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长期双联抗血小板治疗在既往心肌梗死亚组患者中的心血管事件二级预防作用:随机试验的协作荟萃分析。

Long-term dual antiplatelet therapy for secondary prevention of cardiovascular events in the subgroup of patients with previous myocardial infarction: a collaborative meta-analysis of randomized trials.

机构信息

Peter Munk Cardiac Centre and Cardiovascular Division, University Health Network, Heart and Stroke Richard Lewar Centre of Excellence, University of Toronto, 76 Grenville Street, Toronto, Canada ON M5S 1B1 Women's College Research Institute and Cardiovascular Division, Department of Medicine, Women's College Hospital, University of Toronto, Toronto, Canada

TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.

出版信息

Eur Heart J. 2016 Jan 21;37(4):390-9. doi: 10.1093/eurheartj/ehv443. Epub 2015 Aug 31.

Abstract

AIMS

Recent trials have examined the effect of prolonged dual antiplatelet therapy (DAPT) in a variety of patient populations, with heterogeneous results regarding benefit and safety, specifically with regard to cardiovascular and non-cardiovascular mortality. We performed a meta-analysis of randomized trials comparing more than a year of DAPT with aspirin alone in high-risk patients with a history of prior myocardial infarction (MI).

METHODS AND RESULTS

A total of 33 435 patients were followed over a mean 31 months among one trial of patients with prior MI (63.3% of total) and five trials with a subgroup of patients that presented with, or had a history of, a prior MI (36.7% of total). Extended DAPT decreased the risk of major adverse cardiovascular events compared with aspirin alone (6.4 vs. 7.5%; risk ratio, RR 0.78, 95% confidence intervals, CI, 0.67-0.90; P = 0.001) and reduced cardiovascular death (2.3 vs. 2.6%; RR 0.85, 95% CI 0.74-0.98; P = 0.03), with no increase in non-cardiovascular death (RR 1.03, 95% CI 0.86-1.23; P = 0.76). The resultant effect on all-cause mortality was an RR of 0.92 (95% CI 0.83-1.03; P = 0.13). Extended DAPT also reduced MI (RR 0.70, 95% CI 0.55-0.88; P = 0.003), stroke (RR 0.81, 95% CI 0.68-0.97; P = 0.02), and stent thrombosis (RR 0.50, 95% CI 0.28-0.89; P = 0.02). There was an increased risk of major bleeding (1.85 vs. 1.09%; RR 1.73, 95% CI 1.19-2.50; P = 0.004) but not fatal bleeding (0.14 vs. 0.17%; RR 0.91, 95% CI 0.53-1.58; P = 0.75).

CONCLUSION

Compared with aspirin alone, DAPT beyond 1 year among stabilized high-risk patients with prior MI decreases ischaemic events, including significant reductions in the individual endpoints of cardiovascular death, recurrent MI, and stroke. Dual antiplatelet therapy beyond 1 year increases major bleeding, but not fatal bleeding or non-cardiovascular death.

摘要

目的

最近的临床试验研究了在各种患者人群中延长双联抗血小板治疗(DAPT)的效果,关于其益处和安全性的结果存在差异,尤其是在心血管和非心血管死亡率方面。我们对比较既往心肌梗死(MI)史高危患者中 DAPT 超过 1 年与单独使用阿司匹林的随机试验进行了荟萃分析。

方法和结果

一项研究中共有 33435 例患者接受了平均 31 个月的随访(既往 MI 患者占 63.3%),五项研究中有一个亚组患者存在或有既往 MI 史(占 36.7%)。与单独使用阿司匹林相比,延长 DAPT 可降低主要不良心血管事件的风险(6.4% vs. 7.5%;风险比 RR 0.78,95%置信区间 CI 0.67-0.90;P = 0.001),减少心血管死亡(2.3% vs. 2.6%;RR 0.85,95% CI 0.74-0.98;P = 0.03),但非心血管死亡无增加(RR 1.03,95% CI 0.86-1.23;P = 0.76)。全因死亡率的相关影响为 RR 0.92(95% CI 0.83-1.03;P = 0.13)。延长 DAPT 还可降低 MI(RR 0.70,95% CI 0.55-0.88;P = 0.003)、卒中和支架血栓形成(RR 0.81,95% CI 0.68-0.97;P = 0.02)的风险。大出血风险增加(1.85% vs. 1.09%;RR 1.73,95% CI 1.19-2.50;P = 0.004),但致命性出血风险无增加(0.14% vs. 0.17%;RR 0.91,95% CI 0.53-1.58;P = 0.75)。

结论

与单独使用阿司匹林相比,在稳定的既往 MI 高危患者中 DAPT 超过 1 年可降低缺血性事件的发生,包括心血管死亡、复发性 MI 和卒中等单个终点事件的显著减少。DAPT 超过 1 年可增加大出血风险,但不会增加致命性出血或非心血管死亡的风险。

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