Apixaban in patients with atrial fibrillation
N. Engl. j. med
; 364(9): 806-817, 2011. ilus, tab
Article
in English
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1064869
Responsible library:
BR79.1
Localization: BR79.1
ABSTRACT
Background Vitamin K antagonists have been shown to prevent stroke in patients with atrial fibrillation. However, many patients are not suitable candidates for or are unwilling to receive vitamin K antagonist therapy, and these patients have a high risk of stroke. Apixaban, a novel factor Xa inhibitor, may be an alternative treatment for such patients.Methods In a double-blind study, we randomly assigned 5599 patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable to receive apixaban (at a dose of 5 mg twice daily) or aspirin (81 to 324 mgper day), to determine whether apixaban was superior. The mean follow up period was 1.1 years. The primary outcome was the occurrence of stroke or systemic embolism.Results Before enrollment, 40% of the patients had used a vitamin K antagonist. The data and safety monitoring board recommended early termination of the study because of a clear benefit in favor of apixaban. There were 51 primary outcome events (1.6% per year) among patients assigned to apixaban and 113 (3.7% per year) among those assigned to aspirin (hazard ratio with apixaban, 0.45; 95% confidence interval [CI],0.32 to 0.62; P<0.001). The rates of death were 3.5% per year in the apixaban group and 4.4% per year in the aspirin group (hazard ratio, 0.79; 95% CI, 0.62 to 1.02; P = 0.07).There were 44 cases of major bleeding (1.4% per year) in the apixaban group and 39 (1.2% per year) in the aspirin group (hazard ratio with apixaban, 1.13; 95% CI, 0.74 to 1.75; P = 0.57); there were 11 cases of intracranial bleeding with apixaban and 13 with aspirin. The risk of a first hospitalization for cardiovascular causes was reduced with apixaban as compared with aspirin (12.6% per year vs. 15.9% per year, P<0.001). The treatment effects were consistent among important subgroups...
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Collection:
National databases
/
Brazil
Health context:
SDG3 - Target 3.4 Reduce premature mortality due to noncommunicable diseases
Health problem:
Cardiovascular Disease
Database:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Main subject:
Patients
/
Atrial Fibrillation
/
Vitamin K
/
Pharmaceutical Preparations
Type of study:
Controlled clinical trial
Language:
English
Journal:
N. Engl. j. med
Year:
2011
Document type:
Article
Institution/Affiliation country:
Bristol-Myers Squibb/US
/
Cardiology Research and Production Center/RU
/
City Hospital/GB
/
Clinical Research Centre/MY
/
Department of Medicine, University of Cape Town/ZA
/
Estudios Clinícos Latinoamérica/AR
/
FuWai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College/CN
/
HRB Clinical Research Facility/IE
/
Harapan Kita Hospital/ID
/
Institute of Cardiology/UA