Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis.

BACKGROUND The aim of this study was to compare the safety and efficacy of biodegradable-polymer (BP) drug-eluting stents (DES), bare metal stents (BMS), and durable-polymer DES in patients undergoing coronary revascularization, we performed a systematic review and network meta-analysis using a Bayesian framework. METHODS AND RESULTS Study stents included BMS, paclitaxel-eluting (PES), sirolimus-eluting (SES), endeavor zotarolimus-eluting (ZES-E), cobalt-chromium everolimus-eluting (CoCr-EES), platinium-chromium everolimus-eluting (PtCr-EES), resolute zotarolimus-eluting (ZES-R), and BP biolimus-eluting stents (BP-BES). After a systematic electronic search, 113 trials with 90 584 patients were selected. The principal endpoint was definite or probable stent thrombosis (ST) defined according to the Academic Research Consortium within 1 year. RESULTS Biodegradable polymer-biolimus-eluting stents [OR, 0.56; 95% credible interval (CrI), 0.33-0.90], SES (OR, 0.53; 95% CrI, 0.38-0.73), CoCr-EES (OR, 0.34; 95% CrI, 0.23-0.52), and PtCr-EES (OR, 0.31; 95% CrI, 0.10-0.90) were all superior to BMS in terms of definite or probable ST within 1 year. Cobalt-chromium everolimus-eluting stents demonstrated the lowest risk of ST of all stents at all times after stent implantation. Biodegradable polymer-biolimus-eluting stents was associated with a higher risk of definite or probable ST than CoCr-EES (OR, 1.72; 95% CrI, 1.04-2.98). All DES reduced the need for repeat revascularization, and all but PES reduced the risk of myocardial infarction compared with BMS. CONCLUSIONS All DESs but PES and ZES-E were superior to BMS in terms of ST within 1 year. Cobalt-chromium everolimus-eluting stents was safer than any DES even including BP-BES. Our results suggest that not only the biodegradability of polymer, but the optimal combination of stent alloy, design, strut thickness, polymer, and drug all combined determine the safety of DES.

[1]  F. Eberli,et al.  Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial , 2008, The Lancet.

[2]  J. Higgins,et al.  Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0. The Cochrane Collaboration , 2013 .

[3]  L. Räber,et al.  Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction: the COMFORTABLE AMI randomized trial. , 2012, JAMA.

[4]  Seung‐Jung Park,et al.  Everolimus-eluting versus sirolimus-eluting stents: an updated meta-analysis of randomized trials , 2012, Clinical Research in Cardiology.

[5]  K. Stangl,et al.  TCT-173 Safety and Clinical Performance of the Drug Eluting Osiro Stent in the Treatment of Subjects With Single De Novo Coronary Artery Lesions-II (BIOFLOW-II) , 2013 .

[6]  J. Fajadet,et al.  Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent. , 2012, Journal of the American College of Cardiology.

[7]  A. Kastrati,et al.  Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial , 2011, The Lancet.

[8]  Patrick Hunziker,et al.  Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. , 2006, Journal of the American College of Cardiology.

[9]  G. Stone,et al.  A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. , 2004, The New England journal of medicine.

[10]  R. Fattori,et al.  Biodegradable versus durable polymer drug eluting stents in coronary artery disease: Insights from a meta-analysis of 5834 patients , 2014, European journal of preventive cardiology.

[11]  B. Gersh Drug-Eluting Versus Bare Metal Stents in Patients With ST-Segment–Elevation Myocardial Infarction. Eight-Month Follow-Up in the Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION) Trial , 2009 .

[12]  Volkmar Falk,et al.  Guidelines on Myocardial Revascularization the Task Force on Myocardial Revascularization of the European Society of Cardiology (esc) and the European Association for Cardio-thoracic Surgery (eacts) Developed with the Special Contribution of the European Association for Percutaneous Cardiovascular I , 2022 .

[13]  G. Lu,et al.  Combination of direct and indirect evidence in mixed treatment comparisons , 2004, Statistics in medicine.

[14]  Patrick W Serruys,et al.  Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy , 2004, The Lancet.

[15]  Ousa,et al.  A RANDOMIZED COMPARISON OF A SIROLIMUS-ELUTING STENT WITH A STANDARD STENT FOR CORONARY REVASCULARIZATION , 2002 .

[16]  Giuseppe Musumeci,et al.  Localized Hypersensitivity and Late Coronary Thrombosis Secondary to a Sirolimus-Eluting Stent: Should We Be Cautious? , 2004, Circulation.

[17]  Michael Joner,et al.  Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. , 2006, Journal of the American College of Cardiology.

[18]  P. Serruys,et al.  Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial , 2012, The Lancet.

[19]  E. Edelman,et al.  Stent Thrombogenicity Early in High-Risk Interventional Settings Is Driven by Stent Design and Deployment and Protected by Polymer-Drug Coatings , 2011, Circulation.

[20]  P. Serruys,et al.  Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus(R), paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial. , 2007, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[21]  D. Rubin,et al.  Inference from Iterative Simulation Using Multiple Sequences , 1992 .

[22]  Ya‐Ling Han,et al.  [Therapeutic effect and safety of drug eluting stent for patients with acute ST-elevation anterior wall myocardial infarction by left anterior descending artery occluded abruptly]. , 2010, Zhonghua yi xue za zhi.

[23]  Georgia Salanti,et al.  Evaluation of networks of randomized trials , 2008, Statistical methods in medical research.

[24]  Deepak L. Bhatt,et al.  Short- and Long-Term Outcomes With Drug-Eluting and Bare-Metal Coronary Stents: A Mixed-Treatment Comparison Analysis of 117 762 Patient-Years of Follow-Up From Randomized Trials , 2012, Circulation.

[25]  G. Stone,et al.  Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis , 2012, The Lancet.

[26]  F. Eberli,et al.  Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial , 2011, The Lancet.

[27]  Gregg W Stone,et al.  Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. , 2010, The New England journal of medicine.

[28]  P. Smits,et al.  Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial , 2010, The Lancet.

[29]  Deepak L. Bhatt,et al.  Response to letter regarding article, “Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison Analysis of 117,762 patient-years of follow-up from randomized trials”. , 2013, Circulation.

[30]  S. Hahn,et al.  Safety and efficacy of everolimus- versus sirolimus-eluting stents: a systematic review and meta-analysis of 11 randomized trials. , 2013, American heart journal.

[31]  Aloke V. Finn,et al.  Delayed Arterial Healing and Increased Late Stent Thrombosis at Culprit Sites After Drug-Eluting Stent Placement for Acute Myocardial Infarction Patients: An Autopsy Study , 2008, Circulation.

[32]  J. Higgins Cochrane handbook for systematic reviews of interventions. Version 5.1.0 [updated March 2011]. The Cochrane Collaboration , 2011 .

[33]  P. Serruys,et al.  Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions , 2007, Circulation.