Efficacy and safety of flecainide acetate in the maintenance of sinus rhythm after electrical cardioversion of chronic atrial fibrillation or atrial flutter.

The efficacy and safety of flecainide were studied in the maintenance of sinus rhythm after electrical cardioversion for chronic atrial fibrillation or atrial flutter. Eighty-one patients were randomized to flecainide treatment or no treatment. Baseline characteristics of both groups were comparable. Compared to previous studies, patients could be classified as difficult-to-treat patients. Multiple regression analysis showed New York Heart Association class I for exercise tolerance (p = 0.0004) and flecainide treatment (p = 0.01) to be the main factors increasing the arrhythmia-free episode. However, Mantel-Cox lifetable analysis did not reveal significant differences between arrhythmia-free survival curves of both treatment groups. In the flecainide-treated group, 9% of patients experienced side effects, mostly related to negative dromotropic effects. The incidence of ventricular proarrhythmia in this group of patients was low. Thus, flecainide may be effective in postponing arrhythmia recurrence, even in difficult-to-treat patients. Caution should be excercised in treating patients with underlying conduction disturbances, sick sinus syndrome or characteristics favoring development of ventricular proarrhythmia.

RCT Entities:   Population Interventions Outcomes