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依维莫司洗脱支架与紫杉醇洗脱支架治疗小血管冠状动脉疾病的对比:来自 SPIRIT II 和 SPIRIT III 试验的汇总分析。

An everolimus-eluting stent versus a paclitaxel-eluting stent in small vessel coronary artery disease: a pooled analysis from the SPIRIT II and SPIRIT III trials.

机构信息

Centro Cardiologico Monzino, Istituto di Ricovero e Cura a Carattere Scientifico and Department of Cardiovascular Sciences, University of Milan, Monzino Via Parea 4, Milan, Italy.

出版信息

Catheter Cardiovasc Interv. 2010 Jul 1;76(1):60-6. doi: 10.1002/ccd.22452.

Abstract

OBJECTIVES

To evaluate the safety and efficacy of the XIENCE V everolimus-eluting stent compared to the TAXUS paclitaxel-eluting stent in small vessels.

BACKGROUND

The XIENCE V everolimus-eluting stent (EES) has been shown to improve angiographic and clinical outcomes after percutaneous myocardial revascularization, but its performance in small coronary arteries has not been investigated.

METHODS

In this pooled analysis, we studied a cohort of 541 patients with small coronary vessels (reference diameter <2.765 mm) by using patient and lesion level data from the SPIRIT II and SPIRIT III studies. TAXUS Express (73% of lesions) and TAXUS Liberté (27% of lesions) paclitaxel-eluting stents (PES) were used as controls in SPIRIT II. In SPIRIT III, Taxus Express(2) PES was the control.

RESULTS

Mean angiographic in-stent and in-segment late loss was significantly less in the EES group compared with the PES group, (0.15 +/- 0.37 mm vs. 0.30 +/- 0.44 mm; P = 0.011 for in-stent; 0.10 +/- 0.38 mm vs. 0.21 +/- 0.34 mm; P = 0.034 for in-segment). EES also resulted in a significant reduction in composite major adverse cardiac events at 1 year (19/366 [5.2%] vs. 17/159 [10.7%]; P = 0.037), due to fewer non-Q-wave myocardial infarctions and target lesion revascularizations. At 1 year, the rate of non-Q-wave myocardial infarction was significantly lower in the EES group compared with that of the PES group (6/366 [1.6%] vs. 8/159 [5.0%]; P = 0.037).

CONCLUSIONS

In patients with small vessel coronary arteries, the XIENCE V EES was superior to the TAXUS PES.

摘要

目的

评估依维莫司洗脱支架(XIENCE V EES)与紫杉醇洗脱支架(TAXUS PES)在小血管中的安全性和疗效。

背景

依维莫司洗脱支架(EES)已被证明可改善经皮冠状动脉血运重建后的血管造影和临床结果,但尚未研究其在小冠状动脉中的性能。

方法

在这项汇总分析中,我们使用 SPIRIT II 和 SPIRIT III 研究的患者和病变水平数据,对 541 例小冠状动脉(参考直径 <2.765 毫米)患者进行了研究。SPIRIT II 中,TAXUS Express(73%的病变)和 TAXUS Liberté(27%的病变)紫杉醇洗脱支架(PES)作为对照。在 SPIRIT III 中,Taxus Express(2) PES 为对照。

结果

EES 组的支架内和节段内晚期管腔丢失明显低于 PES 组,(0.15 +/- 0.37 毫米比 0.30 +/- 0.44 毫米;支架内,P = 0.011;0.10 +/- 0.38 毫米比 0.21 +/- 0.34 毫米;节段内,P = 0.034)。EES 还显著降低了 1 年时的复合主要不良心脏事件(19/366 [5.2%] vs. 17/159 [10.7%];P = 0.037),这归因于非 Q 波心肌梗死和靶病变血运重建的减少。1 年时,EES 组非 Q 波心肌梗死发生率明显低于 PES 组(6/366 [1.6%] vs. 8/159 [5.0%];P = 0.037)。

结论

在小血管冠状动脉患者中,依维莫司洗脱支架(XIENCE V EES)优于紫杉醇洗脱支架(TAXUS PES)。

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