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Major bleeding with dabigatran and rivaroxaban in patients with atrial fibrillation: a real-world setting.

Author(s): Fontaine GV(1), Mathews KD(2), Woller SC(3), Stevens SM(3), Lloyd JF(4), Evans RS(4).

Affiliation(s): Author information: (1)Department of Pharmacy, Intermountain Medical Center, Murray, UT, USA fontaine.gabe@gmail.com. (2)Department of Pharmacy, Intermountain Medical Center, Murray, UT, USA. (3)Department of Medicine, Intermountain Medical Center, Murray, UT, USA; Department of Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA. (4)Department of Medical Informatics, Intermountain Healthcare, Salt Lake City, UT, USA.

Publication date & source: 2014, Clin Appl Thromb Hemost. , 20(7):665-72

BACKGROUND: Although the rate of bleeding among patients with atrial fibrillation (AF) taking novel oral anticoagulants in randomized controlled trials is described, the rate of bleeding with "real-world" use is uncertain. METHODS: We conducted a retrospective electronic medical record interrogation and subsequent chart review among patients within Intermountain Healthcare between October 2010 and November 2012. Patients were included if they had a diagnosis of AF and were receiving either dabigatran or rivaroxaban. Rates of major bleeding were calculated. RESULTS: Among 2579 patients, 13 (0.5%) experienced major bleeding (95% confidence interval [CI] 0.23-0.77), 5 (0.19%) experienced intracranial hemorrhage (95% CI 0.02-0.36), and 2 (0.08%) experienced fatal bleeding. Of the 13 patients experiencing a major bleed, 8 (61.5%) would have been excluded from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) and Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) clinical trials. CONCLUSION: We observed a rate of major bleeding similar to that reported in randomized clinical trials among patients with AF prescribed dabigatran or rivaroxaban.

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