BioMatrix versus Orsiro Stent for Coronary Artery Disease: A Multicenter, Randomized, Open-Label Study.

AIMS 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). METHODS AND RESULTS This randomized, open-label, non-inferiority trial was conducted among patients undergoing percutaneous coronary intervention. The primary endpoint was target lesion failure (TLF),. Between 21st July 2014 and 28th September 2017, we randomly assigned 2341 patients to BioMatrix stents (n=1,166) or Orsiro stents (n=1,175 ). We analysed 2327 patients who finished 18-month follow-up. The mean patient age was 63.5 years, and 1565 (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: 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 revascularization (18 [1.6%] vs. 10 [0.9%], P=0.124), or stent thrombosis (0 [0%] vs. 2 [0.2%], P=0.50). CONCLUSIONS In patients with a high prevalence of acute coronary syndrome, Orsiro stents were not inferior to BioMatrix stents. Both showed excellent clinical outcomes.