Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable‐Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularization: 2‐Year Results of the BIOSCIENCE Trial

Abstract

Background No data are available on the long‐term performance of ultrathin strut biodegradable polymer sirolimus‐eluting stents ( BP ‐ SES ). We reported 2‐year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP ‐ SES with durable‐polymer everolimus‐eluting stents ( DP ‐ EES ) in patients undergoing percutaneous coronary intervention. Methods and Results A total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP ‐ SES (n=1063) or DP ‐ EES (n=1056). Follow‐up at 2 years was available for 2048 patients (97%). The primary end point was target‐lesion failure, a composite of cardiac death, target‐vessel myocardial infarction, or clinically indicated target‐lesion revascularization. At 2 years, target‐lesion failure occurred in 107 patients (10.5%) in the BP ‐ SES arm and 107 patients (10.4%) in the DP ‐ EES arm (risk ratio [ RR ] 1.00, 95% CI 0.77–1.31, P =0.979). There were no significant differences between BP ‐ SES and DP ‐ EES with respect to cardiac death ( RR 1.01, 95% CI 0.62–1.63, P =0.984), target‐vessel myocardial infarction ( RR 0.91, 95% CI 0.60–1.39, P =0.669), target‐lesion revascularization ( RR 1.17, 95% CI 0.81–1.71, P =0.403), and definite stent thrombosis ( RR 1.38, 95% CI 0.56–3.44, P =0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP ‐ SES arm and 4 cases (0.4%) in the DP ‐ EES arm ( P =0.423). In the prespecified subgroup of patients with ST ‐segment elevation myocardial infarction, BP ‐ SES was associated with a lower risk of target‐lesion failure compared with DP ‐ EES ( RR 0.48, 95% CI 0.23–0.99, P =0.043, P interaction =0.026). Conclusions Comparable safety and efficacy profiles of BP ‐ SES and DP ‐ EES were maintained throughout 2 years of follow‐up. Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique identifier: NCT 01443104.