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Sample records for everolimus-eluting coronary stent

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  2. Current status of the Xience V® everolimus-eluting coronary stent system

    NARCIS (Netherlands)

    Claessen, Bimmer E.; Caixeta, Adriano; Henriques, José P. S.; Piek, Jan J.

    2010-01-01

    The introduction of drug-eluting stents has led to a marked reduction of restenosis, which is a major limitation of percutaneous coronary intervention for coronary artery disease. The next-generation Xience V® (Abbott Vascular, CA, USA) everolimus-eluting stent was designed to address the

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

    DEFF Research Database (Denmark)

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

    2007-01-01

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

  4. Comparison of platinum chromium everolimus-eluting stent with cobalt chromium everolimus-eluting stent in unselected patients undergoing percutaneous coronary intervention.

    Science.gov (United States)

    Li, R-G; Lee, C-H; Low, A; Chan, M; Chan, K H; Richards, A M; Qu, X-K; Fang, W-Y; Tan, H C

    2015-06-01

    The recent PLATINUM trial has demonstrated that the use of the new generation platinum chromium everolimus-eluting stents (PtCr-EES) yield clinical outcomes similar to those obtained by the use of cobalt chromium everolimus-eluting stents (CoCr-EES) in selected patients with 1 or 2 de novo coronary artery lesions. This study aimed to compare the safety and efficacy of the PtCr-EES and CoCr-EES in unselected patients from a real-life single-center registry.   From July 2009 through November 2010, 788 consecutive patients in our institution with symptomatic coronary artery disease who were treated with the CoCr-EES (n = 410) or PtCr-EES (n = 378) were enrolled into this study. The primary endpoint of the study was target-lesion failure (TLF) at 12-month follow-up and the secondary endpoints were major adverse cardiovascular events and stent thrombosis. The prevalence of TLF in the PtCr-EES group (4.5%) was similar to that in the CoCr-EES group (3.9%). In addition, there were no significant differences in the 12-month rates of cardiac death (2.1% vs. 1.5%), myocardial infarction (2.4% vs. 3.9%), ischemia-driven target lesion revascularization (2.4% vs. 2.2%), and definite or probable stent thrombosis (0.5% vs. 1.5%, all p > 0.05). At 12-month follow-up, the PtCr-EES is comparable in safety and efficacy to the CoCr-EES in unselected patients with coronary artery diseases.

  5. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II)

    DEFF Research Database (Denmark)

    Serruys, Patrick W; Chevalier, Bernard; Sotomi, Yohei

    2016-01-01

    BACKGROUND: No medium-term data are available on the random comparison between everolimus-eluting bioresorbable vascular scaffolds and everolimus-eluting metallic stents. The study aims to demonstrate two mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions......-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA......). Randomisation was stratified by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was superiority of the Absorb bioresorbable scaffold versus the Xience metallic stent in angiographic vasomotor reactivity after administration of intracoronary nitrate. The co...

  6. 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

  7. 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

  8. Trial of everolimus-eluting stents or bypass surgery for coronary disease.

    Science.gov (United States)

    Park, Seung-Jung; Ahn, Jung-Min; Kim, Young-Hak; Park, Duk-Woo; Yun, Sung-Cheol; Lee, Jong-Young; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Choo, Suk Jung; Chung, Cheol Hyun; Lee, Jae Won; Cohen, David J; Yeung, Alan C; Hur, Seung Ho; Seung, Ki Bae; Ahn, Tae Hoon; Kwon, Hyuck Moon; Lim, Do-Sun; Rha, Seung-Woon; Jeong, Myung-Ho; Lee, Bong-Ki; Tresukosol, Damras; Fu, Guo Sheng; Ong, Tiong Kiam

    2015-03-26

    Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents. We conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups. After the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG. Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).

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

    Science.gov (United States)

    Sheiban, Imad; Villata, Gianluca; Bollati, Mario; Sillano, Dario; Lotrionte, Marzia; Biondi-Zoccai, Giuseppe

    2008-01-01

    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.

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

    Science.gov (United States)

    Sheiban, Imad; Villata, Gianluca; Bollati, Mario; Sillano, Dario; Lotrionte, Marzia; Biondi-Zoccai, Giuseppe

    2008-01-01

    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. PMID:18629361

  11. Intravascular Ultrasound Predictors of Major Adverse Cardiovascular Events After Implantation of Everolimus-eluting Stents for Long Coronary Lesions.

    Science.gov (United States)

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

    2017-02-01

    There are limited data on the usefulness of intravascular ultrasound (IVUS) for long coronary lesions treated with second-generation drug-eluting stents. We evaluated IVUS predictors of major adverse cardiovascular events (MACE) 12 months after implantation of everolimus-eluting stents for long coronary lesions. A total of 804 patients who underwent both postintervention IVUS examination and long everolimus-eluting stent (≥ 28mm in length) implantation were included from 2 randomized trials. MACE was defined as a composite of cardiac death, myocardial infarction, and target-lesion revascularization. MACE occurred in 24 patients (3.0%) over 12 months. On multivariable Cox regression analysis, independent IVUS predictors of MACE included the postintervention minimum lumen area (MLA) at the target lesion (HR = 0.623; 95%CI, 0.433-0.895; P=.010) and the ratio of MLA/distal reference segment lumen area (HR = 0.744; 95%CI, 0.572-0.969; P=.028). The MLA and MLA-to-distal reference segment lumen area ratio that best predicted patients with MACE from those without these events were 5.0 mm(2) and 1.0, respectively. Patients with MLAMLA of<5.0 mm(2) or a distal reference segment lumen area were at risk for MACE after long everolimus-eluting stent implantation. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  12. Update on the everolimus-eluting coronary stent system: results and implications from the SPIRIT clinical trial program

    Directory of Open Access Journals (Sweden)

    R Michael Kirchner

    2009-12-01

    Full Text Available R Michael Kirchner, J Dawn AbbottDepartment of Cardiology, Rhode Island Hospital, Brown Medical School, Providence, RI, USAAbstract: Drug-eluting stents (DES have had a major impact in interventional cardiology. Compared to bare metal stents, they significantly reduce restenosis and the need for target vessel revascularization. Four DES are available in the US, the first-generation sirolimuseluting (Cypher® and paclitaxel-eluting (Taxus® stents and later approved second-generation everolimus-eluting (Xience V® and zotarolimus-eluting (Endeavor® stents. The Xience V stent was approved on the basis of clinical efficacy and safety data from 3 studies in the SPIRIT clinical trial program. Within this trial series, the Xience V was superior to its bare metal stent counterpart, the Vision® stent, and noninferior to the paclitaxel-eluting stent for target vessel failure at 9 months. This review provides a comprehensive assessment of the data derived from both the pre- and post-approval randomized controlled trials and registry studies of Xience V that comprise the SPIRIT clinical trial program including recently published mid-term outcomes. The implications of the results in terms of interventional practice will be discussed.Keywords: cobalt-chromium, drug-eluting stent, everolimus, percutaneous coronary intervention, Xience V

  13. Effect of Post-Dilatation Following Primary PCI With Everolimus-Eluting Bioresorbable Scaffold Versus Everolimus-Eluting Metallic Stent Implantation

    DEFF Research Database (Denmark)

    Yamaji, Kyohei; Brugaletta, Salvatore; Sabaté, Manel

    2017-01-01

    OBJECTIVES: This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EE...

  14. Incidence and Potential Mechanism(s) of Post-Procedural Rise of Cardiac Biomarker in Patients With Coronary Artery Narrowing After Implantation of an Everolimus-Eluting Bioresorbable Vascular Scaffold or Everolimus-Eluting Metallic Stent

    DEFF Research Database (Denmark)

    Ishibashi, Yuki; Muramatsu, Takashi; Nakatani, Shimpei

    2015-01-01

    OBJECTIVES: This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation. BACKGROUND: A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periproce......OBJECTIVES: This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation. BACKGROUND: A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence...

  15. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Serruys, Patrick W; Silber, Sigmund; Garg, Scot

    2010-01-01

    New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed...

  16. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents

    NARCIS (Netherlands)

    P.W.J.C. Serruys (Patrick); S. Silber (Sigmund); S.A. Garg (Scot); R.J.M. van Geuns (Robert Jan); G. Richard (Gert); P. Buszman (Pawel); H. Kelbaek (Henning); A.J. van Boven (Ad); S.H. Hofma (Sjoerd); A. Linke (Axel); V. Klauss (Volker); W. Wijns (William); C.M. Miguel (Carlos); P. Garot (Phillipe); C. DiMario (Carlo); G. Manoharan (Ganesh); R. Kornowski (Ran); T. Ischinger (Thomas); A. Bartorelli (Antonio); J. Ronden (Jacintha)

    2010-01-01

    textabstractBACKGROUND: New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end

  17. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Serruys, Patrick W; Silber, Sigmund; Garg, Scot

    2010-01-01

    New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the ...

  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. Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable-Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization: 2-Year Results of the BIOSCIENCE Trial.

    Science.gov (United States)

    Zbinden, Rainer; Piccolo, Raffaele; Heg, Dik; Roffi, Marco; Kurz, David J; Muller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Franzone, Anna; Eberli, Franz; Jüni, Peter; Windecker, Stephan; Pilgrim, Thomas

    2016-03-15

    No data are available on the long-term performance of ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES). We reported 2-year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP-SES with durable-polymer everolimus-eluting stents (DP-EES) in patients undergoing percutaneous coronary intervention. A total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP-SES (n=1063) or DP-EES (n=1056). Follow-up at 2 years was available for 2048 patients (97%). The primary end point was target-lesion failure, a composite of cardiac death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. At 2 years, target-lesion failure occurred in 107 patients (10.5%) in the BP-SES arm and 107 patients (10.4%) in the DP-EES arm (risk ratio [RR] 1.00, 95% CI 0.77-1.31, P=0.979). There were no significant differences between BP-SES and DP-EES with respect to cardiac death (RR 1.01, 95% CI 0.62-1.63, P=0.984), target-vessel myocardial infarction (RR 0.91, 95% CI 0.60-1.39, P=0.669), target-lesion revascularization (RR 1.17, 95% CI 0.81-1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56-3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP-SES arm and 4 cases (0.4%) in the DP-EES arm (P=0.423). In the prespecified subgroup of patients with ST-segment elevation myocardial infarction, BP-SES was associated with a lower risk of target-lesion failure compared with DP-EES (RR 0.48, 95% CI 0.23-0.99, P=0.043, Pinteraction=0.026). Comparable safety and efficacy profiles of BP-SES and DP-EES were maintained throughout 2 years of follow-up. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by

  20. Long-term forecasting and comparison of mortality in the Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial: Prospective validation of the SYNTAX Score II

    NARCIS (Netherlands)

    C.A.M. Campos (Carlos); D. van Klaveren (David); V. Farooq (Vasim); C. Simonton (Charles); A.P. Kappetein (Arie Pieter); J.F. Sabik (Joseph); E.W. Steyerberg (Ewout); G.W. Stone (Gregg); P.W.J.C. Serruys (Patrick)

    2015-01-01

    textabstractAims To prospectively validate the SYNTAX Score II and forecast the outcomes of the randomized Evaluation of the Xience Everolimus-Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) Trial. Methods and results Evaluation of the

  1. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease.

    Science.gov (United States)

    Ellis, Stephen G; Kereiakes, Dean J; Metzger, D Christopher; Caputo, Ronald P; Rizik, David G; Teirstein, Paul S; Litt, Marc R; Kini, Annapoorna; Kabour, Ameer; Marx, Steven O; Popma, Jeffrey J; McGreevy, Robert; Zhang, Zhen; Simonton, Charles; Stone, Gregg W

    2015-11-12

    In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes. In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year. Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, -0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13). In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III Clinical

  2. 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.

  3. Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: rationale and design of the BIOSCIENCE trial.

    Science.gov (United States)

    Pilgrim, Thomas; Roffi, Marco; Tüller, David; Muller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Heg, Dik; Jüni, Peter; Windecker, Stephan

    2014-09-01

    Biodegradable polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy. We designed a large scale clinical trial to compare a novel thin strut, cobalt-chromium drug-eluting stent with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the durable polymer-based Xience Prime/Xpedition everolimus-eluting stent (EES) (Xience Prime/Xpedition stent, Abbott Vascular, IL) in an all-comers patient population. The multicenter BIOSCIENCE trial (NCT01443104) randomly assigned 2,119 patients to treatment with biodegradable polymer sirolimus-eluting stents (SES) or durable polymer EES at 9 sites in Switzerland. Patients with chronic stable coronary artery disease or acute coronary syndromes, including non-ST-elevation and ST-elevation myocardial infarction, were eligible for the trial if they had at least 1 lesion with a diameter stenosis >50% appropriate for coronary stent implantation. The primary end point target lesion failure (TLF) is a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization within 12 months. Assuming a TLF rate of 8% at 12 months in both treatment arms and accepting 3.5% as a margin for noninferiority, inclusion of 2,060 patients would provide more than 80% power to detect noninferiority of the biodegradable polymer SES compared with the durable polymer EES at a 1-sided type I error of 0.05. Clinical follow-up will be continued through 5 years. The BIOSCIENCE trial will determine whether the biodegradable polymer SES is noninferior to the durable polymer EES with respect to TLF. Copyright © 2014 Mosby, Inc. All rights reserved.

  4. Early vascular healing after titanium-nitride-oxide-coated stent versus platinum-chromium everolimus-eluting stent implantation in patients with acute coronary syndrome.

    Science.gov (United States)

    Varho, Ville; Kiviniemi, Tuomas O; Nammas, Wail; Sia, Jussi; Romppanen, Hannu; Pietilä, Mikko; Airaksinen, Juhani K; Mikkelsson, Jussi; Tuomainen, Petri; Perälä, Anssi; Karjalainen, Pasi P

    2016-07-01

    Data on early vascular healing response of novel stent designs are scarce. In this randomized prospective trial, we sought to compare early neointimal coverage of cobalt-chromium-based titanium-nitride-oxide-coated bioactive stents (CoCr-BAS) versus platinum-chromium everolimus-eluting stents (PtCr-EES) at 2-month follow-up in patients with acute coronary syndrome (ACS). Forty patients with ACS were randomized to receive either CoCr-BAS (n = 19) or PtCr-EES (n = 21). Neointimal strut coverage and strut apposition were examined by optical coherence tomography; and coronary flow reserve (CFR), fractional flow reserve (FFR) and index of microcirculatory resistance (IMR) were assessed using a coronary pressure wire at 2 months. Two patients in the PtCr-EES underwent OCT out of the time frame of the study, and were excluded from analysis. At 63 ± 8 days, 302 cross-sections (3412 struts) were analysed in the CoCr-BAS group, and 324 cross-sections (3460 struts) in the PtCr-EES group. Median [IQR] neointimal thickness was 203 [108] µm and 42.2 [41] µm for CoCr-BAS and PtCr-EES, respectively (p  0.05 for all). CoCr-BAS showed earlier and more adequate neointimal coverage of struts at 2 months, compared with PtCr-EES, but with more neointimal hyperplasia. Functional healing as assessed by CFR, FFR, and IMR was similar between the two stent arms.

  5. Approach to coronary bifurcation lesions using the everolimus-eluting stent: comparison between a simple strategy and a complex strategy with T-stenting.

    Science.gov (United States)

    Ruiz-Salmerón, Rafael J; Valenzuela, Luis F; Pérez, Inés; Fuentes, Marco; Rodríguez-Leiras, Sergio; Vizcaíno, Manuel; Carrascosa, César; Marcos, Francisco

    2013-08-01

    Coronary bifurcation lesions can be approached using a simple or a complex strategy. In clinical trials with first-generation drug-eluting stents, the complex strategy was not superior to the simple approach. However, to date, the best strategy when using second-generation drug-eluting stents has not been defined. We performed a prospective randomized study comparing a simple vs a complex strategy involving T-stenting for the percutaneous revascularization of bifurcation lesions using the everolimus-eluting stent. Angiographic and clinical follow-up were performed at 9 months. We included 70 lesions in 69 patients, who were randomized to the simple (34 lesions, 33 patients) or complex strategy (36 lesions and patients). In all, 85.6% of the lesions included were true bifurcations. The crossover rate was 17.1%. The binary restenosis rate was 12.1%, with no differences between the groups. Side branch restenosis tended to be higher with the simple strategy in the intention to treat analysis (10.7% vs 0%) but not in the per protocol analysis (5.9% vs 4.2%). The incidence of major adverse cardiac events (cardiac death, myocardial infarction, and target vessel revascularization) was 9.2%, with no differences between groups. There were no cases of stent thrombosis. According to the clinical and angiographic findings, the complex strategy was not significantly superior to the simple approach in the revascularization of bifurcation lesions with second-generation everolimus-drug eluting stents. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  6. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial.

    Science.gov (United States)

    Pilgrim, Thomas; Heg, Dik; Roffi, Marco; Tüller, David; Muller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Fahrni, Therese; Moschovitis, Aris; Noble, Stéphane; Eberli, Franz R; Wenaweser, Peter; Jüni, Peter; Windecker, Stephan

    2014-12-13

    Refinements in stent design affecting strut thickness, surface polymer, and drug release have improved clinical outcomes of drug-eluting stents. We aimed to compare the safety and efficacy of a novel, ultrathin strut cobalt-chromium stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-eluting stent. We did a randomised, single-blind, non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland. We randomly assigned (1:1) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction. Patients and outcome assessors were masked to treatment allocation, but treating physicians were not. The primary endpoint, target lesion failure, was a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularisation at 12 months. A margin of 3·5% was defined for non-inferiority of the biodegradable polymer sirolimus-eluting stent compared with the durable polymer everolimus-eluting stent. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01443104. Between Feb 24, 2012, and May 22, 2013, we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-eluting stents (1063 patients, 1594 lesions) or everolimus-eluting stents (1056 patients, 1545 lesions). 407 (19%) patients presented with ST-segment elevation myocardial infarction. Target lesion failure with biodegradable polymer sirolimus-eluting stents (69 cases; 6·5%) was non-inferior to durable polymer everolimus-eluting stents (70 cases; 6·6%) at 12 months (absolute risk difference -0·14%, upper limit of one

  7. 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.

  8. The REMEDEE-OCT Study: An Evaluation of the Bioengineered COMBO Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent Compared With a Cobalt-Chromium Everolimus-Eluting Stent in Patients With Acute Coronary Syndromes: Insights From Optical Coherence Tomography Imaging Analysis

    NARCIS (Netherlands)

    Jaguszewski, Milosz; Aloysius, Romila; Wang, Wei; Bezerra, Hiram G.; Hill, Jonathan; de Winter, Robbert J.; Karjalainen, Pasi P.; Verheye, Stefan; Wijns, William; Lüscher, Thomas F.; Joner, Michael; Costa, Marco; Landmesser, Ulf

    2017-01-01

    The aim of the present study was to evaluate vascular healing of the bioengineered COMBO Dual Therapy Stent compared with a cobalt-chromium (CoCr) everolimus-eluting stent (EES) as assessed by optical coherence tomography in patients with acute coronary syndromes. CD34+ cells promote endothelial

  9. 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

  10. Zotarolimus-eluting Resolute Integrity versus everolimus-eluting Xience Xpedition stents in the management of very long (>30 mm) de novo coronary artery stenosis

    Energy Technology Data Exchange (ETDEWEB)

    Patra, Soumya, E-mail: dr_soumyapatra@rediffmail.com; Chakraborty, Rabindra Nath; Pande, Arindam; Banerjee, Suvro; Jena, Manabhanjan; Mandal, Prakash Chandra; De, Swapan Kumar; Khan, Aftab; Das, Sankha Suvro; Ghosh, Debashish; Nag, Raja

    2017-04-15

    Background: Procedural and clinical outcomes in patients with very long (>30 mm) coronary lesions who underwent stent-based percutaneous coronary interventions are still unfavorable. Therefore, we compared the relative efficacy and safety of resolute zotarolimus-eluting stents (R-ZES) and Xpedition everolimus-eluting stents (X-EES) for patients with de novo very long coronary lesions. Methods: This comparative single-centre, retrospective study compared long R-ZES and X-EES in consecutive patients admitted with very long (≥30 mm) native ACC/AHA type C coronary lesions in 2014. All patients were followed up clinically at 1, 3, 6 and 12 months. In this study, only symptom-driven angiogram was advised. The study end point was to evaluate immediate procedural success and one-year rate of target lesion failure (TLF), which is a composite of cardiac death, target lesion myocardial infarction, or target lesion revascularization (TLR). Results: Total number of patients enrolled in this study was 185 (R-ZES = 107; X-EES = 78). The baseline characteristics and post procedural success rate were similar between R-ZES and X-EES groups, including the post stenting lesion lengths (36.6 ± 1.92 mm vs 40.71 ± 6.175 mm, P = 0.09). At 12-month follow-up, there were no significant between-group differences in the rate of adverse clinical events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes). Procedural success was achieved in 94% in R-ZES group and 93% in X-EES group (P = 0.24). The incidence of TLF was 5% in R-ZES and 4% in X-EES groups (HR-1.25; 95% CI-0.86-5.6; P = 0.19). Conclusion: Patients with de novo long coronary artery disease, R-ZES implantation showed similar clinical outcome as compared with X-EES implantation. - Highlights: • This is the first study comparing between R-ZES (Resolute Integrity) and X-EES (Xience Xpedition) used in PCI for long coronary artery disease. Here, single stent length of more than 30

  11. The prognostic utility of the SYNTAX score on 1-year outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial

    DEFF Research Database (Denmark)

    Garg, Scot; Serruys, Patrick W; Silber, Sigmund

    2011-01-01

    This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents....

  12. Intensive statin therapy stabilizes C-reactive protein, but not chemokine in stable coronary artery disease treated with an everolimus-eluting stent.

    Science.gov (United States)

    Sukegawa, Hiroaki; Maekawa, Yuichiro; Yuasa, Shinsuke; Anzai, Atsushi; Kodaira, Masaki; Takei, Makoto; Sano, Fumiya; Ueda, Ikuko; Kawakami, Takashi; Hayashida, Kentaro; Kohno, Takashi; Kohsaka, Shun; Abe, Takayuki; Fukuda, Keiichi

    2016-08-01

    Besides its potent plasma cholesterol-lowering activity, statin treatment has several other important effects, including lowering high-sensitive C-reactive protein (hs-CRP), levels, and stabilizing risk factors of atherosclerosis, thereby reducing the risk of cardiovascular events. Our aim in this study was to identify how intensive statin therapy can affect plasma levels of inflammatory markers over the long term. We used a prospective, randomized, open blinded-endpoint design. A total of 30 patients with stable coronary artery disease treated with everolimus-eluting stent implantation were randomized to receive rosuvastatin 2.5 (standard therapy group) or 10 mg (intensive therapy group) for 12 months. Plasma levels of hs-CRP, pentraxin-3, monocyte chemoattractant protein-1, and CXC chemokine ligand 4 were measured after a percutaneous coronary intervention, at 1, 3, 6, 9, and 12 months. Levels of LDL cholesterol (LDL-C) and HDL cholesterol were also measured. We investigated short-term and long-term clinical outcomes. After 12 months of therapy, the intensive therapy group had lower levels of LDL-C than the standard therapy group. Plasma levels of hs-CRP largely fluctuated in the standard therapy group, whereas they were stable in the intensive therapy group during the follow-up period. There were no significant differences in serum pentraxin-3, monocyte chemoattractant protein-1, and CXC chemokine ligand 4 levels, or in the incidence of any clinical adverse events, between the standard and the intensive therapy groups. Intensive rosuvastatin therapy stabilizes hs-CRP levels, but not chemokine levels, besides lowering LDL-C levels. Thus, this therapy may inhibit the progression of atherosclerosis by stably inhibiting the inflammatory cascade.

  13. Fate of post-procedural malapposition of everolimus-eluting polymeric bioresorbable scaffold and everolimus-eluting cobalt chromium metallic stent in human coronary arteries: sequential assessment with optical coherence tomography in ABSORB Japan trial

    NARCIS (Netherlands)

    Sotomi, Yohei; Onuma, Yoshinobu; Dijkstra, Jouke; Miyazaki, Yosuke; Kozuma, Ken; Tanabe, Kengo; Popma, Jeffrey J.; de Winter, Robbert J.; Serruys, Patrick W.; Kimura, Takeshi

    2018-01-01

    The natural course of post-procedural incomplete strut apposition (ISA) after the implantation of bioresorbable scaffolds (BVS) remains unknown. The purpose of the present study was to evaluate the fate of post-procedural ISA after everolimus-eluting Absorb BVS in comparison with the

  14. Pharmacokinetic sub-study in the SPIRIT III Randomized and Controlled Trial of XIENCE V everolimus eluting coronary stent system.

    Science.gov (United States)

    Wang, Qing; Pierson, Wesley; Sood, Poornima; Bol, Cornelis; Cannon, Louis; Gordon, Paul; Saucedo, Jorge; Sudhir, Krishnankutty

    2010-02-01

    Drug-eluting stents (DES) are widely used for treatment of coronary artery disease with benefit of reduced restenosis compared to bare metal stents. The XIENCE VEverolimus Eluting Coronary Stent System is a second-generation DES system for better deliverability while maintaining safety and efficacy profiles. The present pharmacokinetic sub-study from the SPIRIT III Randomized and Controlled Trial (RCT) was to evaluate systemic exposure of patients to everolimus and to further demonstrate safety following implantation of XIENCE Vstents with everolimus doses ranging from 53 to 181 microg. Drug concentrations in whole blood were determined at multiple time points using a validated analytical method with a limit of quantification of 0.1 ng/mL. Individual C(max) ranged from 0.17 to 2.40 ng/mL and occurred between 0.07 and 1.88 hours across all dose levels. Both mean and individual C(max) values were below the trough blood concentrations of everolimus (Certican) for inhibition of organ transplant rejection. The last time point at which drug concentrations could be quantified ranged from 12 to 168 hours postimplantation in individual patients. In most cases, the blood levels dropped below the limit of quantification after 72 hours. This study confirms that the XIENCE Vstent causes a limited and systemic exposure to everolimus. The presumed localized and efficient delivery of everolimus to target vessels coupled with limited and transient systemic drug exposure contributes to the safety and effectiveness of the XIENCE VEECSS in patients of SPIRIT III RCT for longer than 2 years.

  15. 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

  16. Cost-effectiveness of percutaneous coronary intervention with cobalt-chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta-analysis of randomized trials.

    Science.gov (United States)

    Ferko, Nicole; Ferrante, Giuseppe; Hasegawa, James T; Schikorr, Tanya; Soleas, Ireena M; Hernandez, John B; Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W; Valgimigli, Marco

    2017-05-01

    Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus eluting stent (Co-Cr EES) compared with BMS in percutaneous coronary intervention (PCI). To conduct a cost-effectiveness analysis (CEA) of a cobalt-chromium everolimus eluting stent (Co-Cr EES) versus BMS in PCI. A Markov state transition model with a 2-year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co-Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta-analysis of 5 RCTs (n = 4,896). The base-case analysis evaluated stent-related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta-analysis. The base-case and secondary analyses reported an additional 0.018 and 0.013 quality-adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co-Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co-Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. Using data from a recent patient level meta-analysis and contemporary cost data, this analysis found that PCI with Co-Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

  17. Cost‐effectiveness of percutaneous coronary intervention with cobalt‐chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta‐analysis of randomized trials

    Science.gov (United States)

    Ferrante, Giuseppe; Hasegawa, James T.; Schikorr, Tanya; Soleas, Ireena M.; Hernandez, John B.; Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W.; Valgimigli, Marco

    2016-01-01

    Background Second‐generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first‐generation DES with improved cost‐effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt‐chromium everolimus eluting stent (Co‐Cr EES) compared with BMS in percutaneous coronary intervention (PCI). Objective To conduct a cost‐effectiveness analysis (CEA) of a cobalt‐chromium everolimus eluting stent (Co‐Cr EES) versus BMS in PCI. Methods A Markov state transition model with a 2‐year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co‐Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta‐analysis of 5 RCTs (n = 4,896). The base‐case analysis evaluated stent‐related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta‐analysis. Results The base‐case and secondary analyses reported an additional 0.018 and 0.013 quality‐adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co‐Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co‐Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. Conclusions Using data from a recent patient level meta‐analysis and contemporary cost data, this analysis found that PCI with Co‐Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. PMID:27527508

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

    Science.gov (United States)

    Park, Duk-Woo; Park, Seung-Jung

    2017-06-01

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

  19. Prospective rAndomized, single-blind, mulTicenter control clinical study of sirolimus-eluting coRonary stent “Calypso” vs everolimus-elutIng cOronary stenT “Xience Prime”: design and rationale for “PATRIOT” trial

    Directory of Open Access Journals (Sweden)

    А. А. Прохорихин

    2016-12-01

    Full Text Available Aim. This study is aimed at evaluating the efficacy and safety of sirolimus-eluting coronary stent “Calypso” in comparison with everolimus-eluting coronary stent “Xience Prime” in patients with ischemic heart disease. Methods. This is a prospective, randomized, single-blind multicenter clinical trial in patients undergoing coronary revascularization with coronary stenting. Seven clinical sites in Russia will enroll 610 patients with coronary artery disease. Patients suitable for coronary stenting will be randomized in group 1 (n=406 to receive coronary stent “Calypso” (“Angioline”, and group 2 (n=204 to receive coronary stent Xience Prime (Abbott. Clinical follow-up will continue for 1 year. By the end of follow-up, a quantitative coronary angiography will be performed in 122 patients (20 %. Conclusion. A randomized trial “PATRIOT” is designed to prove the efficacy and safety of sirolimus-eluting coronary stent “Calypso” in comparison with everolimus-eluting coronary stent “Xience Prime” in patients with ischemic heart disease.Received 5 October 2016. Accepted 6 December 2016.Funding: This study was funded by “Angioline Interventional Devices”, 630090, 18 Inzhenernaya Street, Novosibirsk, Russian Federation. Conflict of interest: The authors declare no conflict of interest.

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

    DEFF Research Database (Denmark)

    Räber, Lorenz; Onuma, Yoshinobu; Brugaletta, Salvatore

    2015-01-01

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

  1. 10-month angiographic and 4-year clinical outcome of everolimus-eluting versus sirolimus-eluting coronary stents in patients with diabetes mellitus (the DiabeDES IV randomized angiography trial)

    DEFF Research Database (Denmark)

    Maeng, Michael; Baranauskas, Arvydas; Christiansen, Evald H J

    2015-01-01

    OBJECTIVE: We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes. BACKGROUND: There are limited data on long-term outcome after EES vs SES implantation in diabetic patients. METHODS: We...... randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss...... at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up. RESULTS: At 10-month...

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

    Science.gov (United States)

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

    2017-04-24

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

  3. Long-term forecasting and comparison of mortality in the Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial: prospective validation of the SYNTAX Score II.

    Science.gov (United States)

    Campos, Carlos M; van Klaveren, David; Farooq, Vasim; Simonton, Charles A; Kappetein, Arie-Pieter; Sabik, Joseph F; Steyerberg, Ewout W; Stone, Gregg W; Serruys, Patrick W

    2015-05-21

    To prospectively validate the SYNTAX Score II and forecast the outcomes of the randomized Evaluation of the Xience Everolimus-Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) Trial. Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization is a prospective, randomized multicenter trial designed to establish the efficacy and safety of percutaneous coronary intervention (PCI) with the everolimus-eluting stent compared with coronary artery bypass graft (CABG) surgery in subjects with unprotected left-main coronary artery (ULMCA) disease and low-intermediate anatomical SYNTAX scores (EXCEL, the SYNTAX Score II was prospectively applied to predict 4-year mortality in the CABG and PCI arms. The 95% prediction intervals (PIs) for mortality were computed using simulation with bootstrap resampling (10 000 times). For the entire study cohort, the 4-year predicted mortalities were 8.5 and 10.5% in the PCI and CABG arms, respectively [odds ratios (OR) 0.79; 95% PI 0.43-1.50). In subjects with low (≤22) anatomical SYNTAX scores, the predicted OR was 0.69 (95% PI 0.34-1.45); in intermediate anatomical SYNTAX scores (23-32), the predicted OR was 0.93 (95% PI 0.53-1.62). Based on 4-year mortality predictions in EXCEL, clinical characteristics shifted long-term mortality predictions either in favour of PCI (older age, male gender and COPD) or CABG (younger age, lower creatinine clearance, female gender, reduced left ventricular ejection fraction). The SYNTAX Score II indicates at least an equipoise for long-term mortality between CABG and PCI in subjects with ULMCA disease up to an intermediate anatomical complexity. Both anatomical and clinical characteristics had a clear impact on long-term mortality predictions and decision making between CABG and PCI. Published on behalf of the European Society of Cardiology. All rights reserved. © The

  4. Design and rationale for a randomised comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: the EXCEL trial.

    Science.gov (United States)

    Kappetein, Arie Pieter; Serruys, Patrick W; Sabik, Joseph F; Leon, Martin B; Taggart, David P; Morice, Marie-Claude; Gersh, Bernard J; Pocock, Stuart J; Cohen, David J; Wallentin, Lars; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Simonton, Charles A; Stone, Gregg W

    2016-09-18

    Coronary artery bypass graft (CABG) surgery is the standard of care for revascularisation of patients with left main coronary artery disease (LMCAD). Recent studies have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) may provide comparable outcomes in selected patients with LMCAD without extensive CAD. We therefore designed a trial to investigate whether PCI with XIENCE cobalt-chromium everolimus-eluting stents (CoCr-EES) would result in non-inferior or superior clinical outcomes to CABG in selected patients with LMCAD. The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is a prospective, open-label, multicentre, international study of 1,900 randomised subjects. Patients with significant LMCAD with a SYNTAX score ≤32 and local Heart Team consensus that the subject is appropriate for revascularisation by both PCI and CABG are consented and randomised 1:1 to undergo PCI using CoCr-EES or CABG. All patients undergo follow-up for five years. The primary endpoint is the three-year composite rate of death, stroke or myocardial infarction, assessed at a median follow-up of at least three years (with at least two-year follow-up in all patients), powered for sequential non-inferiority and superiority testing. The EXCEL study will define the contemporary roles of CABG and PCI using XIENCE CoCr-EES in patients with LMCAD disease with low and intermediate SYNTAX scores.

  5. Real-life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

    Science.gov (United States)

    Sarno, Giovanna; Lagerqvist, Bo; Olivecrona, Göran; Varenhorst, Christoph; Danielewicz, Mikael; Hambraeus, Kristina; Lindholm, Daniel; Råmunddal, Truls; Witt, Nils; James, Stefan

    2017-11-15

    No previous studies have evaluated the performance of the Synergy stent in a large real-life population. To describe the initial real-life experience with a novel everolimus eluting platinum chromium stent with abluminal biodegradable polymer (SYNERGY) in unselected patients from a nationwide registry. All implanted Synergy stents were compared with other new generation drug eluting stents (n-DES) with >1,000 implantations in Sweden between March 2013 and October 2015. Restenosis, definite stent thrombosis (ST), myocardial infarction (MI) and death rates were assessed using propensity score and Cox regression analyses. A total of 7,886 of Synergy stents and 64,429 other n-DES (BioMatrix, N = 1,953; Orsiro, N = 4,946; Promus Element Plus, N= 2,543; Promus Premier, N= 20,414; Xience Xpedition, N= 7,971, Resolute/Resolute Integrity, N = 19,021; Ultimaster, N = 1,156; Resolute Onyx, N = 6,425) were implanted in 42,357 procedures. Restenosis and stent thrombosis occurred in 642 and 314 cases, respectively, in the overall population at 1 year. The cumulative rate of restenosis (1.1% vs. 1.0%, adjusted HR: 1.24 95% CI: 0.88-1.75; P = 0.21) and ST (0.4% vs. 0.5%, adjusted HR: 0.97; 95% CI: 0.63-1.50; P = 0.17) up to 1 year was low in both the Synergy group and the other n-DES group. Death occurred in 5.2% versus 4.5% (adjusted HR: 1.14; 95% CI: 0.96-1.36; P = 0.11) and MI in 3.2% versus 3.5%, (adjusted HR: 1.11; 95% CI: 0.93-1.33; P = 0.24) up to 1 year. In a large real-life population the Synergy stent appears to be safe and effective with a low rate of restenosis and ST comparable with other n-DES. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  6. Long-term safety of an everolimus-eluting bioresorbable vascular scaffold and the cobalt-chromium XIENCE V stent in a porcine coronary artery model.

    Science.gov (United States)

    Otsuka, Fumiyuki; Pacheco, Erica; Perkins, Laura E L; Lane, Jennifer P; Wang, Qing; Kamberi, Marika; Frie, Michael; Wang, Jin; Sakakura, Kenichi; Yahagi, Kazuyuki; Ladich, Elena; Rapoza, Richard J; Kolodgie, Frank D; Virmani, Renu

    2014-06-01

    The Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb) has shown promising clinical results; however, only limited preclinical data have been published. We sought to investigate detailed pathological responses to the Absorb versus XIENCE V (XV) in a porcine coronary model with duration of implant extending from 1 to 42 months. A total of 335 devices (263 Absorb and 72 XV) were implanted in 2 or 3 main coronary arteries of 136 nonatherosclerotic swine and examined by light microscopy, scanning electron microscopy, pharmacokinetics, and gel permeation chromatography analyses at various time points. Vascular responses to Absorb and XV were largely comparable at all time points, with struts being sequestered within the neointima. Inflammation was mild to moderate (with absence of inflammation at 1 month) for both devices, although the scores were greater in Absorb at 6 to 36 months. Percent area stenosis was significantly greater in Absorb than XV at all time points except at 3 months. The extent of fibrin deposition was similar between Absorb and XV, which peaked at 1 month and decreased rapidly thereafter. Histomorphometry showed expansile remodeling of Absorb-implanted arteries starting after 12 months, and lumen area was significantly greater in Absorb than XV at 36 and 42 months. These changes correlated with dismantling of Absorb seen after 12 months. Gel permeation chromatography analysis confirmed that degradation of Absorb was complete by 36 months. Absorb demonstrates comparable long-term safety to XV in porcine coronary arteries with mild to moderate inflammation. Although Absorb was associated with greater percent stenosis relative to XV, expansile remodeling was observed after 12 months in Absorb with significantly greater lumen area at ≥ 36 months. Resorption is considered complete at 36 months. © 2014 American Heart Association, Inc.

  7. Everolimus-eluting stent implantation for unprotected left main coronary artery stenosis. The PRECOMBAT-2 (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) study.

    Science.gov (United States)

    Kim, Young-Hak; Park, Duk-Woo; Ahn, Jung-Min; Yun, Sung-Cheol; Song, Hae Geun; Lee, Jong-Young; Kim, Won-Jang; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Jang, Yangsoo; Jeong, Myung-Ho; Kim, Hyo-Soo; Hur, Seung-Ho; Rha, Seung-Woon; Lim, Do-Sun; Her, Sung-Ho; Seung, Ki Bae; Seong, In-Whan; Park, Seung-Jung

    2012-07-01

    This study sought to evaluate the safety and efficacy of second-generation drug-eluting stents (DES) for patients with unprotected left main coronary artery (ULMCA) stenosis. The clinical benefit of second-generation DES for ULMCA stenosis has not been determined. The authors assessed 334 consecutive patients who received everolimus-eluting stents (EES) for ULMCA stenosis between 2009 and 2010. The 18-month incidence rates of major adverse cardiac or cerebrovascular events (MACCE), including death, myocardial infarction (MI), stroke, or ischemia-driven target vessel revascularization (TVR), were compared with those of a randomized study comparing patients who received sirolimus-eluting stents (SES) (n = 327) or coronary artery bypass grafts (CABG) (n = 272). EES (8.9%) showed a comparable incidence of MACCE as SES (10.8%; adjusted hazard ratio [aHR] of EES: 0.84; 95% confidence interval [CI]: 0.51 to 1.40; p = 0.51) and CABG (6.7%, aHR of EES: 1.40; 95% CI: 0.78 to 2.54; p = 0.26). The composite incidence of death, MI, or stroke also did not differ among patients receiving EES (3.3%), SES (3.7%; aHR of EES: 0.63; 95% CI: 0.27 to 1.47; p = 0.29), and CABG (4.8%; aHR of EES: 0.67; 95% CI: 0.29 to 1.54; p = 0.34). However, the incidence of ischemia-driven TVR in the EES group (6.5%) was higher than in the CABG group (2.6%, aHR of EES: 2.77; 95% CI: 1.17 to 6.58; p = 0.02), but comparable to SES (8.2%, aHR of EES: 1.14; 95% CI: 0.64 to 2.06; p = 0.65). Angiographic restenosis rates were similar in the SES and EES groups (13.8% vs. 9.2%, p = 0.16). Second-generation EES had a similar 18-month risk of MACCE for ULMCA stenosis as first-generation SES or CABG. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  8. Comparison of clinical outcomes of coronary artery stent implantation in patients with end-stage chronic kidney disease including hemodialysis for three everolimus eluting (EES) stent designs: Bioresorbable polymer-EES, platinum chromium-EES, and cobalt chrome-EES.

    Science.gov (United States)

    Sato, Takao; Hatada, Katsuharu; Kishi, Syohei; Fuse, Koichi; Fujita, Satoshi; Ikeda, Yoshio; Takahashi, Minoru; Matsubara, Taku; Okabe, Masaaki; Aizawa, Yoshifusa

    2017-11-22

    New-generation bioresorbable polymer-everolimus eluting stents (BP-EES) are available. This study aimed to compare the clinical outcomes for BP-EES compared to more established stent designs, namely the platinum chromium-EES (PtCr-EES) and cobalt chrome-EES(CoCr-EES) in patients with the end-stage chronic kidney disease (CKD) including hemodialysis (HD). One-hundred-forty-one consecutive stents (BP-EES [n = 44], PtCr-EES [n = 45], and CoCr-EES [n = 52]) were implanted in 104 patients with CKD. All patients underwent a follow-up coronary angiography at 12 months after implantation. End-stage CKD was defined as an estimated glomerular filtration rate (eGFR) stent groups after implantation and the 12-month follow-up: target lesion revascularization (TLR), stent thrombosis (ST), and major adverse cardiac event (MACE). Minimal stent diameter (MSD) and %diameter-stenosis (%DS) were measured using quantitative coronary angiography. The overall rate of TLR and MACE was 14.6% and 30.8%, respectively, with no incidence of ST. Immediately after implantation, the MSD (P = 0.22) and %DS (P = 0.42) were equivalent among the three groups. However, at the 12-month follow-up, a tendency towards higher TLR was observed for the BP-EES group (22.7%) compared with the PtCr-EES (8.8%) and CoCr-EES (9.6%) groups (P = 0.07). Late loss in lumen diameter was also significantly greater for the BP-EES (0.51 ± 0.64 mm) group than either the PtCr-EES (0.20 ± 0.61 mm) and CoCr-EES (0.25 ± 0.70 mm) groups (P = 0.03). BP-EES might increase the risk of in-stent restenosis in patients with end-stage of CKD or the need for HD. © 2017, Wiley Periodicals, Inc.

  9. Long-term clinical outcome of elderly patients with acute coronary syndrome treated with early percutaneous coronary intervention: Insights from the BASE ACS randomized controlled trial: Bioactive versus everolimus-eluting stents in elderly patients.

    Science.gov (United States)

    Nammas, Wail; de Belder, Adam; Niemelä, Matti; Sia, Jussi; Romppanen, Hannu; Laine, Mika; Karjalainen, Pasi P

    2017-01-01

    The BASE ACS trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of elderly versus non-elderly patients from the BASE ACS trial. We randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Follow-up was planned at 12months and yearly thereafter for up to 7years. Elderly age was defined as ≥65years. Of the 827 patients enrolled in the BASE ACS trial, 360 (43.5%) were elderly. Mean follow-up duration was 4.2±1.9years. MACE was more frequent in elderly versus younger patients (19.7% versus 12.0%, respectively, p=0.002), probably driven by more frequent cardiac death and non-fatal MI events (5.3% versus 1.5%, and 9.7% versus 4.5%, p=0.002 and p=0.003, respectively). The rates of ischemia-driven TLR were comparable (p>0.05). In propensity score-matched analysis (215 pairs), only cardiac death was more frequent in elderly patients (6% versus 1.4%, respectively, p=0.01). Diabetes independently predicted both MACE and cardiac death in elderly patients. Elderly patients treated with stent implantation for ACS had worse long-term clinical outcome, compared with younger ones, mainly due to a higher death rate. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  10. A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: The CENTURY II high risk ACS substudy

    Energy Technology Data Exchange (ETDEWEB)

    Jiménez, Victor A., E-mail: victor.alfonso.jimenez.diaz@sergas.es [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Iñiguez, Andrés; Baz, José A. [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Valdés, Mariano [Hospital Universitario V. Arrixaca, Murcia (Spain); Ortiz, Alberto [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Vuilliomenet, André [Kantonsspital Aarau, Aarau (Switzerland); Mainar, Vicente [Department of Cardiology, University General Hospital of Alicante, Alicante (Spain); Dudek, Dariusz [Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow (Poland); Banai, Shmuel [Tel Aviv Sourasky Medical Centre, Tel Aviv (Israel); Tüller, David [Department of Cardiology, Stadtspital Triemli, Zürich (Switzerland); Bonnet, Jean-Louis [Department of Cardiology, Hospital La Timone, Marseille (France); De Miguel, Antonio; Bastos, Guillermo [Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo (Spain); Wijns, William [Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium); Saito, Shigeru [Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, Kamakura (Japan)

    2016-09-15

    Background: To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymer everolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial. Methods: CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9 month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24 months. Results: The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24 months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P = 0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P = 0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate. Conclusions: BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up. - Highlights: • This study reported the 24-month clinical outcomes of new-generation BP-SES compared with PP-EES in ACS subgroup from CENTURY II study. • This is a pre-specified subgroup analysis of a large randomized, prospective, multicenter clinical trial. • The BP-SES showed good and comparable clinical performance as PP-EES at 24 months. • This substudy has a relatively small sample size and

  11. Sustained low clinical event rates in real-world patients receiving everolimus-eluting coronary stent system from a large, prospective, condition of approval study: 2-year clinical outcomes from the XIENCE V USA Study.

    Science.gov (United States)

    Hermiller, James B; Rutledge, David R; Gruberg, Luis; Katopodis, John N; Lombardi, William; Mao, Vivian W; Zhao, Weiying; Sharma, Samin K; Tamboli, Hoshedar P; Wang, Jin; Jonnavithula, Lalitha; Sudhir, Krishnankutty; Krucoff, Mitchell W

    2012-12-01

    This 2-year follow-up of the XIENCE V USA study examines both the long-term safety and effectiveness of the everolimus-eluting coronary stent system (EECSS) in real-world patients. The safety and effectiveness of EECSS at 1 year in real-world clinical settings have been demonstrated in XIENCE V USA trial with low rates of target lesion revascularization (TLR), cardiac death, myocardial infarction (MI), and stent thrombosis (ST). Data on whether efficacy is maintained after 1 year and the event rate of very late stent thrombosis (VLST) between 1 and 2 years have not yet been reported. XIENCE V USA is a prospective, multicenter, single-arm, FDA required condition of approval study designed to examine the safety and effectiveness of EECSS in an all-inclusive, consecutively enrolled population from real-world clinical settings. Clinical end-point events, including ST, cardiac death, MI, and revascularization were adjudicated by an independent Clinical Events Committee.  Four thousand eight hundred and seventy-three (96.4%) out of 5,054 participants (1,875 standard-risk; 3,059 extended-risk) reached 2-year follow-up. The 2-year rate of Academic Research Consortium (ARC)-defined definite and probable ST was 0.96% (95% CI 0.70-1.28) in the overall population and 0.34% (95% CI 0.12-0.74) and 1.33% (95% CI 0.95-1.81) in the standard-risk and extended-risk cohorts, respectively. The rate of VLST was 0.06% in the overall population, 0.0% in the standard-risk, and 0.10% in the extended-risk cohorts. The 2-year composite rate of cardiac death and ARC-defined MI was 8.9% (95% CI 8.08-9.70) in the overall population and 5.6% (95% CI 4.61-6.78) and 10.8% (95% CI 9.71-11.94) in the standard-risk and extended-risk cohorts, respectively. Low event rates observed at 1 year were maintained through 2 years. Despite the increased number of patients who discontinued dual antiplatelet therapy by 2 years, the ST rate remained consistently low, and <1% at 2 years due to low VLST occurrence

  12. Three-year results comparing platinum-chromium PROMUS element and cobalt-chromium XIENCE V everolimus-eluting stents in de novo coronary artery narrowing (from the PLATINUM Trial).

    Science.gov (United States)

    Meredith, Ian T; Teirstein, Paul S; Bouchard, Alain; Carrié, Didier; Möllmann, Helge; Oldroyd, Keith G; Hall, Jack; Allocco, Dominic J; Dawkins, Keith D; Stone, Gregg W

    2014-04-01

    In the randomized PLATINUM trial, the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES; Boston Scientific, Natick, Massachusetts) was noninferior to the XIENCE V cobalt-chromium everolimus-eluting stent (CoCr-EES; Boston Scientific and Abbott Vascular, Santa Clara, California) for the primary end point of 1-year target lesion failure. This study reports the 3-year outcomes. Patients (n=1,530) with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter≥2.50 mm to ≤4.25 mm and length≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. Three-year follow-up was available in 93.9% (703 of 749) of patients with CoCr-EES and 96.7% (733 of 758) of patients with PtCr-EES. Comparing CoCr-EES with PtCr-EES, 3-year rates of death (4.3% vs 3.7%, hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.52 to 1.48, p=0.62), cardiac death (1.9% vs 1.2%, HR 0.63, 95% CI 0.27 to 1.45, p=0.27), myocardial infarction (2.5% vs 2.3%, HR 0.92, 95% CI 0.48 to 1.79, p=0.81), ischemia-driven target lesion revascularization (4.9% vs 3.5%, HR 0.72, 95% CI 0.43 to 1.20, p=0.21), and Academic Research Consortium definite or probable stent thrombosis (0.5% vs 0.7%, HR 1.23, 95% CI 0.33 to 4.57, p=0.76) were not significantly different. In conclusion, 3-year results of the PLATINUM randomized, controlled, clinical trial demonstrate comparable safety and efficacy outcomes of the PROMUS Element PtCr-EES and the XIENCE V CoCr-EES. Copyright © 2014 Elsevier Inc. All rights reserved.

  13. Three-Year Clinical Outcomes of Everolimus-Eluting Stents From the Post-Marketing Surveillance Study of Cobalt-Chromium Everolimus-Eluting Stent (XIENCE V/PROMUS) in Japan.

    Science.gov (United States)

    Aoki, Jiro; Kozuma, Ken; Awata, Masaki; Nanasato, Mamoru; Shiode, Nobuo; Tanabe, Kengo; Yamaguchi, Junichi; Kusano, Hajime; Nie, Hong; Kimura, Takeshi

    2016-01-01

    The Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) Post-marketing Surveillance (PMS) is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan. We enrolled 2,010 consecutive patients (2,649 lesions) who underwent PCI using CoCr-EES. Clinical outcomes were evaluated for up to 3 years. Clinical follow-up was available in 1,930 patients (96%) at 3 years. Major adverse cardiovascular events (MACE) occurred in 6.8% of patients, including cardiac death (1.7%), myocardial infarction (1.5%), and clinically driven target lesion revascularization (CD-TLR, 4.2%). Late CD-TLR rate was 0.8% from 1 to 2 years, and 0.5% from 2 to 3 years. Definite or probable stent thrombosis occurred in 7 patients (0.3%) up to 1 year. There was no very late definite or probable stent thrombosis from 1 to 3 years. Significant independent predictors for MACE were hemodialysis, prior coronary intervention, triple-vessel coronary artery disease, and age >70 years. Three-year clinical outcomes from the CoCr-EES PMS demonstrated a low incidence of clinical events. There was no major concern about very late stent thrombosis or late catch-up phenomenon in patients treated with EES in routine clinical practice in Japan.

  14. Safety and efficacy of everolimus-eluting stents for bare-metal 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); Torguson, Rebecca; 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)

    2015-04-15

    Objective: The aim of this study was to compare the safety and efficacy of the everolimus-eluting stents (EES) with the paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) for the treatment of bare-metal in-stent restenosis. Background: The optimal treatment for bare-metal in-stent restenosis remains controversial. Methods: The study cohort comprised 322 consecutive patients (543 lesions) who presented with bare-metal in-stent restenosis to our institution and underwent coronary artery stent implantation with EES (114 patients; 181 lesions), PES (65 patients; 116 lesions) and SES (143 patients; 246 lesions). 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 events (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 except for age and chronic kidney disease. The 1-year analyzed clinical parameters were similar in the three groups: death (EES = 3.5%, PES = 4.6%, SES = 4.2%; p = 0.94), MI (EES = 3.5%, PES = 6.3%, SES = 2.1%; p = 0.31), TLR (EES = 9.8%, PES = 9.5%, SES = 5.7%; p = 0.42), TVR (EES = 14.3%, PES = 11.1%, SES = 11.3%; p = 0.74), definite ST (EES = 0.9%, PES = 3.1%, SES = 3.5%; p = 0.38) and MACE (EES = 14.0%, PES = 15.4%, SES = 10.5%; p = 0.54). Male gender (hazard ratio = 0.47; 95% confidence interval = 0.25–0.88) and number of treated lesions (hazard ratio = 1.47; 95% confidence interval = 1.06–2.05) were found to be independent predictors of MACE. Conclusion: The results of the present study indicate that EES may provide similar safety and efficacy as first generation DES for the treatment of patients presenting with bare-metal in-stent restenosis.

  15. The impact of coronary calcification on angiographic and 3-year clinical outcomes of everolimus-eluting stents: results of a XIENCE V/PROMUS post-marketing surveillance study.

    Science.gov (United States)

    Shiode, Nobuo; Kozuma, Ken; Aoki, Jiro; Awata, Masaki; Nanasato, Mamoru; Tanabe, Kengo; Yamaguchi, Junichi; Kusano, Hajime; Nie, Hong; Kimura, Takeshi

    2017-07-19

    Coronary calcification (CCA) is one of the independent predictors for major adverse cardiac events (MACEs) in coronary intervention. Post-marketing surveillance study Japan is a prospective registry designed to evaluate the safety and efficacy of the everolimus-eluting stent (EES, XIENCE V/PROMUS Stent) in routine clinical practice at 47 centers. In this study, 1848 lesions (1546 patients) were assessed using quantitative coronary angiography. In these 1546 patients, renal function data were unknown in 26 patients. Three patients in 70 patients with dialysis and 56 patients in 1450 patients with no dialysis were excluded, because they had multiple lesions with mixed calcification lesions. We evaluated the effects of CCA on 8-month angiographic and 3-year clinical outcomes in dialysis and non-dialysis patients. Moderate-to-severe (Ca group) and none-to-mild CCA (non-Ca group) were observed in 33 lesions (30 patients) and 48 lesions (37 patients) in dialysis patients, and these were observed in 306 lesions (286 patients) and 1303 lesions (1108 patients) in non-dialysis patients, respectively. In non-dialysis patients, the ischemic-driven target lesion revascularization (ID-TLR) and MACE rate over the 3 years were significantly higher in the Ca group than in the non-Ca group (5.8 vs. 3.1%, p = 0.025 and 10.0 vs. 5.0%, p = 0.0011). In dialysis patients, ID-TLR and MACE rates were high in both groups (14.3 vs. 17.9%, p = 0.85 and 17.5 vs. 36.1%, p = 0.16). In non-dialysis patients, 8-month angiographic and 3-year clinical outcomes were worse in the Ca group. However, in dialysis patients, both outcomes were worse regardless of CCA.Clinical Trial registration https://clinicaltrials.gov/ct2/show/NCT01086228 .

  16. Prospective rAndomized, single-blind, mulTicenter study of sirolimus-eluting coRonary stent “Calypso” vs everolimus-eluting cOronary stenT “XiencePrime”: results of the PATRIOT trial

    Directory of Open Access Journals (Sweden)

    A. A. Prokhorikhin

    2017-11-01

    Full Text Available Aim. This trial was aimed at comparing the efficacy and safety of sirolimus-eluting coronary stent “Calypso” (Angioline and everolimus-eluting coronary stent “XiencePrime” (Abbott Vascular when used for treatment of ischemic heart disease patients.Methods. The trial included patients suitable for coronary revascularization with coronary stenting. They underwent a standard revascularization procedure and were randomized in 2:1 ratio to receive “Calypso” coronary stent (Angioline (n = 407 or “XiencePrime” coronary stent (AbbottVascular (n = 203. The follow-up period was 12 months. In order to detect restenosis (secondary endpoint, angiographic follow-up was performed in 20% of cases at 12 months. The trial protocol had no limitations regarding the length of lesions, number of target lesions and number of implanted stents. The main exclusion criterion was STEMI. The composite primary endpoint included one-year target lesion-related complications determined as cardiogenic death, target vessel myocardial infarction, clinically indicated target lesion revascularization. The primary endpoint data were evaluated by an independent committee.Results. In the trial, 55% of patients had acute coronary syndrome with ST elevation and type C lesions were detected in 46% of cases. In “Calypso” and “XiencePrime” groups, TLF occurred in 5.4% and 6.4% respectively (absolute risk difference in TLF accounted for 1%, 95% CI [---;2.1%]; p non-inferiority = 0.017. Thus, the hypothesis of non-inferiority of “Calypso” as compared to “XiencePrime” was confirmed. The incidence of stent thrombosis (definite and probable was relatively low and had no significant differences between “Calypso” and “XiencePrime” groups (0.73% and 0%; p>0.05. Definite stent thrombosis was noted in two cases in the “Calypso” group (0.49%, in one case the cause of thrombosis turned out to be incomplete stent expansion after implantation.Conclusion.

  17. Is quantitative coronary angiography reliable in assessing the late lumen loss of the everolimus-eluting bioresorbable polylactide scaffold in comparison with the cobalt-chromium metallic stent?

    NARCIS (Netherlands)

    Sotomi, Yohei; Onuma, Yoshinobu; Miyazaki, Yosuke; Asano, Taku; Katagiri, Yuki; Tenekecioglu, Erhan; Jonker, Hans; Dijkstra, Jouke; de Winter, Robbert J.; Wykrzykowska, Joanna J.; Stone, Gregg W.; Popma, Jeffrey J.; Kozuma, Ken; Tanabe, Kengo; Serruys, Patrick W.; Kimura, Takeshi

    2017-01-01

    Aims: Immediately after stent/scaffold implantation, quantitative coronary angiography (QCA) in comparison to optical coherence tomography (OCT) more severely underestimates the lumen diameter (LD) in Absorb than in XIENCE. This OCT-QCA discrepancy has not been evaluated at long-term follow-up. The

  18. Rationale and design of the EXAMINATION trial: A randomised comparison between everolimus-eluting stents and cobalt-chromium bare-metal stents in ST-elevation myocardial infarction

    NARCIS (Netherlands)

    M. Sabate (Manel); A. Cequier; A. Iñiguez (Andrés); A. Serra; R. Hernandez-Antolin (Rosana); V. Mainar (Vicente); M. Valgimigli (Marco); M. Tespili (Maurizio); P. den Heijer (Pieter); A. Bethencourt (Armando); N. Vazquez (Nicolás); S. Brugaletta (Salvatore); B.A.M.W. Backx (Bianca); P.W.J.C. Serruys (Patrick)

    2011-01-01

    textabstractAims: To assess the performance of the everolimus-eluting stent (EES) versus cobalt chromium bare-metal stent (BMS) in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI). The implantation

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

    DEFF Research Database (Denmark)

    Valgimigli, Marco; Sabaté, Manel; Kaiser, Christoph

    2014-01-01

    eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. PRIMARY OUTCOMES: The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite......OBJECTIVES: To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents. DESIGN: Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were...... or probable stent thrombosis, target vessel revascularisation, and all cause death. RESULTS: The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had...

  20. 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.

  1. A randomized comparison of platinum chromium-based everolimus-eluting stents versus cobalt chromium-based Zotarolimus-Eluting stents in all-comers receiving percutaneous coronary intervention: HOST-ASSURE (harmonizing optimal strategy for treatment of coronary artery stenosis-safety & effectiveness of drug-eluting stents & anti-platelet regimen), a randomized, controlled, noninferiority trial.

    Science.gov (United States)

    Park, Kyung Woo; Kang, Si-Hyuck; Kang, Hyun-Jae; Koo, Bon-Kwon; Park, Byoung-Eun; Cha, Kwang Soo; Rhew, Jay Young; Jeon, Hui-Kyoung; Shin, Eun-Seok; Oh, Ju Hyeon; Jeong, Myung-Ho; Kim, Sanghyun; Hwang, Kyung-Kuk; Yoon, Jung-Han; Lee, Sung Yun; Park, Tae-Ho; Moon, Keon Woong; Kwon, Hyuck-Moon; Hur, Seung-Ho; Ryu, Jae-Kean; Lee, Bong-Ryul; Park, Yong Whi; Chae, In-Ho; Kim, Hyo-Soo

    2014-07-01

    This study sought to test whether the newly developed platinum chromium (PtCr)-based everolimus-eluting stent (EES) is noninferior to the cobalt chromium (CoCr)-based zotarolimus-eluting stent (ZES) in all-comers receiving percutaneous coronary intervention (PCI). PtCr provides improved radial strength, conformability, and visibility compared with the CoCr alloy, but PtCr-based stents have not been tested in a wide range of patients receiving PCI. Also, recent case series have raised the issue of longitudinal stent deformation (LSD) with newer drug-eluting stents. We randomly assigned 3,755 all-comers receiving PCI to PtCr-EES or CoCr-ZES. The primary outcome was target lesion failure (TLF) at 1-year post-PCI, defined as the composite of cardiac death, nonfatal target vessel-related myocardial infarction, and ischemia-driven target lesion revascularization. Post-hoc angiographic analysis was performed to qualitatively and quantitatively analyze LSD. At 1 year, TLF occurred in 2.9% and 2.9% of the population in the PtCr-EES and CoCr-ZES groups, respectively (superiority p = 0.98, noninferiority p = 0.0247). There were no significant differences in the individual components of TLF as well as the patient-oriented clinical outcome. Of 5,010 stents analyzed, LSD occurred in 0.2% and 0% in the PtCr-EES and CoCr-ZES groups, respectively (p = 0.104). There was no significant difference in post-deployment stent length ratio between the 2 stents (p = 0.352). At 1 year, PtCr-EES was noninferior to CoCr-ZES in all-comers receiving PCI. Although LSD was observed only in PtCr-EES, both the stent length ratio and the frequency of LSD were not significantly different between the 2 stent types, and PtCr-EES was not associated with adverse clinical outcomes. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734). Copyright © 2014 American College of Cardiology

  2. A Randomized Comparison between Everolimus-Eluting Stent and Cobalt Chromium Stent in Patients with Acute ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention Using Routine Intravenous Eptifibatide: The X-MAN (Xience vs. Multi-Link Stent in Acute Myocardial Infarction) Trial, A Pilot Study.

    Science.gov (United States)

    Dharma, Surya; Wardeh, Alexander J; Soerianata, Sunarya; Firdaus, Isman; Jukema, J Wouter

    2014-06-01

    The objective of this study is to determine the efficacy and safety of an everolimus-eluting stent (EES/Xience; Abbott Vascular, Santa Clara, CA) compared with a cobalt chromium stent (CoCr/Multi-Link Vision; Abbott Vascular) in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) with routine administration of eptifibatide infusion. This is a prospective, single center, randomized trial comparing EES (n = 75) and CoCr stent (n = 75) implantation in patients with acute STEMI undergoing primary PCI. Intravenous eptifibatide administration was mandatory by protocol in this pilot study. The primary efficacy endpoint was major adverse cardiac events (MACE) at 30 days, defined as the composite of death, reinfarction, and target vessel revascularization. Secondary safety endpoints were stent thrombosis at 30 days and in-hospital bleeding event. Acute reperfusion parameters were also assessed. One-month MACE rate did not differ between EES and CoCr group (1.3 vs. 1.3%, p = 1.0). No stent thrombosis cases were observed in the EES group. The groups did not differ with respect to in-hospital bleeding events (5 vs. 9%, p = 0.37), achievement of final thrombolysis in myocardial infarction flow 2 or 3 (p = 0.21), achievement of myocardial blush grade 2 or 3 (p = 0.45), creatine kinase-MB level at 8 to 12 hours after stenting (p = 0.29), and left ventricular ejection fraction (p = 0.21). This pilot study demonstrates that after one-month follow-up, the use of EES is as safe and effective as the use of CoCr stents in patients with acute STEMI undergoing primary PCI with routine administration of intravenous eptifibatide.

