This randomized study compared the efficacy and safety of amiodarone, propafenone and sotalol in the prevention of atrial fibrillation.
Methods: The population consisted of 214 consecutive patients (mean age 64 +/- 8 years, 106 men) with recurrent symptomatic atrial fibrillation. After restoration of sinus rhythm, patients were randomized to amiodarone (200 mg/day), propafenone (450 mg/day) or sotalol (320 +/- 20 mg/day). Follow-up evaluations were conducted at 1, 2, 4 and 6 months, and at 3-month intervals thereafter. The proportion of patients developing recurrent atrial fibrillation and/or experiencing unacceptable adverse effects was measured in the three groups by the Kaplan-Meier method.
Results: Recurrent atrial fibrillation occurred in 25 of the 75 patients treated with amiodarone compared to 51 of the 75 patients treated with sotalol and 24 of the 64 patients treated with propafenone. Fourteen patients treated with amiodarone, five with sotalol, and one with propafenone experienced adverse effects while in sinus rhythm, necessitating discontinuation of treatment (P < 0.001 for amiodarone and propafenone vs sotalol). The difference between amiodarone and propafenone was statistically nonsignificant when all events were included in the analysis. However, if the analysis was limited to recurrent atrial fibrillation events, amiodarone was more effective than propafenone (P < 0.05).
Conclusions: Amiodarone and propafenone were superior to sotalol in maintaining long-term normal sinus rhythm in patients with atrial fibrillation. Amiodarone tended to be superior to propafenone, though its long-term efficacy was limited by adverse side effects.