Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
JACC Cardiovasc Interv. 2009 Dec;2(12):1190-8. doi: 10.1016/j.jcin.2009.10.002.
This paper reports the 3-year clinical outcomes of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) compared with the TAXUS (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) in the randomized SPIRIT II (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions) study.
The Xience V EES is a new-generation drug-eluting stent (DES) that might offer advantages over the first-generation DES in terms of improved clinical outcomes and a better safety profile.
The SPIRIT II trial was a multicenter, prospective, randomized, single-blind, clinical trial, randomizing 300 patients with de novo coronary artery lesions in a ratio of 3:1 to either EES or PES. The primary end point was in-stent late loss at 180 days.
At 3-year clinical follow-up cardiac death was numerically lower with EES than PES (0.5% vs. 4.3%, p = 0.056). The observed rate of myocardial infarction was 3.6% for EES and 7.2% for PES (p = 0.31). The rate of ischemia-driven target lesion revascularization was 4.6% and 10.1% for EES and PES, respectively (p = 0.14). Overall, there was a trend for lower major adverse cardiovascular events in the EES group compared with PES (7.2% vs. 15.9%, p = 0.053). The rate of stent thrombosis was low and comparable in both groups (EES 1.0% vs. PES 2.9%).
The present study reports the favorable 3-year clinical outcomes of the EES, which are consistent with the results from other studies of the EES with shorter follow-up.
本文报告了随机 SPIRIT II 研究中，依维莫司洗脱支架（EES）与紫杉醇洗脱支架（PES）在 3 年临床结果的比较。
依维莫司洗脱支架（EES）是一种新一代药物洗脱支架（DES），与第一代 DES 相比，它可能在改善临床结果和更安全的特点方面具有优势。
SPIRIT II 试验是一项多中心、前瞻性、随机、单盲临床试验，将 300 例患有初发冠状动脉病变的患者按 3:1 的比例随机分为 EES 组或 PES 组。主要终点为 180 天的支架内晚期丢失。
在 3 年的临床随访中，EES 组的心脏死亡发生率低于 PES 组（0.5% vs. 4.3%，p=0.056）。EES 组心肌梗死的发生率为 3.6%，PES 组为 7.2%（p=0.31）。缺血驱动的靶病变血运重建率 EES 组和 PES 组分别为 4.6%和 10.1%（p=0.14）。总体而言，EES 组的主要不良心血管事件发生率低于 PES 组（7.2% vs. 15.9%，p=0.053）。支架血栓形成的发生率低且两组相当（EES 1.0% vs. PES 2.9%）。
本研究报告了 EES 的 3 年良好临床结果，与其他 EES 短期随访研究的结果一致。
