Abstract 4101: The Effect of Dronaderone on Hospitalizations in Patients with Atrial Fibrillation. Results from the ATHENA Study
The ATHENA study has demonstrated that dronaderone reduces a combined endpoint of cardiovascular hospitalizations and cardiovascular death in patients with paroxysmal or persistent atrial fibrillation or flutter (AF). Two previous studies have demonstrated dronaderone to reduce risk of AF recurrence. Here we examine the impact of dronaderone on hospitalizations. ATHENA is a double-blind, placebo controlled parallel group study. Eligible patients needed to have documented AF as well as documented sinus rhythm within 6 months year prior to randomization. Patients further needed to document increased risk by an age above 75 years or an age above 70 years and additionally either diabetes, prior stroke, hypertension, reduced left ventricular function or an enlarged left atrium. New York heart association class IV was an exclusion criterion. Randomized patients received dronaderone 400 mig bid or matching placebo. Mean follow-up was 21 months. The primary outcome was cardiovascular hospitalization or death. Cardiovascular hospitalization was a secondary outcome. There were 675 first cardiovascular hospitalizations on dronaderone and 859 on placebo, hazard ratio 0.75 (95% cl 0.67– 0.82, p<0.001). The main reasons for first hospitalization on dronaderone/placebo were: AF 296/457, ischemic heart disease 93/102, heart failure 78/92. Overall there were 438/511 cardiovascular hospitalizations not related to AF/AFL, hazard ratio 0.86 (0.75– 0.97, p=0.02). There were 516/533 non-cardiovascular hospitalizations, hazard ratio 0.98 (0.87–1.11, p=0.8). Examining total hospitalization burden (cardiovascular and non-cardiovascular) there were 9995 nights in hospital on dronaderone and 13986 on placebo, a reduction of 28% (p<0.001). For cardiovascular hospitalizations the number of nights were 5875/9073, a reduction of 35% (p<0.001). In patients with paroxysmal or persistent AF dronaderone substantially reduces the risk of cardiovascular hospitalization and substantially reduces total hospitalization burden.