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双盲、随机、前瞻性比较 600mg 氯吡格雷与 60mg 普拉格雷在拟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中的负荷剂量:ETAMI 试验(早期噻吩吡啶治疗改善急性心肌梗死患者直接经皮冠状动脉介入治疗)。

Double-blind, randomized, prospective comparison of loading doses of 600 mg clopidogrel versus 60 mg prasugrel in patients with acute ST-segment elevation myocardial infarction scheduled for primary percutaneous intervention: the ETAMI trial (early thienopyridine treatment to improve primary PCI in patients with acute myocardial infarction).

机构信息

Klinikum Ludwigshafen and Institut für Herzinfarkt für Herzinfarktforschung, Ludwigshafen, Germany.

Charite Campus Benjamin Franklin, Berlin, Germany.

出版信息

JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):147-154. doi: 10.1016/j.jcin.2014.09.007. Epub 2014 Nov 4.

DOI:10.1016/j.jcin.2014.09.007
PMID:25616919
Abstract

OBJECTIVES

This study compared the timing of onset of antiplatelet action after treatment with clopidogrel and prasugrel at first medical contact in patients with ST-segment elevation myocardial infarction (STEMI) scheduled for primary percutaneous coronary intervention (PPCI).

BACKGROUND

Little is known about the timing of onset of antiplatelet action after a pre-percutaneous coronary intervention (PCI) loading dose of clopidogrel or prasugrel in patients with STEMI.

METHODS

This double-blind, prospective study randomized 62 patients with STEMI scheduled for PPCI in the ambulance or the emergency department to 60 mg prasugrel (n = 31) or 600 mg clopidogrel (n = 31). The primary endpoint was the platelet reactivity index (PRI) measured with the vasodilator-stimulated phosphoprotein assay 2 h after intake of the study medication. Secondary endpoints were PRI after 4 h, TIMI (Thrombolysis In Myocardial Infarction) patency of the infarct-related artery before and after PCI, and clinical events until day 30.

RESULTS

The PRI after 2 h (50.4 ± 32.7% vs. 66.3 ± 22.2%; p = 0.035) and after 4 h (39.1 ± 27.5% vs. 54.5 ± 49.3%; p = 0.038) were significantly lower with prasugrel compared with clopidogrel. In addition, the rate of patients with a PRI <50% tended to be higher with prasugrel compared with clopidogrel after 2 h (46.7% vs. 28.6%; p = 0.15) and after 4 h (63.0% vs. 38.9%; p = 0.06). There were no significant differences in TIMI 2/3 patency before PCI (39.2% vs. 31.0%; p = 0.43) and TIMI 3 patency after PCI (88.5% vs. 89.3%; p = 0.92).

CONCLUSIONS

The pre-PCI administration of prasugrel in patients with STEMI undergoing PPCI was associated with a significant faster platelet inhibition compared with clopidogrel. Therefore, prasugrel should be preferred to clopidogrel in this setting. (ETAMI-Study: Early Thienopyridine Treatment to Improve Primary PCI in Patients With Acute Myocardial Infarction; NCT01327534).

摘要

目的

本研究比较了 ST 段抬高型心肌梗死(STEMI)患者在首次医疗接触时接受氯吡格雷和普拉格雷预处理后抗血小板作用的起始时间,这些患者拟行直接经皮冠状动脉介入治疗(PPCI)。

背景

关于 STEMI 患者行经皮冠状动脉介入治疗(PCI)前负荷剂量氯吡格雷或普拉格雷后抗血小板作用起始时间的信息知之甚少。

方法

这项双盲、前瞻性研究将 62 例拟行救护车或急诊室 PPCI 的 STEMI 患者随机分为普拉格雷 60mg 组(n=31)或氯吡格雷 600mg 组(n=31)。主要终点是研究药物服用后 2 小时用血管扩张刺激磷蛋白测定法测量的血小板反应指数(PRI)。次要终点是 4 小时时的 PRI、梗死相关动脉在 PCI 前后的 TIMI(血栓溶解心肌梗死)通畅率,以及第 30 天前的临床事件。

结果

与氯吡格雷相比,普拉格雷在 2 小时(50.4±32.7% vs. 66.3±22.2%;p=0.035)和 4 小时(39.1±27.5% vs. 54.5±49.3%;p=0.038)时的 PRI 显著更低。此外,与氯吡格雷相比,普拉格雷在 2 小时时(46.7% vs. 28.6%;p=0.15)和 4 小时时(63.0% vs. 38.9%;p=0.06)患者 PRI<50%的比例更高。在 PCI 前 TIMI 2/3 通畅率(39.2% vs. 31.0%;p=0.43)和 PCI 后 TIMI 3 通畅率(88.5% vs. 89.3%;p=0.92)方面,两组之间无显著差异。

结论

在拟行 PPCI 的 STEMI 患者中,PCI 前给予普拉格雷与氯吡格雷相比,血小板抑制作用更快。因此,在这种情况下,普拉格雷应优于氯吡格雷。(ETAMI 研究:急性心肌梗死患者早期噻吩吡啶治疗以改善直接经皮冠状动脉介入治疗;NCT01327534)。

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