethanol

    DEFF Research Database (Denmark)

    Benetti, Ana Raquel; Asmussen, Erik; Munksgaard, E Christian;

    2009-01-01

    The purpose of this study was to investigate the effect of light-curing protocol on softening and elution of monomers in ethanol as measured on a model polymer. It was a further aim to correlate the measured values with previously reported data on degree of conversion and glass transition tempera...

  20. 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.

  1. A proposal for a drug information database and text templates for generating package inserts

    Directory of Open Access Journals (Sweden)

    Okuya R

    2013-07-01

    Full Text Available Ryo Okuya,1 Masaomi Kimura,2 Michiko Ohkura,2 Fumito Tsuchiya3 1Graduate School of Engineering and Science, 2Faculty of Engineering, Shibaura Institute of Technology, Tokyo, 3School of Pharmacy, International University of Health and Welfare, Tokyo, Japan Abstract: To prevent prescription errors caused by information systems, a database to store complete and accurate drug information in a user-friendly format is needed. In previous studies, the primary method for obtaining data stored in a database is to extract drug information from package inserts by employing pattern matching or more sophisticated methods such as text mining. However, it is difficult to obtain a complete database because there is no strict rule concerning expressions used to describe drug information in package inserts. The authors' strategy was to first build a database and then automatically generate package inserts by embedding data in the database using templates. To create this database, the support of pharmaceutical companies to input accurate data is required. It is expected that this system will work, because these companies can earn merit for newly developed drugs to decrease the effort to create package inserts from scratch. This study designed the table schemata for the database and text templates to generate the package inserts. To handle the variety of drug-specific information in the package inserts, this information in drug composition descriptions was replaced with labels and the replacement descriptions utilizing cluster analysis were analyzed. To improve the method by which frequently repeated ingredient information and/or supplementary information are stored, the method was modified by introducing repeat tags in the templates to indicate repetition and improving the insertion of data into the database. The validity of this method was confirmed by inputting the drug information described in existing package inserts and checking that the method could

  2. Sentiment Analysis of User-Generated Content on Drug Review Websites

    Directory of Open Access Journals (Sweden)

    Na, Jin-Cheon

    2015-03-01

    Full Text Available This study develops an effective method for sentiment analysis of user-generated content on drug review websites, which has not been investigated extensively compared to other general domains, such as product reviews. A clause-level sentiment analysis algorithm is developed since each sentence can contain multiple clauses discussing multiple aspects of a drug. The method adopts a pure linguistic approach of computing the sentiment orientation (positive, negative, or neutral of a clause from the prior sentiment scores assigned to words, taking into consideration the grammatical relations and semantic annotation (such as disorder terms of words in the clause. Experiment results with 2,700 clauses show the effectiveness of the proposed approach, and it performed significantly better than the baseline approaches using a machine learning approach. Various challenging issues were identified and discussed through error analysis. The application of the proposed sentiment analysis approach will be useful not only for patients, but also for drug makers and clinicians to obtain valuable summaries of public opinion. Since sentiment analysis is domain specific, domain knowledge in drug reviews is incorporated into the sentiment analysis algorithm to provide more accurate analysis. In particular, MetaMap is used to map various health and medical terms (such as disease and drug names to semantic types in the Unified Medical Language System (UMLS Semantic Network.

  3. Supramolecular nanoparticles generated by the self-assembly of polyrotaxanes for antitumor drug delivery

    Directory of Open Access Journals (Sweden)

    Liu R

    2012-10-01

    Full Text Available Rong Liu,1,2,* Yusi Lai,1,* Bin He,1 Yuan Li,1 Gang Wang,1 Shuang Chang,1 Zhongwei Gu1 1National Engineering Research Center for Biomaterials, Sichuan University, Chengdu, China; 2Dalian Institute of Chemical Physics, Chinese Academy of Sciences, Dalian, China*These authors contributed equally to this paperAbstract: A new approach of fabricating supramolecular nanoparticles generated by self-assembly polyrotaxanes for antitumor drug delivery has been reported. Cinnamic-acid-modified poly(ethylene glycol chains were threaded in a-cyclodextrins to form polyrotaxanes. The polyrotaxanes self-assembled supramolecular nanoparticles. The morphology of the nanoparticles was changed from nanovesicle to micelle after the antitumor drug, doxorubicin, was loaded. The release profile of the drug-loaded nanoparticles was investigated, and it was found that the sustaining release time could last for 32 hours. The drug-loaded nanoparticles were co-cultured with mouse 4T1 breast cancer cells with a drug concentration of 10 µg/mL; the cell survival rate was 3.3% after a 72-hour incubation. In an in vivo study of breast cancer in a mouse model, the drug-loaded nanoparticles were injected in the tail veins of mice with a dose of 5 mg/kg body weight. The tumor inhibition rate of drug-loaded nanoparticles was 53%, which was better than that of doxorubicin hydrochloride. The cardiac toxicity of doxorubicin was decreased greatly after the encapsulation into supramolecular polyrotaxane nanoparticles.Keywords: polyrotaxane, self-assembly, nanoparticle, doxorubicin, supermolecular

  4. Sirolimus-eluting dextran and polyglutamic acid hybrid coatings on AZ31 for stent applications

    Science.gov (United States)

    Ma, Jun; Zhao, Nan; Zhu, Donghui

    2016-01-01

    Magnesium (Mg)-based cardiovascular stents are promising candidate as the next generation of novel stents. Clinical studies have revealed encouraging outcomes, but late restenosis and thrombogenesis still largely exist. Blood and vascular biocompatible coatings with drug-eluting features could be the solution to such problems. Objective This study was to investigate the feasibility of a three-layer hybrid coating on Mg alloy AZ31 with sirolimus-eluting feature for cardiovascular stent application. Materials and methods The first and third layers were low molecular weight dextran loaded with sirolimus, and the second layer was polyglutamic acid (PGA) to control sirolimus release. The hybrid coating was verified by scanning electron microscope (SEM). DC polarization and immersion tests were used to evaluate corrosion rate of the materials. Indirect cell viability and cell proliferation tests were performed by culturing cells with extract solutions of AZ31 samples. Blood compatibility was assessed using hemolysis assay. Results Coated samples had an enhanced corrosion resistance than that of uncoated controls, more PGA slower corrosion. Sirolimus had a burst release for the initial ~3 days and then a slower release until reached a plateau. The PGA thickness was able to control the sirolimus release, the thicker of PGA the slower release. The overall cell viability was extract concentration-dependent, and improved by the hybrid coatings. Cell proliferation was correlated to coating thickness and was inhibited by sirolimus. In addition, all coated AZ31 samples were non-hemolytic. Conclusion Results demonstrated that such a three-layer hybrid coating may be useful to improve the vascular biocompatibility of Mg stent materials. PMID:26202889

  5. 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.

  6. Development of Absorbable, Antibiotic-Eluting Sutures for Ophthalmic Surgery

    Science.gov (United States)

    Kashiwabuchi, Fabiana; Parikh, Kunal S.; Omiadze, Revaz; Zhang, Shuming; Luo, Lixia; Patel, Himatkumar V.; Xu, Qingguo; Ensign, Laura M.; Mao, Hai-Quan; Hanes, Justin; McDonnell, Peter J.

    2017-01-01

    Purpose To develop and evaluate an antibiotic-eluting suture for ophthalmic surgery. Methods Wet electrospinning was used to manufacture sutures composed of poly(L-lactide), polyethylene glycol (PEG), and levofloxacin. Size, morphology, and mechanical strength were evaluated via scanning electron microscopy and tensile strength, respectively. In vitro drug release was quantified using high performance liquid chromatography. In vitro suture activity against Staphylococcus epidermidis was investigated through bacterial inhibition studies. Biocompatibility was determined via histological analysis of tissue sections surrounding sutures implanted into Sprague-Dawley rat corneas. Results Sutures manufactured via wet electrospinning were 45.1 ± 7.7 μm in diameter and 0.099 ± 0.007 newtons (N) in breaking strength. The antibiotic release profile demonstrated a burst followed by sustained release for greater than 60 days. Increasing PEG in the polymer formulation, from 1% to 4% by weight, improved drug release without negatively affecting tensile strength. Sutures maintained a bacterial zone of inhibition for at least 1 week in vitro and elicited an in vivo tissue reaction comparable to a nylon suture. Conclusions There is a need for local, postoperative delivery of antibiotics following ophthalmic procedures. Wet electrospinning provides a suitable platform for the development of sutures that meet size requirements for ophthalmic surgery and are capable of sustained drug release; however, tensile strength must be improved prior to clinical use. Translational Relevance No antibiotic-eluting suture exists for ophthalmic surgery. A biocompatible, high strength suture capable of sustained antibiotic release could prevent ocular infection and preclude compliance issues with topical eye drops. PMID:28083445

  7. In vivo Evaluation of Cenderitide-Eluting Stent (CES) II.

    Science.gov (United States)

    Huang, Yingying; Ng, Xu Wen; Lim, Soon Ghim; Chen, Horng Haur; Burnett, John C; Boey, Yin Chiang Freddy; Venkatraman, Subbu S

    2016-02-01

    The use of drug-eluting coronary stents has led to significant reduction in in-stent restenosis (ISR), but led to delayed endothelialization, necessitating the prolonged use of expensive anti-thrombotic drugs with their side-effects. Cenderitide (CD-NP) is a novel anti-proliferative chimeric peptide of semi-endothelial origin. Our previous work in vitro has demonstrated; that the smooth muscle cells were inhibited significantly more than endothelial cells which is the desirable feature of an anti-restenosis drug. This work reports the effects of implantation of a centeritide-eluting stent (CES) on ISR and endothelialization in an in vivo model. CESs were produced by coating bare metallic stents with CD-NP entrapped in biodegradable poly(ε-caprolactone) using an ultrasonic spray coater. A total of 32 stents were successfully implanted into 16 pigs, and all animal survived for 28 days. The plasma levels of CD-NP were significantly higher in the CES group than in the control group (bare metal stents and polymer-coated stent) at post-stenting, indicating the successful release of CD-NP from the stent in vivo. Furthermore, SEM analysis results showed the greater endothelial coverage of the stent struts, as well as between the struts in CES group. Moreover, histological results showed mild inflammation, and low fibrin score at 28 days. However, plasma cGMP (second messenger, cyclic 3',5' guanosine monophosphate) does not show a significant difference, and the CES is also unable to show significant difference in terms on neointimal area and stenosis, in comparison to BMS at 28 days.

