title: 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis.
abstract: BACKGROUND
  Compared with metallic drug-eluting stents, bioresorbable vascular scaffolds (BVS) offer the potential to improve long-term outcomes of percutaneous coronary intervention. Whether or not these devices are as safe and effective as drug-eluting stents within the first year after implantation is unknown.
  
  
  METHODS
  We did a patient-level, pooled meta-analysis of four randomised trials in which 3389 patients with stable coronary artery disease or a stabilised acute coronary syndrome were enrolled at 301 academic and medical centres in North America, Europe, and the Asia-Pacific region. These patients were randomly assigned to the everolimus-eluting Absorb BVS (n=2164) or the Xience cobalt-chromium everolimus-eluting stent (CoCr-EES; n=1225). The primary endpoints were the 1-year relative rates of the patient-oriented composite endpoint (all-cause mortality, all myocardial infarction, or all revascularisation) and the device-oriented composite endpoint of target lesion failure (cardiac mortality, target vessel-related myocardial infarction, or ischaemia-driven target lesion revascularisation). All analyses were by intention to treat. The four randomised trials included in our meta-analysis are all registered with ClinicalTrials.gov, numbers NCT01751906, NCT01844284, NCT01923740, and NCT01425281.
  
  
  RESULTS
  The summary treatment effect for the 1-year relative rates of the patient-oriented composite endpoint did not differ significantly different between BVS and CoCr-EES (relative risk [RR] 1·09 [0·89-1·34], p=0·38). Similarly, the 1-year relative rates of the device-oriented composite endpoint did not differ between the groups (RR 1·22 [95% CI 0·91-1·64], p=0·17). Target vessel-related myocardial infarction was increased with BVS compared with CoCr-EES (RR 1·45 [95% CI 1·02-2·07], p=0·04), due in part to non-significant increases in peri-procedural myocardial infarction and device thrombosis with BVS (RR 2·09 [0·92-4·75], p=0·08). The relative rates of all-cause and cardiac mortality, all myocardial infarction, ischaemia-driven target lesion revascularisation, and all revascularisation did not differ between BVS and CoCr-EES. Results were similar after multivariable adjustment for baseline imbalances, and were consistent across most subgroups and in sensitivity analysis when two additional randomised trials with less than 1 year of follow-up were included.
  
  
  CONCLUSIONS
  In this meta-analysis, BVS did not lead to different rates of composite patient-oriented and device-oriented adverse events at 1-year follow-up compared with CoCr-EES.
  
  
  BACKGROUND
  Abbott Vascular.
authors.affiliation: New York Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA; Cardiovascular Research Foundation, New York, NY, USA. Electronic address: gs2184@columbia.edu.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Runlin
authors.initials: R
authors.lastname: Gao
authors.affiliation: Kyoto University Hospital, Kyoto, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.affiliation: The Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati, OH, USA.
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Ellis
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: Abbott Vascular, Santa Clara, CA, USA.
authors.forename: Wai-Fung
authors.initials: WF
authors.lastname: Cheong
authors.affiliation: Abbott Vascular, Santa Clara, CA, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Jones-McMeans
authors.affiliation: Abbott Vascular, Santa Clara, CA, USA.
authors.forename: Xiaolu
authors.initials: X
authors.lastname: Su
authors.affiliation: Abbott Vascular, Santa Clara, CA, USA.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: International Centre for Cardiovascular Health, Imperial College, London, UK.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D020341:Absorbable Implants; D003324:Coronary Artery Disease / Q000601:surgery*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors; D054457:Tissue Scaffolds; D016896:Treatment Outcome