  3. The REMEDEE-OCT Study: An Evaluation of the Bioengineered COMBO Dual-Therapy CD34 Antibody-Covered Sirolimus-Eluting Coronary Stent Compared With a Cobalt-Chromium Everolimus-Eluting Stent in Patients With Acute Coronary Syndromes: Insights From Optical Coherence Tomography Imaging Analysis.

    Science.gov (United States)

    Jaguszewski, Milosz; Aloysius, Romila; Wang, Wei; Bezerra, Hiram G; Hill, Jonathan; De Winter, Robbert J; Karjalainen, Pasi P; Verheye, Stefan; Wijns, William; Lüscher, Thomas F; Joner, Michael; Costa, Marco; Landmesser, Ulf

    2017-03-13

    The aim of the present study was to evaluate vascular healing of the bioengineered COMBO Dual Therapy Stent compared with a cobalt-chromium (CoCr) everolimus-eluting stent (EES) as assessed by optical coherence tomography in patients with acute coronary syndromes. CD34+ cells promote endothelial repair after vascular injury. The bioengineered COMBO Dual Therapy Stent combines CD34+ cell-capturing technology with abluminal sirolimus release, but more data from clinical studies evaluating the vascular response are needed. In a prospective randomized multicenter clinical trial, 60 patients with acute coronary syndromes were randomized 1:1 to COMBO or CoCr EES implantation. The primary endpoint was the percentage of uncovered stent struts per stent. Stent assessment by optical coherence tomography was performed at baseline and at 60 days, followed by independent core laboratory analysis. The percentage of uncovered struts per stent was higher with the COMBO than the CoCr EES at 60 days (median 14.7% vs. 7.7%; p = 0.04). However, no significant difference in uncovered stent struts was observed in the strut level-based analysis at 60 days, which also accounted for clustering (COMBO vs. CoCr EES; 13.6% vs. 6.9%; p = 0.09; generalized linear mixed models-adjusted analysis). Neointimal thickness at 60 days was lower with the COMBO compared with the CoCr EES (median 30.17 vs. 50.26 μm; p = 0.02; stent-level analysis). There were no significant differences in the frequency of major adverse cardiac events and each component of major adverse cardiac events within the study population between the 2 groups at 30, 60, 180, 360, and 540 days post-procedure. No target vessel stent thrombosis has been documented within 540 days. The present multicenter, prospective clinical study for the first time compared the vascular response of the bioengineered COMBO Dual Therapy Stent with a CoCr EES in patients early after acute coronary syndrome by using intracoronary optical coherence

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

    Science.gov (United States)

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

    2014-11-04

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

  5. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial

    NARCIS (Netherlands)

    Onuma, Yoshinobu; Sotomi, Yohei; Shiomi, Hiroki; Ozaki, Yukio; Namiki, Atsuro; Yasuda, Satoshi; Ueno, Takafumi; Ando, Kenji; Furuya, Jungo; Igarashi, Keiichi; Kozuma, Ken; Tanabe, Kengo; Kusano, Hajime; Rapoza, Richard; Popma, Jeffrey J.; Stone, Gregg W.; Simonton, Charles; Serruys, Patrick W.; Kimura, Takeshi

    2016-01-01

    We sought to investigate two-year clinical and serial optical coherence tomography (OCT) outcomes after implantation of a fully bioresorbable vascular scaffold (BVS) or a cobalt-chromium everolimus-eluting stent (CoCr-EES). In the ABSORB Japan trial, 400 patients were randomised in a 2:1 ratio to

  6. 3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial.

    Science.gov (United States)

    Kereiakes, Dean J; Ellis, Stephen G; Metzger, Christopher; Caputo, Ronald P; Rizik, David G; Teirstein, Paul S; Litt, Marc R; Kini, Annapoorna; Kabour, Ameer; Marx, Steven O; Popma, Jeffrey J; McGreevy, Robert; Zhang, Zhen; Simonton, Charles; Stone, Gregg W

    2017-12-12

    The Absorb everolimus-eluting poly-L-lactic acid-based bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support functions similar to metallic drug-eluting stents (DES), followed by complete bioresorption in approximately 3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction [TVMI], or ischemia-driven target lesion revascularization) at 1 year in 2,008 patients with coronary artery disease randomized to BVS versus cobalt-chromium everolimus-eluting stents (EES). This study sought to assess clinical outcomes through 3 years following BVS implantation. Clinical outcomes from the ABSORB III trial were analyzed by randomized treatment assignment cumulative through 3 years, and between 1 and 3 years. The primary composite endpoint of target lesion failure through 3 years occurred in 13.4% of BVS patients and 10.4% of EES patients (p = 0.06), and between 1 and 3 years in 7.0% versus 6.0% of patients, respectively (p = 0.39). TVMI through 3 years was increased with BVS (8.6% vs. 5.9%; p = 0.03), as was device thrombosis (2.3% vs. 0.7%; p = 0.01). In BVS-assigned patients, treatment of very small vessels (those with quantitatively determined reference vessel diameter device thrombosis. Longer-term clinical follow-up is required to determine whether bioresorption of the polymeric scaffold will influence patient prognosis. (ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2015-02-01

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

  8. COmplex coronary Bifurcation lesions: RAndomized comparison of a strategy using a dedicated self-expanding biolimus-eluting stent versus a culotte strategy using everolimus-eluting stents: primary results of the COBRA trial.

    Science.gov (United States)

    Dubois, Christophe; Bennett, Johan; Dens, Joseph; De Cock, Dries; Desmet, Walter; Belmans, Ann; Ughi, Giovanni J; Sinnaeve, Peter; Vrolix, Mathias; D'hooge, Jan; Adriaenssens, Tom

    2016-04-20

    We aimed to compare healing responses with optical coherence tomography, and clinical and angiographic outcome after treatment of coronary bifurcation lesions with a dedicated stent versus a conventional culotte technique. Forty patients with true and complex coronary bifurcation lesions were randomly assigned to treatment with the Axxess™ bifurcation stent in the proximal main vessel (MV) and additional BioMatrix™ stents in the branches (Biosensors Europe SA, Morges, Switzerland), versus a culotte technique using XIENCE™ stents (Abbott Vascular, Santa Clara, CA, USA). The primary endpoint of percentage of uncovered struts at nine months was similar with the dedicated strategy vs. culotte in the proximal MV (median 17.8 [IQR 3.3-24.7] vs. 6.8 [2.0-20.5]; p=0.19), bifurcation core (9.5 [5.7-19.5] vs. 4.0 [0.7-17.6]; p=0.17), distal MV (2.6 [2.3-18] vs. 2.2 [0.5-6.0]; p=0.09) and side branch (5.7 [1.5-11.5] vs. 1.9 [0-5.8]; p=0.14). As compared with culotte, a strategy using Axxess resulted in a significantly larger lumen in the proximal MV both acutely (minimum lumen diameter 3.03±0.51 vs. 2.71±0.44 mm, p=0.04) and at follow-up (mean lumen area 10.0±2.1 vs. 7.1±1.8 mm2, pstrategies resulted in good clinical outcomes at one year, and no stent thromboses. As compared with a culotte strategy with XIENCE stents, complex bifurcation stenting using a dedicated strategy combining Axxess and BioMatrix stents results in similar stent strut coverage at nine-month follow-up, and a significantly larger lumen and lower angiographic late lumen loss in the proximal MV.

  9. 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.

  10. The Promus Premier everolimus-eluting platinum chromium stent with durable polymer evaluated in a real world all-comer population in Rotterdam cardiology hospital (the P-SEARCH registry)

    NARCIS (Netherlands)

    Lemmert, M.E.; Mieghem, N.M. van; Geuns, R.J.M. van; Diletti, R.; Bommel, R.J. van; Domburg, R.T. van; Jaegere, P.P. de; Regar, E.; Zijlstra, F.; Boersma, E.; Daemen, J.

    2017-01-01

    BACKGROUND: A new-generation everolimus eluting platinum-chromium stent (EePCS), offering improved radial strength, radiopacity and conformability compared to everolimus-eluting cobalt-chromium stents (EeCCS), was evaluated with regard to safety and efficacy in an all-comer cohort. METHODS: A total

  11. 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

  12. Very Late Pathological Responses to Cobalt-Chromium Everolimus-Eluting, Stainless Steel Sirolimus-Eluting, and Cobalt-Chromium Bare Metal Stents in Humans.

    Science.gov (United States)

    Mori, Hiroyoshi; Atmakuri, Dheeraj R; Torii, Sho; Braumann, Ryan; Smith, Samantha; Jinnouchi, Hiroyuki; Gupta, Anuj; Harari, Emanuel; Shkullaku, Melsi; Kutys, Robert; Fowler, David; Romero, Maria; Virmani, Renu; Finn, Aloke V

    2017-11-17

    The "very late" clinical outcomes for durable polymer drug-eluting stents and bare metal stents (BMSs) have been shown to be dissimilar in clinical studies. Conceptually, the long-term vascular compatibility of BMSs is still regarded to be superior to drug-eluting stents; however, no pathologic study to date has specifically addressed this issue. We evaluated the very late (≥1 year) pathologic responses to durable polymer drug-eluting stents (cobalt-chromium [CoCr] everolimus-eluting stents [EESs] and stainless steel sirolimus-eluting stents [SS-SESs]) versus BMSs (CoCr-BMSs). From the CVPath stent registry, we studied a total of 119 lesions (40 CoCr-EESs, 44 SS-SESs, 35 CoCr-BMSs) from 92 autopsy cases with a duration ranging from 1 to 5 years. Sections of stented coronary segments were pathologically analyzed. Inflammation score and the percentage of struts with giant cells were lowest in CoCr-EESs (median inflammation score: 0.6; median percentage of struts with giant cells: 3.8%) followed by CoCr-BMSs (median inflammation score: 1.3 [Pstents and may have implications for future stent design. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

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

    Science.gov (United States)

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

    2014-07-01

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

  14. Two-year results of an open-label randomized comparison of everolimus-eluting stents and sirolimus-eluting stents.

    Directory of Open Access Journals (Sweden)

    Matthijs A Velders

    Full Text Available BACKGROUND: Second generation drug-eluting stents were developed to improve the safety and efficacy of first generation stents. So far, limited long term randomized data exist comparing the second generation everolimus-eluting stents (EES with first generation sirolimus-eluting stents (SES. METHODS: A prospective, open-label, randomized, single center trial comparing EES and SES in all-comer patients. The primary endpoint was a composite of cardiac mortality, myocardial infarction and target vessel revascularization. Secondary endpoints included individual components of the composite, along with target lesion revascularization and stent thrombosis. RESULTS: In total, 977 patients were randomized, of which 498 patients to EES and 479 to SES. Average age was 65.2 ± 11.2 years and 71.6% of the population was male. Fifty percent of patients were treated for acute coronary syndrome, more often for ST-elevation myocardial infarctions in EES patients (13.7% vs. 9.2% in SES. In contrast, SES patients more often had prior interventions and showed more calcified lesions. Two-year follow-up was available in 98% of patients. The primary endpoint occurred in 10.7% of EES patients compared to 10.6% of SES patients (HR 1.00, 95% CI 0.68-1.48. Additionally, secondary endpoints were similar between groups. The rate of stent thrombosis was low for both stent types. CONCLUSION: In this all-comer population, there were no differences in endpoints between EES and SES during two-year follow-up. Stent thrombosis rates were low, supporting the safety of drug-eluting stent appliance in clinical practice. TRIAL REGISTRATION: TrialRegister.nl NTR3170.

  15. Comparison of early-phase arterial repair following cobalt-chrome everolimus-eluting stent and slow-release zotarolimus-eluting stent: an angioscopic study.

    Science.gov (United States)

    Ishihara, Takayuki; Iida, Osamu; Fujita, Masashi; Masuda, Masaharu; Okamoto, Shin; Nanto, Kiyonori; Kanda, Takashi; Tsujimura, Takuya; Sunaga, Akihiro; Awata, Masaki; Nanto, Shinsuke; Uematsu, Masaaki

    2017-03-02

    Whether arterial repair following implantation of drug-eluting stents (DES) of the second generation differs among stent types remains unknown. We examined 41 DES placed in 28 patients (age 72 ± 7 years, male 89%) presenting with stable angina pectoris due to de novo lesions in native coronary arteries. Coronary angioscopy was performed 4 ± 1 months after stent implantation. Patients were divided into two groups based on the DES types: 22 cobalt-chrome everolimus-eluting stents (CoCr-EES) in 13 patients and 19 slow-release zotarolimus-eluting stents (R-ZES) in 15 patients. Neointimal coverage (NIC) was graded as: grade 0, stent struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous when the NIC grade variation was ≥1. Presence of thrombus was also investigated. Distribution of dominant NIC grade (CoCr-EES: grade 0, 9%; grade 1, 77%; grade 2, 9%; grade 3, 5%; R-ZES: grade 0, 16%; grade 1: 47%; grade 2, 37%; grade 3, 0%, P = 0.38) and heterogeneity of NIC (P = 0.43) were similar between CoCr-EES and R-ZES groups. Existence of thrombus was not significantly different in CoCr-EES and R-ZES (18 versus 42%, P = 0.17). Arterial repair occurred without significant differences between CoCr-EES and R-ZES 4 months after implantation.

  16. Randomized comparison of acute stent malapposition between platinum-chromium versus cobalt-chromium everolimus-eluting stents.

    Science.gov (United States)

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

    2015-02-01

    No randomized data exist regarding optical coherence tomography (OCT) evaluation immediately post-procedure and at the 3-month follow-up for platinum-chromium everolimus-eluting stents (PtCr-EES) versus cobalt-chromium everolimus-eluting stents (CoCr-EES). A total of 100 patients were randomly assigned to undergo PtCr-EES (n = 51) or CoCr-EES (n = 49) implantation. OCT was serially evaluated after stent deployment with nominal pressure and immediately post-procedure, and 3-month follow-up. The primary endpoint was the percentage of malapposed strut after nominal pressure and immediately post-procedure. Compared to the CoCr-EES, the PtCr-EES showed a lower tendency of percent malapposed strut at nominal pressure [median value (interquartile range); 4.1 % (0.5-11.7) vs. 7.6 % (2.9-13.7), p = 0.082] and immediately post-procedure [1.2 % (0-3.4) vs. 2.5 % (0.7-5.3), p = 0.051]. The percentage of cross sections with any malapposed struts was significantly lower with PtCr-EES at nominal pressure [15.0 % (5.6-39.0) vs. 23.8 % (18.2-44.4), p = 0.036] and immediately post-procedure [6.5 % (0-15.3) vs. 10.5 % (7.1-20.0), p = 0.026]. At the 3-month follow-up, both PtCr-EES and CoCr-EES showed comparable percentages of malapposed struts (0 vs. 0 %, respectively, p = 0.332) and uncovered struts (5.3 vs. 4.7 %, respectively, p = 0.829). We found a significant correlation between the immediate post-procedural percentage of malapposed struts versus the percentage of uncovered struts (r = 0.430, p < 0.001) at the 3-month follow-up. Compared to the CoCr-EES, the PtCr-EES shows a lower tendency toward a lower percentage of malapposed struts but no significant difference in strut coverage at the 3-month follow-up. The percentage of malapposed struts immediately post-procedure was correlated with strut coverage at the 3-month follow-up.

  17. Cost-effectiveness of percutaneous coronary intervention with cobalt-chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta-analysis of randomized trials

    NARCIS (Netherlands)

    Ferko, N. (Nicole); G. Ferrante (Giuseppe); Hasegawa, J.T. (James T.); Schikorr, T. (Tanya); Soleas, I.M. (Ireena M.); Hernandez, J.B. (John B.); M. Sabate (Manel); C. Kaiser (Christoph); S. Brugaletta (Salvatore); J.M. De La Torre Hernandez (Jose Maria); S. Galatius (Soren); A. Cequier; F.R. Eberli (Franz Robert); A. De Belder (Adam); P.W.J.C. Serruys (Patrick); M. Valgimigli (Marco)

    2016-01-01

    textabstractBackground: Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus

  18. Analysis of 1 year virtual histology changes in coronary plaque located behind the struts of the everolimus eluting bioresorbable vascular scaffold

    NARCIS (Netherlands)

    S. Brugaletta (Salvatore); J. Gomez-Lara (Josep); H.M. Garcia-Garcia (Hector); J.H. Heo (Jungho); V. Farooq (Vasim); R.J.M. van Geuns (Robert Jan); B. Chevalier (Bernard); S.W. Windecker (Stephan); D. McClean (Dougal); L. Thuesen (Leif); R. Whitbourn (Robert); I. Meredith (Ian); C. Dorange (Cecile); S. Veldhof (Susan); R. Rapoza (Richard); J.A. Ormiston (John); P.W.J.C. Serruys (Patrick)

    2012-01-01

    textabstractSerial intravascular ultrasound virtual histology (IVUS-VH) after implantation of metallic stents has been unable to show any changes in the composition of the scaffolded plaque overtime. The everolimus-eluting ABSORB scaffold potentially allows for the formation of new fibrotic tissue

  19. Outcomes after unrestricted use of everolimus-eluting and sirolimus-eluting stents in routine clinical practice: a multicenter, prospective cohort study.

    Science.gov (United States)

    Park, Duk-Woo; Kim, Young-Hak; Song, Hae-Geun; Ahn, Jung-Min; Kim, Won-Jang; Lee, Jong-Young; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Yun, Sung-Cheol; Her, Sung Ho; Hur, Seung Ho; Park, Jin Sik; Kim, Myeong-Kon; Choi, Yun Seok; Kim, Hyun Sook; Cho, Jang-Hyun; Lee, Sang Gon; Park, Yong Whi; Jeong, Myung-Ho; Lee, Bong Ki; Lee, Nae-Hee; Lim, Do-Sun; Yoon, Junghan; Seung, Ki Bae; Shin, Won-Yong; Rha, Seung-Woon; Kim, Kee-Sik; Tahk, Seung-Jea; Park, Byoung Eun; Ahn, Taehoon; Yang, Joo-Young; Jeong, Yong Seok; Rhew, Jay-Hyun; Park, Seung-Jung

    2012-06-01

    It remains unclear whether there are differences in the safety and efficacy outcomes between everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in contemporary practice. We prospectively enrolled 6166 consecutive patients who received EES (3081 patients) and SES (3085 patients) between April 2008 and June 2010, using data from the Interventional Cardiology Research In-Cooperation Society-Drug-Eluting Stents Registry. The primary end point was a composite of death, nonfatal myocardial infarction (MI), or target-vessel revascularization (TVR). At 2 years of follow-up, the 2 study groups did not differ significantly in crude risk of the primary end point (12.1% for EES versus 12.4% for SES; HR, 0.97; 95% CI, 0.84-1.12, P=0.66). After adjustment for differences in baseline risk factors, the adjusted risk for the primary end point remained similar for the 2 stent types (HR, 0.96; 95% CI, 0.82-1.12, P=0.60). There were also no differences between the stent groups in the adjusted risks of the individual component of death (HR, 0.93; 95% CI, 0.67-1.30, P=0.68), MI (HR, 0.97; 95% CI, 0.79-1.18, P=0.74), and TVR (HR, 1.10; 95% CI, 0.82-1.49, P=0.51). The adjusted risk of stent thrombosis also was similar (HR, 1.16; 95% CI, 0.47-2.84, P=0.75). In contemporary practice of percutaneous coronary intervention procedures, the unrestricted use of EES and SES showed similar rates of safety and efficacy outcomes with regard to death, MI, sent thrombosis, and TVR. Future longer-term follow-up is needed to better define the relative benefits of these drug-eluting stents. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01070420.

  20. Impact of total stent length after cobalt chromium everolimus-eluting stent implantation on 3-year clinical outcomes.

    Science.gov (United States)

    Hiromasa, Takashi; Kuramitsu, Shoichi; Shinozaki, Tomohiro; Jinnouchi, Hiroyuki; Morinaga, Takashi; Kobayashi, Yohei; Domei, Takenori; Soga, Yoshimitsu; Shirai, Shinichi; Ando, Kenji

    2017-02-01

    The objective was to assess whether total stent length (TSL) after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation was associated with long-term clinical outcomes. The impact of TSL after CoCr-EES implantation on long-term clinical outcomes remained unclear. A total of 1,007 consecutive patients with 1,382 lesions treated only with CoCr-EES were analyzed. Patients and lesions were divided into tertile group: TSL per patient (TSL-P) (PA [8-23 mm], n = 382; PB [23-46 mm], n = 312; and PC [46-204 mm], n = 313), and TSL per lesion (TSL-L) (LA [8-18 mm], n = 486; LB [18-28 mm], n = 475; and LC [28-140 mm], n = 421). The cumulative 3-year incidence of clinically driven target-lesion revascularization (CD-TLR) and definite stent thrombosis (ST) based on TSL-P and TSL-L groupings were accessed. After inverse probability of weighted adjustment, the cumulative 3-year incidence of CD-TLR for the TSL-P and TSL-L were higher in the PC and LC groups than in the other groups (hazard ratio [HR] 2.92, 95% confidence intervals [CI] 1.66-5.15, P < 0.001 vs. PA; HR 2.49, 95% CI 1.47-4.20, P < 0.001 vs. PB; HR 1.94, 95% CI 1.15-3.28, P = 0.01 vs. LA; HR 2.80, 95% CI 1.73-4.54, P < 0.001 vs. LB, respectively). No significant differences in the cumulative 3-year incidence of definite ST were observed in both TSL-P and TSL-L groups. TSL after CoCr-EES implantation has significantly impact on CD-TLR rate through 3 years, but it is not associated with an increased incidence of definite ST. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

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

    DEFF Research Database (Denmark)

    Sabaté, Manel; Windecker, Stephan; Iñiguez, Andres

    2015-01-01

    AIMS: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to ...

  2. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: An optical coherence tomography substudy from the RESOLUTE All Comers trial

    NARCIS (Netherlands)

    J.L. Gutiérrez-Chico; R.J.M. van Geuns (Robert Jan); E.S. Regar (Eveline); W.J. van der Giessen (Wim); H. Kelbæk (Henning); K. Saunamäki (Kari); J. Escaned (Javier); N. Gonzalo (Nieves); C. di Mario (Carlo); F. Borgia (Francesco); E. Nüesch (Eveline); H.M. Garcia-Garcia (Hector); S. Silber (Sigmund); S.W. Windecker (Stephan); P.W.J.C. Serruys (Patrick)

    2011-01-01

    textabstractAim s To compare the tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent (ZES) vs. a fluoropolymer-coated everolimus-eluting stent (EES) at 13 months, using optical coherence tomography (OCT) in an 'all-comers population of patients, in order to clarify the

  3. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial

    DEFF Research Database (Denmark)

    Gutiérrez-Chico, Juan Luis; van Geuns, Robert Jan; Regar, Evelyn

    2011-01-01

    To compare the tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent (ZES) vs. a fluoropolymer-coated everolimus-eluting stent (EES) at 13 months, using optical coherence tomography (OCT) in an 'all-comers' population of patients, in order to clarify the mechanism of eventual ...

  4. Comparison of 2-year outcomes between zotarolimus-eluting and everolimus-eluting new-generation cobalt-chromium alloy stents in real-world diabetic patients.

    Science.gov (United States)

    Miyazaki, Tadashi; Latib, Azeem; Panoulas, Vasileios F; Miyazaki, Sakiko; Costopoulos, Charis; Sato, Katsumasa; Naganuma, Toru; Kawamoto, Hiroyoshi; Daida, Hiroyuki; Colombo, Antonio

    2015-07-01

    To date, it remains unknown whether different types of new-generation drug-eluting stents have a differential impact on long-term outcomes in diabetic patients. In this historical cohort study (two Italian centers), we analyzed 400 diabetic patients with 553 coronary lesions treated with new-generation CoCr zotarolimus-eluting stents (R-ZES: 136 patients, 196 lesions) or everolimus-eluting stents (EES: 264 patients, 357 lesions) between October 2006 and August 2012. Primary endpoint was the occurrence of major adverse cardiac events (MACE) over a 2-year follow-up period. MACE was defined as all-cause mortality, any myocardial infarction (MI) and/or target lesion revascularization (TLR). Multivessel revascularization, intervention for restenotic lesion and use of intravascular ultrasound were significantly higher in the R-ZES group, whereas small stent (≤2.5 mm) deployment was significantly higher in the EES group. At 2-year follow-up, there was no significant difference in occurrence of MACE (R-ZES vs EES: 22.8% vs 18.9%, P = 0.39). Similarly, no significant differences were observed in the composite endpoint of all-cause mortality/MI (10.0% vs 10.3%, P = 0.86) or TLR (12.4% vs 7.4%, P = 0.11). Adjustment for confounders and baseline propensity-score matching did not alter the aforementioned associations. After 2 years of follow up similar outcomes (MACE, all-cause mortality/MI, TLR) were observed in real-world diabetic patients, including those with complex lesions and patient characteristics, treated with R-ZES and EES. © 2015 Wiley Periodicals, Inc.

  5. Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial.

    Science.gov (United States)

    Orvin, K; Carrie, D; Richardt, G; Desmet, W; Assali, A; Werner, G; Ikari, Y; Fujii, K; Goicolea, J; Dangoisse, V; Manari, A; Saito, S; Wijns, W; Kornowski, R

    2016-05-01

    To demonstrate the safety and efficacy of a new sirolimus eluting stent with bioresorbable polymer, Ultimaster, (BP-SES) compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in bifurcation lesions with respect to the freedom from Target Lesion Failure at 1-year. Within 1,119 patients enrolled in the CENTURY II randomized controlled multicenter trial, 194 patients were treated for bifurcation lesions and randomized to either BP-SES (n = 95) or PP-EES (n = 99). The primary endpoint was freedom from target lesion failure (TLF) composite endpoint [cardiac death, MI not clearly attributable to a non-target vessel, and clinically driven target lesion revascularization (TLR)] at 1-year. Baseline patient demographic, angiographic, and stenting characteristics were similar in both study arms. A single stent technique with provisional or "cross over" stenting were the most widely used in both arms (93.2% BP-SES vs. 92.4% PP-EES). Freedom from TLF at 1-year was 94.7% for BP-SES and 91.9% for PP-EES (P for noninferiority 0.031). The rate of clinically driven target lesion revascularization (TLR) at 1-year was 3.2% for BP-SES and 3.0% for PP-EES (P = 0.95). There were no significant differences detected in any of the individual clinical endpoints or other secondary clinical endpoints between the study arms at 1-year follow up. The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting in the treatment of patients with bifurcation lesions at 1-year follow up. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  6. Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V® everolimus-eluting stents: one-year results from the XIENCE V USA study.

    Science.gov (United States)

    Sudhir, Krishnankutty; Hermiller, James B; Naidu, Srihari S; Henry, Timothy D; Mao, Vivian W; Zhao, Weiying; Ferguson, Joanne M; Wang, Jin; Jonnavithula, Lalitha; Simonton, Charles A; Rutledge, David R; Krucoff, Mitchell W

    2013-10-01

    The objective of this analysis was to evaluate the safety and effectiveness of XIENCE V in acute myocardial infarction (AMI). The XIENCE V(®) Everolimus-eluting coronary stent was superior to the TAXUS(®) paclitaxel-eluting stent in angiographic and clinical outcomes in the SPIRIT II, III, and IV randomized controlled trials, but patients with AMI were excluded. XIENCE V USA is a large, prospective, multicenter, real-world single-arm postmarket surveillance trial. Consecutive patients undergoing PCI with XIENCE V were enrolled. For this analysis, clinical outcomes in 673 patients presenting with AMI (STEMI, n = 125) were as compared to patients without AMI (n = 3528) at 1 year. At 1 year, ARC-defined stent thrombosis (ST) rates were 1.08% in AMI vs. 0.85% in the non-AMI group (P = 0.4987). The late ST (30 days-1 year) rates were 0.31% vs. 0.47% (AMI vs. non-AMI, P = 0.7551). Rates of target lesion revascularization (TLR) were 4.1% vs. 4.6% (P = 0.6104), and rates of target lesion failure (TLF) were 9.1% vs. 8.5%, (P = 0.5964). With the historical WHO definition of MI, 1 year TLF rates were 7.0% vs. 6.7% (P = 0.8001). Improvements in quality of life, angina frequency, angina stability, and physical limitations occurred at 6 months (each P < 0.0001) and were sustained at 1 year in both groups. There were no significant differences in clinical outcomes between STEMI and non-STEMI patients. At 1 year, AMI patients treated with XIENCE V had low rates of ST, TLR, and TLF, similar to non-AMI patients. Marked improvements in patients' health status in this subgroup were also demonstrated. Copyright © 2012 Wiley Periodicals, Inc.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2016-10-15

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

  8. Metal allergy to everolimus-eluting cobalt chromium stents confirmed by positive skin testing as a cause of recurrent multivessel in-stent restenosis.

    Science.gov (United States)

    Nakajima, Yoshifumi; Itoh, Tomonori; Morino, Yoshihiro

    2016-03-01

    A 54-year-old woman treated with cobalt-chromium everolimus eluting stents (CoCr-EES) for her left distal circumflex and diagonal branch lesions suffered from repeated in-stent restenosis in both lesions. Neointimal proliferation occurred rapidly and almost simultaneously in the two lesions. The cause was established to be metal allergy, as determined by patch tests which were strongly positive for bare metal stents and weakly positive for CoCr-EES. Following the third successive angioplasty, we initiated treatment with prednisolone (30 mg daily) and the anti-allergic and anti-proliferative drug tranilast (300 mg daily). An elective angiogram performed 3 months later showed no evidence of in-stent restenosis in any of the stented lesions. Furthermore, the patient has remained angina-free for 15 months. The unique features of this case include: (1) near-simultaneous repeated multivessel in-stent restenosis in a patient with skin test-documented metal allergy to cobalt-chromium stents; (2) adjunctive systemic medical therapy with prednisolone and tranilast appeared to terminate the malignant restenotic cycle. © 2015 Wiley Periodicals, Inc.

  9. Impact of lesion complexity on long-term vascular response to cobalt-chromium everolimus-eluting stent: five-year follow-up optical coherence tomography study.

    Science.gov (United States)

    Kuramitsu, Shoichi; Sonoda, Shinjo; Shinozaki, Tomohiro; Jinnouch, Hiroyuki; Muraoka, Yoshitaka; Domei, Takenori; Hyodo, Makoto; Shirai, Shinichi; Ando, Kenji; Otsuji, Yutaka

    2017-10-19

    The impact of lesion complexity on long-term vascular response to cobalt-chromium everolimus-eluting stent (CoCrEES) remains unclear. We sought to evaluate them using optical coherence tomography (OCT). A total of 47 patients with 58 lesions treated only with CoCrEES and no target-vessel events within 5 years after implantation were prospectively enrolled and underwent 5-year follow-up OCT. Quantitative parameters and qualitative characteristics of the neointima were evaluated using multilevel logistic or linear regression models with random effects at three levels: lesion, cross-section (CS), and strut. According to the lesion complexity, the lesions were classified into the two groups: the complex lesion (CL) and non-CL group. The CL was defined as having at least 1 high-risk feature such as acute coronary syndrome lesion, lesion length > 20 mm, severe calcification requiring rotational atherectomy, and chronic total occlusion at the index procedure. A total of 11,034 struts (CL, n = 6240; non-CL, n = 4794) and 1202 (CL, n = 683; non-CL, n = 519) CSs were analyzed. The percentage of uncovered and malapposed struts did not differ significantly between the CL and non-CL groups (0.90 vs. 0.54%, P = 0.78; 0.56 vs. 0.10%, P = 0.16, respectively). The incidence of neoatherosclerosis was comparable between both groups in the CS- and lesion-level analysis (3.5 vs. 4.6%, P = 0.91; 32.0 vs. 24.2%, P = 0.52, respectively). At 5 years, CoCrEES shows an excellent vascular healing and similar frequency of neoatheroslerosis in patients without target-vessel events, regardless of the lesion complexity.

  10. Clinical outcomes according to diabetic status in patients treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents: prespecified subgroup analysis of the BIOSCIENCE trial.

    Science.gov (United States)

    Franzone, Anna; Pilgrim, Thomas; Heg, Dik; Roffi, Marco; Tüller, David; Vuilliomenet, André; Muller, Olivier; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Räber, Lorenz; Stortecky, Stefan; Wenaweser, Peter; Jüni, Peter; Windecker, Stephan

    2015-06-01

    Ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) proved noninferior to durable polymer everolimus-eluting stents (DP-EES) for a composite clinical end point in a population with minimal exclusion criteria. We performed a prespecified subgroup analysis of the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation (BIOSCIENCE) trial to compare the performance of BP-SES and DP-EES in patients with diabetes mellitus. BIOSCIENCE trial was an investigator-initiated, single-blind, multicentre, randomized, noninferiority trial comparing BP-SES versus DP-EES. The primary end point, target lesion failure, was a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization within 12 months. Among a total of 2119 patients enrolled between February 2012 and May 2013, 486 (22.9%) had diabetes mellitus. Overall diabetic patients experienced a significantly higher risk of target lesion failure compared with patients without diabetes mellitus (10.1% versus 5.7%; hazard ratio [HR], 1.80; 95% confidence interval [CI], 1.27-2.56; P=0.001). At 1 year, there were no differences between BP-SES versus DP-EES in terms of the primary end point in both diabetic (10.9% versus 9.3%; HR, 1.19; 95% CI, 0.67-2.10; P=0.56) and nondiabetic patients (5.3% versus 6.0%; HR, 0.88; 95% CI, 0.58-1.33; P=0.55). Similarly, no significant differences in the risk of definite or probable stent thrombosis were recorded according to treatment arm in both study groups (4.0% versus 3.1%; HR, 1.30; 95% CI, 0.49-3.41; P=0.60 for diabetic patients and 2.4% versus 3.4%; HR, 0.70; 95% CI, 0.39-1.25; P=0.23, in nondiabetics). In the prespecified subgroup analysis of the BIOSCIENCE trial, clinical outcomes among diabetic patients treated with BP-SES or DP-EES were comparable at 1 year. URL: http://www.clinicaltrials.gov. Unique identifier

  11. Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease: Results From the EXCEL Trial.

    Science.gov (United States)

    Baron, Suzanne J; Chinnakondepalli, Khaja; Magnuson, Elizabeth A; Kandzari, David E; Puskas, John D; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Taggart, David P; Morice, Marie-Claude; Lembo, Nicholas J; Brown, W Morris; Banning, Adrian; Simonton, Charles A; Kappetein, A Pieter; Sabik, Joseph F; Serruys, Patrick W; Stone, Gregg W; Cohen, David J

    2017-12-26

    The EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial compared outcomes in patients with unprotected left main coronary artery disease (LMCAD) treated with coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) using everolimus-eluting stents. Whereas rates of death, stroke, and myocardial infarction were similar at 36 months, event timing and repeat revascularization rates differed by treatment group. To understand the effects of revascularization strategy from the patient's perspective, a prospective quality of life (QoL) substudy was performed alongside the EXCEL trial. Between September 2010 and March 2014, 1,905 patients with LMCAD were randomized to undergo CABG or PCI, of whom 1,788 participated in the QoL substudy. QoL was assessed at baseline and 1, 12, and 36 months using the Seattle Angina Questionnaire, the 12-Item Short Form Health Survey, the Rose Dyspnea Scale, the Patient Health Questionnaire-8, and the EQ-5D. Differences between PCI and CABG were assessed using longitudinal random-effect growth curve models. Over 36 months, both PCI and CABG were associated with significant improvements in QoL compared with baseline. At 1 month, PCI was associated with better QoL than CABG. By 12 months though, these differences were largely attenuated, and by 36 months, there were no significant QoL differences between PCI and CABG. Among selected patients with LMCAD, both PCI and CABG result in similar QoL improvement through 36 months, although a greater early benefit is seen with PCI. Taken together with the 3-year clinical results of EXCEL, these findings suggest that PCI and CABG provide similar intermediate-term outcomes for patients with LMCAD. (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier

  12. Angiographic, optical coherence tomography and histology findings from combination of a drug-coated balloon with an everolimus-eluting stent in a porcine model.

    Science.gov (United States)

    Ong, Paul J L; Kubo, Takashi; Watson, Timothy J; Seah, Agnes S P; Wong, Philip E H; Akasaka, Takashi

    2016-11-15

    We designed a porcine model to compare the angiographic, optical coherence tomography (OCT) and histological findings of implanting an everolimus-eluting stent (EES) in the same segment of the coronary artery pre-treated with a drug-coating balloon (DCB; paccocath as carrier) with EES alone and DCB plus a bare metal stent (BMS). Seven female swine averaging 46.0±2.4kg were treated by random assignment as follows: DCB followed by EES; DCB followed by BMS; and EES alone. Quantitative coronary angiography (QCA) and OCT were carried out post-implantation and repeated after 28±1days. All arteries remained patent and demonstrated no sign of thrombus formation. There was no significant difference at 1month between the treatment groups in lumen loss (0.64±0.43, 0.44±0.43 and 0.33±0.28mm for EES, DCB/EES and DCB/BMS respectively, p=0.37) and binary restenosis (6.86 (2.91-9.12), 4.93 (-1.53-10.7) and 4.18 (3.27-10.2)% respectively, p=0.87). OCT found mean neointimal thickness of 0.15±0.09, 0.07±0.03 and 0.08±0.03mm (p=0.05) for EES, DCB/EES and DCB/BMS respectively. Endothelial strut coverage was 92.3±5.5, 85.4±8.6 and 89.1±8.9% (p=0.05) and mean neointimal area was 1.06±0.42, 0.95±0.24 and 1.20±0.28mm(2) (p=0.09) respectively. Inflammation score was similar between the three groups: 0.20 (0.20-0.28), 0.30 (0.22-0.48), 0.30 (0.20-0.38) for EES, DCB/EES and DCB/BMS respectively (p=0.14) and there were no differences in fibrin deposition. The combination of DCB with EES appeared to be safe and effective. Using EES to bail out suboptimal DCB therapy appeared to be safe and effective in this porcine model. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  13. Analysis of 1 year virtual histology changes in coronary plaque located behind the struts of the everolimus eluting bioresorbable vascular scaffold.

    Science.gov (United States)

    Brugaletta, Salvatore; Gomez-Lara, Josep; Garcia-Garcia, Hector M; Heo, Jung Ho; Farooq, Vasim; van Geuns, Robert J; Chevalier, Bernard; Windecker, Stephan; McClean, Dougal; Thuesen, Leif; Whitbourn, Robert; Meredith, Ian; Dorange, Cecile; Veldhof, Susan; Rapoza, Richard; Ormiston, John A; Serruys, Patrick W

    2012-08-01

    Serial intravascular ultrasound virtual histology (IVUS-VH) after implantation of metallic stents has been unable to show any changes in the composition of the scaffolded plaque overtime. The everolimus-eluting ABSORB scaffold potentially allows for the formation of new fibrotic tissue on the scaffolded coronary plaque during bioresorption. We examined the 12 month IVUS-VH changes in composition of the plaque behind the struts (PBS) following the implantation of the ABSORB scaffold. Using IVUS-VH and dedicated software, the composition of the PBS was analyzed in all patients from the ABSORB Cohort B2 trial, who were imaged with a commercially available IVUS-VH console (s5i system, Volcano Corporation, Rancho Cordova, CA, USA), immediately post-ABSORB implantation and at 12 month follow-up. Paired IVUS-VH data, recorded with s5i system, were available in 17 patients (18 lesions). The analysis demonstrated an increase in mean PBS area (2.39 ± 1.85 mm(2) vs. 2.76 ± 1.79 mm(2), P = 0.078) and a reduction in the mean lumen area (6.37 ± 0.90 mm(2) vs. 5.98 ± 0.97 mm(2), P = 0.006). Conversely, a significant decrease of 16 and 30% in necrotic core (NC) and dense calcium (DC) content, respectively, were evident (median % NC from 43.24 to 36.06%, P = 0.016; median % DC from 20.28 to 11.36%, P = 0.002). Serial IVUS-VH analyses of plaque located behind the ABSORB struts at 12-month demonstrated an increase in plaque area with a decrease in its NC and DC content. Larger studies are required to investigate the clinical impact of these findings.

  14. The Promus Premier everolimus-eluting platinum chromium stent with durable polymer evaluated in a real world all-comer population in Rotterdam cardiology hospital (the P-SEARCH registry).

    Science.gov (United States)

    Lemmert, Miguel E; van Mieghem, Nicolas M; van Geuns, Robert-Jan; Diletti, Roberto; van Bommel, Rutger J; van Domburg, Ron T; de Jaegere, Peter P; Regar, Evelyn; Zijlstra, Felix; Boersma, Eric; Daemen, Joost

    2017-08-01

    A new-generation everolimus eluting platinum-chromium stent (EePCS), offering improved radial strength, radiopacity and conformability compared to everolimus-eluting cobalt-chromium stents (EeCCS), was evaluated with regard to safety and efficacy in an all-comer cohort. A total of 1000 consecutive all-comer patients (including acute coronary syndrome, multivessel disease, calcified lesions) treated with an EePCS (Promus Premier™, Boston Scientific, Natick, Massachusetts) from May 2013 to October 2014 were compared to 1000 consecutive patients treated with an EeCCS (Xience Prime™, Abbott Vascular, Santa Clara, California) from April 2012 to May 2013. Patients were clinically followed for 1year. Mean age was 66±12years with diabetes in 20.7%, previous infarction in 22.7%, and ACS as the indication in 71.2% of patients. The mean number of stents per patient was 1.8±1.13. Total stented length was 35±25mm. Lesion classification was B2/C in 73.9% of patients. At 1year the primary endpoint of major adverse cardiac events (all-cause mortality, myocardial infarction [MI], ischemia-driven target vessel revascularization [TVR]) was reached in 11.7% in the EePCS cohort and 10.9% in the EeCCS cohort (adjusted HR 1.01 [0.77-1.33]; p=0.95). No significant differences were noted in the individual clinical endpoints all-cause mortality (6.8% versus 6.4%), MI (2.2% versus 2.3%), and TVR (4.3% versus 3.7%) in the respective EePCS and EeCCS cohorts. Stent thrombosis occurred in 0.8% and 1.0% respectively. In all-comer patients undergoing percutaneous coronary intervention, the use of EePCS was associated with similar 1-year clinical outcome as compared to EeCCS. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Impact of the Everolimus-eluting Bioresorbable Scaffold in Coronary Atherosclerosis.

    Science.gov (United States)

    Campos, Carlos M; Garcia-Garcia, Hector M; Muramatsu, Takashi; de Araujo Gonçalves, Pedro; Onuma, Yoshinobu; Dudek, Dariusz; Thuesen, Leif; Webster, Mark W I; Kitslaar, Pieter; Veldhof, Susan; Reiber, Johan H C; Nieman, Koen; Ormiston, John A; Serruys, Patrick W

    2016-02-01

    The Absorb bioresorbable vascular scaffold has been shown to decrease total plaque areas in the treated segment. However, it is unknown whether plaque size is modified in scaffolded segments only or whether the modification extends to other coronary segments. Absorb Cohort A is a single-arm, prospective study, with safety and imaging endpoints, in which 30 patients underwent percutaneous coronary intervention with the first generation Absorb bioresorbable vascular scaffold. Noninvasive multislice computed tomography imaging was performed in 18 patients at 18 months and 5 years of follow-up. The present study was an intrapatient comparison of matched segments (normalized by the segment length) of the scaffolded region with nonintervened segments for lumen volume, vessel volume, plaque volume, plaque burden, and percent change in plaque atheroma volume. All 18 scaffolded segments could be analyzed. In the nonintervened segments, 1 of 72 segments had a motion artifact and was excluded. Serial comparison showed that the scaffolded segments showed no significant change in the mean plaque burden, total atheroma volume, total lumen volume, or vessel volume between 18 months and 5 years. Conversely, the untreated segments showed a significant increase in plaque burden (2.7 ± 6.5%; P < .01) and normalized plaque volumes (8.0 ± 22.8mm(3); P < .01). This resulted in a significant difference in plaque burden between scaffolded and nonintervened segments (P = .03). In this small series, the Absorb bioresorbable vascular scaffold showed the potential to provide an additional benefit to pharmacological therapy in locally reducing progression of percent plaque burden. These findings need to be confirmed in larger studies. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  16. One-Year Outcomes in "Real-World" Patients Treated With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study [PE-Plus PAS]).

    Science.gov (United States)

    Kandzari, David E; Amjadi, Nima; Caputo, Christopher; Rowe, Steven K; Williams, Jerome; Tamboli, Hoshedar P; Christen, Thomas; Allocco, Dominic J; Dawkins, Keith D

    2016-02-15

    The PROMUS Element Plus US Post-Approval Study (PE-Plus PAS) was a prospective, open-label, multicenter, observational study designed to examine outcomes in everyday clinical practice in patients treated with everolimus-eluting, platinum-chromium PROMUS Element Plus stents at 52 centers in the United States. This is the first report of results from this large study. The primary end point of the PE-Plus PAS was 12-month cardiac death or myocardial infarction in the more restricted population of "PLATINUM-like" patients pooled from the PE-Plus PAS, PE-PROVE (PROMUS Element European post-approval study), and PLATINUM Workhorse/Small Vessel trials. Additional clinical end points were tested in the overall PE-Plus PAS patient population. Of the 2,683 patients enrolled in PE-Plus PAS, 70% were men, mean age was 64 years, 33% had diabetes, and 29% were "PLATINUM-like." Among the PLATINUM-like patients, 12-month cardiac death or myocardial infarction was 1.8% (33 of 1,855) with an upper 1-sided 95% confidence interval of 2.3%, which was significantly less than the prespecified performance goal of 3.2% (pnoninferiority <0.001). In the overall PE-Plus population, 12-month target vessel failure (defined as death, MI, or revascularization related to the target vessel) was 6.7% (170 of 2,554), cardiac death was 1.4% (37 of 2,554), MI was 1.1% (28 of 2,554), and ARC-definite/probable stent thrombosis was 0.7% (19 of 2,554). A prespecified secondary end point of 12-month target vessel failure in diabetic patients demonstrated a rate of 4.2% (14 of 332) with an upper 1-sided 95% confidence interval of 6.03%, which was significantly less than the performance goal of 12.6% (pnoninferiority <0.001). In conclusion, in this large registry of unselected patients, coronary artery revascularization with the PROMUS Element Plus everolimus-eluting stent demonstrates favorable results with low 1-year clinical event rates. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. 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.

  18. Long-Term Follow-Up of Patients after Percutaneous Coronary Intervention with Everolimus-Eluting Bioresorbable Vascular Scaffold.

    Science.gov (United States)

    Meneguz-Moreno, Rafael Alexandre; Costa, José de Ribamar; Moscoso, Freddy Antônio Britto; Staico, Rodolfo; Tanajura, Luiz Fernando Leite; Centemero, Marinella Patrizia; Chaves, Auréa Jacob; Abizaid, Andrea Claudia Leão de Sousa; Sousa, Amanda Guerra de Moraes Rego E; Abizaid, Alexandre Antonio Cunha

    2017-02-01

    Bioresorbable vascular scaffolds (BVS) were developed to improve the long-term results of percutaneous coronary intervention, restoring vasomotion. To report very late follow-up of everolimus-eluting Absorb BVS (Abbott Vascular, Santa Clara, USA) in our center. Observational retrospective study, in a single Brazilian center, from August 2011 to October 2013, including 49 patients submitted to Absorb BVS implantation. Safety and efficacy outcomes were analyzed in the in-hospital and very late follow-up phases (> 2 years). All 49 patients underwent a minimum follow-up of 2.5 years and a maximum of 4.6 years. Mean age was 56.8 ± 7.6 years, 71.4% of the patients were men, and 26.5% were diabetic. Regarding clinical presentation, the majority (94%) had stable angina or silent ischemia. Device success was achieved in 100% of cases with 96% overall procedure success rate. Major adverse cardiovascular events rate was 4% at 30 days, 8.2% at 1 year, and 12.2% at 2 years, and there were no more events until 4.6 years. There were 2 cases of thrombosis (1 subacute and 1 late). In this preliminary analysis, Absorb BVS showed to be a safe and effective device in the very late follow-up. Establishing the efficacy and safety profiles of these devices in more complex scenarios is necessary. Os suportes vasculares bioabsorvíveis (SVB) foram desenvolvidos com o intuito de melhorar os resultados da intervenção coronária percutânea a longo prazo, restabelecendo-se a vasomotricidade. Reportar o seguimento muito tardio do implante do SVB eluidor de everolimus Absorb® (Abbot Vascular, Santa Clara, EUA) em nosso centro. Estudo observacional, retrospectivo, em um único centro brasileiro, que incluiu 49 pacientes submetidos ao implante do SVB Absorb® entre agosto/2011 e outubro/2013. Foram analisados os desfechos de segurança e eficácia na fase hospitalar e bastante tardia (> 2 anos). Todos os 49 pacientes completaram um seguimento mínimo de 2,5 anos, sendo o máximo de 4,6 anos

  19. Clinical outcomes in real-world patients with bifurcation lesions receiving Xience V everolimus-eluting stents: Four-year results from the Xience V USA study.

    Science.gov (United States)

    Hermiller, James B; Applegate, Robert J; Baird, Colleen; Butler, Michael M; Rutledge, David; Wang, Jin; Kakarala, Kalyan; Krucoff, Mitchell W; Sudhir, Krishnankutty

    2016-07-01

    The Xience V USA Study demonstrated safety and efficacy of the XIENCE V(®) everolimus-eluting stent (EES) in a large, prospective study of a real-world, unselected patient population. There is limited long-term data regarding EES performance in high risk patients with bifurcation lesions (BIF). The objective of this analysis was to evaluate the long-term safety and effectiveness of EES in patients with BIF from the XIENCE V USA study. The Xience V USA Study was a single arm, prospective, multicenter, real-world study (n = 5,054) undergoing PCI with EES. Baseline data and clinical outcomes at 4 years were evaluated in the subgroup of patients with ≥ 1 BIF who did not undergo a staged procedure. Co-primary endpoints were ARC definite/probable stent thrombosis and a composite of cardiac death and ARC-defined myocardial infarction (MI). Endpoints were adjudicated by an independent CEC. Of 4,768 patients who did not undergo a staged procedure, there were 511 (10.7%) patients with BIF and 4,257 (89.3%) patients without BIF. Follow-up data was available in 4,459 patients (466 BIF, 3,993 non-BIF). Through binary outcome analysis, at 1 year the overall definite/probable stent thrombosis rates were higher in the BIF group (1.84% vs. 0.76%, P = 0.03). However, at 4 years, the difference in cumulative rates of ARC definite/probable stent thrombosis (BIF 2.3% vs. non-BIF 1.4%, P = 0.13) remained the same as that at 1 year, with no incremental definite/probable stent thrombosis in BIF patients from 2-4 years. The 4-year rates of composite cardiac death and MI were 13.5% for BIF vs. 14.1% for non-BIF (P = 0.78). At 4 years, target lesion failure (19.1% vs. 18.3%, P = 0.66) and ischemia driven-target lesion revascularization (10.2% vs. 10.1%, P = 0.89) were comparable between the two groups. This subgroup analysis of BIF lesions in a real world population receiving EES demonstrates continued low rates of clinical outcomes in the BIF subgroup at 4

  20. Comparison of early clinical outcomes between ABSORB bioresorbable vascular scaffold and everolimus-eluting stent implantation in a real-world population.

    Science.gov (United States)

    Costopoulos, Charis; Latib, Azeem; Naganuma, Toru; Miyazaki, Tadashi; Sato, Katsumasa; Figini, Filippo; Sticchi, Alessandro; Carlino, Mauro; Chieffo, Alaide; Montorfano, Matteo; Colombo, Antonio

    2015-01-01

    To compare the early clinical outcomes between ABSORB bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA) and cobalt chromium everolimus-eluting stents in real-world patients with mostly complex disease. BVS represents the most interesting development in the drug-eluting stent field over recent years with promising results emerging from clinical trials. Available data however on the use of the ABSORB in real-world patients is limited. All patients (n = 92) treated with BVS and 1296 patients treated with EES were included in this study. Propensity score matching was performed to adjust for differences in baseline clinical characteristics, yielding 92 patient pairs (BVS = 92 patients with 137 lesions and EES = 92 patients with 124 lesions). Clinical outcomes were examined between the 2 groups at 6-months. In both groups, most lesions were classified as either B2 or C (83.9% vs. 77.4%, P = 0.19). Predilatation (97.8% vs. 75.8%, P < 0.01) as well as postdilation (99.3% vs. 77.4%, P < 0.01) was more common in the BVS group. Clinical outcomes at 6-months were similar between the two groups with respect to both target lesion revascularization (3.3% vs. 5.4%, P = 0.41) and major adverse cardiac events (defined as the composite of target vessel revascularization, follow-up myocardial infraction and all-cause death) (3.3% vs. 7.6%, P = 0.19). ABSORB BVS for the treatment of complex lesions appears to be associated with good procedural and early clinical outcomes similar to those observed with conventional drug-eluting stents. Larger studies with long-term follow-up are required in order to fully assess the role of BVS in the treatment of such lesions and how this compares with that of conventional stents. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

  1. 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.

  2. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: Results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial

    NARCIS (Netherlands)

    M. Sabate (Manel); S.W. Windecker (Stephan); A. Iiguez (Andres); Okkels-Jensen, L. (Lisette); A. Cequier; S. Brugaletta (Salvatore); S.H. Hofma (Sjoerd); L. Räber (Lorenz); Christiansen, E.H. (Evald Høi); M.J. Suttorp (Maarten); T. Pilgrim (Thomas); G.A. van Es (Gerrit Anne); Y. Sotomi (Yohei); H.M. Garcia-Garcia (Hector); Y. Onuma (Yoshinobu); P.W.J.C. Serruys (Patrick)

    2016-01-01

    textabstractAims: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the

  3. Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction-TROFI II trial

    NARCIS (Netherlands)

    Sabaté, Manel; Windecker, Stephan; Iñiguez, Andres; Okkels-Jensen, Lisette; Cequier, Angel; Brugaletta, Salvatore; Hofma, Sjoerd H.; Räber, Lorenz; Christiansen, Evald Høi; Suttorp, Maarten; Pilgrim, Thomas; Anne van Es, Gerrit; Sotomi, Yohei; García-García, Hector M.; Onuma, Yoshinobu; Serruys, Patrick W.

    2016-01-01

    Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome

  4. Outcomes after revascularisation with everolimus- and sirolimus-eluting stents in patients with acute coronary syndromes and stable angina pectoris

    DEFF Research Database (Denmark)

    Antonsen, Lisbeth; Thayssen, Per; Hansen, Henrik S

    2014-01-01

    Aims: The aim of this substudy of the SORT OUT IV trial was to compare clinical outcomes among patients with acute coronary syndromes (ACS) and stable angina pectoris (SAP) treated with everolimus-eluting stents (EES) or sirolimus-eluting stents (SES). Methods and results: We performed a post hoc...

  5. Impact of cytochrome P450 2C19 loss-of-function polymorphism on intra-stent thrombi and lesion outcome after everolimus-eluting stent implantation compared to that after first-generation drug-eluting stent implantation.

    Science.gov (United States)

    Konishi, Akihide; Shinke, Toshiro; Otake, Hiromasa; Nishio, Ryo; Sawada, Takahiro; Takaya, Tomofumi; Nakagawa, Masayuki; Osue, Tsuyoshi; Taniguchi, Yu; Iwasaki, Masamichi; Kinutani, Hiroto; Masaru, Kuroda; Takahashi, Hachidai; Terashita, Daisuke; Shite, Junya; Hirata, Ken-ichi

    2015-01-20

    The contribution of clopidogrel response due to cytochrome P450 (CYP) 2C19 loss-of-function polymorphism after drug-eluting stent (DES) implantation is unclear. A total of 196 patients who had undergone optical coherence tomography (OCT) at 8 months following first-generation DES (120 lesions) and current-generation everolimus-eluting stent (EES) implantation (127 lesions) were enrolled. Patients were divided into 3 groups by CYP2C19 polymorphism: extensive metabolizers (EMs), intermediate metabolizers (IMs), and poor metabolizers (PMs). OCT findings were compared among the 3 groups. Responsiveness to clopidogrel was assessed by VerifyNow platelet reactivity unit (PRU). The incidence of intra-stent thrombi was significantly higher after first-generation DES implantation compared with EES implantation (35% vs 13%, respectively; p=0.0001). In the first-generation DES group, the incidence of intra-stent thrombi significantly increased among EMs, IMs, and PMs (21% vs 36% vs 63%, respectively; p=0.007), while there was no significant difference among the 3 groups after EES implantation (10% vs 13% vs 20%, respectively; p=0.55). The PRU significantly increased among EMs, IMs, and PMs in each stent group. In multivariate analyses, although PMs had a 3-fold higher risk of thrombi formation compared with non-PMs after first-generation DES implantation, there were no significant differences in thrombi formation between the 2 groups after EES implantation. The optimal PRU cutoff values for the prediction of intra-stent thrombi with first-generation DES and EES were 234 and 256, respectively. CYP2C19 loss-of-function polymorphism is associated with a higher incidence of intra-stent thrombi after first-generation DES implantation, while the impact is attenuated following EES implantation. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  6. Clinical outcomes in real-world patients with small vessel disease treated with XIENCE V® everolimus-eluting stents: one year results from the XIENCE V® USA condition of approval post-market study.

    Science.gov (United States)

    Hermiller, James B; Rutledge, David R; Mao, Vivian W; Zhao, Weiying; Wang, Jin; Gruberg, Luis; Lombardi, William; Sharma, Samin K; Krucoff, Mitchell W

    2014-07-01

    The purpose of this study was to evaluate the 1-year clinical outcomes of more complex XIENCE V USA real-world patients with small versus nonsmall vessel lesions. Patients with small vessel lesions undergoing coronary stent placement are at higher risk of major adverse cardiac events. Improved safety and efficacy of XIENCE V everolimus eluting stents (EES) have been previously demonstrated in selected low-risk small vessel populations in randomized clinical trials. The XIENCE V USA study was a condition of approval, single-arm study in unselected real-world patients. Baseline and 1-year clinical outcomes were compared between XIENCE V USA patients who received a single 2.5 mm stent (small vessel group, N = 838) and patients implanted with a single >2.5 mm stent (non-small vessel group, N = 2,015). Mean reference vessel diameter was 2.55 ± 0.36 and 3.25 ± 0.46 mm in the small and non-small vessel groups, respectively (P < 0.001). Small vessel group had more females, presented with a higher rate of diabetes, and had more complex lesion characteristics. The definite or probable ST rates analyzed using Kaplan-Meier method were low and not significantly different between the groups at 0.37 and 0.40% for the small and nonsmall vessel group (P = 0.88), respectively. The composite rate of cardiac death or MI was comparable at 4.5% for the small and 5.1% for the non-small vessel 1 groups (P = 0.57). The 1-year target lesion revascularization rate was also comparable in the small vessel group (3.8% vs. 3.0%, P = 0.35). Despite gender difference, higher prevalence of diabetes and more complex lesions in the small vessel groups, the 1-year clinical outcomes were similar in both small and nonsmall vessel groups. These results demonstrate the therapeutic benefit of XIENCE V EES in a real-world all inclusive patient population with small vessel disease. © 2013 Wiley Periodicals, Inc.

  7. One-year outcome of a prospective trial stopping dual antiplatelet therapy at 3 months after everolimus-eluting cobalt-chromium stent implantation: ShortT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent (STOPDAPT) trial.

    Science.gov (United States)

    Natsuaki, Masahiro; Morimoto, Takeshi; Yamamoto, Erika; Shiomi, Hiroki; Furukawa, Yutaka; Abe, Mitsuru; Nakao, Koichi; Ishikawa, Tetsuya; Kawai, Kazuya; Yunoki, Kei; Shimizu, Shogo; Akao, Masaharu; Miki, Shinji; Yamamoto, Masashi; Okada, Hisayuki; Hoshino, Kozo; Kadota, Kazushige; Morino, Yoshihiro; Igarashi, Keiichi; Tanabe, Kengo; Kozuma, Ken; Kimura, Takeshi

    2016-07-01

    There has been no previous prospective study evaluating dual antiplatelet therapy (DAPT) duration shorter than 6 months after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation. STOPDAPT trial is a prospective multi-center single-arm study evaluating 3-month DAPT duration after CoCr-EES implantation. The primary endpoint was a composite of cardiovascular death, myocardial infarction (MI), stroke, definite stent thrombosis (ST) and TIMI major/minor bleeding at 1 year. Between September 2012 and October 2013, a total of 1525 patients were enrolled from 58 Japanese centers, with complete 1-year follow-up in 1519 patients (99.6 %). Thienopyridine was discontinued within 4 months in 1444 patients (94.7 %). The event rates beyond 3 months were very low (cardiovascular death: 0.5 %, MI: 0.1 %, ST: 0 %, stroke: 0.7 %, and TIMI major/minor bleeding: 0.8 %). Cumulative 1-year incidence of the primary endpoint was 2.8 % [upper 97.5 % confidence interval (CI) 3.6 %], which was lower than the pre-defined performance goal of 6.6 % (P < 0.0001). Using the CoCr-EES group in the RESET trial as a historical comparison group, where nearly 90 % of patients had continued DAPT at 1 year, cumulative incidence of the primary endpoint tended to be lower in the STOPDAPT than in the RESET (2.8 versus 4.0 %, P = 0.06) and adjusted hazard ratio was 0.64 (95 % CI 0.42-0.95, P = 0.03). The cumulative incidence of definite/probable ST was lower in the STOPDAPT than in the RESET [0 patient (0 %) versus 5 patients (0.3 %), P = 0.03]. In conclusion, stopping DAPT at 3 months in selected patients after CoCr-EES implantation was at least as safe as the prolonged DAPT regimen adopted in the historical control group.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2016-01-15

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

  9. Impact of lesion calcification on angiographic outcomes after Absorb everolimus-eluting bioresorbable vascular scaffold implantation: An observation from the ABSORB Japan trial

    NARCIS (Netherlands)

    Ohya, M. (Masanobu); K. Kadota (Kazushige); Y. Sotomi (Yohei); K. Kozuma (Ken); K. Tanabe (Kengo); Uematsu, M. (Masaaki); Kawasaki, T. (Tomohiro); Morino, Y. (Yoshihiro); Tobaru, T. (Tetsuya); Nakao, K. (Koichi); Tachibana, K. (Kouichi); Kishi, K. (Koichi); Shibata, Y. (Yoshisato); S. Ying (Shihwa); Kusano, H. (Hajime); G.W. Stone (Gregg); J.J. Popma (Jeffrey); Y. Onuma (Yoshinobu); P.W.J.C. Serruys (Patrick); T. Kimura (Takeshi)

    2017-01-01

    textabstractAims: We aimed to investigate the impact of lesion calcification on angiographic outcomes after Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in comparison with those after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation. Methods and

  10. Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial.

    Science.gov (United States)

    Sabaté, Manel; Brugaletta, Salvatore; Cequier, Angel; Iñiguez, Andrés; Serra, Antonio; Jiménez-Quevedo, Pilar; Mainar, Vicente; Campo, Gianluca; Tespili, Maurizio; den Heijer, Peter; Bethencourt, Armando; Vazquez, Nicolás; van Es, Gerrit Anne; Backx, Bianca; Valgimigli, Marco; Serruys, Patrick W

    2016-01-23

    Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial. In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087. 1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047). Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction. Spanish Heart Foundation. Copyright © 2016 Elsevier Ltd. All rights reserved.

