药物支架置入后双联与单用抗血小板疗效的对比研究

A Comparative Study of Curative Effect of Dual and Simple Antiplatelet Therapy after Implantation of Drug-Eluting Stents

目的评估接受药物洗脱支架(DES)治疗患者,持续双联抗血小板超过1年的潜在效益及风险。方法选择玉林市第二人民医院2005～2011年380例接受DES治疗的患者,随机分为两组,一组接受氯吡格雷+阿司匹林治疗,另一组单服阿司匹林;两组中患者至少12个月内未出现心或脑的主要不良反应事件以及严重出血;主要终点效应是心肌梗死或心源性死亡。结果双联抗血小板治疗持续2年的主要事件累积风险为1.8%,而单独使用阿司匹林组为1.2%(HR=1.65,95%CI为0.8～3.36,P=0.17)。两组在以下几方面的风险没有显著差异:心肌梗死、卒中、支架栓塞、再次血运重建、严重出血、全因死亡。结论在减少心肌梗死或心源性死亡发生率方面,接受药物支架置入患者持续双联抗血小板治疗12个月并不比单独使用阿司匹林者更有效。

Objective To explore the potential benefits and risks of dual antiplatelet therapy exceeding 12-month in patients receiving drug-eluting stents. Methods All 380 patients d with rug eluting stents from 2005 to 201l in our hospital were ran- domly assigned two groups. Group A received the treatment of clopidogrel and aspirin, while Group B received aspirin alone. All patients had been free of major adverse cardiac or eerebrovascular events and major bleeding for a period of at least 12 months. The primary endpoint events were a composite of myocardial infarction or death from cardiac causes. Results The cumulative risk of the primary outcome at 2 years was 1.8% with dual antiplatelet therapy,as compared with 1.2% with aspirin monotherapy （hazard ratio t. 65 ;95 % confidence interval （CI：0.80 to 3.36;P = 0. 17 ）. The individual risks of myocardial infarction, stroke, stent thrombosis, need for repeat revascularization, major bleeding, and death from any cause did not differ significantly between the two groups. Conclusion The use of dual antiplatelet therapy for a period longer than 12 months in patients who had received drug-eluting stents is not significantly more effective than aspirin monotherapy in reducing the rate of myocardial infarction or death from cardiac causes.