Pulmonary vein isolation (PVI) with radiofrequency ablation is safe for patients with symptomatic atrial fibrillation (AF) and significantly superior to the current first-line therapy approach of antiarrhythmic drugs (AAD), according to trial results presented May 11 at the 33rd annual scientific sessions of the Heart Rhythm Society.
Carlos Morillo, MD, of the department of medicine at McMaster University in Hamilton, Ontario, and colleagues aimed to assess whether catheter-based PVI ablation is superior to AAD as first-line therapy in patients with symptomatic paroxysmal/persistent AF who have not been previously treated with antiarrhythmic drugs.
The primary efficacy outcome was time to first recurrence of AF as documented by electrocardiography. The higher percentage of patients that reached AF, the less favorable the outcome.
The trial followed a total of 127 patients at 16 healthcare centers in five countries. Sixty-six were randomized to receive ablation and 61 were randomized to treatment with AAD. Mean age of patients was 55 years, and 76 percent were male. Nearly half had a history of paroxysmal/persistent AF, and mean follow-up was more than 25 months.
Results showed that among the AAD group of patients, 72 percent reached AF. This compares to 55 percent of patients in the PVI ablation group who reached the primary efficacy outcome.
Morillo and colleagues also tracked the proportion of patients with an occurrence of a cluster of serious complications. No deaths were reported in either group, though 20 percent of the AAD group and 8 percent of the ablation group suffered serious complications.
“The analysis revealed that a higher rate of adverse events occur in patients who begin antiarrhythmic drugs first, which is currently the recommended first-line treatment practice,” said Morillo.
Secondary outcomes were more favorable in the PVI ablation group as compared with the AAD group. Overall, PVI ablation showed a 46 percent relative risk reduction in extending time to first recurrence of symptomatic and asymptomatic AF, atrial flutter and atrial tachycardia.
“These findings support the indication of radiofrequency pulmonary vein isolation as the first-line therapy in patients with paroxysmal atrial fibrillation,” said Morillo.