Abstract | BACKGROUND: METHODS AND RESULTS: We compared the effect of apixaban and warfarin on rates of stroke or systemic embolism, major bleeding, and death in patients with and without moderate or severe valvular heart disease using Cox proportional hazards modeling. Of the 18 201 patients enrolled in ARISTOTLE, 4808 (26.4%) had a history of moderate or severe valvular heart disease or previous valve surgery. Patients with valvular heart disease had higher rates of stroke or systemic embolism and bleeding than patients without valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in patients with and without valvular heart disease in reducing stroke and systemic embolism (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.51-0.97 and HR, 0.84; 95%, CI 0.67-1.04; interaction P=0.38), causing less major bleeding (HR, 0.79; 95% CI, 0.61-1.04 and HR, 0.65; 95% CI, 0.55-0.77; interaction P=0.23), and reducing mortality (HR, 1.01; 95% CI, 0.84-1.22 and HR, 0.84; 95% CI, 0.73-0.96; interaction P=0.10). CONCLUSIONS: CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00412984.
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Authors | Alvaro Avezum, Renato D Lopes, Phillip J Schulte, Fernando Lanas, Bernard J Gersh, Michael Hanna, Prem Pais, Cetin Erol, Rafael Diaz, M Cecilia Bahit, Jozef Bartunek, Raffaele De Caterina, Shinya Goto, Witold Ruzyllo, Jun Zhu, Christopher B Granger, John H Alexander |
Journal | Circulation
(Circulation)
Vol. 132
Issue 8
Pg. 624-32
(Aug 25 2015)
ISSN: 1524-4539 [Electronic] United States |
PMID | 26106009
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2015 American Heart Association, Inc. |
Chemical References |
- Anticoagulants
- Pyrazoles
- Pyridones
- apixaban
- Warfarin
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Topics |
- Aged
- Anticoagulants
(therapeutic use)
- Atrial Fibrillation
(diagnosis, drug therapy, epidemiology)
- Female
- Heart Valve Diseases
(diagnosis, drug therapy, epidemiology)
- Humans
- Male
- Middle Aged
- Pyrazoles
(therapeutic use)
- Pyridones
(therapeutic use)
- Stroke
(diagnosis, drug therapy, epidemiology)
- Thromboembolism
(diagnosis, drug therapy, epidemiology)
- Warfarin
(therapeutic use)
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