Four-year follow-up of the randomised comparison between an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II Trial)

Abstract

AIMS No randomised comparison data are available beyond the resorption of the everolimus-eluting bioresorbable scaffold. Absorb is expected to be completely resorbed by 3 years. The purpose of this report is to provide the 4 year results of a randomised, single blind, multicentre evaluation of Absorb versus the metallic stent Xience (Abbott Vascular, Santa Clara, CA, USA). METHODS AND RESULTS Three-year follow-up has been previously published. Patients re-consented for additional follow-up up through to 5 years; 86% (N=289) and 84% (N=139) of whom underwent a 4 year follow-up visit. TLF was noted in 11.5% in the Absorb arm and 6.0% in the Xience arm (p=0.063) at 4 years, with 1.0% and 0.7% absolute difference respectively between 3 and 4 years. No new very late definite/probable scaffold/stent thrombosis was reported between 3 and 4 years, with a 4-year rate of 3.0% versus 0.0% (p=0.035) and a slight decrease in DAPT prescription in both arms at 4 years (25.9% versus 21.1%, p=NS). CONCLUSIONS A downturn of events was recorded beyond the expected resorption time. Further long-term evaluation in larger randomised studies is necessary to confirm this observation.