  11. Early vascular responses to everolimus-eluting cobalt-chromium stent in the culprit lesions of st-elevation myocardial infarction: results from a multicenter prospective optical coherence tomography study (MECHANISM-AMI 2-week follow-up study).

    Science.gov (United States)

    Morino, Yoshihiro; Terashita, Daisuke; Otake, Hiromasa; Kikuchi, Tatsuo; Fusazaki, Tetsuya; Kuriyama, Nehiro; Suzuki, Takahide; Ito, Yoshiaki; Hibi, Kiyoshi; Tanaka, Hiroyuki; Ishihara, Shozo; Kataoka, Toru; Morita, Takashi; Otsuka, Yoritaka; Hayashi, Takatoshi; Tanabe, Kengo; Shinke, Toshiro

    2018-01-09

    The use of cobalt-chromium everolimus-eluting stents (CoCr-EES) for ST-segment elevation myocardial infarction (STEMI) reduces the incidence of stent thrombosis compared with bare metal stents, and a substantial difference is apparent in the initial 2 weeks. However, vascular behavior during this early period remains unclear. This was a prospective study (MECHANISM-AMI-2W) to investigate early vascular responses in STEMI patients immediately after CoCr-EES implantation and at 2-week follow-up using frequency domain-optical coherence tomography (FD-OCT). The study enrolled 52 patients (age 63.7 ± 11.7 years, male 85.0%), of whom 44 patients were available for complete serial FD-OCT analyses. Both % uncovered struts and % malapposed struts were improved at 2-week follow-up (63 ± 20 vs. 21 ± 14%, p stent (28.8 ± 27.7 vs. 18.1 ± 20.2%, p = 0.0001) and maximal area (0.93 ± 0.84 vs. 0.65 ± 0.63 mm2, p = 0.034). As a result, the average lumen area was significantly larger at 2 weeks (6.49 ± 1.82 vs. 6.71 ± 1.89 mm2, p = 0.048, respectively). The number of dissection flaps was lower (0.86 ± 1.11 vs. 0.52 ± 0.90%, p = 0.024). In conclusion, this study showed early vascular responses to CoCr-EES for STEMI lesions-including a significant reduction of thrombus-that resulted in lumen enlargement, earlier progression of strut coverage, and improvements in strut apposition and dissection. The combination of these factors may therefore be responsible for the safety of CoCr-EES within the initial 2 weeks.

  12. Sex-related impact on clinical outcome of everolimus-eluting versus bare-metal stents in ST-segment myocardial infarction. insights from the EXAMINATION trial

    NARCIS (Netherlands)

    A. Regueiro (Ander); J. Fernández-Rodríguez (Juana); S. Brugaletta (Salvatore); V. Martin-Yuste (Victoria); M. Masotti (Monica); X. Freixa (Xavier); A. Cequier; A. Iiguez (Andres); P.W.J.C. Serruys (Patrick); M. Sabate (Manel)

    2015-01-01

    textabstractIntroduction and objectives 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

  13. Association of Coronary Perivascular Adipose Tissue Inflammation and Drug-Eluting Stent-Induced Coronary Hyperconstricting Responses in Pigs:18F-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 ( P inflammation. © 2017 American Heart Association, Inc.

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

    Science.gov (United States)

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

    2014-11-01

    Long-term outcomes are imperative to confirm safety of drug-eluting stents. There have been 2 randomized controlled trials comparing everolimus-eluting stents (EESs) and Resolute zotarolimus-eluting stents (ZES-Rs). To date, long-term clinical outcomes of these stents were limited to only 1 report, which has recently reported 4-year comparisons of these stents. Therefore, more evidence is needed regarding long-term clinical outcomes of the second-generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in "all-comer" cohorts up to 3-year follow-up. The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure) and patient-related composite events up to 3-year follow-up were compared in crude and propensity score-matched analyses. Of 5,054 patients, 3,830 patients (75.8%) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (189 [6.2%] vs 127 [6.4%], p = 0.812) and the patient-related outcome (420 [13.7%] vs 250 [12.5%], p = 0.581) did not differ between EES and ZES-R, respectively, at 3 years, which was corroborated by similar results from the propensity score-matched cohort (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.70 to 1.20, p = 0.523 and 0.85, 95% CI 0.70 to 1.02, p = 0.081, for stent- and patient-related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs 10 [0.5%], p = 0.370) was also similar. The rate of very late definite or probable stent thrombosis was very low and comparable between the 2 stents (3 [0.1%] vs 1 [0.1%], p = 0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440 to 5.354, p <0.001) and off-label indication (adjusted HR 1.782, 95% CI 1.169 to 2.718, p = 0.007) were the strongest predictors of target

  15. Revascularisation versus medical treatment in patients with stable coronary artery disease

    DEFF Research Database (Denmark)

    Windecker, Stephan; Stortecky, Stefan; Stefanini, Giulio G

    2014-01-01

    OBJECTIVE: To investigate whether revascularisation improves prognosis compared with medical treatment among patients with stable coronary artery disease. DESIGN: Bayesian network meta-analyses to combine direct within trial comparisons between treatments with indirect evidence from other trials...... stent, early generation paclitaxel eluting stent, sirolimus eluting stent, and zotarolimus eluting (Endeavor) stent, and new generation everolimus eluting stent, and zotarolimus eluting (Resolute) stent among patients with stable coronary artery disease. DATA SOURCES: Medline and Embase from 1980......: Among patients with stable coronary artery disease, coronary artery bypass grafting reduces the risk of death, myocardial infarction, and subsequent revascularisation compared with medical treatment. All stent based coronary revascularisation technologies reduce the need for revascularisation...

  16. Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis.

    Science.gov (United States)

    Bangalore, Sripal; Toklu, Bora; Amoroso, Nicholas; Fusaro, Mario; Kumar, Sunil; Hannan, Edward L; Faxon, David P; Feit, Frederick

    2013-11-08

    To compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents. Mixed treatment comparison meta-analysis of 258,544 patient years of follow-up from randomized trials. PubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents. Long term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents. From 126 randomized trials and 258,544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased mortality compared with cobalt chromium everolimus eluting stents (1.52, 1

  17. 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

    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.......0-12.6) vs. 0.0 mm(3) (0.0-1.1), P = 0.001]. In-stent % volume obstruction was increased in EES compared to SES [median (interquartile range): 1.6% (0.0-8.2) vs. 0.0% (0.0-1.0), P = 0.001]. Peri-stent external elastic membrane (EEM) volume: (post procedure vs. follow-up EES [300 mm(3) (219-491) vs. 307 mm(3...

  18. Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting resolute and everolimus-eluting Xience V stents: 2-year follow-up of the randomized TWENTE trial.

    Science.gov (United States)

    Tandjung, Kenneth; Sen, Hanim; Lam, Ming Kai; Basalus, Mounir W Z; Louwerenburg, J Hans W; Stoel, Martin G; van Houwelingen, K Gert; de Man, Frits H A F; Linssen, Gerard C M; Saïd, Salah A M; Nienhuis, Mark B; Löwik, Marije M; Verhorst, Patrick M J; van der Palen, Job; von Birgelen, Clemens

    2013-06-18

    The aim of this study was to assess the safety and efficacy of the implantation of Resolute zotarolimus-eluting stents (ZES) (Medtronic Inc., Santa Rosa, California) and Xience V everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, California) following strict discontinuation of dual antiplatelet therapy (DAPT) after 12 months. Only limited long-term follow-up data are available from head-to-head comparisons of second-generation drug-eluting stents. The randomized TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial is an investigator-initiated study performed in a population with many complex patients and lesions and only limited exclusion criteria. Patients were randomly assigned 1:1 to ZES (n = 697) or EES (n = 694). Two-year follow-up information was available on all patients. The rate of continuation of DAPT beyond 12 months was very low (5.4%). The primary endpoint of target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization, did not differ between ZES and EES (10.8% vs. 11.6, p = 0.65), despite fewer target lesion revascularizations in patients with EES (2.6% vs. 4.9%, p = 0.03). The patient-oriented composite endpoint was similar (16.4% vs. 17.1%, p = 0.75). Two-year rates of definite or probable stent thrombosis were 1.2% and 1.4%, respectively (p = 0.63). Very late definite or probable stent thrombosis occurred only in 2 patients in each study arm (0.3% vs. 0.3%, p = 1.00). After 2 years of follow-up and stringent discontinuation of DAPT beyond 12 months, Resolute ZES and Xience V EES showed similar results in terms of safety and efficacy for treating patients with a majority of complex lesions and off-label indications for drug-eluting stents. (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente [TWENTE]; NCT01066650). Copyright © 2013 American College of Cardiology Foundation

  19. 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.

  20. Biocompatibility of Coronary Stents

    Directory of Open Access Journals (Sweden)

    Thamarasee M. Jeewandara

    2014-01-01

    Full Text Available Cardiovascular disease is the dominant cause of mortality in developed countries, with coronary artery disease (CAD a predominant contributor. The development of stents to treat CAD was a significant innovation, facilitating effective percutaneous coronary revascularization. Coronary stents have evolved from bare metal compositions, to incorporate advances in pharmacological therapy in what are now known as drug eluting stents (DES. Deployment of a stent overcomes some limitations of balloon angioplasty alone, but provides an acute stimulus for thrombus formation and promotes neointimal hyperplasia. First generation DES effectively reduced in-stent restenosis, but profoundly delay healing and are susceptible to late stent thrombosis, leading to significant clinical complications in the long term. This review characterizes the development of coronary stents, detailing the incremental improvements, which aim to attenuate the major clinical complications of thrombosis and restenosis. Despite these enhancements, coronary stents remain fundamentally incompatible with the vasculature, an issue which has largely gone unaddressed. We highlight the latest modifications and research directions that promise to more holistically design coronary implants that are truly biocompatible.

  1. A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial

    NARCIS (Netherlands)

    Serruys, Patrick W.; Ong, Andrew T. L.; Piek, Jan J.; Neumann, Franz-Josef; van der Giessen, Willem J.; Wiemer, Marcus; Zeiher, Andreas; Grube, Eberhard; Haase, Jürgen; Thuesen, Leif; Hamm, Christian; Otto-Terlouw, Patricia C.

    2005-01-01

    Background: Everolimus is a sirolimus analogue with similar efficacy in animal models, and has been previously successfully tested in humans using an erodable polymer.Methods: This first-in-man single blind multi-centre randomized controlled trial assessed the safety and efficacy of everolimus

  2. Acute Gain in Minimal Lumen Area Following Implantation of Everolimus-Eluting ABSORB Biodegradable Vascular Scaffolds or Xience Metallic Stents: Intravascular Ultrasound Assessment From the ABSORB II Trial.

    Science.gov (United States)

    Sotomi, Yohei; Ishibashi, Yuki; Suwannasom, Pannipa; Nakatani, Shimpei; Cho, Yun-Kyeong; Grundeken, Maik J; Zeng, Yaping; Tateishi, Hiroki; Smits, Pieter C; Barragan, Paul; Kornowski, Ran; Gershlick, Anthony H; Windecker, Stephan; van Geuns, Robert-Jan; Bartorelli, Antonio L; de Winter, Robbert J; Tijssen, Jan; Serruys, Patrick W; Onuma, Yoshinobu

    2016-06-27

    The study compared, by intravascular ultrasound (IVUS), acute gain (AG) at the site of the pre-procedural minimal lumen area (MLA) achieved by either the Absorb (Abbott Vascular, Santa Clara, California) scaffold or the Xience stent and identified the factors contributing to the acute performance of these devices. It is warranted that the acute performance of Absorb matches that of metallic stents; however, concern exists about acute expansion and lumen gain with the use of Absorb. Of a total of 501 patients (546 lesions) in the ABSORB II (ABSORB II Randomized Controlled Trial) randomized trial, 445 patients with 480 lesions were investigated by IVUS pre- and post-procedure. Comparison of MLA pre- and post-procedure was performed at the MLA site by matching pre- and post-procedural IVUS pullbacks. Lower AG on IVUS (lowest tertile) occurred more frequently in the Absorb arm than in the Xience arm (3.46 mm(2) vs. 4.27 mm(2), respectively; p < 0.001; risk ratio: 3.04; 95% confidence interval: 1.94 to 4.76). The plaque morphology at the MLA cross-section was not independently associated with IVUS acute gain. The main difference in AG in MLD by angiography was observed at the time of device implantation (Xience vs. Absorb, Δ+1.50 mm vs. Δ+1.23 mm, respectively), whereas the gain from post-dilation was similar between the 2 arms (Δ+0.16 mm vs. Δ+0.16 mm) when patients underwent post-dilation, although expected balloon diameter was smaller in the Absorb arm than in the Xience arm (p = 0.003) during post-dilation. At the site of the pre-procedural MLA, the increase of the lumen post-procedure was smaller in the Absorb-arm than in the Xience arm. To achieve equivalent AG to Xience, the implantation of Absorb may require more aggressive strategies at implantation, pre- and post-dilation than the technique used in the ABSORB II trial. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281). Copyright © 2016 American College of Cardiology Foundation. Published

  3. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial

    Science.gov (United States)

    Saito, Shigeru; Valdes-Chavarri, Mariano; Richardt, Gert; Moreno, Raul; Iniguez Romo, Andrés; Barbato, Emanuele; Carrie, Didier; Ando, Kenji; Merkely, Bela; Kornowski, Ran; Eltchaninoff, Hélène; James, Stefan; Wijns, William

    2014-01-01

    Aim The aim of this study was to establish safety and efficacy of a new sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES). Sirolimus-eluting stent with bioresorbable polymer was compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in the frame of a CENTURY II clinical trial designed to make global clinical data compliant with regulatory requirements in Europe and Japan. Methods and results The CENTURY II is a prospective, multicentre, randomized (1 : 1), single blind, controlled, non-inferiority clinical trial conducted at 58 study sites in Japan, Europe, and Korea. A total of 1123 patients requiring a percutaneous coronary intervention (PCI) procedure, with implantation of drug-eluting stent (DES), were enrolled [total population (TP)]. Randomization of patients was stratified for the subset of patients matching requirements for DES in Japan (Cohort JR, n = 722). Baseline patient demographic and angiographic characteristics were similar in both study arms, with minimal differences between the TP and Cohort JR. The primary endpoint, freedom from target lesion failure (TLF) at 9 months—TLF [composite of cardiac death, target-vessel-related myocardial infarction (MI) and target lesion revascularization]—was 95.6% with BP-SES and 95.1% with PP-EES (Pnon-inferiority<0.0001). Composite of cardiac death and MI rate was 2.9 and 3.8% (P = 0.40) and target vessel revascularization was 4.5% with BP-SES and 4.2% with PP-EES (P = 0.77). The stent thrombosis rate was 0.9% in both arms. In Cohort JR, freedom from TLF was 95.9 and 94.6% (Pnon-inferiority < 0.0005) with BP-SES and PP-EES, respectively. Conclusion The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting stent at 9-month follow-up. Study registration number UMIN000006940. PMID:24847155

  4. Auxetic coronary stent endoprosthesis

    DEFF Research Database (Denmark)

    Amin, Faisal; Ali, Murtaza Najabat; Ansari, Umar

    2014-01-01

    was obtained via laser cutting, and surface treatment was performed with acid pickling and electropolishing, followed by an annealing process. In vitro mechanical analysis was performed to analyze the mechanical performance of the auxetic coronary stent. Scanning electronic microscopy (SEM) was used...

  5. Coronary artery stent (image)

    Science.gov (United States)

    ... blocked. The stent is inserted along with a balloon catheter and expands when the balloon is inflated. The stent is ... blocked. The stent is inserted along with a balloon catheter and expands when the balloon is inflated. The stent is ...

  6. Reduced duration of dual antiplatelet therapy using an improved drug-eluting stent for percutaneous coronary intervention of the left main artery in a real-world, all-comer population: Rationale and study design of the prospective randomized multicenter IDEAL-LM trial.

    Science.gov (United States)

    Lemmert, Miguel E; Oldroyd, Keith; Barragan, Paul; Lesiak, Maciej; Byrne, Robert A; Merkulov, Evgeny; Daemen, Joost; Onuma, Yoshinobu; Witberg, Karen; van Geuns, Robert-Jan

    2017-05-01

    Continuous improvements in stent technology make percutaneous coronary intervention (PCI) a potential alternative to surgery in selected patients with unprotected left main coronary artery (uLMCA) disease. The optimal duration of dual antiplatelet therapy (DAPT) in these patients remains undetermined, and in addition, new stent designs using a bioabsorbable polymer might allow shorter duration of DAPT. IDEAL-LM is a prospective, randomized, multicenter study that will enroll 818 patients undergoing uLMCA PCI. Patients will be randomized in a 1:1 fashion to intravascular ultrasound-guided PCI with the novel everolimus-eluting platinum-chromium Synergy stent with a biodegradable polymer (Boston Scientific, Natick, MA) followed by 4 months of DAPT or the everolimus-eluting cobalt-chromium Xience stent (Abbott Vascular, Santa Clara, CA) followed by 12 months of DAPT. The total follow-up period will be 5 years. A subset of 100 patients will undergo optical coherence tomography at 3 months. The primary end point will be major adverse cardiovascular events (composite of all-cause mortality, myocardial infarction, and ischemia-driven target vessel revascularization) at 2 years. Secondary end points will consist of the individual components of the primary end point, procedural success, a device-oriented composite end point, stent thrombosis as per Academic Research Consortium criteria, and bleeding as per Bleeding Academic Research Consortium criteria. IDEAL-LM is designed to assess the safety and efficacy of the novel Synergy stent followed by 4 months of DAPT vs the Xience stent followed by 12 months of DAPT in patients undergoing uLMCA PCI. The study will provide novel insights regarding optimal treatment strategy for patients undergoing PCI of uLMCA disease (www.clinicaltrials.gov, NCT 02303717). Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

  7. 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

  8. Differential aspects between cobalt-chromium everolimus drug-eluting stent and Absorb everolimus bioresorbable vascular scaffold: from bench to clinical use.

    Science.gov (United States)

    Sotomi, Yohei; Suwannasom, Pannipa; Tenekecioglu, Erhan; Tateishi, Hiroki; Abdelghani, Mohammad; Serruys, Patrick W; Onuma, Yoshinobu

    2015-10-01

    Drug-eluting stents have significantly improved the outcomes of percutaneous coronary intervention by substantially reducing in-stent restenosis and stent thrombosis. However, a potential limitation of these stents is the permanent presence of a metallic foreign body within the artery, which may cause vascular inflammation, restenosis, thrombosis, neoatherosclerosis, permanent impairment of the physiological vasomotor function and interference with potential future grafting of the stented segment. Bioresorbable scaffolds have the potential to overcome these limitations as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage and restoring pulsatility, cyclical strain, physiological shear stress and mechanotransduction. This article presents a comparison between the most widespread bioresorbable vascular scaffold 'Absorb BVS' and second-generation drug-eluting stent (cobalt chromium everolimus-eluting stent) from bench to clinical use.

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    the randomised BASKET-PROVE trial (sirolimus-eluting stent vs. everolimus-eluting stent vs. bare metal stent in large-vessel stenting). The primary endpoint was the combined two-year rate of cardiovascular death or non-fatal myocardial infarction (MI). Secondary endpoints were each component of the primary...

  10. Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions: a randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial.

    Science.gov (United States)

    Park, Duk-Woo; Kim, Young-Hak; Song, Hae-Geun; Ahn, Jung-Min; Kim, Won-Jang; Lee, Jong-Young; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Yun, Sung-Cheol; Seung, Ki-Bae; Yang, Tae-Hyun; Lee, Sang-Gon; Lee, Jae-Hwan; Seong, In-Whan; Cheong, Sang-Sig; Lee, Bong-Ki; Lee, Nae-Hee; Lee, Se-Whan; Lee, Seung-Wook; Lee, Keun; Kim, Hyun-Sook; Jeon, Doo-Soo; Kim, Min-Kyu; Nah, Deuk-Young; Tahk, Seung-Jea; Park, Seung-Jung

    2011-10-01

    This study compared everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) for long coronary lesions. Outcomes remain relatively unfavorable for stent-based coronary intervention of lesions with long diseased segments. This randomized, multicenter, prospective trial compared the use of long EES with SES in 450 patients with long (≥ 25 mm) native coronary lesions. The primary endpoint of the trial was in-segment late luminal loss at 9-month angiographic follow-up. The EES and SES groups had similar baseline characteristics. Lesion length was 34.0 ± 15.4 mm in the EES group and 34.3 ± 13.5 mm in the SES group (p = 0.85). Nine-month angiographic follow-up was performed in 80% of the EES group and 81% of the SES group (p = 0.69). In-segment late loss as the primary study endpoint was significantly larger in the EES group than in the SES group (0.17 ± 0.41 mm vs. 0.09 ± 0.30 mm, p for noninferiority = 0.96, p for superiority = 0.04). The in-segment binary restenosis rate was also higher in the EES group than in the SES group (7.3% vs. 2.7%, p = 0.046). However, in-stent late loss (0.22 ± 0.43 mm vs. 0.18 ± 0.28 mm, p = 0.29) and in-stent binary restenosis rate (3.9% vs. 2.7%, p = 0.53) were similar among the 2 groups. The incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes) was not statistically different between the 2 groups. For patients with long native coronary artery disease, EES implantation was associated with greater angiographic in-segment late loss and higher rates of in-segment restenosis compared with SES implantation. However, clinical outcomes were both excellent and not statistically different. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  11. [Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions].

    Science.gov (United States)

    Li, C J; Xu, B; Guan, C D; Gao, R L

    2017-11-24

    Objective: To compare the long term safety and efficacy of the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent(Firehawk stent) and permanent polymer coating everolimus eluting stent(Xience V stent) for the treatment of coronary de novo lesions. Methods: This prospective, multi-center, non-inferiority, randomized control trial(TARGETⅠ trial) was performed between August 2010 and April 2011, a total of 460 patients with primary, de novo, single vessel and single coronary lesion from 16 medical centers were enrolled. The diameter stenosis of target lesion was ≥70%, and lesion length was≤24 mm. The patients were randomly assigned to treatment with Firehawk stent (Firehawk stent group) or Xience V stent (Xience V stent group) groups by a web-based allocation system and was stratified by center. The late lumen loss after 9 months, target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction, or ischemia driven target lesion revascularization, patient-oriented composite endpoint (PoCE) which was a composite of all cause death, all cause myocardial infarction, or any revascularization, and stent thrombosis after 5 years were compared between the two groups. Results: (1) There were 2 patients without stent implantation dropped out of this trial. There were 227 patients in Firehawk stent group, and 231 patients in Xience V stent group. The baseline characteristics were similar between the two groups(all P>0.05). (2) The 9 months late lumen loss in Firehawk stent group was non-inferior to that in Xience V stent group ((0.13±0.24)mm vs. (0.13±0.18)mm, P=0.94). (3) A total of 442 (96.5%) patients completed 5 years clinical follow-up. There were no significant differences on 5-year TLF rate (6.0%(13/217) vs. 6.7% (15/225), P=0.77) and PoCE rate (12.0%(26/217) vs. 17.8% (40/225), P=0.09) between the Firehawk stent group and Xience V stent group. (4) Kaplan-Meier analysis showed that TLF rates between 1

  12. Percutaneous coronary angioscopy and stents

    Science.gov (United States)

    Heuser, Richard R.

    1994-05-01

    With the expanding array of therapies available for coronary intervention, the invasive cardiologist has many choices for treating a specific lesion in an individual patient. Certain types of lesions might respond more effectively with stents, particularly the rigid Palmax- Schatz device. Thrombus and dissection immediately following stent placement are associated with early occlusion, and the interventionist must be able to assess their presence pre- and post-stenting. Angiography is deficient in quantifying minimal disease and in defining lesion architecture and composition, as well as the plaque rupture and thrombosis associated with unstable angina. It is also imprecise in detecting dissection and thrombus. Intravascular ultrasound (IVUS) provides high-resolution images that delineate irregularities and other structures inside the lumen and within the vessel wall and surrounding tissues. Like angiography, IVUS has limited specificity for thrombus differentiation. Angioscopy is superior to angiography and IVUS in detecting thrombus and dissection. Angioscopy allows the clinician to assess the appearance of stent struts after deployment and at follow-up. This may aid in reducing acute complications as well as restenosis. Follow-up angioscopy of stents to detect thrombus or exposed struts may guide therapy in a patient who has clinical symptoms of restenosis.

  13. Incidence and predictors of coronary stent thrombosis

    DEFF Research Database (Denmark)

    D'Ascenzo, Fabrizio; Bollati, Mario; Clementi, Fabrizio

    2013-01-01

    Stent thrombosis remains among the most feared complications of percutaneous coronary intervention (PCI) with stenting. However, data on its incidence and predictors are sparse and conflicting. We thus aimed to perform a collaborative systematic review on incidence and predictors of stent thrombo...

  14. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Park Kyung

    2012-03-01

    Full Text Available Abstract Background Second-generation drug-eluting stents (DES have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES. In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI. A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES and antiplatelet regimen (TAT vs DDAT. The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734.

  15. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: study protocol for a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734. PMID:22463698

  16. Impact of stent platform on longitudinal stent deformation: an in vivo frequency domain optical coherence tomography study.

    Science.gov (United States)

    Yamada, Ryotaro; Okura, Hiroyuki; Kume, Teruyoshi; Fukuhara, Kenzo; Koyama, Terumasa; Higa, Tomitaka; Neishi, Yoji; Yoshida, Kiyoshi; Uemura, Shiro

    2017-07-01

    Recently, longitudinal coronary stent deformation has been highlighted as a possible cause of drug-eluting stent failure. Although bench tests and in vivo studies have demonstrated difference in longitudinal stent strength among the stents with different platforms, its clinical impact is still unknown. Furthermore, it is unknown if modified stent platform favorably affect the incidence of stent deformation. The aim of this study was to investigate the longitudinal deformation of the everolimus-eluting stents (EES) with different stent platforms by using frequency domain optical coherence tomography (FD-OCT). Seventy-eight lesions treated with EES (Xience Prime: n = 26, Promus element: n = 29, Promus premier: n = 23) were studied. After successful stent implantation, FD-OCT was performed and stent length was measured using three-dimensional reconstruction of the images in vivo. Percent longitudinal stent shortening (%SS) was defined as the in vivo stent length divided by nominal stent length. Longitudinal stent deformation was defined as  %SS > 10 %. Patients' and procedural characteristics were similar among 3 EESs. There was no difference in mean  %SS between Xience Prime, Promus Element and Promus Premier (1.0 ± 5.8, 2.9 ± 6.7 and 0.8 ± 3.7 %, p = 0.322). Incidence of the longitudinal stent deformation was significantly higher in Promus Element than the other stents (0, 13.8 and 0 %, p = 0.028). Incidence of longitudinal stent deformation was different between EESs with different stent platforms. Stent material, stent design and/or stent delivery balloon may affect longitudinal stent deformation.

  17. The risk and prognostic impact of definite stent thrombosis or in-stent restenosis after coronary stent implantation

    DEFF Research Database (Denmark)

    Thayssen, Per; Jensen, Lisette Okkels; Lassen, Jens Flensted

    2012-01-01

    Aims: Data are limited on the prognostic impact of stent thrombosis and in-stent restenosis in patients treated with coronary stents. We examined the prognostic impact of stent thrombosis and in-stent restenosis in patients treated with percutaneous coronary intervention (PCI). Methods and result...

  18. Rationale of a novel study design for the BIOFLOW V study, a prospective, randomized multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent system using a Bayesian approach.

    Science.gov (United States)

    Doros, Gheorghe; Massaro, Joseph M; Kandzari, David E; Waksman, Ron; Koolen, Jacques J; Cutlip, Donald E; Mauri, Laura

    2017-11-01

    Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution. This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N=452 and BIOFLOW IV, N=579) by using a Bayesian approach. The primary end point is target lesion failure at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization. The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the

  19. 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.

  20. Hemodynamics in Idealized Stented Coronary Arteries: Important Stent Design Considerations.

    Science.gov (United States)

    Beier, Susann; Ormiston, John; Webster, Mark; Cater, John; Norris, Stuart; Medrano-Gracia, Pau; Young, Alistair; Cowan, Brett

    2016-02-01

    Stent induced hemodynamic changes in the coronary arteries are associated with higher risk of adverse clinical outcome. The purpose of this study was to evaluate the impact of stent design on wall shear stress (WSS), time average WSS, and WSS gradient (WSSG), in idealized stent geometries using computational fluid dynamics. Strut spacing, thickness, luminal protrusion, and malapposition were systematically investigated and a comparison made between two commercially available stents (Omega and Biomatrix). Narrower strut spacing led to larger areas of adverse low WSS and high WSSG but these effects were mitigated when strut size was reduced, particularly for WSSG. Local hemodynamics worsened with luminal protrusion of the stent and with stent malapposition, adverse high WSS and WSSG were identified around peak flow and throughout the cardiac cycle respectively. For the Biomatrix stent, the adverse effect of thicker struts was mitigated by greater strut spacing, radial cell offset and flow-aligned struts. In conclusion, adverse hemodynamic effects of specific design features (such as strut size and narrow spacing) can be mitigated when combined with other hemodynamically beneficial design features but increased luminal protrusion can worsen the stent's hemodynamic profile significantly.

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

    Directory of Open Access Journals (Sweden)

    Jong-Hwa Ahn

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

  2. Transient coronary aneurysm formation after Nevo™ stent implantation versus persistent coronary aneurysm after Cypher Select™ stent implantation

    DEFF Research Database (Denmark)

    Christiansen, Evald Høj; Lassen, Jens Flensted; Jensen, Lisette Okkels

    2011-01-01

    We implanted a Cypher Select™ coronary stent and two months later a Nevo™ sirolimus-eluting coronary stent in another vessel. At a prescheduled angiographic follow-up, coronary aneurysms were seen in the two stented segments, 6 and 8 months after stent implantation, respectively. Six months later......, the aneurysm had healed in the Nevo, but was still present in the Cypher stented segment. We hypothesize that aneurysm formation was induced by sirolimus and the polymer of the implanted stents, and that subsequent healing was possible in the Nevo stent after degradation of the polymer....

  3. Circadian Variation in Coronary Stent Thrombosis

    NARCIS (Netherlands)

    Mahmoud, Karim D.; Lennon, Ryan J.; Ting, Henry H.; Rihal, Charanjit S.; Holmes, David R.

    Objectives We sought to determine the circadian, weekly, and seasonal variation of coronary stent thrombosis. Background Other adverse cardiovascular events such as acute myocardial infarction are known to have higher incidences during the early morning hours, Mondays, and winter months. Methods The

  4. Three-Year Outcomes After Revascularization With Everolimus- and Sirolimus-Eluting Stents From the SORT OUT IV Trial

    DEFF Research Database (Denmark)

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

    2014-01-01

    OBJECTIVES: The study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up. BACKGROUND: In the SORT OUT IV (SORT OUT IV Trial), comparing the EES...

  5. Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents

    DEFF Research Database (Denmark)

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

    2016-01-01

    BACKGROUND: Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown. OBJECTIVES: This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical...

  6. 2-Year Patient-Related Versus Stent-Related Outcomes

    DEFF Research Database (Denmark)

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

    2012-01-01

    OBJECTIVES: There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES). BACKGROUND: In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial......, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. METHODS: The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2.......6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0...

  7. 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.

  8. Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study

    NARCIS (Netherlands)

    R. Diletti (Roberto); A. Karanasos (Antonios); T. Muramatsu (Takashi); T. Nakatani (Tomoya); N.M. van Mieghem (Nicolas); Y. Onuma (Yoshinobu); S.T. Nauta (Sjoerd); Y. Ishibashi (Yuki); M.J. Lenzen (Mattie); J.M.R. Ligthart (Jürgen); C.J. Schultz (Carl); E.S. Regar (Eveline); P.P.T. de Jaegere (Peter); P.W.J.C. Serruys (Patrick); F. Zijlstra (Felix); R.J.M. van Geuns (Robert Jan)

    2014-01-01

    textabstractAimsWe evaluated the feasibility and the acute performance of the everolimus-eluting bioresorbable vascular scaffolds (BVS) for the treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI).Methods and resultsThe present investigation is a prospective,

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

    Science.gov (United States)

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

    2016-06-13

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

  10. Design Optimisation of Coronary Artery Stent Systems.

    Science.gov (United States)

    Bressloff, Neil W; Ragkousis, Giorgos; Curzen, Nick

    2016-02-01

    In recent years, advances in computing power and computational methods have made it possible to perform detailed simulations of the coronary artery stenting procedure and of related virtual tests of performance (including fatigue resistance, corrosion and haemodynamic disturbance). Simultaneously, there has been a growth in systematic computational optimisation studies, largely exploiting the suitability of surrogate modelling methods to time-consuming simulations. To date, systematic optimisation has focussed on stent shape optimisation and has re-affirmed the complexity of the multi-disciplinary, multi-objective problem at hand. Also, surrogate modelling has predominantly involved the method of Kriging. Interestingly, though, optimisation tools, particularly those associated with Kriging, haven't been used as efficiently as they could have been. This has especially been the case with the way that Kriging predictor functions have been updated during the search for optimal designs. Nonetheless, the potential for future, carefully posed, optimisation strategies has been suitably demonstrated, as described in this review.

  11. The conical stent in coronary artery improves hemodynamics compared with the traditional cylindrical stent.

    Science.gov (United States)

    Yu, Yi; Zhou, Yujie; Ma, Qian; Jia, Shuo; Wu, Sijing; Sun, Yan; Liu, Xiaoli; Zhao, Yingxin; Liu, Yuyang; Shi, Dongmei

    2017-01-15

    This study sought to explore the efficacy of the conical stent implantation in the coronary artery by comparing the effects of cylindrical and conical stents on wall shear stress (WSS) and velocity of flow and fractional flow reserve (FFR). The traditional cylindrical stent currently used in the percutaneous coronary intervention (PCI) has a consistent diameter, which does not match the physiological change of the coronary artery. On the contrary, as a new patent, the conical stent with tapering lumen is consistent with the physiological change of vascular diameter. However, the effect of the conical stent implantation on the coronary hemodynamics remains unclear. The coronary artery, artery stenosis and two stent models were established by Solidworks software. All models were imported into the computational fluid dynamics (CFD) software ANSYS ICEM-CFD to establish the fluid model. After the boundary conditions were set, CFD analysis was proceeded to compare the effects of two stent implantation on the change of WSS, velocity of flow and FFR. Hemodynamic indexes including FFR, blood flow velocity distribution (BVD) and WSS were improved by either the cylindrical or the conical stent implantation. However, after the conical stent implantation, the change of FFR seemed to be slower and more homogenous; the blood flow velocity was more appropriate without any obvious blood stagnation and direction changes; the WSS after the conical stent implantation was uniform from the proximal to distal side of the stent. Compared with the cylindrical stent, the conical stent implantation in the coronary artery can make the changes of vascular hemodynamic more closer to the physiological condition, which can reduce the incidence of intra-stent restenosis and thrombosis, thus making it more suitable for PCI therapy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  12. Recurrent post-partum coronary artery dissection

    Directory of Open Access Journals (Sweden)

    Resnic Frederic S

    2010-10-01

    Full Text Available Abstract Coronary artery dissection is a rare but well-described cause for myocardial infarction during the post-partum period. Dissection of multiple coronary arteries is even less frequent. Here we present a case of recurrent post-partum coronary artery dissections. This unusual presentation poses unique problems for management. A 35 year-old female, gravida 3 para 2, presented with myocardial infarction 9 weeks and 3 days post-partum. Cardiac catheterization demonstrated left anterior descending (LAD dissection but an otherwise normal coronary anatomy. The lesion was treated with four everolimus eluting stents. Initially the patient made an unremarkable recovery until ventricular fibrillation arrest occurred on the following day. Unsynchronized cardioversion restored a normal sinus rhythm and repeat catheterization revealed new right coronary artery (RCA dissection. A wire was passed distally, but it was unclear whether this was through the true or false lumen and no stents could be placed. However, improvement of distal RCA perfusion was noted on angiogram. Despite failure of interventional therapy the patient was therefore treated conservatively. Early operation after myocardial infarction has a significantly elevated risk of mortality and the initial dissection had occurred within 24 hours. This strategy proved successful as follow-up transthoracic echocardiography after four months demonstrated a preserved left ventricular ejection fraction of 55-60% without regional wall motion abnormalities. The patient remained asymptomatic from a cardiac point of view.

  13. The MGuard coronary stent: safety, efficacy, and clinical utility

    Directory of Open Access Journals (Sweden)

    Gracida M

    2015-09-01

    Full Text Available Montserrat Gracida, Rafael Romaguera, Francisco Jacobi, Joan A Gómez-Hospital, Angel Cequier Heart Diseases Institute, Hospital Universitari de Bellvitge – IDIBELL, University of Barcelona, Barcelona, Spain Abstract: Atheromatous and thrombotic embolization during percutaneous coronary revascularization is a feared complication that may cause impaired myocardial reperfusion even with a patent epicardial vessel. The MGuard stent is a cobalt chromium bare metal stent with a porous net attached to its outer surface that has been designed to prevent thrombus fragmentation and distal embolization during stent implantation. This review summarizes the available evidence supporting the use of the MGuard stent in different scenarios such as lesions with high thrombus burden, saphenous vein graft interventions, coronary perforations, or carotid lesions. Keywords: Coronary artery disease, myocardial infarction, coronary stent, complication, thrombus, no-reflow phenomenon

  14. Design and modeling balloon-expandable coronary stent for manufacturability

    Science.gov (United States)

    Suryawan, D.; Suyitno

    2017-02-01

    Coronary artery disease (CAD) is a disease that caused by narrowing of the coronary artery. The narrowing coronary artery is usually caused by cholesterol-containing deposit (plaque) which can cause a heart attack. CAD is the most common cause mortality in Indonesia. The commonly CAD treatment use the stent to opens or alleviate the narrowing coronary artery. In this study, the stent design is optimized for the manufacturability. Modeling is used to determine the free stent expansion due to applied pressure in the inner surface of the stent. The stress distribution, outer diameter change, and dogboning phenomena are investigated in the simulation. The result of modeling and simulating was analyzed and used to optimize the stent design before it is manufactured using EDM (Electric Discharge Machine) in the next research.

  15. Coronary Stents: The Impact of Technological Advances on Clinical Outcomes.

    Science.gov (United States)

    Mennuni, Marco G; Pagnotta, Paolo A; Stefanini, Giulio G

    2016-02-01

    Percutaneous coronary interventions (PCI) were proposed in the late 1970s as an alternative to surgical coronary artery bypass grafting for the treatment of coronary artery disease. Important technological progress has been made since. Balloon angioplasty was replaced by bare metal stents, which allowed to permanently scaffold the coronary vessel avoiding acute recoil and abrupt occlusion. Thereafter, the introduction of early generation drug-eluting stents (DES) has significantly improved clinical outcomes, primarily by markedly reducing the risk of restenosis. New generation DES with thinner stent struts, novel durable or biodegradable polymer coatings, and new limus antiproliferative agents, have further improved upon the safety and efficacy profile of early generation DES. The present article aims to review the impact of technological advances on clinical outcomes in the field of PCI with coronary stents, and to provide a brief overview on clinical margins of improvement and unmet needs of available DES.

  16. The nature and pattern of coronary stent recalls.

    Science.gov (United States)

    Kumar, Sanjay; Innasimuthu, Antony L; Marmur, Jonathan D

    2014-09-01

    Each year, over 1 million percutaneous coronary interventions (PCIs) are performed in the United States. Coronary stents have been shown to reduce restenosis or abrupt vessel closure and therefore have improved the success of PCI. Rarely, manufacturers recall stents due to unanticipated problems. We sought to study the extent and pattern of stent recall. To determine the number and rate of stent recall and safety alerts, to identify trends in the rates, and to identify the nature of stent recalls. The Food and Drug Administration (FDA; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm) and Healthcare Recall Management websites (RASMAS; https://alerts.rasmas.noblis.org/rasmas/c/selectViewAlertList.do) were searched. The search terms for recall were, "coronary stent" or "stent." Dates were searched between November 2002 and June 2013. There were 17 coronary stent recalls involving almost 500,000 units; 12 recalls (71%) were before 2006 and 5 recalls (29%) were after. Thirteen recalls (76%) consisted of class II recalls (moderate hazard); the remaining 4 were equally split between class I (severe hazard) and class III (mild hazard; 12% each). The common reasons for recall were concerns with sterility (29%) followed by wrong labeling/packaging (23%) and impaired delivery of stent (18%). In terms of units involved with recalls, 98% (472,189/481,131) were related to wrong labeling/ packaging or misbranding, while 0.1% (542/481,131) were related to potential for broken struts or crack in inflation port hub or sterility. However, approximately 2% of units were related to the potentially lethal problem of impaired balloon inflation. Recalls involved multiple manufacturers with various stent types. The overall incidence of coronary stent recall is low and has declined over the years. The majority of stent recalls are of moderate hazard. However, due to the possibility of serious injury, clinicians should be aware of recalls.

  17. Coronary stent on coronary CT angiography: Assessment with model-based iterative reconstruction technique

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Eun Chae; Kim, Yeo Koon; Chun, Eun Ju; Choi, Sang IL [Dept. of of Radiology, Seoul National University Bundang Hospital, Seongnam (Korea, Republic of)

    2016-05-15

    To assess the performance of model-based iterative reconstruction (MBIR) technique for evaluation of coronary artery stents on coronary CT angiography (CCTA). Twenty-two patients with coronary stent implantation who underwent CCTA were retrospectively enrolled for comparison of image quality between filtered back projection (FBP), adaptive statistical iterative reconstruction (ASIR) and MBIR. In each data set, image noise was measured as the standard deviation of the measured attenuation units within circular regions of interest in the ascending aorta (AA) and left main coronary artery (LM). To objectively assess the noise and blooming artifacts in coronary stent, we additionally measured the standard deviation of the measured attenuation and intra-luminal stent diameters of total 35 stents with dedicated software. All image noise measured in the AA (all p < 0.001), LM (p < 0.001, p = 0.001) and coronary stent (all p < 0.001) were significantly lower with MBIR in comparison to those with FBP or ASIR. Intraluminal stent diameter was significantly higher with MBIR, as compared with ASIR or FBP (p < 0.001, p = 0.001). MBIR can reduce image noise and blooming artifact from the stent, leading to better in-stent assessment in patients with coronary artery stent.

  18. Biocompatibility of coronary stent materials: effect of electrochemical polishing

    Energy Technology Data Exchange (ETDEWEB)

    Scheerder, I. de [University Hospital Leuven (Belgium). Dept. of Cardiology; Sohier, J.; Froyen, L.; Humbeeck, J. van [Louvain Univ. (Belgium). Dept. of Metallurgy and Materials Engineering; Verbeken, E. [University Hospital Leuven (Belgium). Dept. of Pathology

    2001-02-01

    Percutaneous Transluminal Coronary Revascularization (PTCR) is now a widely accepted treatment modality for atherosclerotic coronary artery disease. Current multicenter randomized trials comparing PTCR with the more invasive Coronary Artery Bypass Grafting could not show long-term significant survival differences. During the last two decades progress has been made to further optimize PTCR. The most logic approach to treat atherosclerotic coronary narrowings is to remove the atherosclerotic material using especially developed devices. Several trials, however, could not show a significant beneficial outcome after use of these devices compared to plain old balloon angioplasty. Another approach was to implant a coronary prothesis (stent), scaffolding the diseased coronary artery after PTCA. This approach resulted in a decreased restenosis rate at follow-up. The beneficial effects of stenting, however, was not found to be related to the inhibition of the neointimal cellular proliferation after vascular injury, but simply to be the mechanical result of overstretching of the treated vessel segment. The most important remaining clinical problem after stenting remains the neointimal hyperplasia within the stent, resulting in a significant stent narrowing in 13 to 30% of patients. Further efforts to improve the clinical results of coronary stenting should focus on the reduction of this neointimal hyperplasia. Neointimal hyperplasia after stent implantation results from (1) a healting response to the injury caused by the stent implantation and (2) a foreign body response to the stent itself. Factors that seem to influence the neointimal hyperplastic response are genetic, local disease related, stent delivery related and stent related factors. Biocompatibilisation of coronary stents by looking for more biocompatible metal alloys, optimized surface characteristics and optimized stent designs should result in a better late patency. Furthermore drug eluting and radioactive stents

  19. Insights from 2D and 3D Quantitative Angiographic Assessment of Bioresorbable Everolimus-Eluting Vascular Scaffolds.

    Science.gov (United States)

    Witberg, Guy; Lavi, Ifat; Vaknin Assa, Hana; Orvin, Katia; Assali, Abid; Kornowski, Ran

    2016-07-01

    Bioresorbable vascular scaffold (BVS) is a promising technology that potentially offers several advantages over contemporary coronary drug-eluting stents (DES). Crucial to BVS implantation is the correct choice of scaffold size (diameter and length) in order to avoid "geographic miss" in length, provide the maximal support to the vessel wall, and avoid leaving "free-floating" foreign material in the coronary vasculature. To assess the optimal method for measuring coronary stenosis prior to BVS implantation. We compared the performance of two quantitative coronary angiography assessment (QCA) techniques: two dimensional real-time QCA (2D-QCA) and offline 3D QCA (3D-QCA) for the evaluation of coronary lesions in patients enrolled in a multicenter randomized controlled trial of BVS vs. metallic stents, by calculating the weighted kappa value for agreement regarding optimal BVS size with the reference method - CoreLab offline 2D-QCA measurements..In addition, we collected 2 year clinical outcomes (death/myocardial infarction/repeat revascularization/scaffold thrombosis) in BVS-implanted patients. In 17 patients with available CoreLab data, the weighted kappa for agreement for 3D-QCA was significantly better than for 2D-QCA (0.90, 95%CI 0.72-1.00 vs. 0.439, 95%CI 0.16-0.77). The rate of clinical events at 2 years was low (9.5%). Initial experience in a small group of carefully selected patients at our institution, suggests that the use of BVS for coronary revascularization is associated with a low rate of adverse events in suitable patients. 3D-QCA may be superior to 2D-QCA analysis in terms of reproducibility, and results in more patients receiving optimal size BVS.

  20. Coronary bifurcation lesions treated with simple or complex stenting

    DEFF Research Database (Denmark)

    Behan, Miles W; Holm, Niels R; de Belder, Adam J

    2016-01-01

    AIMS: Randomized trials of coronary bifurcation stenting have shown better outcomes from a simple (provisional) strategy rather than a complex (planned two-stent) strategy in terms of short-term efficacy and safety. Here, we report the 5-year all-cause mortality based on pooled patient-level data...

  1. Late thrombosis of coronary bare-metal stent: Case report

    Directory of Open Access Journals (Sweden)

    Apostolović Svetlana

    2006-01-01

    Full Text Available Stent thrombosis remains the primary cause of death after percutaneous coronary interventions (PCI. Despite modern concepts of PCI, stent thrombosis occurs in 0.5% -2% of elective procedures and even 6% of patients with the acute coronary syndrome (ACS. Stent thrombosis most often develops within the first 48 hours after the PCI, and rarely after a week of stent implantation. Angiographically documented late (>6 months thrombosis of coronary bare-metal stent (BMS is rare, because the stent endothelialization is considered to be completed after four weeks of the intervention. Our patient is a 41 year old male and he had BMS thrombosis 345 days after the implantation, which was clinically manifested as an acute myocardial infarction in the inferoposterolateral localization. Stent Clinical Centre of Serbia, Belgrade thrombosis occurred despite a long term dual antiplatelet therapy and control of known risk factors. Thrombolytic therapy (Streptokinase in a dose of 1 500 000 IU was not successful in reopening the occluded vessel, so the flow through the coronary artery was achieved by rescue balloon angioplasty, followed by implantation of drug eluting stent in order to prevent restenosis.

  2. [Coronary stent evaluation with cardiac CT: Literature review].

    Science.gov (United States)

    Pesenti-Rossi, D; Allouch, P; Gibault-Genty, G; Baron, N; Augusto, S; Convers-Domart, R; Almeida, S; Aubert, S; Squara, P; Livarek, B

    2015-11-01

    Since the introduction of the 64-generation scanners, the accuracy and robustness of the diagnosis of coronary artery disease has progressed. The main advantage of cardiac CT is the exclusion of coronary artery disease by its excellent negative predictive value. Currently, cardiac CT applications extend thanks to innovations both in terms of technological development systems scanner or stents implanted. This is a literature review of stent evaluation with cardiac CT. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  3. Repair of an Atherosclerotic Coronary Artery Aneurysm by Implantation of a Coronary Covered Stent

    Directory of Open Access Journals (Sweden)

    Antenor Portela

    2002-05-01

    Full Text Available An atherosclerotic aneurysm of the right coronary artery complicated by a recent myocardial infarction was successfully treated with coronary artery stenting, using a device consisting of 2 stents with a layer of expandable polytetrafluorethylene (PTFE placed between them. A follow-up angiograph 5 months after the procedure showed sustained initial results.

  4. Repair of an Atherosclerotic Coronary Artery Aneurysm by Implantation of a Coronary Covered Stent

    OpenAIRE

    Portela, Antenor; Bastos, Raldir; Costa, Itamar; Paiva, Jayro

    2002-01-01

    An atherosclerotic aneurysm of the right coronary artery complicated by a recent myocardial infarction was successfully treated with coronary artery stenting, using a device consisting of 2 stents with a layer of expandable polytetrafluorethylene (PTFE) placed between them. A follow-up angiograph 5 months after the procedure showed sustained initial results.

  5. Pulsatile flow in coronary bifurcations for different stenting techniques

    OpenAIRE

    García García, Javier; Manuel Martín, Fernando Jaime; Doce Carrasco, Y.; Castro Ruiz, F.; Crespo Martínez, Antonio; Goicolea Marin, P.; Fernandez Diaz, J.A.

    2012-01-01

    The objective of this work is to analyze the local hem odynamic changes caused in a coronary bifurcation by three different stenting techniques: simple stenting of the main vessel, simple stenting of the main vessel with kissing balloon in the side branch and culotte. To carry out this study an idealized geometry of a coronary bifurcation is used, and two bifurcation angles, 45º and 90º, are chosen as representative of the wide variety of re al configurations. In order to quantify th...

  6. Very late stent thrombosis of bare-metal coronary stent nine years after primary percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Đurić Predrag

    2016-01-01

    Full Text Available Introduction. Stent thrombosis (ST in clinical practice can be classified according to time of onset as early (0–30 days after stent implantation, which is further divided into acute ( 30 days and very late (> 12 months. Myocardial reinfaction due to very late ST in a patient receiving antithrombotic therapy is very rare, and potentially fatal. The procedure alone and related mechanical factors seem to be associated with acute/subacute ST. On the other hand, in-stent neoathero-sclerosis, inflammation, premature cessation of antiplatelet therapy, as well as stent fracture, stent malapposition, un-covered stent struts may play role in late/very late ST. Some findings implicate that the etiology of very late ST of bare-metal stent (BMS is quite different from those following drug-eluting stent (DES implantation. Case report. We presented a 56-year old male with acute inferoposterior ST segment elevation myocardial infarction (STEMI related to very late stent thrombosis, 9 years after BMS implantation, despite antithrombotic therapy. Thrombus aspiration was successfully performed followed by percutaneous coronary intervention (PCI with implantation of DES into the pre-viously implanted two stents to solve the in-stent restenosis. Conclusion. Very late stent thrombosis, although fortu-nately very rare, not completely understood, might cause myocardial reinfaction, but could be successfully treated with thrombus aspiration followed by primary PCI. Very late ST in the presented patient might be connected with neointimal plaque rupture, followed by thrombotic events.

  7. FORMATION OF SIX SIGMA INFRASTRUCTURE FOR THE CORONARY STENTING PROCESS

    Directory of Open Access Journals (Sweden)

    Mehmet Tolga Taner

    2013-10-01

    Full Text Available The purpose of this study is to show how a tertiary care center in Turkey operating mainly in cardiology initiated Six Sigma principles to reduce the number of complications occuring during coronary stent insertion process. A Six Sigma’s Define-Measure-Analyze-Improve-Control (DMAIC model for coronary stent insertion is suggested. Data were collected for 24-months. Twenty-two Critical-to-Quality (CTQ factors were identified for successful coronary stent insertion. The most frequent causes of complications in the process were found to be patients with previous bypass surgery or PCI, inexperience of staff members, highly damaged vessel structure, thin and/or long vessel diameter, inappropriate selection of stent type, inappropriate selection of balloon type and poor image quality.

  8. Spontaneous coronary artery dissection: complete angiographic resolution without stenting

    Directory of Open Access Journals (Sweden)

    Alexandre Abizaid

    2007-09-01

    Full Text Available A case of spontaneous coronary artery dissection in a 49-year-oldwoman is presented. She did not present the classical cardiovascular riskfactors. Etiology and treatment are discussed. She underwent primarypercutaneous coronary intervention of the left anterior descendingartery with no stenting and had complete angiographic resolution.

  9. Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and XIENCE V drug-eluting stents

    NARCIS (Netherlands)

    Sen, Hanim; Tandjung, Kenneth; Basalus, Mounir W.Z.; Löwik, Marije M.; van Houwelingen, Gert K.; Stoel, Martin G.; Louwerenburg, Hans W.; de Man, Frits H.A.F.; Linssen, Gerard C.M.; Nijhuis, Rogier; Nienhuis, Mark B.; Verhorst, Patrick M.J.; van der Palen, Job; von Birgelen, Clemens

    2012-01-01

    Aims: The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial

  10. Longitudinal deformation of a third generation zotarolimus eluting stent: "The concertina returns!"

    Science.gov (United States)

    Panoulas, Vasileios F; Demir, Ozan M; Ruparelia, Neil; Malik, Iqbal

    2017-01-26

    In the current case series we describe two cases of longitudinal stent deformation in ostial lesions treated with a new generation zotarolimus eluting stent and review current literature on longitudinal stent deformation. Historically not a common occurrence, longitudinal deformation occurred mainly in Promus Element everolimus eluting stents, which had only two rather than the commonly used 3 links between stent rings. Longitudinal deformation commonly occurs secondary to compression of the proximal edge of the stent by either the guide catheters, or intravascular balloons and imaging catheters. The degree of deformation however, depends on the longitudinal strength and design of the stent.

  11. Compliance of a cobalt chromium coronary stent alloy – the COVIS trial

    OpenAIRE

    Hagemeister, Jens; Baer, Frank M; Schwinger, Robert HG; Höpp, Hans W

    2005-01-01

    Abstract Background Cobalt chromium coronary stents are increasingly being used in percutaneous coronary interventions. There are, however, no reliable data about the characteristics of unfolding and visibility of this stent alloy in vivo. The aim of this study is to compare cobalt chromium coronary stents with conventional stainless steel stents using intracoronary ultrasound. Methods Twenty de novo native coronary stenoses ≤ 20 mm in length (target vessel reference diameter ≥ 2.5 and ≤ 4.0 ...

  12. Coronary artery stent mimicking intracardiac thrombus on cardiac magnetic resonance imaging due to signal loss

    DEFF Research Database (Denmark)

    Qayyum, Abbas Ali; Vejlstrup, Niels Grove; Ahtarovski, Kiril Aleksov

    2012-01-01

    Since the introduction of percutaneous coronary intervention for coronary artery disease, thousands of patients have been treated with the implantation of coronary stents. Moreover, several of the patients with coronary stent undergo cardiac magnetic resonance (CMR) imaging every year. This case ...... the signal loss on MRI associated with implanted metallic devices is known, we report a case where an implanted coronary stent in the left circumflex artery led to an intracardiac signal loss mimicking intracardiac thrombus/tumor....

  13. Randomized comparison of coronary bifurcation stenting with the crush versus the culotte technique using sirolimus eluting stents: the Nordic stent technique study

    DEFF Research Database (Denmark)

    Erglis, Andrejs; Kumsars, Indulis; Niemelä, Matti

    2009-01-01

    BACKGROUND: In a number of coronary bifurcation lesions, both the main vessel and the side branch need stent coverage. Using sirolimus eluting stents, we compared 2 dedicated bifurcation stent techniques, the crush and the culotte techniques in a randomized trial with separate clinical and angiog......BACKGROUND: In a number of coronary bifurcation lesions, both the main vessel and the side branch need stent coverage. Using sirolimus eluting stents, we compared 2 dedicated bifurcation stent techniques, the crush and the culotte techniques in a randomized trial with separate clinical...

  14. Complex bifurcation lesions: Randomized comparison of a fully bioresorbable modified t stenting strategy versus bifurcation reconstruction with a dedicated self-expanding stent in combination with bioresorbable scaffolds, an OCT study: Rationale and design of the COBRA II trial.

    Science.gov (United States)

    Bennett, J; Adriaenssens, T; Desmet, W; Dubois, C

    2016-11-15

    There is an ongoing controversy regarding the efficacy and safety of different percutaneous stenting techniques for coronary bifurcation lesions needing >1 stent. The promise of safe vessel restoration with bioresorbable scaffolds (BRS) may not be transferable to complex double BRS bifurcation techniques, and permanent metallic scaffolding of the bifurcation core may be needed. We identified modified-T stenting as the most promising fully bioresorbable 2-stent strategy in a preclinical setting. The objective of this study is to assess acute performance and compare long-term vessel healing with this strategy, versus an approach combining BRS with a dedicated metallic drug-eluting bifurcation stent. In a single center, 60 consecutive patients with true and complex coronary bifurcation lesions will be randomly assigned to treatment with the dedicated self-expanding Axxess™ biolimus-eluting bifurcation stent in the proximal main vessel and additional Absorb™ everolimus-eluting BRS in the branches versus a modified T technique using Absorb™ only. Angiography and optical coherence tomography (OCT) will be performed immediately after implantation and at 30 months, and clinical follow-up is foreseen up to 5 years after implantation. The primary endpoint is the change in minimal luminal area assessed with OCT from baseline to 30 months in pre-specified bifurcation segments. To date the use of Absorb™ BRS in complex coronary bifurcations has not been evaluated in a randomized clinical trial setting. The COBRA II study will examine the role and safety of a double BRS strategy in coronary bifurcations, alone or in combination with a metallic dedicated bifurcation device. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  15. Surface Topographical Modification of Coronary Stent: A Review

    Science.gov (United States)

    Tan, C. H.; Muhamad, N.; Abdullah, M. M. A. B.

    2017-06-01

    Driven by the urge of mediating the inflammatory response from coronary stent implant to improve patency rates of the current coronary stent, concern has been focusing on reducing the risk of in-stent restenosis and thrombosis for long-term safety. Surface modification approach has been found to carry great potential due to the surface is the vital parts that act as a buffer layer between the biomaterial and the organic material like blood and vessel tissues. Nevertheless, manipulating cell response in situ using physical patterning is very complex as the exact mechanism were yet elucidated. Thus, the aim of this review is to summarise the recent efforts on modifying the surface topography of coronary stent at the micro- and nanometer scale with the purpose of inducing rapid in situ endothelialization to regenerate a healthy endothelium layer on biomaterial surface. In particular, a discussion on the surface patterns that have been investigated on cell selective behaviour together with the methods used to generate them are presented. Furthermore, the probable future work involving the surface modification of coronary stent were indicated.

  16. 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.

  17. Clinical utility of platinum chromium bare-metal stents in coronary heart disease

    OpenAIRE

    Jorge C; Dubois C.

    2015-01-01

    Claudia Jorge,1 Christophe Dubois1,2 1Department of Cardiovascular Medicine, University Hospitals Leuven, 2Department of Cardiovascular Sciences, Katholieke Universiteit Leuven, Leuven, Belgium Abstract: Coronary stents represent a key development for the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. While drug-eluting stents gained wide acceptance in contemporary percutaneous coronary intervention practice, further development...

  18. In vivo assessment of stent recoil of biodegradable polymer-coated cobalt-chromium sirolimus-eluting coronary stent system.

    Science.gov (United States)

    Abhyankar, Atul D; Thakkar, Ashok S

    2012-01-01

    Immediate and acute stent recoil has been observed following balloon deflation in normal and diseased coronary arteries, and the degree varies by stent design. A total of 19 patients, who underwent elective stent implantation for single de novo native coronary artery lesions, were enrolled: all patients treated with the biodegradable polymer-coated sirolimus-eluting cobalt-chromium coronary stent system (Supralimus-Core(®)). The immediate, acute and cumulative stent recoil was assessed by quantitative coronary angiography. The cumulative stent recoil was measured at 24 h of stent implantation. The absolute late loss due to recoil was found 0.08 ± 0.19 mm for Immediate Stent Recoil (ISR), 0.05 ± 0.21 mm for Acute Stent Recoil (ASR) and 0.11 ± 0.25 mm for Cumulative Stent Recoil (CSR) respectively. In vivo acute stent recoil of the Supralimus-Core(®) has higher radial strength compared to other available standard drug-eluting stents. Copyright © 2012 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  19. Pooled analysis of two randomized trials comparing titanium-nitride-oxide-coated stent versus drug-eluting stent in STEMI.

    Science.gov (United States)

    Tuomainen, Petri O; Sia, Jussi; Nammas, Wail; Niemelä, Matti; Airaksinen, Juhani K E; Biancari, Fausto; Karjalainen, Pasi P

    2014-07-01

    We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P=.49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P=.51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P=.04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P=.30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  20. Clinical and economic studies of eptifibatide in coronary stenting

    OpenAIRE

    Pasala T; Sattayaprasert P; Bhat PK; Athappan G; Gandhi S

    2014-01-01

    Tilak Pasala, Prasongchai Sattayaprasert, Pradeep K Bhat, Ganesh Athappan, Sanjay Gandhi The Heart and Vascular Center, Case Western Reserve University/MetroHealth, Cleveland, OH, USA Abstract: Platelet adhesion and aggregation at the site of coronary stenting can have catastrophic clinical and economic consequences. Therefore, effective platelet inhibition is vital during and after percutaneous coronary intervention. Eptifibatide is an intravenous antiplatelet agent that blocks the final co...

  1. Developed pulsatile flow in a deployed coronary stent.

    Science.gov (United States)

    Banerjee, Rupak K; Devarakonda, Surendra B; Rajamohan, Divakar; Back, Lloyd H

    2007-01-01

    The patho-physiologic process of restenosis and tissue growth may not be completely eliminated and is the primary concern of clinicians performing angioplasty and stent implantation procedures. Recent evidence suggests that the restenosis process is influenced by several factors: (1) geometry and size of vessel; (2) stent design; and (3) it's location that alter hemodynamic parameters, including local wall shear stress (WSS) distributions. The present three-dimensional (3D) analysis of pulsatile flow in a deployed coronary stent: (1) shows complex 3D variation of hemodynamic parameters; and (2) quantifies the changes in local WSS distributions for developed flow and compares with recently published WSS data for developing flow. Higher order of magnitude of WSS of 290 dyn/cm(2) is observed on the surface of cross-link intersections at the entrance of the stent for developed flow, which is about half of that for developing flow. Low WSS of 0.8 dyn/cm(2) and negative WSS of -8 dyn/cm(2) are seen at the immediate upstream and downstream regions of strut intersections. Persistent recirculation is observed at the downstream region of each strut cross-link and the regions of low and negative WSS may lead to patho-physiologic conditions near the stented region. The key finding of this study is that the location of stent in the coronary artery determines the developing or developed nature of the flow, which in turn, results in varied level of WSS.

  2. Safety of spinal anaesthesia in patients with recent coronary stents ...

    African Journals Online (AJOL)

    We report on a patient with a known history of chronic obstructive airway disease with respiratory tract infection who presented for emergency pseudoaneurysm repair. He underwent recent coronary stent implantation and was treated with clopidogrel and aspirin. Despite dual antiplatelet therapy, spinal anaesthesia was ...

  3. Coated stents to prevent restenosis in coronary heart disease

    Directory of Open Access Journals (Sweden)

    Hagen, Anja

    2005-11-01

    Full Text Available Background: In-stent-restenosis (ISR is considered to be an essential limiting factor of stenting in coronary heart disease (CHD. The development of coated stents has raised expectations on substantial lowering restenosis after stenting with decreasing the rate of restenosis and a reduction in the rate of clinical events. Objectives: The present analysis addresses the questions on medical effectiveness and cost-effectiveness of the use of various coated stent types in CHD. Methods: The literature was searched in December 2004 in the most relevant medical and economic databases. The medical evaluation was conducted on the basis of published RCT. The data from the studies regarding various angiographic, sonographic and clinical endpoints were checked for methodical quality and summarised in meta-analyses. Within the scope of economic evaluation the primary studies were analysed and modelling was performed, applying clinical effect estimates from the meta-analyses of the medical evaluation and current estimates of German costs. Results: Medical evaluation: Ten different stenttypes were used in the included 26 RCT. The results for heparin, silicon-carbide, carbon and PTFE coated stenttypes could not reveal any significant differences between the medical effectiveness of coated and uncoated stents. The application of sirolimus, paclitaxel, everolimus and 7-hexanoyltaxol eluting stents showed a significant lower restenosis at 6-9 months with decrease in the rate of restenosis for polymer-based sirolimus, paclitaxel and 7-hexanoyltaxol eluting stents. In contrast, the use of gold-coated and actinomycin-D eluting stents was associated with a significantly higher restenosis. The polymer-based sirolimus and paclitaxel eluting stents also showed a significant and considerable reduction in the rate of repeated percutaneous revascularisations at 6-12 months (3.5% vs. 19.7%; p<0.0001, RR=0.19 [95%CI: 0.11; 0.33] and 3.5% vs. 12.2%; p<0.0001, RR=0.30 [95%CI: 0

  4. Clinical utility of platinum chromium bare-metal stents in coronary heart disease

    Directory of Open Access Journals (Sweden)

    Jorge C

    2015-08-01

    Full Text Available Claudia Jorge,1 Christophe Dubois1,2 1Department of Cardiovascular Medicine, University Hospitals Leuven, 2Department of Cardiovascular Sciences, Katholieke Universiteit Leuven, Leuven, Belgium Abstract: Coronary stents represent a key development for the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. While drug-eluting stents gained wide acceptance in contemporary percutaneous coronary intervention practice, further developments in bare-metal stents remain crucial for patients who are not candidates for drug-eluting stents, or to improve metallic platforms for drug elution. Initially, stent platforms used biologically inert stainless steel, restricting stent performance due to limitations in flexibility and strut thickness. Later, cobalt chromium stent alloys outperformed steel as the material of choice for stents, allowing latest generation stents to be designed with significantly thinner struts, while maintaining corrosion resistance and radial strength. Most recently, the introduction of the platinum chromium alloy refined stent architecture with thin struts, high radial strength, conformability, and improved radiopacity. This review will provide an overview of the novel platinum chromium bare-metal stent platforms available for coronary intervention. Mechanical properties, clinical utility, and device limitations will be summarized and put into perspective. Keywords: bare metal stent, coronary stent alloys, coronary artery disease

  5. Saphenous vein covered stenting for right coronary artery lesion containing thrombus.

    Science.gov (United States)

    Joseph, D; Bashi, V V; Guhathakurtha, S; Harilal, H; Jacob, A; George, T; Suguna, S

    1997-12-01

    Vein covered stenting to close coronary pseudoaneurysm and perforation and in the setting of acute myocardial infarction have been described. This case report describes saphenous vein covered stenting to exclude a large thrombus in a right coronary artery lesion. Vein covered stenting may be considered as an option when dealing with a thrombus containing lesion.

  6. Biomimicry, vascular restenosis and coronary stents.

    Science.gov (United States)

    Schwartz, R S; van der Giessen, W J; Holmes, D R

    1998-01-01

    Biomimicry is in its earliest stages and is being considered in the realm of tissue engineering. If arterial implants are to limit neointimal thickening, purely passive structures cannot succeed. Bioactivity must be present, either by pharmacologic intervention or by fabricating a 'living stent' that contains active cellular material. As tissue engineering evolves, useful solutions will emerge from applying this knowledge directly to vascular biologic problems resulting from angioplasty, stenting, and vascular prosthesis research.

  7. Stents versus coronary-artery bypass grafting for left main coronary artery disease.

    Science.gov (United States)

    Seung, Ki Bae; Park, Duk-Woo; Kim, Young-Hak; Lee, Seung-Whan; Lee, Cheol Whan; Hong, Myeong-Ki; Park, Seong-Wook; Yun, Sung-Cheol; Gwon, Hyeon-Cheol; Jeong, Myung-Ho; Jang, Yangsoo; Kim, Hyo-Soo; Kim, Pum Joon; Seong, In-Whan; Park, Hun Sik; Ahn, Taehoon; Chae, In-Ho; Tahk, Seung-Jea; Chung, Wook-Sung; Park, Seung-Jung

    2008-04-24

    Several studies have compared the treatment effects of coronary stenting and coronary-artery bypass grafting (CABG). However, there are limited data regarding the long-term outcomes of these two interventions for patients with unprotected left main coronary artery disease. We evaluated 1102 patients with unprotected left main coronary artery disease who underwent stent implantation and 1138 patients who underwent CABG in Korea between January 2000 and June 2006. We compared adverse outcomes (death; a composite outcome of death, Q-wave myocardial infarction, or stroke; and target-vessel revascularization) with the use of propensity-score matching in the overall cohort and in separate subgroups according to type of stent. In the overall matched cohort, there was no significant difference between the stenting and CABG groups in the risk of death (hazard ratio for the stenting group, 1.18; 95% confidence interval [CI], 0.77 to 1.80) or the risk of the composite outcome (hazard ratio for the stenting group, 1.10; 95% CI, 0.75 to 1.62). The rates of target-vessel revascularization were significantly higher in the group that received stents than in the group that underwent CABG (hazard ratio, 4.76; 95% CI, 2.80 to 8.11). Comparisons of the group that received bare-metal stents with the group that underwent CABG and of the group that received drug-eluting stents with the group that underwent CABG produced similar results, although there was a trend toward higher rates of death and the composite end point in the group that received drug-eluting stents. In a cohort of patients with unprotected left main coronary artery disease, we found no significant difference in rates of death or of the composite end point of death, Q-wave myocardial infarction, or stroke between patients receiving stents and those undergoing CABG. However, stenting, even with drug-eluting stents, was associated with higher rates of target-vessel revascularization than was CABG. Copyright 2008

  8. In vitro evaluation of 56 coronary artery stents by 256-slice multi-detector coronary CT

    Energy Technology Data Exchange (ETDEWEB)

    Steen, Henning, E-mail: henning.steen@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Andre, Florian, E-mail: Florian.Andre@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Korosoglou, Grigorios, E-mail: Grigorios.Korosoglou@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Mueller, Dirk, E-mail: Dirk.Mueller@philips.com [Philips GmbH Healthcare Division, Luebeckertordamm 5, Hamburg 20099 (Germany); Hosch, Waldemar, E-mail: Waldemar.Hosch@med.uni-heidelberg.de [University of Heidelberg, Department of Diagnostic and Interventional Radiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Kauczor, Hans-Ulrich, E-mail: Hans-Ulrich.Kauczor@med.uni-heidelberg.de [University of Heidelberg, Department of Diagnostic and Interventional Radiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Giannitsis, Evangelos, E-mail: Evangelos.Giannitsis@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany); Katus, Hugo A., E-mail: Hugo.Katus@med.uni-heidelberg.de [University of Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, Heidelberg 69120 (Germany)

    2011-10-15

    Objective: We sought to investigate stent lumen visibility of 56 coronary stents with the newest 256-multi-slice-CT (256-MDCT) technology for different reconstruction algorithms in an in vitro model. Background: Early identification of in-stent restenosis (ISR) is important to avoid recurrent ischemia and prevent acute myocardial infarction (AMI). Since angiography has the disadvantage of high costs and its invasiveness, MDCT could be a convenient and safe non-invasive alternative for detection of ISR. Material and methods: Percentages of in-stent lumen diameter and in-stent signal attenuation (measured as contrast-to-noise ratio (CNR)) of 56 coronary stents (group A {<=}2.5 mm; group B = 2.75-3.0 mm; group C = 3.5-4.0 mm) were evaluated in a coronary vessel in vitro phantom (iodine-filled plastic tubes) employing four different reconstruction algorithms (XCD, CC, CD, XCB) on a novel 256-MDCT (Philips-iCT, collimation = 128 mm x 0.625 mm; rotation time = 270 ms; tube current = 800 mA s with 120 kV). Analysis was conducted with the semi-automatical full-width-at-half-maximum (FWHM) method. P-values <0.05 were regarded statistically significant. Results: In-stent lumen diameter >60% for group C stents was significantly larger and CNR was significantly lower (both p < 0.05) for sharp kernels (CD; XCD) when compared to groups A/B. The FWHM-method showed significantly smaller in-stent lumen diameter (p < 0.05) when compared to the manual method. Conclusion: 256-MDCT could potentially be employed for clinical assessment of stent patency in stents >3.0 mm when analysed with cardio-dedicated sharp kernels, although clinical studies corroborating this claim should be performed. However, stents {<=}3.0 mm reconstructed by soft kernels revealed insufficient in-stent lumen visualisation and should not be used in clinical practice. Further improvements in spatial and temporal image resolution as well as reductions of radiation exposure and image noise have to be accomplished

  9. Influence of metal alloy and the profile of coronary stents in patients with multivessel coronary disease

    Science.gov (United States)

    Maurício de Abreu Filho, Luciano; da Cruz Forte, Antonio Artur; Kiyoshi Sumita, Marcos; Favarato, Desidério; César Ximenes Meireles, George

    2011-01-01

    BACKGROUND: In Brazil, despite the recommendations of the Brazilian Society of Hemodynamics and Interventional Cardiology, the National Health System has not yet approved the use of drug-eluting stents. In percutaneous coronary interventions performed in the public and part of the private health care system, bare metal stents are used as the only option. Therefore, new information on bare metal stents is of great importance. The primary endpoint was to evaluate the influence of the alloy and the profile of coronary stents on late loss and restenosis rates 6 months after implantation in patients with multivessel coronary disease. METHODS: Single center, randomized and prospective study comparison of cobalt–chromium versus stainless steel stent implantation in 187 patients with multivessel coronary disease. At least one cobalt–chromium and one stainless steel stent were implanted per patient. RESULTS: Mean age of patients was 59.5±10.1 years with a prevalence of males (66.3%) and patients with acute coronary syndrome (56%). Baseline clinical characteristics were similar with hypertension in 146 (78%), dyslipidemia in 85 (45.5%) and diabetes in 68 (36.4%). Two hundred and twenty-nine cobalt–chromium and 284 stainless steel stents were implanted. Angiographic variables showed no statistically significant difference. Angiographic follow-up to 6 months after implantation showed similar late loss and restenosis rates. CONCLUSION: The use of two different alloys, stainless steel and cobalt–chrome stents, in the same patient and in the same vessel produced similar 6-month restenosis and late loss rates. PMID:21808863

  10. Influence of metal alloy and the profile of coronary stents in patients with multivessel coronary disease

    Directory of Open Access Journals (Sweden)

    Luciano Maurício de Abreu Filho

    2011-01-01

    Full Text Available BACKGROUND: In Brazil, despite the recommendations of the Brazilian Society of Hemodynamics and Interventional Cardiology, the National Health System has not yet approved the use of drug-eluting stents. In percutaneous coronary interventions performed in the public and part of the private health care system, bare metal stents are used as the only option. Therefore, new information on bare metal stents is of great importance. The primary endpoint was to evaluate the influence of the alloy and the profile of coronary stents on late loss and restenosis rates 6 months after implantation in patients with multivessel coronary disease. METHODS: Single center, randomized and prospective study comparison of cobalt-chromium versus stainless steel stent implantation in 187 patients with multivessel coronary disease. At least one cobalt-chromium and one stainless steel stent were implanted per patient. RESULTS: Mean age of patients was 59.5 + 10.1 years with a prevalence of males (66.3% and patients with acute coronary syndrome (56%. Baseline clinical characteristics were similar with hypertension in 146 (78%, dyslipidemia in 85 (45.5% and diabetes in 68 (36.4%. Two hundred and twenty-nine cobalt-chromium and 284 stainless steel stents were implanted. Angiographic variables showed no statistically significant difference. Angiographic follow-up to 6 months after implantation showed similar late loss and restenosis rates. CONCLUSION: The use of two different alloys, stainless steel and cobalt-chrome stents, in the same patient and in the same vessel produced similar 6-month restenosis and late loss rates.

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

    DEFF Research Database (Denmark)

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

    2012-01-01

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

  12. Sensor to detect endothelialization on an active coronary stent

    Directory of Open Access Journals (Sweden)

    Coffey Arthur C

    2010-11-01

    Full Text Available Abstract Background A serious complication with drug-eluting coronary stents is late thrombosis, caused by exposed stent struts not covered by endothelial cells in the healing process. Real-time detection of this healing process could guide physicians for more individualized anti-platelet therapy. Here we present work towards developing a sensor to detect this healing process. Sensors on several stent struts could give information about the heterogeneity of healing across the stent. Methods A piezoelectric microcantilever was insulated with parylene and demonstrated as an endothelialization detector for incorporation within an active coronary stent. After initial characterization, endothelial cells were plated onto the cantilever surface. After they attached to the surface, they caused an increase in mass, and thus a decrease in the resonant frequencies of the cantilever. This shift was then detected electrically with an LCR meter. The self-sensing, self-actuating cantilever does not require an external, optical detection system, thus allowing for implanted applications. Results A cell density of 1300 cells/mm2 on the cantilever surface is detected. Conclusions We have developed a self-actuating, self-sensing device for detecting the presence of endothelial cells on a surface. The device is biocompatible and functions reliably in ionic liquids, making it appropriate for implantable applications. This sensor can be placed along the struts of a coronary stent to detect when the struts have been covered with a layer of endothelial cells and are no longer available surfaces for clot formation. Anti-platelet therapy can be adjusted in real-time with respect to a patient's level of healing and hemorrhaging risks.

  13. Fourth update on CT angiography of coronary stents: in vitro evaluation of 24 novel stent types.

    Science.gov (United States)

    Hickethier, Tilman; Wenning, Justus; Doerner, Jonas; Maintz, David; Michels, Guido; Bunck, Alexander C

    2017-01-01

    Background Non-invasive evaluation of coronary stent patency by coronary computed tomography angiography (cCTA) remains challenging. Multiple studies showed that CT technology but also individual stent design strongly influence the assessability of coronary stents by cCTA. Purpose To expand the available data on cCTA characteristics of coronary stents by 24 novel types to help interpreting examinations of patients after stent placement and selecting which stents are suitable for assessment by cCTA. Material and Methods Twenty-four novel coronary stents (17 cobalt-chromium, six stainless-steel, one platinum-chromium) were examined in a coronary phantom. Standard cCTA parameters with stent-specific algorithms were used. Image quality was quantified for each stent using established parameters (in-stent attenuation alteration and visible lumen diameter). Results Most stents (n = 14) showed lumen visibilities of 45-55%. No severe restriction of lumen visibility (>60%) was found. The majority of stents (n = 13) caused only small intraluminal attenuation deviations and no severe alterations (>20%) were found. When grouped by manufacturing material, no significant differences were found between cobalt-chromium and stainless-steel with identical mean visible diameters (1.52 ± 0.17 mm vs. 1.52 ± 0.13 mm) and comparable attenuation alterations (35.04 ± 16.56 HU vs. 21.25 ± 14.60 HU). The only platinum-chromium stent showed a smaller visible diameter (1.23 mm) and higher attenuation alteration (41.70 HU), but was also deemed to be assessable by cCTA. Conclusion All 24 novel evaluated stents are eligible for non-invasive evaluation by cCTA without significant differences between cobalt-chromium and stainless-steel stents. This updated catalogue of CT appearances of current coronary stents may serve as reference when taking care of patients with stents in need of coronary imaging.

  14. Update on multidetector coronary CT angiography of coronary stents: in vitro evaluation of 29 different stent types with dual-source CT

    Energy Technology Data Exchange (ETDEWEB)

    Maintz, David; Burg, Matthias C.; Seifarth, Harald; Bunck, Alexander C.; Oezguen, Murat; Juergens, Kai Uwe; Heindel, Walter [University of Muenster, Department of Clinical Radiology, Muenster (Germany); Fischbach, Roman [University of Muenster, Department of Clinical Radiology, Muenster (Germany); Asklepios Klinikum Altona, Department of Radiology and Nuclear Medicine, Hamburg (Germany)

    2009-01-15

    The aim of this study was to test a large sample of the latest coronary artery stents using four image reconstruction approaches with respect to lumen visualization, lumen attenuation, and image noise in dual-source multidetector row CT (DSCT) in vitro and to provide a CT catalogue of currently used coronary artery stents. Twenty-nine different coronary artery stents (19 steel, 6 cobalt-chromium, 2 tantalum, 1 iron, 1 magnesium) were examined in a coronary artery phantom (vessel diameter 3 mm, intravascular attenuation 250 HU, extravascular density -70 HU). Stents were imaged in axial orientation with standard parameters: 32 x 0.6 collimation, pitch 0.24, 400 mAs, 120 kV, rotation time 0.33 s. Image reconstructions were obtained with four different convolution kernels (soft, medium-soft, standard high-resolution, stent-dedicated). To evaluate visualization characteristics of the stent, the lumen diameter, intraluminal density, and noise were measured. The stent-dedicated kernel offered best average lumen visualization (54{+-}8.3%) and most realistic lumen attenuation (222{+-}44 HU) at the expense of increased noise (23.9{+-}1.9 HU) compared with standard CTA protocols (p<0.001 for all). The magnesium stent showed the least artifacts with a lumen visibility of 90%. The majority of stents (79%) exhibited a lumen visibility of 50-59%. Less than half of the stent lumen was visible in only six stents. Stent lumen visibility largely varies depending on the stent type. Magnesium is by far more favorable a stent material with regard to CT imaging when compared with the more common materials steel, cobalt-chromium, or tantalum. The magnesium stent exhibits a lumen visibility of 90%, whereas the majority of the other stents exhibit a lumen visibility of 50-59%. (orig.)

  15. Outcomes after coronary stent implantation in patients with metal allergy.

    Science.gov (United States)

    Romero-Brufau, Santiago; Best, Patricia J M; Holmes, David R; Mathew, Verghese; Davis, Mark D P; Sandhu, Gurpreet S; Lennon, Ryan J; Rihal, Charanjit S; Gulati, Rajiv

    2012-04-01

    Clinical outcomes after stent placement in patients with a history of metal allergy remain incompletely understood. We performed a single-center retrospective study to evaluate such outcomes. Twenty-nine allergic patients who underwent coronary stent implantation were compared with a nonallergic group (n=250) matched for demographics and a propensity score for allergy to metal. Hypersensitivity to nickel was reported in 26 of 29 and chromium in 9 of 29. Patch testing performed in 11 of 29 patients was positive in all. Comparing allergy versus control subjects, there were no differences in number of segments treated (1.4±0.7 versus 1.5±0.7), stents placed (1.7±1.1 versus 1.6±0.9), and frequency of drug-eluting stent usage (52% versus 60%). In-hospital death (0% versus 0%), myocardial infarction (MI, 4% versus 3%, P=0.27), and 30-day death (3% versus 0%, P=0.53) and MI (3% versus 4%, P=0.71) were statistically similar. There were no differences in 4-year death (12% versus 13%), target lesion revascularization (TLR, 13 versus 17%, P=0.54), or death/MI/TLR (24% versus 34%, P=0.20). Clinically driven repeat angiography in 12 of 29 allergy patients revealed binary restenosis rates of 27% in bare metal stents and 0% in drug-eluting stents, with mean diameter in-stent restenosis of 36% and 8%, respectively. There was no change in circulating eosinophil and lymphocyte counts after stenting in the allergy group (0.19-0.20, P=0.67, and 1.90-1.79, P=0.59, respectively). A history of metal allergy was not associated with adverse early or late outcomes in this single-center study.

  16. Stent thrombosis after coronary stent implantation: a protective effect of high-dose statin therapy?

    Science.gov (United States)

    Jeger, Raban V; Brunner-La Rocca, Hans Peter; Bertel, Osmund; Kiowski, Wolfgang; Pfisterer, Matthias E; Kaiser, Christoph A

    2013-01-01

    To assess independent predictors of stent thrombosis (ST) in an all-comer trial. This is an observational case-control study based on a retrospective analysis of the Basel Stent Kosten Effektivitäts Trial (BASKET) (n = 826). Patients with ST were compared to controls with regard to baseline parameters. Multivariate models were performed to identify independent predictors of ST. At 36 months, there were 53 (6.4%) patients with ST, 17 (32%) of whom had early ST and 36 (68%) of whom had late/very late ST. Patients with ST were at a higher cardiovascular risk but received lower doses of statins than the controls (n = 212). Stents in ST patients were longer, had more overlap and were not as well expanded, with significantly more remaining stenoses than the stents in the controls. Multivariable analysis revealed interventions in saphenous vein grafts, malapposed stents, an overlap >3 mm, complex coronary anatomy and treatment with low-dose/no statins as risk factors for ST, while interventions in saphenous vein grafts, underexpanded or malapposed stents, a history of myocardial infarction and treatment with low-dose/no statins were risk factors for late ST. The use of statins might have a protective effect against ST. This observation is new, hypothesis-generating and should be evaluated in an adequately powered randomized trial. Copyright © 2013 S. Karger AG, Basel.

  17. Degradable, drug-eluting stents: a new frontier for the treatment of coronary artery disease.

    Science.gov (United States)

    Kohn, Joachim; Zeltinger, Joan

    2005-11-01

    This article reviews the clinical use of stents in the treatment of coronary artery disease and the rationale for the use of degradable, drug-eluting polymer stents. The authors note the challenges of using off-the-shelf polymers for the development of degradable stents, as well as the interplay between polymer properties and a functional stent design. Drug-eluting metal stents are the most significant advancement in the treatment of coronary artery disease, and have significantly reduced the occurrence of in-stent restenosis after placement. Some regard drug-eluting metal stents as the final technologic advancement in the treatment of coronary artery disease, others consider the future development of degradable, drug-eluting stents as the next logical step.

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

    DEFF Research Database (Denmark)

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

    2012-01-01

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

  19. Nickel-free stainless steel avoids neointima formation following coronary stent implantation

    Science.gov (United States)

    Fujiu, Katsuhito; Manabe, Ichiro; Sasaki, Makoto; Inoue, Motoki; Iwata, Hiroshi; Hasumi, Eriko; Komuro, Issei; Katada, Yasuyuki; Taguchi, Tetsushi; Nagai, Ryozo

    2012-12-01

    SUS316L stainless steel and cobalt-chromium and platinum-chromium alloys are widely used platforms for coronary stents. These alloys also contain nickel (Ni), which reportedly induces allergic reactions in some subjects and is known to have various cellular effects. The effects of Ni on neointima formation after stent implantation remain unknown, however. We developed coronary stents made of Ni-free high-nitrogen austenitic stainless steel prepared using a N2-gas pressurized electroslag remelting (P-ESR) process. Neointima formation and inflammatory responses following stent implantation in porcine coronary arteries were then compared between the Ni-free and SUS316L stainless steel stents. We found significantly less neointima formation and inflammation in arteries implanted with Ni-free stents, as compared to SUS316L stents. Notably, Ni2+ was eluted into the medium from SUS316L but not from Ni-free stainless steel. Mechanistically, Ni2+ increased levels of hypoxia inducible factor protein-1α (HIF-1α) and its target genes in cultured smooth muscle cells. HIF-1α and their target gene levels were also increased in the vascular wall at SUS316L stent sites but not at Ni-free stent sites. The Ni-free stainless steel coronary stent reduces neointima formation, in part by avoiding activation of inflammatory processes via the Ni-HIF pathway. The Ni-free-stainless steel stent is a promising new coronary stent platform.

  20. Nickel-free stainless steel avoids neointima formation following coronary stent implantation

    Science.gov (United States)

    Fujiu, Katsuhito; Manabe, Ichiro; Sasaki, Makoto; Inoue, Motoki; Iwata, Hiroshi; Hasumi, Eriko; Komuro, Issei; Katada, Yasuyuki; Taguchi, Tetsushi; Nagai, Ryozo

    2012-01-01

    SUS316L stainless steel and cobalt–chromium and platinum–chromium alloys are widely used platforms for coronary stents. These alloys also contain nickel (Ni), which reportedly induces allergic reactions in some subjects and is known to have various cellular effects. The effects of Ni on neointima formation after stent implantation remain unknown, however. We developed coronary stents made of Ni-free high-nitrogen austenitic stainless steel prepared using a N2-gas pressurized electroslag remelting (P-ESR) process. Neointima formation and inflammatory responses following stent implantation in porcine coronary arteries were then compared between the Ni-free and SUS316L stainless steel stents. We found significantly less neointima formation and inflammation in arteries implanted with Ni-free stents, as compared to SUS316L stents. Notably, Ni2+ was eluted into the medium from SUS316L but not from Ni-free stainless steel. Mechanistically, Ni2+ increased levels of hypoxia inducible factor protein-1α (HIF-1α) and its target genes in cultured smooth muscle cells. HIF-1α and their target gene levels were also increased in the vascular wall at SUS316L stent sites but not at Ni-free stent sites. The Ni-free stainless steel coronary stent reduces neointima formation, in part by avoiding activation of inflammatory processes via the Ni-HIF pathway. The Ni-free-stainless steel stent is a promising new coronary stent platform. PMID:27877545

  1. Long-term results of young patients with acute coronary syndrome undergoing coronary stent implantation.

    Science.gov (United States)

    Yao, Yuan; Zhang, Yao

    2016-09-01

    Long-term follow-up studies on young patients with acute coronary syndrome (ACS) undergoing coronary stent implantation are relatively scarce. This study was applied to review the long-term results of young ACS patients who had undergone coronary stenting in our hospital. One hundred and two young patients with ACS underwent coronary stent implantation in our hospital. In this study, inpatient records and long-term data of the 102 patients were comprehensively collected for analysis. Major gender of the young patients was men. Most of the patients had smoking, and each patient had at least one risk factor. During hospitalization, no patient died. At last follow-up, all patients were alive and the occurrence rate of major adverse cardio/cerebrovascular accidents was 4.9%. In summary, long-term follow-ups revealed extremely satisfactory outcomes in young ACS patients after coronary stent implantation. Smoking and traditional ACS risk factors are the leading causes of ACS in young population.

  2. Coronary stent occlusion: reverse attenuation gradient sign observed at computed tomography angiography improves diagnostic performance

    Energy Technology Data Exchange (ETDEWEB)

    Li, Minghua; Zhang, Jiayin [Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, Department of Radiology, Shanghai (China); Zhang, Qingyong; Pan, Jingwei; Lu, Zhigang; Wei, Meng [Shanghai Jiao Tong University Affiliated Sixth People' s Hospital, Department of Cardiology, Shanghai (China)

    2014-09-26

    To evaluate the incidence and diagnostic performance of reverse attenuation gradient (RAG) sign in patients with coronary stent occlusion. We retrospectively included patients with suspected restenosis who underwent both coronary computed tomography angiography (CCTA) and invasive coronary angiography (ICA) within 2 weeks. Stent occlusion at CCTA was defined as (1) complete contrast filling defect of large calibre stents (at least 3 mm), or (2) presence of RAG sign in patients with small calibre stents (less than 3 mm) or (3) presence of RAG sign in patients with non-diagnostic image quality of stents. The diagnostic performance of RAG sign was further assessed by comparison to ICA results. A total of 162 patients with 231 implanted stents were included. ICA confirmed stent occlusion in 59 patients (99 stents). RAG sign was present in 59.3 % (35/59) of all stent occlusions. As shown by patient-based analysis, the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of our diagnostic criteria for detection of stent occlusion were 79.7 % (47/59), 100 % (103/103), 100 % (47/47) and 89.6 % (103/115) respectively. Superior diagnostic performance was confirmed by receiver operating characteristic (ROC) analysis with an area under the curve of 0.898. RAG sign observed at CCTA in patients with coronary stenting represents reverse collateral flow distal to stents and is highly specific to indicate stent occlusion. (orig.)

  3. Coronary Stenting With the Genous(TM) Bio-Engineered R Stent(TM) in Elderly Patients

    NARCIS (Netherlands)

    Damman, P.; Iñiguez, A.; Klomp, M.; Beijk, M.; Woudstra, P.; Silber, S.; Ribeiro, E.E.; Suryapranata, H.; Sim, K.H.; Tijssen, J.G.P.; de Winter, R.J.

    2011-01-01

    Background: We evaluated the Genous(TM) Bio-engineered R stent(TM) in elderly patients undergoing non-urgent percutaneous coronary intervention. The elderly have an increased risk of (temporary) discontinuation of clopidogrel, which is associated with a higher risk of developing stent thrombosis

  4. Compliance of a cobalt chromium coronary stent alloy – the COVIS trial

    Directory of Open Access Journals (Sweden)

    Schwinger Robert HG

    2005-10-01

    Full Text Available Abstract Background Cobalt chromium coronary stents are increasingly being used in percutaneous coronary interventions. There are, however, no reliable data about the characteristics of unfolding and visibility of this stent alloy in vivo. The aim of this study is to compare cobalt chromium coronary stents with conventional stainless steel stents using intracoronary ultrasound. Methods Twenty de novo native coronary stenoses ≤ 20 mm in length (target vessel reference diameter ≥ 2.5 and ≤ 4.0 mm received under sequential intracoronary ultrasound either a cobalt chromium stent (Multi-Link Vision®; n = 10 or a stainless steel stent (Multi-Link Zeta®; n = 10. Results For optimal unfolding, the cobalt chromium stent requires a higher balloon deployment pressure (13.90 ± 2.03 atm than the stainless steel stent (11.50 ± 2.12 atm. Furthermore, the achieved target vessel diameter of the cobalt chromium stent (Visibility-Index QCA/IVUS Multi-Link Vision®1.13 / Multi-Link Zeta® 1.04 is more easily overrated by Quantitative Coronary Analysis. Conclusion These data indicate that stent material-specific recommendations for optimal implantation pressure and different stent material with an equal design should both be considered in interpreting QCA-analysis.

  5. Clinical utility of platinum chromium bare-metal stents in coronary heart disease

    Science.gov (United States)

    Jorge, Claudia; Dubois, Christophe

    2015-01-01

    Coronary stents represent a key development for the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. While drug-eluting stents gained wide acceptance in contemporary percutaneous coronary intervention practice, further developments in bare-metal stents remain crucial for patients who are not candidates for drug-eluting stents, or to improve metallic platforms for drug elution. Initially, stent platforms used biologically inert stainless steel, restricting stent performance due to limitations in flexibility and strut thickness. Later, cobalt chromium stent alloys outperformed steel as the material of choice for stents, allowing latest generation stents to be designed with significantly thinner struts, while maintaining corrosion resistance and radial strength. Most recently, the introduction of the platinum chromium alloy refined stent architecture with thin struts, high radial strength, conformability, and improved radiopacity. This review will provide an overview of the novel platinum chromium bare-metal stent platforms available for coronary intervention. Mechanical properties, clinical utility, and device limitations will be summarized and put into perspective. PMID:26345228

  6. Silicon-carbide coated coronary stents have low platelet and leukocyte adhesion during platelet activation

    NARCIS (Netherlands)

    Monnink, SHJ; van Boven, AJ; Tigchelaar, [No Value; de Kam, PJ; Crijns, HJGM; van Oeveren, W

    Background: Stent thrombosis and restenosis are of great clinical significance. We constructed a closed loop in vitro heparinized whole human blood circulation model for testing hemocompatibility of coronary stents, This model allows evaluation of human blood activation by blood-stent interaction in

  7. Hemodynamics of Stent Implantation Procedures in Coronary Bifurcations: an in vitro study

    CERN Document Server

    Brindise, Melissa C; Burzotta, Francesco; Migliavacca, Francesco; Vlachos, Pavlos P

    2016-01-01

    Stent implantation in coronary bifurcations presents unique challenges and currently there is no universally accepted stent deployment approach. Despite clinical and computational studies, to date, the effect of each stent implantation method on the coronary artery hemodynamics is not well understood. In this study the hemodynamics of stented coronary bifurcations under pulsatile flow conditions were investigated experimentally. Three implantation methods, provisional side branch (PSB), culotte (CUL), and crush (CRU), were investigated using time-resolved particle image velocimetry (PIV) to measure the velocity fields. Subsequently, hemodynamic parameters including wall shear stress (WSS), oscillatory shear index (OSI), and relative residence time (RRT) were calculated and the pressure field through the vessel was non-invasively quantified. The effects of each stented case were evaluated and compared against an un-stented case. CRU provided the lowest compliance mismatch, but demonstrated detrimental stent in...

  8. Coronary artery stents: influence of adaptive statistical iterative reconstruction on image quality using 64-HDCT.

    Science.gov (United States)

    Gebhard, Cathérine; Fiechter, Michael; Fuchs, Tobias A; Stehli, Julia; Müller, Ennio; Stähli, Barbara E; Gebhard, Caroline E; Ghadri, Jelena R; Klaeser, Bernd; Gaemperli, Oliver; Kaufmann, Philipp A

    2013-10-01

    The assessment of coronary stents with present-generation 64-detector row computed tomography (HDCT) scanners is limited by image noise and blooming artefacts. We evaluated the performance of adaptive statistical iterative reconstruction (ASIR) for noise reduction in coronary stent imaging with HDCT. In 50 stents of 28 patients (mean age 64 ± 10 years) undergoing coronary CT angiography (CCTA) on an HDCT scanner the mean in-stent luminal diameter, stent length, image quality, in-stent contrast attenuation, and image noise were assessed. Studies were reconstructed using filtered back projection (FBP) and ASIR-FBP composites. ASIR resulted in reduced image noise vs. FBP (P ASIR with significantly larger luminal area visualization compared with FBP (+42.1 ± 5.4% with 100% ASIR vs. FBP alone; P Reconstruction of CCTA from HDCT using 40 and 60% ASIR incrementally improves intra-stent luminal area, diameter visualization, and image quality compared with FBP reconstruction.

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  10. Development and Validation of a Stent Thrombosis Risk Score in Patients With Acute Coronary Syndromes

    NARCIS (Netherlands)

    Dangas, George D.; Claessen, Bimmer E.; Mehran, Roxana; Xu, Ke; Fahy, Martin; Parise, Helen; Henriques, José P. S.; Ohman, E. Magnus; White, Harvey D.; Stone, Gregg W.

    2012-01-01

    Objectives This study sought to develop a practical risk score to predict the risk of stent thrombosis (ST) after percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS). Background ST is a rare, yet feared complication after PCI with stent implantation. A risk score for ST after

  11. Clinical and economic studies of eptifibatide in coronary stenting

    Directory of Open Access Journals (Sweden)

    Pasala T

    2014-08-01

    Full Text Available Tilak Pasala, Prasongchai Sattayaprasert, Pradeep K Bhat, Ganesh Athappan, Sanjay Gandhi The Heart and Vascular Center, Case Western Reserve University/MetroHealth, Cleveland, OH, USA Abstract: Platelet adhesion and aggregation at the site of coronary stenting can have catastrophic clinical and economic consequences. Therefore, effective platelet inhibition is vital during and after percutaneous coronary intervention. Eptifibatide is an intravenous antiplatelet agent that blocks the final common pathway of platelet aggregation and thrombus formation by binding to glycoprotein IIb/IIIa receptors on the surface of platelets. In clinical studies, eptifibatide was associated with a significant reduction of mortality, myocardial infarction, or target vessel revascularization in patients with acute coronary syndrome undergoing percutaneous coronary intervention. However, recent trials conducted in the era of dual antiplatelet therapy and newer anticoagulants failed to demonstrate similar results. The previously seen favorable benefit of eptifibatide was mainly offset by the increased risk of bleeding. Current American College of Cardiology/American Heart Association guidelines recommend its use as an adjunct in high-risk patients who are undergoing percutaneous coronary intervention with traditional anticoagulants (heparin or enoxaparin, who are not otherwise at high risk of bleeding. In patients receiving bivalirudin (a newer safer anticoagulant, routine use of eptifibatide is discouraged except in select situations (eg, angiographic complications. Although older pharmacoeconomic studies favor eptifibatide, in the current era of P2Y12 inhibitors and newer safer anticoagulants, the increased costs associated with bleeding make the routine use of eptifibatide an economically nonviable option. The cost-effectiveness of eptifibatide with the use of strategies that decrease the bleeding risk (eg, transradial access is unknown. This review provides an

  12. 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.

  13. CT virtual endoscopy and 3D stereoscopic visualisation in the evaluation of coronary stenting

    Science.gov (United States)

    Sun, Z; Lawrence-Brown

    2009-01-01

    The aim of this case report is to present the additional value provided by CT virtual endoscopy and 3D stereoscopic visualisation when compared with 2D visualisations in the assessment of coronary stenting. A 64-year old patient was treated with left coronary stenting 8 years ago and recently followed up with multidetector row CT angiography. An in-stent restenosis of the left coronary artery was suspected based on 2D axial and multiplanar reformatted images. 3D virtual endoscopy was generated to demonstrate the smooth intraluminal surface of coronary artery wall, and there was no evidence of restenosis or intraluminal irregularity. Virtual fly-through of the coronary artery was produced to examine the entire length of the coronary artery with the aim of demonstrating the intraluminal changes following placement of the coronary stent. In addition, stereoscopic views were generated to show the relationship between coronary artery branches and the coronary stent. In comparison with traditional 2D visualisations, virtual endoscopy was useful for assessment of the intraluminal appearance of the coronary artery wall following coronary stent implantation, while stereoscopic visualisation improved observers’ understanding of the complex cardiac structures. Thus, both methods could be used as a complementary tool in cardiac imaging. PMID:21610990

  14. Patient with Recent Coronary Artery Stent Requiring Major Non Cardiac Surgery

    OpenAIRE

    Usha Kiran; Neeti Makhija

    2009-01-01

    Summary Anaesthesiologists are increasingly confronted with patients who had a recent coronary artery stent implantation and are on dual anti-platelet medication. Non cardiac surgery and most invasive procedures increase the risk of stent thrombosis especially when procedure is performed early after stent implantation. Anaesthesiologist faces the dilemma of stopping the antiplatelet therapy before surgery to avoid bleeding versus perioperative stent thrombosis. Individualized approach should ...

  15. Off-pump coronary artery bypass grafting or percutaneous transluminal coronary angioplasty with stenting for proximal left anterior descending coronary artery disease?

    NARCIS (Netherlands)

    Drenth, Derk Jan

    2005-01-01

    This thesis describes and discusses the results of a prospective randomized controlled clinical trial comparing percutaneous coronary angioplasty with stenting (stenting) and off-pump coronary artery bypass grafting with a left internal mammary artery (surgery) in patients with a high-grade stenosis

  16. A novel antithrombotic coronary stent: lysine-poly(HEMA)-modified cobalt-chromium stent with fibrinolytic activity.

    Science.gov (United States)

    Wang, Shasha; Li, Dan; Chen, Hong; Wu, Zhaoqiang; Xu, Yajun; Brash, John L

    2013-01-01

    Prevention of coagulation appears not to be possible when a foreign surface is in contact with blood; the alternative concept of a clot lysing surface has therefore been suggested. In this work, a mimic of the fibrinolytic system was constructed on L605 cobalt-chromium coronary stents. Lysine which, immobilized on a surface, has been shown previously to adsorb plasminogen in contact with blood was attached to the stent using poly(2-hydroxyethyl methacrylate) (poly(HEMA)) as a spacer. The lysine-poly(HEMA) modified stent was shown to have low nonspecific protein adsorption and to bind plasminogen in high quantity from plasma. Following exposure to plasma and treatment with tissue plasminogen activator, the lysine-modified stents showed clot-lysing properties in vitro while the unmodified L605 stents did not. It was shown that the modified stents retained their clot lysing properties after 24 h exposure to plasma.

  17. Mechanical and Histopathological Comparison between Commercialized and Newly Designed Coronary Bare Metal Stents in a Porcine Coronary Restenosis Model

    Science.gov (United States)

    Lim, Kyung Seob; Bae, In Ho; Kim, Jung Ha; Park, Dae Sung; Kim, Jong Min; Kim, Jung Hyun; Sim, Doo Sun; Hong, Young Joon

    2013-01-01

    The aim of this study was to compare the stent designed by Chonnam National University Hospital (designated as CNUH) with commercial cobalt-chromium coronary stent in a porcine coronary overstretch restenosis model. CNUH stent was subjected to mechanical performance tests. Pigs were randomized into two groups in which the coronary arteries (10 pigs, 10 coronaries in each group) had either CNUH stent or control commercial bare metal stent. Histopathologic analysis was assessed at 28 days after stenting. In mechanical performance tests, CNUH stent showed 2.65N, 35.1N, 0.52N, 1.94%, 4.29% in the flat plate radial compression, radial force, 3 point bending, Foreshortening and recoil test, respectively. There was no significant difference in the injury score, internal elastic lamina (IEL), lumen area, neointima area, percent area stenosis, inflammation score and fibrin score between the two groups (1.2±0.35, 4.1±0.41 mm2, 2.7±0.56 mm2, 1.6±0.47 mm2, 36.7±11.2%, 1.2±0.62, 0.2±0.34 in CNUH stent group vs. 1.2±0.38, 3.7±0.64 mm2, 2.5±0.49 mm2, 1.5±0.61 mm2, 36.3±12.17%, 1.1±0.12, 0.4±0.46 in commercial stent group, respectively). In the mechanical performance test, CNUH stent showed the moderated performance under the guideline of FDA. CNUH stent demonstrated similar histological reactions compared with commercial cobalt-chromium stent in a porcine coronary overstretch restenosis model. PMID:23678471

  18. Drug-eluting stents vs bare metal stents for the treatment of large coronary vessels.

    Science.gov (United States)

    Quizhpe, Arturo R; Feres, Fausto; de Ribamar Costa, José; Abizaid, Alexandre; Maldonado, Galo; Costa, Ricardo; Abizaid, Andrea; Cano, Manuel; Moreira, Adriana C; Staico, Rodolfo; Mattos, Luiz Alberto; Tanajura, Luiz Fernando; Chaves, Aurea; Centemero, Marinella; Sousa, Amanda M R; Sousa, J Eduardo M R

    2007-08-01

    Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat revascularization in a wide subset of lesion and patients. However, their benefit for the treatment of large vessels (> 3.0 mm) has yet to be established. We investigated whether DES are superior to bare metal stents (BMS) in terms of clinical outcomes for the treatment of large coronary vessels. This study assessed the long-term outcomes (cardiac death, acute myocardial infarction, and need for repeat intervention in the treated vessel) of patients treated with either a DES (Cypher and Taxus) or a BMS of > or = 3.5 mm in diameter. A total of 250 consecutive patients who underwent DES implantation were clinically followed for 1 year and compared to 250 patients who were treated with BMS. Interventions in the setting of acute ST elevation myocardial infarction and treatment of bypass grafts were excluded. Cypher was the DES deployed in 70.8% of cases. Most of the enrolled patients were men (78%) with single vessel disease (65.6%). The left anterior descending artery was the culprit vessel in 34.2% of cases. Bare metal stent and DES cohorts had equivalent interpolated reference vessel diameter (3.19 +/- 0.3 mm for BMS vs 3.18 +/- 0.2 for DES; P = .1). Lesion was significantly longer in the group treated with DES (13.4 +/- 5.1 mm for BMS group vs 14.3 +/- 3.5 for DES; P = .0018). After 1 year of clinical follow-up, 95.2% of patients treated with DES and 91.2% of the patients who received BMS were free of major events (P = .2). A trend toward higher target-lesion revascularization was noticed in the group treated with BMS (4.8% vs 1.6%; P = .07). Percutaneous treatment of large coronary vessels carries a low risk of clinical events irrespective of the type of stent used.

  19. Flow disturbances in stent-related coronary evaginations

    DEFF Research Database (Denmark)

    Radu, Maria D; Pfenniger, Aloïs; Räber, Lorenz

    2014-01-01

    non-diseased coronary arteries. The change in flow with varying evagination sizes was assessed using a particle tracing test where the particle transit time within the segment with evagination was compared with that of a control vessel. The presence of the evagination caused a delayed particle transit......-dynamic (CFD) simulations, whether OCT-detected coronary evaginations can induce local changes in blood flow. Methods and results: OCT-detected evaginations are defined as outward bulges in the luminal vessel contour between struts, with the depth of the bulge exceeding the actual strut thickness. Evaginations...... can be characterised cross ectionally by depth and along the stented segment by total length. Assuming an ellipsoid shape, we modelled 3-D evaginations with different sizes by varying the depth from 0.2-1.0 mm, and the length from 1-9 mm. For the flow simulation we used average flow velocity data from...

  20. Good visibility of TITAN-2 coronary stents demonstrable on cardiac computer tomographic angiography: a report of 2 cases.

    Science.gov (United States)

    Ong, Paul Jau; Jau, Ong Paul; Ho, Hee Hwa; Hwa, Ho Hee; Jafary, Fahim Haider; Haider, Jafary Fahim; Loh, Kwok Kong; Kong, Loh Kwok; Ooi, Yau Wei; Wei, Ooi Yau; Wong, Chun Pong; Pong, Wong Chun; Foo, David; David, Foo

    2011-09-01

    Numerous studies have sought to assess stent patency by cardiac computer tomographic angiography (CCTA) in comparison with invasive coronary angiography in patients who had undergone percutaneous coronary stenting. Even with newer generation scanners, CCTA has been of limited value in the assessment of the revascularized patient. The main reason being blooming artifact from metallic stents often obscures stent luminal dimension, making the stented segment unassessable. We report on a novel finding of good visibility of TITAN-2 coronary stents demonstrable on CCTA for 2 patients and discuss the possible mechanism and potential implications of this observation.

  1. Clinical and economic studies of eptifibatide in coronary stenting.

    Science.gov (United States)

    Pasala, Tilak; Sattayaprasert, Prasongchai; Bhat, Pradeep K; Athappan, Ganesh; Gandhi, Sanjay

    2014-01-01

    Platelet adhesion and aggregation at the site of coronary stenting can have catastrophic clinical and economic consequences. Therefore, effective platelet inhibition is vital during and after percutaneous coronary intervention. Eptifibatide is an intravenous antiplatelet agent that blocks the final common pathway of platelet aggregation and thrombus formation by binding to glycoprotein IIb/IIIa receptors on the surface of platelets. In clinical studies, eptifibatide was associated with a significant reduction of mortality, myocardial infarction, or target vessel revascularization in patients with acute coronary syndrome undergoing percutaneous coronary intervention. However, recent trials conducted in the era of dual antiplatelet therapy and newer anticoagulants failed to demonstrate similar results. The previously seen favorable benefit of eptifibatide was mainly offset by the increased risk of bleeding. Current American College of Cardiology/American Heart Association guidelines recommend its use as an adjunct in high-risk patients who are undergoing percutaneous coronary intervention with traditional anticoagulants (heparin or enoxaparin), who are not otherwise at high risk of bleeding. In patients receiving bivalirudin (a newer safer anticoagulant), routine use of eptifibatide is discouraged except in select situations (eg, angiographic complications). Although older pharmacoeconomic studies favor eptifibatide, in the current era of P2Y12 inhibitors and newer safer anticoagulants, the increased costs associated with bleeding make the routine use of eptifibatide an economically nonviable option. The cost-effectiveness of eptifibatide with the use of strategies that decrease the bleeding risk (eg, transradial access) is unknown. This review provides an overview of key clinical and economic studies of eptifibatide well into the current era of potent antiplatelet agents, novel safer anticoagulants, and contemporary percutaneous coronary intervention.

  2. Neoatherosclerosis: Coronary stents seal atherosclerotic lesions but result in making a new problem of atherosclerosis.

    Science.gov (United States)

    Komiyama, Hidenori; Takano, Masamichi; Hata, Noritake; Seino, Yoshihiko; Shimizu, Wataru; Mizuno, Kyoichi

    2015-11-26

    Chronic inflammation of the native vessel wall with infiltration of lipid-laden foamy macrophages through impaired endothelium results in atherosclerosis. Percutaneous coronary intervention, including metallic stent implantation, is now widely utilized for the treatment of atherosclerotic lesions of the coronary artery. Bare-metal stents and the subsequently developed drug-eluting stents seal the atherosclerosis and resolve lumen stenosis or obstruction of the epicardial coronary artery and myocardial ischemia. After stent implantation, neointima proliferates within the stented segment. Chronic inflammation caused by a foreign body reaction to the implanted stent and subsequent neovascularization, which is characterized by the continuous recruitment of macrophages into the vessel, result in the transformation of the usual neointima into an atheromatous neointima. Neointima with an atherosclerotic appearance, such as that caused by thin-cap fibroatheromas, is now recognized as neoatherosclerosis, which can sometimes cause in-stent restenosis and acute thrombotic occlusion originating from the stent segment following disruption of the atheroma. Neoatherosclerosis is emerging as a new coronary stent-associated problem that has not yet been resolved. In this review article, we will discuss possible mechanisms, clinical challenges, and the future outlook of neoatherosclerosis.

  3. Computational fluid dynamics study of commercially available stents inside an idealised curved coronary artery

    Science.gov (United States)

    Chen, Winson Xiao; Ooi, Andrew; Hutchins, Nicholas; Poon, Eric; Thondapu, Vikas; Barlis, Peter

    2015-11-01

    Stent placement restores blood flow in diseased coronary arteries and is the standard treatment for obstructive coronary atherosclerosis. Analysis of the hemodynamic characteristics of stented arteries is essential for better understanding of the relationship between key fluid dynamic variables and stent designs. Previous computational studies have been limited to idealised stents in curved arterial segments or more realistic stents in straight segments. In clinical practice, however, it is often necessary to place stents in geometrically complex arterial curvatures. Thus, numerical simulations of the incompressible Navier-Stokes equations are carried out to investigate the effects of curvature on hemodynamics using detailed, commercially available coronary stents. The computational domain is a 3mm curved coronary artery model and simulations are conducted using a physiologically realistic inlet condition. The averaged flow rate is about 80 mL/min, similar to the normal human resting condition. The examination of hemodynamic parameters will assess the performance of several commercially available stents in curved arteries and identify regions that may be at risk for restenosis. It is anticipated that this information will lead to improvements in future stent design and deployment.

  4. Development and characterization of a coronary polylactic acid stent prototype generated by selective laser melting.

    Science.gov (United States)

    Flege, Christian; Vogt, Felix; Höges, Simon; Jauer, Lucas; Borinski, Mauricio; Schulte, Vera A; Hoffmann, Rainer; Poprawe, Reinhart; Meiners, Wilhelm; Jobmann, Monika; Wissenbach, Konrad; Blindt, Rüdiger

    2013-01-01

    In-stent restenosis is still an important issue and stent thrombosis is an unresolved risk after coronary intervention. Biodegradable stents would provide initial scaffolding of the stenosed segment and disappear subsequently. The additive manufacturing technology Selective Laser Melting (SLM) enables rapid, parallel, and raw material saving generation of complex 3- dimensional structures with extensive geometric freedom and is currently in use in orthopedic or dental applications. Here, SLM process parameters were adapted for poly-L-lactid acid (PLLA) and PLLA-co-poly-ε-caprolactone (PCL) powders to generate degradable coronary stent prototypes. Biocompatibility of both polymers was evidenced by assessment of cell morphology and of metabolic and adhesive activity at direct and indirect contact with human coronary artery smooth muscle cells, umbilical vein endothelial cells, and endothelial progenitor cells. γ-sterilization was demonstrated to guarantee safety of SLM-processed parts. From PLLA and PCL, stent prototypes were successfully generated and post-processing by spray- and dip-coating proved to thoroughly smoothen stent surfaces. In conclusion, for the first time, biodegradable polymers and the SLM technique were combined for the manufacturing of customized biodegradable coronary artery stent prototypes. SLM is advocated for the development of biodegradable coronary PLLA and PCL stents, potentially optimized for future bifurcation applications.

  5. 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

  6. In vivo assessment of stent recoil of biodegradable polymer-coated cobalt–chromium sirolimus-eluting coronary stent system☆

    Science.gov (United States)

    Abhyankar, Atul D.; Thakkar, Ashok S.

    2012-01-01

    Introduction Immediate and acute stent recoil has been observed following balloon deflation in normal and diseased coronary arteries, and the degree varies by stent design. Methods A total of 19 patients, who underwent elective stent implantation for single de novo native coronary artery lesions, were enrolled: all patients treated with the biodegradable polymer-coated sirolimus-eluting cobalt–chromium coronary stent system (Supralimus-Core®). The immediate, acute and cumulative stent recoil was assessed by quantitative coronary angiography. The cumulative stent recoil was measured at 24 h of stent implantation. Results The absolute late loss due to recoil was found 0.08 ± 0.19 mm for Immediate Stent Recoil (ISR), 0.05 ± 0.21 mm for Acute Stent Recoil (ASR) and 0.11 ± 0.25 mm for Cumulative Stent Recoil (CSR) respectively. Conclusions In vivo acute stent recoil of the Supralimus-Core® has higher radial strength compared to other available standard drug-eluting stents. PMID:23253404

  7. Safety and efficacy of angioplasty with intracoronary stenting in patients with unstable coronary syndromes. Comparison with stable coronary syndromes

    Directory of Open Access Journals (Sweden)

    Luís C. L. Correia

    2000-06-01

    Full Text Available OBJECTIVE: To assess safety and efficacy of coronary angioplasty with stent implantation in unstable coronary syndromes. METHODS: Retrospective analysis of in-hospital and late evolution of 74 patients with unstable coronary syndromes (unstable angina or infarction without elevation of the ST segment undergoing coronary angioplasty with stent placement. These 74 patients were compared with 31 patients with stable coronary syndromes (stable angina or stable silent ischemia undergoing the same procedure. RESULTS: No death and no need for revascularization of the culprit artery occurred in the in-hospital phase. The incidences of acute non-Q-wave myocardial infarction were 1.4% and 3.2% (p=0.6 in the unstable and stable coronary syndrome groups, respectively. In the late follow-up (11.2±7.5 months, the incidences of these events combined were 5.7% in the unstable coronary syndrome group and 6.9% (p=0.8 in the stable coronary syndrome group. In the multivariate analysis, the only variable with a tendency to significance as an event predictor was diabetes mellitus (p=0.07; OR=5.2; 95% CI=0.9-29.9. CONCLUSION: The in-hospital and late evolutions of patients with unstable coronary syndrome undergoing angioplasty with intracoronary stent implantation are similar to those of the stable coronary syndrome group, suggesting that this procedure is safe and efficacious when performed in unstable coronary syndrome patients.

  8. Usefulness of Drug Eluting Stent in Percutaneous Coronary Intervention—A Single Center Experience in Taiwan

    Directory of Open Access Journals (Sweden)

    Juey-Jen Hwang

    2007-08-01

    Conclusion: The use of DES in the Taiwanese population yielded comparable results as those in large clinical trials. Subacute stent thrombosis rate was higher in acute coronary syndrome. The safety of DES in these situations should be further clarified.

  9. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

    DEFF Research Database (Denmark)

    Urban, Philip; Meredith, Ian T; Abizaid, Alexandre

    2015-01-01

    BACKGROUND: Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9),...... therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.)....

  10. 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...

  11. Patient with Recent Coronary Artery Stent Requiring Major Non Cardiac Surgery

    Directory of Open Access Journals (Sweden)

    Usha Kiran

    2009-01-01

    Full Text Available Anaesthesiologists are increasingly confronted with patients who had a recent coronary artery stent implanta-tion and are on dual anti-platelet medication. Non cardiac surgery and most invasive procedures increase the risk of stent thrombosis especially when procedure is performed early after stent implantation. Anaesthesiologist faces the dilemma of stopping the antiplatelet therapy before surgery to avoid bleeding versus perioperative stent thrombosis. Individualized approach should be adopted with following precautions. i In a surgical patient with a history of percu-taneous coronary intervention (PCI and coronary stent, determine the date of the procedure, the kind of the stent inserted and the possibility of complications during the procedure. ii Consider all patents with a recent stent implan-tation (e.g. less than three months for bare metal stents and less than one year for brachytherapy or drug eluting stents as high risk and consult an interventional cardiologist. iii Any decision to postpone surgery, continue, modify or discontinue antiplatelet regimes must involve the cardiologist, anaesthesiologist, surgeon, haematologist and the intensivist to balance the risk and benefit of each decision.

  12. 6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial.

    Science.gov (United States)

    Gilard, Martine; Barragan, Paul; Noryani, Arif A L; Noor, Hussam A; Majwal, Talib; Hovasse, Thomas; Castellant, Philippe; Schneeberger, Michel; Maillard, Luc; Bressolette, Erwan; Wojcik, Jaroslaw; Delarche, Nicolas; Blanchard, Didier; Jouve, Bernard; Ormezzano, Olivier; Paganelli, Franck; Levy, Gilles; Sainsous, Joël; Carrie, Didier; Furber, Alain; Berland, Jacques; Darremont, Oliver; Le Breton, Hervé; Lyuycx-Bore, Anne; Gommeaux, Antoine; Cassat, Claude; Kermarrec, Alain; Cazaux, Pierre; Druelles, Philippe; Dauphin, Raphael; Armengaud, Jean; Dupouy, Patrick; Champagnac, Didier; Ohlmann, Patrick; Endresen, Knut; Benamer, Hakim; Kiss, Robert Gabor; Ungi, Imre; Boschat, Jacques; Morice, Marie-Claude

    2015-03-03

    The currently recommended duration of dual antiplatelet therapy (DAPT) in drug-eluting stent (DES) recipients is 12 months to reduce the risk of late stent thrombosis, particularly in those with acute coronary syndrome (ACS). This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients. A multicenter, randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6- or 24-month DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting. A total of 2,031 patients were enrolled in 70 European and Middle Eastern centers. The trial was prematurely terminated due to recruitment problems, leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT. The 2 treatment groups had similar baseline and procedural characteristics. There was no significant difference in the primary endpoint (24-month: 1.5% vs. 6-month: 1.6%; p = 0.85). Noninferiority was demonstrated for 6- versus 24-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p for noninferiority = 0.0002). There were no significant differences in stent thrombosis or bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ (hazard ratio: 1.7 [95% confidence interval: 0.519 to 6.057; p = 0.361]). Rates of bleeding and thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders. (Is There A LIfe for DES After Discontinuation of Clopidogrel [ITALICplus]; NCT01476020). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  13. 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 C...

  14. Snare removal of a deformed coronary stent via radial artery during percutaneous intervention for acute myocardial infarction.

    Science.gov (United States)

    Hanson, Ivan; Trivax, Justin; Hanzel, George

    2014-01-01

    A 49-year-old man underwent emergent coronary angiography for acute inferior myocardial infarction (MI). After balloon angioplasty of culprit right coronary artery (RCA) occlusion, a Promus Element stent would not advance to the target lesion. The proximal end of the stent became compressed against the tip of the guiding catheter, such that the stent could neither be advanced nor withdrawn. This case illustrates the technical aspects of snare removal of a severely deformed stent via the radial artery.

  15. Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.

    Science.gov (United States)

    Kesselheim, Aaron S; Xu, Shuai; Avorn, Jerry

    2014-01-01

    Medical device innovation remains poorly understood, and policymakers disagree over how to incentivize early development. We sought to elucidate the components of transformative health care innovation by conducting an in-depth case study of development of a key medical device: coronary artery stents. We conducted semi-structured interviews with the innovators whose work contributed to the development of coronary artery stents who we identified based on a review of the regulatory, patent, and medical literature. Semi-structured interviews with each participant covered the interviewee's personal involvement in coronary artery stent development, the roles of institutions and other individuals in the development process, the interplay of funding and intellectual property in the interviewee's contribution, and finally reflections on lessons arising from the experience. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis. We found that the first coronary artery stents emerged from three teams: Julio Palmaz and Richard Schatz, Cesare Gianturco and Gary Roubin, and Ulrich Sigwart. First, these individual physician-inventors saw the need for coronary artery stents in their clinical practice. In response, they developed prototypes with the support of academic medical centers leading to early validation studies. Larger companies entered afterwards with engineering support. Patents became paramount once the technology diffused. The case of coronary stents suggests that innovation policy should focus on supporting early physician-inventors at academic centers.

  16. Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.

    Directory of Open Access Journals (Sweden)

    Aaron S Kesselheim

    Full Text Available Medical device innovation remains poorly understood, and policymakers disagree over how to incentivize early development. We sought to elucidate the components of transformative health care innovation by conducting an in-depth case study of development of a key medical device: coronary artery stents.We conducted semi-structured interviews with the innovators whose work contributed to the development of coronary artery stents who we identified based on a review of the regulatory, patent, and medical literature. Semi-structured interviews with each participant covered the interviewee's personal involvement in coronary artery stent development, the roles of institutions and other individuals in the development process, the interplay of funding and intellectual property in the interviewee's contribution, and finally reflections on lessons arising from the experience. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis.We found that the first coronary artery stents emerged from three teams: Julio Palmaz and Richard Schatz, Cesare Gianturco and Gary Roubin, and Ulrich Sigwart. First, these individual physician-inventors saw the need for coronary artery stents in their clinical practice. In response, they developed prototypes with the support of academic medical centers leading to early validation studies. Larger companies entered afterwards with engineering support. Patents became paramount once the technology diffused. The case of coronary stents suggests that innovation policy should focus on supporting early physician-inventors at academic centers.

  17. Angiographic complexity of coronary artery disease according to SYNTAX score and clinical outcomes after revascularisation with newer-generation drug-eluting stents: a substudy of the BIOSCIENCE trial.

    Science.gov (United States)

    Franzone, Anna; Taniwaki, Masanori; Rigamonti, Fabio; Heg, Dik; Piccolo, Raffaele; Roffi, Marco; Tüller, David; Muller, Olivier; Vuilliomenet, Andre; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Jüni, Peter; Windecker, Stephan; Pilgrim, Thomas

    2016-08-05

    We sought to assess the performance of drug-eluting stents combining an ultrathin cobalt-chromium platform with a biodegradable polymer across categories of increasing SYNTAX score (SS). Patients included in the BIOSCIENCE trial and randomly allocated to treatment with biodegradable polymer sirolimus-eluting stents (BP-SES) or durable polymer everolimus-eluting stents (DP-EES) were categorised according to SS tertiles (low 15). The primary endpoint, target lesion failure (TLF), was defined as a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation. The patient-oriented endpoint (POCE) included death, myocardial infarction, or any repeat revascularisation. The SS was available in 2,041 out of 2,119 patients (96.3%). At two-year follow-up, patients with an SS >15 experienced higher rates of both TLF and POCE as compared to patients with medium and low SS (14.5% vs. 8.1% and vs. 5.9%, p<0.001; 22.7% vs. 14.9% and vs. 12.4%; p<0.001), respectively. Comparable rates of the composite endpoints were documented for both stent types in each category of SS. Increasing lesion complexity as assessed by SS was associated with higher rates of TLF and POCE in a contemporary PCI population with minimal exclusion criteria. BP-SES and DP-EES showed comparable performance across the entire spectrum of CAD severity.

