Raoul Bacquelin1, Emmanuel Oger2, Emmanuelle Filippi3, Jean-Philippe Hacot4, Vincent Auffret5, Marielle Le Guellec6, Isabelle Coudert7, Philippe Castellant8, Benoît Moquet9, Philippe Druelles10, Antoine Rialan11, Gilles Rouault12, Bertrand Boulanger3, Josiane Treuil13, Guillaume Leurent5, Marc Bedossa5, Dominique Boulmier5, Bertrand Avez9, Martine Gilard8, Hervé Le Breton14. 1. Department of Cardiology, Rennes University Hospital, 35000 Rennes, France; Rennes 1 University, LTSI, 35000 Rennes, France. Electronic address: raoul.bacquelin@gmail.com. 2. Rennes 1 University, LTSI, 35000 Rennes, France; Centre d'investigation clinique, INSERM CIC 0203, 35000 Rennes, France. 3. Centre hospitalier Chubert, 56000 Vannes, France. 4. Centre hospitalier Bretagne-Sud, 56100 Lorient, France. 5. Department of Cardiology, Rennes University Hospital, 35000 Rennes, France; Rennes 1 University, LTSI, 35000 Rennes, France. 6. Centre d'investigation clinique, INSERM CIC 0203, 35000 Rennes, France. 7. Emergency Service, Rennes University Hospital, 35000 Rennes, France. 8. Department of Cardiology, Brest University Hospital, 29200 Brest, France. 9. Centre hospitalier Yves-Le-Foll, 22000 Saint-Brieuc, France. 10. Department of Cardiology, clinique Saint-Laurent, 35000 Rennes, France. 11. Centre hospitalier de Saint-Malo, 35400 Saint-Malo, France. 12. Centre hospitalier de Cornouaille, 29000 Quimper, France. 13. Emergency Service, Brest University Hospital, 29200 Brest, France. 14. Department of Cardiology, Rennes University Hospital, 35000 Rennes, France; Rennes 1 University, LTSI, 35000 Rennes, France; INSERM U1099, 35000 Rennes, France.
Abstract
BACKGROUND: 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.
BACKGROUND: 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.
Keywords:
Bleeding; Patients dans la « vraie vie »; Prasugrel; Real-world patients; ST-segment elevation myocardial infarction; Saignements; Syndrome coronarien aigu avec sus-décalage du segment ST
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