title: 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).
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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Cardiology, Rennes University Hospital, 35000 Rennes, France; Rennes 1 University, LTSI, 35000 Rennes, France. Electronic address: raoul.bacquelin@gmail.com.
authors.forename: Raoul
authors.initials: R
authors.lastname: Bacquelin
authors.affiliation: Rennes 1 University, LTSI, 35000 Rennes, France; Centre d'investigation clinique, INSERM CIC 0203, 35000 Rennes, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Oger
authors.affiliation: Centre hospitalier Chubert, 56000 Vannes, France.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Filippi
authors.affiliation: Centre hospitalier Bretagne-Sud, 56100 Lorient, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Hacot
authors.affiliation: Department of Cardiology, Rennes University Hospital, 35000 Rennes, France; Rennes 1 University, LTSI, 35000 Rennes, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Auffret
authors.affiliation: Centre d'investigation clinique, INSERM CIC 0203, 35000 Rennes, France.
authors.forename: Marielle
authors.initials: M
authors.lastname: Le Guellec
authors.affiliation: Emergency Service, Rennes University Hospital, 35000 Rennes, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Coudert
authors.affiliation: Department of Cardiology, Brest University Hospital, 29200 Brest, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Castellant
authors.affiliation: Centre hospitalier Yves-Le-Foll, 22000 Saint-Brieuc, France.
authors.forename: Benoît
authors.initials: B
authors.lastname: Moquet
authors.affiliation: Department of Cardiology, clinique Saint-Laurent, 35000 Rennes, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Druelles
authors.affiliation: Centre hospitalier de Saint-Malo, 35400 Saint-Malo, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Rialan
authors.affiliation: Centre hospitalier de Cornouaille, 29000 Quimper, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Rouault
authors.affiliation: Centre hospitalier Chubert, 56000 Vannes, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Boulanger
authors.affiliation: Emergency Service, Brest University Hospital, 29200 Brest, France.
authors.forename: Josiane
authors.initials: J
authors.lastname: Treuil
authors.affiliation: Department of Cardiology, Rennes University Hospital, 35000 Rennes, France; Rennes 1 University, LTSI, 35000 Rennes, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Leurent
authors.affiliation: Department of Cardiology, Rennes University Hospital, 35000 Rennes, France; Rennes 1 University, LTSI, 35000 Rennes, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Bedossa
authors.affiliation: Department of Cardiology, Rennes University Hospital, 35000 Rennes, France; Rennes 1 University, LTSI, 35000 Rennes, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Boulmier
authors.affiliation: Centre hospitalier Yves-Le-Foll, 22000 Saint-Brieuc, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Avez
authors.affiliation: Department of Cardiology, Brest University Hospital, 29200 Brest, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Gilard
authors.affiliation: Department of Cardiology, Rennes University Hospital, 35000 Rennes, France; Rennes 1 University, LTSI, 35000 Rennes, France; INSERM U1099, 35000 Rennes, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Le Breton
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000009:adverse effects; D000077144:Clopidogrel; D004359:Drug Therapy, Combination; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D018579:Patient Selection; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D000068799:Prasugrel Hydrochloride / Q000009:adverse effects*; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D000068799:Prasugrel Hydrochloride; D013988:Ticlopidine; D001241:Aspirin
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