title: Characterizing major bleeding in patients with nonvalvular atrial fibrillation: a pharmacovigilance study of 27 467 patients taking rivaroxaban.
abstract: BACKGROUND
  In nonvalvular atrial fibrillation (NVAF), rivaroxaban is used to prevent stroke and systemic embolism.
  
  
  OBJECTIVE
  To evaluate major bleeding (MB) in NVAF patients treated with rivaroxaban in a real-world clinical setting.
  
  
  METHODS
  From January 1, 2013, to March 31, 2014, US Department of Defense electronic health care records were queried to describe MB rates and demographics. Major bleeding was identified using a validated algorithm.
  
  
  RESULTS
  Of 27 467 patients receiving rivaroxaban, 496 MB events occurred in 478 patients, an incidence of 2.86 per 100 person-years (95% confidence interval: 2.61-3.13). The MB patients were older, mean (SD) age of 78.4 (7.7) vs 75.7 (9.7) years, compared with non-MB patients. Patients with MB had higher rates of hypertension (95.6% vs 75.8%), coronary artery disease (64.2% vs 36.7%), heart failure (48.5% vs 23.7%), and renal disease (38.7% vs 16.7%). Of MB patients, 63.2% were taking 20 mg, 32.2% 15 mg, and 4.6% 10 mg of rivaroxaban. Four percent of MB patients took warfarin within the prior 30 days. Major bleeding was most commonly gastrointestinal (88.5%) or intracranial (7.5%). Although 46.7% of MB patients received a transfusion, none had sufficient evidence of receiving any type of clotting factor. Fourteen died during their MB hospitalization, yielding a fatal bleeding incidence rate of 0.08 per 100 person-years (95% confidence interval: 0.05-0.14). Mean age at death was 82.4 years.
  
  
  CONCLUSIONS
  In this large observational study, the MB rate was generally consistent with the registration trial results, and fatal bleeds were rare.
authors.affiliation: Department of Cardiology, Naval Medical Center, Portsmouth, Virginia.
authors.forename: Sally
authors.initials: S
authors.lastname: Tamayo
authors.forename: W
authors.initials: W
authors.lastname: Frank Peacock
authors.forename: Manesh
authors.initials: M
authors.lastname: Patel
authors.forename: Nicholas
authors.initials: N
authors.lastname: Sicignano
authors.forename: Kathleen P
authors.initials: KP
authors.lastname: Hopf
authors.forename: Larry E
authors.initials: LE
authors.lastname: Fields
authors.forename: Troy
authors.initials: T
authors.lastname: Sarich
authors.forename: Shujian
authors.initials: S
authors.lastname: Wu
authors.forename: Daniel
authors.initials: D
authors.lastname: Yannicelli
authors.forename: Zhong
authors.initials: Z
authors.lastname: Yuan
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects*; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D057286:Electronic Health Records; D004617:Embolism / Q000175:diagnosis / Q000401:mortality / Q000517:prevention & control*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced* / Q000175:diagnosis / Q000401:mortality / Q000628:therapy; D017052:Hospital Mortality; D006760:Hospitalization; D006801:Humans; D015994:Incidence; D008297:Male; D008887:Military Medicine; D060735:Pharmacovigilance; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D000069552:Rivaroxaban / Q000009:adverse effects*; D020521:Stroke / Q000175:diagnosis / Q000401:mortality / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D000925:Anticoagulants; D000069552:Rivaroxaban