Three‐year clinical outcome of biodegradable hybrid polymer Orsiro sirolimus‐eluting stent and the durable biocompatible polymer Resolute Integrity zotarolimus‐eluting stent: A randomized controlled trial

AIMS: We compared long‐term clinical outcomes between patients treated with Orsiro sirolimus‐eluting stent (O‐SES) and those treated with durable biocompatible polymer Resolute Integrity zotarolimus‐eluting stent (R‐ZES). METHODS AND RESULTS: The ORIENT trial was a randomized controlled noninferiority trial to compare angiographic outcomes between O‐SES and R‐ZES. We performed a post hoc analysis of 3‐year clinical outcomes and included 372 patients who were prospectively enrolled and randomly assigned to O‐SES (n = 250) and R‐ZES (n = 122) groups in a 2:1 ratio. The primary endpoint was target lesion failure defined as a composite of cardiac death, nonfatal myocardial infarction, and target lesion revascularization. At 3 years, target lesion failure occurred in 4.7% and 7.8% of O‐SES and R‐ZES groups, respectively (hazard ratio, 0.58; 95% confidence intervals, 0.24–1.41; p = .232 by log‐rank test). Secondary endpoints including cardiac death, myocardial infarction, and target lesion revascularization showed no significant differences between the groups. Stent thrombosis occurred in two patients in R‐ZES group (0.0% vs. 1.6%, p = .040). CONCLUSION: This study confirms long‐term safety and efficacy of the two stents. We found a trend for lower target lesion failure with O‐SES compared to R‐ZES, although statistically insignificant.