What is the best treatment for patients with paroxysmal atrial fibrillation who have failed at least one trial of an antiarrhythmic drug?
There is a desparate need for a large, well-designed study comparing catheter ablation with medical therapy for different groups of patients with atrial fibrillation (AF). Although this study and others have shown that the procedure can be effective, the improvements in symptoms and in quality of life are of questionable significance, and serious complications can occur. (LOE = 1b-)
Jaïs P, Cauchemez B, Macle L, et al. Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: The A4 study. Circulation 2008; 118(24):2498-2505. [PMID:19029470]
Randomized controlled trial (nonblinded)
There are relatively few studies comparing catheter ablation with antiarrhythmic drug therapy (ADT) for paroxysmal AF. A systematic review published in 2008 identified 4 studies with 214 patients that found some evidence of better quality of life and recurrence free survival, but also some serious complications of the ablation procedure, such as stroke (Arch Intern Med 2008; 168: 581-6). In this study, 112 patients who had failed at least 1 attempt at ADT were randomized to either catheter ablation or ADT using 1 or more alternate drugs. This was a fairly young group of patients, with a mean age of 51 years; 85% were men. They had a mean of 12 episodes of AF per month with a mean duration of 5.5 hours per episode. Patients were followed up for 1 year, at which time more patients in the catheter ablation group were free of recurrent AF (89% vs 23%; P < .0001; number needed to treat = 2). Analysis was by intention to treat, but the method of randomization or allocation concealment, if any, was not described. Outcomes were also not blindly assessed, and the source of funding was not disclosed. There were many crossovers from ADT to ablation (63%), but few from ablation to ADT (9%). Patients who underwent ablation had somewhat better physical and mental component scores than those in the ADT group, but the differences were unlikely to be clinically signficant. Mean symptom severity and frequency improved in both groups, and although statistically significant, the clinical significance was similarly questionable. Patients undergoing ablation procedures had 2 episodes of cardiac tamponade and 2 groin hematomas, as well as 1 patient who required stenting of the pulmonary vein.
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