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Safety of prasugrel in real-world patients with ST-segment elevation myocardial infarction: 1-year results from a prospective observational study (Bleeding and Myocardial Infarction Study)

机译:普拉格雷在现实世界中ST段抬高型心肌梗死患者中的安全性:前瞻性观察研究(出血和心肌梗死研究)的1年结果

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Summary Background. — Antiplatelet therapies, including prasugrel, are a cornerstone in the treatment of ST-segment elevation myocardial infarction (STEAAI), but are associated with a bleeding risk. This risk has been evaluated in randomized trials, but few data on real-world patients are available. Aim. — To evaluate prasugrel safety in real-world patients with STEMI. Methods. - Consecutive patients with STEMI were recruited over 1 year. Follow-up was done at 3 months and 1 year to evaluate prasugrel safety from hospital discharge to the STEMI anniversary date. The primary outcome was occurrence of any major bleeding according to the Bleeding Academic Research Consortium (BARC) 3 or 5 definitions, or minor bleeding according to the BARC 2 definition. Results. - Overall, 1083 patients were recruited. Compared to patients treated with aspirin+ clopidogrel, patients treated with aspirin + prasugrel had fewer BARC 3 or 5 bleedings (two [0.4%] patients vs. nine [1.8%] patients; P=0.04), but more BARC 2 bleedings (45 [9.3%] patients vs. 20 [4.0%] patients; P<0.001). The baseline characteristics of prasugrel-and clopidogrel-treated patients differed because the former were carefully selected (younger, higher body mass index, less frequent history of stroke). In the overall population, rates of in-hospital and out-of-hospital major bleeding were 2.6% (n = 28) and 1.3% (n = 13), respectively. Conclusion. — The rate of major bleeding, particularly out-of-hospital bleeding, in patients treated with prasugrel is low within 1 year after a STEMI. Accurate selection of patient candidates for prasugrel is likely to have reduced the risk of bleeding.
机译:摘要背景。 —抗血小板疗法(包括普拉格雷)是ST段抬高型心肌梗死(STEAAI)治疗的基石,但与出血风险相关。已经在随机试验中评估了这种风险,但是几乎没有关于实际患者的数据。目标。 —评估真实世界中STEMI患者的普拉格雷安全性。方法。 -连续1年招募连续性STEMI患者。在3个月零1年时进行随访,以评估从出院到STEMI周年纪念日的普拉格雷安全性。主要结局是根据出血学术研究协会(BARC)3或5定义发生的任何大出血,或根据BARC 2定义的发生小出血。结果。 -总共招募了1083名患者。与接受阿司匹林+氯吡格雷治疗的患者相比,接受阿司匹林+普拉格雷治疗的患者的BARC 3或5出血少(2例[0.4%],9例[1.8%]患者; P = 0.04),但BARC 2出血更多(45 [ 9.3%]的患者与20 [4.0%]的患者; P <0.001)。普拉格雷和氯吡格雷治疗的患者的基线特征有所不同,因为前者是经过精心选择的(年轻,体重指数较高,中风史较少)。在总人口中,院内和院外大出血发生率分别为2.6%(n = 28)和1.3%(n = 13)。结论。 — STEMI后1年内,接受普拉格雷治疗的患者的大出血率,尤其是院外出血率低。准确选择普拉格雷的患者候选人可能会减少出血的风险。

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