Modified HAS-BLED Score and Risk of Major Bleeding in Patients Receiving Dabigatran and Rivaroxaban: A Retrospective, Case-Control Study

OBJECTIVE: To determine if a modified HAS-BLED score (hypertension, abnormal renal/liver dysfunction, stroke, bleeding history, elderly, drugs) predicts risk for major bleeding in patients prescribed dabigatran or rivaroxaban. DESIGN: A retrospective, case-control study. SETTING: Two inpatient medical centers. PATIENTS: Patients prescribed dabigatran or rivaroxaban who experienced a major bleed from June 1, 2011, to August 31, 2013. INTERVENTIONS: Medication and demographic information were collected for patients who experienced a major bleeding episode. Each bleeding case was matched to four control patients based on drug, indication, month and year, and hospital. MAIN OUTCOME MEASURES: The primary outcome was the association between a modified HAS-BLED score and major bleeding in patients receiving dabigatran or rivaroxaban. The secondary objective was to determine which risk factors, whether individual components of HAS-BLED or alternative variables, were associated with major bleeding in patients receiving dabigatran or rivaroxaban. RESULTS: Thirty-eight major bleeds were identified, with 23 bleeds having occurred in patients receiving rivaroxaban, and 15 patients taking dabigatran. The most frequent type of bleed was gastrointestinal. Logistic regression yielded only protime (P < 0.001) and albumin (P < 0.042) as statistically significant risk factors for bleeding. CONCLUSIONS: A modified HAS-BLED score was not predictive of risk of major bleeding in this cohort of primarily elderly patients taking dabigatran or rivaroxaban.