  8. Sex-related Impact on Clinical Outcome of Everolimus-eluting Versus Bare-metal Stents in ST-segment Myocardial Infarction. Insights From the EXAMINATION Trial.

    Science.gov (United States)

    Regueiro, Ander; Fernández-Rodríguez, Diego; Brugaletta, Salvatore; Martín-Yuste, Victoria; Masotti, Monica; Freixa, Xavier; Cequier, Ángel; Íñiguez, Andrés; Serruys, Patrick W; Sabaté, Manel

    2015-05-01

    The use of second-generation drug-eluting stents compared with bare-metal stents in patients with ST-segment elevation myocardial infarction reduces the rate of major adverse cardiac events. We aimed to evaluate the impact of sex on the performance of everolimus-eluting stents vs bare-metal stents in ST-segment elevation myocardial infarction at 2-year follow-up. This is a sub-study of the EXAMINATION trial that randomized 1498 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention to everolimus-eluting or bare-metal stents. Primary end point was combined all-cause death, any recurrent myocardial infarction, and any revascularization. All end points were analyzed according to sex at 2-year follow-up. Of 1498 patients included in the trial, 254 (17.0%) were women. Women were older and had higher prevalence of hypertension and lower prevalence of smoking compared with men. In contrast with men, stent diameter was smaller in women. After multivariate analysis, the primary end point was similar between women and men (hazard ratio=0.95; 95% confidence interval, 0.66-1.37), and among women, between those treated with bare-metal vs everolimus-eluting stents (hazard ratio=2.48; 95% confidence interval, 0.95-6.46). Women showed a lower rate of repeat revascularization than men (hazard ratio=0.55; 95% confidence interval, 0.32-0.95) despite worse baseline characteristics. This difference was driven by better performance of the everolimus-eluting stent in women. Despite poorer baseline clinical characteristics, women with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention showed outcomes similar to men. The use of everolimus-eluting stents may represent an added value in women as it showed a reduced rate of repeated revascularization compared to men. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  9. Usefulness of preprocedure high-sensitivity C-reactive protein to predict death, recurrent myocardial infarction, and stent thrombosis according to stent type in patients with ST-segment elevation myocardial infarction randomized to bare metal or drug-eluting stenting during primary percutaneous

    DEFF Research Database (Denmark)

    Schoos, Mikkel Malby; Kelbæk, Henning; Kofoed, Klaus F;

    2011-01-01

    It is unknown whether high-sensitivity C-reactive protein (hs-CRP) predicts outcome depending on implanted stent type. We investigated the prognostic value of hs-CRP in relation to type of stent implanted in patients with ST-segment elevation myocardial infarction (STEMI). Immediately before...... primary percutaneous coronary intervention (pPCI), 301 patients had blood drawn. Patients were categorized according to hs-CRP levels and combination of hs-CRP (≤2 vs >2 mg/L) and stent type (bare metal stent [BMS] vs drug-eluting stent [DES]). Hs-CRP >2 mg/L (median, hazard ratio 2.7, 95% confidence...... type. Survival analysis demonstrated significant differences for occurrence of death and MI: 4.8% in BMS + CRP ≤2 mg/L, 11.9% in DES + CRP ≤2 mg/L, 17.6% in DES + CRP >2 mg/L, and 27.9% in BMS + CRP >2 mg/L. None of the 14 stent thromboses occurred in patients with BMS + CRP ≤2 mg/L. In conclusion...

  10. 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.

  11. Expansion of chemical space for collaborative lead generation and drug discovery: the European Lead Factory Perspective.

    Science.gov (United States)

    Karawajczyk, Anna; Giordanetto, Fabrizio; Benningshof, Jorg; Hamza, Daniel; Kalliokoski, Tuomo; Pouwer, Kees; Morgentin, Remy; Nelson, Adam; Müller, Gerhard; Piechot, Alexander; Tzalis, Dimitrios

    2015-11-01

    High-throughput screening (HTS) represents a major cornerstone of drug discovery. The availability of an innovative, relevant and high-quality compound collection to be screened often dictates the final fate of a drug discovery campaign. Given that the chemical space to be sampled in research programs is practically infinite and sparsely populated, significant efforts and resources need to be invested in the generation and maintenance of a competitive compound collection. The European Lead Factory (ELF) project is addressing this challenge by leveraging the diverse experience and know-how of academic groups and small and medium enterprises (SMEs) engaged in synthetic and/or medicinal chemistry. Here, we describe the novelty, diversity, structural complexity, physicochemical characteristics and overall attractiveness of this first batch of ELF compounds for HTS purposes.

  12. In situ generation of sodium alginate/hydroxyapatite nanocomposite beads as drug-controlled release matrices.

    Science.gov (United States)

    Zhang, J; Wang, Q; Wang, A

    2010-02-01

    In order to find a new way to slow down the release of drugs and to solve the burst release problem of drugs from traditionally used hydrogel matrices, a series of novel pH-sensitive sodium alginate/hydroxyapatite (SA/HA) nanocomposite beads was prepared by the in situ generation of HA micro-particles in the beads during the sol-gel transition process of SA. The SA/HA nanocomposites were characterized by Fourier transform IR spectroscopy, X-ray fluorescence spectrometry, scanning electron microscopy and field emission SEM in order to reveal their composition and surface morphology as well as the role that the in situ generated HA micro-particles play. The factors influencing the swelling behavior, drug loading and controlled release behavior of the SA/HA nanocomposite beads were also investigated using diclofenac sodium (DS) as the model drug. The HA micro-particles act as inorganic crosslinkers in the nanocomposites, which could contract and restrict the movability of the SA polymer chains, and then change the surface morphology and decrease the swell ratio. Meanwhile, the entrapment efficiency of DS was improved, and the burst release of DS was overcome. The factors (including concentration of Ca(2+), reaction time and temperature) affecting the growth of HA micro-particles have a clear influence on the entrapment efficiency and release rate of DS. In this work, the nanocomposite beads prepared under optimum condition could prolong the release of DS for 8h more compared with the pristine SA hydrogel beads.

  13. Clinical follow-up of patients with premature coronary artery disease undergoing intervention with drug-eluting stents%药物洗脱支架植入治疗早发冠心病的近期临床随访研究

    Institute of Scientific and Technical Information of China (English)

    张晓峰; 丁震; 马根山; 冯毅; 章晓国; 沈成兴; 汤成春; 方瑛; 陈忠

    2011-01-01

    Objective To investigate the clinical characteristics, short-term outcomes in patients with premature coronary disease ( PCAD) undergoing coronary intervention with drug -eluting stents ( DESs). Methods The baseline clinical and coronary angiographic data of 517 patients ( female < 65 years, male < 55 years) undergoing coronaiy angiography ( CAG) were collected and analyzed. Patients were divided into PCAD group ( n = 290) and non-CAD group ( n = 227) . 180 patients with PCAD implanted with DESs ( sirolimus-eluting stents or paclitaxel-eluting stents ) were assessed for the single and cumulative incidence of' major adverse cardiac events ( MACEs) during half-year follow-up. Results Patients with PCAD had significantly higher rate of male , hypertension ,diabetic mellitus,smoking ,drinking and obesity ,higher levels of TC,LDL-C, apo B and Lp ( a) than that in non-CAD group ( all P <0. 05 ). There is higher ratio of diabetic mellitus in the multiple branch lesions group than in single branch lesion group (P < 0. 01 ) .Both patients implanted with DESs in multiple branch lesions group and single branch lesion group had similar half -year prognosis ( P >0. 05 ) . Conclusions Patients with PCAD had more cardiovascular risk factors and better half -year prognosis after implanted with DESs .%目的 研究接受药物洗脱支架治疗的早发冠心病(PCAD)患者近期预后.方法 收集290 例PCAD 患者(男<55 岁,女<65 岁)和227 例非冠心病对照者临床资料,对PCAD 中行药物洗脱支架(西罗莫司或紫杉醇洗脱支架)植入治疗的180 例患者(单支病变组62 例及多支病变组118 例)进行6 个月随访研究.结果 PCAD 组男性、高血压、糖尿病、吸烟、肥胖及饮酒比例及总胆醇、低密度脂蛋白胆固醇、载脂蛋白B、脂蛋白(a)及空腹血糖水平均高于非冠心病对照组(P 均<0.05).药物洗脱支架治疗多支病变组糖尿病比例高于单支病变组(P <0.01).接受

  14. Generation of Mouse STO Feeder Cell Lines That Confer Resistance to Several Types of Selective Drugs.

    Science.gov (United States)

    Saitoh, Issei; Sato, Masahiro; Iwase, Yoko; Inada, Emi; Nomura, Toshiki; Akasaka, Eri; Yamasaki, Youichi; Noguchi, Hirofumi

    2012-01-01

    Feeder cells are generally required for establishment and maintenance of embryonic stem (ES)/induced pluripotent stem (iPS) cells. Increased demands for generation of those cells carrying various types of vectors (i.e., KO vectors and transgenes) also require feeder cells that confer resistance to any types of preexisting selective drugs. Unfortunately, the use of the feeders that are resistant to various drugs appears to be limited to a few laboratories. Here we generated a set of gene-engineered STO feeder cells that confer resistance to several commercially available drugs. The STO cells, which have long been used as a feeder for mouse ES and embryonal carcinoma (EC) cells, were transfected with pcBIH [carrying bleomycin resistance gene (ble) and hygromycin B phosphotransferase gene (Hyg)], pcBIP [carrying ble and puromycin resistance gene (puro)], or pcBSN [carrying ble and neomycin resistance gene (neo)]. The resulting stably transfectants (termed SHB for pcBIH, SPB for pcBIP, and SNB for pcBSN) exhibited bleomycin/hygromycin, bleomycin/puromycin, or bleomycin/neomycin, as expected. The morphology of these cells passaged over 18 generations was indistinguishable from that of parental STO cells. Of isolated clones, the SHB3, SPB3, and SNB2 clones successfully supported the growth of mouse ES cells in an undifferentiated state, when coculture was performed. PCR analysis revealed the presence of the selective markers in these clones, as expected. These SHB3, SPB3, and SNB2 cells will thus be useful for the acquisition and maintenance of genetically manipulated ES/iPS cells.

  15. 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)....

  16. 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

  17. Titania nanotubes with adjustable dimensions for drug reservoir sites and enhanced cell adhesion.

    Science.gov (United States)

    Çalışkan, Nazlı; Bayram, Cem; Erdal, Ebru; Karahaliloğlu, Zeynep; Denkbaş, Emir Baki

    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.