  18. Titanium-nitride-oxide-coated coronary stents: insights from the available evidence.

    Science.gov (United States)

    Karjalainen, Pasi P; Nammas, Wail

    2017-06-01

    Coating of stent surface with a biocompatible material is suggested to improve stent safety profile. A proprietary process was developed to coat titanium-nitride-oxide on the stent surface, based on plasma technology that uses the nano-synthesis of gas and metal. Preclinical in vitro and in vivo investigation confirmed blood compatibility of titanium (nitride-) oxide films. Titanium-nitride-oxide-coated stents demonstrated a better angiographic outcome, compared with bare-metal stents at mid-term follow-up; however, they failed to achieve non-inferiority for angiographic outcome versus second-generation drug-eluting stents. Observational studies showed adequate clinical outcome at mid-term follow-up. Non-randomized studies showed an outcome of titanium-nitride-oxide-coated stents comparable to - or better than - first-generation drug-eluting stents at long-term follow-up. Two randomized controlled trials demonstrated comparable efficacy outcome, and a better safety outcome of titanium-nitride-oxide-coated stents versus drug-eluting stents at long-term follow-up. Evaluation by optical coherence tomography at mid-term follow-up revealed better neointimal strut coverage associated with titanium-nitride-oxide-coated stents versus drug-eluting stents; yet, neointimal hyperplasia thickness was greater. Key messages Stents coated with titanium-nitride-oxide demonstrated biocompatibility in preclinical studies: they inhibit platelet and fibrin deposition, and reduce neointimal growth. In observational and non-randomized studies, titanium-nitride-oxide-coated stents were associated with adequate safety and efficacy outcome. In randomized trials of patients with acute coronary syndrome, titanium-nitride-oxide-coated stents were associated with a better safety outcome, compared with drug-eluting stents; efficacy outcome was comparable.

  19. The effects of intravascular stents on vasomotion in porcine coronary arteries.

    Science.gov (United States)

    Jenkins, J S; Webel, R; Laughlin, M H; Rowland, S M; Yoklavich, M F; Branson, K; Parker, J L; Myers, P R

    1995-09-01

    Intravascular stents are being increasingly utilized in the treatment of atherosclerotic coronary artery disease, however little is known about the effects of stents on coronary vasomotion. The purpose of the present study was to compare the effects of a heparin treated tantalum stent and balloon injury on coronary artery vasorelaxation and vasoconstriction. Male miniswine underwent cardiac catheterization and oversized balloon injury to the right and left circumflex coronary arteries. After two weeks, one artery was either balloon-injured again, or underwent implantation of a stent. Four weeks later, the coronary arteries were prepared for in vitro isometric ring studies. Vasodilator responses to bradykinin and A23187 calcium ionophore were significantly impaired in balloon-injured vessels. The bradykinin and A23187 responses in stented vessels showed significantly less vasorelaxation, compared to both balloon-injured and normal vessels. There were no significant differences between any of the groups in their vasodilator response to nitroprusside. Vasoconstrictor responses to acetylcholine were significantly greater in balloon-injured vessels, compared to normal vessels. Stented vessels, however, showed markedly less vasoconstriction to acetylcholine compared to both balloon-injured and normal vessels. The maximal KCI vasoconstrictor responses in balloon injured vessels and normal controls were not significantly different. However, the maximal KCI responses in stented vessels showed significantly less constriction compared to both balloon injured and normal vessels. In conclusion, the data demonstrated that coronary arteries implanted with a heparin treated tantalum stent were capable of vasomotor activity. Both conventional balloon angioplasty and stents resulted in impaired endothelium-dependent vasorelaxation. Endothelium-independent vasorelaxation, however, was not impaired.(ABSTRACT TRUNCATED AT 250 WORDS)

  20. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions

    DEFF Research Database (Denmark)

    Kelbaek, Henning; Kløvgaard, Lene; Helqvist, Steffen

    2008-01-01

    OBJECTIVES: Our purpose was to evaluate the long-term use of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with complex coronary artery lesions. BACKGROUND: Although the use of SES has proved to be effective in patients with simple coronary artery lesions, there are limited...... benefit was observed up to 3 years after implantation of SES in patients with complex coronary artery lesions. The rate of late adverse events was similar in the 2 groups, and stent thromboses occurred rarely after 1 year. (Sirolimus Eluting Stents in Complex Coronary Lesions [SCANDSTENT]; NCT00151658)...

  1. The CID Chrono cobalt-chromium alloy carbofilm-coated coronary stent system.

    Science.gov (United States)

    Visconti, Gabriella; Focaccio, Amelia; Tavano, Davide; Airoldi, Flavio; Briguori, Carlo

    2011-06-02

    In an attempt to improve the stent's safety, development of bare metal stents (BMS) continues, with new materials and geometry. Chrono (CID, Italy) is a thin strut cobalt-chromium (Co-Cr) stent combining the clinical benefits of the bio- and haemo-compatible Carbofilm coating. We assessed the safety and efficacy of percutaneous coronary interventions (PCI) using the new Co-Cr Chrono stent in patients undergoing elective PCI for de novo lesions in native coronary vessels. The patients were followed for 12 months for the occurrence of major cardiac events (MACE, defined as death, myocardial infarction, repeat PCI and bypass surgery). Patients with complex (B2/C) lesions were compared to those with non-complex lesions (A/B1). A total of 340 consecutive patients were analysed: 155 patients with complex lesions (Complex group) and 185 patients with non-complex lesions (Non-complex group). Dual antiplatelet therapy was maintained >1 month in 21% of patients in both Complex and Non-complex group. Stent length was longer in the Complex group (25 ± 10 mm versus 17 ± 6 mm; pStent diameter stent thrombosis (ARC criteria) was 1.29% in the Complex group and 1.08% in the Non-complex group (p=1.0). Implantation of the Co-Cr Chrono stent results in a good safety and efficacy for both complex and non-complex de-novo coronary artery lesions. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  2. Advantages of novel BioMimeTM Sirolimus Eluting Coronary Stent system. Moving towards biomimicry.

    Science.gov (United States)

    Upendra, K; Sanjeev, B

    2012-02-01

    Since the first reported use of percutaneous transluminal coronary angioplasty (PTCA), advancements in interventional cardiology arena have been fast paced. Within the last ten years, these developments have been exponential. Developers & clinicians are fast adapting from the learning curve awarded by the time course of DES evolution. In that light BioMimeTM Sirolimus Eluting Coronary Stent comes as a fresh thought in taking stents towards a biomimicry concept. The stent is built on an ultra-low strut thickness (65 µm) cobalt chromium stent platform, using an intelligent hybrid of close and open cells allowing for morphology mediated expansion, employs a well known anti-proliferative - Sirolimus that elutes from a biodegradable co-polymer formulation in 30 days and ensures high coating integrity and low coating thickness of 2 µm. The resultant stent demonstrates almost 100% endothelialization at 30 days in preclinical model and zero percent MACE >18 months in the primary efficacy and safety clinical study.

  3. Eosinophilic responses to stent implantation and the risk of Kounis hypersensitivity associated coronary syndrome.

    Science.gov (United States)

    Kounis, Nicholas G; Giannopoulos, Sotiris; Tsigkas, Grigorios G; Goudevenos, John

    2012-04-19

    The use of drug eluting stents constitutes a major breakthrough in current interventional cardiology because it is more than halves the need of repeat interventions. It is incontrovertible that coronary stents, in general, have been beneficial for the vast majority of patients. A small increase in thrombosis, following DES implantation, is offset by a diminished risk of complications associated with repeat vascularization. However, late and, especially, very late stent thrombosis is a much feared complication because it is associated with myocardial infarction with increased mortality. Despite that stent thrombosis is thought to be multifactorial, so far clinical reports and reported pathology findings in patients died from coronary stent thrombosis as well as animal studies and experiments, point toward a hypersensitivity inflammation. The stented and thrombotic areas are infiltrated by interacting, via bidirectional stimuli inflammatory cells including eosinophils, macrophages, T-cells and mast cells. Stented regions constitute an ideal surrounding for endothelial damage and dysfunction, together with hemorheologic changes and turbulence as well as platelet dysfunction, coagulation and fibrinolytic disturbances. Drug eluting stent components include the metal strut which contains nickel, chromium, manganese, titanium, molybdenum, the polymer coating and the impregnated drugs which for the first generation stents are: the antimicrotubule antineoplastic agent paclitaxel and the anti-inflammatory, immunosuppressive and antiproliferative agent sirolimus. The newer stents which are called cobalt-chromiun stents and elute the sirolimus analogs everolimus and zotarolimus both contain nickel and other metals. All these components constitute an antigenic complex inside the coronary arteries which apply chronic, continuous, repetitive and persistent inflammatory action capable to induced Kounis syndrome and stent thrombosis. Allergic inflammation goes through three phases

  4. Coronary artery bypass surgery or coronary stenting in diabetic patients: too soon to make a statement?

    Energy Technology Data Exchange (ETDEWEB)

    Rodriguez, Alfredo E., E-mail: arodriguez@centroceci.com.ar

    2014-11-15

    Diabetic patients have been associated with poor procedural and long term outcome if they were treated either with percutaneous coronary interventions or coronary artery bypass surgery. Recently several randomized clinical trials (RCT) in this subset of patients have been published showing a greater incidence of major adverse cardiovascular events, death/myocardial infarction/stroke, if they were treated with first generation drug eluting stents (DES) which was not observed previously in the bare metal stent era. However, almost simultaneously with this data, several RCT demonstrated better safety profile with new generation DES including biocompatible polymers, biodegradable polymers and lately complete absorbable DES, all of them showed reduction in adverse cardiac events compared to 1st generation DES in patients with diabetes. In this editorial we review the old and new randomized data in diabetic patients and conclude that there are many unresolved issues to make a definitive statement regarding which is the best revascularization preference in diabetic patients and the measured final efficacy of PCI and CABG will not be reached until the arrival of RCT using next generation DES, including complete absorbable scaffolds. - Highlights: • Diabetic patients have been associated with poor procedural and long term outcome if they were treated either with percutaneous coronary interventions or coronary artery bypass surgery. Recently several randomized clinical trials (RCT) in this subset of patients have been published showing a greater incidence of major adverse cardiovascular events, death/myocardial infarction/stroke, if they were treated with first generation drug eluting stents (DES) which was not observed previously in the bare metal stent era. • In recent years, several RCT demonstrated better safety profile with new generation DES including biocompatible polymers, biodegradable polymers and lately complete absorbable DES, all of them showed reduction in

  5. High-Definition Computed Tomography for Coronary Artery Stent Imaging: a Phantom Study

    Energy Technology Data Exchange (ETDEWEB)

    Yang, Wen Jie; Chen, Ke Min; Pang, Li Fang; Zhang, Huang; Pan, Zi Lai [Rui Jin Hospital, Medical School, Shanghai Jiao Tong University, Shangha (China); Guo, Ying; Li, Jian Ying [Beijing Economic and Technology Development Area, Beijing (China)

    2012-01-15

    To assess the performance of a high-definition CT (HDCT) for imaging small caliber coronary stents ({<=} 3 mm) by comparing different scan modes of a conventional 64-row standard-definition CT (SDCT). A cardiac phantom with twelve stents (2.5 mm and 3.0 mm in diameter) was scanned by HDCT and SDCT. The scan modes were retrospective electrocardiography (ECG)-gated helical and prospective ECG-triggered axial with tube voltages of 120 kVp and 100 kVp, respectively. The inner stent diameters (ISD) and the in-stent attenuation value (AVin-stent) and the in-vessel extra-stent attenuation value (AVin-vessel) were measured by two observers. The artificial lumen narrowing (ALN = [ISD - ISDmeasured]/ISD) and artificial attenuation increase between in-stent and in-vessel (AAI = AVin-stent - AVin-vessel) were calculated. All data was analyzed by intraclass correlation and ANOVA-test. The correlation coefficient of ISD, AVin-vessel and AVin-stent between the two observers was good. The ALNs of HDCT were statistically lower than that of SDCT (30 {+-} 5.7% versus 35 {+-} 5.4%, p < 0.05). HDCT had statistically lower AAI values than SDCT (15.7 {+-} 81.4 HU versus 71.4 {+-} 90.5 HU, p < 0.05). The prospective axial dataset demonstrated smaller ALN than the retrospective helical dataset on both HDCT and SDCT (p < 0.05). Additionally, there were no differences in ALN between the 120 kVp and 100 kVp tube voltages on HDCT (p = 0.05). High-definition CT helps improve measurement accuracy for imaging coronary stents compared to SDCT. HDCT with 100 kVp and the prospective ECG-triggered axial technique, with a lower radiation dose than 120 kVp application, may be advantageous in evaluating coronary stents with smaller calibers ({<=} 3 mm).

  6. Aspirin and clopidogrel hyporesponsiveness and nonresponsiveness in patients with coronary artery stenting

    Directory of Open Access Journals (Sweden)

    Rakesh K Sharma

    2009-11-01

    Full Text Available Rakesh K Sharma1, Hanumanth K Reddy1, Vibhuti N Singh2, Rohit Sharma1, Donald J Voelker1, Girish Bhatt11Medical Center of South Arkansas, El Dorado, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 2Bayfront Medical Center, St. Petersburg, University of South Florida, Tampa, FL, USAAbstract: Patients undergoing coronary artery stenting receive an antiplatelet regimen to reduce the risk of antithrombotic complications. Current guidelines recommend the use of acetyl salicylic acid (aspirin and clopidogrel as evidenced by large clinical trials. There has been a concern about variable responses of patients to aspirin and clopidogrel which may predispose them to subacute stent thrombosis or late stent thrombosis. Up to 25% of patients with acute myocardial infarction (AMI undergoing percutaneous coronary intervention (PCI were found to have hyporesponsiveness or resistance to clopidogrel which may predispose them to recurrent events. Dual antiplatelet regimen is a standard therapy in these patients and there is always a concern about variable responses to aspirin and clopidogrel predisposing them to acute coronary syndrome (ACS. Prevalence of this hyporesponsiveness or resistance may be due to noncompliance, genetic mutations, co-morbid situations and concomitant use of other drugs. This issue is of considerable importance in the era of coronary drug eluting stents when a long-term dual antiplatelet regimen is needed. This paper is a review for clinicians taking care of such patients with hyporesponsiveness or nonresponsiveness to dual antiplatelet regimen.Keywords: aspirin, clopidogrel, acute coronary syndrome, coronary artery stenting

  7. Comparative clinical-angiographic evaluation of long-term results of coronary stenting in patients with coronary artery disease using drug-sents a different cover

    Directory of Open Access Journals (Sweden)

    А. Г. Осиев

    2015-10-01

    Full Text Available The formation of restenosis after coronary stent implantation remains a major challenge for endovascular treatment of patients with coronary atherosclerosis. In the course of the study were analyzed in a comparative perspective, the frequency and nature of developing the long-term restenosis after implantation of coronary stents in the Cypher coated with sirolimus (Cordis, Johnson & Johnson (U.S. and eucaTAX double coated - artificial glycocalyx (artificial endothelium and paclitaxel (eucatech AG, Germany in patients with chronic coronary artery disease. The advantages of stent Cypher, in reducing the incidence of restenosis and repeated endovascular interventions in the late postoperative period in patients with coronary artery disease.

  8. Periprocedural (30-day) risk of myocardial infarction after drug-eluting coronary stent implantation: a meta-analysis comparing cobalt-chromium and stainless steel drug-eluting coronary stents.

    Science.gov (United States)

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

    2011-03-01

    Because of the reduction in the rate events related with in-stent restenosis, most events after drug-eluting stent implantation occur shortly after coronary stenting. Cobalt-chromium alloys allow to reduce strut thickness and improve flexibility and deliverability of coronary stent platforms, and thus could be associated with lower short-term events after stenting. The aim of this study was to test the hypothesis that drug-eluting coronary stents with a cobalt-chromium platform reduce the incidence of periprocedural (30-day) myocardial infarction in comparison with stainless steel drug-eluting coronary stents. A meta-analysis from nine randomised trials comparing cobalt-chromium and stainless steel drug-eluting coronary stents that overall included 11,313 patients was performed. The incidence of myocardial infarction, stent thrombosis, and cardiac death at 30 days was compared between both types of stents. At 30 days, the incidence of acute myocardial infarction was significantly lower in patients allocated to cobalt-chromium drug-eluting stents (2.3% vs. 3.9%, respectively; p=0.006; odds ratio 0.72, 95% confidence interval 0.58-0.91), due to a significant reduction in the rate of non-Q-wave myocardial infarction (odds ratio 0.67, 95% confidence interval 0.51-0.88). The incidence of stent thrombosis was similar between both groups of patients, (0.5% vs. 0.5%, p=0.76; odds ratio 1.09, 95% confidence interval 0.63-1.89). Drug-eluting coronary stents that use cobalt-chromium stent platforms have a better safety profile at 30 days in comparison with stainless steel drug-eluting stents, due to a significant reduction in the rate of myocardial infarction.

  9. Clinical outcomes after heterogeneous overlap stenting with drug-eluting stents and bare-metal stents for de novo coronary artery narrowings.

    Science.gov (United States)

    Aoki, Jiro; Kirtane, Ajay J; Dangas, George D; Lansky, Alexandra J; Morales, Andy; Kimura, Masashi; Kim, Young-Hak; Moussa, Issam; Weisz, Giora; Kreps, Edward M; Collins, Michael; Frankin-Bond, Theresa; Stone, Gregg W; Moses, Jeffrey W; Leon, Martin B; Mehran, Roxana

    2008-01-01

    When it is difficult to deliver multiple drug-eluting stents (DES) or when size constraints limit DES implantation, bare-metal stents (BMS) may be implanted contiguous to DES. However, the clinical outcomes after overlapping DES and BMS implantation are not known. From September 2004 to June 2006, 4,872 consecutive patients who underwent percutaneous coronary intervention consented to be enrolled in a prospective registry. Of these patients, 44 (0.9%) with de novo lesions were treated with DES and BMS overlap stenting. All patients were followed to 12 months for the assessment of clinical outcomes. The average implanted stent diameter was 2.68 +/- 0.30 mm for DES and 2.35 +/- 0.38 mm for BMS. Overlapping BMS were implanted distal to DES in all but 1 case. One patient (2.3%) experienced acute stent thrombosis and died 2 days after the procedure. No other patient died or had a myocardial infarction during 12 months. The target vessel revascularization rate at 12 months, however, was 31.8%, mainly driven by diffuse in-stent restenosis in the BMS segments. In conclusion, the incidence of DES and BMS overlap stenting is rare in daily practice, but this procedure is associated with a high rate of target vessel revascularization.

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

    Science.gov (United States)

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

    2017-01-01

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

  11. 64-slice multidetector coronary CT angiography: in vitro evaluation of 68 different stents

    Energy Technology Data Exchange (ETDEWEB)

    Maintz, David; Seifarth, Harald; Rink, Michael; Oezguen, Murat; Heindel, Walter; Fischbach, Roman [University of Muenster, Department of Clinical Radiology, Muenster (Germany); Raupach, Rainer; Flohr, Thomas [Siemens Medical Solutions, Forchheim (Germany); Sommer, Torsten [University of Bonn, Department of Radiology, Bonn (Germany)

    2006-04-15

    The purpose of this study was to test a large sample of different coronary artery stents using four image reconstruction approaches with respect to lumen visualization, lumen attenuation, and image noise in 64-slice multidetector-row computed tomography (MDCT) in vitro and to provide a catalogue of currently used coronary artery stents when imaged with state-of the-art MDCT. We examined 68 different coronary artery stents (57 stainless steel, four cobalt-chromium, one cobalt-alloy, two nitinol, four tantalum) in a coronary artery phantom (vessel diameter 3 mm, intravascular attenuation 250 HU, extravascular density -70). Stents were imaged in axial orientation with standard parameters: 32x0.6 collimation, pitch 0.24, 680 mAs, 120 kV, rotation time 0.37 s. Four different image reconstructions were obtained with varying convolution kernels and section thicknesses: (1) soft, 0.6 mm, (2) soft, 0.75, (3) medium soft, 0.6, and (4) stent-optimized sharp, 0.6. To evaluate visualization characteristics of of the stent, the lumen diameter, intraluminal density and noise were measured. The high-resolution kernel offered significantly better average lumen visualization (57% {+-}10%) and more realistic lumen attenuation (222 HU {+-}66 HU) at the expense of increased noise (15.3 HU {+-}3.7 HU) compared with the soft and medium-soft CT angiography (CTA) protocol (p<0.001 for all). Stents with a lumen visibility of more than 66% were: Arthos pico, Driver, Flex, Nexus2, S7, Tenax complete, Vision (all 67%), Symbiot, Teneo (70%), and Radius (73%). Only ten stents showed a lumen visibility of less than 50%. Stent lumen visibility largely varies depending on the stent type. Even with the improved spatial resolution of 64-slice CT, a stent-optimized kernel remains beneficial for stent visualization when compared with the standard medium-soft CTA protocol. Using 64-slice CT and high-resolution kernel, the majority of stent products show a lumen visibility of more than 50% of the stent

  12. Optimal kissing balloon inflation after single-stent deployment in a coronary bifurcation model.

    Science.gov (United States)

    Murasato, Yoshinobu; Iwasaki, Kiyotaka; Yamamoto, Tadashi; Yagi, Takanobu; Hikichi, Yutaka; Suematsu, Yasunori; Yamamoto, Tomohiko

    2014-12-01

    To define the optimal kissing balloon inflation (KBI) after single-stent deployment in a coronary bifurcation model. We deployed stents in main vessels (MV) followed by KBI in various conditions and compared the stent configurations. A) KBI at the operator's discretion vs. under the guidelines of minimal balloon overlapping (MBO). Various stent configurations were observed after the former option, whereas similar maximal dilation points were observed under the MBO guidelines. B) Long balloon overlapping (LBO) vs. MBO with proximal MV dilated by a large balloon. The proximal MV was dilated to an ideal round shape with MBO versus an oval shape with LBO. C) Two-link vs. 3-link stents. Although the 2-link stent was advantageous to open the side branch, it incurred a risk of overdilatation of the proximal struts, whereas the 3-link stent preserved its structure. Computed simulations of coronary flow were analysed in the following left main coronary models: circle with a diameter of 4 and 5.5 mm, ellipse with longitudinal direction and tilt position. They revealed that the overdilated side was exposed to low shear stress regardless of its shape. Optimal KBI can be achieved with MBO and proximal dilatation by an optimally sized balloon.

  13. 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...... 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...

  14. A third generation ultra-thin strut cobalt chromium stent: histopathological evaluation in porcine coronary arteries.

    Science.gov (United States)

    Jabara, Refat; Geva, Sarah; Ribeiro, Henrique B; Chen, Jack P; Hou, Dongming; Li, Jinsheng; King, Spencer B; Chronos, Nicolas; Robinson, Keith A

    2009-11-01

    The present study was designed to evaluate a novel third generation bare-metal stent (BMS) comprised of an ultra-thin-strut, cobalt-chromium platform with fixed geometry, uniform cell size, and superior surface finish in a porcine coronary artery model. A total of 47 BMS of two types were implanted in pig coronary arteries using QCA to optimise stent apposition: a commercially available cobalt alloy thin-strut stent (91 microm) as control (Driver; n=17), and an ultra-thin-strut (65 microm) cobalt-chromium stent (Protea; n=18). Animals underwent angiographic restudy and termination one week and one month post-implant for coronary artery histology. In addition, 12 overlapping Protea stents were analysed at one month. At one week, comparable thin neointima and mild inflammation were observed in both groups. At one month, Protea demonstrated significantly lower angiographic % stenosis (2+/-1% vs. 17+/-5%, p=0.006), intimal thickness (0.11+/-0.01 mm vs. 0.23+/-0.03 mm, p=0.003), and histologic % area stenosis (19+/-2% vs. 32+/-3%, p=0.003). Mean stent strut injury scores were low and similar between groups. Angiographic % stenosis, intimal thickness, and histologic % area stenosis of overlapping Protea stents were 3+/-1%, 0.13+/-0.01 mm, and 22+/-2%, respectively, and similar to the single Protea group. Stable fibrocellular neointimal incorporation, with complete endothelialisation and minimal inflammation, were observed at one month in all stents, including overlapped Protea segments. When compared to a commercially available cobalt alloy BMS, the new third generation Protea stent demonstrated favourable coronary arterial response with significant reduction of neointimal formation in the porcine model. Our results showed how seemingly trivial improvements to the BMS technology can result in substantial biological responses. Future, long-term investigations are needed to ascertain the clinical applicability and implications of these findings.

  15. Elevated blood viscosity and micro-recirculation linked to coronary stent malapposition.

    Science.gov (United States)

    Poon, Eric; Thondapu, Vikas; Hayat, Umair; Barlis, Peter; Yap, Chooi; Kuo, Po; Wang, Qisen; Ma, Jiawei; Zhu, Shuang; Moore, Stephen; Ooi, Andrew

    2018-02-14

    One particular complexity of coronary artery is the natural tapering of the vessel with proximal segments having larger caliber and distal tapering as the vessel get smaller. The natural tapering of a coronary artery often leads to proximal incomplete stent apposition (ISA). ISA alters coronary hemodynamics and creates pathological path to develop complications such as in-stent restenosis, and more worryingly, stent thrombosis. By employing state-of-the-art computer-aided design software, generic stent hoops were virtually deployed in an idealized tapered coronary artery with decreasing malapposition distance. Pulsatile blood flow simulations were carried out using computational fluid dynamics (CFD) on these computer-aided design models. CFD results reveal unprecedented details in both spatial and temporal development of micro-recirculation environments throughout the cardiac cycle. Arterial tapering also introduces secondary micro-recirculation. These primary and secondary micro-recirculations provoke significant fluctuations in arterial wall shear stress (WSS). There has been a direct correlation with changes in WSS and the development of atherosclerosis. Further, the presence of these micro-recirculations influence strongly on the local levels of blood viscosity in the vicinity of the malapposed stent struts. The observation of secondary micro-recirculations and changes in blood rheology is believed to complement the wall (-based) shear stress, perhaps providing additional physical explanations for tissue accumulation near ISA detected from high resolution optical coherence tomography. This work may aid in helping to optimize future stent properties and designs that will translate to innovations that directly impact clinical outcomes.

  16. The use of coronary stent in hepatic artery stenosis after orthotopic liver transplantation

    Energy Technology Data Exchange (ETDEWEB)

    Huang Mingsheng [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Shan Hong [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China)]. E-mail: gzshsums@public.guangzhou.gd.cn; Jiang Zaibo [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Li Zhengran [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Zhu Kangshun [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Guan Shouhai [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Qian Jiesheng [Department of Radiology, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Chen Guihua [Transplantation Center, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Lu Minqiang [Transplantation Center, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China); Yang Yang [Transplantation Center, the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510630, Guangdong Province (China)

    2006-12-15

    Purpose: This retrospective study was undertaken to evaluate the effectiveness of coronary stent placement in hepatic artery stenosis after orthotopic liver transplantation (OLT). Materials and methods: Of 430 consecutive adult orthotopic liver transplant recipients between November 2003 and September 2005, 17 had hepatic artery stenosis (HAS). Fourteen of them underwent coronary stent placement in the HAS. The technical results, complications, hepatic artery patency and clinical outcome were reviewed. Results: Technical and immediate success was 100%. After a mean follow-up of 159.4 days (range, 9-375 days), all patients obtained patent hepatic arteries except 2 patients occurred hepatic artery restenoses at 26 and 45 days after stent placement, respectively. Kaplan-Meier curve of patency showed cumulated stent patency at 3, 6, and 12 months of 78%, 58% and 45%, respectively. During the follow-up, 8 patients survived, 5 died of septic multiple-organ failure, 1 received retransplantation because of refractory biliary infection. Hepatic artery dissection induced by a guiding catheter occurred in one patient and was successfully treated with a coronary stent. Conclusion: Hepatic artery stenosis after OLT can be successfully treated with coronary stent placement with low complication rate and an acceptable 1-year hepatic artery patency rate.

  17. High-definition computed tomography for coronary artery stents imaging: Initial evaluation of the optimal reconstruction algorithm

    Energy Technology Data Exchange (ETDEWEB)

    Cui, Xiaoming, E-mail: mmayzy2008@126.com; Li, Tao, E-mail: litaofeivip@163.com; Li, Xin, E-mail: lx0803@sina.com.cn; Zhou, Weihua, E-mail: wangxue0606@gmail.com

    2015-05-15

    Highlights: • High-resolution scan mode is appropriate for imaging coronary stent. • HD-detail reconstruction algorithm is stent-dedicated kernel. • The intrastent lumen visibility also depends on stent diameter and material. - Abstract: Objective: The aim of this study was to evaluate the in vivo performance of four image reconstruction algorithms in a high-definition CT (HDCT) scanner with improved spatial resolution for the evaluation of coronary artery stents and intrastent lumina. Materials and methods: Thirty-nine consecutive patients with a total of 71 implanted coronary stents underwent coronary CT angiography (CCTA) on a HDCT (Discovery CT 750 HD; GE Healthcare) with the high-resolution scanning mode. Four different reconstruction algorithms (HD-stand, HD-detail; HD-stand-plus; HD-detail-plus) were applied to reconstruct the stented coronary arteries. Image quality for stent characterization was assessed. Image noise and intrastent luminal diameter were measured. The relationship between the measurement of inner stent diameter (ISD) and the true stent diameter (TSD) and stent type were analysed. Results: The stent-dedicated kernel (HD-detail) offered the highest percentage (53.5%) of good image quality for stent characterization and the highest ratio (68.0 ± 8.4%) of visible stent lumen/true stent lumen for luminal diameter measurement at the expense of an increased overall image noise. The Pearson correlation coefficient between the ISD and TSD measurement and spearman correlation coefficient between the ISD measurement and stent type were 0.83 and 0.48, respectively. Conclusions: Compared with standard reconstruction algorithms, high-definition CT imaging technique with dedicated high-resolution reconstruction algorithm provides more accurate stent characterization and intrastent luminal diameter measurement.

  18. 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.

  19. 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.

  20. Optimal duration of dual antiplatelet therapy after coronary stent implantation.

    Science.gov (United States)

    Witberg, Guy; Lev, Eli; Kornowski, Ran

    2015-11-15

    Dual antiplatelet pharmacotherapy reduces ischemic events at the cost of excess bleeding in patients who underwent coronary stenting. The currently recommended treatment period is based on trials held some 20 years ago and not relevant to current clinical practice. In recent years, numerous clinical trials have tried to answer the question of what is the optimal duration of therapy to maximize clinical benefit. These trials showed 2 seemingly conflicting answers-on one hand, shorter treatment duration seems to be safer in reducing bleeding while not increasing ischemic events, and on the other hand, longer duration is superior in terms of preventing ischemic events albeit at the cost of increased bleeding rates. In this review, we summarize the evidence favoring each approach, highlight the limitations of the various pivotal clinical trials in this field, review future directions of research and changes in practice that may influence the duration of antiplatelet therapy, and attempt to propose a personalized approach to achieve maximal benefit for the individual patient. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Fibrin clot formation and fibrinolysis in patients with a history of coronary stent thrombosis.

    Science.gov (United States)

    Godschalk, Thea C; Konings, Joke; Govers-Riemslag, José W; Ten Berg, Jurriën M; Hackeng, Christian M; Ten Cate, Hugo

    2016-07-01

    Coronary stent thrombosis is a devastating complication of percutaneous coronary intervention (PCI). Multiple factors underlie the pathophysiological mechanisms of stent thrombosis. Previous studies demonstrated that patients with stent thrombosis, compared to control PCI patients, formed denser fibrin clots in vitro which were more resistant to fibrinolysis, suggesting that altered fibrin clot properties may contribute to the pathophysiology of stent thrombosis. We assessed the plasma fibrin clot formation and fibrinolysis of patients with and without stent thrombosis. Cases (patients with stent thrombosis) and matched controls (patients without stent thrombosis) were included for a matched case-control study. Matching was performed on indication and time of the index PCI (initial stent implantation) from the cases. Fibrin clot formation and fibrinolysis were assessed in vitro by turbidimetric assays, with human thrombin to initiate fibrin polymerization and tissue type plasminogen activator to initiate fibrinolysis. Lag time, maximal absorbance and clot lysis time were determined by these assays. In total, 27 cases and 27 controls were included. No significant differences were observed between cases and controls in lag time (173 vs. 162s, p=0.18), maximal absorbance (0.78 vs. 0.83, p=0.36), and clot lysis time (69 vs. 71min, p=0.78). Fibrin clot formation and fibrinolysis were not associated with stent thrombosis. Plasma fibrin clot formation and fibrinolysis were not significantly different between patients with stent thrombosis and matched control patients, suggesting that fibrin clot formation and fibrinolysis play no significant role in the pathophysiology of stent thrombosis. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Neointimal coverage and late apposition of everolimus-eluting bioresorbable scaffolds implanted in the acute phase of myocardial infarction: OCT data from the PRAGUE-19 study.

    Science.gov (United States)

    Toušek, Petr; Kočka, Viktor; Malý, Martin; Lisa, Libor; Buděšínský, Tomáš; Widimský, Petr

    2016-06-01

    Incomplete stent apposition and uncovered struts are associated with a higher risk of stent thrombosis. No data exist on the process of neointimal coverage and late apposition status of the bioresorbable vascular scaffold (BVS) when implanted in the highly thrombogenic setting of ST-segment elevation acute myocardial infarction (STEMI). The aim of this study was to assess the serial changes in strut apposition and early neointimal coverage of the BVS using optical coherence tomography (OCT) in selected patients enrolled in the PRAGUE-19 study. Intracoronary OCT was performed in 50 patients at the end of primary percutaneous coronary intervention for acute STEMI. Repeated OCT of the implanted BVS was performed in 10 patients. Scaffold area, scaffold mean diameter and incomplete strut apposition (ISA) were compared between baseline and control OCT. Furthermore, strut neointimal coverage was assessed during the control OCT. Mean scaffold area and diameter did not change between the baseline and control OCT (8.59 vs. 9.06 mm(2); p = 0.129 and 3.31 vs. 3.37 mm; p = 0.202, respectively). Differences were observed in ISA between the baseline and control OCT (0.63 vs. 1.47 %; p OCT was performed 4-6 weeks after BVS implantation, and 100 % covered struts in two patients 6 months after BVS implantation. Persistent strut apposition and early neointimal coverage were observed after biodegradable vascular scaffold implantation in patients with acute ST-segment elevation myocardial infarction.

  3. Two hour ambulation after coronary angioplasty and stenting with 6 F guiding catheters and low dose heparin

    NARCIS (Netherlands)

    Koch, K. T.; Piek, J. J.; de Winter, R. J.; Mulder, K.; Schotborgh, C. E.; Tijssen, J. G.; Lie, K. I.

    1999-01-01

    OBJECTIVE: To evaluate the feasibility and safety of ambulation of patients two hours after elective coronary angioplasty or stenting, or both. METHODS: Coronary angioplasty and stenting were performed using 6 F guiding catheters by the femoral approach and a standard dose of heparin 5000 IU. There

  4. New-generation stents compared with coronary bypass surgery for unprotected left main disease: A word of caution.

    Science.gov (United States)

    Benedetto, Umberto; Taggart, David P; Sousa-Uva, Miguel; Biondi-Zoccai, Giuseppe; Di Franco, Antonino; Ohmes, Lucas B; Rahouma, Mohamed; Kamel, Mohamed; Caputo, Massimo; Girardi, Leonard N; Angelini, Gianni D; Gaudino, Mario

    2018-01-12

    With the advent of bare metal stents and drug-eluting stents, percutaneous coronary intervention has emerged as an alternative to coronary artery bypass grafting surgery for unprotected left main disease. However, whether the evolution of stents technology has translated into better results after percutaneous coronary intervention remains unclear. We aimed to compare coronary artery bypass grafting with stents of different generations for left main disease by performing a Bayesian network meta-analysis of available randomized controlled trials. All randomized controlled trials with at least 1 arm randomized to percutaneous coronary intervention with stents or coronary artery bypass grafting for left main disease were included. Bare metal stents and drug-eluting stents of first- and second-generation were compared with coronary artery bypass grafting. Poisson methods and Bayesian framework were used to compute the head-to-head incidence rate ratio and 95% credible intervals. Primary end points were the composite of death/myocardial infarction/stroke and repeat revascularization. Nine randomized controlled trials were included in the final analysis. Six trials compared percutaneous coronary intervention with coronary artery bypass grafting (n = 4654), and 3 trials compared different types of stents (n = 1360). Follow-up ranged from 6 months to 5 years. Second-generation drug-eluting stents (incidence rate ratio, 1.3; 95% credible interval, 1.1-1.6), but not bare metal stents (incidence rate ratio, 0.63; 95% credible interval, 0.27-1.4), and first-generation drug-eluting stents (incidence rate ratio, 0.85; 95% credible interval, 0.65-1.1) were associated with a significantly increased risk of death/myocardial infarction/stroke when compared with coronary artery bypass grafting. When compared with coronary artery bypass grafting, the highest risk of repeat revascularization was observed for bare metal stents (hazard ratio, 5.1; 95% confidence interval, 2

  5. Modeling smooth muscle cell proliferation of coronary artery expanded with a drug eluting stent

    Science.gov (United States)

    Lyu, Suping

    2010-03-01

    The drug eluting coronary stent is for the treatment of narrowed coronary artery. A high strength balloon is used to open the narrowed vessel and leave behind a tiny metal mesh, or stent, to mechanically prevent the vessel from re-narrowing and biologically slow down proliferation of the smooth muscle cells. However, the drug eluting stents that had better performance also more seriously prevented the healing processes of the vessels, which could cause serious thrombotic reactions. In this study, we assume the healing process is controlled by proper proliferation of smooth cells. We also assume that the inflammation reactions and mechanical traction drive the smooth muscle cells to proliferate while the drug loaded in the stents drives the processes at the opposite direction. Numerical calculation was applied to the system. The drug distribution and elution durations, inflammation reactions and mechanical traction were discussed.

  6. 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 or r...... to cobalt-chromium bare-metal stents in this relevant, low-risk group of everyday patients. In addition, a comparison with similar BASKET patients will allow to estimate the impact of 12-versus 6-month dual antiplatelet therapy on these outcomes Udgivelsesdato: 2008/4......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...... or refute this hypothesis, we set up an 11-center 4-country prospective trial of 2260 consecutive patients treated with >= 3.0-mm stents only, randomized to receive Cypher (Johnson & Johnson, Miami Lakes, FL), Vision (Abbott Vascular, Abbott Laboratories, IL), or Xience stents (Abbott Vascular). Only...

  7. Rationale and design of EXPLORE: a randomized, prospective, multicenter trial investigating the impact of recanalization of a chronic total occlusion on left ventricular function in patients after primary percutaneous coronary intervention for acute ST-elevation myocardial infarction

    Science.gov (United States)

    2010-01-01

    Background In the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup. It is unclear whether ST-elevation myocardial infarction patients with a chronic total occlusion in a non-infarct related artery should undergo additional percutaneous coronary intervention of the chronic total occlusion on top of optimal medical therapy shortly after primary percutaneous coronary intervention. Possible beneficial effects include reduction in adverse left ventricular remodeling and preservation of global left ventricular function and improved clinical outcome during future coronary events. Methods/Design The Evaluating Xience V and left ventricular function in Percutaneous coronary intervention on occLusiOns afteR ST-Elevation myocardial infarction (EXPLORE) trial is a randomized, prospective, multicenter, two-arm trial with blinded evaluation of endpoints. Three hundred patients after primary percutaneous coronary intervention for ST-elevation myocardial infarction with a chronic total occlusion in a non-infarct related artery are randomized to either elective percutaneous coronary intervention of the chronic total occlusion within seven days or standard medical treatment. When assigned to the invasive arm, an everolimus-eluting coronary stent is used. Primary endpoints are left ventricular ejection fraction and left ventricular end-diastolic volume assessed by cardiac Magnetic Resonance Imaging at four months. Clinical follow-up will continue until five years. Discussion The ongoing EXPLORE trial is the first randomized clinical trial powered to investigate whether recanalization of a chronic total occlusion in a non-infarct related artery after primary percutaneous coronary intervention for ST-elevation myocardial infarction results in a better preserved residual left ventricular ejection fraction, reduced end-diastolic volume and enhanced clinical

  8. Evaluation Of Cobalt and Chromium Levels Following Implantation of Cobalt Chromium Coronary Stents: A Pilot Study.

    Science.gov (United States)

    Di Santo, Pietro; Motazedian, Pouya; Jung, Richard G; Simard, Trevor; Ramirez, F Daniel; Chong, Aun-Yeong; Glover, Christopher; Hibbert, Benjamin; Dwivedi, Girish

    2017-12-14

    Large increases in myocardial trace elements may adversely affect metabolism and become detrimental to cardiac function. Percutaneous coronary intervention (PCI) allows for the revascularisation of obstructive coronary artery disease using drug-eluting stents. These stents are comprised of a metallic stent backbone covered in an engineered polymer which delivers a drug over a prescribed period to the vessel wall. Given the potential implications of trace metal accumulation within the myocardium, our goal is to determine if metallic coronary stents are able to cause detectable elevations in serum cobalt and/or chromium levels. This study was a single centre, observational, pilot study with 20 patients who underwent planned PCI with implantation of a cobalt chromium drug eluting stent. Serum blood samples were drawn at baseline prior to PCI, 4hours post-stent deployment and at the time of routine follow-up after PCI. All blood samples were analysed for cobalt and chromium concentrations. The primary outcome of this study was the difference in serum cobalt and chromium levels at routine clinical follow-up. The mean follow up was 64.1±17.3 days. There was no difference in serum cobalt levels when comparing baseline and routine clinical follow up (3.32±2.14nmol/L vs. 3.14±1.00nmol/L, p=0.99) nor in chromium levels (4.24±2.31nmol/L vs. 2.82±1.22 nmol/L, p=0.11). There was also no difference between baseline and 4hours post-PCI serum concentrations. Percutaneous coronary intervention with cobalt chromium coronary stents does not appear to cause an elevation in these trace element serum concentrations. Copyright © 2017 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). All rights reserved.

  9. Coronary artery rupture during high-pressure post-dilatation of coronary stent in a heavily calcified lesion of an ectatic right coronary artery

    Directory of Open Access Journals (Sweden)

    Sina Ali

    2016-06-01

    Full Text Available Coronary artery perforation (CAP is a rare but feared complication of percutaneous coronary intervention. With the use of novel instruments, including hydrophilic and ultrarigid guidewires, rotablator devices, and cutting balloons, the success rate of intervention for coronary artery chronic total occlusion (CTOs and calcified lesions has increased. Along with these changes, the risk of CAP has also increased. In this case report, we present a tip III CAP due to high-pressure postdilatation of coronary stent in a heavily calcified lesion of an ectatic right coronary artery.

  10. [Percutaneous approach for the treatment of unprotected left main coronary stenosis. New perspectives with the use of coronary stents].

    Science.gov (United States)

    Pessanha, A V; Rodrigues, C; Fuks, V; Murad, H; Murad, M

    1997-03-01

    We describe a case of coronary stenosis located in an unprotected left main coronary artery, treated primarily and electively with the placement of a coronary stent. As a function of the large mass of myocardium involved, this patient would be considered a classical candidate for direct surgery, because the inherent risk involved with conventional balloon angioplasty, mainly due to the eventual occurrence of acute closure during the procedure. Since the previsibility of the immediate results with the use of coronary stents was significantly improved, we propose this new therapeutic approach for this traditionally surgical case, that has been performed with success and without any complication. This strategy for the treatment of unprotected left main lesions with the elective placement of Palmaz-Schatz stents, has not yet been proposed or applied in our country, and may represent a new universe of indication of percutaneous treatment of coronary artery disease, no longer approaching the left main stem only in special or emergency situations, usually a result of complications of left main manipulation during angioplasty of the coronary system. The patient involved in this case did not show any contraindication for the treatment with conventional open heart surgery.

  11. Selective endothelin A-receptor blockade attenuates coronary microvascular dysfunction after coronary stenting in patients with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Nikolaos Östlund Papadogeorgos

    2009-10-01

    Full Text Available Nikolaos Östlund Papadogeorgos, Mattias Bengtsson, Majid KalaniKarolinska Institute, Department of Clinical Sciences, Department of Cardiology, Danderyd Hospital, Stockholm, SwedenBackground: Endothelin-1 may be involved in the development of diabetic microangiopathy. We studied the effect of endothelin-1 blockade on myocardial microcirculation during coronary stenting.Patients and methods: Patients with type 2 diabetes and stable coronary artery disease undergoing elective percutaneous coronary intervention (PCI were randomized to bolus dose of 500 mg bosentan (n = 4, a dual endothelin receptor blocker, or intracoronary administration of 0.03 mmol BQ123 (n = 6, a selective endothelin A-receptor blocker, or placebo (n = 5, respectively. Coronary flow reserve (CFR was measured immediately post-PCI. CFR was also measured in five nondiabetic controls post-coronary stenting.Results: Patients in the placebo group had (P < 0.05 lower values of CFR (2.3 ± 1.2 as compared to those who received endothelin blockade (n = 10; 3.1 ± 0.7 and nondiabetic controls (4.9 ± 2.3. Patients who received BQ123 showed significantly higher CFR (3.3 ± 0.5; P < 0.05 as compared to those on placebo. Nondiabetic patients had significantly higher CFR as compared to patients with diabetes (4.9 ± 2.3 and 2.8 ± 1.0, respectively; P < 0.05. Conclusion: Coronary microvascular dysfunction is present during coronary stenting in patients with type 2 diabetes and may be reversed by selective endothelin A-receptor blockade. Targeting endothelin system may be of importance in protecting the myocardium against ischemic events during elective PCI in type 2 diabetic patients.Keywords: coronary flow reserve, diabetes, endothelin-1, coronary artery disease, coronary angioplasty

  12. Twelve-month outcomes after coronary stenting with the Genous bio-engineered R Stent in diabetic patients from the e-HEALING registry

    NARCIS (Netherlands)

    Damman, P.; Klomp, M.; Beijk, M.A.; Silber, S.; Grisold, M.; Ribeiro, E.E.; Suryapranata, H.; Wojcik, J.; Sim, K.H.; Tijssen, J.G.P.; Winter, R.J. de

    2011-01-01

    OBJECTIVES: We compared 12-month outcomes, regarding ischemic events, repeat intervention, and ST, between diabetic and nondiabetic patients treated with the Genous EPC capturing R stent during routine nonurgent percutaneous coronary intervention (PCI) using data from the multicenter, prospective

  13. Safety and Technical Success of Percutaneous Left Main Coronary Artery Stenting

    Science.gov (United States)

    Ali, Liaqat; Malik, Shahid Nawaz; Khalid, Abdullah Bin; Sultan, Mehboob; Sadiq, Nadeem

    2014-01-01

    Objective: Critical stenosis of left main coronary artery (LMCA) has always remained a challenge for interventional cardiologists. Conventionally Coronary Artery Bypass Grafting (CABG) is done for these patients but recently Percutaneous Coronary Intervention (PCI) is also being tried more frequently, but data of PCI is scarce in this regard. Our objective was to determine the safety and technical success rate of percutaneous left main coronary artery stenting. Methods: This was 12 month follow up study conducted at Pakistan Institute of Medical Sciences (PIMS), Islamabad from 11th Jan 2012 to 11th Jan 2013. All symptomatic patients who underwent coronary angiogram at PIMS and were found to have either isolated LMCA disease or coexisting osteal Left Anterior Descending (LAD) artery disease were potentially eligible for the study. Patients who had previous surgical treatment for coronary artery disease and those with renal dysfunction requiring dialysis were excluded. Patients were counselled in detail regarding the pros and cons of PCI versus CABG.Those who opted for PCI were included in the study. All these patients were treated with percutaneous left main coronary artery stenting with or without osteal LAD stenting. Results: Seventy two patients had LMCA disease during angiogram. Fifteen patients opted for CABG. Four patients did not meet the inclusion criteria, whereas 53 patients were finally enrolled. Mean age of patients were 55.45±10.275 years. Twenty nine patients were with acute coronary syndrome and 22 presented with unstable angina.PCI with stenting was technically successful in all patients. One patient died three months after PCI, there was no other mortality. Conclusion: Our study showed that Percutaneous Coronary Intervention (PCI) to LMS has good technical success rate; the safety of the procedure is also acceptable. PMID:25097507

  14. Diagnostic accuracy of 64 multislice CT angiography in the assessment of coronary in-stent restenosis: A meta-analysis

    Energy Technology Data Exchange (ETDEWEB)

    Sun Zhonghua [Discipline of Medical Imaging, Department of Imaging and Applied Physics, Curtin University of Technology, Perth, WA (Australia)], E-mail: z.sun@curtin.edu.au; Almutairi, Abdulrahman Marzouq D. [Discipline of Medical Imaging, Department of Imaging and Applied Physics, Curtin University of Technology, Perth, WA (Australia)

    2010-02-15

    Purpose: The aim of this study was to perform a meta-analysis of the diagnostic accuracy of 64-slice CT angiography for the detection of coronary in-stent restenosis in patients treated with coronary stents when compared to conventional coronary angiography. Materials and methods: A search of PUBMED/MEDLINE, ProQuest and Cochrane library databases for English literature was performed. Only studies comparing 64-slice CT angiography with conventional coronary angiography for the detection of coronary in-stent restenosis (more than 50% stenosis) were included for analysis. Sensitivity and specificity estimates pooled across studies were tested using a fixed effects model. Results: Fourteen studies met selection criteria for inclusion in the analysis. The mean value of assessable stents was 89%. Prevalence of in-stent restenosis following coronary stenting was 20% among these studies. Pooled estimates of the sensitivity and specificity of overall 64-slice CT angiography for the detection of coronary in-stent restenosis was 90% (95% CI: 86%, 94%) and 91% (95% CI: 90%, 93%), respectively, based on the evaluation of assessable stents. Diagnostic value of 64-slice CT angiography was found to decrease significantly when the analysis was performed with inclusion of nonassessable segments in five studies, with pooled sensitivity and specificity being 79% (95% CI: 68%, 88%) and 81% (95% CI: 77%, 84%). Stent diameter is the main factor affecting the diagnostic value of 64-slice CT angiography. Conclusion: Our results showed that 64-slice CT angiography has high diagnostic value (both sensitivity and specificity) for detection of coronary in-stent restenosis based on assessable segments when compared to conventional coronary angiography.

  15. In-Vitro Evaluation of Coronary Stents and 64-Detector-Row Computed Tomography Using a Newly Developed Model of Coronary Artery Stenosis

    Energy Technology Data Exchange (ETDEWEB)

    Schlosser, T.; Scheuermann, T.; Ulzheimer, S.; Mohrs, O.K.; Kuehling, M.; Albrecht, P.E.; Voigtlaender, T.; Barkhausen, J.; Schmermund, A. (Cardiovascular Center Bethanien (CCB), Frankfurt (DE))

    2008-02-15

    Background: Stent implantation is the predominant therapy for non-surgical myocardial revascularization in patients with coronary artery disease. However, despite substantial advances in multidetector computed tomography (MDCT) coronary imaging, a reliable detection of coronary in-stent restenosis is currently not possible. Purpose: To examine the ability of 64-detector-row CT to detect and to grade in-stent stenosis in coronary stents using a newly developed ex-vivo vessel phantom with a realistic CT density pattern, artificial stenosis, and a thorax phantom. Material and Methods: Four different stents (Liberte and Lunar ROX, Boston Scientific; Driver, Medtronic; Multi-Link Vision, Guidant) were examined. The stents were placed on a polymer tube with a diameter of 2.5, 3.0, 3.5, or 4.0 mm. Different degrees of stenosis (0%, 30%, 50%, 70-80%) were created inside the tube. For quantitative analysis, attenuation values were measured in the non-stenotic vessel outside the stent, in the non-stenotic vessel inside the stent, and in the stenotic area inside the stent. The grade of stenosis was visually assessed by two observers. Results: All stents led to artificial reduction of attenuation, the least degree of which was found in the Liberte stent (11.3+-10.2 HU) and the Multi-Link Vision stent (17.6+-17.9 HU; P 0.25). Overall, the non-stenotic vessel was correctly diagnosed in 55.5%, the low-grade stenosis in 58.3%, the intermediate stenosis in 63.8%, and the high-grade stenosis in 80.5%. In the 3.0-, 3.5-, and 4.0-mm vessels, in none of the cases was a non-stenotic or low-grade stenotic vessel misdiagnosed as intermediate or high-grade stenosis. The average deviation from the real grade of stenosis was 0.40 for the Liberte stent, 0.46 for the Lunar ROX stent, 0.45 for the Driver stent, and 0.58 for the Multi-Link Vision stent. Conclusion: Our ex-vivo data show that non-stenotic stents and low-grade in-stent stenosis can be reliably differentiated from intermediate and

  16. Reduction of late in-stent stenosis in a porcine coronary artery model by cobalt chromium stents with a nanocoat of polyphosphazene (Polyzene-F).

    Science.gov (United States)

    Stampfl, Ulrike; Sommer, Christof-Matthias; Thierjung, Heidi; Stampfl, Sibylle; Lopez-Benitez, Ruben; Radeleff, Boris; Berger, Irina; Richter, Goetz M

    2008-01-01

    The purpose of this study was to investigate the potential of nanoscale coating with the highly biocompatible polymer Polyzene-F (PZF), in combination with cobalt chromium and stainless steel stents, to reduce in-stent stenosis, thrombogenicity, and vessel wall injury and inflammation. One bare cobalt chromium, PZF-nanocoated stainless steel or PZF-nanocoated cobalt chromium stent was implanted in right coronary artery of 30 mini-pigs (4- or 12-week follow-up). Primary study end points were in-stent stenosis and thrombogenicity. Secondary study end points were vessel wall injury and inflammation as evaluated by microscopy and a new immunoreactivity score applying C-reactive protein (CRP), tumor-necrosis factor alpha (TNFalpha), and TGFbeta. At 12 weeks, angiography showed a significantly lower average loss in lumen diameter (2.1% +/- 3.05%) in PZF-nanocoated cobalt chromium stents compared with stents in the other groups (9.73% +/- 4.93% for bare cobalt chromium stents and 9.71% +/- 7% for PZF-nanocoated stainless steel stents; p = 0.04), which was confirmed at microscopy (neointima 40.7 +/- 16 lm in PZF-nanocoated cobalt chromium stents, 74.7 +/- 57.6 lm in bare cobalt chromium stents, and 141.5 +/- 109 lm in PZF-nanocoated stainless steel stents; p = 0.04). Injury and inflammation scores were low in all stents and were without significant differences. PZF-nanocoated cobalt chromium stents provided the highest efficacy in reducing in-stent stenosis at long-term follow-up. The PZF nanocoat proved to be biocompatible with respect to thromboresistance and inflammation. Our data suggest that its combination with cobalt chromium stents might provide an interesting passive stent platform.

  17. Long-term clinical effects of magnetic resonance imaging in patients with coronary artery stent implantation.

    Science.gov (United States)

    Kaya, Mehmet Gungor; Okyay, Kaan; Yazici, Huseyin; Sen, Nihat; Tavil, Yusuf; Turkoglu, Sedat; Timurkaynak, Timur; Ozdemir, Murat; Cemri, Mustafa; Yalcin, Ridvan; Cengel, Atiye

    2009-03-01

    We sought to investigate the early and late effects of magnetic resonance imaging (MRI) on stent thrombosis and major adverse coronary events after coronary artery stent (CAS) implantation at a long-term follow-up period. Forty-three patients (28 men, mean age 63+/-10 years) who underwent CAS implantation before MRI examination were included. MRI was performed on a 1.5-T MR-system with a phased array multicoil. An average of 1.3 stents per patient were implanted (1-4 stents). More than one MRI was performed for two patients. Patients who underwent MRI within 8 weeks after the procedure were included in the early-term group (17 patients), and those who underwent MRI after 8 weeks were included in the late-term group (26 patients). Mean follow-up period was 36+/-15 months. There was no acute or subacute stent thrombosis. Late stent thrombosis that resulted in acute myocardial infarction was observed in a patient from the early group after an operation for prostate hyperplasia 5 months after MRI, and the patient underwent percutaneous coronary artery angioplasty. De-nova lesion was observed in four patients in the early group and two patients in the late group (P=0.14). In-stent restenosis was recorded in two patients in the early group and three patients in the late group (P=0.98). Composite major adverse cardiac events (acute coronary syndrome, myocardial infarction, death, and cerebrovascular event) were observed in seven of the early-group patients (41%), and in six of the late-group patients (23%) (P=0.20). MRI can be safely performed in patients with CAS implantation both in the early and late course, and is not associated with an increased risk of major adverse clinical cardiac events at long-term follow-up.

  18. Detailing radio frequency heating induced by coronary stents: a 7.0 Tesla magnetic resonance study.

    Directory of Open Access Journals (Sweden)

    Davide Santoro

    Full Text Available The sensitivity gain of ultrahigh field Magnetic Resonance (UHF-MR holds the promise to enhance spatial and temporal resolution. Such improvements could be beneficial for cardiovascular MR. However, intracoronary stents used for treatment of coronary artery disease are currently considered to be contra-indications for UHF-MR. The antenna effect induced by a stent together with RF wavelength shortening could increase local radiofrequency (RF power deposition at 7.0 T and bears the potential to induce local heating, which might cause tissue damage. Realizing these constraints, this work examines RF heating effects of stents using electro-magnetic field (EMF simulations and phantoms with properties that mimic myocardium. For this purpose, RF power deposition that exceeds the clinical limits was induced by a dedicated birdcage coil. Fiber optic probes and MR thermometry were applied for temperature monitoring using agarose phantoms containing copper tubes or coronary stents. The results demonstrate an agreement between RF heating induced temperature changes derived from EMF simulations versus MR thermometry. The birdcage coil tailored for RF heating was capable of irradiating power exceeding the specific-absorption rate (SAR limits defined by the IEC guidelines by a factor of three. This setup afforded RF induced temperature changes up to +27 K in a reference phantom. The maximum extra temperature increase, induced by a copper tube or a coronary stent was less than 3 K. The coronary stents examined showed an RF heating behavior similar to a copper tube. Our results suggest that, if IEC guidelines for local/global SAR are followed, the extra RF heating induced in myocardial tissue by stents may not be significant versus the baseline heating induced by the energy deposited by a tailored cardiac transmit RF coil at 7.0 T, and may be smaller if not insignificant than the extra RF heating observed under the circumstances used in this study.

  19. Stent Thrombosis is the Primary Cause of ST-Segment Elevation Myocardial Infarction following Coronary Stent Implantation: A Five Year Follow-Up of the SORT OUT II Study

    DEFF Research Database (Denmark)

    Kristensen, S. L.; Galloe, A. M.; Thuesen, L.

    2014-01-01

    stent implantation, use of statins, initial PCI urgency (STEMI [primary PCI], NSTEMI/unstable angina [subacute PCI] or stable angina [elective PCI]), and glucose-lowering agents did not seem to influence risk of stent thrombosis. Conclusion: In a contemporary cohort of coronary stented patients, stent...

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

    Science.gov (United States)

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

    2017-10-03

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

  1. Successful Coronary Stent Retrieval from the Saphenous Vein Graft to Right Coronary Artery

    Directory of Open Access Journals (Sweden)

    Mustafa Aydin

    2009-01-01

    Full Text Available Stent dislodgement and migration is a rare but serious complication of stent usage. For extraction of unexpanded stents different techniques have been described previously. We describe a case which used small baloon catheter for retrieval of a stent from the SVG-RCA.

  2. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial

    DEFF Research Database (Denmark)

    Kelbaek, H.; Klovgaard, L.; Helqvist, S.

    2008-01-01

    OBJECTIVES: Our purpose was to evaluate the long-term use of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with complex coronary artery lesions. BACKGROUND: Although the use of SES has proved to be effective in patients with simple coronary artery lesions, there are limited...... data of the long-term outcome of patients with complex coronary artery lesions. METHODS: We randomly assigned 322 patients with total coronary occlusions or lesions located in bifurcations, ostial, or angulated segments of the coronary arteries to have SES or BMS implanted. RESULTS: At 3 years, major...

  3. Bioresorbable vascular scaffold (BVS) for in-stent chronic total occlusion: Antegrade recanalization and IVUS-guided BVS implantation by radial access

    Energy Technology Data Exchange (ETDEWEB)

    Medda, Massimo [Interventional Cardiology Unit, Istituto Clinico Sant' Ambrogio, Milano (Italy); Casilli, Francesco, E-mail: frcasill@tin.it [Interventional Cardiology Unit, Istituto Clinico Sant' Ambrogio, Milano (Italy); Bande, Marta [Interventional Cardiology Unit, Istituto Clinico Sant' Ambrogio, Milano (Italy); Latini, Maria Giulia [Cardiologia Interventistica, IRCCS Policlinico San Donato, San Donato Milanese, Milano (Italy); Ghommidh, Mehdi [Interventional Cardiology Unit, Istituto Clinico Sant' Ambrogio, Milano (Italy); Del Furia, Francesca [Unità Operativa di Cardiologia, Azienda Ospedaliera di Melegnano, Milano (Italy); Inglese, Luigi [Interventistica Cardiovascolare, Gruppo Sanitario Policlinico di Monza, Milano (Italy)

    2016-01-15

    The completely absorbable stents represent one of the latest innovations in the field of interventional cardiology, prospecting the possibility of “vascular repair”. In the published trials (ABSORB Cohort A and B, ABSORB EXTEND, and ABSORB II, III and IV) chronic total occlusions (CTOs) were considered an exclusion criteria. More recently the CTO-ABSORB pilot study demonstrated the safety and feasibility of bioresorbable vascular scaffold (BVS) use in case of CTO recanalization. We present the first case, to our knowledge, of in-stent occlusion successfully treated with an everolimus-eluting BVS and discuss its potential advantages in such kind of lesions.

  4. Microstructure and Deformation of Coronary Stents from CoCr-Alloys with Different Designs

    Directory of Open Access Journals (Sweden)

    Sabine Weiss

    2015-05-01

    Full Text Available Coronary heart disease is still one of the most common sources for death in western industrial countries. Since 1986, a metal vessel scaffold (stent has been inserted to prevent the vessel wall from collapsing. Most of these coronary stents are made from CrNiMo­steel (316L. Due to its austenitic structure, the material shows a good combination of strength, ductility, corrosion resistance, and biocompatibility. However, this material has some disadvantages like its non-MRI compatibility and its poor fluoroscopic visibility. Other typically used materials are the Co­Base alloys L-605 and F-562 which are MRI compatible as well as radiopaque. Another interesting fact is their excellent radial strength and therefore the ability to produce extra thin struts with increased strength. However, because of a strut diameter much less than 100 μm, the cross section consists of about 5 to 10 crystal grains (oligo­crystalline. Thus, very few or even just one grain can be responsible for the success or failure of the whole stent. To investigate the relation between microstructure, mechanical factors and stent design, commercially available Cobalt-Chromium stents were investigated with focus on distinct inhomogeneous plastic deformation due to crimping and dilation. A characteristic, material related deformation behavior with predominantly primary slip was identified to be responsible for the special properties of CoCr stents.

  5. Shrinking the Supply Chain for Implantable Coronary Stent Devices.

    Science.gov (United States)

    Moore, Sean S; O'Sullivan, Kevin J; Verdecchia, Francesco

    2016-02-01

    Stenting treatments for the management of disease in the heart, arterial and venous systems, biliary ducts, urethras, ureters, oesophageal tract and prostate have made enormous technical advances since their introduction into clinical use. The progression from metallic to polymer based bio-absorbable stents, coupled with the advances in additive manufacturing techniques, present a unique opportunity to completely re-envision the design, manufacture, and supply chain of stents. This paper looks at current stenting trends and proposes a future where the stent supply chain is condensed from ~150 days to ~20 min. The Cardiologist therefore has the opportunity to become a designer, manufacturer and user with patients receiving custom stents specific to their unique pathology that will be generated, delivered and deployed in the Cath-lab. The paper will outline this potentially revolutionary development and consider the technical challenges that will need to be overcome in order to achieve these ambitious goals. A high level overview of the generating eluting stents in situ program-GENESIS-is outlined including some early experimental work.

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

    NARCIS (Netherlands)

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

    2016-01-01

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

  7. Coronary artery aneurysm formation following implantation of a bioresorbable vascular scaffold for in-stent restenosis.

