Safety and efficacy of everolimus-eluting bioresorbable vascular scaffolds versus durable polymer everolimus-eluting metallic stents assessed at 1-year follow-up: A systematic review and meta-analysis of studies

INTERNATIONAL JOURNAL OF CARDIOLOGY

卷:221

Review

Mukete, Bertrand N.¹  van der Heijden, Liefke C.²  Tandjung, Kenneth²  Baydoun, Hassan¹  Yadav, Kapil¹  Saleh, Qusai A.¹  Doggen, Carine J. M.³  Rafeh, Nidal Abi¹  Le Jemtel, Thierry H.¹  von Birgelen, Clemens² 

[1] Tulane Univ, Sch Med, Inst Heart & Vasc, Div Cardiol,Dept Med, New Orleans, LA 70118 USA

[2] Med Spectrum Twente, Thoraxctr Twente, Koningspl 1, NL-7512 KZ Enschede, Netherlands

[3] Univ Twente, MIRA Inst Biomed Technol & Tech Med, Hlth Technol & Serv Res, Enschede, Netherlands

关键词: Bioresorbable vascular scaffold;    Biodegradable device;    Everolimus-eluting stent;    Scaffold thrombosis;    Stent thrombosis;    Percutaneous coronary intervention;   

DOI  :  10.1016/j.ijcard.2016.07.101

来源: Elsevier

【 摘 要 】

Background: The Absorb bioresorbable vascular scaffold (BVS) was developed to address long-term safety issues of metallic drug-eluting stents. However, it may be associated with an increased event risk during the first year. Methods: A systematic literature search was performed (in MEDLINE/PubMed, Cochrane CENTRAL, EMBASE, and scientific meeting abstracts) to identify studies that compared BVS and cobalt-chromium durable polymer everolimus-eluting stents (EES). For randomized clinical trials and non-randomized propensity score matched studies that reported 1-year outcome data, fixed/random-effects models were used to generate pooled estimates of outcomes, presented as odds ratios (OR) with 95%-confidence intervals (CI). Results: The 1-year follow-up data of 6 trials with 5588 patients were analyzed. A device-oriented composite endpoint (DOCE -cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization (TLR)) was reached by 308 BVS or EES patients (195/3253 vs. 113/2315). Meta-analysis showed that patients who received BVS had an increased risk of MI (4.3% vs. 2.3%; OR: 1.63, 95%-CI: 1.18-2.25, p < 0.01) and definite-or-probable scaffold thrombosis (1.3% vs. 0.6%; OR: 2.10, 95%-CI: 1.13-3.87, p = 0.02). However, there was no significant between-group difference in risk of DOCE (6.0% vs. 4.9%; OR: 1.19, 95%-CI: 0.94-1.52, p = 0.16), cardiac death (0.8% vs. 0.7%; OR: 1.14, 95%-CI: 0.54-2.39, p = 0.73), or TLR (2.5% vs. 2.5%; OR: 0.98, 95%CI: 0.69-1.40, p = 0.92). Conclusions: During the first year of follow-up, patients treated with BVS had a higher incidence of MI and scaffold thrombosis. The risk of DOCE was not significantly different. As BVS may pay off later, future robust data on long-term clinical outcome will be of paramount importance. (C) 2016 The Authors. Published by Elsevier Ireland Ltd.

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