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A Randomized Trial

Oussama M. Wazni, MD; Nassir F. Marrouche, MD; David O. Martin, MD; Atul Verma, MD; Mandeep Bhargava, MD; Walid Saliba, MD; Dianna Bash, RN; Robert Schweikert, MD; Johannes Brachmann, MD; Jens Gunther, MD; Klaus Gutleben, MD; Ennio Pisano, MD; Dominico Potenza, MD; Raffaele Fanelli, MD; Antonio Raviele, MD; Sakis Themistoclakis, MD; Antonio Rossillo, MD; Aldo Bonso, MD; Andrea Natale, MD

JAMA. 2005;293:2634-2640.

Context  Treatment with antiarrhythmic drugs and anticoagulation is considered first-line therapy in patients with symptomatic atrial fibrillation (AF). Pulmonary vein isolation (PVI) with radiofrequency ablation may cure AF, obviating the need for antiarrhythmic drugs and anticoagulation.

Objective  To determine whether PVI is feasible as first-line therapy for treating patients with symptomatic AF.

Design, Setting, and Participants  A multicenter prospective randomized study conducted from December 31, 2001, to July 1, 2002, of 70 patients aged 18 to 75 years who experienced monthly symptomatic AF episodes for at least 3 months and had not been treated with antiarrhythmic drugs.

Intervention  Patients were randomized to receive either PVI using radiofrequency ablation (n=33) or antiarrhythmic drug treatment (n=37), with a 1-year follow-up.

Main Outcome Measures  Recurrence of AF, hospitalization, and quality of life assessment.

Results  Two patients in the antiarrhythmic drug treatment group and 1 patient in the PVI group were lost to follow-up. At the end of 1-year follow-up, 22 (63%) of 35 patients who received antiarrhythmic drugs had at least 1 recurrence of symptomatic AF compared with 4 (13%) of 32 patients who received PVI (P<.001). Hospitalization during 1-year follow-up occurred in 19 (54%) of 35 patients in the antiarrhythmic drug group compared with 3 (9%) of 32 in the PVI group (P<.001). In the antiarrhythmic drug group, the mean (SD) number of AF episodes decreased from 12 (7) to 6 (4), after initiating therapy (P = .01). At 6-month follow-up, the improvement in quality of life of patients in the PVI group was significantly better than the improvement in the antiarrhythmic drug group in 5 subclasses of the Short-Form 36 health survey. There were no thromboembolic events in either group. Asymptomatic mild or moderate pulmonary vein stenosis was documented in 2 (6%) of 32 patients in the PVI group.

Conclusion  Pulmonary vein isolation appears to be a feasible first-line approach for treating patients with symptomatic AF. Larger studies are needed to confirm its safety and efficacy.

Author Affiliations: Department of Cardiovascular Medicine, Center for Atrial Fibrillation, Cleveland Clinic Foundation, Cleveland, Ohio (Drs Wazni, Marrouche, Martin, Verma, Bhargava, Saliba, Schweikert, and Natale, and Ms Bash); Klinikum Coburg, Coburg, Germany (Drs Brachmann, Gunther, and Gutleben); Casa Sollievo della Sofferenza, San Giovanni, Rotondo, Italy (Drs Pisano, Potenza, and Fanelli); Umberto I Hospital, Mestre, Venice, Italy (Drs Raviele, Themistoclakis, Rossillo, and Bonso).

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