    Science.gov (United States)

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

    2017-06-01

    Coronary artery aneurysm (CAA) formation is a rare complication of coronary intervention that may develop after implantation of bare-metal or drug-eluting stents. The etiology of this entity appears to be multifactorial and its prognosis is poorly understood, but it has been associated with an increased risk of stent thrombosis. To date few cases of CAAs related to bioresorbable vascular scaffold (BVS) implantation have been reported, and the development of CAA after BVS implantation for the treatment of in-stent restenosis (ISR) has not been previously described. Here we present two cases of CAA formation after BVS, which represent the first demonstration of CAA formation after the use of BVS for ISR. Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

  8. Similar five-year outcome with paclitaxel- and sirolimus-eluting coronary stents

    DEFF Research Database (Denmark)

    Bligaard, Niels; Thuesen, Leif; Saunamäki, Kari

    2014-01-01

    OBJECTIVE: Millions of patients were treated with the sirolimus-eluting Cypher™ and the paclitaxel-eluting Taxus™ coronary stents with potential late-occurring increase in event rates. Therefore, the long-term outcome follow-up is of major clinical interest. DESIGN: In total, 2.098 unselected...

  9. Automatic detection of bioabsorbable coronary stents in IVUS images using a cascade of classifiers.

    Science.gov (United States)

    Rotger, David; Radeva, Petia; Bruining, Nico

    2010-03-01

    Bioabsorbable drug-eluting coronary stents present a very promising improvement to the common metallic ones solving some of the most important problems of stent implantation: the late restenosis. These stents made of poly-L-lactic acid cause a very subtle acoustic shadow (compared to the metallic ones) making difficult the automatic detection and measurements in images. In this paper, we propose a novel approach based on a cascade of GentleBoost classifiers to detect the stent struts using structural features to code the information of the different subregions of the struts. A stochastic gradient descent method is applied to optimize the overall performance of the detector. Validation results of struts detection are very encouraging with an average F-measure of 81%.

  10. Bioresorbable vascular scaffold for coronary in-stent restenosis: A novel concept

    Directory of Open Access Journals (Sweden)

    Surender Deora

    2014-07-01

    Full Text Available The management of patients with significant in-stent restenosis (ISR with drug-eluting stent is still not well defined. Various treatment modalities include plain old balloon angioplasty (POBA, metallic stent, cutting or scoring balloon and drug-eluting balloon (DEB. Bioresorbable vascular scaffold (BVS is the latest technology for the treatment of de novo coronary artery lesions. The use of BVS in ISR is based on the rationale of local drug delivery as achieved by DEB without the permanent bi-layer of metal and also stabilizes dissection flaps and prevents acute recoil as provided by metallic stent. To the best of our knowledge this is the first case report of the use of BVS in patient with ISR.

  11. Prospective registry evaluating safety and efficacy of cobalt-chromium stent implantation in patients with de novo coronary lesions.

    Science.gov (United States)

    Buszman, Paweł; Trznadel, Stanisław; Zurakowski, Aleksander; Milewski, Krzysztof; Kinasz, Leszek; Król, Marek; Kondys, Marek

    2007-09-01

    Cobalt-chromium (Co-Cr) stents are a new type of endovascular prostheses characterised by better mechanical properties than traditional stainless steel stents. To assess the safety and efficacy of percutaneous coronary interventions (PCI) using the new Co-Cr Kos stent (Balton, Poland). A total of 59 patients with coronary artery diseases (76% men, aged 60+/-9 years, diabetes - 16.9%, smoking - 62.7%, 11.8% - acute myocardial infarction) underwent PCI for de novo lesions in native coronary vessels. The patients were followed for 6 months for the occurrence of cardiac events. Quantitative coronary angiography was performed at baseline and after 6 months. In total, we implanted 62 stents in 59 coronary arteries. The mean diameter of the stents was 3.18+/-0.18 mm, and length - 14.62+/-2.12 mm. During a one-month follow-up period no cardiac events were noted. During a 6-month follow-up no death or new myocardial infarction were recorded. Control angiography was done in 55 (92%) subjects. Repeated target vessel revascularisation due to recurrent angina or in-stent restenosis was required in 10 (17%) patients; however, off-line core evaluation found significant re-narrowing in implanted stents (>50% diameter stenosis) only in 6 cases (10.9%). The mean late vessel lumen loss was 0.55+/-0.6 mm and stenosis 25.2+/-17.9%. Implantation of the new Co-Cr Kos stent during PCI is safe and effective.

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

    DEFF Research Database (Denmark)

    Rasmussen, Klaus; Maeng, Michael; Kaltoft, Anne

    2010-01-01

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

  13. Microvascular Coronary Flow Comparison in Acute Myocardial Infarction Angioplasty treated with a mesh covered stent (MGUARD Stent) versus Bare Metal Stent

    Energy Technology Data Exchange (ETDEWEB)

    Lindefjeld, Dante S., E-mail: dslindef@puc.cl [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Hospital Dr. Sótero del Río, Santiago-Chile (Chile); Guarda, Eduardo [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Méndez, Manuel [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Hospital Dr. Sótero del Río, Santiago-Chile (Chile); Martínez, Alejandro [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Pérez, Osvaldo [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Hospital Dr. Sótero del Río, Santiago-Chile (Chile); Fajuri, Alejandro; Marchant, Eugenio [Hospital Clínico, Pontificia Universidad Católica de Chile (Chile); Aninat, Mauricio; Torres, Humberto [Hospital Dr. Gustavo Fricke, Viña del Mar-Chile (Chile); Dussaillant, Gastón [Hospital Clínico Universidad de Chile, Santiago-Chile (Chile)

    2013-01-15

    Background: Distal embolization of thrombus/platelet aggregates decreases myocardial reperfusion during primary percutaneous coronary intervention (PCI), and is associated with worse immediate and long-term prognosis of patients with ST-elevation myocardial infarction (STEMI). Objective: Assess the efficacy of a mesh covered stent (MGuard™ stent, MGS) in preventing distal embolization and microvascular reperfusion impairment during primary PCI, compared with a bare metal stent (BMS). Methods: Forty patients with STEMI referred for primary PCI were randomized for stenting the culprit lesion with the MGS (n = 20) or a BMS (n = 20). Blinded experts performed off-line measurements of angiographic epicardial and microvascular reperfusion criteria: TIMI flow grade, myocardial blush, corrected TIMI frame count (cTFC). Results: At baseline clinical, angiographic and procedural variables were not different between groups. Post PCI TIMI flow grade was similar in both groups. We observed better myocardial Blush grade in group MGS compared to BMS (median value 3.0 vs 2.5, 2p = 0.006) and cTFC (mean cTFC: MGS 19.65 ± 4.07 vs BMS 27.35 ± 7.15, 2p < 0.001, cTFC mean difference MGS-BMS: 7.7, CI 95%: 3.94 to 11.46). MGS stent group had a higher percentage of successful angioplasty (cTFC ≤ 23: MGS 85% vs BMS 30%, 2p < 0.001). We had two cases of acute stent thrombosis (one for each group) at 30 days follow up, but no clinical events at 6 months follow up. Conclusions: In this exploratory study, MGS significantly improved microvascular reperfusion criteria compared with a BMS in primary PCI. However its safety and impact on clinical outcomes should be verified in larger randomized clinical trials.

  14. A Review of Stent Thrombosis Following Percutaneous Coronary Intervention at Tripler Army Medical Center: 2002–2012

    Science.gov (United States)

    Fentanes, Emilio; Wisenbaugh, Thomas

    2013-01-01

    Background Stent thrombosis is a leading cause of death after percutaneous coronary intervention (PCI). Over the past decade, 929 PCI procedures were performed. We have found that half of the 18 deaths occurring within 30-days were related to stent thrombosis, and that of 32 patients who had definite or probable stent thrombosis at up to 26 months after PCI, more than half (17) died. To reduce the incidence of this often-fatal outcome, we need to identify and avoid repeating mistakes. Methods We reviewed records and angiograms of 12 patients with definite stent thrombosis. Results Technical factors possibly relevant to stent thrombosis: only half the patients were treated with drug-eluting rather than bare metal stents. Intravascular ultrasound (IVUS) was used to confirm adequate deployment in only 2 cases. Only 1 stent was 10% compared to proximal or distal reference vessel diameter. An untreated edge dissection was identified in only one case. In 5 cases multiple stents were used in bifurcation stenoses including one case of culotte stenting, a well-known risk factor for stent thrombosis. Patient factors possibly relevant to stent thrombosis: Four patients were still smoking at the time of stent thrombosis. One patient had discontinued clopidogrel 10 months after receiving a bare metal stent, and had thrombosis 4 months later. Two years after receiving a drug-eluting stent, 1 patient had stent thrombosis 16 days after discontinuing clopidogrel for a prostate biopsy. In two cases of subsequent, sub-acute stent thrombosis, the stents had been deployed emergently for, respectively, STEMI in the setting of hip surgery and coronary bypass surgery for myocardial infarction associated with 3-vessel disease. Discussion To reduce the incidence of the often-fatal complication of stent thrombosis, we need to try harder to get our patients to quit smoking and to continue diligently following their compliance with clopidogrel. Patient selection is important: those with

  15. The EBC TWO Study (European Bifurcation Coronary TWO): A Randomized Comparison of Provisional T-Stenting Versus a Systematic 2 Stent Culotte Strategy in Large Caliber True Bifurcations.

    Science.gov (United States)

    Hildick-Smith, David; Behan, Miles W; Lassen, Jens F; Chieffo, Alaide; Lefèvre, Thierry; Stankovic, Goran; Burzotta, Francesco; Pan, Manuel; Ferenc, Miroslaw; Bennett, Lorraine; Hovasse, Thomas; Spence, Mark J; Oldroyd, Keith; Brunel, Philippe; Carrie, Didier; Baumbach, Andreas; Maeng, Michael; Skipper, Nicola; Louvard, Yves

    2016-09-01

    For the treatment of coronary bifurcation lesions, a provisional strategy is superior to systematic 2-stent techniques for the most bifurcation lesions. However, complex anatomies with large side branches (SBs) with significant ostial disease length are considered by expert consensus to warrant a 2-stent technique upfront. This consensus view has not been scientifically assessed. Symptomatic patients with large caliber true bifurcation lesions (SB diameter ≥2.5 mm) and significant ostial disease length (≥5 mm) were randomized to either a provisional T-stent strategy or a dual stent culotte technique. Two hundred patients aged 64±10 years, 82% male, were randomized in 20 European centers. The clinical presentations were stable coronary disease (69%) and acute coronary syndromes (31%). SB stent diameter (2.67±0.27 mm) and length (20.30±5.89 mm) confirmed the extent of SB disease. Procedural success (provisional 97%, culotte 94%) and kissing balloon inflation (provisional 95%, culotte 98%) were high. Sixteen percent of patients in the provisional group underwent T-stenting. The primary end point (a composite of death, myocardial infarction, and target vessel revascularization at 12 months) occurred in 7.7% of the provisional T-stent group versus 10.3% of the culotte group (hazard ratio, 1.02; 95% confidence interval, 0.78-1.34; P=0.53). Procedure time, x-ray dose, and cost all favored the simpler procedure. When treating complex coronary bifurcation lesions with large stenosed SBs, there is no difference between a provisional T-stent strategy and a systematic 2-stent culotte strategy in a composite end point of death, myocardial infarction, and target vessel revascularization at 12 months. URL: http://www.clinicaltrials.gov. Unique identifier: NCT 01560455. © 2016 American Heart Association, Inc.

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

    Directory of Open Access Journals (Sweden)

    Darío Echeverri

    2010-04-01

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

  17. A Novel Stent Coated with Antibodies to Endoglin Inhibits Neointimal Formation of Porcine Coronary Arteries

    Directory of Open Access Journals (Sweden)

    Song Cui

    2014-01-01

    Full Text Available Endoglin/CD105 is an accessory protein of the transforming growth factor-β receptor system that plays a critical role in proliferation of endothelial cells and neovasculature. Here, we aimed to assess the effect of novel stents coated with antibodies to endoglin (ENDs on coronary neointima formation. Thirty ENDs, thirty sirolimus-eluting stents (SESs, and thirty bare metal stents (BMSs were randomly assigned and placed in the coronary arteries in 30 juvenile pigs. Histomorphometric analysis and scanning electron microscopy were performed after stent implantation. Our results showed that after 7 days, there was no difference in the neointimal area and percent area stenosis in ENDs compared with SMSs or BMSs. After 14 days, the neointima area and percent area stenosis in ENDs were markedly decreased than those in BMSs or SESs (P<0.05. Moreover, the percentage of reendothelialization was significantly higher in ENDs than that in SESs or BMSs (P<0.01 at 7 and 14 days. The artery injury and the inflammation scores were similar in all groups at 7 and 14 days. In conclusion, our results demonstrated for the first time to our knowledge that endoglin antibody-coated stents can markedly reduce restenosis by enhancing reendothelialization in the porcine model and potentially offer a new approach to prevent restenosis.

  18. Flow disturbances in stent-related coronary evaginations: a computational fluid-dynamic simulation study.

    Science.gov (United States)

    Radu, Maria D; Pfenniger, Aloïs; Räber, Lorenz; de Marchi, Stefano F; Obrist, Dominik; Kelbæk, Henning; Windecker, Stephan; Serruys, Patrick W; Vogel, Rolf

    2014-05-01

    Angiographic ectasias and aneurysms in stented segments have been associated with late stent thrombosis. Using optical coherence tomography (OCT), some stented segments show coronary evaginations reminiscent of ectasias. The purpose of this study was to explore, using computational fluid-dynamic (CFD) simulations, whether OCT-detected coronary evaginations can induce local changes in blood flow. OCT-detected evaginations are defined as outward bulges in the luminal vessel contour between struts, with the depth of the bulge exceeding the actual strut thickness. Evaginations can be characterised cross-sectionally by depth and along the stented segment by total length. Assuming an ellipsoid shape, we modelled 3-D evaginations with different sizes by varying the depth from 0.2-1.0 mm, and the length from 1-9 mm. For the flow simulation we used average flow velocity data from non-diseased coronary arteries. The change in flow with varying evagination sizes was assessed using a particle tracing test where the particle transit time within the segment with evagination was compared with that of a control vessel. The presence of the evagination caused a delayed particle transit time which increased with the evagination size. The change in flow consisted locally of recirculation within the evagination, as well as flow deceleration due to a larger lumen - seen as a deflection of flow towards the evagination. CFD simulation of 3-D evaginations and blood flow suggests that evaginations affect flow locally, with a flow disturbance that increases with increasing evagination size.

  19. Role of red blood cell distribution in predicting drug-eluting stent restenosis in patients with stable angina pectoris after coronary stenting.

    Science.gov (United States)

    Zhao, Kai; Li, Yong-Jian; Gao, Sheng

    2015-05-01

    It has been reported that increased red blood cell distribution width (RDW) predicts adverse events in cardiovascular disease and in patients undergoing percutaneous coronary intervention. However, the role of serum RDW levels in drug-eluting stent (DES) restenosis remains unclear. We aimed to investigate the relationship between serum RDW levels and in-stent restenosis (ISR) after coronary stenting with DES in stable angina pectoris (SAP) patients. A total of 293 consecutive chronic SAP patients with coronary DES implantation were enrolled in this study. The ISR was analyzed by coronary angiography analysis at a mean follow-up of 8 months. According to whether ISR was detected, patients were divided into two groups: the ISR group (n=45) and the non-ISR group (n=247). Serum RDW was assessed both at admission and at the 8-month follow-up in all patients. Standard medication was continued throughout the investigation period. Baseline characteristics of the two groups were similar. Patients in the ISR group had significantly higher RDW levels compared with patients in the non-ISR group both at admission and at follow-up (Psmoking, RDW levels, C-reactive protein levels, stent length, and stent diameter were associated independently with ISR. Serum RDW level may independently predict ISR at both admission and follow-up in SAP patients with coronary DES implantation, which indicates that a chronic inflammatory response might be involved in the pathogenesis of ISR.

  20. Treatment of high risk symptomatic intracranial atherosclerosis with balloon mounted coronary stents and Wingspan stents: single center experience over a 10 year period.

    Science.gov (United States)

    Tarlov, Nicholas; Jahan, Reza; Saver, Jeffrey L; Sayre, James W; Ali, Latisha K; Kim, Doojin; Duckwiler, Gary R; Tateshima, Satoshi; Viñuela, Fernando; Liebeskind, David S

    2012-01-01

    Stenting of symptomatic intracranial atherosclerosis remains under investigation, yet this option to potentially avert subsequent stroke has been offered at select centers under humanitarian device exemption and off-label use for several years. Retrospective case series of consecutive patients undergoing stenting with Wingspan and balloon mounted coronary stents for symptomatic intracranial atherosclerosis at a single institution. Recurrent symptomatic ischemia in the territory of the stented artery was ascertained. Rates of recurrent ischemic stroke were calculated per patient-year of follow-up and were compared with medically treated patients in the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial. During the 10 year study period, 41 cases of intracranial stenting were identified. Stenoses were severe (>70%) in 88% of patients. Stenting procedures occurred a median of 14 days from the most recent symptomatic event. 19 Wingspan stents and 22 balloon mounted coronary stents were deployed. Four strokes occurred within 24 h of stenting, seven within 1 month and eight within 3 months. By 3 months after stenting, no further strokes occurred during up to 2 years of follow-up. Patients had 0.194 ischemic strokes per person-year of follow-up, compared with 0.083 ischemic strokes per person-year of follow-up in the aspirin arm of WASID and 0.065 ischemic strokes per person-year of follow-up in the warfarin arm of WASID. Stenting of symptomatic intracranial atherosclerosis in a high risk subset of cases with advanced degree of luminal stenosis may be associated with an increased early risk of recurrent ischemic stroke.

  1. Modelling Drug Release from Polymer-Free Coronary Stents with Microporous Surfaces.

    Science.gov (United States)

    Vo, Tuoi T N; Morgan, Sarah; McCormick, Christopher; McGinty, Sean; McKee, Sean; Meere, Martin

    2017-12-08

    Traditional coronary drug-eluting stents (DES) are made from metal and are coated with a permanent polymer film containing an anti-proliferative drug. Subsequent to stent deployment in a diseased coronary artery, the drug releases into the artery wall and helps prevent restenosis by inhibiting the proliferation of smooth muscle cells. Although this technology has proven to be remarkably successful, there are ongoing concerns that the presence of a polymer in the artery can lead to deleterious medical complications, such as late stent thrombosis. Polymer-free DES may help overcome such shortcomings. However, the absence of a rate-controlling polymer layer makes optimisation of the drug release profile a particular challenge. The use of microporous stent surfaces to modulate the drug release rate is an approach that has recently shown particularly promising clinical results. In this study, we develop a mathematical model to describe drug release from such stents. In particular, we develop a mathematical model to describe drug release from microporous surfaces. The model predicts a two-stage release profile, with a relatively rapid initial release of most of the drug, followed by a slower release of the remaining drug. In the model, the slow release phase is accounted for by an adsorption/desorption mechanism close to the stent surface. The theoretical predictions are compared with experimental release data obtained in our laboratory, and good agreement is found. The valuable insights provided by our model will serve as a useful guide for designing the enhanced polymer-free stents of the future. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

  2. Synergy between direct coronary stenting technique and use of the novel thin strut cobalt chromium Skylor™ stent: the MACE in follow up patients treated with Skylor stent [MILES Study].

    Science.gov (United States)

    Giordano, Arturo; Polimeno, Michele; Corcione, Nicola; Fattore, Luciano; Di Lorenzo, Luigi; Biondi-Zoccai, Giuseppe; Ferraro, Paolo; Romano, Maria Fiammetta

    2012-02-01

    Despite significant improvements in stent platform, currently available bare-metal stents (BMS) are still associated with restenosis. Thin-strut design cobalt-chromium alloys hold the promise of improving results of BMS, especially when implanted with direct technique. We performed an observational study to appraise outcomes of the novel Skylor™ stent, stratifying outcomes according to stenting technique. We included all consecutive patients undergoing coronary stenting with Skylor™ at 2 centers between 2006 and 2009. The primary end-point was the long-term rate of major adverse cardiac events (MACE, i.e. death, myocardial infarction (MI), coronary artery bypass grafting (CABG) or target vessel revascularization (TVR)). As pre-specified analysis, we compared patients undergoing direct stenting versus those stent implantation following predilation. A total of 1020 patients were included (1292 Skylor™ stents), with procedural success obtained in 99%. Comparing patients undergoing direct stenting (66%) versus pre-dilation (34%) at 16±7 months of follow-up, MACE had occurred in, respectively, 8% versus 14% (p=0.001), with death in 1% versus 2= (p=0.380), MI in 1% versus 2% (p=0.032), CABG in 0.2% versus 2% (p=0.012), and TVR in 6% versus 9% [p=0.071]. Even at multivariable analysis with propensity adjustment, direct stenting was associated with significantly fewer MACE [hazard ratio 0.60 [0.38-0.93], p=0.024]. This observational study suggests the presence of a beneficial synergy between direct coronary stenting technique and use of the novel thin-strut cobalt-chromium Skylor™ stent in real-world patients undergoing PCI.

  3. In vivo evaluation of a biolimus eluting nickel titanium self expanding stent with overlapping balloon expandable drug eluting and bare metal stents in a porcine coronary model.

    Science.gov (United States)

    Cilingiroglu, Mehmet; Elliott, James; Sangi, Pramod; Matthews, Holly; Tio, Fermin; Trauthen, Brett; Elicker, John; Bailey, Steven R

    2009-01-01

    Long lesions and complex vessel anatomy frequently require the use of overlapping stents to treat a lesion. The purpose of this study was to evaluate the long-term effects of overlapping the Axxess Biolimus A9 eluting stent (BES) with two of the most commonly used, commercially available drug eluting stents. These stents were compared to BxVelocity bare metal (BMS) stents in a porcine coronary stent-injury model. Nineteen juvenile farm swine, 25-35 kg in weight, 3-6 months in age were utilised. Each animal received an Axxess stent to their coronary artery as permitted by the individual animal's anatomy. A second stent, either a Cypher, sirolimus eluting stent (SES) or, a Taxus, paclitaxel eluting stent (PES), or a BxVelocity bare metal stent (BMS) were implanted in an overlapped fashion. The animals were then followed for either 28 or 180 days as specified by a randomisation scheme. At the end of each follow-up period, they were euthenised, and the vessels containing the overlapping stents were harvested, processed into histological sections, and analysed. Compared to bare metal stents, overlapped segments using DES exhibited delayed vascular healing compared to both the proximal and distal non-overlap sites at each of the follow-up time point. Overall, in the non-overlap stent segments, SES induced significantly more inflammation and neointimal hyperplasia compared to PES and BMS. In this study of BMS and two different types of DES overlapped with the Axxess Biolimus A9 eluting stent, we found that while there was a delay in the degree of vascular healing with DES compared to BMS, the specific type of DES that was overlapped with BES did not affect the behaviour of the overlap zone in terms of most of the histomorphometric measures at 28 or 180 days. This was true whether the stent was drug eluting or bare metal. More inflammation with delayed healing was seen in the SES compared to PES and BMS.

  4. Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary arteries.

    Science.gov (United States)

    Popma, Jeffrey J; Leon, Martin B; Moses, Jeffrey W; Holmes, David R; Cox, Nicholas; Fitzpatrick, Michelle; Douglas, John; Lambert, Charles; Mooney, Michael; Yakubov, Steven; Kuntz, Richard E

    2004-12-21

    Sirolimus-eluting stents (SESs) reduce angiographic restenosis in patients with focal, native coronary artery stenoses. This study evaluated the usefulness of SESs in complex native-vessel lesions at high risk for restenosis. Angiographic follow-up at 240 days was obtained in 701 patients with long (15- to 25-mm) lesions in small-diameter (2.5- to 3.5-mm) native vessels who were randomly assigned to treatment with SESs or bare-metal stents (BMSs) in the SIRIUS trial. Quantitative angiographic measurements of minimal lumen diameter and percent diameter stenosis were obtained within the treated segment, within the stent, and within its 5-mm proximal and distal edges. Patients treated with SESs had lower rates of binary (>50% diameter stenosis) angiographic restenosis within the segment (8.9% versus 36.3% with the BMS; P<0.001) and within the stent (3.2% versus 35.4% with the BMS; P<0.001). SESs were associated with significantly less late lumen loss within the treated segment, within the stent, and within its 5-mm proximal and distal edges (all P<0.001). The reduction of restenosis with the SES was consistent in patients at risk for restenosis, including those with small vessels, long lesions, and diabetes mellitus. The frequency of late aneurysms was similar in the 2 groups. Compared with BMSs, SESs reduced angiographic late lumen loss within the stent and its adjacent 5-mm margins in patients with complex native-vessel lesions.

  5. 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....

  6. Multi-objective optimization of coronary stent using Kriging surrogate model.

    Science.gov (United States)

    Li, Hongxia; Gu, Junfeng; Wang, Minjie; Zhao, Danyang; Li, Zheng; Qiao, Aike; Zhu, Bao

    2016-12-28

    In stent design optimization, the functional relationship between design parameters and design goals is nonlinear, complex, and implicit and the multi-objective design of stents involves a number of potentially conflicting performance criteria. Therefore it is hard and time-consuming to find the optimal design of stent either by experiment or clinic test. Fortunately, computational methods have been developed to the point whereby optimization and simulation tools can be used to systematically design devices in a realistic time-scale. The aim of the present study is to propose an adaptive optimization method of stent design to improve its expansion performance. Multi-objective optimization method based on Kriging surrogate model was proposed to decrease the dogboning effect and the radial elastic recoil of stents to improve stent expansion properties and thus reduce the risk of vascular in-stent restenosis injury. Integrating design of experiment methods and Kriging surrogate model were employed to construct the relationship between measures of stent dilation performance and geometric design parameters. Expected improvement, an infilling sampling criterion, was employed to balance local and global search with the aim of finding the global optimal design. A typical diamond-shaped coronary stent-balloon system was taken as an example to test the effectiveness of the optimization method. Finite element method was used to analyze the stent expansion of each design. 27 iterations were needed to obtain the optimal solution. The absolute values of the dogboning ratio at 32 and 42 ms were reduced by 94.21 and 89.43%, respectively. The dogboning effect was almost eliminated after optimization. The average of elastic recoil was reduced by 15.17%. This article presents FEM based multi-objective optimization method combining with the Kriging surrogate model to decrease both the dogboning effect and radial elastic recoil of stents. The numerical results prove that the proposed

  7. OCT guidance during stent implantation in primary PCI: A randomized multicenter study with nine months of optical coherence tomography follow-up.

    Science.gov (United States)

    Kala, Petr; Cervinka, Pavel; Jakl, Martin; Kanovsky, Jan; Kupec, Andrej; Spacek, Radim; Kvasnak, Martin; Poloczek, Martin; Cervinkova, Michaela; Bezerra, Hiram; Valenta, Zdenek; Attizzani, Guilherme F; Schnell, Audrey; Hong, Lu; Costa, Marco A

    2018-01-01

    To assess the possible merits of optical coherence tomography (OCT) guidance in primary percutaneous coronary intervention (pPCI). 201 patients with ST-elevation myocardial infarction (STEMI) were enrolled in this study. Patients were randomized either to pPCI alone (angio-guided group, n=96) or to pPCI with OCT guidance (OCT-guided group, n=105) and also either to biolimus A9 or to everolimus-eluting stent implantation. All patients were scheduled for nine months of follow-up angiography and OCT study. OCT guidance led to post-pPCI optimization in 29% of cases (59% malapposition and 41% dissections). No complications were found related to the OCT study. OCT analysis at nine months showed significantly less in-segment area of stenosis (6% [-11, 19] versus 18% [3, 33]; p=0.0002) in favor of the OCT-guided group. The rate major adverse cardiovascular events were comparable at nine months in both groups (3% in the OCT group versus 2% in the angio-guided group; p=0.87). This study demonstrates the safety of OCT guidance during pPCI. The use of OCT optimized stent deployment in 1/3 of patients in this clinical scenario and significantly reduced in-segment area of stenosis at nine months of follow-up. Whether such improvements in OCT endpoints will have a positive impact on late clinical outcomes, they demand both a larger and longer-term follow-up study. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. Sequential structural and fluid dynamic numerical simulations of a stented bifurcated coronary artery.

    Science.gov (United States)

    Morlacchi, Stefano; Chiastra, Claudio; Gastaldi, Dario; Pennati, Giancarlo; Dubini, Gabriele; Migliavacca, Francesco

    2011-12-01

    Despite their success, stenting procedures are still associated to some clinical problems like sub-acute thrombosis and in-stent restenosis. Several clinical studies associate these phenomena to a combination of both structural and hemodynamic alterations caused by stent implantation. Recently, numerical models have been widely used in the literature to investigate stenting procedures but always from either a purely structural or fluid dynamic point of view. The aim of this work is the implementation of sequential structural and fluid dynamic numerical models to provide a better understanding of stenting procedures in coronary bifurcations. In particular, the realistic geometrical configurations obtained with structural simulations were used to create the fluid domains employed within transient fluid dynamic analyses. This sequential approach was applied to investigate the final kissing balloon (FKB) inflation during the provisional side branch technique. Mechanical stresses in the arterial wall and the stent as well as wall shear stresses along the arterial wall were examined before and after the FKB deployment. FKB provoked average mechanical stresses in the arterial wall almost 2.5 times higher with respect to those induced by inflation of the stent in the main branch only. Results also enlightened FKB benefits in terms of improved local blood flow pattern for the side branch access. As a drawback, the FKB generates a larger region of low wall shear stress. In particular, after FKB the percentage of area characterized by wall shear stresses lower than 0.5 Pa was 79.0%, while before the FKB it was 62.3%. For these reasons, a new tapered balloon dedicated to bifurcations was proposed. The inclusion of the modified balloon has reduced the mechanical stresses in the proximal arterial vessel to 40% and the low wall shear stress coverage area to 71.3%. In conclusion, these results show the relevance of the adopted sequential approach to study the wall mechanics and

  9. Coronary stenting approaches in the treatment of chronic total occlusion: contemporary registry-based experience.

    Science.gov (United States)

    Vaduganathan, Muthiah; Kornowski, Ran; Vaknin-Assa, Hana; Greenberg, Gabriel; Bental, Tamir; Lev, Eli I; Assali, Abid R

    2016-09-01

    This 'real-world' investigation attempted to determine the long-term prognoses of patients who have undergone successful revascularization of chronic total occlusion (CTO) lesions. All consecutive unselected patients from January 2006 to June 2011, undergoing stenting for CTO (n = 272), were retrospectively identified through an institutional registry. Procedural failure was defined as final diameter stenosis greater than 30% or postdilatation thrombolysis in myocardial infarction flow less than 3. Outcomes were assessed based on stenting type [bare metal stent (BMS), drug-eluting stent (DES), or mixed] in the successful procedural cohort. Multiple logistic regression analyses were used to account for known baseline cardiovascular risk imbalances. The primary endpoint was 2-year target vessel revascularization. Overall procedural failure occurred in 55 (20.2%) patients presenting with CTO lesions. Failed revascularization was independently associated with multivessel disease, lesion lengths greater than 15 mm, tortuous segments, and presence of calcifications. Major complications included coronary dissection (10%) and perforation (2%). Of the successful procedures, 141 (64%) underwent pure DES, 46 (21%) pure BMS, and 34 (15%) mixed stenting. At 2-year follow-up, fewer patients in the DES group required repeat revascularization compared to the mixed stenting group (6 vs. 26%; P = 0.002). Mixed stenting was an independent predictor of long-term target vessel revascularization (adjusted odds ratio 2.1, 95% confidence interval 1.1-4.1, P = 0.02) compared to DES. Failed revascularization of CTO lesions occurs in a fifth of patients and appears to be associated with complex vessel anatomy. Our data suggest that DES use in this setting are associated with improved 2-year clinical endpoints compared with pure BMS or mixed stenting approaches.

  10. Coronary stenting as an adjunct to balloon angioplasty

    NARCIS (Netherlands)

    B.H. Strauss (Bradley)

    1991-01-01

    textabstractAndreas Gruentzig initiated the era of interventional cardiology in 19n with the introduction of percutaneous transluminal coronary angioplasty (PTCA) (1). The acceptance of coronary angioplasty is obvious by the widespread use of the procedure (>300,000 cases in the United States in

  11. Drug eluting stent induced coronary artery aneurysm repair by exclusion. Where are we headed?

    Science.gov (United States)

    Subramaniam, Krishnan Ganapathy; Akhunji, Zakir

    2009-07-01

    We present a case of left anterior descending (LAD) coronary artery aneurysm at the site of previous stent placement 3 years previously. The patient presented with recent worsening of angina. Angiography and 64 slice CT angiography confirmed the presence of 6mm aneurysm of LAD at the site of previous stent involving the origin of diagonal, with thrombus proximal and distal to the stent. This patient was successfully managed by taking the posterior wall of the anterior descending artery while suturing the heel of the left internal mammary artery (LIMA)-LAD anastomosis. The idea was to create severe stenosis upstream to prevent distal embolisation from the site of aneurysm. The diagonal was grafted with a saphenous venous graft. Follow-up angiogram at 3 months demonstrated successful exclusion of the aneurysm and unobstructed flow through the grafts.

  12. Long-term efficacy and safety of biodegradable-polymer biolimus-eluting stents: main results of the Basel Stent Kosten-Effektivitäts Trial-PROspective Validation Examination II (BASKET-PROVE II), a randomized, controlled noninferiority 2-year outcome trial.

    Science.gov (United States)

    Kaiser, Christoph; Galatius, Soeren; Jeger, Raban; Gilgen, Nicole; Skov Jensen, Jan; Naber, Christoph; Alber, Hannes; Wanitschek, Maria; Eberli, Franz; Kurz, David J; Pedrazzini, Giovanni; Moccetti, Tiziano; Rickli, Hans; Weilenmann, Daniel; Vuillomenet, André; Steiner, Martin; Von Felten, Stefanie; Vogt, Deborah R; Wadt Hansen, Kim; Rickenbacher, Peter; Conen, David; Müller, Christian; Buser, Peter; Hoffmann, Andreas; Pfisterer, Matthias

    2015-01-06

    Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear. To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; -1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES. In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. http://www.clinicaltrials.gov. Unique identifier: NCT01166685. © 2014 American Heart Association, Inc.

  13. [Progress in genetic and epigenetic research on in-stent restenosis after percutaneous coronary interventions].

    Science.gov (United States)

    Kang, Yan-hong; Lao, Hai-yan; Yu, Xi-yong; Chen, Ji-yan; Zhong, Shi-long

    2012-02-01

    Coronary heart disease is one of the most important causes of death in human, and consumes vast medical resources. Percutaneous coronary intervention (PCI) has been a significant breakthrough for its treatment. However, clinical application has been hampered by in-stent restenosis (ISR). Although drug eluting stent (DES) has reduced the occurrence of restenosis, incidence of ISR is still about 5% to 10%. The main reasons for restenosis after PCI are hyperplasia of vascular endothelial cells and smooth muscle cell migration. The exact mechanism of personalized differences in restenosis is not clear yet, but there may be a variety of risk factors. In addition to aging, smoking and diabetes, an increasing number of studies have found that genetic and epigenetic factors play an important role in ISR. In this article, authors have reviewed genetic and epigenetic factors on the progression of ISR, which may help to determine the genetic risk factors in patients with ISR after PCI.

  14. Novel nanostructured biomaterials: implications for coronary stent thrombosis

    Science.gov (United States)

    Karagkiozaki, Varvara; Karagiannidis, Panagiotis G; Kalfagiannis, Nikolaos; Kavatzikidou, Paraskevi; Patsalas, Panagiotis; Georgiou, Despoina; Logothetidis, Stergios

    2012-01-01

    Background Nanomedicine has the potential to revolutionize medicine and help clinicians to treat cardiovascular disease through the improvement of stents. Advanced nanomaterials and tools for monitoring cell–material interactions will aid in inhibiting stent thrombosis. Although titanium boron nitride (TiBN), titanium diboride, and carbon nanotube (CNT) thin films are emerging materials in the biomaterial field, the effect of their surface properties on platelet adhesion is relatively unexplored. Objective and methods In this study, novel nanomaterials made of amorphous carbon, CNTs, titanium diboride, and TiBN were grown by vacuum deposition techniques to assess their role as potential stent coatings. Platelet response towards the nanostructured surfaces of the samples was analyzed in line with their physicochemical properties. As the stent skeleton is formed mainly of stainless steel, this material was used as reference material. Platelet adhesion studies were carried out by atomic force microscopy and scanning electron microscopy observations. A cell viability study was performed to assess the cytocompatibility of all thin film groups for 24 hours with a standard immortalized cell line. Results The nanotopographic features of material surface, stoichiometry, and wetting properties were found to be significant factors in dictating platelet behavior and cell viability. The TiBN films with higher nitrogen contents were less thrombogenic compared with the biased carbon films and control. The carbon hybridization in carbon films and hydrophilicity, which were strongly dependent on the deposition process and its parameters, affected the thrombogenicity potential. The hydrophobic CNT materials with high nanoroughness exhibited less hemocompatibility in comparison with the other classes of materials. All the thin film groups exhibited good cytocompatibility, with the surface roughness and surface free energy influencing the viability of cells. PMID:23269867

  15. Optical Coherence Tomography Findings in Patients With Coronary Stent Thrombosis: A Report of the PRESTIGE Consortium (Prevention of Late Stent Thrombosis by an Interdisciplinary Global European Effort).

    Science.gov (United States)

    Adriaenssens, Tom; Joner, Michael; Godschalk, Thea C; Malik, Nikesh; Alfonso, Fernando; Xhepa, Erion; De Cock, Dries; Komukai, Kenichi; Tada, Tomohisa; Cuesta, Javier; Sirbu, Vasile; Feldman, Laurent J; Neumann, Franz-Josef; Goodall, Alison H; Heestermans, Ton; Buysschaert, Ian; Hlinomaz, Ota; Belmans, Ann; Desmet, Walter; Ten Berg, Jurrien M; Gershlick, Anthony H; Massberg, Steffen; Kastrati, Adnan; Guagliumi, Giulio; Byrne, Robert A

    2017-09-12

    Stent thrombosis (ST) is a serious complication following coronary stenting. Intravascular optical coherence tomography (OCT) may provide insights into mechanistic processes leading to ST. We performed a prospective, multicenter study to evaluate OCT findings in patients with ST. Consecutive patients presenting with ST were prospectively enrolled in a registry by using a centralized telephone registration system. After angiographic confirmation of ST, OCT imaging of the culprit vessel was performed with frequency domain OCT. Clinical data were collected according to a standardized protocol. OCT acquisitions were analyzed at a core laboratory. Dominant and contributing findings were adjudicated by an imaging adjudication committee. Two hundred thirty-one patients presenting with ST underwent OCT imaging; 14 (6.1%) had image quality precluding further analysis. Of the remaining patients, 62 (28.6%) and 155 (71.4%) presented with early and late/very late ST, respectively. The underlying stent type was a new-generation drug-eluting stent in 50.3%. Mean reference vessel diameter was 2.9±0.6 mm and mean reference vessel area was 6.8±2.6 mm2. Stent underexpansion (stent expansion index presenting very late ST, uncovered stent struts were a common dominant finding in drug-eluting stents, and neoatherosclerosis was a common dominant finding in bare metal stents. In patients with ST, uncovered and malapposed struts were frequently observed with the incidence of both decreasing with longer time intervals between stent implantation and presentation. The most frequent dominant observation varied according to time intervals from index stenting: uncovered struts and underexpansion in acute/subacute ST and neoatherosclerosis and uncovered struts in late/very late ST. © 2017 The Authors.

  16. Stent thrombosis with ticagrelor versus clopidogrel in patients with acute coronary syndromes: an analysis from the prospective, randomized PLATO trial.

    Science.gov (United States)

    Steg, P Gabriel; Harrington, Robert A; Emanuelsson, Håkan; Katus, Hugo A; Mahaffey, Kenneth W; Meier, Bernhard; Storey, Robert F; Wojdyla, Daniel M; Lewis, Basil S; Maurer, Gerald; Wallentin, Lars; James, Stefan K

    2013-09-03

    We aimed to describe the effects of ticagrelor versus clopidogrel on stent thrombosis in the Platelet Inhibition and Patient Outcomes (PLATO) trial. Of 18 624 patients hospitalized for acute coronary syndromes, 11 289 (61%) had at least 1 intracoronary stent. Ticagrelor reduced stent thrombosis compared with clopidogrel across all definitions: definite, 1.37% (n=71) versus 1.93% (n=105; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.50-0.90; P=0.0091); definite or probable, 2.21% (n=118) versus 2.87% (n=157; HR, 0.75; 95% CI, 0.59-0.95; P=0.017); and definite, probable, and possible, 2.94% (n=154) versus 3.77 (n=201; HR, 0.77; 95% CI, 0.62-0.95). The reduction in definite stent thrombosis was consistent regardless of acute coronary syndrome type, presence of diabetes mellitus, stent type (drug-eluting or bare metal stent), CYP2C19 genetic status, loading dose of aspirin, dose of clopidogrel before randomization, and use of glycoprotein IIb/IIIa inhibitors at randomization. The reduction in stent thrombosis with ticagrelor was numerically greater for late (>30 days; HR, 0.48; 95% CI, 0.24-0.96) and subacute (4 hours-30 days; HR, 0.60; 95% CI, 0.39-0.93) compared with acute (<24 hours; HR, 0.94; 95% CI, 0.43-2.05) stent thrombosis or for patients compliant to therapy (ie, taking blinded study treatment ≥80% of the time) compared with less compliant patients. Randomization to ticagrelor was a strong independent inverse predictor of definite stent thrombosis (HR, 0.65; 95% CI, 0.48-0.88). Ticagrelor compared with clopidogrel reduces the incidence of stent thrombosis in patients with acute coronary syndromes, with consistent benefit across a broad range of patient, stent, and treatment characteristics.

  17. Long-term endothelial dysfunction is more pronounced after stenting than after balloon angioplasty in porcine coronary arteries

    NARCIS (Netherlands)

    Beusekom, H.M.M. van; Whelan, D.M.; Hofma, S.H.; Krabbendam, S.C.; Hinsbergh, V.W.M. van; Verdouw, P.D.; Giessen, W.J. van der

    1998-01-01

    Objectives. To compare percutaneous transluminal coronary angioplasty (PTCA) and stent implantation with respect to the long-term changes they induce in the newly formed endothelium in porcine coronary arteries by studying both morphological and functional parameters of the endothelium at 2 weeks

  18. Caracterización de la restenosis de stents coronarios convencionales y liberadores de medicamentos en pacientes incluidos en el registro DRug Eluting STent (DREST Characterization of conventional coronary stents restenosis and drug eluting stents in patients included in the Drug Eluting Stent Registry (DREST

    Directory of Open Access Journals (Sweden)

    Jorge A Arroyave C

    2012-06-01

    risk factor associated with stent restenosis of drug-eluting stents (p <0.002. We found smaller diameter of the vessel involved as well as smaller diameter of the implanted stent mainly in the drug-eluting stents associated with stent restenosis (p = 0.000. The focal pattern of stent restenosis was higher with drug eluting stents, while the diffuse pattern with standard stents (p = 0.000. The one-year survival was higher in patients with drug-eluting stent. Conclusions: The rates of stent restenosis and the related characteristics found are similar to those currently published. Dyslipidemia appears as a significant associated factor. The stent restenosis manifested as acute coronary syndrome in 60% of cases; it can not be regarded as a benign condition in this population.

  19. Successful technical and clinical outcome using a second generation balloon expandable coronary stent for transplant renal artery stenosis: Our experience

    Science.gov (United States)

    Salsamendi, Jason; Pereira, Keith; Baker, Reginald; Bhatia, Shivank S; Narayanan, Govindarajan

    2015-01-01

    Transplant renal artery stenosis (TRAS) is a vascular complication frequently seen because of increase in the number of renal transplantations. Early diagnosis and management is essential to optimize a proper graft function. Currently, the endovascular treatment of TRAS using angioplasty and/or stenting is considered the treatment of choice with the advantage that it does not preclude subsequent surgical correction. Treatment of TRAS with the use of stents, particularly in tortuous transplant renal anatomy presents a unique challenge to an interventional radiologist. In this study, we present three cases from our practice highlighting the use of a balloon-expandable Multi-Link RX Ultra coronary stent system (Abbott Laboratories, Abbott Park, Illinois, USA) for treating high grade focal stenosis along very tortuous renal arterial segments. Cobalt–Chromium alloy stent scaffold provides excellent radial force, whereas the flexible stent design conforms to the vessel course allowing for optimal stent alignment. PMID:26629289

  20. Successful technical and clinical outcome using a second generation balloon expandable coronary stent for transplant renal artery stenosis: Our experience.

    Science.gov (United States)

    Salsamendi, Jason; Pereira, Keith; Baker, Reginald; Bhatia, Shivank S; Narayanan, Govindarajan

    2015-10-01

    Transplant renal artery stenosis (TRAS) is a vascular complication frequently seen because of increase in the number of renal transplantations. Early diagnosis and management is essential to optimize a proper graft function. Currently, the endovascular treatment of TRAS using angioplasty and/or stenting is considered the treatment of choice with the advantage that it does not preclude subsequent surgical correction. Treatment of TRAS with the use of stents, particularly in tortuous transplant renal anatomy presents a unique challenge to an interventional radiologist. In this study, we present three cases from our practice highlighting the use of a balloon-expandable Multi-Link RX Ultra coronary stent system (Abbott Laboratories, Abbott Park, Illinois, USA) for treating high grade focal stenosis along very tortuous renal arterial segments. Cobalt-Chromium alloy stent scaffold provides excellent radial force, whereas the flexible stent design conforms to the vessel course allowing for optimal stent alignment.

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

    DEFF Research Database (Denmark)

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

    2017-01-01

    -EXPANDED, and BIOSIS from their inception to January 2017. We also searched two clinical trials registers, the European Medicines Agency and the US Food and Drug Administration databases, and pharmaceutical company websites. In addition, we searched the reference lists of review articles and relevant trials. SELECTION...... 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 myocardial infarction.No trials reported results on quality of life or angina. AUTHORS' CONCLUSIONS: The current evidence suggests that drug-eluting stents may lead to fewer serious adverse events compared with bare-metal stents without increasing the risk of all-cause mortality or major cardiovascular...

  2. Comparison of stenting and surgical revascularization strategy in non-ST elevation acute coronary syndromes and complex coronary artery disease (from the Milestone Registry).

    Science.gov (United States)

    Buszman, Pawel E; Buszman, Piotr P; Bochenek, Andrzej; Gierlotka, Marek; Gąsior, Mariusz; Milewski, Krzysztof; Orlik, Bartłomiej; Janas, Adam; Wojakowski, Wojciech; Kiesz, R Stefan; Zembala, Marian; Poloński, Lech

    2014-10-01

    The optimal revascularization strategy in patients with complex coronary artery disease and non-ST-segment elevation acute coronary syndromes is undetermined. In this multicenter, prospective registry, 4,566 patients with non-ST-segment elevation myocardial infarctions, unstable angina, and multivessel coronary disease, including left main disease, were enrolled. After angiography, 3,033 patients were selected for stenting (10.3% received drug-eluting stents) and 1,533 for coronary artery bypass grafting. Propensity scores were used for baseline characteristic matching and result adjustment. Patients selected for percutaneous coronary intervention (PCI) were younger (mean age 64.4±10 vs 65.2±9 years, p=0.03) and more frequently presented with non-ST-segment elevation myocardial infarctions (32.0% vs 14.5%, p=0.01), cardiogenic shock (1.5% vs 0.7%, p65 years, women, patients with unstable angina, those with European System for Cardiac Operative Risk Evaluation scores>5, those with Thrombolysis In Myocardial Infarction (TIMI) risk scores >4, those receiving drug-eluting stents, and those with 2-vessel disease. In conclusion, in patients presenting with non-ST-segment elevation acute coronary syndromes and complex coronary artery disease, immediate stenting was associated with lower mortality risk in the long term compared with surgical revascularization, especially in subgroups at high clinical risk. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. Percutaneous coronary intervention with ABSORB biodegradable vascular scaffold in patients with left anterior descending artery disease

    Directory of Open Access Journals (Sweden)

    К. М. Ваккосов

    2017-04-01

    Full Text Available Aim. The article evaluates 30-day results of percutaneous coronary intervention (PCI with ABSORB biodegradable vascular scaffold (BVS implanted in the case of stenosis of the left anterior descending (LAD coronary artery in patients with stable angina.Methods. 64 patients with significant (≥ 70% LAD disease were included in the study. At 30 days, scaffold thrombosis and major adverse cardiovascular events (all-cause mortality, myocardial infarction, stroke, target vessel revascularization were evaluated. The indicator of successful percutaneous coronary intervention (residual stenosis ≤20% in the presence of counterpulsation corresponding to TIMI 3rd Grade and in the absence of significant in-patient clinical complications and successful intervention assessed by clinical criteria (successful percutaneous coronary intervention alongside with a decrease in objective and subjective symptoms of myocardial ischemia, or their complete disappearance were also analyzed. Results. Mean age of patients was 61.6±8.5 years, with males accounting for 64%; 33% had earlier MI, 14% – diabetes mellitus. Mean left ventricular ejection fraction was 61.3±6.8%. Left anterior descending artery disease was presented in 89% of patients with SYNTAX Score 6.6±2.2. Mean number of implanted stents was 1.2±0.4, with mean length of the stented segment equal to18.7±1.8 mm and mean diameter 3.2±0.3 mm. At 30-day follow-up, the success of intervention assessed by clinical criteria amounted to 96.9% (n=62; that of myocardial infarction 3.1% (n=2; stent thrombosis 1.56% (n=1; repeated revascularization 1.56% (n=1; major adverse cardiovascular events (MACE 3.1%.Conclusion. The implantation of everolimus-eluting BVS for LAD stenosis demonstrates satisfactory results at 30-day follow-up.Received 16 January 2017. Accepted 21 March 2017.Financing: The study did not have sponsorship.Conflict of interest: The authors declare no conflict of interest.

  4. Levels of circulating CD34+/KDR+ cells do not predict coronary in-stent restenosis.

    Science.gov (United States)

    Haine, Steven E; Van Craenenbroeck, Emeline M; Hoymans, Vicky Y; Miljoen, Hielko P; Vandendriessche, Tom R; Claeys, Marc J; Frederix, Geert; Conraads, Viviane M; Bosmans, Johan M; Vrints, Christiaan J

    2014-01-01

    Angiographic and clinical parameters are poor predictors of in-stent restenosis. Bone marrow-derived CD34(+) cells that coexpress a receptor for vascular endothelial growth factor (kinase insert domain receptor [KDR]) are committed to endothelial lineage. Mobilization and infusion of CD34(+)/KDR(+) cells accelerates re-endothelialization and reduces neointimal thickness in vascular injury models. Bioengineered stents capturing CD34(+) cells also show expedited re-endothelialization. We examined whether circulating CD34(+)/KDR(+) cell counts can be used to predict restenosis in a bare-metal stent (BMS). CD34(+)/KDR(+) cells were counted by flow cytometry in 124 nondiabetic patients before BMS implantation and the relation to in-stent late luminal loss (LLL) was examined by angiography at 6 months (primary end point). Neointima was also quantified as the maximum percentage area stenosis (M%AS) and percentage volume intima hyperplasia (%VIH) on intravascular ultrasonography (secondary end points). Multiple linear regression analysis, taking into account implanted stent length and diameter, revealed no relation between CD34(+)/KDR(+) cell counts and LLL (partial regression coefficient b = 0.11; 95% confidence interval [CI], -0.19-0.42; P = 0.46). Similarly, no relation between CD34(+)/KDR(+) cell counts and M%AS or %VIH could be demonstrated. Moreover, the increase in CD34(+)/KDR(+) cell counts over 6 months was unrelated to LLL (b = -0.15; 95% CI, -0.42-0.12; P = 0.28), M%AS, and %VIH. Although our study does not exclude a pathophysiologic role for CD34(+)/KDR(+) cells in the formation of neointima, cell counts before percutaneous coronary intervention proved to be unrelated to LLL or intravascular ultrasonographically derived restenosis parameters in coronary BMSs at 6 months. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  5. 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

    2014-01-01

    reduced the risk of restenosis in native coronary artery lesions. In saphenous vein grafts (SVG) the outcome after DES compared with BMS is insufficiently described. METHODS: From January 1, 2002 to December 31, 2010 all patients with PCI of SVG lesions were identified among 3.0 million inhabitants. Stent...

  6. Effect of a Dual Drug-Coated Stent With Abciximab and Alpha-Lipoic Acid in a Porcine Coronary Restenosis Model

    Science.gov (United States)

    Lim, Kyung Seob; Hong, Young Joon; Hachinohe, Daisuke; Ahmed, Khurshid; Kim, Jung Ha; Sim, Doo Sun; Lee, Min Goo; Park, Keun-Ho; Kim, Ju Han; Ahn, Youngkeun; Cho, Jeong Gwan; Park, Jong Chun; Song, Sun-Jung; Jung, Kyoung Woon; Cho, Dong Lyun; Kang, Jung Chaee

    2011-01-01

    Background and Objectives The aim of this study was to examine the anti-proliferative and anti-inflammatory effects of a stent coated with abciximab and alpha-lipoic acid (ALA) in a porcine coronary overstretch restenosis model. Materials and Methods A total of 10 pigs were randomized into two groups (10 pigs, 10 coronaries in each group) in which the coronary arteries were stented with a dual-coated stent and a bare metal stent (control) by randomization. Stents were deployed with oversizing (stent/artery ratio 1.3 : 1) in the porcine coronary arteries, and histopathology was assessed 28 days after stenting. Results There was no significant difference in the injury score between the two groups. In the neointima, the lymphohistiocyte count was significantly lower in dual-coat stent group compared with the control stent group (120±85 cells vs. 159±80 cells, p=0.048). There was no significant difference in the fibrin score between the two groups (0.16±0.34 in the dual-coated stent group vs. 0.25±0.48 in the control stent group, p=0.446). The neointima area was not significantly different between both groups (1.55±0.8 mm2 in dual-coated stent group vs. 1.40±0.86 mm2 in the control stent group, p=0.447). Conclusion Although the dual-coated stent with abciximab and ALA showed no significant difference in inhibition of neointimal hyperplasia when compared with the bare metal stent, it was associated with a reduced inflammatory reaction when compared with the control stent in a porcine coronary restenosis model. PMID:21731564

  7. Corrosion resistance improvement for 316L stainless steel coronary artery stents by trimethylsilane plasma nanocoatings.

    Science.gov (United States)

    Eric Jones, John; Chen, Meng; Yu, Qingsong

    2014-10-01

    To improve their corrosion resistance and thus long-term biocompatibility, 316L stainless steel coronary artery stents were coated with trimethylsilane (TMS) plasma coatings of 20-25 nm in thickness. Both direct current (DC) and radio-frequency (RF) glow discharges were utilized for TMS plasma coatings and additional NH₃/O₂ plasma treatment to tailor the surface properties. X-ray photoelectron spectroscopy (XPS) was used to characterize the coating surface chemistry. It was found that both DC and RF TMS plasma coatings had Si- and C-rich composition, and the O- and N-contents on the surfaces were substantially increased after NH₃/O₂ plasma treatment. Surface contact angle measurements showed that DC TMS plasma nanocoating with NH₃/O₂ plasma treatment generated very hydrophilic surface. The corrosion resistance of TMS plasma coated stents was evaluated through potentiodynamic polarization and electrochemical impedance spectroscopy (EIS) techniques. The potentiodynamic polarization demonstrated that the TMS plasma coated stents imparted higher corrosion potential and pitting potential, as well as lower corrosion current densities as compared with uncoated controls. The surface morphology of stents before and after potentiodynamic polarization testing was analyzed with scanning electron microscopy, which indicated less corrosion on coated stents than uncoated controls. It was also noted that, from EIS data, the hydrophobic TMS plasma nanocoatings showed stable impedance modulus at 0.1 Hz after 21 day immersion in an electrolyte solution. These results suggest improved corrosion resistance of the 316L stainless steel stents by TMS plasma nanocoatings and great promise in reducing and blocking metallic ions releasing into the bloodstream. © 2014 Wiley Periodicals, Inc.

  8. Corrosion resistance improvement for 316L stainless steel coronary artery stents by trimethylsilane plasma nanocoatings

    Science.gov (United States)

    Jones, John Eric; Chen, Meng; Yu, Qingsong

    2015-01-01

    To improve their corrosion resistance and thus long-term biocompatibility, 316L stainless steel coronary artery stents were coated with trimethylsilane (TMS) plasma coatings of 20–25 nm in thickness. Both direct current (DC) and radio-frequency (RF) glow discharges were utilized for TMS plasma coatings and additional NH3/O2 plasma treatment to tailor the surface properties. X-ray photoelectron spectroscopy (XPS) was used to characterize the coating surface chemistry. It was found that both DC and RF TMS plasma coatings had Si- and C-rich composition, and the O-and N-contents on the surfaces were substantially increased after NH3/O2 plasma treatment. Surface contact angle measurements showed that DC TMS plasma nanocoating with NH3/O2 plasma treatment generated very hydrophilic surface. The corrosion resistance of TMS plasma coated stents was evaluated through potentiodynamic polarization and electro-chemical impedance spectroscopy (EIS) techniques. The potentiodynamic polarization demonstrated that the TMS plasma coated stents imparted higher corrosion potential and pitting potential, as well as lower corrosion current densities as compared with uncoated controls. The surface morphology of stents before and after potentiodynamic polarization testing was analyzed with scanning electron microscopy, which indicated less corrosion on coated stents than uncoated controls. It was also noted that, from EIS data, the hydrophobic TMS plasma nanocoatings showed stable impedance modulus at 0.1 Hz after 21 day immersion in an electrolyte solution. These results suggest improved corrosion resistance of the 316L stainless steel stents by TMS plasma nanocoatings and great promise in reducing and blocking metallic ions releasing into the bloodstream. PMID:24500866

  9. Effect of oral sirolimus therapy on inflammatory biomarkers following coronary stenting

    Directory of Open Access Journals (Sweden)

    W.C.M. Rosa

    2010-08-01

    Full Text Available We studied the effect of oral sirolimus, administered to prevent and treat in-stent restenosis (ISR, on the variation of serum levels of inflammatory markers following coronary stenting with bare metal stents. The mean age of the patients was 56 ± 13 years, 65% were males and all had clinically manifested ischemia. Serum levels of high sensitivity C-reactive protein (hs-CRP concentration were determined by chemiluminescence and serum levels of all other biomarkers by ELISA. One group of patients at high risk for ISR received a loading oral dose of 15 mg sirolimus and 5 mg daily thereafter for 28 days after stenting (SIR-G. A control group (CONT-G was submitted to stenting without sirolimus therapy. The increase in hs-CRP concentration was highest at 24 h after stenting in both groups. A significant difference between SIR-G and CONT-G was observed at 4 weeks (-1.50 ± 5.0 vs -0.19 ± 0.4, P = 0.008 and lost significance 1 month after sirolimus discontinuation (-1.73 ± 4.3 vs -0.01 ± 0.7, P = 0.0975. A continuous fall in MMP-9 concentration was observed in SIR-G, with the greatest reduction at 4 weeks (-352.9 ± 455 vs +395.2 ± 377, P = 0.0004, while a positive variation was noted 4 weeks after sirolimus discontinuation (227 ± 708 vs 406.2 ± 472.1, P = 0.0958. SIR-G exhibited a higher increase in P-selectin after sirolimus discontinuation at week 8 (46.1 ± 67.9 vs 5.8 ± 23.7, P = 0.0025. These findings suggest that the anti-restenotic actions of systemic sirolimus include anti-proliferative effects and modulation of the inflammatory response with inhibition of adhesion molecule expression.

  10. Long-term safety and effectiveness of unprotected left main coronary stenting with drug-eluting stents compared with bare-metal stents.

    Science.gov (United States)

    Kim, Young-Hak; Park, Duk-Woo; Lee, Seung-Whan; Yun, Sung-Cheol; Lee, Cheol Whan; Hong, Myeong-Ki; Park, Seong-Wook; Seung, Ki Bae; Gwon, Hyeon-Cheol; Jeong, Myung-Ho; Jang, Yangsoo; Kim, Hyo-Soo; Seong, In-Whan; Park, Hun Sik; Ahn, Taehoon; Chae, In-Ho; Tahk, Seung-Jea; Chung, Wook-Sung; Park, Seung-Jung

    2009-08-04

    Limited information is available on long-term outcomes for patients with unprotected left main coronary artery disease who received drug-eluting stents (DES). In the multicenter registry evaluating outcomes among patients with unprotected left main coronary artery stenosis undergoing stenting with either bare metal stents (BMS) or DES, 1217 consecutive patients were divided into 2 groups: 353 who received only BMS and 864 who received at least 1 DES. The 3-year outcomes were compared by use of the adjustment of inverse-probability-of-treatment-weighted method. Patients receiving DES were older and had a higher prevalence of diabetes mellitus, hypertension, hyperlipidemia, and multivessel disease. In the overall population, with the use of DES, the 3-year adjusted risk of death (8.0% versus 9.5%; hazard ratio, 0.71; 95% confidence interval, 0.36 to 1.40; P=0.976) or death or myocardial infarction (14.3% versus 14.9%; hazard ratio, 0.83; 95% confidence interval, 0.49 to 1.40; P=0.479) was similar compared with BMS. However, the risk of target lesion revascularization was significantly lower with the use of DES than BMS (5.4% versus 12.1%; hazard ratio, 0.40; 95% confidence interval, 0.22 to 0.73; P=0.003). When patients were classified according to lesion location, DES was still associated with lower risk of target lesion revascularization in patients with bifurcation (6.9% versus 16.3%; hazard ratio, 0.38; 95% confidence interval, 0.18 to 0.78; P=0.009) or nonbifurcation (3.4% versus 10.3%; hazard ratio, 0.39; 95% confidence interval, 0.17 to 0.88; P=0.024) lesions with a comparable risk of death or myocardial infarction. Compared with BMS, DES was associated with a reduction in the need for repeat revascularization without increasing the risk of death or myocardial infarction for patients with unprotected left main coronary artery stenosis.

  11. Feasibility of coronary calcium and stent image subtraction using 320-detector row CT angiography

    DEFF Research Database (Denmark)

    Fuchs, Andreas; Kühl, J Tobias; Chen, Marcus Y

    2015-01-01

    . The use of coronary calcium image subtraction improved the reader confidence in 66% of these segments. In target segments, specificity (86% vs 65%; P positive predictive value (71% vs 51%, P = .03) were improved using CCTAsub compared to CCTAconv without loss in negative predictive value....... We defined target segments on CCTAconv as motion-free coronary segments with calcification or stent and low reader confidence. The effect of CCTAsub was assessed. No approval from the ethics committee was required according to Danish law. RESULTS: A total of 76 target segments were identified...... severity leading to false-positive results. In a pilot study, we tested the feasibility of a new coronary calcium image subtraction algorithm in relation to reader confidence and diagnostic accuracy. METHODS: Forty-three patients underwent clinically indicated ICA and CCTA using a 320-detector row CT...

  12. Results of genotype-guided antiplatelet therapy in patients who undergone percutaneous coronary intervention with stent.

