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急性冠脉综合征后转换双联抗血小板治疗的获益:TOPIC(急性冠脉综合征后血小板抑制的时机)随机研究。

Benefit of switching dual antiplatelet therapy after acute coronary syndrome: the TOPIC (timing of platelet inhibition after acute coronary syndrome) randomized study.

机构信息

Département de Cardiologie, CHU Timone, Marseille F-13385, France.

INSERM, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », Marseille F-13385, France.

出版信息

Eur Heart J. 2017 Nov 1;38(41):3070-3078. doi: 10.1093/eurheartj/ehx175.

Abstract

AIMS

Newer P2Y12 blockers (prasugrel and ticagrelor) demonstrated significant ischaemic benefit over clopidogrel after acute coronary syndrome (ACS). However, both drugs are associated with an increase in bleeding complications. The objective of the present study was to evaluate the benefit of switching dual antiplatelet therapy (DAPT) from aspirin plus a newer P2Y12 blocker to aspirin plus clopidogrel 1 month after ACS.

METHODS AND RESULTS

We performed an open-label, monocentric, and randomized trial. From March 2014 to April 2016, patients admitted with ACS requiring coronary intervention, on aspirin and a newer P2Y12 blocker and without adverse event at 1 month, were assigned to switch to aspirin and clopidogrel (switched DAPT) or continuation of their drug regimen (unchanged DAPT). The primary outcome was a composite of cardiovascular death, urgent revascularization, stroke and bleeding as defined by the Bleeding Academic Research Consortium (BARC) classification ≥2 at 1 year post ACS. Six hundred and forty six patients were randomized and 645 analysed, corresponding to 322 patients in the switched DAPT and 323 in the unchanged DAPT group. The primary endpoint occurred in 43 (13.4%) patients in the switched DAPT group and in 85 (26.3%) patients in the unchanged DAPT (HR 95%CI 0.48 (0.34-0.68), P < 0.01). No significant differences were reported on ischaemic endpoints, while BARC ≥ 2 bleeding occurred in 13 (4.0%) patients in the switched DAPT and in 48 (14.9%) in the unchanged DAPT group (HR 95%CI 0.30 (0.18-0.50), P < 0.01).

CONCLUSION

A switched DAPT is superior to an unchanged DAPT strategy to prevent bleeding complications without increase in ischaemic events following ACS.

摘要

目的

新型 P2Y12 抑制剂(普拉格雷和替格瑞洛)在急性冠脉综合征(ACS)后与氯吡格雷相比具有显著的缺血益处。然而,这两种药物都与出血并发症的增加有关。本研究的目的是评估在 ACS 后 1 个月将双重抗血小板治疗(DAPT)从阿司匹林加新型 P2Y12 抑制剂转换为阿司匹林加氯吡格雷的获益。

方法和结果

我们进行了一项开放标签、单中心、随机试验。从 2014 年 3 月至 2016 年 4 月,因 ACS 需要经皮冠状动脉介入治疗且正在服用阿司匹林和新型 P2Y12 抑制剂且在 1 个月时无不良事件的患者被随机分配至转换为阿司匹林和氯吡格雷(转换 DAPT)或继续其药物治疗方案(未改变的 DAPT)。主要结局是心血管死亡、紧急血运重建、卒中和出血的复合终点,定义为 ACS 后 1 年按 Bleeding Academic Research Consortium(BARC)分类≥2 级的出血。646 例患者被随机分组,645 例患者进行了分析,转换 DAPT 组有 322 例患者,未改变 DAPT 组有 323 例患者。转换 DAPT 组有 43 例(13.4%)患者发生主要终点事件,未改变 DAPT 组有 85 例(26.3%)患者发生(HR 95%CI 0.48(0.34-0.68),P<0.01)。缺血终点无显著差异,而转换 DAPT 组有 13 例(4.0%)患者和未改变 DAPT 组有 48 例(14.9%)患者发生 BARC≥2 级出血(HR 95%CI 0.30(0.18-0.50),P<0.01)。

结论

与未改变的 DAPT 策略相比,转换 DAPT 可预防 ACS 后出血并发症,而不增加缺血事件。

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