title: Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials.
abstract: BACKGROUND
  Bioresorbable coronary stents might improve outcomes of patients treated with percutaneous coronary interventions. The everolimus-eluting bioresorbable vascular scaffold is the most studied of these stent platforms; however, its performance versus everolimus-eluting metallic stents remains poorly defined. We aimed to assess the efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with ischaemic heart disease treated with percutaneous revascularisation.
  
  
  METHODS
  We searched Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), scientific sessions abstracts, and relevant websites for randomised trials investigating everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents published or posted between Nov 30, 2006, and Oct 12, 2015. The primary efficacy outcome was target lesion revascularisation and the primary safety outcome was definite or probable stent (scaffold) thrombosis. Secondary outcomes were target lesion failure (the composite of cardiac death, target-vessel myocardial infarction, or ischaemia-driven target lesion revascularisation), myocardial infarction, death, and in-device late lumen loss. We derived odds ratios (ORs) and weighted mean differences with 95% CIs, and calculated the risk estimates for the main outcomes according to a random-effects model. This study is registered with PROSPERO, number CRD42015026374.
  
  
  RESULTS
  We included six trials, comprising data for 3738 patients randomised to receive percutaneous coronary intervention with either an everolimus-eluting bioresorbable vascular scaffold (n=2337) or an everolimus-eluting metallic stent (n=1401). Median follow-up was 12 months (IQR 9-12). Patients treated with bioresorbable vascular scaffolds had a similar risk of target lesion revascularisation (OR 0.97 [95% CI 0.66-1.43]; p=0.87), target lesion failure (1.20 [0.90-1.60]; p=0.21), myocardial infarction (1.36 [0.98-1.89]; p=0.06), and death (0.95 [0.45-2.00]; p=0.89) as those treated with metallic stents. Patients treated with a bioresorbable vascular scaffold had a higher risk of definite or probable stent thrombosis than those treated with a metallic stent (OR 1.99 [95% CI 1.00-3.98]; p=0.05), with the highest risk between 1 and 30 days after implantation (3.11 [1.24-7.82]; p=0.02). Lesions treated with a bioresorbable vascular scaffold had greater in-device late lumen loss than those treated with a metallic stent (weighted mean difference 0.08 [95% CI 0.05-0.12]; p<0.0001).
  
  
  CONCLUSIONS
  Compared with everolimus-eluting metallic stents, everolimus-eluting bioresorbable vascular scaffolds had similar rates of repeat revascularisation at 1 year of follow-up, despite inferior mid-term angiographic performance. However, patients treated with a bioresorbable vascular scaffold had an increased risk of subacute stent thrombosis. Studies with extended follow-up in a larger number of patients are needed to fully assess the long-term advantages of everolimus-eluting bioresorbable vascular scaffolds.
  
  
  BACKGROUND
  None.
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. Electronic address: cassese@dhm.mhn.de.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cassese
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Gjin
authors.initials: G
authors.lastname: Ndrepepa
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Kufner
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Wiebe
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Janika
authors.initials: J
authors.lastname: Repp
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.
authors.forename: Heribert
authors.initials: H
authors.lastname: Schunkert
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Fusaro
authors.affiliation: Department of Cardiovascular Medicine, Kyoto University Hospital, Kyoto, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D017202:Myocardial Ischemia / Q000188:drug therapy*; D009204:Myocardial Revascularization / Q000295:instrumentation / Q000379:methods; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation / Q000379:methods; D016032:Randomized Controlled Trials as Topic; D012086:Reoperation / Q000706:statistics & numerical data; D054457:Tissue Scaffolds; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus