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氯吡格雷负荷后行直接经皮冠状动脉介入治疗的急性ST段抬高型心肌梗死患者使用阿昔单抗:一项随机双盲试验。

Abciximab in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention after clopidogrel loading: a randomized double-blind trial.

作者信息

Mehilli Julinda, Kastrati Adnan, Schulz Stefanie, Früngel Stefan, Nekolla Stephan G, Moshage Werner, Dotzer Franz, Huber Kurt, Pache Jürgen, Dirschinger Josef, Seyfarth Melchior, Martinoff Stefan, Schwaiger Markus, Schömig Albert

机构信息

Deutsches Herzzentrum, Technische Universität, Munich, Germany.

出版信息

Circulation. 2009 Apr 14;119(14):1933-40. doi: 10.1161/CIRCULATIONAHA.108.818617. Epub 2009 Mar 30.

Abstract

BACKGROUND

The glycoprotein IIb/IIIa receptor inhibitor abciximab has improved the efficacy of primary percutaneous coronary interventions in patients with acute myocardial infarction. However, it is not known whether abciximab remains beneficial after adequate clopidogrel loading in patients with acute ST-segment-elevation myocardial infarction.

METHODS AND RESULTS

A total of 800 patients with acute ST-segment-elevation myocardial infarction within 24 hours from symptom onset, all treated with 600 mg clopidogrel, were randomly assigned in a double-blind fashion to receive either abciximab (n=401) or placebo (n=399) in the intensive care unit before being sent to the catheterization laboratory. The primary end point, infarct size measured by single-photon emission computed tomography with technetium-99m sestamibi before hospital discharge, was 15.7+/-17.2% (mean+/-SD) of the left ventricle in the abciximab group and 16.6+/-18.6% of the left ventricle in the placebo group (P=0.47). At 30 days, the composite of death, recurrent myocardial infarction, stroke, or urgent revascularization of the infarct-related artery was observed in 20 patients in the abciximab group (5.0%) and 15 patients in the placebo group (3.8%) (relative risk, 1.3; 95% CI, 0.7 to 2.6; P=0.40). Major bleeding complications were observed in 7 patients in each group (1.8%).

CONCLUSIONS

Upstream administration of abciximab is not associated with a reduction in infarct size in patients presenting with acute myocardial infarction within 24 hours of symptom onset and receiving 600 mg clopidogrel.

摘要

背景

糖蛋白IIb/IIIa受体抑制剂阿昔单抗已提高了急性心肌梗死患者直接经皮冠状动脉介入治疗的疗效。然而,在急性ST段抬高型心肌梗死患者中,给予足量氯吡格雷负荷量后阿昔单抗是否仍有益处尚不清楚。

方法与结果

共有800例症状发作24小时内的急性ST段抬高型心肌梗死患者,均接受600mg氯吡格雷治疗,在被送往导管室之前,于重症监护病房以双盲方式随机分配接受阿昔单抗(n = 401)或安慰剂(n = 399)治疗。主要终点为出院前采用锝-99m甲氧基异丁基异腈单光子发射计算机断层扫描测量的梗死面积,阿昔单抗组为左心室的15.7±17.2%(均值±标准差),安慰剂组为左心室的16.6±18.6%(P = 0.47)。30天时,阿昔单抗组有20例患者(5.0%)出现死亡、再发心肌梗死、卒中或梗死相关动脉紧急血运重建的复合事件,安慰剂组有15例患者(3.8%)出现(相对危险度,1.3;95%可信区间,0.7至2.6;P = 0.40)。每组均有7例患者(1.8%)出现严重出血并发症。

结论

对于症状发作24小时内且接受600mg氯吡格雷治疗的急性心肌梗死患者,上游给予阿昔单抗与梗死面积缩小无关。

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