Final 5‐year report of BIONYX comparing the thin‐composite wire‐strut zotarolimus‐eluting stent versus ultrathin‐strut sirolimus‐eluting stent

Abstract Background The BIONYX randomized trial is the first study to evaluate the Resolute Onyx durable polymer‐coated zotarolimus‐eluting stent (ZES) in all‐comers. Furthermore, it is the first trial to assess safety and efficacy of this stent versus the Orsiro biodegradable‐polymer sirolimus‐eluting stent (SES) in all‐comers, paying particular attention to patients with diabetes. It has previously shown promising results until 3 years of follow‐up. Aims We aimed to assess long‐term clinical outcome after percutaneous coronary intervention (PCI) with Onyx ZES versus Orsiro SES at 5‐year follow‐up. Methods The main composite endpoint was target vessel failure (TVF): cardiac death, target vessel myocardial infarction, or target vessel revascularization. Time to primary and secondary endpoints was assessed using Kaplan–Meier methods, applying the log‐rank test for between‐group comparison. Results Follow‐up was available in 2414/2488 (97.0%) patients. After 5 years, TVF showed no significant difference between Onyx ZES and Orsiro SES (12.7% vs. 13.7%, hazard ratio HR 0.94, 95% confidence interval CI 0.75–1.17, p log‐rank = 0.55). Landmark analysis between 3‐ and 5‐year follow‐up found a lower target lesion revascularization rate for Onyx ZES (1.1% vs. 2.4%, HR 0.47, 95% CI 0.24–0.93, p log‐rank = 0.026). A prespecified subgroup analysis showed no significant between‐stent difference in clinical outcome among patients with diabetes. After treatment with Onyx ZES, patients aged ≥75 years had significantly lower rates of TVF (13.8% vs. 21.9%, HR 0.60, 95% CI 0.39–0.93, p log‐rank = 0.023). Conclusions The final 5‐year analysis of the randomized BIONYX trial showed favorable and similar long‐term outcomes of safety and efficacy for Onyx ZES and Orsiro SES in both all‐comers and patients with diabetes.