Major Bleeding in Patients With Atrial Fibrillation Receiving Apixaban or Warfarin

被引:276
|
作者
Hylek, Elaine M. [1 ]
Held, Claes [2 ]
Alexander, John H. [3 ]
Lopes, Renato D. [3 ]
De Caterina, Raffaele [4 ]
Wojdyla, Daniel M. [3 ]
Huber, Kurt [5 ]
Jansky, Petr [6 ]
Steg, Philippe Gabriel [7 ]
Hanna, Michael [8 ]
Thomas, Laine [3 ]
Wallentin, Lars [2 ]
Granger, Christopher B. [3 ]
机构
[1] Boston Univ, Med Ctr, Boston, MA 02118 USA
[2] Uppsala Univ, Uppsala Clin Res Ctr, Uppsala, Sweden
[3] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC USA
[4] Univ G dAnnunzio, Chieti, Italy
[5] Wilhelminen Hosp, Vienna, Austria
[6] Motol Univ Hosp, Prague, Czech Republic
[7] Hop Bichat Claude Bernard, F-75877 Paris 18, France
[8] Bristol Myers Squibb Co, Princeton, NJ USA
关键词
atrial fibrillation; bleeding; factor Xa inhibitor; PROTHROMBIN COMPLEX CONCENTRATE; VITAMIN-K ANTAGONISTS; RISK-FACTORS; FACTOR VIIA; ANTICOAGULATION; HEMORRHAGE; THERAPY; STROKE; OUTPATIENTS; REVERSAL;
D O I
10.1016/j.jacc.2014.02.549
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives This study sought to characterize major bleeding on the basis of the components of the major bleeding definition, to explore major bleeding by location, to define 30-day mortality after a major bleeding event, and to identify factors associated with major bleeding. Background Apixaban was shown to reduce the risk of major hemorrhage among patients with atrial fibrillation in the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) 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 to 0.80; p < 0.001). Compared with warfarin, major extracranial hemorrhage associated with apixaban led to reduced hospitalization, 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 than in those receiving warfarin (HR 0.50, 95% CI: 0.33 to 0.74; p < 0.001). Older age, prior hemorrhage, prior stroke or transient ischemic attack, diabetes, lower creatinine clearance, decreased hematocrit, aspirin therapy, 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. (c) 2014 by the American College of Cardiology Foundation
引用
收藏
页码:2141 / 2147
页数:7
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