    Science.gov (United States)

    Sánchez-Ramos, Jesús; Dávila-Fajardo, Cristina Lucía; Toledo Frías, Pablo; Díaz Villamarín, Xando; Martínez-González, Luis Javier; Martínez Huertas, Susana; Burillo Gómez, Francisco; Caballero Borrego, Juan; Bautista Pavés, Alicia; Marín Guzmán, Mª Carmen; Ramirez Hernández, José Antonio; Correa Vilches, Concepción; Cabeza Barrera, Jose

    2016-12-15

    Clopidogrel has provided beneficial effects in acute coronary syndrome and percutaneous coronary intervention. Different polymorphisms have been associated with differences in clopidogrel response. The aim of this study was to check if CYP2C19/ABCB1-genotype-guided strategy reduces the rates of cardiovascular events and bleeding. This experimental study included patients undergoing percutaneous coronary intervention with stent. The prospective genotype-guided strategy (intervention group) was compared against a retrospective non-tailored strategy (control group). Primary efficacy endpoint was the composite of cardiovascular death, acute coronary syndrome or stroke during 12months after intervention. Secondary endpoint was to compare the efficacy of the different antiplatelet therapies used in genotyping conditions. The study included 719 patients undergone stent, more than 86% with acute coronary syndrome. The primary endpoint occurred in 32 patients (10.1%) in the genotyping group and in 59 patients (14.1%) in the control group (HR 0.63, 95% CI (0.41-0.97), p =0.037). There was no difference in The Thrombolysis in Myocardial Infarction major and minor bleeding criteria between the two groups (4.1% vs. 4.7%, HR=0.80, 95% CI (0.39-1.63), p=0.55). In intervention group, there was no difference in the rate of events in patients treated with clopidogrel versus patients treated with other antiplatelet treatments (9.1% vs 11.5% p=0.44), or bleeding (3.7% vs 4.6%, p=0.69). The genotype-guided strategy could reduce the rates of composite of cardiovascular events and bleeding during 12months after percutaneous coronary intervention compared to a non-genotype-guide strategy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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

    DEFF Research Database (Denmark)

    Rasmussen, Klaus; Maeng, Michael; Kaltoft, Anne

    2010-01-01

    BACKGROUND: In low-risk patients, the zotarolimus-eluting stent has been shown to reduce rates of restenosis without increasing the risk of stent thrombosis. We compared the efficacy and safety of the zotarolimus-eluting stent versus the sirolimus-eluting stent in patients with coronary artery...... percutaneous coronary intervention centres between January, 2006, and August, 2007. Computer-generated block randomisation and a telephone allocation service were used to randomly assign patients to receive the zotarolimus-eluting or the sirolimus-eluting stent. Data for follow-up were obtained from national...... is registered with ClinicalTrials.gov, number NCT00660478. FINDINGS: 1162 patients (1619 lesions) were assigned to receive the zotarolimus-eluting stent, and 1170 patients (1611 lesions) to receive the sirolimus-eluting stent. 67 patients (72 lesions) had stent failure, and six patients were lost to follow...

  14. Diagnostic accuracy of in-stent coronary restenosis detection with multislice spiral computed tomography: a meta-analysis

    Energy Technology Data Exchange (ETDEWEB)

    Hamon, Michele [University Hospital of Caen, Department of Radiology, 14033 Caen Cedex, Normandy (France); Champ-Rigot, Laure; Riddell, John W. [University Hospital of Caen, Department of Cardiology, 14033 Caen Cedex, Normandy (France); Morello, Remy [University Hospital of Caen, Department of Statistics, 14033 Caen Cedex, Normandy (France); Hamon, Martial [University Hospital of Caen, Department of Cardiology, 14033 Caen Cedex, Normandy (France); Institut Pasteur de Lille, INSERM 744, Lille (France); Centre Hospitalier Universitaire de Caen, Service des Maladies du Coeur et des Vaisseaux, 14033 Caen Cedex, Normandy (France)

    2008-02-15

    This study was designed to define the current role of multislice spiral computed tomography (MSCT) for the diagnosis of coronary in-stent restenosis using a meta-analytic process. Restenosis remains a limitation after coronary stent implantation and contributes to a substantial number of coronary re-assessments by conventional invasive coronary angiography (CA). We identified 15 studies (807 patients) evaluating in-stent restenosis by means of both MSCT ({>=}16 slices) and conventional CA until February 2007. After data extraction the analysis was performed according to a random-effects model. The analysis pooled the results from 15 studies with a total of 1,175 stents. A substantial number of unassessable stents (13%) were excluded from the analysis underscoring the shortcomings of MSCT. With this major limitation the diagnostic performance of MSCT for in-stent restenosis detection can be summarized as follows: the sensitivity and specificity were 84% [95% confidence interval (CI) 77-89%] and 91% (95% CI 89-93%), respectively, with positive and negative likelihood ratios of 12.2 (95% CI 6.6-22.6) and 0.23 (95% CI 0.17-0.31), respectively, and with a diagnostic odds ratio of 67.9 (95% CI 34.4-134.1). MSCT has shortcomings difficult to overcome in daily practice for in-stent restenosis detection and continues to have moderately high sensitivity and specificity. The diagnostic role of this emerging technology as an alternative to CA for in-stent restenosis detection remains limited. (orig.)

  15. Prospective study one-year clinical outcomes of the Calypso coronary stent in patients presenting with acute coronary syndrome

    Directory of Open Access Journals (Sweden)

    В. Л. Воробьев

    2017-04-01

    Full Text Available Aim. To evaluate the effectiveness of the stent use Calypso Angiolain Russia with primary percutaneous transluminal coronary angioplasty (PTCA.Methods. The study prospectively included 150 patients who underwent PTCA in acute coronary syndrome (ACS for the period from January to December 2015. During the one-year follow-up period were evaluated indicators insolvency target lesion (cardiac death, myocardial infarction in the pool target artery, target lesion revascularization when clinically indicated, major adverse cardiac events (death from any cause, myocardial infarction, repeat revascularization as clinically indicated. Results. In one year, the incidence of target lesion failure was 6.66% for cardiac death rate of 1.33%, myocardial infarction in the target artery 3.33% and target lesion revascularization at 5.3%. The frequency of cardiac major adverse cardiac events was 12% at mortality 2.66%, myocardial infarction 4% and revascularization when clinically indicated 8.66%. Conclusion. The use of stents in primary PTCA Calypso is possible, the percentage of cardiovascular complications is comparable with the data of clinical trials.Received 31 January 2017. Accepted 17 March 2017.Financing: The study did not have sponsorship.Conflict of interest: The authors declare no conflict of interest.

  16. Triple antithrombotic therapy in patients with atrial fibrillation undergoing coronary artery stenting: hovering among bleeding risk, thromboembolic events, and stent thrombosis

    Directory of Open Access Journals (Sweden)

    Menozzi Mila

    2012-10-01

    Full Text Available Abstract Dual antiplatelet treatment with aspirin and clopidogrel is the antithrombotic treatment recommended after an acute coronary syndrome and/or coronary artery stenting. The evidence for optimal antiplatelet therapy for patients, in whom long-term treatment oral anticoagulation is mandatory, is however scarce. To evaluate the safety and efficacy of the various antithrombotic strategies adopted in this population, we reviewed the available evidence on the management of patients receiving oral anticoagulation, such as a vitamin-k-antagonists, referred for coronary artery stenting. Atrial fibrillation is the most frequent indication for oral anticoagulation. The need of starting antiplatelet therapy in this clinical scenario raises concerns about the combination to choose: triple therapy with warfarin, aspirin, and a thienopyridine being the most frequent and advised. The safety of this regimen appeared suboptimal because of an increased risk in hemorrhagic complications. On the other hand, the combination of oral anticoagulation and an antiplatelet agent is suboptimal in preventing thromboembolic events and stent thrombosis; dual antiplatelet therapy may be considered only when a high hemorrhagic risk and low thromboembolic risk are perceived. Indeed, the need for prolonged multiple-drug antithrombotic therapy increases the bleeding risks when drug eluting stents are used. Since current evidence derives mainly from small, single-center and retrospective studies, large-scale prospective multicenter studies are urgently needed.

  17. Clinical Coronary In-Stent Restenosis Follow-Up after Treatment and Analyses of Clinical Outcomes

    Directory of Open Access Journals (Sweden)

    Barbara Campos Abreu Marino

    2015-05-01

    Full Text Available Background: Clinical in-stent restenosis (CISR is the main limitation of coronary angioplasty with stent implantation. Objective: Describe the clinical and angiographic characteristics of CISR and the outcomes over a minimum follow-up of 12 months after its diagnosis and treatment. Methods: We analyzed in 110 consecutive patients with CISR the clinical presentation, angiographic characteristics, treatment and combined primary outcomes (cardiovascular death, nonfatal acute myocardial infarction [AMI] and combined secondary (unstable angina with hospitalization, target vessel revascularization and target lesion revascularization during a minimal follow-up of one year. Results: Mean age was 61 ± 11 years (68.2% males. Clinical presentations included acute coronary syndrome (ACS in 62.7% and proliferative ISR in 34.5%. CISR was treated with implantation of drug-eluting stents (DES in 36.4%, Bare Metal Stent (BMS in 23.6%, myocardial revascularization surgery in 18.2%, balloon angioplasty in 15.5% and clinical treatment in 6.4%. During a median follow-up of 19.7 months, the primary outcome occurred in 18 patients, including 6 (5.5% deaths and 13 (11.8% AMI events. Twenty-four patients presented a secondary outcome. Predictors of the primary outcome were CISR with DES (HR = 4.36 [1.44–12.85]; p = 0.009 and clinical treatment for CISR (HR = 10.66 [2.53–44.87]; p = 0.001. Treatment of CISR with BMS (HR = 4.08 [1.75–9.48]; p = 0.001 and clinical therapy (HR = 6.29 [1.35–29.38]; p = 0.019 emerged as predictors of a secondary outcome. Conclusion: Patients with CISR present in most cases with ACS and with a high frequency of adverse events during a medium-term follow-up.

  18. DK mini-culotte stenting in the treatment of true coronary bifurcation lesions: a propensity score matching comparison with T-provisional stenting.

    Science.gov (United States)

    Fan, Lin; Chen, Lianglong; Luo, Yukun; Zhang, Linlin; Zhong, Wenliang; Lin, Chaogui; Chen, Zhaoyang; Peng, Yafei; Zhen, Xingchun; Dong, Xianfeng

    2016-03-01

    The conventional culotte technique remains not to be widely used for the treatment of coronary bifurcation lesions due to its inherent drawbacks. Here, we developed a double kissing mini-culotte stenting (DK mini-culotte) and assessed its efficacy and safety by a propensity score matching comparison (PSM) with T-provisional stenting. From June 2010 to June 2012, a total of 223 consecutive patients with true coronary bifurcation lesions (TCBLs) were treated with DK mini-culotte (91 patients with 92 lesions) or T-provisional stenting (132 patients with 135 lesions). We performed a PSM to correct the confounders from clinical and lesion's characteristics. The primary endpoint was cumulative major adverse cardiac event (MACE) at 1 year including cardiac death, myocardial infarction, and target vessel revascularization or target lesion revascularization (TVR/TLR). The secondary endpoint was the rate of side branch (SB) restenosis at 12 months. After a PSM, there were 66 patients in each group. Additional SB stenting in the T-provisional group was performed in 10 (15.2 %) lesions. The incidence of 1-year cumulative MACE was 4.55 % for the DK mini-culotte versus 13.6 % for T-provisional stenting (P = 0.127), the rate of TVR/TLR was 1.52 % for DK mini-culotte versus 12.12 % for T-provisional stenting (P = 0.033). The SB binary restenosis rate was 5.6 % in the DK mini-culotte group and 22.4 % in the T-provisional group (P = 0.014). In summary, despite that there is no difference in MACE between groups, DK mini-culotte significantly reduce TVR/TLR and SB restenosis in the treatment of true coronary bifurcation lesions.

  19. Development and validation of a stent thrombosis risk score in patients with acute coronary syndromes.

    Science.gov (United States)

    Dangas, George D; Claessen, Bimmer E; Mehran, Roxana; Xu, Ke; Fahy, Martin; Parise, Helen; Henriques, José P S; Ohman, E Magnus; White, Harvey D; Stone, Gregg W

    2012-11-01

    This study sought to develop a practical risk score to predict the risk of stent thrombosis (ST) after percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS). ST is a rare, yet feared complication after PCI with stent implantation. A risk score for ST after PCI in ACS can be a helpful tool to personalize risk assessment. This study represents a patient-level pooled analysis of 6,139 patients undergoing PCI with stent implantation for ACS in the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trials who were randomized to treatment with bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor. The cohort was randomly divided into a risk score development cohort (n = 4,093) and a validation cohort (n = 2,046). Cox regression methods were used to identify clinical, angiographic, and procedural characteristics associated with Academic Research Consortium-defined definite/probable ST at 1 year. Each covariate in this model was assigned an integer score based on the regression coefficients. Variables included in the risk score were type of ACS (ST-segment elevation myocardial infarction, non-ST-segment elevation ACS with ST deviation, or non-ST-segment elevation ACS without ST changes), current smoking, insulin-dependent diabetes mellitus, prior PCI, baseline platelet count, absence of early (pre-PCI) anticoagulant therapy, aneurysmal/ulcerated lesion, baseline TIMI (Thrombolysis In Myocardial Infarction) flow grade 0/1, final TIMI flow grade development cohort (p for trend validation cohort (p for trend = 0.006). The C-statistic for this risk score was over 0.65 in both cohorts. The individual risk of ST can be predicted using a simple risk score based on clinical, angiographic, and procedural variables. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT

  20. A randomized, controlled, multicenter trial to evaluate the safety and efficacy of Zotarolimus- vs. Paclitaxel-eluting stents in de novo occlusive lesions in coronary arteries

    DEFF Research Database (Denmark)

    Chevalier, Bernard; Dimario, Carlo; Neumann, Franz-Josef

    2013-01-01

    The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis at the pr......The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis...... at the primary endpoint of 9 months has been reported previously. The purpose of this follow-on analysis was to describe the clinical results of the ZoMaxx and Taxus cohorts of the ZOMAXX I trial after 5 years....

  1. Direct coronary stenting versus stenting with balloon pre-dilation: incidence of enzyme release and follow-up results of a multicentre, prospective, randomized study. The CK and Troponin I Estimation in direct STenting (CK TEST) trial.

    Science.gov (United States)

    Balducelli, M; Varani, E; Vecchi, G; Paloscia, L; Manari, A; Santarelli, A; Cappi, B; Shoeib, A; Valenti, S; Maresta, A

    2007-06-01

    The aim of this study was to assess the safety of direct coronary stenting, its influence on costs, duration of the procedure, radiation exposure, clinical outcome and the incidence of periprocedural myocardial damage as assessed by enzyme release determination. We randomized 103 patients (109 lesions) to direct stent implant or stent implant following balloon predilatation. Patients with heavily calcified lesions, bifurcations, total occlusions, left main lesions and very tortuous vessels were excluded. Three samples of blood were drawn; before, 12 and 24 h after the procedure and total CK, CK MB mass and troponin I determination was carried out in a single centralized laboratory. Direct stenting was successful in 62/62 lesions (100%). No single loss or embolization of the stent occurred. All stents in the group with predilatation were effectively deployed. The immediate post procedure angiographic results were similar with both techniques. Contrast media consumption and procedural time were significantly lower in direct stenting (150+/-82 cc and 30+/-13 min) than in pre-dilated stenting (184+/-85 cc and 36+/-14 min) (P=0.04 and P=0.036 respectively) while fluoroscopy time was similar (9.1+/-12 vs 9.19+/-15 min, P=0.97). The incidence of enzyme release was similar in the groups with only three non Q MI all in the pre-dilated group (P=0.149). Any elevation of CK MB and troponin I occurred in 7% of direct stent vs 12% of pre-dilated group (P=0.66), isolated troponin I elevation in 21% of both groups. Major adverse cardiac events during hospitalization were 0 in direct and 3 in pre-dilated stenting (P=0.66), but there were no significant differences at follow-up at 1, 6 and 12 months between the 2 groups (target lesion revascularization at 12 months 11 vs 14% in the 2 groups respectively). Direct stenting is as safe as pre-dilated stenting in selected coronary lesions. Acute results and myocardial damage as assessed by enzyme release determination are similar, but

  2. Clopidogrel discontinuation and platelet reactivity following coronary stenting

    LENUS (Irish Health Repository)

    2011-01-01

    Summary. Aims: Antiplatelet therapy with aspirin and clopidogrel is recommended for 1 year after drug-eluting stent (DES) implantation or myocardial infarction. However, the discontinuation of antiplatelet therapy has become an important issue as recent studies have suggested a clustering of ischemic events within 90 days of clopidogrel withdrawal. The objective of this investigation was to explore the hypothesis that there is a transient ‘rebound’ increase in platelet reactivity within 3 months of clopidogrel discontinuation. Methods and Results: In this prospective study, platelet function was assessed in patients taking aspirin and clopidogrel for at least 1 year following DES implantation. Platelet aggregation was measured using a modification of light transmission aggregometry in response to multiple concentrations of adenosine diphosphate (ADP), epinephrine, arachidonic acid, thrombin receptor activating peptide and collagen. Clopidogrel was stopped and platelet function was reassessed 1 week, 1 month and 3 months later. Thirty-two patients on dual antiplatelet therapy were recruited. Discontinuation of clopidogrel increased platelet aggregation to all agonists, except arachidonic acid. Platelet aggregation in response to ADP (2.5, 5, 10, and 20 μm) and epinephrine (5 and 20 μm) was significantly increased at 1 month compared with 3 months following clopidogrel withdrawal. Thus, a transient period of increased platelet reactivity to both ADP and epinephrine was observed 1 month after clopidogrel discontinuation. Conclusions: This study demonstrates a transient increase in platelet reactivity 1 month after clopidogrel withdrawal. This phenomenon may, in part, explain the known clustering of thrombotic events observed after clopidogrel discontinuation. This observation requires confirmation in larger populations.

  3. Coronary stent implantation is superior to balloon angioplasty for chronic coronary occlusions: six-year clinical follow-up of the GISSOC trial.

    Science.gov (United States)

    Rubartelli, Paolo; Verna, Edoardo; Niccoli, Luigi; Giachero, Corinna; Zimarino, Marco; Bernardi, Guglielmo; Vassanelli, Corrado; Campolo, Luigi; Martuscelli, Eugenio

    2003-05-07

    We investigated whether the benefits of stent implantation over balloon percutaneous transluminal coronary angioplasty (PTCA) for treatment of chronic total coronary occlusions (CTO) are maintained in the long term. Several randomized trials have shown that in CTO, stent implantation confers clinical and angiographic mid-term outcomes superior to those observed after PTCA. However, limited information on the long-term results of either technique is available. Six-year clinical follow-up of patients enrolled in the Gruppo Italiano di Studio sullo Stent nelle Occlusioni Coronariche (GISSOC) trial was performed by direct visit or telephone interview. Major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, target lesion revascularization (TLR), and anginal status, were recorded. Freedom from MACE at six years was 76.1% in the stent group, compared with 60.4% in the PTCA group (p = 0.0555). This difference was due mainly to TLR-free survival rates (85.1% vs. 65.5% for the stent and PTCA groups, respectively; p = 0.0165). Eleven patients underwent TLR after the nine-month follow-up visit (stent group: n = 5; PTCA group: n = 6); however, in most cases, restenosis of the study occlusion was evident at nine-month angiography. This study represents the longest reported clinical follow-up of patients after percutaneous recanalization of CTO and demonstrates that the superiority of stent implantation over balloon PTCA is maintained in the long term. Stent and PTCA results appear to remain stable after nine-month angiographic follow-up. Stent implantation in CTO that can be recanalized percutaneously is therefore a valuable long-term therapeutic option.

  4. CT evaluation of coronary artery stents with iterative image reconstruction: improvements in image quality and potential for radiation dose reduction.

    Science.gov (United States)

    Ebersberger, Ullrich; Tricarico, Francesco; Schoepf, U Joseph; Blanke, Philipp; Spears, J Reid; Rowe, Garrett W; Halligan, William T; Henzler, Thomas; Bamberg, Fabian; Leber, Alexander W; Hoffmann, Ellen; Apfaltrer, Paul

    2013-01-01

    Comparison of coronary artery stent assessment with cardiac CT angiography (cCTA) using traditional filtered back projection (FBP) and sinogram affirmed iterative reconstruction (SAFIRE), in both full- and half-radiation dose image data. Dual-source cCTA studies of 37 implanted stents were reconstructed at full- and half-radiation dose with FBP and SAFIRE. Half-dose data were based on projections from one DSCT detector. In-stent noise, signal-to-noise ratio (SNR), and stent-lumen attenuation increase ratio (SAIR) were measured and image quality graded. Stent volumes were measured to gauge severity of beam hardening artefacts. Full-dose SAFIRE reconstructions were superior to full-dose FBP vis-à-vis in-stent noise (21.2 ± 6.6 vs. 35.7 ± 17.5; P  0.05). Comparing half-dose SAFIRE with full-dose FBP, in-stent noise (26.7 ± 13.0 vs. 35.7 ± 17.5; P  0.05), stent volume (129.6 ± 57.3 vs. 129.8 ± 65.0 mm(3); P > 0.05), and image quality (3.5 ± 1.0 vs. 3.7 ± 1.1; P > 0.05) did not differ. Radiation dose decreased from 8.7 ± 5.2 to 4.3 ± 2.6 mSv. Iterative reconstruction significantly improves imaging of coronary artery stents by CT compared with FBP, even with half-radiation-dose data.

  5. 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...

  6. Percutaneous Stent Implantation for Treating Multivessel Coronary Disease in Patients with and without Involvement of the Proximal Segment of the Anterior Descending Coronary Artery

    Directory of Open Access Journals (Sweden)

    Salgueiro Sandro

    2002-01-01

    Full Text Available OBJECTIVE: To assess coronary stent placement in patients with multivessel coronary disease and involvement of the proximal portion of the anterior descending coronary artery. METHODS: We retrospectively analyzed the in-hospital and late evolution of 189 patients with multivessel coronary disease, who underwent percutaneous coronary stent placement. These patients were divided into 2 groups as follows: group I (GI - 59 patients with involvement of the proximal segment of the anterior descending coronary artery; and group II (GII - 130 patients without involvement of the proximal segment of the anterior descending coronary artery. RESULTS: No significant difference was observed in the success rate of the procedure (91.5% versus 97.6%, p=0.86, nor in the occurrence of major adverse cardiac events (5.1% versus 1.5%, p=0.38, nor in the occurrence of major vascular complications (1.7% versus 0%, p=0.69 in the in-hospital phase. In the late follow-up, the incidence of major adverse cardiac events (15.4% versus 13.7%, p=0.73 and the need for new revascularization (13.5% versus 10.3%, p=0.71 were similar for both groups. CONCLUSION: The in-hospital and late evolution of patients with multivessel coronary disease with and without involvement of the proximal segment of the anterior descending coronary artery treated with coronary stent placement did not differ. This suggests that this revascularization method is an effective procedure and a valuable option for treating these types of patients.

  7. Coronary Angiography

    Science.gov (United States)

    ... is used to diagnose coronary heart disease and coronary microvascular disease after chest pain, sudden cardiac arrest, or abnormal ... Cardiac CT Scan Clinical Trials Coronary Heart Disease Coronary Microvascular Disease Electrocardiogram Heart Attack Percutaneous Coronary Intervention Stents Stress ...

  8. JAK2 mutation and acute coronary syndrome complicated with stent thrombosis.

    Science.gov (United States)

    Inami, Toru; Okabe, Masahiro; Matsushita, Masato; Kobayashi, Nobuaki; Inokuchi, Koiti; Hata, Noritake; Seino, Yoshihiko; Shimizu, Wataru

    2016-10-01

    Acute coronary syndrome (ACS) could be a precious opportunity for patients to reveal concealed diseases other than conventional risk factors for ACS, such as hypertension, dyslipidemia, diabetes mellitus, etc. In the setting of ACS, the intracoronary and systemic prothrombotic environment has led to an increase in the risk of stent thrombosis of which mortality was higher among patients with ACS, especially with the highest mortality in patients with ST elevation myocardial infarction. The some specific conditions which were concealed beyond the cardiovascular pathophysiology except well-known risk factors for ACS and stent thrombosis might involve the onset of ACS. We describe a case of a 64-year-old man who was admitted to intensive care unit for chest pain. This case found the possibility that polycythemia vera with Janus kinase 2 (JAK2) V617F mutation might be a underlying disease of ACS with stent thrombosis, and highlighted the importance of recognizing polycythemia vera with JAK2 V617F mutation as concealed disease for cardiologists. We would like to report and review the relationship between ACS and polycythemia vera with JAK2 V617F mutation.

  9. Plasma big endothelin-1 and stent thrombosis: An observational study in patients undergoing percutaneous coronary intervention in China.

    Science.gov (United States)

    Chen, Yan; Li, Jian-Xin; Song, Ying; Xu, Jing-Jing; Tang, Xiao-Fang; Jiang, Lin; Jiang, Ping; Liu, Ru; Wang, Huan-Huan; Zhao, Xue-Yan; Chen, Jue; Gao, Zhan; Qiao, Shu-Bin; Gao, Run-Lin; Yang, Yue-Jin; Xu, Bo; Yuan, Jin-Qing

    2017-11-01

    Stent thrombosis (ST) is a rare but catastrophic complication of percutaneous coronary intervention, leading to poor prognosis. Endothelin-1 (ET-1) plays an important role in endothelial dysfunction and thrombogenesis. However, the impact of big ET-1 level on ST in patients with coronary stenting is unknown. We aimed to evaluate big ET-1 level as a potential predictor of ST in patients undergoing percutaneous coronary intervention. From January 2013 to December 2013, 8106 consecutive patients underwent successful coronary stent implantation and were prospectively enrolled in this study. Patients were stratified into three groups based on plasma big ET-1 level at admission. The incidence of definite and probable ST at 2years postoperatively was 0.84%; ST incidence was lowest in the low big ET-1 group (0.56%), highest in the high big ET-1 group (1.48%), and intermediate in the medium big ET-1 group (0.74%, log-rank p=0.001). Compared with the low big ET-1 group, the multivariate-adjusted hazard ratio (HR) for ST in the high big ET-1 group was 2.06 (95% confidence interval (CI) 1.14-3.73, p=0.017). In subgroup analyses, high big ET-1 level was independently associated with ST in patients with acute coronary syndrome (HR 2.29, 95% CI 1.03-5.06, p=0.041), but not in those with stable coronary artery disease (p=0.331), and tended to be associated with older age. Plasma big ET-1 level is a valuable independent predictor of ST in patients with coronary stents, especially in the acute coronary syndrome population. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. Comparing the use of cobalt chromium stents to stainless steel stents in primary percutaneous coronary intervention for acute myocardial infarction: a prospective registry.

    Science.gov (United States)

    Koh, Angela S; Choi, L M; Sim, L L; Tan, Jack W; Khin, L W; Chua, Terrance S J; Koh, T H; Chia, Stanley

    2011-12-01

    To determine clinical outcome and rates of target vessel revascularization (TVR) in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI who were treated with cobalt-chromium stents compared to stainless steel bare metal stents (BMS). The newer generation cobalt chromium stents were reported to achieve lower rates of TVR compared with conventional BMS. Consecutive STEMI cases admitted within 12 h of symptom onset and undergoing primary angioplasty and bare metal stent implantation 1 January 2002 and 31 December 2008 were identified. Primary outcomes were rates of clinically-driven TVR at six months as well as occurrence of major adverse cardiovascular events (MACE) either of all-cause death, repeat myocardial infarction or TVR at six months. 1030 cases with 1175 lesions (84% males) and median age of 58 years underwent primary PCI for STEMI in our registry. Overall procedural success rate was 98%. Stainless steel stents were inserted in 65% of the culprit lesions (stainless steel, n = 766 versus cobalt chromium, n = 264). Primary outcomes of TVR (3.5% in the stainless steel group and 3.4% in the cobalt chromium group, P = 0.93) and MACE (8.4% in the stainless steel group and 5.3% in the cobalt chromium group, P = 0.11) after six months were no different between the two groups. However, there were more deaths at 30 days in the stainless steel group compared to the cobalt chromium group (3.5% versus 0.4%, HR 4.04 (1.03-3.88), P = 0.04). Both cobalt-chromium and stainless steel coronary stents were associated with similar and low risk of clinically-driven TVR.

  11. ANGIOPLASTIA PERCUTÁNEA CON STENT EN EL TRONCO PRINCIPAL DE LA ARTERIA CORONARIA IZQUIERDA / Percutaneous angioplasty with stent in the left main coronary artery

    Directory of Open Access Journals (Sweden)

    Javier Almeida Gómez

    2012-10-01

    Full Text Available ResumenIntroducción y objetivos: La afectación significativa del tronco común izquierdo, es la más letal de las presentaciones de la enfermedad arterial coronaria. El tratamiento de elección, es la cirugía de derivación aorto-coronaria. En varios estudios multicéntricos, se sugiere la posibilidad de tratar la enfermedad de tronco mediante el intervencionismo coronario percutáneo con implantación de prótesis endoluminal o stent. El objetivo de esta investigación fue caracterizar la angioplastia percutánea con stent en el tronco principal de la arteria coronaria izquierda. Método: Se realizó un estudio observacional, descriptivo y transversal en 21 pacientes con angioplastia percutánea con stent en el tronco principal de la arteria coronaria izquierda, realizadas en el laboratorio de Hemodinámica y Cardiología Intervencionista del Hospital "Hermanos Ameijeiras", entre enero 2010 y julio 2011. Resultados: No existió diferencia significativa en el sexo. Predominó el grupo de edad entre 50-64 años (47,6 % y el color de la piel blanca (76,19 %. El factor de riesgo cardiovascular más encontrado fue la HTA (85,71 %, seguido de dislipidemia (47,61 %. El diagnóstico más observado fue la angina de esfuerzo estable, 14 casos (66,66 %. La lesión en el cuerpo del tronco (12 pacientes, 57,1 %, fue la más encontrada, seguida de la ostial (8 casos. El tipo de stent más utilizado fue el liberador de fármacos (61,9 %, y solamente 4 pacientes presentaban troncos protegidos quirúrgicamente. Conclusiones: La mayor cantidad de casos fueron electivos, con predominio de los troncos no protegidos. El factor de riesgo coronario más encontrado fue la HTA. Se encontró asociación significativa entre la diabetes mellitus y la localización ostial de la lesión tratada. / AbstractIntroduction and Objectives: Significant impairment of the left main coronary artery is the most lethal presentation of coronary artery disease. The treatment of choice

  12. Covered stent implantation through a single 8-french guide catheter for the management of a distal coronary perforation.

    Science.gov (United States)

    Sandoval, Yader; Lobo, Angie S; Brilakis, Emmanouil S

    2017-10-01

    Distal coronary perforation can cause early or late tamponade and is usually treated with fat or coil embolization. An alternative treatment strategy is occlusion of the ostium of the perforated vessel via implantation of a covered stent in the main vessel, which is typically achieved using the ping-pong guide catheter technique. In this technique, a balloon is inflated over one guide catheter to stop pericardial bleeding and a covered stent is delivered through a second guide catheter due to inability to fit both a balloon and a covered stent through a single guide catheter. With development of lower profile rapid exchange covered stents, a single guide catheter can be used to both occlude the target vessel and deliver the covered stent. We describe a case of distal vessel perforation in which a balloon was inflated to stop pericardial bleeding, followed by delivery of a covered stent (Graftmaster, Abbott Vascular) through a single 8-Fr guide catheter. This "block and deliver" technique represents a novel paradigm for treating coronary perforations through a single guide catheter, obviating the need for the ping-pong guide catheter technique. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  13. Safety and efficacy of a non-polymeric paclitaxel-eluting microporous stent in real-world percutaneous coronary intervention

    Science.gov (United States)

    WANG, SHAO-PENG; HUANG, RONG-CHONG; ZHU, HAO; ZHANG, BO; ZHENG, ZHEN-GUO; YIN, DA; WANG, JUN-JIE; ZHOU, XU-CHEN

    2013-01-01

    At present, there is an increasing focus on stents that have a biodegradable polymer coating, rather than a permanent polymer coating. This is due to the fact that following the implantation of a drug-eluting stent (DES) with a permanent polymer coating, the continued existence of the coating may result in a foreign body reaction and delayed re-endothelialization. The aim of the present study was to evaluate the safety and efficacy of a non-polymeric paclitaxel-eluting microporous (YINYI™) stent in real-life percutaneous coronary intervention (PCI) for patients with coronary artery disease (CAD). A total of 686 YINYI™ stents were implanted in 404 patients with CAD in a PCI procedure and outpatient follow-ups were performed 1, 6, 12 and 15 months subsequent to the PCI, respectively. The observation endpoints were major adverse cardiac events (MACEs), including cardiac death, non-fatal myocardial infarction (MI), restenosis, target lesion revascularization, stent thrombosis and recurrence of angina pectoris. The average follow-up time was 15 months. The results revealed that the cumulative incidences of MACEs were as follows: mortality, 0.99%; non-fatal MI, 0.74%; restenosis, 4.0%; and target lesion revascularization, 2.7%. The results at the short- and long-term clinical follow-ups indicated that YINYI™ stents are effective and safe for use in PCI for patients with CAD. PMID:24137271

  14. Aspirin challenge/desensitisation before coronary stenting in subjects with history of hypersensitivity. A pragmatic approach.

    Science.gov (United States)

    Cortellini, G; Testi, S; Severino, M; Chechi, T; Iorno, M L; Santucci, A; Corvetta, A; Piovaccari, G; Santarelli, A; Franco, N; Canonica, G W; Passalacqua, G

    2012-08-01

    Aspirin hypersensitivity may represent a major problem in patients with ischemic coronary disease who need a stenting procedure. In those patients, clinically unsettled reasonably quick desensitisation procedures are needed. In our study we attempted to select the most suitable procedure on the basis of characteristics and severity of ASA hypersensitivity. Thirty patients with a history of mild reactions to anti-inflammatory doses of aspirin (> 325 mg) were considered at low risk and underwent a tolerance test in 5 steps. Thirty-one patients, with a history of severe reactions to anti-platelet doses of aspirin 0 mg) underwent a slow desensitisation in 12 steps, reaching a cumulative dose of 150 mg ASA in 220 minutes. In the first group, 29 patients tolerated the challenge. One developed urticaria, thus underwent challenge/desensitisation and achieved tolerance. In the second group, 3 patients did not tolerate the procedure and had to discontinue. CONCLUSION. Our approach to aspirin hypersensitivity in patients needing coronary stenting, based on a severity stratification, allowed to achieve an effective tolerance to aspirin in the majority of subject in a reasonable short time.

  15. Zotarolimus-eluting stent utilization in small-vessel coronary artery disease (ZEUS).

    Science.gov (United States)

    Jim, Man-Hong; Yiu, Kai-Hang; Fung, Raymond Chi-Yan; Ho, Hee-Hwa; Ng, Andrew Kei-Yan; Siu, Chung-Wah; Chow, Wing-Hing

    2014-01-01

    The role of the second-generation zotarolimus-eluting stent RESOLUTE in small-vessel coronary artery disease is unclear. The aim of this study was examine the angiographic results of RESOLUTE in de novo coronary lesions of ≥50 % diameter stenosis in target vessels ≤2.5 mm. From August 2008 to April 2010, 142 symptomatic patients with 159 lesions who fitted the inclusion criteria were treated with RESOLUTE. The mean age of patients was 66 ± 10 years, with male predominance (66 %). Diabetes mellitus was found in 62 (43.7 %) patients, whereas multivessel disease was observed in 105 (73.9 %). The mean stent size and length used were 2.33 ± 0.13 and 22 ± 8 mm, respectively. Follow-up angiography was performed on 143 (89.9 %) lesions in 127 (89.4 %) patients at a mean of 10.3 ± 3.6 months. Angiographic restenosis was found in 9 (6.3 %) lesions; the late loss was 0.26 ± 0.34 mm. At 1-year follow-up there were four cardiovascular deaths, two nonfatal myocardial infarctions, and six repeated revascularizations. The resultant major adverse cardiac event rate was 8.5 %. The use of RESOLUTE to treat small-vessel disease is associated with good clinical and angiographic outcomes at 1 year.

  16. 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 AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions [ENDEAVOR II]; NCT00614848).

  17. Comparison between ticlopidine and clopidogrel in patients with ST-segment elevation myocardial infarction treated with coronary stenting

    NARCIS (Netherlands)

    De Luca, G.; Suryapranata, H.; van't Hof, A.W.J.; Ottervanger, J.P.; Hoorntje, J.C.A.; Gosselink, A.T.M.; Damibrink, J.H.E.; Zijlstra, F.; Boer, M.J.C.

    Controversy still surrounds the question, which antiplatelet drug should be added to aspirin in patients undergoing coronary stent implantation. The aim of the current study was to compare ticlopidine and clopidogrel in a consecutive series of patients with ST-segment elevation myocardial infarction

  18. 'Ins' and 'outs' of triple therapy: Optimal antiplatelet therapy in patients on chronic oral anticoagulation who need coronary stenting.

    NARCIS (Netherlands)

    Dewilde, W.; Verheugt, F.W.A.; Breet, N.; Koolen, J.J.; Berg, J.M. ten

    2010-01-01

    Chronic oral anticoagulant treatment is obligatory in patients (class I) with mechanical heart valves and in patients with atrial fibrillation with CHADS2 score >1. When these patients undergo percutaneous coronary intervention with placement of a stent, there is also an indication for treatment

  19. Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction

    DEFF Research Database (Denmark)

    Dangas, George D; Schoos, Mikkel M.; Steg, Philippe Gabriel

    2016-01-01

    BACKGROUND: Early stent thrombosis (ST) within 30 days after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction is a serious event. We sought to determine the predictors of and risk of mortality after early ST according to procedural antithrombotic therapy. M...

  20. 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

    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...

  1. Evaluation of the MiStent sustained sirolimus eluting biodegradable polymer coated stent for the treatment of coronary artery disease: does uniform sustained abluminal drug release result in earlier strut coverage and better safety profile?

    NARCIS (Netherlands)

    Tijssen, Ruben Y. G.; Kraak, Robin P.; Lu, Huangling; Mifek, Jeffrey G.; Carlyle, Wenda C.; Donohoe, Dennis J.; de Winter, Robbert J.; Koch, Karel T.; Wykrzykowska, Joanna J.

    2017-01-01

    Treatment of coronary artery disease has made strides over the last decades. Development of drug eluting stents (DES), coated with a polymer layer and an anti-proliferative drug to reduce neointimal hyperplasia, has reduced the incidence of in-stent-restenosis relative to treatment with bare metal

  2. One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions: an analysis from the RAVEL trial

    NARCIS (Netherlands)

    B.A. van Hout (Ben); P.A. Lemos Neto (Pedro); G.A. van Es (Gerrit Anne); W.K. Lindeboom (Wietze); M-C. Morice (Marie-Claude); M.J.B.M. van den Brand (Marcel); P.W.J.C. Serruys (Patrick)

    2005-01-01

    textabstractOBJECTIVE: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo

  3. One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions : an analysis from the RAVEL trial

    NARCIS (Netherlands)

    van Hout, BA; Serruys, PW; Lemos, PA; van den Brand, MJBM; van Es, GA; Lindeboom, WK; Morice, MC

    Objective: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL ( randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native

  4. Successful treatment of cardiogenic shock by stenting of the left main coronary artery in acute myocardial infarction

    Directory of Open Access Journals (Sweden)

    Knežević Božidarka

    2008-01-01

    Full Text Available Introduction. Patients with non-ST elevation acute coronary syndromes (NSTE-ACS are sometimes severely hemodynamicly compromised. Urgent coronary angiography should be performed in these patients in percutaneous coronary intervention (PCI centers according to the ESC NSTE-ACS guidelines to determine suitabilty for percutaneous or surgical revascularization. Case report. We reported a 62-year-old male with chest pain admitted to the Coronary Care Unit. ST segment depression of 2 mm in leads I, L and V4-6 was revealed at electrocardiogram. After following 6 hours the patient had chest pain and signs of cardiogenic shock despite of the therapy. Chest x-ray showed pulmonary edema. Echocardiographic examination showed dyskinetic medium and apical segments of septum. The patient underwent coronary angiography immediately which revealed 75% stenosis of the left main coronary artery with thrombus. The use of a GPIIb/III inhibitor-tirofiban and stent implantation resulted in TIMI III flow. After that the patient had no chest pain and acute heart failure subsided in the following days Echocardiography done at the fourth day from PCI showed only hypokinesis medium and apical segment of septum. The patient was discharged at day 11 from admission in a stable condition. Conclusion. Stenting of left main coronary artery stenosis in patients with cardiogenic shock and non- ST segment elevation acute coronary syndromes may be a life saving procedure.

  5. Predictors of long-term outcomes after bypass grafting versus drug-eluting stent implantation for left main or multivessel coronary artery disease

    NARCIS (Netherlands)

    Chang, Mineok; Lee, Cheol Whan; Ahn, Jung-Min; Cavalcante, Rafael; Sotomi, Yohei; Onuma, Yoshinobu; Han, Minkyu; Park, Seong-Wook; Serruys, Patrick W.; Park, Seung-Jung

    2017-01-01

    Background: We assessed predictors of long-term outcomes after coronary artery bypass grafting (CABG) versus those after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in 3,230 patients with left main or multivessel coronary artery disease (CAD). Methods and Results: Data

  6. Coronary stent thrombosis with vorapaxar versus placebo: results from the TRA 2° P-TIMI 50 trial.

    Science.gov (United States)

    Bonaca, Marc P; Scirica, Benjamin M; Braunwald, Eugene; Wiviott, Stephen D; O'Donoghue, Michelle L; Murphy, Sabina A; Morrow, David A

    2014-12-09

    Vorapaxar, a novel thrombin receptor antagonist, reduces cardiovascular death and recurrent thrombotic events when added to standard antiplatelet therapy in patients with stable atherosclerotic vascular disease. The goal of this study was to test the hypothesis that treatment with vorapaxar reduces the rate of coronary stent thrombosis (ST) in stable patients with a history of coronary stenting. TRA 2° P-TIMI 50 (Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Patients With Atherosclerosis-Thrombolysis In Myocardial Infarction 50) was a multinational, randomized, double-blind, placebo-controlled trial of vorapaxar in stable patients with prior myocardial infarction, peripheral arterial disease, or stroke. We evaluated the rates of definite ST as adjudicated by a central events committee using Academic Research Consortium (ARC) criteria. A total of 26,449 patients were randomized, with 14,042 (53%) having a history of a coronary stent implantation before randomization, and an additional 449 patients receiving a coronary stent during the trial (total 14,491). During follow-up (median 2.5 years), there were 152 definite ST events, with the majority (92%) occurring late or very late. Vorapaxar reduced ARC definite ST (1.1% vs. 1.4%, hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.51 to 0.98; p = 0.037). The reduction was consistent, regardless of time from percutaneous coronary intervention, history of diabetes, use of drug-eluting stents, and use of dual antiplatelet therapy (DAPT) at randomization. Vorapaxar increased GUSTO moderate/severe bleeding (HR: 1.57, 95% CI: 1.26 to 1.94; p TRA 2° P-TIMI 50] [P04737]; NCT00526474). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  7. Safety and efficacy of the cobalt chromium PRO-Kinetik coronary stent system: results of the MULTIBENE study.

    Science.gov (United States)

    Vermeersch, Paul; Appelman, Yolande; Horstkotte, Dieter; Richardt, Gert; Boland, Jean; Lalmand, Jacques; Coussement, Patrick; Castadot, Marc; Janssens, Luc; Agostoni, Pierfrancesco; Buysschaert, Ian; Suttorp, Maarten J

    2012-01-01

    The aim of this MULTIBENE study was to evaluate the safety and efficacy of the silicon carbide coated cobalt chromium PRO-Kinetik coronary stent system in patients with single de novo coronary lesions. This prospective international multicenter study included 202 patients at 10 European sites. Analysis was performed on the per protocol population of 197 patients. Patients were followed until 12 months, a subset of patients (n=72) underwent additional coronary angiography at 6 months. Primary endpoint was 6-months rate of target vessel failure (TVF), defined as a composite of cardiac death, myocardial infarction and target vessel revascularization (TVR). At 6 months, rate of TVF was 10.9% and rate of major adverse cardiac events, a composite of cardiac death, MI, target lesion revascularization (TLR) and coronary artery bypass graft, was 11.4%, both being mainly attributed to TVR respective TLR. No cardiac death or stent thrombosis occurred. In-segment late lumen loss was 0.66±0.61mm and binary restenosis was 20.8%, as determined by core laboratory in the angiographic subgroup. Based on these data, the PRO-Kinetik coronary stent system was found to be safe and effective. Copyright © 2012 Elsevier Inc. All rights reserved.

  8. Relationship between the total length of the stents and patients' quality of life after percutaneous coronary intervention.

    Science.gov (United States)

    Liu, Wei; Yang, Xuming; Dong, Pingshuan; Li, Zhijuan

    2015-01-01

    The aim of this study was to examine the relationship between the total length of the stents and the postoperative life quality of patients with multi-vessel coronary artery disease who undergo percutaneous coronary intervention (PCI). Using the short-form health survey (SF-36) items, we analyzed the data on the postoperative life quality of 166 patients with multi-vessel coronary artery disease who underwent percutaneous transluminal coronary intervention in the Department of Cardiology of the First Affiliated Hospital of Henan University of Science and Technology from September 2011 to September 2013. Follow-up was performed 6 months later. All of the dimensionalities, except general health and mental health, showed significantly higher scores after PCI. No significant relationships were observed between the total length of the stents and the postoperative life quality of patients with multi-vessel coronary artery disease who underwent PCI. PCI can effectively improve the postoperative life quality of patients; however, there was no significant relationship between the total length of the stents and postoperative life quality of patients.

  9. Impact of drug-eluting stent generation on patient- and stent-related adverse events of diabetic patients treated by percutaneous coronary intervention.

    Science.gov (United States)

    D'Amico, G; Fabris, T; Mojoli, M; Napodano, M; Frigo, A C; Buja, P; Hoxha, B; Lunardon, A; Zanetti, C; Isabella, G; Iliceto, S; Tarantini, G

    2014-02-01

    Aim of the present study was to assess stent- and patient-related outcomes of the first- vs. second-generation drug-eluting stents (DES) in diabetics, according to the insulin requirement status. Data were obtained from a prospective, single-center registry of 816 consecutive patients with diabetes mellitus (23% insulin-requiring) who underwent percutaneous coronary intervention (PCI) between April 2003 and May 2012 with first- (N.=534) or second-generation DES (N.=282) at our Institution, with at least 12 months of follow-up. We assessed the occurrence of stent-related outcome, including cardiac death, target vessel-related myocardial infarction and target lesion revascularization, versus patient-related outcome, including any cause death, any myocardial infarction and any coronary revascularization. Patients treated with second-generation DES were older and had more complex lesions than patients treated with first-generation DES. Both among patients treated with first-generation DES and those treated with second generation DES, patient-related events were almost double than stent-related events. No interactions were observed between the DES generation type and insulin requirement status. In this observational study, first- and second-generation DES were equally safe and efficacious in diabetic patients undergoing PCI, regardless of insulin requirements. The greater number of patient-related than stent-related events in patients with complex clinical and lesion characteristics emphasizes that the optimization of secondary prevention is at least as important as the selection of which new generation DES to implant in a specific lesion.

  10. Randomized trial of stents versus bypass surgery for left main coronary artery disease.

    Science.gov (United States)

    Park, Seung-Jung; Kim, Young-Hak; Park, Duk-Woo; Yun, Sung-Cheol; Ahn, Jung-Min; Song, Hae Geun; Lee, Jong-Young; Kim, Won-Jang; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Chung, Cheol-Hyun; Lee, Jae-Won; Lim, Do-Sun; Rha, Seung-Woon; Lee, Sang-Gon; Gwon, Hyeon-Cheol; Kim, Hyo-Soo; Chae, In-Ho; Jang, Yangsoo; Jeong, Myung-Ho; Tahk, Seung-Jea; Seung, Ki Bae

    2011-05-05

    Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis, although coronary-artery bypass grafting (CABG) has been considered to be the treatment of choice. We randomly assigned patients with unprotected left main coronary artery stenosis to undergo CABG (300 patients) or PCI with sirolimus-eluting stents (300 patients). Using a wide margin for noninferiority, we compared the groups with respect to the primary composite end point of major adverse cardiac or cerebrovascular events (death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 1 year. Event rates at 2 years were also compared between the two groups. The primary end point occurred in 26 patients assigned to PCI as compared with 20 patients assigned to CABG (cumulative event rate, 8.7% vs. 6.7%; absolute risk difference, 2.0 percentage points; 95% confidence interval [CI], -1.6 to 5.6; P=0.01 for noninferiority). By 2 years, the primary end point had occurred in 36 patients in the PCI group as compared with 24 in the CABG group (cumulative event rate, 12.2% vs. 8.1%; hazard ratio with PCI, 1.50; 95% CI, 0.90 to 2.52; P=0.12). The composite rate of death, myocardial infarction, or stroke at 2 years occurred in 13 and 14 patients in the two groups, respectively (cumulative event rate, 4.4% and 4.7%, respectively; hazard ratio, 0.92; 95% CI, 0.43 to 1.96; P=0.83). Ischemia-driven target-vessel revascularization occurred in 26 patients in the PCI group as compared with 12 patients in the CABG group (cumulative event rate, 9.0% vs. 4.2%; hazard ratio, 2.18; 95% CI, 1.10 to 4.32; P=0.02). In this randomized trial involving patients with unprotected left main coronary artery stenosis, PCI with sirolimus-eluting stents was shown to be noninferior to CABG with respect to major adverse cardiac or cerebrovascular events. However, the noninferiority margin was wide, and the results cannot be considered

  11. Recurrent Myocardial Infarction After Primary Percutaneous Coronary Intervention in Multivessel Coronary Disease Is Primarily Related to Stent Failure: Post-Hoc Analysis of the PASSION Trial.

    Science.gov (United States)

    Vink, Maarten A; Vos, Nicola S; Dirksen, Maurits T; Suttorp, Maarten J; Slagboom, Ton; Patterson, Mark S; Kiemeneij, Ferdinand; Laarman, GertJan

    2015-12-01

    Our aim was to investigate the risk of events related to non-culprit lesions after primary percutaneous coronary intervention (PCI) in patients with multivessel coronary disease (MVD). In patients undergoing primary PCI for ST-elevation myocardial infarction (STEMI) who are diagnosed with MVD, the optimal treatment strategy is currently under debate. Although observational data exposed an increased risk of multivessel PCI in the acute phase of STEMI, 2 recently published randomized controlled trials showed a reduction of death or recurrent myocardial infarction (MI) after preventive PCI of non-culprit lesions when compared with culprit-lesion PCI only. We performed a post-hoc analysis of 279 patients with MVD included in the Paclitaxel-Eluting Stent versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation (PASSION) trial. We analyzed the incidence and cause of recurrent MI. Recurrent MI due to stent failure was assumed in the event of definite or probable stent thrombosis. After 5 years, 14 patients (5.7%) with MVD had a recurrent MI versus 17 (5.4%) patients with 1-vessel disease (HR 1.06, 95%CI 0.52-2.15, P = 0.87). The majority of events was attributable to stent failure, while of the remaining 6 events, only 1 was proven to originate from a lesion that was judged significant at enrolment. In this post-hoc analysis of the PASSION trial, recurrent MI in patients with MVD was mainly related to stent failure rather than a new event originating from a significant stenosis in a non-culprit coronary artery. © 2015, Wiley Periodicals, Inc.

  12. Multi-objective optimisation of stent dilation strategy in a patient-specific coronary artery via computational and surrogate modelling.

    Science.gov (United States)

    Ragkousis, Georgios E; Curzen, Nick; Bressloff, Neil W

    2016-01-25

    Although contemporary stents have been shown to improve short and long term clinical outcomes, the optimum dilation protocol is still uncertain in challenging cases characterised by long, highly calcified and tortuous anatomy. Recent clinical studies have revealed that in these cases, sub-optimal delivery can result in stent thrombosis (ST) and/or neointimal thickening as a result of stent malapposition (SM) and/or severe vessel trauma. One of the major contributors to vessel trauma is the damage caused by balloon dilation during stent deployment. In the present work, a Kriging based response surface modelling approach has been implemented to search for optimum stent deployment strategies in a clinically challenging, patient specific diseased coronary artery. In particular, the aims of this study were: (i) to understand the impact of the balloon pressure and unpressurised diameter on stent malapposition, drug distribution and wall stresses via computer simulations and (ii) obtain potentially optimal dilation protocols to simultaneously minimise stent malapposition and tissue wall stresses and maximise drug diffusion in the tissue. The results indicate that SM is inversely proportional to tissue stresses and drug deliverability. After analytical multi-objective optimisation, a set of "non-dominated" dilation scenarios was proposed as a post-optimisation methodology for protocol selection. Using this method, it has been shown that, for a given patient specific model, optimal stent expansion can be predicted. Such a framework could potentially be used by interventional cardiologists to minimise stent malapposition and tissue stresses whilst maximising drug deliverability in any patient-specific case. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. Optical coherence tomography assessment of a coronary bare cobalt chromium stent deformed by the removal of an entrapped "jailed" guidewire.

    Science.gov (United States)

    Agostoni, Pierfrancesco; Van Belle, Eric; Stella, Pieter R

    2010-09-01

    A 64-year-old male with an ongoing acute coronary syndrome was treated percutaneously for a subtotal occlusion of a first diagonal branch. After predilatation of the diagonal, an important secondary branch was evident at the level of the subocclusion. A jailed wire was placed in this vessel, and stenting of the main diagonal branch was performed with a last-generation thin-strut bare cobalt-chromium stent. Conventional retrieval of the jailed wire was impossible, as the distal tip of the wire remained entrapped at the level of the stent. The strong pulling of the wire led only to a deep intubation of the guiding catheter with possible risk of dissection. Retrieval of the wire was finally possible with the support of an over-the-wire microcatheter. However, the stent, though still patent, appeared deformed. At a scheduled control angiogram 4 months later (while the patient was still asymptomatic), an optical coherence tomography (OCT) investigation of the stented segment confirmed the deformation of the stent. OCT showed a complete lack of stent struts on the side of origin of the secondary branch and an "overlap" or "accumulation" of several layers of stent struts on the other side. There were no signs of uncovered struts overall nor malapposition, and even the sites where multiple stent layers were visible were completely covered by neointimal hyperplasia. Despite the multiple layers of metal, the neointimal reaction was moderate and did not lead to a flow-limiting stenosis, thus the patient was further treated medically without the need for a new intervention.

  14. Percutaneous coronary intervention outcomes in a low-volume center: survival, stent thrombosis, and repeat revascularization.

    Science.gov (United States)

    Kenney, Kimberly M; Marzo, Mitchell C; Ondrasik, Nicholas R; Wisenbaugh, Thomas

    2009-11-01

    American College of Cardiology (ACC) guidelines state that percutaneous coronary interventions (PCI) be performed at centers and by operators with high-volume (>400 yearly/center) whose historical and current risk-adjusted outcomes statistics are comparable to those reported in large registries. Tripler Army Medical Center is a low-volume treatment facility but has a geographic need and special mission requirement for providing this service. We computed 30-day incidence of stent thrombosis, need for repeat revascularization, and all-cause mortality for all PCIs performed at Tripler from January 2002 through June 2008. The New York State Registry regression model was selected among 3 risk-adjustment models that we assessed in our patients. This model was used to compute expected mortality rate based on patient risk factors. The 30-day incidence of stent thrombosis and repeat revascularization was also determined, and the long-term incidence of these events was estimated with the Kaplan-Meier method as was survival. For all 546 PCI procedures, 30-day mortality was 1.47%, the incidence of stent thrombosis 2.1%, the incidence of any repeat revascularization 5.1%, and the combined event rate 5.9%. Based on risk factors used in the New York State Registry, our expected mortality was 1.93% and not significantly different from the observed rate. Although survival at 1 and 3 years appeared comparable with benchmarks at 94.6% and 89.3%, as did repeat revascularization rates at 13.0% and 21.4%, the incidence of stent thrombosis was regarded as high whether the definition included possible cases (3.2% and 3.9%) or only those regarded as definite or probable (2.7% and 3.1%). We did not identify any remediable risk factors for stent thrombosis, nor were we able to identify significant differences by year or by operator. However, visual inspection of a plot of deciles of New York State risk of death demonstrated 2 outlier cases among the 8 who died, who could have been considered

  15. Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt-chromium coronary stent system.

    Science.gov (United States)

    Ando, Kenji; Ishii, Katsuhisa; Tada, Eiji; Kataoka, Kazuaki; Hirohata, Atsushi; Goto, Kenji; Kobayashi, Katsuyuki; Tsutsui, Hiroshi; Nakahama, Makoto; Nakashima, Hitoshi; Uchikawa, Shinichiroh; Kanda, Junji; Yasuda, Satoshi; Yajima, Junji; Kitabayashi, Hiroshi; Sakurai, Shumpei; Nakanishi, Keita; Inoue, Naoto; Noike, Hirofumi; Hasebe, Terumitsu; Sato, Tetsuya; Yamasaki, Masao; Kimura, Takeshi

    2017-07-01

    The purpose of this multi-center, non-randomized, and open-label clinical trial was to determine the non-inferiority of diamond-like carbon (DLC)-coated cobalt-chromium coronary stent, the MOMO DLC coronary stent, relative to commercially available bare-metal stents (MULTI-LINK VISION®). Nineteen centers in Japan participated. The study cohort consisted of 99 patients from 19 Japanese centers with single or double native coronary vessel disease with de novo and restenosis lesions who met the study eligibility criteria. This cohort formed the safety analysis set. The efficacy analysis set consisted of 98 patients (one case was excluded for violating the eligibility criteria). The primary endpoint was target vessel failure (TVF) rate at 9 months after stent placement. Of the 98 efficacy analysis set patients, TVF occurred in 11 patients (11.2 %, 95 % confidence interval 5.7-19.2 %) at 9 months after the index stent implantation. The upper 95 % confidence interval for TVF of the study stent was lower than that previously reported for the commercially available MULTI-LINK VISION® (19.6 %), demonstrating non-inferiority of the study stent to MULTI-LINK VISION®. All the TVF cases were related to target vascular revascularization. None of the cases developed in-stent thrombosis or myocardial infarction. The average in-stent late loss and binary restenosis rate at the 6-month follow-up angiography were 0.69 mm and 10.5 %, respectively, which are lower than the reported values for commercially available bare-metal stents. In conclusion, the current pivotal clinical study evaluating the new MOMO DLC-coated coronary stent suggested its low rates of TVF and angiographic binary restenosis, and small in-stent late loss, although the data were considered preliminary considering the small sample size and single arm study design.

  16. A higher volume of fibrotic tissue on virtual histology prior to coronary stent implantation predisposes to more pronounced neointima proliferation.

    Science.gov (United States)

    Haine, Steven; Wouters, Kristien; Miljoen, Hielko; Vandendriessche, Tom; Claeys, Marc; Bosmans, Johan; Vrints, Christiaan

    2017-08-11

    Since neointima smooth muscle cells (SMC) mainly originate from the vessel wall, we investigated whether atherosclerotic plaque composition influences subsequent in-stent neointima proliferation and restenosis. We performed intravascular ultrasound (IVUS) with virtual histology in 98 patients prior to elective bare-metal stent (BMS) implantation in de novo coronary artery lesions. Virtual histology variables pre-percutaneous coronary intervention (PCI) were related to in-stent neointima proliferation six months after implantation assessed as late luminal loss of 0.88 mm (interquartile range (IQR) 0.37-1.23 mm) on angiography and as maximal percentage area stenosis of 42% (IQR 33-59%) and percentage volume intima hyperplasia of 27% (IQR 20-36%) on IVUS. A ridge-trace based multiple linear regression model was constructed to account for multicollinearity of the virtual histology variables and was corrected for implanted stent length (18 mm, IQR 15-23 mm), stent diameter (3.0 mm, IQR 2.75-3.5 mm) and lesion volume (146 mm³, IQR 80-201 mm³) prior to PCI. Fibrous tissue volume prior to PCI (49 mm³, IQR 30-77 mm³) was significantly and independently related to late luminal loss (p = .038), maximal percentage area stenosis (p = .041) and percentage volume intima hyperplasia (p = .004). Neither absolute nor relative amounts of fibrofatty, calcified or necrotic core tissue appeared related to any of the restenosis parameters. Subgroup analysis after exclusion of acute coronary syndrome (ACS) patients yielded similar results. Lesions with more voluminous fibrotic tissue pre-PCI show more pronounced in-stent neointima proliferation, even after correction for lesion plaque volume.

  17. Frequency of Cardiac Death and Stent Thrombosis in Patients With Chronic Obstructive Pulmonary Disease Undergoing Percutaneous Coronary Intervention (from the BASKET-PROVE I and II Trials)

    DEFF Research Database (Denmark)

    Jatene, Tannas; Biering-Sørensen, Tor; Nochioka, Kotaro

    2017-01-01

    is not well known. We analyzed 4,605 patients who underwent percutaneous coronary intervention with bare-metal stents (33.1%) or DES (66.9%) from the Basel Stent Kosten-Effektivitats Trial-Prospective Validation Examination trials I and II. COPD patients (n = 283, 6.1%), were older and had more frequently...

  18. Eptifibatide and abciximab exhibit equivalent antiplatelet efficacy in an experimental model of stenting in both healthy volunteers and patients with coronary artery disease

    NARCIS (Netherlands)

    Amoroso, G; van Boven, AJ; van Veldhuisen, DJ; Tio, RA; Balje-Volkers, CP; Petronio, AS; van Oeveren, W

    2001-01-01

    Platelet deposition and aggregation are the major determinants of acute thrombosis in coronary stents. We aimed to compare the antiplatelet efficacy of different treatments-glycoprotein (Gp) IIb/IIIa inhibitors and conventional antiaggregants-in an experimental model for stenting. Blood samples were

  19. 'Ins' and 'outs' of triple therapy: Optimal antiplatelet therapy in patients on chronic oral anticoagulation who need coronary stenting.

    Science.gov (United States)

    Dewilde, W; Verheugt, F W A; Breet, N; Koolen, J J; Ten Berg, J M

    2010-09-01

    Chronic oral anticoagulant treatment is obligatory in patients (class I) with mechanical heart valves and in patients with atrial fibrillation with CHADS2 score >1. When these patients undergo percutaneous coronary intervention with placement of a stent, there is also an indication for treatment with aspirin and clopidogrel. Unfortunately, triple therapy is known to increase the bleeding risk. For this group of patients, the bottom line is to find the ideal therapy in patients with indications for both chronic anticoagulation therapy and percutaneous intervention to prevent thromboembolic complications such as stent thrombosis without increasing the risk of bleeding. (Neth Heart J 2010;18:444-50.).

  20. Randomized Comparisons Between Different Stenting Approaches for Bifurcation Coronary Lesions With or Without Side Branch Stenosis.

    Science.gov (United States)

    Kim, Young-Hak; Lee, Jae-Hwan; Roh, Jae-Hyung; Ahn, Jung-Min; Yoon, Sung-Han; Park, Duk-Woo; Lee, Jong-Young; Yun, Sung-Cheol; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Seung, Ki Bae; Shin, Won-Yong; Lee, Nae-Hee; Lee, Bong-Ki; Lee, Sang-Gon; Nam, Chang-Wook; Yoon, Junghan; Yang, Joo-Young; Hyon, Min-Su; Lee, Keun; Jang, Jae-Sik; Kim, Hyun-Sook; Park, Seong-Wook; Park, Seung-Jung

    2015-04-20

    This study sought to evaluate the optimal percutaneous coronary intervention techniques using drug-eluting stents for bifurcation coronary lesions. The optimal bifurcation stenting technique needs to be evaluated. The trial included 2 randomization studies separated by the presence of side branch (SB) stenosis for patients having non-left main bifurcation lesions. For 306 patients without SB stenosis, the routine final kissing balloon or leave-alone approaches were compared. Another randomization study compared the crush or single-stent approaches for 419 patients with SB stenosis. Between the routine final kissing balloon and leave-alone groups for nondiseased SB lesions, angiographic restenosis occurred in 17.9% versus 9.3% (p=0.064), comprising 15.1% versus 3.7% for the main branch (p=0.004) and 2.8% versus 5.6% for the SB (p=0.50) from 214 patients (69.9%) receiving 8-month angiographic follow-up. Incidence of major adverse cardiac events including death, myocardial infarction, or target vessel revascularization over 1 year was 14.0% versus 11.6% between the routine final kissing balloon and leave-alone groups (p=0.57). In another randomization study for diseased SB lesions, 28.2% in the single-stent group received SB stents. From 300 patients (71.6%) receiving angiographic follow-up, between the crush and single-stent groups, angiographic restenosis rate was 8.4% versus 11.0% (p=0.44), comprising 5.2% versus 4.8% for the main branch (p=0.90) and 3.9% versus 8.3% for the SB (p=0.12). One-year major adverse cardiac events rate between the crush and single-stent groups was 17.9% versus 18.5% (p=0.84). Angiographic and clinical outcomes were excellent after percutaneous coronary intervention using drug-eluting stents with any stent technique for non-left main bifurcation lesions once the procedure was performed successfully. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  1. Successful Implantation of a Coronary Stent Graft in a Peripheral Vessel

    Directory of Open Access Journals (Sweden)

    Alexander Hess

    2015-01-01

    Full Text Available Peripheral artery disease (PAD is a complex, often underdiagnosed illness with rising prevalence in western world countries. During the past decade there has been a rapid advance especially in the field of endovascular treatment of PAD. Here we present for the first time a case reporting on the placement of coronary stent graft in a peripheral vessel for the management of a peripheral side branch perforation. Interventional angiologists or radiologists may consider such an option for complication management after injury of smaller vessels during peripheral percutaneous interventions. Further specialization and novel options of complication management as described in our case may shift the treatment from surgical to even more endovascular treatment procedures in the future.

