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新型口服或静脉 P2Y12 抑制剂与氯吡格雷对冠心病患者主要缺血和出血事件的影响:一项随机试验的荟萃分析。

Impact of new oral or intravenous P2Y12 inhibitors and clopidogrel on major ischemic and bleeding events in patients with coronary artery disease: a meta-analysis of randomized trials.

机构信息

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.

Nursing School, Beijing University of Chinese Medicine, Beijing 100102, China.

出版信息

Atherosclerosis. 2014 Apr;233(2):568-578. doi: 10.1016/j.atherosclerosis.2014.01.017. Epub 2014 Jan 21.

DOI:10.1016/j.atherosclerosis.2014.01.017
PMID:24534451
Abstract

OBJECTIVE

New P2Y12 inhibitors can be classified as oral (prasugrel and ticagrelor) and intravenous drugs (cangrelor and elinogrel). These P2Y12 inhibitors might be superior to clopidogrel for reducing ischemic events in patients with coronary artery disease (CAD). We performed a meta-analysis of randomized trials that compared new oral or intravenous P2Y12 inhibitors with clopidogrel to determine their efficacy and safety in patients.

METHODS AND RESULTS

Twelve randomized, placebo-controlled studies and two subgroup analyses of included studies on ST-segment elevation myocardial infarction (STEMI) were included. The database consisted of 82,784 patients, with 43,875 (53%) on new oral P2Y12 inhibitors and 38909 (47%) on intravenous P2Y12 inhibitors compared with clopidogrel. The primary efficacy endpoint was major adverse cardiac events (MACEs). The primary safety endpoint was thrombolysis in myocardial infarction (TIMI) major bleeding. New oral P2Y12 inhibitors significantly decreased MACEs (odds ratio: 0.85, p<0.0001 for the whole cohort; OR: 0.77, p=0.04 for STEMI) and all-cause death (OR: 0.88, p=0.04 for the whole cohort; OR: 0.77, p=0.01 for STEMI). Among new intravenous P2Y12 inhibitors, only cangrelor significantly decreased the risk of MACEs. An increase in TIMI major bleeding was observed only by prasugrel among the new P2Y12 inhibitors.

CONCLUSIONS

New oral P2Y12 inhibitors reduce ischemic events, but there is no obvious increase in major bleeding in patients with CAD, and the risk/benefit ratio is particularly favorable for STEMI patients. Moreover, only cangrelor is beneficial for ischemic events in patients on new intravenous P2Y12 inhibitors.

摘要

目的

新型 P2Y12 抑制剂可分为口服(普拉格雷和替格瑞洛)和静脉用(坎格瑞洛和依诺格雷洛)药物。这些 P2Y12 抑制剂在降低冠心病患者的缺血性事件方面可能优于氯吡格雷。我们对比较新型口服或静脉用 P2Y12 抑制剂与氯吡格雷的随机试验进行了荟萃分析,以确定它们在患者中的疗效和安全性。

方法和结果

纳入了 12 项随机、安慰剂对照研究和两项 ST 段抬高型心肌梗死(STEMI)亚组分析。该数据库包含 82784 例患者,其中 43875 例(53%)接受新型口服 P2Y12 抑制剂治疗,38909 例(47%)接受静脉用 P2Y12 抑制剂治疗,与氯吡格雷相比。主要疗效终点是主要不良心脏事件(MACEs)。主要安全性终点是心肌梗死溶栓治疗(TIMI)大出血。新型口服 P2Y12 抑制剂显著降低 MACEs(全队列比值比:0.85,p<0.0001;STEMI 比值比:0.77,p=0.04)和全因死亡(全队列比值比:0.88,p=0.04;STEMI 比值比:0.77,p=0.01)。在新型静脉用 P2Y12 抑制剂中,只有坎格瑞洛显著降低了 MACEs 的风险。新型 P2Y12 抑制剂中只有普拉格雷会增加 TIMI 大出血。

结论

新型口服 P2Y12 抑制剂可减少缺血性事件,但在 CAD 患者中并未明显增加大出血风险,风险/获益比特别有利于 STEMI 患者。此外,只有坎格瑞洛对新静脉用 P2Y12 抑制剂患者的缺血性事件有益。

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