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)

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• 作者：Raoul Bacquelin^a ; ^b ; ^{raoul.bacquelin@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Emmanuel Oger^b ; ^c ; Emmanuelle Filippi^d ; Jean-Philippe Hacot^e ; Vincent Auffret^a ; ^b ; Marielle Le Guellec^c ; Isabelle Coudert^f ; Philippe Castellant^g ; Benoî ; t Moquet^h ; Philippe Druellesⁱ ; Antoine Rialan^j ; Gilles Rouault^k ; Bertrand Boulanger^d ; Josiane Treuil^l ; Guillaume Leurent^a ; ^b ; Marc Bedossa^a ; ^b ; Dominique Boulmier^a ; ^b ; Bertrand Avez^h ; Martine Gilard^g ; Hervé ; Le Breton^a ; ^b ; ^m
• 关键词：Prasugrel ; Bleeding ; ST-segment elevation myocardial infarction ; Real-world patients
• 刊名：Archives of Cardiovascular Diseases
• 出版年：2016
• 出版时间：January 2016
• 年：2016
• 卷：109
• 期：1
• 页码：31-38
• 全文大小：727 K

文摘

Antiplatelet therapies, including prasugrel, are a cornerstone in the treatment of ST-segment elevation myocardial infarction (STEMI), 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.