This work, presented at TCT 2018 and published simultaneously in The Lancet, is the first randomized study comparing a zotarolimus-eluting stent with a new thin-strut structure and limited radiographic visibility (Onyx), and a bioresorbable polymer-coated sirolimus-eluting stent (Orsiro).
Onyx was developed to improve visibility while reducing strut thickness. To that end, a dense platinum–iridium core and an outer cobalt–chromium layer were used.
This study included a non-selected population of patients randomized 1:1 to Onyx vs. Orsiro. Randomization was stratified by sex and diabetes status.
The primary endpoint was a composite of cardiac death, target-vessel infarction, and target-vessel revascularization.
Read also: EuroPCR 2018 | BIO-RESORT: Polymer vs. Bioresorbable Polymer; Have We Reached a Plateau with DES?
The study enrolled 2488 patients (1243 in the Onyx group vs. 1245 in the Orsiro group). Overall, 70.9% of the population presented with acute coronary syndrome; among these, 51.2% were instances of acute myocardial infarction.
After a 1-year follow-up, the primary endpoint was met by 4.5% of all patients in the Onyx group and 4.7% in the Orsiro group, thus establishing non-inferiority. Definite stent thrombosis occurred in one (0.1%) patient in the Onyx group vs. 0.7% in the Orsiro group.
The low event rate in both groups suggests that both devices are safe and effective.
Original title: Thin Composite Wire Strut, Durable Polymer-Coated (Resolute Onyx) Versus Ultrathin Cobalt–Chromium Strut, Bioresorbable Polymer-Coated (Orsiro) Drug-Eluting Stents in Allcomers with Coronary Artery Disease (BIONYX): An International, Single-Blind, Randomised Non-Inferiority Trial.
Presenter: Prof. Clemens von Birgelen.
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