  18. Development of immuno-oncology drugs - from CTLA4 to PD1 to the next generations.

    Science.gov (United States)

    Hoos, Axel

    2016-04-01

    Since the regulatory approval of ipilimumab in 2011, the field of cancer immunotherapy has been experiencing a renaissance. This success is based on progress in both preclinical and clinical science, including the development of new methods of investigation. Immuno-oncology has become a sub-specialty within oncology owing to its unique science and its potential for substantial and long-term clinical benefit. Immunotherapy agents do not directly attack the tumour but instead mobilize the immune system - this can be achieved through various approaches that utilize adaptive or innate immunity. Therefore, immuno-oncology drug development encompasses a broad range of agents, including antibodies, peptides, proteins, small molecules, adjuvants, cytokines, oncolytic viruses, bi-specific molecules and cellular therapies. This Perspective summarizes the recent history of cancer immunotherapy, including the factors that led to its success, provides an overview of novel drug-development considerations, summarizes three generations of immunotherapies that have been developed since 2011 and, thus, illustrates the breadth of opportunities these new generations of immunotherapies represent.

  19. Stabilizing ability of surfactant on physicochemical properties of drug nanoparticles generated from solid dispersions.

    Science.gov (United States)

    Thongnopkoon, Thanu; Puttipipatkhachorn, Satit

    2017-07-01

    This study was aimed to examine the nanoparticle formation from redispersion of binary and ternary solid dispersions. Binary systems are composed of various ratios of glibenclamide (GBM) and polyvinylpyrrolidone K30 (PVP-K30), whereas a constant amount at 2.5%w/w of a surfactant, sodium lauryl sulfate (SLS) or Gelucire44/14 (GLC), was added to create ternary systems. GBM nanoparticles were collected after the systems were dispersed in water for 15 min. The obtained nanoparticles were characterized for size distribution, crystallinity, thermal behavior, molecular structure, and dissolution properties. The results indicated that GBM nanoparticles could be formed when the drug content of the systems was lower than 30%w/w in binary systems and ternary systems containing SLS. The particle size ranged from 200 to 500 nm in diameter with narrow size distribution. The particle size was increased with increasing drug content in the systems. The obtained nanoparticles were spherical and showed the amorphous state. Furthermore, because of being amorphous form and reduced particle size, the dissolution of the generated nanoparticles was markedly improved compared with the GBM powder. In contrast, all the ternary solid dispersions prepared with GLC anomalously provided the crystalline particles with the size ranging over 5 µm and irregular shape. Interestingly, this was irrelevant to the drug content in the systems. These results indicated the ability of GLC to destabilize the polymer network surrounding the particles during particle precipitation. Therefore, this study suggested that drug content, quantity, and type of surfactant incorporated in solid dispersions drastically affected the physicochemical properties of the precipitated particles.

  20. Differential in vitro inhibition of thrombin generation by anticoagulant drugs in plasma from patients with cirrhosis.

    Directory of Open Access Journals (Sweden)

    Wilma Potze

    Full Text Available BACKGROUND: Treatment and prevention of thrombotic complications is frequently required in patients with cirrhosis. However anticoagulant therapy is often withheld from these patients, because of the perceived bleeding diathesis. As a result of the limited clinical experience, the anticoagulant of choice for the various indications is still not known. OBJECTIVES: We evaluated the in vitro effect of clinically approved anticoagulant drugs in plasma from patients with cirrhosis. PATIENTS/METHODS: Thirty patients with cirrhosis and thirty healthy controls were studied. Thrombin generation assays were performed before and after addition of unfractionated heparin, low molecular weight heparin, fondaparinux, dabigatran, and rivaroxaban, to estimate anticoagulant potencies of these drugs. RESULTS: Addition of dabigatran led to a much more pronounced reduction in endogenous thrombin potential in patients compared to controls (72.6% reduction in patients vs. 12.8% reduction in controls, P<0.0001. The enhanced effect of dabigatran was proportional to the severity of disease. In contrast, only a slightly increased anticoagulant response to heparin and low molecular weight heparin and even a reduced response to fondaparinux and rivaroxaban was observed in plasma from cirrhotic patients as compared to control plasma. CONCLUSIONS: The anticoagulant potency of clinically approved drugs differs substantially between patients with cirrhosis and healthy individuals. Whereas dabigatran and, to a lesser extent, heparin and low molecular weight heparin are more potent in plasma from patients with cirrhosis, fondaparinux and rivaroxaban showed a decreased anticoagulant effect. These results may imply that in addition to dose adjustments based on altered pharmacokinetics, drug-specific dose adjustments based on altered anticoagulant potency may be required in patients with cirrhosis.

  1. A novel amorphous calcium phosphate drug-eluting stent:its biocompatibility after implantation into mini-swine coronary artery%新型纳米材料无定形磷酸钙药物支架置入小型猪冠状动脉后的生物相容性

    Institute of Scientific and Technical Information of China (English)

    谭峥; 李莉; 马燚

    2016-01-01

    BACKGROUND:As previously reported, poly-L-lactic acid stents have been mostly used as coronary artery stents, but this stent has a lack of early support force and produces some acidic products that wil induce local vascular inflammatory reactions. OBJECTIVE:To explore the biocompatibility of a novel amorphous calcium phosphate drug-eluting stent, after implantation into mini-swine coronary artery. METHODS:Twenty mini-swine were randomly equivalently divided into observation group and control group. The right femoral arteries of animals were separated layer by layer and the new type of biodegradable stent and poly-L-lactic acid stent were implanted, respectively. RESULTS AND CONCLUSION:The vessel lumes in the two groups were smooth and unobstructed showed by coronary artery angiography immediately after implantation. At 4 weeks after implantation, the coronary angiography showed the patency of vessel lumens with no stent thrombosis and stenosis in both two groups. The C-reactive protein levels in the two groups had no significant differences before and 4 weeks after stent implantation. At 4 weeks after implantation, the number of lymphocytes and inflammatory score in the observation group were significantly higher than those in the control group, but the neointimal area and percentage of stenosis area had no significant difference between the two groups. These results indicate that the novel amorphous calcium phosphate drug-eluting stent after implantation into mini-swine coronary artery has good biocompatibility.%背景:以往冠状动脉植入支架大多为聚左旋乳酸,但存在早期支撑力不足的问题,且会产生一定的酸性产物,导致血管局部出现炎性反应。  目的:探讨新型纳米材料无定形磷酸钙药物支架置入小型猪冠状动脉后的生物相容性。  方法:20只小型猪随机等分为观察组和对照组,对动物右侧股动脉予以逐层分离,分别置入新型生物全降解支架和

  2. A randomized clinical trial comparing long-term clopidogrel vs aspirin monotherapy beyond dual antiplatelet therapy after drug-eluting coronary stent implantation: Design and rationale of the Harmonizing Optimal Strategy for Treatment of coronary artery stenosis-Extended Antiplatelet Monotherapy (HOST-EXAM) trial.

    Science.gov (United States)

    Lee, Heesun; Koo, Bon-Kwon; Park, Kyung Woo; Shin, Eun-Seok; Lim, Sang Wook; Rha, Seung-Woon; Bae, Jang-Whan; Jeon, Dong Woon; Oh, Seok-Kyu; Hur, Seung-Ho; Kim, Bum-Su; Lee, Jung-Hee; Park, Tae-Ho; Lee, Nam Ho; Kim, Hyo-Soo

    2017-03-01

    Percutaneous coronary intervention (PCI) has been developed by drug-eluting stent (DES), but stent implantation has brought the issue of stent thrombosis and optimal antiplatelet therapy. Guidelines recommend at least 6- to 12 months of dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor such as clopidogrel. Beyond DAPT after PCI with DES, however, there has been still a debate for antiplatelet regimen. Therefore, we report on the upcoming HOST-EXAM trial (NCT02044250), which will evaluate the efficacy and safety of aspirin and clopidogrel monotherapies beyond DAPT after DES implantation. The HOST-EXAM is a prospective, randomized, open-label, multicenter, comparative effectiveness trial, to compare between clopidogrel (75 mg once daily) and aspirin (100 mg once daily) as long-term antiplatelet agents. A total of 5,530 patients with no clinical events during combined antiplatelet therapy for 12±6 months after index PCI will be screened, enrolled, and randomized to either group (1:1 ratio) receiving antiplatelet monotherapy for 2 years. The primary endpoint will be the rate of clinical events defined as a composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, or major bleeding at 24 months after randomization. The HOST-EXAM will be the first large-scale randomized controlled study to directly compare the efficacy and safety of long-term antiplatelet monotherapy beyond DAPT after DES implantation. This study will provide clinical evidence to establish optimal regimen for long-term antiplatelet therapy after DES implantation. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Generation of Pig Induced Pluripotent Stem Cells with a Drug-Inducible System

    Institute of Scientific and Technical Information of China (English)

    Zhao Wu; Jijun Chen; Jiangtao Ren; Lei Bao; Jing Liao; Chun Cui; Linjun Rao; Hui Li; Yijun Gu; Huiming Dai; Hui Zhu; Xiaokun Teng; Lu Cheng; Lei Xiao

    2009-01-01

    Domesticated ungulate pluripotent embryonic stem (ES) cell lines would be useful for generating precise gene-modified animals. To date, many efforts have been made to establish domesticated ungulate pluripotent ES cells from early embryos without success.Here, we report the generation of porcine-induced pluripotent stem (iPS) cells using drug-inducible expression of defined factors.We showed that porcine iPS cells expressed alkaline phosphatase, SSEA3, SSEA4, Tra-1-60, Tra-1-81, Oct3/4, Nanog, Sox2, Rex1 and CDH1. Pig iPS cells expressed high levels of telomerase activity and showed normal karyotypes. These cells could differentiate into cell types of all three germ layers in vitro and in teratomas. Our study reveals properties of porcine pluripotent stem cells that may facilitate the eventual establishment of porcine ES cells. Moreover, the porcine iPS cells produced may be directly useful for the generation of precise gene-modified pigs.

