Risk of major bleeding in patients with atrial fibrillation taking dronedarone in combination with a direct acting oral anticoagulant (from a U.S. claims database)
The American Journal of Cardiology — Gandhi SK, Reiffel JA, Boiron R, et al. | October 19, 2021
Concomitant use of dronedarone (an antiarrhythmic drug) and any of the direct oral anticoagulants (DOACs; apixaban, dabigatran, and rivaroxaban) in atrial fibrillation (AF) patients did not result in increased risk of intracranial hemorrhage [ICH] or bleeding at other sites (non-gastrointestinal [GI], non-ICH). However, prospective analyses, preferably randomized controlled studies, are required for further exploration.
This is a retrospective cohort analysis, using the United States Truven Health MarketScan claims, to compare concomitant users of dronedarone to DOAC alone users in patients with AF.
Treatment with dronedarone and apixaban did not confer increased risk of major bleeding (adjusted Hazard Ratio [aHR]: 0.69) vs apixaban alone users.
Use of dronedarone and dabigatran led to a modestly increased risk of GI bleeding but not overall bleeding (aHR bleeding: 1.18; aHR GI bleeding: 1.40) vs dabigatran alone users.
Administration of dronedarone and rivaroxaban resulted in an increased risk of overall bleeding, driven by GI bleeding (aHR bleeding: 1.31; aHR GI bleeding: 1.39) vs rivaroxaban alone users.