A randomized placebo-controlled trial with amiodarone for persistent atrial fibrillation in rheumatic mitral stenosis after successful balloon mitral valvuloplasty

OBJECTIVE: Atrial fibrillation is the most common sustained arrhythmia in patients with rheumatic heart disease (RHD). This study was conducted to determine the maintenance of sinus rhythm with amiodarone therapy following DC cardioversion (DCCV), early after successful balloon mitral valvuloplasty (BMV). METHODS: Patients were randomized to amiodarone group and placebo group and their baseline characteristics were recorded. DCCV was done 48 h after BMV. After cardioversion, oral amiodarone was started initially 200 mg three times a day for 2 weeks, then 200 mg twice daily for two weeks followed by 200 mg once daily for 12 months. Patients in placebo group received DCCV alone without preloading amiodarone. After DCCV, they were given placebo for 12 months. RESULTS: The 3 months follow-up period was completed by 77 patients (95%). Of them, 31 (77.5%) patients in amiodarone group and 14 (34.1%) in placebo group remained in sinus rhythm (SR). The 12 months follow-up period was completed by 73 patients (90.1%). Of them, 22 (55%) patients in amiodarone group and 7 (17.1%) in placebo group remained in SR. CONCLUSION: We conclude that amiodarone is more effective than placebo in maintenance of SR at the end of 3 months following successful cardioversion and more patients continued to remain in SR even at the end of 12 months without major serious adverse effects.