Gandhi SK, Reiffel JA, Boiron R, et al. - 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.