BioMatrix versus Orsiro biodegradable polymer stents in all-comer patients with coronary artery disease: the multicentre, randomised BIODEGRADE trial.

Abstract

The aim of this trial was to compare the safety and efficacy of a thin-strut biodegradable polymer sirolimus-eluting cobalt-chromium stent (Orsiro) to a thick-strut biodegradable polymer biolimus-eluting stent (BioMatrix). This randomised, open-label, non-inferiority trial was conducted among patients undergoing percutaneous coronary intervention. The primary endpoint was target lesion failure (TLF). Between July 2014 and September 2017, we randomly assigned 2,341 patients to BioMatrix stents (n=1,166) or Orsiro stents (n=1,175). We analysed 2,327 patients who completed 18-month follow-up. The mean patient age was 63.5 years, and 1,565 (67.3%) patients presented with acute coronary syndrome. At 18 months, 34 (2.9%) patients with BioMatrix stents and 24 (2.1%) with Orsiro stents experienced TLF (hazard ratio [HR] 0.70, upper limit of one-sided 95% confidence interval: 1.18, p for non-inferiority <0.0001). No significant differences were noted in rates of cardiac death (16 [1.4%] vs 12 [1.0%], p=0.558), target lesion-related myocardial infarction (0 [0%] vs 3 [0.3%], p=0.250), target lesion revascularisation (18 [1.6%] vs 10 [0.9%], p=0.124), or stent thrombosis (0 [0%] vs 2 [0.2%], p=0.50). In patients with a high prevalence of acute coronary syndrome, Orsiro stents were not inferior to BioMatrix stents. Both showed good clinical outcomes.