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冠状动脉支架置入术与冠状动脉搭桥术治疗多支血管病变的五年疗效:动脉血运重建治疗研究(ARTS)随机试验的最终分析

Five-year outcomes after coronary stenting versus bypass surgery for the treatment of multivessel disease: the final analysis of the Arterial Revascularization Therapies Study (ARTS) randomized trial.

作者信息

Serruys Patrick W, Ong Andrew T L, van Herwerden Lex A, Sousa J Eduardo, Jatene Adib, Bonnier Johannes J R M, Schönberger Jacques P M A, Buller Nigel, Bonser Robert, Disco Clemens, Backx Bianca, Hugenholtz Paul G, Firth Brian G, Unger Felix

机构信息

Interventional Cardiology Department, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.

出版信息

J Am Coll Cardiol. 2005 Aug 16;46(4):575-81. doi: 10.1016/j.jacc.2004.12.082.

Abstract

OBJECTIVES

The long-term (five-year) comparative results of treatment of multivessel coronary artery disease with stenting or coronary artery bypass grafting (CABG) is at present unknown.

BACKGROUND

The Arterial Revascularization Therapies Study (ARTS) was designed to compare CABG and stenting in patients with multivessel disease.

METHODS

A total of 1,205 patients with the potential for equivalent revascularization were randomly assigned to CABG (n = 605) or stent implantation (n = 600). The primary clinical end point was freedom from major adverse cardiac and cerebrovascular events (MACCE) at one year; MACCE at five-year follow-up constituted the final secondary end point.

RESULTS

At five years, there were 48 and 46 deaths in the stent and CABG groups, respectively (8.0% vs. 7.6%; p = 0.83; relative risk [RR], 1.05; 95% confidence interval [CI], 0.71 to 1.55). Among 208 diabetic patients, mortality was 13.4% in the stent group and 8.3% in the CABG group (p = 0.27; RR, 1.61; 95% CI, 0.71 to 3.63). Overall freedom from death, stroke, or myocardial infarction was not significantly different between groups (18.2% in the stent group vs. 14.9% in the surgical group; p = 0.14; RR, 1.22; 95% CI, 0.95 to 1.58). The incidence of repeat revascularization was significantly higher in the stent group (30.3%) than in the CABG group (8.8%; p < 0.001; RR, 3.46; 95% CI, 2.61 to 4.60). The composite event-free survival rate was 58.3% in the stent group and 78.2% in the CABG group (p < 0.0001; RR, 1.91; 95% CI, 1.60 to 2.28).

CONCLUSIONS

At five years there was no difference in mortality between stenting and surgery for multivessel disease. Furthermore, the incidence of stroke or myocardial infarction was not significantly different between the two groups. However, overall MACCE was higher in the stent group, driven by the increased need for repeat revascularization.

摘要

目的

目前尚不清楚多支冠状动脉疾病采用支架置入术或冠状动脉旁路移植术(CABG)治疗的长期(五年)比较结果。

背景

动脉血运重建治疗研究(ARTS)旨在比较多支血管疾病患者的CABG和支架置入术。

方法

总共1205例具有同等血运重建可能性的患者被随机分配至CABG组(n = 605)或支架植入组(n = 600)。主要临床终点是一年时无主要不良心脑血管事件(MACCE);五年随访时的MACCE构成最终次要终点。

结果

五年时,支架组和CABG组分别有48例和46例死亡(8.0% 对7.6%;p = 0.83;相对风险[RR],1.05;95%置信区间[CI],0.71至1.55)。在208例糖尿病患者中,支架组死亡率为13.4%,CABG组为8.3%(p = 0.27;RR,1.61;95% CI,0.71至3.63)。两组间总体无死亡、卒中或心肌梗死情况无显著差异(支架组为18.2%,手术组为14.9%;p = 0.14;RR,1.22;95% CI,0.95至1.58)。支架组再次血运重建的发生率显著高于CABG组(30.3% 对8.8%;p < 0.001;RR,3.46;95% CI,2.61至4.60)。支架组复合无事件生存率为58.3%,CABG组为78.2%(p < 0.0001;RR,1.91;95% CI,1.60至2.28)。

结论

五年时,多支血管疾病的支架置入术和手术治疗在死亡率方面无差异。此外,两组间卒中或心肌梗死的发生率无显著差异。然而,由于再次血运重建需求增加,支架组总体MACCE更高。

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