Thinner Strut Sirolimus-Eluting BRS Versus EES in Patients With Coronary Artery Disease: FUTURE-II Trial
Lei Song, Bo Xu, Yundai Chen, Yujie Zhou, Shaobin Jia, Zhixiong Zhong, Xi Su, Yitong Ma, Qi Zhang, Jian Liu, Yang Wang, Changdong Guan, Ming Zheng, Shubin Qiao, Runlin Gao, FUTURE-II Trial Investigators, Lei Song, Bo Xu, Yundai Chen, Yujie Zhou, Shaobin Jia, Zhixiong Zhong, Xi Su, Yitong Ma, Qi Zhang, Jian Liu, Yang Wang, Changdong Guan, Ming Zheng, Shubin Qiao, Runlin Gao, FUTURE-II Trial Investigators
Abstract
Objectives: The aim of the present study was to evaluate the safety and efficacy of thinner strut Firesorb (100/125 μm) sirolimus-eluting bioresorbable scaffolds (BRS) versus cobalt-chromium everolimus-eluting stents (CoCr-EES) in patients with coronary artery disease.
Background: First-generation thicker strut BRS were associated with unexpected device-related adverse outcomes at long-term follow-up.
Methods: Eligible patients with 1 or 2 de novo noncomplex coronary lesions were randomized to the Firesorb BRS group or CoCr-EES group in a 1:1 ratio. The primary endpoint was 1-year angiographic in-segment late loss (LL), powered for noninferiority testing. The key secondary endpoint was the 1-year proportion of covered struts assessed on optical coherence tomography, powered for noninferiority and subsequent superiority testing.
Results: A total of 433 participants from 28 Chinese centers were randomized to the Firesorb BRS group (n = 215) or CoCr-EES group (n = 218). Patient-level 1-year in-segment LL was 0.17 ± 0.27 mm in the Firesorb BRS group and 0.18 ± 0.37 mm in the CoCr-EES group (difference -0.01 mm; 95% confidence interval [CI]: -0.07 to 0.06; pnoninferiority < 0.0001) in the intention-to-treat population and was 0.17 ± 0.27 mm in the Firesorb BRS group and 0.19 ± 0.37 mm in the CoCr-EES group (difference -0.005 mm; 95% CI: -0.07 to 0.06; pnoninferiority < 0.0001) in the per-protocol set. The proportion of covered struts was 99.3% in the Firesorb BRS group and 98.8% in the CoCr-EES group (difference 0.8%; 95% CI: -0.5% to 2.1%; pnoninferiority < 0.0001; psuperiority = 0.21). One-year clinical outcomes were similar between groups.
Conclusions: The thinner strut Firesorb BRS was noninferior to the CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL and the key secondary endpoint of 1-year proportion of covered struts by optical coherence tomography. (A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II [FUTURE-II]; NCT02890160).
Keywords: bioresorbable scaffold; coronary artery disease; optical coherence tomography; percutaneous coronary intervention.
Conflict of interest statement
Funding Support and Author Disclosures The FUTURE-II study was sponsored and funded by MicroPort Medical (Group). Dr. Zheng is an employee of MicroPort. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed