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在 ENDEAVOR IV 试验中,比较 Endeavor 佐他莫司洗脱支架与 Taxus 紫杉醇洗脱支架在治疗初发原生冠状动脉病变中的 12 个月结果的随机对照研究。

A randomized comparison of the Endeavor zotarolimus-eluting stent versus the TAXUS paclitaxel-eluting stent in de novo native coronary lesions 12-month outcomes from the ENDEAVOR IV trial.

机构信息

Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York, USA.

出版信息

J Am Coll Cardiol. 2010 Feb 9;55(6):543-54. doi: 10.1016/j.jacc.2009.08.067.

Abstract

OBJECTIVES

The ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the zotarolimus-eluting stent (ZES) compared with the paclitaxel-eluting stent (PES).

BACKGROUND

First-generation drug-eluting stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-eluting stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results.

METHODS

This is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization.

RESULTS

Among a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months, ZES was noninferior to PES with rates of target vessel failure 6.6% versus 7.1%, respectively (p(noninferiority) < or = 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in rates of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis. Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs. 10.4%; p = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756).

CONCLUSIONS

These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269).

摘要

目的

ENDEAVOR IV(随机比较冠状动脉疾病患者中使用佐他莫司洗脱支架和紫杉醇洗脱支架的疗效)试验评估了与紫杉醇洗脱支架(PES)相比,佐他莫司洗脱支架(ZES)的安全性和疗效。

背景

第一代药物洗脱支架降低了血管造影和临床再狭窄率,但长期安全性仍存在争议。第二代药物洗脱支架通过在钴合金薄壁支架上使用生物相容性的磷酸胆碱聚合物输送强效抗增殖剂佐他莫司,已显示出有前途的实验和早期临床结果。

方法

这是一项前瞻性、随机(1:1)、单盲、对照试验,比较了接受 ZES 或 PES 治疗的单处初发冠状动脉病变患者的结局。主要终点是 9 个月时非劣效性目标血管失败定义为心脏死亡、心肌梗死或目标血管血运重建。

结果

在总共 1548 名被分配到 ZES(n = 773)或 PES(n = 775)的患者中,在 9 个月时,ZES 与 PES 的非劣效性结果分别为 6.6%和 7.1%(p(非劣效性)≤0.001)。ZES 组围手术期心肌梗死发生率较低(0.5% vs. 2.2%;p = 0.007),而在 12 个月时,两组之间的心脏死亡、心肌梗死、目标血管血运重建或支架血栓形成发生率无显著差异。尽管 ZES 组与 PES 组相比,8 个月时的二元血管造影节段内再狭窄发生率较高(15.3% vs. 10.4%;p = 0.284),但 12 个月时的目标病变血运重建率相似(4.5% vs. 3.2%;p = 0.228),尤其是在没有计划进行血管造影随访的患者中(3.6% vs. 3.2%;p = 0.756)。

结论

这些发现表明,在简单和中等复杂的单处初发冠状动脉病变中,ZES 的临床安全性和疗效与 PES 相似。(ENDEAVOR IV 临床试验;NCT00217269)。

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