Background: Atrial fibrillation (Afib) patients are at an increased risk of stroke. Patients at moderate to high risk of stroke typically receive antithrombotics, placing them at an increased risk of bleeding. The HAS-BLED tool has been validated in Afib patients receiving warfarin for prediction of major bleeding events. Although HAS-BLED has been researched in patients receiving warfarin, this tool has not been validated with the novel anticoagulant rivaroxaban.
Methods: The trial design was retrospective case-control approved by the Institutional Review Board at University of Tennessee Medical Center. Patients who were identified as having a bleeding event were cross-referenced with a list of patients receiving rivaroxaban. Inclusion criteria were adult patients with atrial fibrillation who were taking rivaroxaban for at least six months, with a CHA2DS2-VASc score greater than or equal to 2 OR CHADS2 score greater than or equal to 1. The primary endpoint is the predictive ability of HAS-BLED as measured through the c-statistic. Secondary endpoints include correlation of HAS-BLED and bleeding risk.
Results: After reviewing 9621 medical records, 15 patients met the inclusion criteria for major bleeding. Ninety patients were randomly selected for inclusion as the matched control group. The predictive ability of HAS-BLED was not statistically significant (c statistic = 0.68; p = 0.07), but did show some diagnostic ability to predict major bleeding events. Patients with major bleeding were more likely to have a history of bleeding and use concomitant antiplatelet agents. There were significantly more patients with a HAS-BLED score greater than or equal to 3 in the patients that experienced a major bleeding event.
Conclusion: HAS-BLED demonstrated some diagnostic ability to predict major bleeding events in patients receiving rivaroxaban but this was not statistically significant due to limited sample size.
Credits: Gorman EW; Perkel D; Dennis D; Yates J; Heidel RE; Wortham D