Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease ABSORB China Trial
Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease ABSORB China Trial
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DOI：
10.1016/j.jacc.2015.09.054
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发表时间：
2015-12-01
影响因子：
24
通讯作者：
Stone, Gregg W.
中科院分区：
文献类型：
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作者：
Gao, Runlin;Yang, Yuejin;Stone, Gregg W.
背景依维莫司洗脱生物可吸收血管支架（BVS）的设计目的是在一年内达到与金属药物洗脱支架相当的效果，并改善长期结果。 BVS 的 1 年临床和血管造影结果是否不劣于当前一代药物洗脱支架尚未确定。 目的 本研究旨在通过一项随机试验评估 BVS 的血管造影疗效以及临床安全性和有效性，该试验旨在使 BVS 在中国获得批准。 方法 患有 1 或 2 处新发自体冠状动脉病变的合格患者被随机分配至 BVS 或钴铬依维莫司洗脱支架(CoCr-EES) 按 1:1 的比例根据糖尿病和治疗的病变数量进行分层。所有患者计划在一年后进行血管造影和临床随访。主要终点是血管造影节段内晚期丢失 (LL)，以 0.15 mm 的裕度为非劣效性提供动力。 结果 共有 480 名患者在 24 个地点被随机分配（241 名 BVS 与 239 名 CoCr-EES）。 BVS 和 CoCr-EES 治疗的患者的急性临床装置成功率（98.0% 与 99.6%；p = 0.22）和手术成功率（97.0% 和 98.3%；p = 0.37）分别相当。 BVS 1 年时段内 LL 的主要终点为 0.19 +/- 0.38 mm，而 CoCr-EES 为 0.13 +/- 0.38 mm；差异的单侧 97.5% 置信上限为 0.14 mm，与 CoCr-EES 相比，实现了 BVS 的非劣效性（P-非劣效性 = 0.01）。 BVS 和 CoCr-EES 的 1 年靶病变失败率（心源性死亡、靶血管心肌梗死或缺血驱动的靶病变血运重建；分别为 3.4% 与 4.2%；p = 0.62）和明确/可能的支架/支架血栓形成率（分别为 0.4% 与 0.0%；p = 1.00）也相似。 结论试验中，对于 1 年时段内 LL 的主要终点，BVS 不劣于 CoCr-EES。 （Absorb 生物可吸收血管支架 [Absorb BVS] 系统在中国人群中的临床评价 - ABSORB CHINA 随机对照试验 [RCT]；NCT01923740） (C) 2015，美国心脏病学会基金会。
BACKGROUND The everolimus-eluting bioresorbable vascular scaffold (BVS) is designed to achieve results comparable to metallic drug-eluting stents at 1 year, with improved long-term outcomes. Whether the 1-year clinical and angiographic results of BVS are noninferior to current-generation drug-eluting stents has not been established.OBJECTIVES This study sought to evaluate the angiographic efficacy and clinical safety and effectiveness of BVS in a randomized trial designed to enable approval of the BVS in China.METHODS Eligible patients with 1 or 2 de novo native coronary artery lesions were randomized to BVS or cobalt-chromium everolimus-eluting stents (CoCr-EES) in a 1: 1 ratio stratified by diabetes and the number of lesions treated. Angiographic and clinical follow-up were planned at 1 year in all patients. The primary endpoint was angiographic in-segment late loss (LL), powered for noninferiority with a margin of 0.15 mm.RESULTS A total of 480 patients were randomized (241 BVS vs. 239 CoCr-EES) at 24 sites. Acute clinical device success (98.0% vs. 99.6%; p = 0.22) and procedural success (97.0% and 98.3%; p = 0.37) were comparable in BVS- and CoCr-EES-treated patients, respectively. The primary endpoint of in-segment LL at 1 year was 0.19 +/- 0.38 mm for BVS versus 0.13 +/- 0.38 mm for CoCr-EES; the 1-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving noninferiority of BVS compared with CoCr-EES (P-noninferiority = 0.01). BVS and CoCr-EES also had similar 1-year rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization; 3.4% vs. 4.2%, respectively; p = 0.62) and definite/probable scaffold/stent thrombosis (0.4% vs. 0.0%, respectively; p = 1.00).CONCLUSIONS In the present multicenter randomized trial, BVS was noninferior to CoCr-EES for the primary endpoint of in-segment LL at 1 year. (A Clinical Evaluation of Absorb Bioresorbable Vascular Scaffold [Absorb BVS] System in Chinese Population-ABSORB CHINA Randomized Controlled Trial [RCT]; NCT01923740) (C) 2015 by the American College of Cardiology Foundation.