title: Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  Patients were randomized to receive either PVI using radiofrequency ablation (n=33) or antiarrhythmic drug treatment (n=37), with a 1-year follow-up.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Cardiovascular Medicine, Center for Atrial Fibrillation, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
authors.forename: Oussama M
authors.initials: OM
authors.lastname: Wazni
authors.forename: Nassir F
authors.initials: NF
authors.lastname: Marrouche
authors.forename: David O
authors.initials: DO
authors.lastname: Martin
authors.forename: Atul
authors.initials: A
authors.lastname: Verma
authors.forename: Mandeep
authors.initials: M
authors.lastname: Bhargava
authors.forename: Walid
authors.initials: W
authors.lastname: Saliba
authors.forename: Dianna
authors.initials: D
authors.lastname: Bash
authors.forename: Robert
authors.initials: R
authors.lastname: Schweikert
authors.forename: Johannes
authors.initials: J
authors.lastname: Brachmann
authors.forename: Jens
authors.initials: J
authors.lastname: Gunther
authors.forename: Klaus
authors.initials: K
authors.lastname: Gutleben
authors.forename: Ennio
authors.initials: E
authors.lastname: Pisano
authors.forename: Dominico
authors.initials: D
authors.lastname: Potenza
authors.forename: Raffaele
authors.initials: R
authors.lastname: Fanelli
authors.forename: Antonio
authors.initials: A
authors.lastname: Raviele
authors.forename: Sakis
authors.initials: S
authors.lastname: Themistoclakis
authors.forename: Antonio
authors.initials: A
authors.lastname: Rossillo
authors.forename: Aldo
authors.initials: A
authors.lastname: Bonso
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
mesh_terms: D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000628:therapy*; D017115:Catheter Ablation; D006801:Humans; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011667:Pulmonary Veins; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents