title: Incidence and consequence of major bleeding in primary percutaneous intervention for ST-elevation myocardial infarction in the era of radial access: an analysis of the international randomized Acute myocardial infarction Treated with primary angioplasty and intravenous enoxaparin Or unfractionated heparin to Lower ischemic and bleeding events at short- and Long-term follow-up trial.
abstract: OBJECTIVE
  The aims of the study are to compare the outcome with and without major bleeding and to identify the independent correlates of major bleeding complications and mortality in patients described in the ATOLL study.
  
  
  METHODS
  The ATOLL study included 910 patients randomly assigned to either 0.5 mg/kg intravenous enoxaparin or unfractionated heparin before primary percutaneous coronary intervention. Incidence of major bleeding and ischemic end points was assessed at 1 month, and mortality, at 1 and 6 months. Patients with and without major bleeding complication were compared. A multivariate model of bleeding complications at 1 month and mortality at 6 months was realized. Intention-to-treat and per-protocol analyses were performed.
  
  
  RESULTS
  The most frequent bleeding site appears to be the gastrointestinal tract. Age >75 years, cardiac arrest, and the use of insulin or >1 heparin emerged as independent correlates of major bleeding at 1 month. Patients presenting with major bleeding had significantly higher rates of adverse ischemic complications. Mortality at 6 months was higher in bleeders. Major bleeding was found to be one of the independent correlates of 6-month mortality. The addition or mixing of several anticoagulant drugs was an independent factor of major bleeding despite the predominant use of radial access.
  
  
  CONCLUSIONS
  This study shows that major bleeding is independently associated with poor outcome, increasing ischemic events, and mortality in primary percutaneous coronary intervention performed mostly with radial access.
authors.affiliation: ACTION Study Group, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Université Paris 6, Paris, France; Cardiology Department, CHUV, Lausanne, Switzerland.
authors.forename: Cyril
authors.initials: C
authors.lastname: Pellaton
authors.affiliation: ACTION Study Group, Cardiology Department, CHU Carémeau, Nîmes, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cayla
authors.affiliation: ACTION Study Group, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Université Paris 6, Paris, France.
authors.forename: Johanne
authors.initials: J
authors.lastname: Silvain
authors.affiliation: Herzzentrum Klinikum, Medizinische Klinik B, Ludwigshafen, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Zeymer
authors.affiliation: Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ.
authors.forename: Marc
authors.initials: M
authors.lastname: Cohen
authors.affiliation: SAMU, CHRU Lille, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Goldstein
authors.affiliation: Department of Internal Medicine, Cardiology and Emergency Medicine, Wilhelminen Hospital, Vienna, Austria.
authors.forename: Kurt
authors.initials: K
authors.lastname: Huber
authors.affiliation: Pennsylvania Hospital, University of Pennsylvania, Philadelphia, PA.
authors.forename: Charles
authors.initials: C
authors.lastname: Pollack
authors.affiliation: ACTION Study Group, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Université Paris 6, Paris, France.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Kerneis
authors.affiliation: ACTION Study Group, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Université Paris 6, Paris, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Collet
authors.affiliation: ACTION Study Group, Unité de Recherche Clinique, Lariboisière Hospital (AP-HP), Université Paris 7, Paris, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Vicaut
authors.affiliation: ACTION Study Group, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Université Paris 6, Paris, France; ACTION Study Group, SMUR, Pitié-Salpêtrière Hospital (AP-HP), Université Paris 6, Paris, France. Electronic address: gilles.montalescot@psl.aphp.fr.
authors.forename: Gilles
authors.initials: G
authors.lastname: Montalescot
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000379:methods; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods; D004562:Electrocardiography; D017984:Enoxaparin / Q000008:administration & dosage / Q000009:adverse effects*; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D007275:Injections, Intravenous; D008297:Male; D009203:Myocardial Infarction / Q000188:drug therapy / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000379:methods; D019106:Postoperative Hemorrhage / Q000139:chemically induced / Q000453:epidemiology*; D017534:Radial Artery; D013997:Time Factors; D014481:United States / Q000453:epidemiology
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D006493:Heparin