BIONYX: Improved Visibility for New Zotarolimus-eluting Stent

A polymer-coated zotarolimus-eluting stent (Resolute Onyx) with a novel thin-strut metallic platform demonstrated noninferiority to an ultrathin-strut bioresorbable polymer-coated sirolimus-eluting stent (Orsiro) with a chromium strut platform, new study results presented at TCT 2018 in San Diego indicated.

Researchers for the BIONYX trial enrolled 2,488 all-comer patients in the intent-to-treat analysis, of whom 1,75 (70.9%) presented with an acute coronary syndrome, and 1,275 (51.2%) were treated for an acute myocardial infarction at study enrollment. Participants were between 30 and 96 years of age (23.9% women). The primary study endpoint was target vessel failure at one year.

According to the results, the primary study endpoint was met by 55 of the 1,243 assigned to the zotarolimus-eluting stent compared to 58 of 1,245 assigned to the sirolimus-eluting stent (4.5% vs. 4.7%, respectively). The zotarolimus-eluting stent demonstrated noninferiority with an absolute risk difference of -0.2% (95% CI, -1.9 to -1.4) and an upper limit of the once-sided 95% CI of 1.1% (P_{noninferiority}=0.0005, P_superiority=0.77). Cardiac death rates, target vessel-related MI, and clinically indicated target vessel revascularization were similar between the study groups. Definite or probable stent thrombosis was higher in the sirolimus group (HR=0.11; 95% CI, 0.01 to 0.87; p=0.0112).

“Despite the difference in stent strut materials and thicknesses and the dissimilar durable and bioresorbable polymer coatings of the two study stents, the BIONYX study found no advantage for one stent over the other,” said Clemens von Birgelen, MD, PhD, an Interventional Cardiologist at Thoraxcentrum Twente and Professor of Interventional Cardiology at the University of Twente in Enschede, The Netherlands, in a press release. “Treatment with both stents was similarly safe and effective with excellent one-year clinical outcomes in a complex all-comer patient population. The observed very low stent thrombosis rate in Resolute Onyx warrants further clinical investigation.”

This study was simultaneously published in The Lancet.