A Randomized Trial Comparing the NeoVas Sirolimus-Eluting Bioresorbable Scaffold and Metallic Everolimus-Eluting Stents
Yaling Han, Bo Xu, Guosheng Fu, Xiaozeng Wang, Kai Xu, Chongying Jin, Ling Tao, Lang Li, Yuqing Hou, Xi Su, Quan Fang, Lianglong Chen, Huiliang Liu, Bin Wang, Zuyi Yuan, Chuanyu Gao, Shenghua Zhou, Zhongwei Sun, Yanyan Zhao, Changdong Guan, Gregg W Stone, NeoVas Randomized Controlled Trial Investigators, Yaling Han, Bo Xu, Guosheng Fu, Xiaozeng Wang, Kai Xu, Chongying Jin, Ling Tao, Lang Li, Yuqing Hou, Xi Su, Quan Fang, Lianglong Chen, Huiliang Liu, Bin Wang, Zuyi Yuan, Chuanyu Gao, Shenghua Zhou, Zhongwei Sun, Yanyan Zhao, Changdong Guan, Gregg W Stone, NeoVas Randomized Controlled Trial Investigators
Abstract
Objectives: The authors sought to evaluate the safety and effectiveness of the NeoVas bioresorbable scaffold (BRS) compared with metallic drug-eluting stents.
Background: BRS have the potential to improve very late outcomes compared with metallic drug-eluting stents, but some BRS have been associated with increased rates of device thrombosis before complete bioresorption. NeoVas is a new poly-l-lactic acid BRS that elutes sirolimus from a poly-D, l-lactide coating.
Methods: Eligible patients with a single de novo native coronary artery lesion with a reference vessel diameter 2.5 to 3.75 mm and a lesion length ≤20 mm were randomized 1:1 to NeoVas BRS versus cobalt-chromium everolimus-eluting stents (CoCr-EES). Angiographic follow-up was performed in all patients at 1 year. The primary endpoint was angiographic in-segment late loss (LL), and the major secondary endpoint was the rate of angina. Baseline and follow-up optical coherence tomography and fractional flow reserve were performed in a pre-specified subgroup of patients.
Results: The authors randomized 560 patients at 32 centers to treatment with NeoVas (n = 278) versus CoCr-EES (n = 282). One-year in-segment LL with NeoVas and CoCr-EES were 0.14 ± 0.36 mm versus 0.11 ± 0.34 mm (difference 0.03 mm; upper 1-sided 97.5% confidence interval 0.09 mm; pnoninferiority < 0.0001; psuperiority = 0.36). Clinical outcomes at 1 year were similar in the 2 groups, as were the rates of recurrent angina (27.9% vs. 32.1%; p = 0.26). Optical coherence tomography at 1 year demonstrated a higher proportion of covered struts (98.7% vs. 96.2%; p < 0.001), less strut malapposition (0% vs. 0.6%; p <0.001), and a smaller minimal lumen area (4.71 ± 1.64 vs. 6.00 ± 2.15 mm2; p < 0.001) with NeoVas compared with CoCr-EES respectively, with nonsignificant differences in fractional flow reserve (0.89 ± 0.08 vs. 0.91 ± 0.06; p = 0.07).
Conclusions: The NeoVas BRS was noninferior to CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL, and resulted in comparable 1-year clinical outcomes, including recurrent angina. (NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial; NCT02305485).
Keywords: bioresorbable scaffolds; drug-eluting stent(s); randomized controlled trial.
Copyright © 2018. Published by Elsevier Inc.
Source: PubMed