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对接受直接血管成形术并同时使用普拉格雷或氯吡格雷进行上游抗血小板治疗的ST段抬高型心肌梗死患者的多国非干预性研究——欧洲MULTIPRAC注册研究

MULTInational non-interventional study of patients with ST-segment elevation myocardial infarction treated with PRimary Angioplasty and Concomitant use of upstream antiplatelet therapy with prasugrel or clopidogrel--the European MULTIPRAC Registry.

作者信息

Clemmensen Peter, Grieco Niccolò, Ince Hüseyin, Danchin Nicolas, Goedicke Jochen, Ramos Yvonne, Schmitt Josef, Goldstein Patrick

机构信息

Rigshospitalet, University of Copenhagen, Denmark

Hospital Niguarda Cà Granda Milano, Italy.

出版信息

Eur Heart J Acute Cardiovasc Care. 2015 Jun;4(3):220-9. doi: 10.1177/2048872614547449. Epub 2014 Sep 2.

Abstract

AIMS

Early initiation of dual antiplatelet therapy (DAPT) is guideline-recommended. MULTIPRAC was conducted to gain insights into the use patterns and outcomes of pre-hospital DAPT initiation with prasugrel or clopidogrel.

METHODS AND RESULTS

MULTIPRAC is a multinational, multicentre, prospective registry enrolling 2053 ST-segment elevation myocardial infarction (STEMI) patients. Patients were grouped according to adherence to the initially prescribed thienopyridine. Pre-hospital use of prasugrel increased from 12.5% to 67.1% at study end. Prasugrel compared to clopidogrel-initiated patients more often adhered to the medication through discharge (87% vs. 38%) whereas 49% of the clopidogrel-initiated patients were switched to prasugrel. Patients who continued on clopidogrel were substantially older. In-hospital mortality was 0.5%, early stent thrombosis 0.1%. The major adverse cardiac events (MACE) rate was 1.6% in prasugrel-treated vs. 2.3% in clopidogrel-treated patients (adjusted OR 0.749, 95% CI [0.285-1.968]). Non-coronary artery bypass graft (non-CABG) bleeding occurred in 4.1% of prasugrel-treated vs. 6.1% of clopidogrel-treated patients (adjusted OR 0.686 [0.349-1.349]). Pre-percutaneous coronary intervention (PCI) TIMI flow 2-3 was seen in 38.7% treated with prasugrel vs. 35.6% with clopidogrel (adjusted OR 1.170 [0.863-1.585]). Post PCI ST-segment resolution ⩾50%, was 71.6% with prasugrel vs. 65.0% with clopidogrel (adjusted OR 1.543 [1.138-2.093], p=0.0052).

CONCLUSIONS

MULTIPRAC demonstrated a steady increase in prasugrel use over time without an increase in bleeding rates compared to clopidogrel. ST resolution was more pronounced with prasugrel. Switching between antiplatelet drugs occurs frequently. The low rates of MACE, in-hospital mortality and bleeding, suggests that pre-hospital loading with thienopyridines is confined to low-risk patients. These results emphasize the need for more randomized pre-hospital studies and should be seen in the context of upcoming randomized trials involving pre-hospital antiplatelet therapies.

摘要

目的

指南推荐尽早开始双联抗血小板治疗(DAPT)。开展MULTIPRAC研究以深入了解院前使用普拉格雷或氯吡格雷启动DAPT的使用模式和结果。

方法和结果

MULTIPRAC是一项跨国、多中心的前瞻性注册研究,纳入了2053例ST段抬高型心肌梗死(STEMI)患者。患者根据对最初处方的噻吩并吡啶的依从性进行分组。在研究结束时,院前使用普拉格雷的比例从12.5%增加到67.1%。与氯吡格雷启动治疗的患者相比,普拉格雷启动治疗的患者在出院时更常坚持用药(87%对38%),而49%氯吡格雷启动治疗的患者改用了普拉格雷。继续使用氯吡格雷的患者年龄更大。住院死亡率为0.5%,早期支架血栓形成率为0.1%。普拉格雷治疗组的主要不良心脏事件(MACE)发生率为1.6%,氯吡格雷治疗组为2.3%(调整后的OR为0.749,95%CI[0.285 - 1.968])。普拉格雷治疗组非冠状动脉旁路移植术(非CABG)出血发生率为4.1%,氯吡格雷治疗组为6.1%(调整后的OR为0.686[0.349 - 1.349])。普拉格雷治疗组在经皮冠状动脉介入治疗(PCI)前TIMI血流2 - 3级的比例为38.7%,氯吡格雷治疗组为35.6%(调整后的OR为1.170[0.863 - 1.585])。PCI术后ST段回落≥50%,普拉格雷治疗组为71.6%,氯吡格雷治疗组为65.0%(调整后的OR为1.543[1.138 - 2.093],p = 0.0052)。

结论

MULTIPRAC研究表明,随着时间的推移,普拉格雷的使用稳步增加,与氯吡格雷相比出血率并未增加。普拉格雷治疗时ST段回落更明显。抗血小板药物之间的转换很常见。MACE、住院死亡率和出血发生率较低,表明院前负荷使用噻吩并吡啶仅限于低风险患者。这些结果强调了需要更多的院前随机研究,并且应结合即将开展的涉及院前抗血小板治疗的随机试验来看待。

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