Po-01-133 real-world comparison of dronedarone vs. sotalol in anti-arrhythmic drug naïve patients with atrial fibrillation

Sotalol and dronedarone have class II/III anti-arrhythmic drug (AAD) properties and are used for rhythm control in atrial fibrillation (AF). While sotalol requires monitoring for proarrhythmia on initiation, dronedarone does not. These treatments have not been compared head-to-head. To compare the safety and clinical outcomes of dronedarone and sotalol in AAD naïve patients using real-world data. Using Veterans Affairs data, we identified 11296 AAD naïve patients with AF prescribed dronedarone or sotalol in 2012 or later. We excluded those with prior conduction disease, pacemaker/ICDs, ventricular arrhythmia, cancer, renal failure, liver disease, or heart failure. We used 1:1 propensity score matching, based on patient demographics, comorbidities, and medications, and Cox regression to compare strategies. We performed falsification analysis against non-plausible outcomes. The matched cohort comprised 6212 patients (3106 dronedarone, 3106 sotalol; age 71±10 yrs, 2.5% female, CHA2DS2-VASC 2 ±1.3; 53.3% and 53.9% on anticoagulants, correspondingly). Dronedarone, compared to sotalol, was associated with lower risk of ventricular pro-arrhythmia and conduction disorders, but there was no significant difference in CV hospitalization or death (Figure). The findings did not falsify for the the composite falsification endpoint of hip fractures, cancer, or infections. Dronedarone had similar effectiveness to sotalol for CV hospitalization with lower risk of ventricular pro-arrhythmia and conduction disorders. These observational data provide the basis for prospective efficacy and safety trials.