论文部分内容阅读
背景药物洗脱支架后的病人使用>12个月的双抗血小板治疗的潜在益处或风险尚未得到确定。方法通过2项试验,将使用了药物洗脱支架且无严重负性心脏或脑血管事件和严重出血的2 701例病人随机分组:用氯吡格雷+阿司匹林或仅用阿司匹林,至少12个月。主要终点是心肌梗死和心源性死亡。对2项试验合并数据进行分析。结果跟踪中位时间为19.2个月。主要结果2年累计风险,双抗血小板疗法1.8%,而阿司匹林单药疗法为1.2%[HR 1.65,95%CI(0.80,3.36),P=0.17]。心肌梗死、脑卒中、支架血栓、需血管再通术、严重出血和全因死亡个体风险,两组无显著差异。然而,与仅用阿司匹林组比较,双治疗组心肌梗死、脑卒中和全因死亡混合风险[HR1.73,95%CI(0.99,3.00),P=0.051]及心肌梗死、脑卒中或医源性死亡混合风险[HR1.84,95%CI(0.99,3.45),P=0.06]未见显著增加。结论用药物洗脱支架病人,就减少心肌梗死率或心源性死亡率而言,>12个月的双抗血小板疗法并不比阿司匹林单药疗法更有效。为了确定或质疑这些发现,还需进行更多、跟踪期更长的随机临床试验。
The potential benefits or risks of using antiplatelet therapy> 12 months after background drug-eluting stents have not yet been determined. Methods Two hundred and seventy-one patients randomized to drug-eluting stents without serious negative cardiac or cerebrovascular events and severe bleeding were randomized in two trials: clopidogrel + aspirin or aspirin alone for at least 12 months. The primary endpoint was myocardial infarction and cardiac death. Analyze the combined data of two experiments. The median follow-up time was 19.2 months. The primary outcome was a 2-year cumulative risk with 1.8% dual antiplatelet therapy versus 1.2% for aspirin monotherapy (HR 1.65, 95% CI 0.80, 3.36, P 0.17). Myocardial infarction, stroke, stent thrombosis, need for revascularization, severe bleeding and all-cause mortality risk, no significant difference between the two groups. However, the risk of MI, stroke and all-cause death in the dual-treatment group was significantly higher than that in the aspirin-only group (HR 1.73, 95% CI 0.99, 3.00, P 0.05 1) and myocardial infarction, stroke, or iatrogenic There was no significant increase in the risk of sexual death [HR 1.84, 95% CI (0.99, 3.45), P = 0.06]. Conclusions Patients with drug-eluting stents are not more effective than aspirin monotherapy in double-antiplatelet therapy> 12 months in terms of reducing myocardial infarction or cardiac mortality. In order to identify or question these findings, more randomized clinical trials with longer follow-up periods are needed.