Efficacy of propafenone for maintaining sinus rhythm in patients with recent onset or persistent atrial fibrillation after conversion: a randomized, placebo-controlled study

Abstract

Objective — The aim of this study was to investigate the efficacy and safety of propafenone in the prevention of atrial fibrillation (AF) relapse after restoration of sinus rhythm.Methods — This study consisted of 110 consecutive patients with recent onset and persistent AF. After restoration of sinus rhythm, patients were randomized to propafenone (n: 58, age: 60 ± 12 years) or placebo (n: 52, age: 62 ± 10 years).There were 11 withdrawals (7 in the propafenone and 4 in the placebo group) during follow-up. Follow-up evalutations were conducted at the first, 3rd and then at an interval of three months during 15 months. The clinical characteristics in both groups were comparable.The AF relapse was analysed by the Kaplan-Meier method.Results — At 15-month follow-up, AF relapsed in 20 (39%) and 31 (65%) patients in the propafenone and placebo groups, respectively (p = 0.015). In subgroup analysis, AF recurrence was significantly lower in the propafenone group than in the placebo group only in the recent onset AF patients with spontaneous conversion (21% vs. 61%, p = 0.01). However, the AF relapse rates were similar in patients with persistent AF and with recent AF who converted to sinus rhythm pharmacologically or electrically in the propafenone and placebo groups. Four patients on propafenone and one on placebo had adverse effects necessitating discontinuation of the drug (p = 0.36).Conclusion — At 15 months, propafenone seems to be superior to placebo for maintaining sinus rhythm in patients with recent onset or peristent AF. This superiority originates mainly from patients with recent onset AF in whom sinus rhythm occurred spontaneously. Its adverse effects are similar to placebo. (Acta Cardiol 2004; 59(3): 255-261)