  2. Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents.

    Directory of Open Access Journals (Sweden)

    Kevin P Weinfurt

    2008-05-01

    Full Text Available Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006.We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents. We recorded article characteristics, including information about authors' financial disclosures. The main outcome measures were the prevalence, nature, and consistency of financial disclosures. There were 746 articles, 2985 authors, and 135 journals in the database. Eighty-three percent of the articles did not contain disclosure statements for any author (including declarations of no interests. Only 6% of authors had an article with a disclosure statement. In comparisons between articles by the same author, the types of disagreement were as follows: no disclosure statements vs declarations of no interests (64%; specific disclosures vs no disclosure statements (34%; and specific disclosures vs declarations of no interests (2%. Among the 75 authors who disclosed at least 1 relationship with an organization, there were 2 cases (3% in which the organization was disclosed in every article the author wrote.In the rare instances when financial interests were disclosed, they were not disclosed consistently, suggesting that there are problems with transparency in an area of the literature that has important implications for patient care. Our findings suggest that the inconsistencies we observed are due to both the policies of journals and the behavior of some authors.

  3. Serotonin Antagonism Improves Platelet Inhibition in Clopidogrel Low-Responders after Coronary Stent Placement: An In Vitro Pilot Study

    Science.gov (United States)

    Duerschmied, Daniel; Ahrens, Ingo; Mauler, Maximilian; Brandt, Christoph; Weidner, Stefanie; Bode, Christoph; Moser, Martin

    2012-01-01

    Increased residual platelet reactivity remains a burden for coronary artery disease (CAD) patients who received a coronary stent and do not respond sufficiently to treatment with acetylsalicylic acid and clopidogrel. We hypothesized that serotonin antagonism reduces high on-treatment platelet reactivity. Whole blood impedance aggregometry was performed with arachidonic acid (AA, 0.5 mM) and adenosine diphosphate (ADP, 6.5 µM) in addition to different concentrations of serotonin (1–100 µM) in whole blood from 42 CAD patients after coronary stent placement and 10 healthy subjects. Serotonin increased aggregation dose-dependently in CAD patients who responded to clopidogrel treatment: After activation with ADP, aggregation increased from 33.7±1.3% to 40.9±2.0% in the presence of 50 µM serotonin (pclopidogrel low-responders (from 59.9±3.1% to 37.4±3.5, pclopidogrel responders. These results were confirmed with light transmission aggregometry in platelet-rich plasma in a subset of patients. Serotonin hence increased residual platelet reactivity in patients who respond to clopidogrel after coronary stent placement. In clopidogrel low-responders, serotonin receptor antagonism improved platelet inhibition, almost reaching responder levels. This may justify further investigation of triple antiplatelet therapy with anti-serotonergic agents. PMID:22384279

  4. CT evaluation of coronary artery stents with iterative image reconstruction: improvements in image quality and potential for radiation dose reduction

    Energy Technology Data Exchange (ETDEWEB)

    Ebersberger, Ullrich [Medical University of South Carolina, Department of Radiology and Radiological Science and Division of Cardiology, Department of Medicine, Charleston, SC (United States); Heart Centre Munich-Bogenhausen, Department of Cardiology and Intensive Care Medicine, Munich (Germany); Tricarico, Francesco [Catholic University of the Sacred Heart, ' ' A. Gemelli' ' Hospital, Department of Bioimaging and Radiological Sciences, Rome (Italy); Schoepf, U.J. [Medical University of South Carolina, Department of Radiology and Radiological Science and Division of Cardiology, Department of Medicine, Charleston, SC (United States); Medical University of South Carolina, Heart and Vascular Center, Charleston, SC (United States); Blanke, Philipp [Medical University of South Carolina, Department of Radiology and Radiological Science and Division of Cardiology, Department of Medicine, Charleston, SC (United States); University Hospital Freiburg, Department of Diagnostic Radiology, Freiburg (Germany); Spears, J.R.; Rowe, Garrett W.; Halligan, William T. [Medical University of South Carolina, Department of Radiology and Radiological Science and Division of Cardiology, Department of Medicine, Charleston, SC (United States); Henzler, Thomas; Apfaltrer, Paul [Medical University of South Carolina, Department of Radiology and Radiological Science and Division of Cardiology, Department of Medicine, Charleston, SC (United States); University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Institute of Clinical Radiology and Nuclear Medicine, Heidelberg (Germany); Bamberg, Fabian [University of Munich - Grosshadern Campus, Institute of Clinical Radiology, Munich (Germany); Leber, Alexander W. [University of Toronto, Institute for Cardiovascular Intervention and Imaging, Schulich Heart Center, Sunnybrook Health Science Centre, Toronto (Canada); Hoffmann, Ellen [Heart Centre Munich-Bogenhausen, Department of Cardiology and Intensive Care Medicine, Munich (Germany)

    2013-01-15

    Comparison of coronary artery stent assessment with cardiac CT angiography (cCTA) using traditional filtered back projection (FBP) and sinogram affirmed iterative reconstruction (SAFIRE), in both full- and half-radiation dose image data. Dual-source cCTA studies of 37 implanted stents were reconstructed at full- and half-radiation dose with FBP and SAFIRE. Half-dose data were based on projections from one DSCT detector. In-stent noise, signal-to-noise ratio (SNR), and stent-lumen attenuation increase ratio (SAIR) were measured and image quality graded. Stent volumes were measured to gauge severity of beam hardening artefacts. Full-dose SAFIRE reconstructions were superior to full-dose FBP vis-a-vis in-stent noise (21.2 {+-} 6.6 vs. 35.7 {+-} 17.5; P < 0.05), SNR (22.1 {+-} 8.6 vs. 14.3 {+-} 6.7; P < 0.05), SAIR (19.6 {+-} 17.6 vs. 33.4 {+-} 20.4%; P < 0.05), and image quality (4.2 {+-} 0.86 vs. 3.5 {+-} 1.0; P < 0.05). Stent volumes were lower measured with SAFIRE (119.9 {+-} 53.7 vs. 129.8 {+-} 65.0 mm{sup 3}; P > 0.05). Comparing half-dose SAFIRE with full-dose FBP, in-stent noise (26.7 {+-} 13.0 vs. 35.7 {+-} 17.5; P < 0.05) and SNR (18.2 {+-} 6.9 vs. 14.3 {+-} 6.7; P < 0.05) improved significantly. SAIR (31.6 {+-} 24.3 vs. 33.4 {+-} 20.4%; P > 0.05), stent volume (129.6 {+-} 57.3 vs. 129.8 {+-} 65.0 mm{sup 3}; P > 0.05), and image quality (3.5 {+-} 1.0 vs. 3.7 {+-} 1.1; P > 0.05) did not differ. Radiation dose decreased from 8.7 {+-} 5.2 to 4.3 {+-} 2.6 mSv. Iterative reconstruction significantly improves imaging of coronary artery stents by CT compared with FBP, even with half-radiation-dose data. (orig.)

  5. Late thrombotic events after bioresorbable scaffold implantation: a systematic review andmeta-analysis of randomized clinical trials

    NARCIS (Netherlands)

    Collet, Carlos; Asano, Taku; Miyazaki, Yosuke; Tenekecioglu, Erhan; Katagiri, Yuki; Sotomi, Yohei; Cavalcante, Rafael; de Winter, Robbert J.; Kimura, Takeshi; Gao, Runlin; Puricel, Serban; Cook, Stéphane; Capodanno, Davide; Onuma, Yoshinobu; Serruys, Patrick W.

    2017-01-01

    Aims To compare the long-term safety and efficacy of bioresorbable vascular scaffold (BVS) with everolimus-eluting stent (EES) after percutaneous coronary interventions. Methods and results A systematic review and meta-analysis of randomized clinical trials comparing clinical outcomes of patients

  6. Preditores independentes de resultados intra-hospitalares pós-implante de stent coronariano Independent predictors of in-hospital outcomes following coronary stent implantation

    Directory of Open Access Journals (Sweden)

    Antônio José Neri-Souza

    2006-10-01

    Full Text Available OBJETIVO: Identificar preditores clínicos e angiográficos independentes, determinantes de resultados imediatos pós-implante de stent coronário. MÉTODOS: Novecentos e quarenta e seis pacientes com idade média de 61,04 ± 10,98 anos (31 a 91 anos, foram submetidos a implante de stents, sendo 580 do sexo masculino (61,3%. Sucesso do procedimento foi definido quando pelo menos um vaso era dilatado com sucesso, com estenose residual OBJECTIVE: To identify the clinical and angiographic predictors of early outcome following coronary stent implantation. METHODS: Nine hundred and forty-six patients (pt [61.04 ± 10.98 years old, range 31 to 91] underwent stent implantation; 580 male (61.3%. Procedural success was defined when a pt had at least one vessel successfully dilated with a residual stenosis < 20%. Clinical success occured when a pt had at least one vessel successfully dilated without a major complication (MC [death, myocardial infarction (MI, coronary artery bypass graft] during the hospital stay. Clinical and angiographic determinants of outcome were studied. All variables related to early outcome evaluated by univariate analysis were included in a multiple logistic regression analysis (MLR. RESULTS: Procedural success was achieved in 98.9%; clinical success in 95.7%; an unsuccessful uncomplicated outcome in 0.1% and major complications in 4.2%. By MLR, procedural success was related to restenotic lesion, calcification, and irregular contour. Clinical success was related to diabetes mellitus, cardiogenic shock, acute coronary syndromes, age, left ventricular dysfunction, calcification, and total occlusion. Major complications was predicted by diabetes mellitus, cardiogenic shock, acute coronary syndromes, age, multivessel disease, left ventricular dysfunction, calcification, long lesions, and total occlusions. Mortality was predicted by cardiogenic shock, acute coronary syndromes, age, arterial hypertension, and left ventricular

  7. Long-term safety and efficacy of percutaneous coronary intervention with stenting and coronary artery bypass surgery for multivessel coronary artery disease: A meta-analysis with 5-year patient-level data from the ARTS, ERACI-II, MASS-II, and SoS trials

    NARCIS (Netherlands)

    J. Daemen (Joost); H. Boersma (Eric); M. Flather (Marcus); J. Booth (Jean); R.H. Stables (Rodney); A. Rodriguez (Alfredo Chapin); G.A. Rodriguez-Granillo (Gaston); W.A. Hueb (Whady Armindo); P.A. Lemos Neto (Pedro); P.W.J.C. Serruys (Patrick)

    2008-01-01

    textabstractBackground - Randomized trials that studied clinical outcomes after percutaneous coronary intervention (PCI) with bare metal stenting versus coronary artery bypass grafting (CABG) are underpowered to properly assess safety end points like death, stroke, and myocardial infarction. Pooling

  8. Combined paclitaxel-eluting balloon and Genous cobalt-chromium alloy stent utilization in de novo coronary stenoses (PEGASUS).

    Science.gov (United States)

    Jim, Man-Hong; Fung, Raymond Chi-Yan; Yiu, Kai-Hang; Ng, Andrew Kei-Yan; Siu, Chung-Wah; Fan, Katherine Yu-Yan

    2013-12-01

    The aim of this study was to examine the angiographic result and its outcome predictors using the combination of paclitaxel-eluting balloon (PEB) and Genous stent. This approach to treat coronary stenoses is a logical strategy to strike a balance between minimizing restenosis and stent thrombosis. From November 2010 to June 2012, 40 symptomatic patients with 44 de novo coronary lesions of diameter stenosis ≥ 50% were treated with the combination of PEB and Genous stents. Angiographic and clinical follow-up were intended at 6 and 9 months, respectively. The mean age of patients was 61 ± 11 years, with male predominance (83%). Diabetes mellitus and end-stage renal failure on peritoneal dialysis were found in 15 (38%) and 10 (25%) patients, respectively. Patients received dual antiplatelet therapy for 5.1 ± 1.5 months post procedure. The size and length of PEB used was larger than the stents (3.13 ± 0.46 mm and 28 ± 9 mm vs. 2.98 ± 0.36 mm and 23 ± 7 mm). Restudy angiography was performed on 41 (95%) lesions in 37 (93%) patients at 5.9 ± 1.7 months. Angiographic restenosis was seen in 5 (12%) lesions, and significantly associated with diabetes mellitus and dialysis dependency; the late lumen loss was 0.38 ± 0.37 mm. At 9-month follow-up, no stent thrombosis was observed. The use of PEB combined with Genous stent is associated with a reasonably low restenosis and late lumen loss, whereas diabetes mellitus and renal failure with dialysis are poor predictors of angiographic restenosis. © 2013, Wiley Periodicals, Inc.

  9. Long Term Outcomes of MGuard Stent Deployment in Saphenous Vein Grafts and Native Coronary Arteries: A Single Center Experience.

    Science.gov (United States)

    Vaknin-Assa, Hana; Assali, Abid; Lev, Eli I; Greenberg, Gabriel; Orvin, Katia; Valzer, Orna; Paul, Gideon; Levi, Amos; Kornowski, Ran

    2017-03-01

    The MGuard™ stent (InspireMD, Tel Aviv, Israel) is a bare metal mesh-covered stent, developed to prevent no-reflow phenomenon during percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) and acute myocardial infarction (MI), both associated with significant atherothrombotic lesions. To report on local experience with patients treated with the MGuard stent until follow-up at 1 year. We followed 163 consecutive patients who underwent MGuard stent deployment during the period 2009 to 2014 in a large tertiary cardiac center in central Israel. The MGuard stent was used in 67% of patients who underwent SVG-PCI while 33% were treated for native coronary artery disease, the majority during ST-elevation MI (STEMI). The mean age was 67 years and 83% were males. The clinical presentation was STEMI in 30% and non-STEMI/unstable angina in 60% of patients. Of the total number of patients, 47% had diabetes and 29% had chronic kidney disease. All patients had follow-up at 1 year. Mortality in the native group was 1.9% vs. 10% in the vein graft cohort. ST was 2% in both groups. The major adverse cardiac event (MACE) rates were 11% in the native artery and 29% in the vein graft group, mainly due to respective target lesion revascularization/target vessel revascularization rates of 6% and 7% in the native vessel group and 11% and 15% in the SVG group. In suitable patients undergoing SVG-PCI or native lesion intervention during acute MI, the MGuard stent is a viable treatment strategy. Its potential merits and limitations warrant further evaluation.

  10. Concomitant use of clopidogrel and statins and risk of major adverse cardiovascular events following coronary stent implantation

    DEFF Research Database (Denmark)

    Schmidt, Morten; Johansen, Martin B; Mæng, Michael

    2012-01-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • The CYP3A4 inhibition by lipophilic statins may attenuate the effectiveness of clopidogrel. • No studies have measured drug exposure in a time-varying manner that detects discontinuation and restart of clopidogrel and statin therapy, allowing clinical...... quantification of the interaction effect. WHAT THIS STUDY ADDS • Clopidogrel and CYP3A4-metabolizing statin use were each associated with a substantially reduced rate of major adverse cardiovascular events within 12 months after coronary stent implantation. • Although we observed an interaction between use...... of clopidogrel and statins, statin use vs. non-use was not associated with an increased rate of major adverse cardiovascular events in patients using clopidogrel after coronary stent implantation. AIMS To examine whether CYP3A4-metabolizing statin use modified the association between clopidogrel use and major...

  11. Prevention of the renarrowing of coronary arteries using drug-eluting stents in the perioperative period: an update

    Directory of Open Access Journals (Sweden)

    Juan V Llau

    2010-09-01

    Full Text Available Juan V Llau1, Raquel Ferrandis1, Pilar Sierra2, Aurelio Gómez-Luque31Department of Anaesthesiology and Critical Care Medicine, Hospital Clínic Universitari, València, Spain; 2Department of Anaesthesiology, Fundació Puigvert, Barcelona, Spain; 3Department of Anaesthesiology and Critical Care Medicine, Hospital Clínico Universitario, Málaga, SpainAbstract: The management of patients scheduled for surgery with a coronary stent, and receiving 1 or more antiplatelet drugs, has many controversies. The premature discontinuation of antiplatelet drugs substantially increases the risk of stent thrombosis (ST, myocardial infarction, and cardiac death, and surgery under an altered platelet function could also lead to an increased risk of bleeding in the perioperative period. Because of the conflict in the recommendations, this article reviews the current antiplatelet protocols after positioning a coronary stent, the evidence of increased risk of ST associated with the withdrawal of antiplatelet drugs and increased bleeding risk associated with its maintenance, the different perioperative antiplatelet protocols when patients are scheduled for surgery or need an urgent operation, and the therapeutic options if excessive bleeding occurs.Keywords: stent thrombosis, antiplatelet agents, aspirin, clopidogrel, surgical bleeding, perioperative management

  12. Multicenter assessment of the reproducibility of volumetric radiofrequency-based intravascular ultrasound measurements in coronary lesions that were consecutively stented

    DEFF Research Database (Denmark)

    Huisman, Jennifer; Egede, Rasmus; Rdzanek, Adam

    2012-01-01

    To assess in a multicenter design the between-center reproducibility of volumetric virtual histology intravascular ultrasound (VH-IVUS) measurements with a semi-automated, computer-assisted contour detection system in coronary lesions that were consecutively stented. To evaluate the reproducibility...... of volumetric VH-IVUS measurements, experienced analysts of 4 European IVUS centers performed independent analyses (in total 8,052 cross-sectional analyses) to obtain volumetric data of 40 coronary segments (length 20.0 ± 0.3 mm) from target lesions prior to percutaneous intervention that were performed...

  13. Concomitant use of clopidogrel and statins and risk of major adverse cardiovascular events following coronary stent implantation

    Science.gov (United States)

    Schmidt, Morten; Johansen, Martin B; Maeng, Michael; Kaltoft, Anne; Jensen, Lisette O; Tilsted, Hans-Henrik; Bøtker, Hans E; Baron, John A; Sørensen, Henrik Toft

    2012-01-01

    AIMS To examine whether CYP3A4-metabolizing statin use modified the association between clopidogrel use and major adverse cardiovascular events (MACE) after coronary stent implantation, using time-varying drug exposure ascertainment. METHODS We conducted this population-based cohort study in Western Denmark (population: 3 million) using medical databases. We identified all 13 001 patients with coronary stent implantation between 2002 and 2005 and their comorbidities. During 12 months of follow-up, we tracked the use of clopidogrel and CYP3A4-metabolizing statins and the rate of MACE. We used Cox regression to compute hazard ratios (HRs) controlling for potential confounders. RESULTS The rate of MACE per 1000 person years was 104 for concomitant clopidogrel and statin use, 130 for clopidogrel without statin use, 108 for statin without clopidogrel use and 446 for no use of either drug. The adjusted HR comparing clopidogrel use with non-use was 0.68 (95% confidence interval (CI) 0.58, 0.79) among statin users and 0.34 (95% CI 0.29, 0.40) among statin non-users, yielding an interaction effect (i.e. relative rate increase) of 1.97 (95% CI 1.59, 2.44). The adjusted HR for MACE comparing statin use with non-use was 0.97 (95% CI 0.83, 1.13) among clopidogrel users and 0.49 (95% CI 0.42, 0.57) among clopidogrel non-users. CONCLUSIONS Clopidogrel and CYP3A4-metabolizing statin use were each associated with a substantially reduced rate of MACE within 12 months after coronary stent implantation. Although we observed an interaction between use of clopidogrel and statins, statin use vs. non-use was not associated with an increased rate of MACE in patients using clopidogrel after coronary stent implantation. PMID:22243420

  14. The importance of tests applied to evaluate the effectiveness of antiplatelet therapy in patients with recurrent coronary stent thrombosis

    Directory of Open Access Journals (Sweden)

    Grdinić Aleksandra

    2009-01-01

    Full Text Available Background. Stent thrombosis is potentially lethal complication with huge economic burden. The role of insufficient response to antiplatelet therapy is still unclear reason for its occurrence. Case report. We presented 54-year-old man with recurrent stent thrombosis on the 4th, 9th and 12th day after the primary percutaneous coronary intervention in spite of double antiaggregation therapy (aspirin+ clopidogrel. All possible procedural causes were excluded and reimplantation of intracoronary stent was insufficient to resolve the problem, so four platelet tests were performed: flow cytometry, Platelet Function Analyzer-100 test, aggregometry, and determination of gene polymorphism for P2Y12 receptor (directly involved in the mechanism of thienopyridine, and GPIIbIIIa receptor (final receptor in aggregation. The patient was the carrier of the major haplotype H1H1 for P2Y12 receptor and minor A1A2 for GPIIbIIIa receptor. The results of all the performed tests showed insufficient antiplatelet effect of aspirin and sufficient response to thienopyridin (not to clopidogrel, but to ticlopidine. Conclusion. Performance of platelet function tests is necessary in the case of major adverse cardiac events especially stent thrombosis, after implantation of intracoronary stent.

  15. Carotid artery stenting in patients with acute coronary syndrome: a possible primary therapy for symptomatic carotid stenosis.

    Science.gov (United States)

    Casana, Renato; Halliday, Alison; Bianchi, Paolo; Fresa, Emanuele; Silani, Vincenzo; Parati, Gianfranco; Blengino, Simonetta; Cireni, Lea; Adobbati, Laura; Calvillo, Laura; Tolva, Valerio S

    2013-08-01

    To report the results of carotid artery stenting (CAS) in symptomatic patients (stroke/transient ischemic attack) after recent percutaneous transluminal coronary angioplasty (PTCA) for acute coronary syndrome (ACS). Between January 2009 and July 2011, 28 consecutive patients (18 women; mean age 66 years, range 42-82) underwent protected CAS for symptomatic carotid stenosis following recent PTCA that included bare or drug-eluting stents requiring uninterrupted dual antiplatelet therapy. Primary technical success, neurological complications, major adverse cardiovascular events, and death were evaluated at 30 days and over midterm follow-up. Technical success was 96%; 1 patient suffered a nonfatal major stroke (3.5% 30-day stroke rate) during the procedure. During a median 21.6-month follow-up, 4 (14%) patients died of myocardial infarction (all diabetic smokers with ejection fractions 34 kg/m(2). This preliminary experience demonstrated that CAS is a reasonable, safe, and effective treatment for patients with symptomatic carotid artery stenosis who were recently treated with coronary stents requiring uninterrupted dual antiplatelet therapy.

  16. Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: the INtegrilin plus STenting to Avoid myocardial Necrosis Trial.

    Science.gov (United States)

    Biondi-Zoccai, Giuseppe; Valgimigli, Marco; Margheri, Massimo; Marzocchi, Antonio; Lettieri, Corrado; Stabile, Amerigo; Petronio, A Sonia; Binetti, Giorgio; Bolognese, Leonardo; Bellone, Pietro; Sardella, Gennaro; Contarini, Marco; Sheiban, Imad; Marra, Sebastiano; Piscione, Federico; Romeo, Francesco; Colombo, Antonio; Sangiorgi, Giuseppe

    2012-05-01

    The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions (PCIs) is uncertain. We aimed to assess the impact of glycoprotein IIb/IIIa (GpIIb/IIIa) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions. Patients with stable coronary artery disease undergoing PCI by means of implantation of >33 mm of drug-eluting stent were single-blindedly randomized to heparin plus eptifibatide versus heparin alone. The primary end point was the rate of abnormal post-PCI creatine kinase-MB mass values. Secondary end points were major adverse cardiovascular events (MACEs) (ie, cardiac death, myocardial infarction, or urgent revascularization) and MACE plus bailout GpIIb/IIIa inhibitor use. The study was stopped for slow enrollment and funding issues after including a total of 91 patients: 44 were randomized to heparin plus eptifibatide, and 47, to heparin alone. Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase-MB mass values in the heparin-plus-eptifibatide group (18 [41%]) versus the heparin-alone group (26 [55%], relative risk 0.74 [95% CI 0.48-1.15], P = .169). Similar nonstatistically significant trends were found for rates of MACE, their components, or MACE plus bailout GpIIb/IIIa inhibitors (all P > .05). Notably, heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups (all P > .05). Given its lack of statistical power, the INSTANT study cannot definitively provide evidence against or in favor of routine eptifibatide administration in stable patients undergoing implantation of multiple drug-eluting stent for diffuse coronary disease. However, the favorable trend evident for the primary end point warrants further larger randomized studies. Copyright © 2012 Mosby, Inc. All rights reserved.

  17. Relationship between heparin anticoagulation and clinical outcomes in coronary stent intervention: observations from the ESPRIT trial.

    Science.gov (United States)

    Tolleson, Thaddeus R; O'Shea, J Conor; Bittl, John A; Hillegass, William B; Williams, Kathryn A; Levine, Glenn; Harrington, Robert A; Tcheng, James E

    2003-02-05

    We evaluated the relationship between the degree of heparin anticoagulation and clinical efficacy and bleeding in patients undergoing contemporary percutaneous coronary intervention (PCI) with stent implantation. Despite universal acceptance of heparin anticoagulation as a standard of care in PCI, considerable controversy still exists regarding the appropriate dosing of heparin. The study population (n = 2,064) comprised all patients enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial. The index activated clotting time (ACT) was defined as the ACT measured after the last heparin dose and before first device activation and was correlated with outcome and bleeding events. No association was observed between decreasing ACT levels and the rate of ischemic events in the treatment or placebo arms. The incidence of the primary composite end point (death, myocardial infarction, urgent target vessel revascularization, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy at 48 h) was actually lowest in the lowest ACT tertile for both the placebo (10.0%) and treatment groups (6.1%). When analyzed by tertile, major bleeding rates did not increase in the lowest ACT tertile in patients given placebo (0.6%) versus those receiving eptifibatide (0.7%). Major bleeding rates increased as the ACT increased in the eptifibatide-treated patients. Ischemic end points in patients undergoing contemporary PCI with stent placement do not increase by decreasing ACT levels, at least to a level of 200 s. Bleeding events do increase with increasing ACT levels and are enhanced with eptifibatide treatment. An ACT of 200 to 250 s is reasonable in terms of efficacy and safety with the use of contemporary technology and pharmacotherapy.

  18. Therapeutic strategies after coronary stenting in chronically anticoagulated patients: the MUSICA study.

    Science.gov (United States)

    Sambola, A; Ferreira-González, I; Angel, J; Alfonso, F; Maristany, J; Rodríguez, O; Bueno, H; López-Minguez, J R; Zueco, J; Fernández-Avilés, F; San Román, A; Prendergast, B; Mainar, V; García-Dorado, D; Tornos, P

    2009-09-01

    To identify the therapeutic regimens used at discharge in patients receiving oral anticoagulant therapy (OAT) who undergo stenting percutaneous coronary intervention and stent implantation (PCI-S), and to assess the safety and efficacy associated with different therapeutic regimens according to thromboembolic risk. A prospective multicentre registry. In hospital, after discharge and follow-up by telephone call. 405 patients (328 male/77 female; mean (SD) age 71 (9) years) receiving OAT who underwent PCI-S between November 2003 and June 2006 from nine catheterisation laboratories of tertiary care teaching hospitals in Spain and one in the United Kingdom were included. Three therapeutic regimens were identified at discharge: triple therapy (TT) -- that is, any anticoagulant (AC) plus double antiplatelet therapy (DAT; 278 patients (68.6%); AC and a single antiplatelet (AC+AT; 46 (11.4%)) and DAT only (81 (20%)). At 6 months, patients receiving TT showed the greatest rate of bleeding events. No patients receiving DAT at low thromboembolic risk presented a bleeding event (14.8% receiving TT, 11.8% receiving AC+AT and 0% receiving DAT, p = 0.033) or cardiovascular event (6.7% receiving TT, 0% receiving AC+AT and 0% receiving DAT, p = 0.126). The combination of AC+AT showed the worst rate of adverse events in the whole cohort, especially in patients at moderate-high thromboembolic risk. In patients receiving OAT, TT was the most commonly used regimen after PCI-S. DAT was associated with the lowest rate of bleeding events and a similar efficacy to TT in patients at low thromboembolic risk. TT should probably be restricted to patients at moderate-high thromboembolic risk.

  19. Cobalt-chromium KAname™ coRonary stEnt system in the treatment of patients with coronary artery disease (KARE study).

    Science.gov (United States)

    Carrie, Didier; Schächinger, Volker; Danzi, Gian Battista; Macaya, Carlos; Zeymer, Uwe; Putnikovic, Biljana; Iniguez, Andres; Moreno, Raul; Mehmedbegovic, Zlatko; Beleslin, Branko

    2014-10-01

    To evaluate the safety and effectiveness of the Kaname™ cobalt-chromium (Co-Cr), thin strut, bare metal stent (BMS) system for the treatment of coronary artery lesions. Despite widespread use of drug-eluting stents, a certain percentage of patients with coronary artery disease are still treated with BMS. Therefore, it is essential to evaluate their clinical performance. Two hundred eighty-two patients were enrolled in this prospective, single-arm study including a predefined subset of 79 patients with small vessels. The primary end-point was freedom from target vessel failure (TVF) at 6 months. Key angiographic and intravascular ultrasound (IVUS) end-points were late loss, diameter stenosis, binary restenosis, and neointimal hyperplasia volume. Freedom from TVF at 6 months was 93.3% and at 1 year 90.8% in total population, and 92.4% and 87.3% in small vessels, respectively. Clinically driven target lesion revascularization (TLR) rates at 6 and 12 months were 4.3% and 6.4% in total population, and 3.8% and 7.6% in small vessels, respectively. At 6 months in-stent late loss was 0.75 ± 0.43 mm and binary restenosis rate was 16.9% in total population, and 0.64 ± 0.40 mm and 26.1% in small vessels, while IVUS assessed neointimal hyperplasia volume at 6 months was 128.9 ± 42.6 mm(3) for total population. There were no definite and probable stent thromboses up to 12 months. Results indicate good safety and effectiveness of the Kaname™ stent with clinically equivalent results in small and larger vessels, as such providing useful treatment option for patients with ischemic heart disease considered for BMS implantation. © 2014, Wiley Periodicals, Inc.

  20. Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F nanocoated cobalt-chromium stents in the minipig coronary artery model.

    Science.gov (United States)

    Radeleff, Boris; Thierjung, Heidi; Stampfl, Ulrike; Stampfl, Sibylle; Lopez-Benitez, Ruben; Sommer, Christof; Berger, Irina; Richter, Goetz M

    2008-01-01

    To date no direct experimental comparison between the CYPHER-Select and TAXUS-Express stents is available. Therefore, we investigated late in-stent stenosis, thrombogenicity, and inflammation, comparing the CYPHER-Select, TAXUS-Express, and custom-made cobalt chromium Polyzene-F nanocoated stents (CCPS) in the minipig coronary artery model. The three stent types were implanted in the right coronary artery of 30 minipigs. The primary endpoint was in-stent stenosis assessed by quantitative angiography and microscopy. Secondary endpoints were inflammation and thrombogenicity evaluated by scores for inflammation and immunoreactivity (C-reactive protein and transforming growth factor beta). Follow-up was at 4 and 12 weeks. Stent placement was successful in all animals; no thrombus deposition occurred. Quantitative angiography did not depict statistically significant differences between the three stent types after 4 and 12 weeks. Quantitative microscopy at 4 weeks showed a statistically significant thicker neointima (p = 0.0431) for the CYPHER (105.034 +/- 62.52 microm) versus the TAXUS (74.864 +/- 66.03 microm) and versus the CCPS (63.542 +/- 39.57 microm). At 12 weeks there were no statistically significant differences. Inflammation scores at 4 weeks were significantly lower for the CCPS and CYPHER compared with the TAXUS stent (p = 0.0431). After 12 weeks statistical significance was only found for the CYPHER versus the TAXUS stent (p = 0.0431). The semiquantitative immunoreactivity scores for C-reactive protein and transforming growth factor beta showed no statistically significant differences between the three stent types after 4 and 12 weeks. The CCPS provided effective control of late in-stent stenosis and thrombogenicity in this porcine model compared with the two drug-eluting stents. Its low inflammation score underscores its noninflammatory potential and might explain its equivalence to the two DES.

  1. Coronary Artery Stent Evaluation Using a Vascular Model at 64-Detector Row CT: Comparison between Prospective and Retrospective ECG-Gated Axial Scans

    Energy Technology Data Exchange (ETDEWEB)

    Suzuki, Shigeru; Furui, Shigeru; Kaminaga, Tatsuro; Miyazawa, Akiyoshi; Ueno, Yasunari; Konno, Kumiko [Teikyo University School of Medicine, Tokyo (Japan); Kuwahara, Sadatoshi; Mehta, Dhruv [Philips Electronics Japan, Ltd. Medical Systems, Tokyo (Japan)

    2009-06-15

    We wanted to evaluate the performance of prospective electrocardiogram (ECG)-gated axial scans for assessing coronary stents as compared with retrospective ECG-gated helical scans. As for a vascular model of the coronary artery, a tube of approximately 2.5-mm inner diameter was adopted and as for stents, three (Bx-Velocity, Express2, and Micro Driver) different kinds of stents were inserted into the tube. Both patent and stenotic models of coronary artery were made by instillating different attenuation (396 vs. 79 Hounsfield unit [HU]) of contrast medium within the tube in tube model. The models were scanned with two types of scan methods with a simulated ECG of 60 beats per minute and using display field of views (FOVs) of 9 and 18 cm. We evaluated the in-stent stenosis visually, and we measured the attenuation values and the diameter of the patent stent lumen. The visualization of the stent lumen of the vascular models was improved with using the prospective ECG-gated axial scans and a 9-cm FOV. The inner diameters of the vascular models were underestimated with mean measurement errors of -1.10 to -1.36 mm. The measurement errors were smaller with using the prospective ECG-gated axial scans (Bx-Velocity and Express2, p < 0.0001; Micro Driver, p = 0.0004) and a 9-cm FOV (all stents: p < 0.0001), as compared with the other conditions, respectively. The luminal attenuation value was overestimated in each condition. For the luminal attenuation measurement, the use of prospective ECG-gated axial scans provided less measurement error compared with the retrospective ECG-gated helical scans (all stents: p < 0.0001), and the use of a 9-cm FOV tended to decrease the measurement error. The visualization of coronary stents is improved by the use of prospective ECG-gated axial scans and using a small FOV with reduced blooming artifacts and increased spatial resolution.

  2. 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.

  3. Aspirin desensitization in patients undergoing planned or urgent coronary stent implantation. A single-center experience

    NARCIS (Netherlands)

    Luca, G. De; Verdoia, M.; Binda, G.; Schaffer, A.; Suryapranata, H.; Marino, P.

    2013-01-01

    INTRODUCTION: Dual antiplatelet therapy (aspirin and ADP-antagonists) is mandatory after stent implantation in order to avoid stent thrombosis, especially in the era of DES. In fact, a delayed re-endothelization process may enlarge the window of occurrence of stent thrombosis beyond 1-year after

  4. Novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomised, placebo-controlled trial.

    Science.gov (United States)

    2000-12-16

    The platelet glycoprotein IIb/IIIa inhibitors, although effective in reducing ischaemic complications of percutaneous coronary intervention, are used in few coronary stent implantation procedures. ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy) is a randomised, placebo-controlled trial to assess whether a novel, double-bolus dose of eptifibatide could improve outcomes of patients undergoing coronary stenting. We recruited 2064 patients undergoing stent implantation in a native coronary artery. Immediately before percutaneous coronary intervention, patients were randomly allocated to receive eptifibatide, given as two 180 microg/kg boluses 10 min apart and a continuous infusion of 2.0 microg/kg/min for 18-24 h, or placebo, in addition to aspirin, heparin, and a thienopyridine. The primary endpoint was the composite of death, myocardial infarction, urgent target vessel revascularisation, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy within 48 h after randomisation. The key secondary endpoint was the composite of death, myocardial infarction, or urgent target vessel revascularisation at 30 days. The trial was terminated early for efficacy. The primary endpoint was reduced from 10.5% (108 of 1024 patients on placebo [95% CI 8.7-12.4%]) to 6.6% (69 of 1040 [5.1-8.1%]) with treatment (p=0.0015). The key 30 day secondary endpoint was also reduced, from 10.5% (107 of 1024 patients on placebo [8.6-12.3%]) to 6.8% (71 of 1040 [5.3-8.4%]; p=0.0034). There was consistency in reduction of events across all components of the composite endpoint and among the major subgroups. Major bleeding was infrequent but arose more often with eptifibatide than placebo (1.3%, 13 of 1040 [0.7-2.1%]) vs 0.4%, 4 of 1024 [0.1-1.0%]; p=0.027). Routine glycoprotein IIb/IIIa inhibitor pretreatment with eptifibatide substantially reduces ischaemic complications in coronary stent intervention and is better than a strategy of reserving treatment

  5. Lung resection for non-small cell lung cancer after prophylactic coronary angioplasty and stenting: short- and long-term results.

    Science.gov (United States)

    Voltolini, L; Rapicetta, C; Luzzi, L; Paladini, P; Ghiribelli, C; Scolletta, S; Fineschi, M; Gotti, G

    2012-02-01

    Recent studies have reported a high incidence of perioperative in-stent trombosis with myocardial infarction (MI), in patients undergoing non-cardiac surgery, early after coronary angioplasty and stenting. The short and long-term results of surgery for non-small cell lung cancer (NSCLC) after prophylatic coronary angioplasty and stenting were analyzed. Prospective collected data were examined for postoperative complications and long-term survival in 16 consecutive patients who underwent mayor lung resection for NSCLC after prophylactic coronary angioplasty and stenting for significant coronary artery disease , from 2001 to 2008. One and two non-drug-eluting stents were placed in 75% or (25% of the patient, respectively. All patients had four weeks of dual antiplatelet therapy, that was discontinued 5 days prior to surgery and replaced by low molecular weight heparin. Patients were keep sedated and intubated overnight, according to our protocol. There were no postoperative deaths nor MI. A patient experienced pulmonary embolism with moderate troponin release and underwent coronary angiography that showed patency of the stent. Two patients developed postoperative bleeding complications haemothorax requiring a re-thoracotomy in 1, gastric bleeding requiring blood transfusion in 1. At the mean follow-up of 30 months (range 3-95), none of the patients showed evidence of myocardial ischemia, while 5 (31%) patients died, mostly (N.=4) due to distant metastasis. The five-year survival rate was 53%. In contrast to previous reports, lung resection after prophylactic coronary angioplasty and stenting is a safe and effective treatment for NSCLC and myocardial ischemia. The application of a refined protocol could be the key factor for improved results.

  6. Safety and efficacy of coronary stent implantation. Acute and six month outcomes of 1,126 consecutive patients treated in 1996 and 1997

    Directory of Open Access Journals (Sweden)

    Luiz Alberto Mattos

    1999-07-01

    Full Text Available PURPOSE: The authors analyzed the 30-day and 6-month outcomes of 1,126 consecutive patients who underwent coronary stent implantation in 1996 and 1997. METHODS: The 30-day results and 6-month angiographic follow-up were analyzed in patients treated with coronary stents in 1996 and 1997. All patients underwent coronary stenting with high-pressure implantation (>12 atm and antiplatelet drug regimen (aspirin plus ticlopidine. RESULTS: During the study period, 1,390 coronary stents were implanted in 1,200 vessels of 1,126 patients; 477 patients were treated in the year 1996 and 649 in 1997. The number of percutaneous procedures performed using stents increased significantly in 1997 compared to 1996 (64 % vs 48%, p=0.0001. The 30-day results were similar in both years; the success and stent thrombosis rates were equal (97% and 0.8%, respectively. The occurrence of new Q wave MI (1.3% vs 1.1%, 1996 vs 1997, p=NS, emergency coronary bypass surgery (1% vs 0.6%, 1996 vs 1997, p=NS and 30-day death rates (0.2% vs 0.5%, 1996 vs 1997, p=NS were similar. The 6-month restenosis rate was 25% in 1996 and 27% in 1997 (p= NS; the target vessel revascularization rate was 15% in 1996 and 16% in 1997 (p = NS. CONCLUSIONS: Intracoronary stenting showed a high success rate and a low incidence of 30-day occurrence of new major coronary events in both periods, despite the greater angiographic complexity of the patients treated with in 1997. These adverse variables did not have a negative influence at the 6-month clinical and angiographic follow-up, with similar rates of restenosis and ischemia-driven target lesion revascularization rates.

  7. A systematic review of outcomes in patients with staged carotid artery stenting and coronary artery bypass graft surgery.

    Science.gov (United States)

    Guzman, Luis A; Costa, Marco A; Angiolillo, Dominick J; Zenni, Martin; Wludyka, Peter; Silliman, Scott; Bass, Theodore A

    2008-02-01

    Although current guidelines state that carotid endarterectomy is probably recommended before or concomitant to coronary artery bypass grafting (CABG) in patients with carotid stenosis, significant controversies to this recommendation still persist. Carotid artery stenting has been recently introduced as an alternative revascularization modality in high-risk patients. The aim of this study was to define, based on the published information, if carotid artery stenting is beneficial in this setting. A search of MEDLINE and a manual search of the literature from selected articles were performed. A total of 6 studies with 277 patients reporting carotid stenting followed by staged CABG were available for this clinical outcome analysis. All were retrospective and single-center studies. The mean age was 69 years; 78% were males. Asymptomatic carotid stenosis was present in 76% of patients. The mean time to CABG was 32 days. The incidence of stroke and death associated with the stent procedure was 4.7%. Only 6 patients (2.2%) developed stroke associated with CABG. The overall combined 30-day event rate after CABG, including all events during carotid artery stenting, were as follows: minor stroke, 2.9%; major stroke, 3.2%; mortality, 7.6%; and combined death and any stroke, 12.3%. In this pooled analysis, the combined incidence of death and stroke in patients undergoing carotid artery stenting and staged CABG remains elevated. These results confirm that the presence of carotid stenosis is per se a marker of risk that might persists independent of its treatment. A systematic or randomized evaluation appears warranted.

  8. Effect of Bleeding Risk on Type of Stent Used in Patients Presenting With Acute Coronary Syndrome.

    Science.gov (United States)

    Alraies, M Chadi; Lee, Sang Yeub; Lipinski, Michael J; Buchanan, Kyle; Steinvil, Arie; Rogers, Toby; Koifman, Edward; Gai, Jiaxiang; Torguson, Rebecca; Ben-Dor, Itsik; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

    2017-10-15

    Patients at high bleeding risk (HBR) are at increased risk of bleeding following percutaneous coronary intervention (PCI) with drug-eluting stents (DES) due to the need for longer dual antiplatelet duration. We sought to evaluate the likelihood of receiving DES during PCI in HBR populations and to characterize DES utilization trends over time. Consecutive patients who underwent PCI from April 2003 to September 2015 were identified. HBR is defined as patients fulfilling 1 or more of the HBR criteria: age ≥75 years, anticoagulation use at discharge, history of stroke, cancer in previous 3 years, glucocorticoid use, hemoglobin (Hgb) HBR definition. When adjusting for known risk factors, HBR patients were less likely to receive a DES compared with non-HBR patients (odds ratio [OR] 0.58, 95% confidence interval [CI] 0.54 to 0.62, p HBR patients, having 3 or more HBR criteria versus HBR criteria had lower likelihood of receiving a DES (OR 0.50, 95% CI 0.44 to 0.57, p HBR has a significant impact upon the decision to use DES. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. One-year results of the CRISTAL Trial, a randomized comparison of cypher sirolimus-eluting coronary stents versus balloon angioplasty for restenosis of drug-eluting stents.

    Science.gov (United States)

    Chevalier, Bernard; Moulichon, Robert; Teiger, Emmanuel; Brunel, Philippe; Metzger, Jean-Philippe; Pansieri, Michel; Carrie, Didier; Stoll, Hans-Peter; Wittebols, Kristel; Spaulding, Christian; Fajadet, Jean

    2012-12-01

     We compared the efficacy of the Cypher Select (Cordis Corporation, Bridgewater, NJ, USA) sirolimus-eluting stent (SES) versus balloon angioplasty (BA) in in-stent restenosis (ISR) of Taxus or Taxus Liberté paclitaxel-eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES. Optimal treatment strategies have not been identified for drug-eluting stent (DES) ISR. Patients with a native coronary artery SES or PES ISR were randomized to SES or BA. In addition, a control group included BMS ISR treated with SES. Angiographic control was performed at 12 months. 281 patients were enrolled. Significant differences favoring SES over BA were noted in immediate and net gain (1.39 ± 0.51 vs. 0.97 ± 0.54 mm, P < 0.0001 and 1.07 ± 0.69 vs. 0.49 ± 0.67 mm, P < 0.0001), 12-month mean luminal diameter (MLD; 2.14 ± 0.62 vs. 1.71 ± 0.55 mm, P < 0.0001) and percent diameter stenosis (%DS; 21 ± 19.24 vs. 29.82 ± 18.47, P = 0.001). There was no significant difference at 12 months between SES and BA in the primary end-point late lumen loss (LLL; 0.37 ± 0.57 vs.0.41 ± 0.63, P = 0.73) and in in-stent binary restenosis (11.1% vs. 14%, P = 0.59). Target-lesion revascularization (TLR) was numerically lower in patients treated with SES (5.9% vs. 13.1%, P = 0.097). There was no difference according to the initial DES. In contrast, significantly higher immediate and net gains and MLD were noted in the BMS control group treated by SES. In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed abstract optimal treatment strategies have not been identified for sirolimus-(SES) or paclitaxel-eluting stent (PES) in-stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There

  10. Two-year outcome after biodegradable polymer sirolimus- and biolimus- eluting coronary stents

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Maeng, Michael; Raungaard, Bent

    2018-01-01

    AIMS: The SORT OUT VII trial compared the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent with a slow polymer degradation and the thicker-strut stainless steel biolimus-eluting Nobori stent with a moderate-term polymer degradation in an all-comer patient population. METHODS AND RESULTS......: The 2-year pre-specified endpoint target lesion failure did not differ significantly between the sirolimus-eluting stent: 6.7% and the biolimus-eluting stent: 7.0% (rate ratio (RR) 0.94, 95% confidence interval (CI) 0.70-1.28). Definite stent thrombosis were numerically lower in the sirolimus...... in the two groups (0.4% versus 0.2%, RR 1.68, 95% CI 0.40-7.03). CONCLUSIONS: In an all-comer patient population, 2-year target lesions failure was similar for the sirolimus-eluting Orsiro stent and the biolimus-eluting Nobori stent....

  11. Corrosion Behavior of Platinum-Enhanced Radiopaque Stainless Steel (PERSS®) for Dilation-Baloon Expandable Coronary Stents

    Energy Technology Data Exchange (ETDEWEB)

    Covino, Jr., Bernard S.; Craig, Charles H.; Cramer, Stephen D.; Bullard, Sophie J.; Ziomek-Moroz, Margaret; Jablonski, Paul D.; Turner, Paul C.; Radisch, Jr., Herbert R.; Gokcen, Nev A.; Friend, Clifford M.; Edwards, Michael R.

    2002-05-01

    Dilation-balloon expandable coronary stents are commonly made of implant grade stainless steels conforming to ASTM F138/F139, e.g., Biodur? 316LS (UNS S31673). Typical of such stents is the Boston Scientific/Interventional Technologies? (BS/IVT) LP-StentTM. In 2000, BS/IVT determined that the addition of 5 to 6 wt % platinum to Biodur 316LS produced a stainless steel with enhanced radiopacity to make their stents more visible radiographically and thus more effective clinically. A goal of the program was to ensure platinum additions would not adversely affect the corrosion resistance of Biodur 316LS. The corrosion resistance of 5-6 wt % PERSS? alloys and Biodur 316LS was determined using electrochemical tests for general, pitting, crevice and intergranular corrosion. Experimental methods included ASTM A262E, F746, F2129, and potentiodynamic polarization. The 6 wt % PERSS? alloy (IVT 78) had a resistance to pitting, crevice and intergranular corrosion that was similar to the Biodur 316LS base material. IVT 78 was a single-phase austenitic alloy with no evidence of inclusions or precipitates. It was more resistant to pitting corrosion than 5 wt % PERSS? alloys. Performance of the PERSS? alloys was not a function of alloy oxygen content in the range 0.01 to 0.03 wt %.

  12. Expansion of the Multi-Link Frontier™ Coronary Bifurcation Stent: Micro-Computed Tomographic Assessment in Human Autopsy and Porcine Heart Samples

    Science.gov (United States)

    Kralev, Stefan; Haag, Benjamin; Spannenberger, Jens; Lang, Siegfried; Brockmann, Marc A.; Bartling, Soenke; Marx, Alexander; Haase, Karl-Konstantin; Borggrefe, Martin; Süselbeck, Tim

    2011-01-01

    Background Treatment of coronary bifurcation lesions remains challenging, beyond the introduction of drug eluting stents. Dedicated stent systems are available to improve the technical approach to the treatment of these lesions. However dedicated stent systems have so far not reduced the incidence of stent restenosis. The aim of this study was to assess the expansion of the Multi-Link (ML) Frontier™ stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection. Methodology/Principal Findings Nine ML Frontier™ stents were implanted in seven human autopsy heart samples with known coronary artery disease and five ML Frontier™ stents were implanted in five porcine hearts. Proximal, distal and side branch diameters (PD, DD, SBD, respectively), corresponding opening areas (PA, DA, SBA) and the mean stent length (L) were assessed by micro-computed tomography (micro-CT). PD and PA were significantly smaller in human autopsy heart samples than in porcine heart samples (3.54±0.47 mm vs. 4.04±0.22 mm, p = 0.048; 10.00±2.42 mm2 vs. 12.84±1.38 mm2, p = 0.034, respectively) and than those given by the manufacturer (3.54±0.47 mm vs. 4.03 mm, p = 0.014). L was smaller in human autopsy heart samples than in porcine heart samples, although data did not reach significance (16.66±1.30 mm vs. 17.30±0.51 mm, p = 0.32), and significantly smaller than that given by the manufacturer (16.66±1.30 mm vs. 18 mm, p = 0.015). Conclusions/Significance Micro-CT is a feasible tool for exact surveying of dedicated stent systems and could make a contribution to the development of these devices. The proximal diameter and proximal area of the stent system were considerably smaller in human autopsy heart samples than in porcine heart samples and than those given by the manufacturer. Special consideration should be given to the stent deployment procedure (and to the follow-up) of dedicated

  13. Expansion of the Multi-Link Frontier™ coronary bifurcation stent: micro-computed tomographic assessment in human autopsy and porcine heart samples.

    Science.gov (United States)

    Kralev, Stefan; Haag, Benjamin; Spannenberger, Jens; Lang, Siegfried; Brockmann, Marc A; Bartling, Soenke; Marx, Alexander; Haase, Karl-Konstantin; Borggrefe, Martin; Süselbeck, Tim

    2011-01-01

    Treatment of coronary bifurcation lesions remains challenging, beyond the introduction of drug eluting stents. Dedicated stent systems are available to improve the technical approach to the treatment of these lesions. However dedicated stent systems have so far not reduced the incidence of stent restenosis. The aim of this study was to assess the expansion of the Multi-Link (ML) Frontier™ stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection. Nine ML Frontier™ stents were implanted in seven human autopsy heart samples with known coronary artery disease and five ML Frontier™ stents were implanted in five porcine hearts. Proximal, distal and side branch diameters (PD, DD, SBD, respectively), corresponding opening areas (PA, DA, SBA) and the mean stent length (L) were assessed by micro-computed tomography (micro-CT). PD and PA were significantly smaller in human autopsy heart samples than in porcine heart samples (3.54±0.47 mm vs. 4.04±0.22 mm, p = 0.048; 10.00±2.42 mm(2) vs. 12.84±1.38 mm(2), p = 0.034, respectively) and than those given by the manufacturer (3.54±0.47 mm vs. 4.03 mm, p = 0.014). L was smaller in human autopsy heart samples than in porcine heart samples, although data did not reach significance (16.66±1.30 mm vs. 17.30±0.51 mm, p = 0.32), and significantly smaller than that given by the manufacturer (16.66±1.30 mm vs. 18 mm, p = 0.015). Micro-CT is a feasible tool for exact surveying of dedicated stent systems and could make a contribution to the development of these devices. The proximal diameter and proximal area of the stent system were considerably smaller in human autopsy heart samples than in porcine heart samples and than those given by the manufacturer. Special consideration should be given to the stent deployment procedure (and to the follow-up) of dedicated stent systems, considering final intravascular ultrasound or

  14. Expansion of the Multi-Link Frontier™ coronary bifurcation stent: micro-computed tomographic assessment in human autopsy and porcine heart samples.

    Directory of Open Access Journals (Sweden)

    Stefan Kralev

    Full Text Available BACKGROUND: Treatment of coronary bifurcation lesions remains challenging, beyond the introduction of drug eluting stents. Dedicated stent systems are available to improve the technical approach to the treatment of these lesions. However dedicated stent systems have so far not reduced the incidence of stent restenosis. The aim of this study was to assess the expansion of the Multi-Link (ML Frontier™ stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection. METHODOLOGY/PRINCIPAL FINDINGS: Nine ML Frontier™ stents were implanted in seven human autopsy heart samples with known coronary artery disease and five ML Frontier™ stents were implanted in five porcine hearts. Proximal, distal and side branch diameters (PD, DD, SBD, respectively, corresponding opening areas (PA, DA, SBA and the mean stent length (L were assessed by micro-computed tomography (micro-CT. PD and PA were significantly smaller in human autopsy heart samples than in porcine heart samples (3.54±0.47 mm vs. 4.04±0.22 mm, p = 0.048; 10.00±2.42 mm(2 vs. 12.84±1.38 mm(2, p = 0.034, respectively and than those given by the manufacturer (3.54±0.47 mm vs. 4.03 mm, p = 0.014. L was smaller in human autopsy heart samples than in porcine heart samples, although data did not reach significance (16.66±1.30 mm vs. 17.30±0.51 mm, p = 0.32, and significantly smaller than that given by the manufacturer (16.66±1.30 mm vs. 18 mm, p = 0.015. CONCLUSIONS/SIGNIFICANCE: Micro-CT is a feasible tool for exact surveying of dedicated stent systems and could make a contribution to the development of these devices. The proximal diameter and proximal area of the stent system were considerably smaller in human autopsy heart samples than in porcine heart samples and than those given by the manufacturer. Special consideration should be given to the stent deployment procedure (and to the follow

  15. Snuggle T and protrusion (S-TAP) technique for coronary bifurcation stenting: A step-by-step angiographic and illustration demonstration.

    Science.gov (United States)

    Dahdouh, Ziad; Fadel, Bahaa M; Roule, Vincent; Sarkis, Antoine; Grollier, Gilles

    2017-09-01

    T and small protrusion (TAP) is a stenting technique that is utilized for the management of coronary bifurcation lesions when using a two-stent strategy. This technique is also useful whenever stenting of a main vessel (MV) jeopardizes a side branch (SB) or when a sub-optimal result is encountered in a daughter vessel after starting with one-stent approach. The conversion from one-stent strategy to TAP could be achieved smoothly and often leads to good results. Technically, optimal positioning of the SB stent to achieve the required protrusion into the lumen of the MV remains a challenge. Toward that goal we propose an added step that involves inflating a balloon in the MV to serve as an anvil with simultaneous pullback of the SB stent, to be followed by stent deployment. We refer to this approach as the snuggle T and protrusion (S-TAP) technique owing to close contact between the SB stent and the MV balloon during simultaneous inflation. In this manuscript, we detail this interventional technique and provide a demonstrative case study. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. Prospective versus retrospective ECG gating for dual source CT of the coronary stent: Comparison of image quality, accuracy, and radiation dose

    Energy Technology Data Exchange (ETDEWEB)

    Zhao Lei, E-mail: zhaolei219@sohu.com [Beijing Anzhen Hospital of the Capital University of Medical Sciences (China); Zhang Zhaoqi; Fan Zhanming; Yang Lin; Du Jing [Beijing Anzhen Hospital of the Capital University of Medical Sciences (China)

    2011-03-15

    Objective: To compare image quality, diagnostic accuracy and radiation dose of prospective and retrospective electrocardiogram (ECG) gated dual source computed tomography (DSCT) for the evaluation of the coronary stent, using conventional coronary angiography (CA) as a standard reference. Design, setting and patients: Sixty patients (heart rates {<=}70 bpm) with previous stent implantation who were scheduled for CA were divided in two groups, receiving either prospective or retrospective ECG gated DSCT separately. Two reviewers scored coronary stent image quality and evaluated stent lumen. Results: There was no significant difference in image quality between the two groups. In the prospective group, there were 86.4% (51/59) stents with interpretable images, in the retrospective group, there were 87.5% (49/56) stents with interpretable images. Image quality was not influenced by age, body mass index or heart rate in either group, but heart rate variability had a weak impact on the image quality of the prospective group. Image noise was higher in the prospective group, but this difference reached statistical significance only by using a smooth kernel reconstruction. Per-stent based sensitivity, specificity, and positive and negative predictive value were 100%, 84.1%, 68.2%, and 100%, respectively, in the prospective CT angiography group and 94.4%, 86.8%, 77.3%, and 97.1%, respectively, in the retrospective CT angiography group. There was a significant difference in the effective radiation dose between the two groups, mean effective dose in the prospective and retrospective group was 2.2 {+-} 0.5 mSv (1.5-3.2 mSv) and 14.6 {+-} 3.3 mSv (10.0-20.4 mSv) (p < .001) respectively. Conclusions: Compared with retrospective CT angiography, prospective CT angiography has a similar performance in assessing coronary stent patency, but a lower effective dose in selected patients with regular heart rates {<=}70 bpm.

  17. Impact of coronary artery calcification in percutaneous coronary intervention with paclitaxel-eluting stents: Two-year clinical outcomes of paclitaxel-eluting stents in patients from the ARRIVE program.

    Science.gov (United States)

    Lee, Michael S; Yang, Tae; Lasala, John; Cox, David

    2016-11-15

    The purpose of this study was to evaluate clinical outcomes after percutaneous coronary intervention (PCI) in patients with coronary artery calcification (CAC). Smaller studies have reported worse clinical outcomes in patients with CAC who undergo PCI. The impact of CAC in the drug-eluting stent era is unclear. Data from 7,492 patients treated by PCI with ≥1 TAXUS Express stent in the ARRIVE registry with no inclusion/exclusion criteria were stratified by the severity of CAC, as determined by the operator. Endpoints were independently adjudicated. All major adverse cardiac events were assessed at 2 years. Moderate/severe CAC was present in 19.6%. The nil/mild CAC group had higher rate of current smokers. The moderate/severe CAC group was older and had a higher prevalence of hypertension, kidney disease, prior coronary artery bypass grafting, congestive heart failure, and left main disease. After adjustment for imbalanced baseline variables, patients with moderate/severe CAC had higher 2 year rates of major adverse cardiac events (18.3% vs 13.5%, p = 0.01) and death (10.3% vs 5.6%, p = 0.02). Moderate/severe CAC was associated with increased clinical events in patients who underwent PCI with TAXUS stents. This may be explained in part due to differences important baseline characteristics including more patients with more comorbidities and more complex lesions. After adjustment for imbalanced baseline variables, the moderate/severe CAC group had a higher risk of major adverse cardiac events and death. Improvements in treatment strategies are needed for this high-risk group of patients who undergo PCI. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

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

    DEFF Research Database (Denmark)

    Wein, Bastian; Coslovsky, Michael; Jabbari, Reza

    2017-01-01

    BACKGROUND: Clinical and cost-effectiveness of prasugrel vs. clopidogrel in acute coronary syndrome (ACS) was only evaluated using TRITON-TIMI 38 event rates. A comparative analysis of both drugs in contemporary European ACS patients is lacking. METHODS: To address this issue, cardiac and bleeding...... events of 2 "sister" multicenter stent trials, BASKET-PROVE (BP) I with clopidogrel and BPII with prasugrel (for 12months each) were used in a hybrid analysis. Medication costs were 2015 sales prices, event costs modelled for Denmark (DNK), Germany (GER) and Switzerland (SUI) and quality adjusted life...... years (QALY) by EQ-5D-3L questionnaire. RESULTS: In BPI and II, 1012 and 985 ACS-patients received drug eluting stents, respectively, followed-up for 2years. Compared to clopidogrel, prasugrel-treated patients had no more major cardiac events (5.2% vs. 6.4%, p=0.422) nor cardiac deaths (1.6% vs. 1.0%, p...

  19. Relationship between the Level of Circulating CD45+ Platelets and Development of Restenosis after Implantation of Drug-Eluting Stents to Patients with Coronary Heart Disease.

    Science.gov (United States)

    Gabbasov, Z A; Kozlov, S G; Byazrova, S V; Mel'nikov, I S; Saburova, O S

    2017-02-01

    The study was carried out in 126 patients with stable angina pectoris, who underwent elective coronary artery stenting with drug-eluting stents and follow-up angiography within 6-12 months thereafter. Five significant risk factors of restenosis were identified by binary comparisons of different variables. The logistic regression equation that included the level of CD45-positive platelets, diabetes, small vessel stenting, number of simultaneously implanted stents in one patient, and lesion length demonstrates the highest level of prediction of in-stent restenosis (OR=22.8; plogit model (area under ROC curve 0.87, p<0.001). The data suggest that a close relationship exists between the development of restenosis and the level of circulating CD45+ platelets.

  20. Effect of cold deformation on pitting corrosion of 00Cr18Mn15Mo2N0.86 stainless steel for coronary stent application.

    Science.gov (United States)

    Ren, Yibin; Zhao, Haochuan; Liu, Wenpeng; Yang, Ke

    2016-03-01

    The high nitrogen nickel-free stainless steel has offered an alternative to further improve the performance of the coronary stents, and simultaneously avoids the potential harms of nickel element. Both cold deformation and pitting corrosion are very important for coronary stents made of stainless steel. In this work, the effect of cold deformation on the pitting corrosion resistance of a high nitrogen nickel-free stainless steel (00Cr18Mn15Mo2N0.86) in 0.9% saline solution was investigated. The results showed that the pitting corrosion of the steel was nearly unchanged with increases of the cold deformation up to 50%, indicating that the higher nitrogen content can reduce the negative effect of cold deformation on the pitting corrosion resistance, which is beneficial for the long term service of coronary stents in blood vessel. Copyright © 2015 Elsevier B.V. All rights reserved.

  1. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: Design and statistical methods of the PERSEUS clinical program

    Directory of Open Access Journals (Sweden)

    Wehrenberg Scott

    2010-01-01

    Full Text Available Abstract Background Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the TAXUS Element stent are being evaluated in the pivotal PERSEUS clinical trials. Methods/Design The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1, single-blind, non-inferiority trial in subjects with lesion length ≤28 mm and vessel diameter ≥2.75 mm to ≤4.0 mm which compares TAXUS Element to the TAXUS Express2 paclitaxel-eluting stent system. The Workhorse study employs a novel Bayesian statistical approach that uses prior information to limit the number of study subjects exposed to the investigational device and thus provide a safer and more efficient analysis of the TAXUS Element stent. PERSEUS Small Vessel is a prospective, single-arm, superiority trial in subjects with lesion length ≤20 mm and vessel diameter ≥2.25 mm to Discussion The TAXUS PERSEUS clinical trial program uses a novel statistical approach to evaluate whether design and metal alloy iterations in the TAXUS Element stent platfor