Risk of major hemorrhage for outpatients treated with warfarin

J Gen Intern Med. 1998 May;13(5):311-6. doi: 10.1046/j.1525-1497.1998.00096.x.


Objective: To determine the incidence of major hemorrhage among outpatients started on warfarin therapy after the recommendation in 1986 for reduced-intensity anticoagulation therapy was made, and to identify baseline patient characteristics that predict those patients who will have a major hemorrhage.

Design: Retrospective cohort study.

Setting: A university-affiliated Veterans Affairs Medical Center.

Patients: Five hundred seventy-nine patients who were discharged from the hospital after being started on warfarin therapy.

Measurements and main results: The primary outcome variable was major hemorrhage. In our cohort of 579 patients, there were 40 first-time major hemorrhages with only one fatal bleed. The cumulative incidence was 7% at 1 year. The average monthly incidence of major hemorrhage was 0.82% during the first 3 months of treatment and decreased to 0.36% thereafter. Three independent predictors of major hemorrhage were identified: a history of alcohol abuse, chronic renal insufficiency, and a previous gastrointestinal bleed. Age, comorbidities, medications known to influence prothrombin levels, and baseline laboratory values were not associated with major hemorrhage.

Conclusions: The incidence of major hemorrhage in this population of outpatients treated with warfarin was lower than previous estimates of major hemorrhage measured before the recommendation for reduced-intensity anticoagulation therapy was made, but still higher than estimates reported from clinical trials. Alcohol abuse, chronic renal insufficiency, and a previous gastrointestinal bleed were associated with increased risk of major hemorrhage.

MeSH terms

  • Aged
  • Alcoholism / epidemiology
  • Ambulatory Care*
  • Anticoagulants / adverse effects*
  • Anticoagulants / therapeutic use
  • Cohort Studies
  • Female
  • Gastrointestinal Hemorrhage / epidemiology
  • Hemorrhage / chemically induced*
  • Hemorrhage / epidemiology
  • Humans
  • Incidence
  • Kidney Failure, Chronic / epidemiology
  • Male
  • Retrospective Studies
  • Risk Factors
  • Warfarin / adverse effects*
  • Warfarin / therapeutic use


  • Anticoagulants
  • Warfarin