Aims: We conducted a multi-centre, prospective, controlled, randomized trial to investigate the adjunctive role of ablation therapy to antiarrhythmic drug therapy in preventing atrial fibrillation (AF) relapses in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy had already failed.
Methods and results: One hundred and thirty seven patients were randomized to ablation and antiarrhythmic drug therapy (ablation group) or antiarrhythmic drug therapy alone (control group). In the ablation group, patients underwent cavo-tricuspid and left inferior pulmonary vein (PV)-mitral isthmus ablation plus circumferential PV ablation. The primary end-point of the study was the absence of any recurrence of atrial arrhythmia lasting >30 s in the 1-year follow-up period, after 1-month blanking period. Three (4.4%) major complications were related to ablation: one patient had a stroke during left atrium ablation, another suffered transient phrenic paralysis, and the third had a pericardial effusion which required pericardiocentesis. After 12 months of follow-up, 63/69 (91.3%) control group patients had at least one AF recurrence, whereas 30/68 (44.1%) (P<0.001) ablation group patients had atrial arrhythmia recurrence (four patients had atrial flutter, 26 patients AF).
Conclusion: Ablation therapy combined with antiarrhythmic drug therapy is superior to antiarrhythmic drug therapy alone in preventing atrial arrhythmia recurrences in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy has already failed.