Characterizing major bleeding in patients with nonvalvular atrial fibrillation: a pharmacovigilance study of 27 467 patients taking rivaroxaban

Clin Cardiol. 2015 Feb;38(2):63-8. doi: 10.1002/clc.22373. Epub 2015 Jan 14.

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.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anticoagulants / adverse effects*
  • Atrial Fibrillation / diagnosis
  • Atrial Fibrillation / drug therapy*
  • Atrial Fibrillation / mortality
  • Electronic Health Records
  • Embolism / diagnosis
  • Embolism / mortality
  • Embolism / prevention & control*
  • Female
  • Hemorrhage / chemically induced*
  • Hemorrhage / diagnosis
  • Hemorrhage / mortality
  • Hemorrhage / therapy
  • Hospital Mortality
  • Hospitalization
  • Humans
  • Incidence
  • Male
  • Military Medicine
  • Pharmacovigilance
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Rivaroxaban / adverse effects*
  • Stroke / diagnosis
  • Stroke / mortality
  • Stroke / prevention & control*
  • Time Factors
  • Treatment Outcome
  • United States / epidemiology

Substances

  • Anticoagulants
  • Rivaroxaban