Apixaban versus warfarin in patients with atrial fibrillation. Granger, C. B., Alexander, J. H., McMurray, J. J. V., Lopes, R. D., Hylek, E. M., Hanna, M., Al-Khalidi, H. R., Ansell, J., Atar, D., Avezum, A., Bahit, M. C., Diaz, R., Easton, J. D., Ezekowitz, J. A., Flaker, G., Garcia, D., Geraldes, M., Gersh, B. J., Golitsyn, S., Goto, S., Hermosillo, A. G., Hohnloser, S. H., Horowitz, J., Mohan, P., Jansky, P., Lewis, B. S., Lopez-Sendon, J. L., Pais, P., Parkhomenko, A., Verheugt, F. W. A., Zhu, J., Wallentin, L., ARISTOTLE Committees, & Investigators The New England Journal of Medicine, 365(11):981–992, September, 2011.
Apixaban versus warfarin in patients with atrial fibrillation [link]Paper  doi  abstract   bibtex   
BACKGROUND: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. METHODS: In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. RESULTS: The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P\textless0.001 for noninferiority; P=0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P\textless0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P=0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P\textless0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P=0.42). CONCLUSIONS: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.).
@article{granger_apixaban_2011,
	title = {Apixaban versus warfarin in patients with atrial fibrillation},
	volume = {365},
	issn = {1533-4406},
	url = {http://www.nejm.org/doi/full/10.1056/NEJMoa1107039},
	doi = {10.1056/NEJMoa1107039},
	abstract = {BACKGROUND: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin.
METHODS: In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause.
RESULTS: The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27\% per year in the apixaban group, as compared with 1.60\% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95\% confidence interval [CI], 0.66 to 0.95; P{\textless}0.001 for noninferiority; P=0.01 for superiority). The rate of major bleeding was 2.13\% per year in the apixaban group, as compared with 3.09\% per year in the warfarin group (hazard ratio, 0.69; 95\% CI, 0.60 to 0.80; P{\textless}0.001), and the rates of death from any cause were 3.52\% and 3.94\%, respectively (hazard ratio, 0.89; 95\% CI, 0.80 to 0.99; P=0.047). The rate of hemorrhagic stroke was 0.24\% per year in the apixaban group, as compared with 0.47\% per year in the warfarin group (hazard ratio, 0.51; 95\% CI, 0.35 to 0.75; P{\textless}0.001), and the rate of ischemic or uncertain type of stroke was 0.97\% per year in the apixaban group and 1.05\% per year in the warfarin group (hazard ratio, 0.92; 95\% CI, 0.74 to 1.13; P=0.42).
CONCLUSIONS: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.).},
	language = {eng},
	number = {11},
	journal = {The New England Journal of Medicine},
	author = {Granger, Christopher B. and Alexander, John H. and McMurray, John J. V. and Lopes, Renato D. and Hylek, Elaine M. and Hanna, Michael and Al-Khalidi, Hussein R. and Ansell, Jack and Atar, Dan and Avezum, Alvaro and Bahit, M. Cecilia and Diaz, Rafael and Easton, J. Donald and Ezekowitz, Justin A. and Flaker, Greg and Garcia, David and Geraldes, Margarida and Gersh, Bernard J. and Golitsyn, Sergey and Goto, Shinya and Hermosillo, Antonio G. and Hohnloser, Stefan H. and Horowitz, John and Mohan, Puneet and Jansky, Petr and Lewis, Basil S. and Lopez-Sendon, Jose Luis and Pais, Prem and Parkhomenko, Alexander and Verheugt, Freek W. A. and Zhu, Jun and Wallentin, Lars and {ARISTOTLE Committees and Investigators}},
	month = sep,
	year = {2011},
	pmid = {21870978},
	keywords = {Aged, Anticoagulants, Atrial Fibrillation, Double-Blind Method, Factor Xa Inhibitors, Female, Follow-Up Studies, Hemorrhage, Humans, International Normalized Ratio, Kaplan-Meier Estimate, Male, Middle Aged, Pyrazoles, Pyridones, Stroke, Thromboembolism, Treatment Outcome, Warfarin},
	pages = {981--992},
}
Downloads: 0
About
Documentation
Keywords
Search
Users
Terms and Conditions of Use
Privacy Policy
Sitemap
© BibBase.org 2021