Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable -Polymer Everolimus-Eluting Stents for Coronary Revascularization 3-Year Outcomes From the Randomized BIOFLOW V Trial

OBJECTIVES The aim of this study was to compare late-term clinical outcomes among patients treated with ultrathin- strut (60- mm) bioresorbable-polymer sirolimus-eluting stents (BP SES) and thin-strut (81 mm) durable-polymer everoli- mus-eluting stents (DP EES). BACKGROUND Emerging evidence from comparative studies of drug-eluting stents demonstrates improved safety and ef ficacy with ultrathin-strut drug-eluting stents, but limited insight exists regarding late-term outcomes. METHODS BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With Up to Three De Novo or Restenotic Coronary Artery Lesions V) is an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure. Analysis of pre-speci fied 3-year clinical outcomes was performed. Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 3-year rate of target lesion failure was 8.2% for BP SES and 13.6% for DP EES (p = 0.002), driven by differences in both target vessel myocardial infarction (MI) (5.0% vs. 9.2%; p = 0.003) and clinically driven target lesion revascularization (3.2% vs. 6.7%; p = 0.006). In landmark analysis, signi ficant differences in target vessel MI and target lesion revascularization were observed favoring treatment with BP SES. De finite or probable late or very late stent thrombosis was signi ficantly lower with BP SES (0.1% vs. 1.2%; p = 0.018). Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively. CONCLUSIONS In a large randomized trial, both target lesion failure and the outcomes of target vessel MI, clinically driven target lesion revascularization, and late or very late stent thrombosis at 3 years were signi ficantly lower among patients treated with BP SES versus DP EES. The results endorse the continued superiority of ultrathin-strut BP SES compared with DP EES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946) (J Am Coll Cardiol Intv 2020;13:1343-53) (c) 2020 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).