Safety of apixaban in combination with dronedarone in patients with atrial fibrillation.

BACKGROUND: There have been concerns about bleeding risks for patients with atrial fibrillation treated with dronedarone in combination with new oral anticoagulants (NOACs). The aim of the study was to compare the bleeding risks with the apixaban + dronedarone and warfarin + dronedarone combinations.

METHOD: Retrospective study of Swedish nationwide health registers. All patients with atrial fibrillation who used dronedarone in combination with apixaban or warfarin during 2013-2016 were identified. Two propensity matched cohorts of each 1681 patients were compared. The main endpoint included intracranial bleeding, bleedings with hospitalization and fatal bleedings.

RESULTS: Bleedings thus defined occurred at rates of 1.31 and 2.14 per 100 years at risk with the apixaban and warfarin combinations respectively (p = 0.121). The hazard ratio with the apixaban combination was 0.66 (CI 0.35-1.23) compared to the warfarin combination. No significant differences were seen regarding secondary endpoints.

CONCLUSION: Major bleedings were rare among patients with atrial fibrillation treated with dronedarone in combination with apixaban or warfarin. No significant differences in favour of either drug combination were found.