A randomized clinical trial of the efficacy of radiofrequency catheter ablation and amiodarone in the treatment of symptomatic atrial fibrillation.

The limited efficacy and proarrhythmic risks of antiarrhythmia agents have resulted in alternative therapeutic approaches. Radiofrequency ablation has been reported to be an effective treatment of patients with atrial fibrillation. However, there is no randomized clinical trial comparing drug and radiofrequency ablation. The authors randomized 30 patients with chronic atrial fibrillation refractory to medication into amiodarone and radiofrequency ablation. The primary objective of this study was to compare the efficacy of amiodarone and radiofrequency ablation in the maintenance of sinus rhythm at 1 year after randomization. Pulmonary vein isolation and linear ablation of right atrium was the technique used for radiofrequency ablation. There were no significant differences in baseline patient characteristics between the 2 groups. The results of this study showed that the probability of free from atrial fibrillation was better in the radiofrequency ablation group compared to amiodarone (78.6% in the ablation group and 40% in the amiodarone group, p = 0.018). Radiofrequency ablation results in a significant reduction in symptoms relating to atrial fibrillation and a significant improvement in quality of life, whereas amiodarone had no significant effect on symptoms and quality of life. There was an ischemic stroke as a major complication related to radiofrequency ablation. Amiodarone was associated with adverse effects in 46.7 per cent of patients and needed discontinuation in 1 patient. In conclusion, radiofrequency ablation is an effective alternative treatment in patients with atrial fibrillation refractory to medication.