Comparison of the Ultrathin Strut, Biodegradable Polymer Sirolimus-eluting Stent With a Durable Polymer Everolimus-eluting Stent in a Chinese Population: The Randomized BIOFLOW VI Trial

Abstract

PurposeThe BIOFLOW-VI (Biotronik–Safety and Clinical Performance of the Drug Eluting Orsiro Stent in the Treatment of Subjects With De Novo Coronary Artery Lesions–VI) study evaluates the angiographic efficacy, clinical safety, and effectiveness of the ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES) compared with a durable polymer everolimus-eluting stent (DP-EES). This randomized controlled clinical trial was designed to enable approval of new drug-eluting stents in China. MethodsA total of 440 eligible patients from 11 sites with up to 2 de novo native coronary artery lesions were randomly assigned to receive either BP-SES (n = 220) or DP-EES (n = 220) from July 2014 to September 2016 in this prospective, multicenter, noninferiority trial. FindingsThe primary end point of 9-month in-stent late lumen loss (LLL) was 0.05 (0.02) mm in the BP-SES group versus 0.07 (0.02) mm in the DP-EES group, with a mean difference of −0.02 mm (95% CI, −0.06 to 0.03; P = 0.44; Pnoninferiority < 0.0001). At 1 year, the target lesion failure rate (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) was similar between the 2 groups (BP-SES 2.3% vs DP-EES 1.4%; P = 0.50). No definite or probable stent thrombosis had occurred in any of the 2 treatment arms. ImplicationsThe randomized BIOFLOW-VI trial showed that BP-SES was noninferior to DP-EES with regard to the primary end point of 9-month in-stent LLL in a Chinese population. ClinicalTrials.gov Identifier: NCT02870985