Pooled Meta-Analysis of 1-Year Data From Four Absorb Bioresorbable Scaffold Trials Published

March 28, 2016—One-year outcomes from a meta-analysis of Abbott Vascular’s Absorb bioresorbable scaffold (BVS) in patients with coronary artery disease (CAD) were published by Gregg W. Stone, MD, et al in The Lancet (2016;387:1277–1289).

The investigators conducted a patient-level, pooled meta-analysis of four randomized trials in which 3,389 patients with stable CAD or a stabilized acute coronary syndrome were enrolled at 301 academic and medical centers in North America, Europe, and the Asia-Pacific region. The four randomized trials were ABSORB III, ABSORB JAPAN, ABSORB CHINA, and ABSORB II.

The patients were randomly assigned to the everolimus-eluting Absorb BVS (n = 2,164) or Abbott Vascular’s Xience cobalt-chromium everolimus-eluting stent (CoCr-EES; n = 1,225).

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, concluded the investigators.

As summarized in The Lancet, the primary endpoints were the 1-year relative rates of the patient-oriented composite endpoint (all-cause mortality, all myocardial infarction [MI], or all revascularization) and the device-oriented composite endpoint of target lesion failure (cardiac mortality, target vessel-related MI, or ischemia-driven target lesion revascularization). All analyses were by intention to treat. 

The investigators reported that 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 = .38). Similarly, the 1-year relative rates of the device-oriented composite endpoint did not differ between the groups (RR, 1.22; 95% confidence interval [CI], 0.91–1·64; P = .17). 

Target-vessel–related MI was increased with BVS compared with CoCr-EES (RR, 1.45; 95% CI, 1.02–2.07; P = .04), caused in part by nonsignificant increases in periprocedural MI and device thrombosis with BVS (RR, 2.09; 0.92–4.75; P = .08). 

The relative rates of all-cause and cardiac mortality, all MI, ischemia-driven target lesion revascularization, and all revascularization 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 randomized trials with less than 1 year of follow-up were included, advised the investigators in The Lancet.