title: Predictors of bleeding in patients with acute coronary syndromes treated with prasugrel.
abstract: BACKGROUND
  When considering antiplatelet therapy for acute coronary syndrome (ACS), it is essential to balance benefits (less thrombotic/ischaemic events) versus bleeding risks related to intense platelet inhibition via antagonism of P2Y12 receptors. This analysis aimed to identify predictors of bleeding events among A Comparison of Prasugrel at the Time of PCI or as Pretreatment at the Time of Diagnosis in Patients with NSTEACS (ACCOAST) study population.
  
  
  RESULTS
  The ACCOAST study randomised 4033 patients with non-ST-segment elevation myocardial infarction (NSTEMI) to (A) a 30 mg prasugrel loading dose (LD) followed by coronary angiography with an additional 30 mg prasugrel at the time of percutaneous coronary intervention (PCI) or (B) a placebo LD followed by a 60 mg prasugrel at the time of PCI. Patients received standard of care, including use of aspirin. Independent predictors of Thrombolysis in Myocardial Infarction (TIMI) major bleeding not related to coronary artery bypass grafting (CABG) within 7 days were assessed using stepwise Cox proportional model for time to first occurrence of the event. Non-CABG-related TIMI major or minor bleeding was similarly analysed. Non-CABG-related TIMI major bleeding occurred in 36 (0.9%) patients, and TIMI major or minor bleeding occurred in 81 (2.0%) patients. Independent predictors for TIMI major bleeding alone were pretreatment with prasugrel LD (HR 3.02; 95% CI 1.42 to 6.43), femoral access (HR 2.45; 95% CI 1.11 to 5.38), female sex (HR 2.57; 95% CI 1.32 to 5.00), placement of >1 stent (HR 2.50; 95% CI 1.26 to 4.95) and age (HR 1.05; 95% CI 1.02 to 1.09). Pretreatment with prasugrel LD (HR 3.05; 95% CI 1.84 to 5.07), femoral access (HR 3.06; 95% CI 1.74 to 5.38), female sex (HR 2.62; 95% CI 1.67 to 4.12), performed PCI (HR 2.21; 95% CI 1.23 to 3.99), therapy with glycoprotein IIb/IIIa inhibitors (HR 1.88; 95% CI 1.06 to 3.33) and age (increased bleed per year of age HR 1.04; 95% CI 1.02 to 1.06) were independent predictors of TIMI major or minor bleeding through 7 days.
  
  
  CONCLUSIONS
  Pretreatment, age, gender and procedural variables predicted bleeding risk in patients with NSTEMI.
  NCT01015287.
authors.affiliation: Cardiocenter, Third Faculty of Medicine, Charles University Prague, Prague, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Widimsky
authors.affiliation: Cardiocenter, Third Faculty of Medicine, Charles University Prague, Prague, Czech Republic.
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Motovska
authors.affiliation: Cardiovascular and Neurological Department Azienda Ospedaliera, Arezzo, Italy.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Bolognese
authors.affiliation: Institute of Cardiology, Jagiellonian University Medical College, University Hospital, Krakow, Poland.
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.affiliation: Kerckhoff Heart and Thoraxcenter, Bad Nauheim and Medical Clinic I, University of Giessen Germany, Bad Nauheim, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Hamm
authors.affiliation: MD Interventional Cardiology and Research Program, Université de Montréal, Montreal, Quebec, Canada.
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Tanguay
authors.affiliation: Department of Cardiology, St. Antonius Hospital, Nieuwegein, Netherlands.
authors.forename: Jurrien
authors.initials: J
authors.lastname: Ten Berg
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
authors.forename: Eileen
authors.initials: E
authors.lastname: Brown
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
authors.forename: LeRoy
authors.initials: L
authors.lastname: LeNarz
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
authors.forename: Debra L
authors.initials: DL
authors.lastname: Miller
authors.affiliation: Institut de Cardiologie, Centre Hospitalier Universitaire Pitié-Salpêtriėre (ACTION Study Group, AP-HP, Université Paris 6), Paris, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Montalescot
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000188:drug therapy / Q000628:therapy*; D000367:Age Factors; D000368:Aged; D016009:Chi-Square Distribution; D001026:Coronary Artery Bypass / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced* / Q000175:diagnosis; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000188:drug therapy / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects; D010879:Piperazines / Q000009:adverse effects*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D000068799:Prasugrel Hydrochloride; D016016:Proportional Hazards Models; D058921:Purinergic P2Y Receptor Antagonists / Q000009:adverse effects*; D018570:Risk Assessment; D012307:Risk Factors; D012737:Sex Factors; D013876:Thiophenes / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010879:Piperazines; D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D013876:Thiophenes; D000068799:Prasugrel Hydrochloride