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佐他莫司洗脱 Endeavor 支架的药理学与临床试验项目概述

Overview of pharmacology and clinical trials program with the zotarolimus-eluting endeavor stent.

作者信息

Kandzari David E, Leon Martin B

机构信息

Duke Clinical Research Institute, Durham, North Carolina 27705, USA.

出版信息

J Interv Cardiol. 2006 Oct;19(5):405-13. doi: 10.1111/j.1540-8183.2006.00184.x.

DOI:10.1111/j.1540-8183.2006.00184.x
PMID:17020565
Abstract

Despite considerable benefits associated with current drug-eluting stents (DES), continued attention to the safety, efficacy, and deliverability of first-generation DES has led to the development of new antiproliferative agents with alternative stent platforms and different drug carrier systems. Zotarolimus is a recently developed pharmacologic agent with both antiproliferative and anti-inflammatory properties. The Endeavor drug-eluting stent (Medtronic Vascular, Santa Rosa, CA) represents the combination of zotarolimus, a low-profile cobalt alloy stent platform, and a biocompatible phosphorylcholine drug carrier system. At present, four clinical trials examining the safety and efficacy of the Endeavor stent have been performed. Although these studies have enrolled patients with similar clinical and angiographic characteristics, they have differed in trial design and study population size and have been performed across a broad geographic and physician distribution. Despite these differences, the results of these trials demonstrate consistently low rates of angiographic restenosis and repeat revascularization in addition to a favorable safety profile, with no occurrences of late stent thrombosis through 1 year of follow-up. This review describes the pharmacology and design on the Endeavor stent, summarizes results from recent clinical trials evaluating the Endeavor stent, and provides an overview of ongoing and future directions for clinical investigation.

摘要

尽管当前药物洗脱支架(DES)具有诸多益处,但对第一代DES安全性、有效性及可输送性的持续关注促使人们研发出了具有不同支架平台和药物载体系统的新型抗增殖药物。佐他莫司是一种最近研发出的兼具抗增殖和抗炎特性的药物。安进药物洗脱支架(美敦力血管公司,加利福尼亚州圣罗莎)代表了佐他莫司、低轮廓钴合金支架平台以及生物相容性磷酸胆碱药物载体系统的结合。目前,已开展了四项关于安进支架安全性和有效性的临床试验。尽管这些研究纳入了临床和血管造影特征相似的患者,但在试验设计、研究人群规模方面存在差异,且在广泛的地理区域和医生群体中进行。尽管存在这些差异,但这些试验结果一致显示,血管造影再狭窄和再次血管重建发生率较低,安全性良好,随访1年未发生晚期支架血栓形成。本综述描述了安进支架的药理学和设计,总结了近期评估安进支架的临床试验结果,并概述了正在进行的和未来临床研究的方向。

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