title: 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.
abstract: 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.
authors.affiliation: Division of Cardiology, Department of Medicine, Tulane University School of Medicine, Heart and Vascular Institute, New Orleans, LA, USA.
authors.forename: Bertrand N
authors.initials: BN
authors.lastname: Mukete
authors.affiliation: Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Liefke C
authors.initials: LC
authors.lastname: van der Heijden
authors.affiliation: Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Tandjung
authors.affiliation: Division of Cardiology, Department of Medicine, Tulane University School of Medicine, Heart and Vascular Institute, New Orleans, LA, USA.
authors.forename: Hassan
authors.initials: H
authors.lastname: Baydoun
authors.affiliation: Division of Cardiology, Department of Medicine, Tulane University School of Medicine, Heart and Vascular Institute, New Orleans, LA, USA.
authors.forename: Kapil
authors.initials: K
authors.lastname: Yadav
authors.affiliation: Division of Cardiology, Department of Medicine, Tulane University School of Medicine, Heart and Vascular Institute, New Orleans, LA, USA.
authors.forename: Qusai A
authors.initials: QA
authors.lastname: Saleh
authors.affiliation: Health Technology and Services Research, MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, The Netherlands.
authors.forename: Carine J M
authors.initials: CJ
authors.lastname: Doggen
authors.affiliation: Division of Cardiology, Department of Medicine, Tulane University School of Medicine, Heart and Vascular Institute, New Orleans, LA, USA.
authors.forename: Nidal
authors.initials: N
authors.lastname: Abi Rafeh
authors.affiliation: Division of Cardiology, Department of Medicine, Tulane University School of Medicine, Heart and Vascular Institute, New Orleans, LA, USA.
authors.forename: Thierry H
authors.initials: TH
authors.lastname: Le Jemtel
authors.affiliation: Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands; Health Technology and Services Research, MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, The Netherlands. Electronic address: c.vonbirgelen@mst.nl.
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects; D001807:Blood Vessel Prosthesis / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000601:surgery*; D023903:Coronary Restenosis / Q000209:etiology; D054855:Drug-Eluting Stents / Q000145:classification*; D000068338:Everolimus / Q000494:pharmacology*; D006801:Humans; D010043:Outcome and Process Assessment, Health Care; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D054457:Tissue Scaffolds / Q000009:adverse effects
chemical_list: D000068338:Everolimus
keywords: Biodegradable device; Bioresorbable vascular scaffold; Everolimus-eluting stent; Percutaneous coronary intervention; Scaffold thrombosis; Stent thrombosis