  4. Drug-eluting-Devices in den Beinschlagadern - Update 2012

    Directory of Open Access Journals (Sweden)

    Baumann F

    2012-01-01

    Full Text Available Die Restenoseproblematik bleibt seit der Einführung der perkutanen transluminalen Angioplastie (PTA im Jahre 1977 in Zürich ein relevanter Nachteil dieser eleganten minimal- invasiven Behandlungsmethode. Die meist kaliberschwachen Unterschenkelarterien sind hiervon noch häufiger betroffen als die Arterien des iliakalen oder femoro-poplitealen Segments. Verschiedene Bestrebungen, die Restenoserate nach PTA zu senken, wie zum Beispiel die endovaskuläre Bestrahlung (Brachytherapie, und verschiedene medikamentöse Ansätze konnten unsere Erwartungen bislang nicht erfüllen. In den vergangenen Jahren sind im femoropoplitealen Segment vermehrt hochflexible Nitinolstents zum Einsatz gekommen, mit dem Ziel, die Restenosehäufigkeit für sekundäre Eingriffe an der initial behandelten Zielläsion zu senken. Im Rahmen erster klinischer Untersuchungen wurden Sirolimus-beschichtete Nitinolstents an Oberschenkelarterien untersucht (Sirocco-Studie. Es zeigte sich jedoch nach initialer Publikation hoffnungsvoller 6-Monats-Ergebnisse, dass diese Stents, welche für die komplexen biomechanischen Anforderungen der femoropoplitealen Strombahn zu rigide waren und häufig Stentfrakturen aufwiesen, keinen mittelfristigen Nutzen zu bringen vermochten. Medikamenten-freisetzende PTA-Ballons und Stents haben das Ziel, die neointimale Proliferation zu unterdrücken und sind eine erfolgversprechende Technologieentwicklung. Verschiedene Studien aus der koronaren und femoro-poplitealen Strohmbahn haben deren klinischen Einsatz und Nutzen bereits belegt. Dieses Manuskript soll eine Übersicht über den klinischen Nutzen von antiproliferativ beschichteten Devices in der peripher-arteriellen Intervention vermitteln.

  5. Three-year clinical outcome of patients with bifurcation treatment with second-generation Resolute and Xience V stents in the randomized TWENTE trial

    NARCIS (Netherlands)

    Lam, Ming Kai; Sen, Hanim; Houwelingen, van K. Gert; Löwik, Marije M.; Heijden, van der Liefke C.; Kok, Marlies M.; Man, de Frits H.A.F.; Linssen, Gerard C.M.; Tandjung, Kenneth; Doggen, C.J.M.; Birgelen, von C.

    2015-01-01

    Background Only limited data from large randomized clinical trials have been published on the long-term performance of second-generation drug-eluting stents in bifurcation lesions. Methods We investigated in patients in the randomized TWENTE trial the long-term safety and efficacy of treating bifur

  6. Mass transfer coefficients determination from linear gradient elution experiments.

    Science.gov (United States)

    Pfister, David; Morbidelli, Massimo

    2015-01-02

    A procedure to estimate mass transfer coefficients in linear gradient elution chromatography is presented and validated by comparison with experimental data. Mass transfer coefficients are traditionally estimated experimentally through the van Deemter plot, which represents the HETP as a function of the fluid velocity. Up to now, the HETP was obtained under isocratic elution conditions. Unfortunately, isocratic elution experiments are often not suitable for large biomolecules which suffer from severe mass transfer hindrances. Yamamoto et al. were the first to propose a semi-empirical equation to relate HETPs measured from linear gradient elution experiments to those obtained under isocratic conditions [7]. Based on his pioneering work, the approach presented in this work aims at providing an experimental procedure supported by simple equations to estimate reliable mass transfer parameters from linear gradient elution chromatographic experiments. From the resolution of the transport model, we derived a rigorous analytical expression for the HETP in linear gradient elution chromatography.

  7. Strategies for conducting ADME studies during lead generation in the drug discovery process.

    Science.gov (United States)

    Cramer, Jeffrey W; Mattioni, Brian E; Savin, Kenneth A

    2010-12-01

    Although the benefit of early ADME screening is widely recognized in the pharmaceutical industry, the implementation of this paradigm is often performed with insufficient resources and poor collaboration between functions. Dedicated and consistent integration efforts of ADME knowledge during the lead generation (LG) phase of drug discovery enables informed resourcing decisions and also increases the quality of initial starting points for discovery projects. To facilitate the efficient and consistent application of ADME resources to early projects at Eli Lilly and Co, a team of scientists was formed to provide dedicated ADME support to the LG phase of the discovery portfolio. This feature review discusses the working construct of the team, the general philosophy that was employed, and the outcomes of this endeavor.

  8. The new generation drug candidate molecules: Spectral, electrochemical, DNA-binding and anticancer activity properties

    Science.gov (United States)

    Gölcü, Ayşegül; Muslu, Harun; Kılıçaslan, Derya; Çeşme, Mustafa; Eren, Özge; Ataş, Fatma; Demirtaş, İbrahim

    2016-09-01

    The new generation drug candidate molecules [Cu(5-Fu)2Cl2H2O] (NGDCM1) and [Zn(5-Fu)2(CH3COO)2] (NGDCM2) were obtained from the reaction of copper(II) and zinc(II) salts with the anticancer drug 5-fluoracil (5-Fu). These compounds have been characterized by spectroscopic and analytical techniques. Thermal behavior of the compounds were also investigated. The electrochemical properties of the compounds have been investigated by cyclic voltammetry (CV) using glassy carbon electrode. The biological activity of the NGDCM1 and NGDCM2 has been evaluated by examining their ability to bind to fish sperm double strand DNA (FSdsDNA) with UV spectroscopy. UV studies of the interaction of the 5-Fu and metal derivatives with FSdsDNA have shown that these compounds can bind to FSdsDNA. The binding constants of the compounds with FSdsDNA have also been calculated. Thermal decomposition of the compounds lead to the formation of CuO and ZnO as final products. The effect of proliferation 5-Fu, NGDCM1 and NGDCM2 were examined on the HeLa cells using real-time cell analyzer with three different concentrations.

  9. A bibliometric study of scientific research conducted on second-generation antipsychotic drugs in Singapore.

    Science.gov (United States)

    López-Muñoz, Francisco; Sim, Kang; Shen, Winston Wu; Huelves, Lorena; Moreno, Raquel; Molina, Juan de Dios; Rubio, Gabriel; Noriega, Concha; Pérez-Nieto, Miguel Ángel; Alamo, Cecilio

    2014-01-01

    A bibliometric study was carried out to ascertain the volume and impact of scientific literature published on second-generation antipsychotic drugs (SGAs) in Singapore from 1997 to 2011. A search of the EMBASE and MEDLINE databases was performed to identify articles originating from Singapore that included the descriptors 'atypic* antipsychotic*', 'second-generation antipsychotic*', 'clozapine', 'risperidone', 'olanzapine', 'ziprasidone', 'quetiapine', 'sertindole', 'aripiprazole', 'paliperidone', 'amisulpride', 'zotepine', 'asenapine', 'iloperidone', 'lurasidone', 'perospirone' and 'blonanserin' in the article titles. Certain bibliometric indicators of production and dispersion (e.g. Price's Law on the increase of scientific literature, and Bradford's Law) were applied, and the participation index of various countries was calculated. The bibliometric data was also correlated with some social and health data from Singapore, such as the total per capita expenditure on health and gross domestic expenditure on research and development. From 1997 to 2011, a total of 51 articles on SGAs in Singapore were published. Our results suggested non-fulfilment of Price's Law (r = 0.0648 after exponential adjustment vs. r = 0.2140 after linear adjustment). The most widely studied drugs were clozapine (21 articles), risperidone (16 articles) and olanzapine (8 articles). Division into Bradford zones yielded a nucleus occupied by the Journal of Clinical Psychopharmacology (6 articles) and the Singapore Medical Journal(4 articles). The analysed material was published in a total of 30 journals, with the majority from six journals. Four of these six journals have an impact factor greater than 2. Publications on SGAs in Singapore are still too few to confirm an exponential growth of scientific literature.

  10. Clinical Impact of Dual Antiplatelet Therapy Use in Patients Following Everolimus-eluting Stent Implantation: Insights from the SEEDS Study

    Directory of Open Access Journals (Sweden)

    Yao-Jun Zhang

    2015-01-01

    Full Text Available Background: Studies have suggested that use of prolonged dual antiplatelet therapy (DAPT following new generation drug-eluting stent implantation may increase costs and potential bleeding events. This study aimed to investigate the association of DAPT status with clinical safety in patients undergoing everolimus-eluting stent (EES implantation in the SEEDS study (A Registry to Evaluate Safety and Effectiveness of Everolimus Drug-eluting Stent for Coronary Revascularization at 2-year follow-up. Methods: The SEEDS study is a prospective, multicenter study, where patients (n = 1900 with small vessel, long lesion, or multi-vessel diseases underwent EES implantation. Detailed DAPT status was collected at baseline, 6-month, 1- and 2-year. DAPT interruption was defined as any interruption of aspirin and/or clopidogrel more than 14 days. The net adverse clinical events (NACE, a composite endpoint of all-cause death, all myocardial infarction (MI, stroke, definite/probable stent thrombosis (ST, and major bleeding (Bleeding Academic Research Consortium II-V were investigated according to the DAPT status at 2-year follow-up. Results: DAPT was used in 97.8% of patients at 6 months, 69.5% at 12 months and 35.4% at 2 years. It was observed that the incidence of NACE was low (8.1% at 2 years follow-up, especially its components of all-cause death (0.9%, stroke (1.1%, and definite/probable ST (0.7%. DAPT was not an independent predictor of composite endpoint of all-cause death/MI/stroke (hazard ratio [HR]: 0.693, 95% confidence interval [CI]: 0.096-4.980, P = 0.715 and NACE (HR: 1.041, 95% CI: 0.145-7.454, P = 0.968. Of 73 patients who had DAPT interruption, no patient had ST at 12-month, and only 1 patient experienced ST between 1- and 2-year (1.4%. There was a high frequency of major bleeding events (53/65, 82.5% occurred in patients receiving DAPT treatment. Conclusions: Prolonged DAPT use was not associated with improved clinical safety. The study

  11. 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.

