Effects of dronedarone on clinical outcomes in patients with lone atrial fibrillation: pooled post hoc analysis from the ATHENA/EURIDIS/ADONIS studies.

INTRODUCTION Dronedarone has been shown to reduce cardiovascular hospitalizations or death in patients with atrial fibrillation (AF) and additional risk factors. This post hoc exploratory analysis examines its effects in the subgroup of lone AF patients. METHODS AND RESULTS Individual data from patients with lone AF enrolled in the EURIDIS, ADONIS, and ATHENA trials were entered in a central database. The effects of dronedarone compared to placebo on the composite endpoint of cardiovascular hospitalizations or death, and their individual components, were evaluated. A total of 432 (192 placebo and 240 dronedarone) patients (7% of the total population) were classified as having lone AF (69.4% male patients, mean age 64 ± 13 years). The patients were followed for 13.8 ± 7.2 months. The risk for first cardiovascular hospitalizations or death from any cause in the placebo group after 1 year was 25% in the lone AF group compared to 29% the rest of the population. For patients with lone AF, dronedarone led to a 44% reduction of cardiovascular hospitalizations or death (hazard ratio (HR) 0.56; 95%CI 0.36-0.88, P = 0.004) and to a 46% reduction in cardiovascular hospitalizations alone (HR 0.54; 95%CI 0.34-0.87, P = 0.004) compared to placebo. HR for all-cause mortality was 1.02 (95%CI 0.31-3.34, P = 0.885). All findings were homogeneous across the 3 studies and similar to those observed in the overall population. CONCLUSION According to this post hoc analysis, patients with lone AF have a high risk for cardiovascular hospitalization within 1 year. Dronedarone when added to standard of care reduces the risk of cardiovascular hospitalizations in this population.