Abstract | AIMS: History of bleeding strongly influences decisions for anticoagulation in atrial fibrillation (AF). We analyzed outcomes in relation to history of bleeding and randomization in ARISTOTLE trial patients. METHODS AND RESULTS: The on-treatment safety population included 18,140 patients receiving at least 1 dose of study drug ( apixaban) or warfarin. Centrally adjudicated outcomes in relation to bleeding history were analyzed using a Cox proportional hazards model adjusted for randomized treatment and established risk factors. Efficacy end points were analyzed on the randomized (intention to treat) population. A bleeding history was reported at baseline in 3,033 patients (16.7%), who more often were male, with a history of prior stroke/ transient ischemic attack/systemic embolism and diabetes; higher CHADS2 scores, age, and body weight; and lower creatinine clearance and mean systolic blood pressure. Major (but not intracranial) bleeding occurred more frequently in patients with versus without a history of bleeding (adjusted hazard ratio 1.35, 95% CI 1.14-1.61). There were no significant interactions between bleeding history and treatment for stroke/systemic embolism, hemorrhagic stroke, death, or major bleeding, with fewer outcomes with apixaban versus warfarin for all of these outcomes independent of the presence/absence of a bleeding history. CONCLUSION:
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Authors | Raffaele De Caterina, Ulrika Andersson, John H Alexander, Sana M Al-Khatib, M Cecilia Bahit, Shinya Goto, Michael Hanna, Claes Held, Stefan Hohnloser, Elaine M Hylek, Fernando Lanas, Renato D Lopes, José López-Sendón, Giulia Renda, John Horowitz, Christopher B Granger, Lars Wallentin, ARISTOTLE Investigators |
Journal | American heart journal
(Am Heart J)
Vol. 175
Pg. 175-83
(May 2016)
ISSN: 1097-6744 [Electronic] United States |
PMID | 27179738
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Anticoagulants
- Pyrazoles
- Pyridones
- apixaban
- Warfarin
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Topics |
- Aged
- Anticoagulants
(administration & dosage, adverse effects)
- Atrial Fibrillation
(complications)
- Drug Monitoring
- Female
- Hemorrhage
(chemically induced, diagnosis)
- Humans
- Male
- Middle Aged
- Outcome and Process Assessment, Health Care
- Pyrazoles
(administration & dosage, adverse effects)
- Pyridones
(administration & dosage, adverse effects)
- Stroke
(etiology, prevention & control)
- Thromboembolism
(etiology, prevention & control)
- Warfarin
(administration & dosage, adverse effects)
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