  12. 吡格列酮降低非糖尿病患者冠状动脉药物洗脱支架再狭窄的研究%Study of pioglitazone reducing in-stent restenosis on non-diabetic patients with drug-eluting stents

    Institute of Scientific and Technical Information of China (English)

    魏广和; 刘立新; 王铁成; 王建军; 高荣华; 张韶辉

    2012-01-01

    Objective:To investigate the effects and mechanisms of pioglitazone on in-stent restenosis after coronary stenting in nondiabetic patients with coronary artery disease. Method:One hundred and twenty-eight nondia-betic patients after rapamycin eluting stent implantation were randomly assigned to pioglitazone (pioglitazone group, h=71, 30 mg/d) or placebo (control group, n = 57) treatment in addition to standard therapy. Selective coronary angiography was performed at 6 —8 months follow-up. Fasting blood glucose, fasting insulin, leptin, adiponectin as well as lipid parameters were measured at study entry and 6 — 8 months follow-up. In addition, the homeostasis model assessment of insulin resistance index (HOMA-IR) of patients were calculated. Result: The incidence of in-stent restenosis in pioglitazone group was significantly lower than the control group (2.82% vs 12. 28% , P = 0. 037). After 6 — 8 months follow-up, there was no significant difference of serum lipids and fasting blood glucose in 2 group. However, HOMA-IR, adiponectin and A/L in pioglitazone group were significantly different from the control group. Conclusion: Pioglitazone can reduce the restenosis of non-diabetic patients with drug-eluting stents. Improving insulin resistance and endothelial dysfunction is probably the important mechanisms of pioglitazone preventing in-stent restenosis.%目的:探讨吡格列酮对非糖尿病患者冠状动脉(冠脉)支架内再狭窄的影响及其可能机制.方法:选择置入雷帕霉素洗脱支架的非糖尿病患者128例,并排除糖耐量异常者,随机分成吡格列酮组(71例)和对照组(57例),吡格列酮组在对照组常规治疗的基础上加用吡格列酮(30mg,qd);冠脉支架置入术后6~8个月行选择性冠脉造影术,于治疗前及随访6~8个月复查时先后分别测定血脂、空腹血糖、空腹胰岛素、血清瘦素及血清脂联素,并计算胰岛素抵抗指数(HOMA-IR).结果:吡格列酮组支架内再

  13. Safety and Effectiveness of Everolimus-Eluting Stents in Chronic Total Coronary Occlusion Revascularization: Results From the EXPERT CTO Multicenter Trial (Evaluation of the XIENCE Coronary Stent, Performance, and Technique in Chronic Total Occlusions).

    Science.gov (United States)

    Kandzari, David E; Kini, Annapoorna S; Karmpaliotis, Dimitri; Moses, Jeffrey W; Tummala, Pradyumna E; Grantham, J Aaron; Orr, Charles; Lombardi, William; Nicholson, William J; Lembo, Nicholas J; Popma, Jeffrey J; Wang, Jin; Larracas, Cristina; Rutledge, David R

    2015-05-01

    This study sought to evaluate procedural and clinical outcomes among patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using contemporary methods and everolimus-eluting stents (EES). Limited studies have detailed the procedural and late-term safety and efficacy of CTO revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents. Among 20 centers, 250 consecutive patients were enrolled for attempted CTO PCI. Procedural and in-hospital clinical outcomes were examined in addition to the 1-year primary endpoint of death, myocardial infarction, and target lesion revascularization (major adverse cardiac events [MACE]). Demographic, lesion, and procedural characteristics included prior bypass surgery: 9.9%; diabetes: 40.1%; lesion length: 36.1 ± 18.5 mm; and stent length: 51.7 ± 27.2 mm. Procedural success, defined as guidewire recanalization with no in-hospital MACE, was 96.4%. Success with antegrade-only methods was 97.9% and 86.2% by retrograde/combined methods, respectively. Compared with a pre-specified performance goal derived from 6 prior CTO drug-eluting stent trials (1-year MACE: 24.4%), treatment with EES was associated with significantly lower composite adverse events for both intent-to-treat (18.5%, 1-sided upper confidence interval: 23.4%, p = 0.025) and per-protocol populations (8.2%, 1-sided upper confidence interval: 12.3%, p CTO PCI in a patient population with high lesion complexity. (EXPERT CTO: Evaluation of the XIENCE PRIME LL and XIENCE Nano Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions; NCT01435031). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  14. Pitavastatin-incorporated nanoparticle-eluting stents attenuate in-stent stenosis without delayed endothelial healing effects in a porcine coronary artery model.

    Science.gov (United States)

    Tsukie, Noriaki; Nakano, Kaku; Matoba, Tetsuya; Masuda, Seigo; Iwata, Eiko; Miyagawa, Miho; Zhao, Gang; Meng, Wei; Kishimoto, Junji; Sunagawa, Kenji; Egashira, Kensuke

    2013-01-01

    The use of currently marketed drug-eluting stents presents safety concerns including increased late thrombosis, which is thought to result mainly from delayed endothelial healing effects (impaired re-endothelialization resulting in abnormal inflammation and fibrin deposition). We recently developed a bioabsorbable polymeric nanoparticle (NP)-eluting stent using a novel cationic electrodeposition technology. Statins are known to inhibit the proliferation of vascular smooth muscle cells (VSMC) and to promote vascular healing. We therefore hypothesized that statin-incorporated NP-eluting stents would attenuate in-stent stenosis without delayed endothelial healing effects. Among six marketed statins, pitavastatin (Pitava) was found to have the most potent effects on VSMC proliferation and endothelial regeneration in vitro. We thus formulated a Pitava-NP-eluting stent (20µg Pitava per stent). In a pig coronary artery model, Pitava-NP-eluting stents attenuated in-stent stenosis as effectively as polymer-coated sirolimus-eluting stents (SES). At SES sites, delayed endothelial healing effects were noted, whereas no such effects were observed in Pitava-NP-eluting stent sites. Pitava-NP-eluting stents attenuated in-stent stenosis as effectively as SES without the delayed endothelial healing effects of SES in a porcine coronary artery model. This nanotechnology platform could be developed into a safer and more effective device in the future.

  15. Randomized clinical trial comparing abluminal biodegradable polymer sirolimus-eluting stents with durable polymer sirolimus-eluting stents

    Science.gov (United States)

    Zhang, Haijun; Wang, Xiangfei; Deng, Wei; Wang, Shenguo; Ge, Junbo; Toft, Egon

    2016-01-01

    Abstract Background: The biodegradable polymer drug-eluting stents (DES) were developed to improve vascular healing. However, further data and longer-term follow-up are needed to confirm safety and efficacy of these stents. This randomized clinical trial aimed to compare safety and efficacy of 2 sirolimus-eluting stents (SES): Cordimax—a novel abluminal biodegradable polymer SES and Cypher Select—a durable polymer SES, at 9 months angiographic and 5-year clinical follow-up. Methods: We randomized 402 patients with coronary artery disease to percutaneous coronary intervention with Cordimax (n = 202) or Cypher select (n = 200). Angiographic follow-up was performed at 9 months after the index procedure and clinical follow-up annually up to 5 years. The primary endpoint was angiographic in-stent late luminal loss (LLL). Secondary endpoints included angiographic restenosis rate, target vessel revascularization (TVR), and major adverse cardiac events (MACEs; defined as cardiac death, myocardial infarction, or TVR) at 5-year follow-up. Results: Cordimax was noninferior to Cypher select for in-stent LLL (0.25 ± 0.47 vs 0.18 ± 0.49 mm; P = 0.587) and in-stent mean diameter stenosis (22.19 ± 12.21% vs 19.89 ± 10.79%; P = 0.064) at 9 months angiographic follow-up. The MACE rates were not different at 1 year (5.9% vs 4.0%, P = 0.376); however, MACE rates from 2 to 5 years were lower in the Cordimax group (6.8% vs 13.1%; P = 0.039). Conclusion: Abluminal biodegradable polymer SES is noninferior to durable polymer SES at 9-month angiographic and 1-year clinical follow-up. However, MACE rates from 2 to 5 years were less in the abluminal biodegradable polymer group. PMID:27661023

  16. Dual-action Hybrid Compounds - A New Dawn in the Discovery of Multi-target Drugs: Lead Generation Approaches.

    Science.gov (United States)

    Abdolmalekia, Azizeh; Ghasemi, Jahan B

    2016-09-27

    Finding high quality beginning compounds is a critical job at the start of the lead generation stage for multi-target drug discovery (MTDD). Designing hybrid compounds as a selective multi-target chemical entity is a challenge, opportunity, and new idea to better act against specific multiple targets. One hybrid molecule is formed by two (or more) pharmacophore group's participation. So, these new compounds often exhibit two or more activities going about as multi-target drugs (mt-drugs) and may have superior safety or efficacy. Application of integrating a range of information and sophisticated new in silico, bioinformatics, structural biology, pharmacogenomics methods may be useful to discover/design, and synthesis of the new hybrid molecules. In this regard, many rational and screening approaches have followed by medicinal chemists for the lead generation in MTDD. Here, we review some popular lead generation approaches that have been used for designing multiple ligands (DMLs). This paper focuses on dual- acting chemical entities that incorporate a part of two drugs or bioactive compounds to compose hybrid molecules. Also, it presents some of key concepts and limitations/strengths of lead generation methods by comparing combination framework method with screening approaches. Besides, a number of examples to represent applications of hybrid molecules in the drug discovery are included.

  17. Modeling the elution of organic chemicals from a melting homogeneous snow pack.

    Science.gov (United States)

    Meyer, Torsten; Wania, Frank

    2011-06-01

    Organic chemicals are often released in peak concentrations from melting snow packs. A simple, mechanistic snowmelt model was developed to simulate and predict the elution of organic substances from melting, homogeneous snow, as influenced by chemical properties and snow pack characteristics. The model calculates stepwise the chemical transport along with the melt water flow in a multi-layered snow pack, based on chemical equilibrium partitioning between the individual bulk snow phases. The model succeeds in reproducing the elution behavior of several organic contaminants observed in previously conducted cold room experiments. The model aided in identifying four different types of enrichment of organic substances during snowmelt. Water soluble substances experience peak releases early during a melt period (type 1), whereas chemicals that strongly sorb to particulate matter (PM) or snow grain surfaces elute at the end of melting (type 2). Substances that are somewhat water soluble and at the same time have a high affinity for snow grain surfaces may exhibit increasing concentrations in the melt water (type 3). Finally, elution sequences involving peak loads both at the beginning and the end of melting are simulated for chemicals that are partially dissolved in the aqueous melt water phase and partially sorbed to PM (type 4). The extent of type 1 enrichment mainly depends on the snow depth, whereby deeper snow generates more pronounced concentration peaks. PM influences the elution behavior of organic chemicals strongly because of the very large natural variability in the type and amount of particles present in snow. Urban and road-side snow rich in PM can generate type 2 concentration peaks at the end of the melt period for even relatively water soluble substances. From a clean, melting snow pack typical for remote regions, even fairly hydrophobic chemicals can be released in type 1 mode while being almost completely dissolved in the aqueous melt water phase. The

  18. [Drugs during pregnancy--effects on the mother and next generation].

