ABSTRACT

Methods - We did a systematic review and meta-analysis of randomised trials in which patients were randomly assigned to everolimus-eluting Absorb BVS or metallic everolimus-eluting stents (EES) and followed up for at least 2 years. We searched MEDLINE, the Cochrane database, TCTMD, ClinicalTrials.gov, Clinical Trial Results, CardioSource, and abstracts and presentations from major cardiovascular meetings up to April 1, 2017, to identify relevant studies. The primary efficacy outcome measure was the device-oriented composite endpoint (cardiac mortality, target vessel-related myocardial infarction, or ischaemia-driven target lesion revascularisation) and the primary safety outcome measure was definite or probable device thrombosis. Individual patient data from the four ABSORB trials were used for landmark and subgroup analysis and multivariable modelling.

Findings - We identified seven randomised trials in which 5583 patients were randomly assigned to Absorb BVS (n=3261) or metallic EES (n=2322) and followed up for 2 years. BVS had higher 2-year relative risks of the device-oriented composite endpoint than did EES (9.4% [304 of 3217] vs 7.4% [169 of 2299]; relative risk [RR] 1.29 [95% CI 1.08-1.56], p=0.0059). These differences were driven by increased rates of target vessel-related myocardial infarction (5.8% [187 of 3218] vs 3.2% [74 of 2299]; RR 1.68 [95% CI 1.29-2.19], p=0.0003) and ischaemia-driven target lesion revascularisation (5.3% [169 of 3217] vs 3.9% [90 of 2300]; 1.40 [1.09-1.80], p=0.0090) with BVS, with non-significant differences in cardiac mortality. The cumulative 2-year incidence of device thrombosis was higher with BVS than with EES (2.3% [73 of 3187] vs 0.7% [16 of 2281]; RR 3.35 [95% CI 1.96-5.72], p<0.0001). Landmark analysis between 1 and 2 years also showed higher rates of the device-oriented composite endpoint (3.3% [69 of 2100] vs 1.9% [23 of 1193]; RR 1.64 [95% CI 1.03-2.61], p=0.0376) and device thrombosis (0.5% [11 of 2085] vs none [0 of 1183], p<0.0001) in BVS-treated patients than in EES-treated patients.

Interpretation - BVS was associated with increased rates of composite device-oriented adverse events and device thrombosis cumulatively at 2 years and between 1 and 2 years of follow-up compared with EES.