A Randomized Trial Comparing the NeoVas Sirolimus-Eluting Bioresorbable Scaffold and Metallic Everolimus-Eluting Stents

作者：Han, Yaling^*; Xu, Bo; Fu, Guosheng; Wang, Xiaozeng; Xu, Kai; Jin, Chongying; Tao, Ling; Li, Lang; Hou, Yuqing; Su, Xi; Fang, Quan; Chen, Lianglong; Liu, Huiliang; Wang, Bin; Yuan, Zuyi; Gao, Chuanyu; Zhou, Shenghua; Sun, Zhongwei; Zhao, Yanyan; Guan, Changdong; Stone, Gregg W.

来源：JACC: Cardiovascular Interventions , 2018, 11(3): 261-272.

DOI：10.1016/j.jcin.2017.09.037

• bioresorbable scaffolds
• drugeluting stent(s)
• randomized controlled trial

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 angio-graphic 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; p(noninferiority) < 0.0001; p(superiority) = 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 mm(2); 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.

• 出版日期2018-2-12
• 单位中国人民解放军沈阳军区总医院