1. Gastrointestinal bleeding in patients with atrial fibrillation treated with Apixaban or warfarin: Insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial.
- Author
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Garcia DA, Fisher DA, Mulder H, Wruck L, De Caterina R, Halvorsen S, Granger CB, Held C, Wallentin L, Alexander JH, and Lopes RD
- Subjects
- Age Factors, Aged, Anticoagulants therapeutic use, Atrial Fibrillation complications, Female, Gastrointestinal Hemorrhage chemically induced, Humans, Intracranial Hemorrhages chemically induced, Male, Middle Aged, Mortality, Proportional Hazards Models, Pyrazoles therapeutic use, Pyridones therapeutic use, Risk, Risk Factors, Severity of Illness Index, Stroke etiology, Treatment Outcome, Warfarin therapeutic use, Anticoagulants adverse effects, Atrial Fibrillation drug therapy, Gastrointestinal Hemorrhage epidemiology, Intracranial Hemorrhages epidemiology, Pyrazoles adverse effects, Pyridones adverse effects, Stroke prevention & control, Warfarin adverse effects
- Abstract
Objectives: A history of gastrointestinal bleeding (GIB) in patients with atrial fibrillation (AF) may impact decisions about anticoagulation treatment. We sought to determine whether prior GIB in patients with AF taking anticoagulants was associated with an increased risk of stroke or major hemorrhage., Methods: We analyzed key efficacy and safety outcomes in patients with prior GIB in ARISTOTLE. Centrally adjudicated outcomes according to GIB history were analyzed using Cox proportional hazards models adjusted for randomized treatment and established risk factors., Results: A total of 784 (4.3%) patients had prior GIB events (321 [41%] lower, 463 [59%] upper); 215 (27%) occurred <1 year before study enrollment. Patients with prior GIB were older, had more comorbidities, and higher CHADS
2 and HAS-BLED scores than those with no GIB. Major GIB occurred more frequently in those with prior GIB (lower: aHR 1.72, 95% CI 0.86-3.42; upper: aHR 3.13, 95% CI 1.97-4.96). This association with major GIB was more pronounced in patients with GIB <1 year before randomization versus no recent GIB (recent lower: aHR 2.58, 95% CI 0.95-7.01; recent upper: aHR 5.16, 95% CI 2.66-10.0). There was no association between prior GIB and risk of stroke/systemic embolism or all-cause death. In those with prior GIB, the apixaban versus warfarin relative risks for stroke/systemic embolism, hemorrhagic stroke, death, or major bleeding were consistent with the results of the overall trial., Conclusions: In patients with AF on oral anticoagulants, prior GIB was associated with an increased risk of subsequent major GIB but not stroke, intracranial bleeding, or all-cause mortality. For the key outcomes of stroke, hemorrhagic stroke, death, and major bleeding, we found no evidence that the treatment effect (apixaban vs. warfarin) was modified by a history of GIB., (Copyright © 2019 Elsevier Inc. All rights reserved.)- Published
- 2020
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