title: Major bleeding with dabigatran and rivaroxaban in patients with atrial fibrillation: a real-world setting.
abstract: 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.
  
  
  CONCLUSIONS
  We observed a rate of major bleeding similar to that reported in randomized clinical trials among patients with AF prescribed dabigatran or rivaroxaban.
authors.affiliation: Department of Pharmacy, Intermountain Medical Center, Murray, UT, USA fontaine.gabe@gmail.com.
authors.forename: Gabriel V
authors.initials: GV
authors.lastname: Fontaine
authors.affiliation: Department of Pharmacy, Intermountain Medical Center, Murray, UT, USA.
authors.forename: Katy D
authors.initials: KD
authors.lastname: Mathews
authors.affiliation: Department of Medicine, Intermountain Medical Center, Murray, UT, USA; Department of Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA.
authors.forename: Scott C
authors.initials: SC
authors.lastname: Woller
authors.affiliation: Department of Medicine, Intermountain Medical Center, Murray, UT, USA; Department of Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA.
authors.forename: Scott M
authors.initials: SM
authors.lastname: Stevens
authors.affiliation: Department of Medical Informatics, Intermountain Healthcare, Salt Lake City, UT, USA.
authors.forename: James F
authors.initials: JF
authors.lastname: Lloyd
authors.affiliation: Department of Medical Informatics, Intermountain Healthcare, Salt Lake City, UT, USA.
authors.forename: R Scott
authors.initials: RS
authors.lastname: Evans
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001281:Atrial Fibrillation / Q000188:drug therapy / Q000453:epidemiology; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects; D000069604:Dabigatran; D016208:Databases, Factual; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D008297:Male; D016347:Medical Records Systems, Computerized; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage / Q000009:adverse effects; D000069552:Rivaroxaban; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects; D015091:beta-Alanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D001562:Benzimidazoles; D065427:Factor Xa Inhibitors; D009025:Morpholines; D013876:Thiophenes; D015091:beta-Alanine; D000069552:Rivaroxaban; D000069604:Dabigatran
keywords: anticoagulants; bleeding; cardiology; clinical pharmacology; factor Xa inhibitors