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血管大小对西罗莫司洗脱支架和紫杉醇洗脱支架植入术后预后的影响:SIRTAX试验的亚组分析

Impact of vessel size on outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents: a subgroup analysis of the SIRTAX trial.

作者信息

Togni Mario, Eber Stéphanie, Widmer Jeannette, Billinger Michael, Wenaweser Peter, Cook Stéphane, Vogel Rolf, Seiler Christian, Eberli Franz R, Maier Willibald, Corti Roberto, Roffi Marco, Lüscher Thomas F, Garachemani Ali, Hess Otto M, Wandel Simon, Meier Bernhard, Jüni Peter, Windecker Stephan

机构信息

Department of Cardiology, University Hospital Bern, Switzerland.

出版信息

J Am Coll Cardiol. 2007 Sep 18;50(12):1123-31. doi: 10.1016/j.jacc.2007.06.015. Epub 2007 Sep 4.

DOI:10.1016/j.jacc.2007.06.015
PMID:17868802
Abstract

OBJECTIVES

We assessed the impact of vessel size on angiographic and long-term clinical outcome after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) within a randomized trial (SIRTAX [Sirolimus-Eluting Stent Compared With Paclitaxel-Eluting Stent for Coronary Revascularization]).

BACKGROUND

Percutaneous coronary intervention in small-vessel disease is associated with an increased risk of major adverse cardiac events (MACE).

METHODS

A total of 1,012 patients were randomly assigned to treatment with SES (n = 503) or PES (n = 509). A stratified analysis of angiographic and clinical outcome was performed up to 2 years after PCI according to size of the treated vessel (reference vessel diameter < or =2.75 vs. >2.75 mm).

RESULTS

Of 1,012 patients, 370 patients (37%) with 495 lesions underwent stent implantation in small vessels only, 504 patients (50%) with 613 lesions in large vessels only, and 138 patients (14%) with 301 lesions in both small and large vessels (mixed). In patients with small-vessel stents, SES reduced MACE by 55% (10.4% vs. 21.4%; p = 0.004), mainly driven by a 69% reduction of target lesion revascularization (TLR) (6.0% vs. 17.7%; p = 0.001) compared with PES at 2 years. In patients with large- and mixed-vessel stents, rates of MACE (large: 10.4% vs. 13.1%; p = 0.33; mixed: 16.7% vs. 18.0%; p = 0.83) and TLR (large: 6.9% vs. 8.6%; p = 0.47; mixed: 16.7% vs. 15.4%; p = 0.86) were similar for SES and PES. There were no significant differences with respect to death and myocardial infarction between the 3 groups.

CONCLUSIONS

Compared with PES, SES more effectively reduced MACE and TLR in small-vessel disease. Differences between SES and PES appear less pronounced in patients with large- and mixed-vessel disease. (The SIRTAX trial; http://clinicaltrials.gov/ct/show/NCT00297661?order=1; NCT00297661).

摘要

目的

在一项随机试验(SIRTAX[西罗莫司洗脱支架与紫杉醇洗脱支架用于冠状动脉血运重建的比较])中,我们评估了血管大小对使用西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)进行经皮冠状动脉介入治疗(PCI)后血管造影结果和长期临床结局的影响。

背景

小血管疾病的经皮冠状动脉介入治疗与主要不良心脏事件(MACE)风险增加相关。

方法

总共1012例患者被随机分配接受SES治疗(n = 503)或PES治疗(n = 509)。根据治疗血管的大小(参考血管直径≤2.75 vs.>2.75 mm),对PCI后长达2年的血管造影和临床结局进行分层分析。

结果

在1012例患者中,370例患者(37%)的495处病变仅在小血管中进行了支架植入,504例患者(50%)的613处病变仅在大血管中,138例患者(14%)的301处病变在小血管和大血管中均有(混合)。在植入小血管支架的患者中,与PES相比,SES在2年时将MACE降低了55%(10.4%对21.4%;p = 0.004),主要是由于靶病变血运重建(TLR)降低了69%(6.0%对17.7%;p = 0.001)。在植入大血管和混合血管支架的患者中,SES和PES的MACE发生率(大血管:10.4%对13.1%;p = 0.33;混合血管:16.7%对18.0%;p = 0.83)和TLR发生率(大血管:6.9%对8.6%;p = 0.47;混合血管:16.7%对15.4%;p = 0.86)相似。三组之间在死亡和心肌梗死方面无显著差异。

结论

与PES相比,SES在小血管疾病中更有效地降低了MACE和TLR。在大血管和混合血管疾病患者中,SES和PES之间的差异似乎不那么明显。(SIRTAX试验;http://clinicaltrials.gov/ct/show/NCT00297661?order=1;NCT00297661)

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