    Science.gov (United States)

    Slamberová, R

    2003-02-01

    Drug abuse during pregnancy is a growing problem in all developed countries of the world. Drug-abusing women have irregular menstrual cycle often resulting in amenorrhea. However, the irregular cycle does not mean that the drug-abusing women cannot become pregnant and in that case they expose to the effects of the drug not only themselves but also their fetus. The drug easily crosses the placental barrier into the fetal body and to the maternal milk and affects both pre- and postnatal development of the child. After the cessation of the drug exposure the child has similar withdrawal symptoms as drug-abusing adults. Maternal drug abuse affects the developing system and its long-term effects can persist till adulthood. It was demonstrated that prenatal drug exposure (to drugs such as cocaine, metamphetamine, heroin, and morphine) decreases the weight of the newborns and decreases the rate of their maturation. Prenatal drug exposure also impairs learning and memory, alters responses to the new environment and stressors, changes seizure susceptibility and sexual behavior of the adult progeny. These effects seem to be due to alterations in neurotransmitter systems in the central nervous system affected by the prenatal drug exposure. The best known therapy is prevention and an attempt to diminish the drug abuse especially during pregnancy. This would be a solution not only for the issues raised in this article but for the drug abuse problem in general as well.

  19. Five-Year Long-Term Clinical Follow-Up of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de novo Coronary Artery Lesions: The SPIRIT FIRST Trial

    NARCIS (Netherlands)

    M. Wiemer; P.W. Serruys; K. Miquel-Hebert; F.J. Neumann; J.J. Piek; E. Grube; J. Haase; L. Thuesen; C. Hamm

    2010-01-01

    Background: Drug-eluting stents have shown to be superior over bare metal stents in clinical and angiographic outcomes after percutaneous treatment of coronary artery stenosis. However, long-term follow-up data are scarce and only available for sirolimus- and paclitaxel-eluting stents. Aim: To asses

  20. UNIFIED THEORETICAL MOMENT EXPRESSIONS FOR ELUTION CHROMATOGRAPHY AND FRONTAL CHROMATOGRAPHY

    Institute of Scientific and Technical Information of China (English)

    YANGGengliang; TAOZuyi

    1992-01-01

    The unified theoretical moment expressions for elution chromatography and frontal chromatography when the sorption process is described by a linear model were derived. The moment expressions derived by previous authors can be obtained from these unified theoretical moment expressions. In this paper, a mathematical analysis has been carried out so as to set up a unified theoretical basis for elution and frontal chromatography.

  1. 斑块组成对晚期药物支架贴壁不良影响的虚拟组织学血管内超声研究%Effect of plaque compositions on LSM after drug-eluting stent implantation : A virtual histology study on IVUS

    Institute of Scientific and Technical Information of China (English)

    迟云鹏; 郭成军; 吴小凡; 杨娅; 何东方; 赵林; 卢春山

    2013-01-01

    目的 探讨基线斑块组成对药物洗脱支架(drug-eluting stent,DES)置入术后晚期支架贴壁不良(late stent malapposition,LSM)的影响.方法 入选不稳定性心绞痛患者76例(113处病变)行冠状动脉原位病变DES置入及基线和随访虚拟组织学血管内超声检查,分为LSM组11例和无LSM组65例.结果 11例患者有16处(14.2%)病变,随访时发现LSM.不同DES比较,差异无统计学意义(P>0.05).LSM组糖尿病(63.6% vs29.2%,P<0.05)、支架长度[(29.4±5.5)mm vs (26.2±6.0)mm,P<0.05]、坏死核心体积[(29.8±14.0)mm3 vs(21.4±9.5)mm3,P<0.01]及坏死核心体积百分比[(26.5±6.6)% vs (20.1±6.6)%,P<0.01]均明显高于无LSM组.多因素回归分析显示,坏死核心体积百分比(OR=1.144,95%CI:1.052~1.243,P=0.002)和糖尿病(OR=3.829,95%CI:1.158~12.663,P=0.028)是LSM的独立预测因素.结论 病变坏死核心成分和糖尿病与不稳定性心绞痛DES置入术后LSM形成有关.

  2. 易损斑块对晚期药物支架贴壁不良影响的虚拟组织学血管内超声研究%Vulnerable plaque is associated with late stent malapposition after drug-eluting stent implantation: a virtual histology intravascular ultrasound analysis

    Institute of Scientific and Technical Information of China (English)

    吴小凡; 郭成军; 葛长江; 杨娅; 方冬平; 迟云鹏; 张晓江

    2014-01-01

    目的:探讨基线斑块组织分型对药物支架(drug-eluting stent,DES)置入术后晚期支架贴壁不良(late stent malapposition,LSM)的影响.方法:入选不稳定性心绞痛患者112例,行冠状动脉原位病变药物支架置入及基线和随访,平均随访时间(11.5±1.7)个月,虚拟组织学血管内超声(VH-IVUS)检查,分为易损斑块组(n=38)和非易损斑块组(n=74).结果:16例患者(14.3%)随访时发现LSM,易损斑块组明显多于非易损斑块组(28.9% vs.6.8%,P=0.001).易损斑块组糖尿病(52.6% vs.28.4%,P=0.012),支架长度,坏死核心体积[(28.7±9.6)vs.(22.0±11.2)mm3,P =0.004]及其百分比[(25.7±6.6)vs.(21.5±6.6)%,P<0.001]均明显高于非易损斑块组.多因素回归分析显示,易损斑块(OR=3.162,95%CI:1,052 ~ 11.278,P=0.001)和糖尿病(OR=1.145,95% CI:1.005~1.332,P=0.024)是LSM的独立预测因素.结论:易损斑块和糖尿病与不稳定心绞痛DES置入术后LSM形成有关.

  3. Uso de stents farmacológicos na "vida real": a importância dos registros Uso de stents farmacológicos en la "vida real": la importancia de los registros Real-world use of drug-eluting stents: the importance of registries

    Directory of Open Access Journals (Sweden)

    Expedito E. Ribeiro

    2010-07-01

    Full Text Available Nas últimas décadas, a eficácia e a segurança dos stents não-farmacológicos (SNF e dos stents farmacológicos (SF têm sido demonstradas em muitos ambientes clínicos diferentes, levando ao seu uso em mais de 75% de procedimentos no mundo todo. Comparados aos SNF, os SF mostraram menores taxas de reestenose angiográfica e revascularização do vaso-alvo. Esse benefício foi inicialmente demonstrado em estudos que excluíram pacientes com lesões mais complexas, tais como aquelas com vasos mais calibrosos ou finos, oclusão crônica, lesões bifurcadas, reestenose de stent, lesões longas e do tronco da coronária esquerda. Essa população do "mundo real" tem sido recentemente avaliada em muitos registros e meta-análises que são aqui revisados.En las últimas décadas, la eficacia de la seguridad de los stents no-farmacológicos (SNF y de los stents farmacológicos (SF ha sido demostrada en muchos ambientes clínicos diferentes, llevando a su uso en más de 75% de los procedimientos en todo el mundo. Comparados a los SNF, los SF mostraron menores tasas de reestenosis angiográfica y revascularización del vaso a tratar. Ese beneficio fue inicialmente demostrado en estudios que excluyeron a pacientes con lesiones más complejas, tales como aquellas con vasos más dilatados o finos, oclusión crónica, lesiones bifurcadas, reestenosis de stent, lesiones largas y del tronco de la coronaria izquierda. Esa población del "mundo real" ha sido recientemente evaluada en muchos registros y meta-análisis que son aquí revisados.over the last decades the efficacy and safety of bare metal (BMS and drug eluting stents (DES have been demonstrated in many different clinical scenarios, leading to their use in more than 75% of the procedures worldwide. Compared to BMS, DES have shown lower rates of angiographic restenosis and target-vessel revascularization. This benefit was initially demonstrated in trials that excluded patients with more complex

  4. On the hydrolysis mechanism of the second-generation anticancer drug carboplatin.

    Science.gov (United States)

    Pavelka, Matej; Lucas, Maria Fatima A; Russo, Nino

    2007-01-01

    The hydrolysis reaction mechanisms of carboplatin, a second-generation anticancer drug, have been explored by combining density functional theory (DFT) with the conductor-like dielectric continuum model (CPCM) approach. The decomposition of carboplatin in water is expected to take place through a biphasic mechanism with a ring-opening process followed by the loss of the malonato ligand. We have investigated this reaction in water and acid conditions and established that the number of protons present in the malonato ligand has a direct effect on the energetics of this system. Close observation of the optimised structures revealed a necessary systematic water molecule in the vicinity of the amino groups of carboplatin. For this reason we have also investigated this reaction with an explicit water molecule. From the computed potential-energy surfaces it is established that the water hydrolysis takes place with an activation barrier of 30 kcal mol(-1), confirming the very slow reaction observed experimentally. The decomposition of carboplatin upon acidification was also investigated and we have computed a 21 kcal mol(-1) barrier to be overcome (experimental value 23 kcal mol(-1)). We have also established that the rate-limiting process is the first hydration, and ascertained the importance of a water molecule close to the two amine groups in lowering the activation barriers for the ring-opening reaction.

