Antiarrhythmic drugs are commonly used for prevention of recurrent atrial fibrillation
(AF) despite inconsistent efficacy and frequent adverse effects. Catheter ablation
has been proposed as an alternative treatment for paroxysmal AF.
To determine the efficacy of catheter ablation compared with antiarrhythmic drug therapy
(ADT) in treating symptomatic paroxysmal AF.
A prospective, multicenter, randomized (2:1), unblinded, Bayesian-designed study conducted
at 19 hospitals of 167 patients who did not respond to at least 1 antiarrhythmic drug
and who experienced at least 3 AF episodes within 6 months before randomization. Enrollment
occurred between October 25, 2004, and October 11, 2007, with the last follow-up on
January 19, 2009.
Catheter ablation (n = 106) or ADT (n = 61), with assessment for effectiveness in
a comparable 9-month follow-up period.
Time to protocol-defined treatment failure. The proportion of patients who experienced
major treatment-related adverse events within 30 days of catheter ablation or ADT
was also reported.
At the end of the 9-month effectiveness evaluation period, 66% of patients in the
catheter ablation group remained free from protocol-defined treatment failure compared
with 16% of patients treated with ADT. The hazard ratio of catheter ablation to ADT
was 0.30 (95% confidence interval, 0.19-0.47; P < .001). Major 30-day treatment-related
adverse events occurred in 5 of 57 patients (8.8%) treated with ADT and 5 of 103 patients
(4.9%) treated with catheter ablation. Mean quality of life scores improved significantly
in patients treated by catheter ablation compared with ADT at 3 months; improvement
was maintained during the course of the study.
Among patients with paroxysmal AF who had not responded to at least 1 antiarrhythmic
drug, the use of catheter ablation compared with ADT resulted in a longer time to
treatment failure during the 9-month follow-up period.
clinicaltrials.gov Identifier: NCT00116428.