A prospective, randomized controlled trial comparing the efficacy and safety of sotalol, amiodarone, and digoxin for the reversion of new-onset atrial fibrillation

Study objective: A prospective, randomized controlled trial of new-onset at rial fibrillation was conducted to compare the efficacy and safety of sotal ol and amiodarone (active treatment) with rate control by digoxin atone for successful reversion to sinus rhythm at 48 hours. Methods: We prospectively randomly assigned 120 patients with atrial fibril lation of less than 24 hours' duration to treatment with sotalol, amiodaron e, or digoxin using a single intravenous dose followed by 48 hours of oral treatment. Patients had ECG monitoring for 48 hours, and time of reversion, adequacy of rate control, and numbers of adverse events were compared. Aft er 48 hours, those still in atrial fibrillation under went cardioversion ac cording to a standardized protocol. After 48 hours of therapy and attempted cardioversion, the number of patients whose rhythms had successfully rever ted were compared. Results: There was a significant reduction in the time to reversion with bo th sotalol (13.0+/-2.5 hours, P<.01) and amiodarone (18.1+/-2.9 hours, P<.0 5) treatment compared with digoxin only (26.9+/-3.4 hours). By 48 hours, th e active treatment group was significantly more likely to have reverted to sinus rhythm than the rate control group (95% versus 78%, P<.05; risk ratio 5.4, 95% confidence interval [CI] 1.5 to 19.2). In those patients whose rh ythms did not revert to sinus rhythm, there was superior ventricular rate c ontrol in the sotalol group at both 24 and 48 hours compared with those who received either amiodarone or digoxin. There were also fewer adverse event s in the active treatment group compared with the rate control group. Conclusion: Immediate pharmacologic therapy for new-onset atrial fibrillati on with class III antiarrhythmic drugs (sotalol or amiodarone) improves com plication-free 48-hour reversion rates compared with rate control with digo xin.