  5. Generation of a Drug-inducible Reporter System to Study Cell Reprogramming in Human Cells*

    Science.gov (United States)

    Ruiz, Sergio; Panopoulos, Athanasia D.; Montserrat, Nuria; Multon, Marie-Christine; Daury, Aurélie; Rocher, Corinne; Spanakis, Emmanuel; Batchelder, Erika M.; Orsini, Cécile; Deleuze, Jean-François; Izpisua Belmonte, Juan Carlos

    2012-01-01

    Reprogramming of somatic cells into induced pluripotent stem cells is achieved by the expression of defined transcription factors. In the last few years, reprogramming strategies on the basis of doxycycline-inducible lentiviruses in mouse cells became highly powerful for screening purposes when the expression of a GFP gene, driven by the reactivation of endogenous stem cell specific promoters, was used as a reprogramming reporter signal. However, similar reporter systems in human cells have not been generated. Here, we describe the derivation of drug-inducible human fibroblast-like cell lines that express different subsets of reprogramming factors containing a GFP gene under the expression of the endogenous OCT4 promoter. These cell lines can be used to screen functional substitutes for reprogramming factors or modifiers of reprogramming efficiency. As a proof of principle of this system, we performed a screening of a library of pluripotent-enriched microRNAs and identified hsa-miR-519a as a novel inducer of reprogramming efficiency. PMID:23019325

  6. The AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusion (ACE-CTO) Study.

    Science.gov (United States)

    Kotsia, Anna; Navara, Rachita; Michael, Tesfaldet T; Sherbet, Daniel P; Roesle, Michele; Christopoulos, George; Rangan, Bavana V; Haagen, Donald; Garcia, Santiago; Maniu, Calin; Pershad, Ashish; Abdullah, Shuaib M; Hastings, Jeffrey L; Kumbhani, Dharam J; Luna, Michael; Addo, Tayo; Banerjee, Subhash; Brilakis, Emmanouil S

    2015-09-01

    There are limited data on outcomes after implantation of second-generation drug-eluting stents in coronary chronic total occlusions (CTOs). We aimed to evaluate the frequency of angiographic restenosis and clinical outcomes after implantation of the everolimus-eluting stent (EES) in coronary CTOs. One hundred patients undergoing successful CTO percutaneous coronary intervention using EES at our institution between 2009 and 2012 were enrolled. The primary study endpoint was binary in-segment restenosis at 8-month follow-up quantitative coronary angiography. Secondary endpoints included death, myocardial infarction, target-lesion and target-vessel revascularization, and symptom improvement. Mean age was 64 ± 7 years and 99% of the patients were men. The successful crossing technique was antegrade wiring in 51 patients, antegrade dissection/reentry in 24 patients, and retrograde in 25 patients. Binary angiographic restenosis occurred in 46% of the patients (95% confidence interval [CI], 35%-57%). The pattern of restenosis was focal, proliferative, and total occlusion in 19 lesions (46%), 14 lesions (34%), and 8 lesions (20%), respectively. At 12 months, the incidences of death, myocardial infarction, target-lesion revascularization, and target-vessel revascularization were 2%, 2%, 37%, and 39%, respectively. At 12 months, symptoms were improved, unchanged, or worse compared with baseline in 89 patients, 8 patients, and 1 patient, respectively (2 patients died before the 12-month follow-up). On multivariable analysis, smaller stent diameter was associated with higher risk for binary angiographic restenosis. High rates of angiographic restenosis and repeat revascularization were observed among patients receiving EES in coronary CTOs, but most had significant symptom improvement.

  7. Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial.

    Science.gov (United States)

    Turco, Mark A; Ormiston, John A; Popma, Jeffrey J; Mandinov, Lazar; O'Shaughnessy, Charles D; Mann, Tift; McGarry, Thomas F; Wu, Chiung-Jen; Chan, Charles; Webster, Mark W I; Hall, Jack J; Mishkel, Gregory J; Cannon, Louis A; Baim, Donald S; Koglin, Joerg

    2007-04-24

    The goal of this research was to assess non-inferiority of the next-generation TAXUS Liberté stent (Boston Scientific Corp., Natick, Massachusetts) versus the TAXUS Express stent (Boston Scientific Corp.). The introduction of drug-eluting stents (DES) has shifted clinical practice towards more complex lesion subsets, prompting the need for more deliverable DES. TAXUS Liberté was designed to combine the established polymer-based, paclitaxel-elution TAXUS technology with the more advanced Liberté stent platform. The TAXUS ATLAS study is a global, prospective, single-arm trial evaluating outcomes in de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.5 to 4.0 mm in diameter. The control group is an entry-criteria-matched population of TAXUS Express patients from the TAXUS IV and V trials. The primary end point is non-inferiority of TAXUS Liberté versus TAXUS Express for 9-month target vessel revascularization. Despite similar inclusion criteria, quantitative coronary angiography-determined baseline lesion characteristics were significantly more complex for TAXUS Liberté than TAXUS Express. The primary non-inferiority end point was met with the 1-sided 95% confidence bound of 2.98% less than the pre-specified non-inferiority margin of 3% (p = 0.0487). Despite the treatment of more complex lesions with TAXUS Liberté, the primary end point was met, demonstrating that TAXUS Liberté is non-inferior to TAXUS Express. The successful transfer of the proven TAXUS technology to the more advanced TAXUS Liberté platform was demonstrated. (TAXUS ATLAS: TAXUS Liberté-SR Stent for the Treatment of De Novo Coronary Artery Lesions; http://www.clinicaltrials.gov/ct/show/NCT00371709?order=1; NCT00371709).

  8. In vitro hemocompatibility and cytocompatibility of dexamethasone-eluting PLGA stent coatings

    Science.gov (United States)

    Zhang, Jiang; Liu, Yang; Luo, Rifang; Chen, Si; Li, Xin; Yuan, Shuheng; Wang, Jin; Huang, Nan

    2015-02-01

    Drug-eluting stents (DESs) have been an important breakthrough for interventional cardiology applications since 2002. Though successful in reducing restenosis, some adverse clinical problems still emerged, which were mostly caused by the bare-metal stents and non-biodegradable polymer coatings, associated with the delayed endothelialization process. In this study, dexamethasone-loaded poly (lactic-co-glycolic acid) (PLGA) coatings were developed to explore the potential application of dexamethasone-eluting stents. Dexamethasone-eluting PLGA stents were prepared using ultrasonic atomization spray method. For other tests like stability and cytocompatibility and hemocompatibility tests, dexamethasone loaded coatings were deposited on 316L SS wafers. Fourier transform-infrared spectroscopy (FT-IR) results demonstrated that there was no chemical reaction between PLGA and dexamethasone. The balloon expansion experiment and surface morphology observation suggested that the stent coatings were smooth and uniform, and could also withstand the compressive and tensile strains imparted without cracking after stent expansion. The drug release behavior in vitro indicated that dexamethasone existed burst release within 1 day, but it presented linear release characteristics after 6 days. In vitro platelets adhesion, activation test and APTT test were also done, which showed that after blending dexamethasone into PLGA, the hemocompatibility was improved. Besides, dexamethasone and dexamethasone-loaded PLGA coatings could significantly inhibit the attachment and proliferation of smooth muscle cells.

  9. Rapid development of late stent malappositon and coronary aneurysm following implantation of a paclitaxel-eluting coronary stent

    Institute of Scientific and Technical Information of China (English)

    ZHANG Feng; QIAN Ju-ying; GE Jun-bo

    2007-01-01

    @@ Late stent malapposition (LSM), an unusual intravascular ultrasound (IVUS) finding at follow-up, has been reported to be more common after drug-eluting stent (DES) implantation than after bare metal stent(BMS) implantation.1-3 However, there has been no clear elucidation of time course and mechanism. We reported a case who developed LSM and coronary aneurysm very early after paclitaxel-eluting stent (PES) implantation. A review of the literature reveals no previous report describing rapid development of LSM and coronary aneurysm after PES implantation.

  10. One year clinical follow up of paclitaxel eluting stents for acute myocardial infarction compared with sirolimus eluting stents

    NARCIS (Netherlands)

    S.H. Hofma (Sjoerd); M. Valgimigli (Marco); C.A.G. van Mieghem (Carlos); P.J. de Feyter (Pim); P.W.J.C. Serruys (Patrick); W.J. van der Giessen (Wim); P.P.T. de Jaegere (Peter); E.S. Regar (Eveline); G. Sianos (Georgios); J. Aoki (Jiro); G.A. Rodriguez-Granillo (Gaston); E.P. McFadden (Eugene); A.T.L. Ong (Andrew); R.T. van Domburg (Ron)

    2005-01-01

    textabstractOBJECTIVE: To compare clinical outcome of paclitaxel eluting stents (PES) versus sirolimus eluting stents (SES) for the treatment of acute ST elevation myocardial infarction. DESIGN AND PATIENTS: The first 136 consecutive patients treated exclusively with PES in the setting of primary pe

  11. 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.

  12. 无保护左主干病变冠状动脉搭桥术与雷帕霉素洗脱支架治疗的对比研究%Comparison between drug-eluting stents and coronary artery bypass surgery for the treatment of unprotected left main coronary artery stenosis

    Institute of Scientific and Technical Information of China (English)

    庞明杰; 张宏; 赵燕; 陶杰; 张云梅; 吴咏昕

    2012-01-01

    Objective:To evaluate the effect of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for unprotected left main coronary artery disease and investigate the relevance between the risk of lesion and major adverse cardiac and cerebrovascular event (MACCE) by syntax score system. Method: We reviewed outcomes among 176 consecutive patients with unprotected left main coronary artery disease who underwent PCI or CAGB. Eighty patients underwent CABG (CABG group) and nin-ty-six patients received drug-eluting stents (PCI group). Base features, angiographic characteristics, operation data, SYNTAX SCORE and MACCE rates followed up 3 years after operation were recorded. Result:There were more target vessel revascularization events in the PCI group than in the CABG group, although MACCE and MACCE-free rates were similar at 3 years follow-up. Patients were divided into high-score group (≥30.0) and low-score group (30. 0 is the independent risk factor of the outcomes of PCI. In the high-score group, MACCE was higher and MACCE-free rate was lower at 3 years in patients underwent PCI than CABG (23. 53% vs 18. 05%, P0. 05), but MACCE-free rate was lower in patients underwent CABG than PCI at 3 years follow-up (75.00% vs 82. 14%, P<0. 05). Conclusion: PCI with DES is feasible and effective for patients with unprotected left main coronary artery disease.%目的:回顾性分析无保护左主干病变患者使用雷帕霉素洗脱支架(DES)的经皮冠状动脉介入治疗(PCI)与冠状动脉旁路移植手术(CABG)治疗的中、远期疗效,并探讨应用SYNTAX SCORE来评估病变风险与临床事件的相关性.方法:本研究回顾性收集了176例无保护左主干病变患者,其中CABG组80例,PCI-DES组96例.收集患者的基本情况、左主干病变特点及SYNTAX评分、CABG和PCI手术情况,随访患者术后3年的主要不良心脑血管事件(MACCE)的发生率.结果:术后3年随访,PCI-DES组

  13. 药物洗脱支架植入术后心房颤动患者抗栓治疗方案疗效对比%Comparison of different antithrombotic regime in patients with atrial fibrillation undergoing Drug-Eluting Stent imolantation

    Institute of Scientific and Technical Information of China (English)

