Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
Catheter Lab, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.
JACC Cardiovasc Interv. 2018 Feb 12;11(3):260-272. doi: 10.1016/j.jcin.2017.09.037.
The authors sought to evaluate the safety and effectiveness of the NeoVas bioresorbable scaffold (BRS) compared with metallic drug-eluting stents.
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.
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.
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 < 0.0001; p = 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; 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).
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).
作者旨在评估与金属药物洗脱支架相比，NeoVas 生物可吸收支架（BRS）的安全性和有效性。
BRS 具有改善金属药物洗脱支架的晚期结果的潜力，但一些 BRS 在完全生物吸收之前与设备血栓形成的发生率增加有关。NeoVas 是一种新的聚 L-乳酸 BRS，它从聚 D，L-乳酸涂层中洗脱西罗莫司。
符合条件的患者为单一大隐冠状动脉病变，参考血管直径 2.5 至 3.75 毫米，病变长度≤20 毫米，按 1:1 随机分为 NeoVas BRS 与钴铬依维莫司洗脱支架（CoCr-EES）。所有患者在 1 年时进行血管造影随访。主要终点为血管造影节段晚期丢失（LL），主要次要终点为心绞痛发生率。在预先指定的患者亚组中进行基线和随访光学相干断层扫描和血流储备分数。
作者在 32 个中心随机分配 560 名患者接受 NeoVas（n=278）或 CoCr-EES（n=282）治疗。NeoVas 和 CoCr-EES 的 1 年节段 LL 分别为 0.14±0.36 毫米和 0.11±0.34 毫米（差值 0.03 毫米；上 1 侧 97.5%置信区间 0.09 毫米；p<0.0001；p=0.36）。两组 1 年临床结局相似，复发性心绞痛发生率也相似（27.9% vs. 32.1%；p=0.26）。1 年时的光学相干断层扫描显示，NeoVas 组的覆盖支架比例更高（98.7% vs. 96.2%；p<0.001），支架贴壁不良更少（0% vs. 0.6%；p<0.001），最小管腔面积更小（4.71±1.64 毫米 vs. 6.00±2.15 毫米；p<0.001），而 NeoVas 与 CoCr-EES 之间的血流储备分数无显著差异（0.89±0.08 与 0.91±0.06；p=0.07）。
NeoVas BRS 在 1 年血管造影节段 LL 的主要终点上不劣于 CoCr-EES，并且导致 1 年临床结局相当，包括复发性心绞痛。（NeoVas 生物可吸收冠状动脉支架随机对照试验；NCT02305485）。
