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 - 18/09/15
for the
ATOLL Investigators
Résumé |
Aims |
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.
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| Conflicts of interest: G.C. reports receiving a research grant from the Fédération Française de Cardiologie; consultant fees from Abbott Vascular, AstraZeneca, CLS Behring, Daiichi Sankyo, and Eli Lilly; and lecture fees from Abbott Vascular, AstraZeneca, Biotronik, CLS Behring, Daiichi-Sankyo, Eli Lilly, and Iroko Cardio. J.-P.C. reports receiving research grants from Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly, Guerbet Medical, Medtronic, Boston Scientific, Cordis, Stago, Fondation de France, INSERM, Fédération Française de Cardiologie, and Société Française de Cardiologie; consulting fees from Sanofi-Aventis, Eli Lilly, and Bristol-Myers Squibb; and lecture fees from Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly, and AstraZeneca. P.G. reports receiving consulting or board fees and lecture fees from AstraZeneca, Boehringer Ingelheim, Daiichi-Sankyo, Eli Lilly, Sanofi-Aventis, and The Medicines Company. K.H. reports receiving lecture fees from AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Eli Lilly, Pfizer, Sanofi-Aventis, Schering-Plough, and The Medicines Company. G.M. reports receiving grant support from Abbott Vascular, Boston Scientific, Cordis, Eli Lilly, Fédération Française de Cardiologie, Fondation de France, Guerbet Medical, INSERM, ITC Edison, Medtronic, Pfizer, Sanofi-Aventis, Société Française de Cardiologie, and Stago; consulting or board fees and lecture fees from AstraZeneca, Bayer, Boehringer Ingelheim, Cardiovascular Research Foundation, Cleveland Clinic Research Foundation, Daiichi-Sankyo, Duke Institute, Eli Lilly, Europa, Lead-up, GlaxoSmithKline, Institut de Cardiologie de Montreal, Menarini, Nanospheres, Novartis, Pfizer, Portola, Sanofi-Aventis, The Medicines Company, and the TIMI study group. C.P. reports receiving research support and consulting fees from Sanofi-Aventis and The Medicines Company. J.S. reports receiving research grants from Sanofi-Aventis, Daiichi-Sankyo, Eli Lilly, Brahms, INSERM, Fédération Française de Cardiologie, and Société Française de Cardiologie; consulting fees from Daiichi-Sankyo and Eli Lilly; and speakers' honoraria from AstraZeneca, Daiichi-Sankyo, Eli Lilly, and Servier. E.V. reports receiving consulting fees and lecture fees from Abbott, Amgen, Eli Lilly, Pfizer, Sanofi-Aventis, and Servier. U.Z. reports receiving research grants and speakers' honoraria from Bristol-Myers Squibb, Eli Lilly, and Sanofi-Aventis and consulting fees and lecture fees from AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Portola, and The Medicines Company. All other authors declare that they have no conflicts of interest. This paper had no additional support. |
Vol 170 - N° 4
P. 778-786 - octobre 2015 Retour au numéro
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