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用于治疗冠状动脉疾病的生物可吸收血管支架:随机对照试验的临床结果。

Bioresorbable vascular scaffolds for the treatment of coronary artery disease: Clinical outcomes from randomized controlled trials.

作者信息

Rizik David G, Hermiller James B, Kereiakes Dean J

机构信息

Director of Structural and Coronary Intervention, HonorHealth and the Scottsdale-Lincoln Health Network, Scottsdale, Arizona.

Director of Interventional Cardiology and Director of Interventional Cardiology Fellowship, St. Vincent Heart Center of Indiana, Indianapolis, Indiana.

出版信息

Catheter Cardiovasc Interv. 2016 Nov;88(S1):21-30. doi: 10.1002/ccd.26810.

Abstract

The permanent metal prosthesis common to bare metal stents (BMS) as well as both first- and second-generation drug-eluting stents (DES) following treatment of coronary artery disease represents a long-lasting substrate for late adverse coronary events including restenosis, thrombosis, and neoatherosclerosis. Following resorbtion, bioresorbable scaffolds (BRS) may eliminate this nidus and improve late outcomes through restoration of the vessel to more normal vascular structure and function. BRS represents a single platform which incorporates the mechanical features of metallic stents to provide safe and effective revascularization, suppression of restenosis and prevention of constrictive remodeling with long-term restoration of the treated vessel to a more natural state. The landscape of BRS is rapidly evolving with new materials which target various performance goals for the duration of vascular support and polymer resorption time. The Absorb bioresorbable vascular scaffold (Absorb BVS), recently approved by United States Food and Drug Administration, has extensive clinical evidence to date in support of its clinical efficacy and safety. Recently published data from well-executed randomized clinical trials (RCTs) as part of the ABSORB Clinical development program along with other investigator-initiated trials provide insights into the safety and performance of this device in patients with de novo coronary lesions as well in the setting of ST-segment elevation myocardial infarction (STEMI). This review provides a comprehensive, outcomes based understanding of the available evidence from RCTs that offer head-to-head comparisons of Absorb BVS with metallic everolimus-eluting stents (EES). © 2016 Wiley Periodicals, Inc.

摘要

在冠状动脉疾病治疗后,裸金属支架(BMS)以及第一代和第二代药物洗脱支架(DES)所共有的永久性金属假体是包括再狭窄、血栓形成和新生动脉粥样硬化在内的晚期不良冠状动脉事件的长期底物。在吸收后,生物可吸收支架(BRS)可以消除这个病灶,并通过使血管恢复到更正常的血管结构和功能来改善晚期结果。BRS代表了一个单一平台,它融合了金属支架的机械特性,以提供安全有效的血管再通,抑制再狭窄,并防止狭窄性重塑,同时使治疗后的血管长期恢复到更自然的状态。随着针对血管支撑持续时间和聚合物吸收时间的各种性能目标的新材料的出现,BRS的格局正在迅速演变。美国食品药品监督管理局最近批准的Absorb生物可吸收血管支架(Absorb BVS),迄今为止有广泛的临床证据支持其临床疗效和安全性。作为ABSORB临床开发项目一部分的精心设计的随机临床试验(RCT)以及其他研究者发起的试验最近发表的数据,为该装置在初发冠状动脉病变患者以及ST段抬高型心肌梗死(STEMI)患者中的安全性和性能提供了见解。这篇综述基于结果全面理解了RCTs中现有证据,这些证据提供了Absorb BVS与金属依维莫司洗脱支架(EES)的直接对比。© 2016威利期刊公司

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