Major Bleeding in Patients with Atrial Fibrillation Receiving Apixaban or Warfarin in the ARISTOTLE Trial: Predictors, Characteristics, and Clinical Outcomes.
J Am Coll Cardiol. 2014 Mar 5;
Authors: Hylek EM, Held C, Alexander JH, Lopes RD, De Caterina R, Wojdyla DM, Huber K, Jansky P, Steg PG, Hanna M, Thomas L, Wallentin L, Granger CB
OBJECTIVES: We sought to characterize major bleeding based on the components of the major bleeding definition, explore major bleeding by location, define 30-day mortality after a major bleeding event, and identify factors associated with major bleeding.
BACKGROUND: Apixaban was shown to reduce the risk of major hemorrhage among individuals with atrial fibrillation in the ARISTOTLE trial.
METHODS: All patients who received at least 1 dose of a study drug were included. Major bleeding was defined according to the criteria of the International Society on Thrombosis and Haemostasis. Factors associated with major hemorrhage were identified using a multivariable Cox model.
RESULTS: The on-treatment, safety population included 18,140 patients. The rate of major hemorrhage among patients in the apixaban group was 2.13% per year compared with 3.09% per year in the warfarin group (hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.60-0.80; P<0.001). Compared with warfarin, major extracranial hemorrhage associated with apixaban less often led to hospitalization, a medical or surgical intervention, transfusion, or change in antithrombotic therapy. Major hemorrhage followed by mortality within 30 days occurred half as often in apixaban-treated patients compared with warfarin (HR 0.50, 95% CI 0.33-0.74; P<0.001). Older age, prior hemorrhage, prior stroke or transient ischemic attack, diabetes, lower creatinine clearance, decreased hematocrit, aspirin, and nonsteroidal anti-inflammatory drugs were independently associated with an increased risk.
CONCLUSIONS: Apixaban compared with warfarin was associated with fewer intracranial hemorrhages, less adverse consequences following extracranial hemorrhage, and a 50% reduction in fatal consequences at 30 days in cases of major hemorrhage.
PMID: 24657685 [PubMed - as supplied by publisher]