Five-Year Outcomes in Patients With Diabetes Mellitus Treated With Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents

Background The choice of optimal drug‐eluting stent therapy for patients with diabetes mellitus ( DM ) undergoing percutaneous coronary intervention remains uncertain. We aimed to assess the long‐term clinical outcomes after percutaneous coronary intervention with biodegradable polymer sirolimus‐eluting stents ( BP ‐ SES ) versus durable polymer everolimus‐eluting stents ( DP ‐ EES ) in patients with DM . Methods and Results In a prespecified subgroup analysis of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularization) trial ( NCT 01443104), patients randomly assigned to ultrathin‐strut BP ‐ SES or thin‐strut DP ‐ EES were stratified according to diabetic status. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, at 5 years. Among 2119 patients, 486 (22.9%) presented with DM . Compared with individuals without DM, patients with DM were older and had a greater baseline cardiac risk profile. In patients with DM, target lesion failure at 5 years occurred in 74 patients (cumulative incidence, 31.0%) treated with BP ‐ SES and 57 patients (25.8%) treated with DP ‐ EES (risk ratio, 1.23; 95% CI , 0.87–1.73 [ P =0.24]). In individuals without DM, target lesion failure at 5 years occurred in 124 patients (16.8%) treated with BP ‐ SES and 132 patients (16.8%) treated with DP ‐ EES (risk ratio, 0.98; 95% CI, 0.77–1.26 [ P =0.90; P for interaction=0.31]). Cumulative 5‐year incidence rates of cardiac death, target vessel myocardial infarction, clinically indicated target lesion revascularization, and definite stent thrombosis were similar among patients with DM treated with BP ‐ SES or DP ‐ EES . There was no interaction between diabetic status and treatment effect of BP ‐ SES versus DP ‐ EES . Conclusions In a prespecified subgroup analysis of the BIOSCIENCE trial, we found no difference in clinical outcomes throughout 5 years between patients with DM treated with ultrathin‐strut BP ‐ SES or thin‐strut DP ‐ EES . Clinical Trial Registration URL : https://www.clinicaltrials.gov/ . Unique identifier: NCT 01443104.