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J Am Coll Cardiol. 2014 May 27;63(20):2141-2147. doi: 10.1016/j.jacc.2014.02.549. Epub 2014 Mar 19.

Major bleeding in patients with atrial fibrillation receiving apixaban or warfarin: The ARISTOTLE Trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation): Predictors, Characteristics, and Clinical Outcomes.

Author information

1
Boston University Medical Center, Boston, Massachusetts. Electronic address: ehylek@bu.edu.
2
Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
3
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
4
G. d'Annunzio University, Chieti, Italy.
5
Wilhelminen Hospital, Vienna, Austria.
6
Motol University Hospital, Prague, Czech Republic.
7
Hôpital Bichat-Claude Bernard, Paris, France.
8
Bristol-Myers Squibb, Princeton, New Jersey.

Abstract

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.

KEYWORDS:

atrial fibrillation; bleeding; factor Xa inhibitor

PMID:
24657685
DOI:
10.1016/j.jacc.2014.02.549
[Indexed for MEDLINE]
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