    冯仕勇; 许勇

    2011-01-01

    Objective To compare the prognosis of different antithrombotic regimen in patients with atrial fibrillation(AF) undergoing drug-eluting stent implantation.Methods We enrolled 549 consecutive patients who had a history of AF or newly diaguosed AF undergoing drug-eluting stent implantation.Among them, 115 patients ( TF group) continued triple antithrombotic therapy including aspirin, clopidogrel and warfarin after discharge ;347 patients( DT group) prescribed dual antiplatelet therapy ;87 patients( WS group) discharged with warfarin and single antiplatelet agent.In patients with warfarin target INR value was set as 1.8 to 2.5 before discharge and ordered regular INR monitoring after discharge.Results Patients with triple antithrombotic therapy had a significant reduction in stroke and major adverse cardiac and cerebral events(MACCE) (7.1% vs 21.5% vs 17.3% ,P <0.01 ) as compared with either DT or WS group.In Cox regression analysis,non-administration with warfarin( hazard ratio[HR]=2.27;95% confidence interval[CI]1.39 to 3.70; P < 0.01 ) and baseline CHADS2 score ≥2 ( HR = 2.49;95% CI: 1.51 to 4.11; P < 0.01 ) were independent predictors of MACCE.Importantly, the incidence of major bleeding was comparable among three groups( 3.6% vs 1.8% vs 2.5% , P > 0.05 ), although there was an increased risk of overall bleeding in TT group.Kaplan-Meier analysis indicated the TT group was associated with the best net clinical outcome.Conclusion Our study confirmed the cardiovascular benefits of triple antithrombotic therapy by reducing MACCE rate,and suggested the major bleeding rate was comparable with other treatment options despite an increased minor bleeding risk.%目的 对比不同抗栓治疗方案在接受药物洗脱支架(DES)植入的冠心病伴心房颤动患者中的作用.方法 连续入选接受介入治疗置入DES,合并房颤病史或新诊断的房颤患者549名,根据患者出院后不同抗栓治疗方案分为三组:三联抗栓

  14. Efetividade e segurança dos stents farmacológicos em um serviço de cardiologia em Curitiba-PR Efectividad y seguridad de los Stents farmacológicos en un servicio de cardiología en Curitiba-PR Effectiveness and safety of drug-eluting stents in a cardiology clinic in Curitiba, PR, Brazil

    Directory of Open Access Journals (Sweden)

    Chiu Yun Yu Braga

    2010-07-01

    . De esos pacientes, 85 (41,87% eran asintomáticos, y 146 (71,92%, multiarteriales. En las características de las lesiones, 77,45% fueron B2/C (AHA/ACC. Taxus fue implantado en 73,62% de los pacientes. En 381 (81,96%, se constataron stents con diámetro > 2,5 mm. El largo del stent era de BACKGROUND: The effectiveness and safety of drug-eluting stents (DES have still been questioned. OBJECTIVE: The objective of this study was to evaluate the effectiveness and safety of these stents, as well as the incidence of target lesion revascularization (TLR, in addition to identifying possible variables influencing the need for TLR. METHODS: A total of 203 patients from Hospital Costantini who were clinically followed up for one to 3 years were selected. RESULTS: The sample characteristics were as follows: 470 lesions; 171 (84.24% male patients; 54 (26.6% had diabetes; 131 (64.35% had hypertension; 127 (62.56%, dyslipidemia; 40 (19.70% were smokers; and 79 (38.92% had a family history of coronary artery disease. Also: 49 (24.14% patients presented with stable angina; 58 (28.57%, unstable angina; and 6 (2.96%, myocardial infarction. Eighty five (41.87% patients were asymptomatic, and 146 (71.92%, had multivessel disease. As for the characteristics of the lesions, 77.45% were B2/C (AHA/ACC. Taxus was implanted in 73.62% of the patients. Stents with diameter > 2.5 mm were used in 381 (81.96% patients. The stent length was < 30 mm in 67.87% of the lesions, with a mean of 2.3 stents per patient. After follow-up, 19 patients (9.3% underwent TLR. Four patients died (1.97%, two of them of MI (0.98%, one of stroke (0.49%, and one of abdominal aneurysm (0.49%. Also, one patient died of late thrombosis (0.49%, and one of reinfarction (0.49%. In the statistical analysis carried out, only the bifurcation lesions variable reached values close to the statistical significance level, with p < 0.06. CONCLUSION: In conclusion, drug-eluting stents have good effectiveness and safety profiles; the

  15. Small-Column Cesium Ion Exchange Elution Testing of Spherical Resorcinol-Formaldehyde

    Energy Technology Data Exchange (ETDEWEB)

    Brown, Garrett N.; Russell, Renee L.; Peterson, Reid A.

    2011-10-21

    This report summarizes the work performed to evaluate multiple, cesium loading, and elution cycles for small columns containing SRF resin using a simple, high-level waste (HLW) simulant. Cesium ion exchange loading and elution curves were generated for a nominal 5 M Na, 2.4E-05 M Cs, 0.115 M Al loading solution traced with 134Cs followed by elution with variable HNO3 (0.02, 0.07, 0.15, 0.23, and 0.28 M) containing variable CsNO3 (5.0E-09, 5.0E-08, and 5.0E-07 M) and traced with 137Cs. The ion exchange system consisted of a pump, tubing, process solutions, and a single, small ({approx}15.7 mL) bed of SRF resin with a water-jacketed column for temperature-control. The columns were loaded with approximately 250 bed volumes (BVs) of feed solution at 45 C and at 1.5 to 12 BV per hour (0.15 to 1.2 cm/min). The columns were then eluted with 29+ BVs of HNO3 processed at 25 C and at 1.4 BV/h. The two independent tracers allowed analysis of the on-column cesium interaction between the loading and elution solutions. The objective of these tests was to improve the correlation between the spent resin cesium content and cesium leached out of the resin in subsequent loading cycles (cesium leakage) to help establish acid strength and purity requirements.

  16. 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.

  17. In vitro hemocompatibility and cytocompatibility of dexamethasone-eluting PLGA stent coatings

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, Jiang; Liu, Yang; Luo, Rifang; Chen, Si; Li, Xin; Yuan, Shuheng; Wang, Jin, E-mail: jinxxwang@263.net; Huang, Nan

    2015-02-15

    Highlights: • Biodegradable dexamethasone-eluting PLGA stent coatings were developed. • Stent coatings can withstand the compressive and tensile strains without cracking. • Stent coatings presented favorable release kinetic for the lesion site. • Stent coatings can effectively inhibit the adhesion and activation of platelets. • Stent coatings can effectively inhibit the proliferation of SMC. - Abstract: Drug-eluting stents (DESs) have been an important breakthrough for interventional cardiology applications since 2002. Though successful in reducing restenosis, some adverse clinical problems still emerged, which were mostly caused by the bare-metal stents and non-biodegradable polymer coatings, associated with the delayed endothelialization process. In this study, dexamethasone-loaded poly (lactic-co-glycolic acid) (PLGA) coatings were developed to explore the potential application of dexamethasone-eluting stents. Dexamethasone-eluting PLGA stents were prepared using ultrasonic atomization spray method. For other tests like stability and cytocompatibility and hemocompatibility tests, dexamethasone loaded coatings were deposited on 316L SS wafers. Fourier transform-infrared spectroscopy (FT-IR) results demonstrated that there was no chemical reaction between PLGA and dexamethasone. The balloon expansion experiment and surface morphology observation suggested that the stent coatings were smooth and uniform, and could also withstand the compressive and tensile strains imparted without cracking after stent expansion. The drug release behavior in vitro indicated that dexamethasone existed burst release within 1 day, but it presented linear release characteristics after 6 days. In vitro platelets adhesion, activation test and APTT test were also done, which showed that after blending dexamethasone into PLGA, the hemocompatibility was improved. Besides, dexamethasone and dexamethasone-loaded PLGA coatings could significantly inhibit the attachment and

  18. Factorial study on influence of gas generating agent and diluent on drug release kinetics of clopidogrel bisulfate floating tablets

    Directory of Open Access Journals (Sweden)

    K R Koteswara Rao

    2013-01-01

    Full Text Available The purpose of present work was to formulate and characterize a floating drug delivery system for Clopidogrel bisulphate to improve bioavailability and to minimize the side-effects of the drug such as gastric bleeding and drug resistance development. Clopidogrel floating tablets were prepared by direct compression technique by the use of xanthan gum at different concentrations (20%, 25% and 30% w/w. Sodium bicarbonate (15% w/w and microcrystalline cellulose (MCC (30% w/w were used as gas generating agent and diluent respectively. The effects of sodium bicarbonate and MCC on the drug release kinetics and floating properties were investigated. A 2 2 factorial design was applied systematically to optimized formulation. The percentage amount of sodium bicarbonate (X 1 and percentage amount of MCC (X 2 were selected as independent variables. The drug release rate constant (K and time required for 85% drug dissolution (T85 was selected as dependent variables. Factorial design revealed that the percentage amount of sodium bicarbonate and MCC had insignificant effect on drug release kinetics (K, T85 within the chosen levels and a high level of sodium bicarbonate (X 1 and the low level of MCC (X 2 favor the preparation of clopidogrel floating tablets. All the Clopidogrel floating formulations followed first order kinetics, Higuchi drug release kinetics with diffusion as the dominant mechanism of drug release. As per Korsmeyer-Peppas equation, the release exponent "n" ranged 0.455-0.654 indicating that drug release from all the formulations was by non-fickian diffusion mechanism.

  19. The Next Generation of Platinum Drugs: Targeted Pt(II) Agents, Nanoparticle Delivery, and Pt(IV) Prodrugs.

    Science.gov (United States)

    Johnstone, Timothy C; Suntharalingam, Kogularamanan; Lippard, Stephen J

    2016-03-09

    The platinum drugs, cisplatin, carboplatin, and oxaliplatin, prevail in the treatment of cancer, but new platinum agents have been very slow to enter the clinic. Recently, however, there has been a surge of activity, based on a great deal of mechanistic information, aimed at developing nonclassical platinum complexes that operate via mechanisms of action distinct from those of the approved drugs. The use of nanodelivery devices has also grown, and many different strategies have been explored to incorporate platinum warheads into nanomedicine constructs. In this Review, we discuss these efforts to create the next generation of platinum anticancer drugs. The introduction provides the reader with a brief overview of the use, development, and mechanism of action of the approved platinum drugs to provide the context in which more recent research has flourished. We then describe approaches that explore nonclassical platinum(II) complexes with trans geometry or with a monofunctional coordination mode, polynuclear platinum(II) compounds, platinum(IV) prodrugs, dual-threat agents, and photoactivatable platinum(IV) complexes. Nanoparticles designed to deliver platinum(IV) complexes will also be discussed, including carbon nanotubes, carbon nanoparticles, gold nanoparticles, quantum dots, upconversion nanoparticles