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European Heart Journal Advance Access originally published online on October 7, 2005
European Heart Journal 2006 27(2):216-221; doi:10.1093/eurheartj/ehi583
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© The European Society of Cardiology 2005. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study){dagger}

Giuseppe Stabile1,*, Emanuele Bertaglia2, Gaetano Senatore3, Antonio De Simone1, Franco Zoppo2, Giovanni Donnici3, Pietro Turco1, Pietro Pascotto2, Massimo Fazzari3 and Dino Franco Vitale4

1Laboratorio di Elettrofisiologia, Casa di Cura San Michele, Maddaloni (CE), Italy
2Ospedale Civile di Mirano, Mirano (VE), Italy
3Ospedale Civile di Ciriè, Ciriè (TO), Italy
4Fondazione Salvatore Maugeri, I.R.C.C.S., Istituto Scientifico di Telese, Telese (BN), Italy

Received 10 April 2005; revised 8 September 2005; accepted 22 September 2005; online publish-ahead-of-print 7 October 2005.

* Corresponding author. Tel: +39 0823208503; fax: +39 0823402474. E-mail address: gmrstabile{at}tin.it

See page 130 for the editorial comment on this article (doi:10.1093/eurheartj/ehi625)

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.

Key Words: Catheter ablation • Fibrillation


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