title: Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial.
abstract: BACKGROUND
  Antiarrhythmic drugs are commonly used for prevention of recurrent atrial fibrillation (AF) despite inconsistent efficacy and frequent adverse effects. Catheter ablation has been proposed as an alternative treatment for paroxysmal AF.
  
  
  OBJECTIVE
  To determine the efficacy of catheter ablation compared with antiarrhythmic drug therapy (ADT) in treating symptomatic paroxysmal AF.
  
  
  METHODS
  A prospective, multicenter, randomized (2:1), unblinded, Bayesian-designed study conducted at 19 hospitals of 167 patients who did not respond to at least 1 antiarrhythmic drug and who experienced at least 3 AF episodes within 6 months before randomization. Enrollment occurred between October 25, 2004, and October 11, 2007, with the last follow-up on January 19, 2009.
  
  
  METHODS
  Catheter ablation (n = 106) or ADT (n = 61), with assessment for effectiveness in a comparable 9-month follow-up period.
  
  
  METHODS
  Time to protocol-defined treatment failure. The proportion of patients who experienced major treatment-related adverse events within 30 days of catheter ablation or ADT was also reported.
  
  
  RESULTS
  At the end of the 9-month effectiveness evaluation period, 66% of patients in the catheter ablation group remained free from protocol-defined treatment failure compared with 16% of patients treated with ADT. The hazard ratio of catheter ablation to ADT was 0.30 (95% confidence interval, 0.19-0.47; P < .001). Major 30-day treatment-related adverse events occurred in 5 of 57 patients (8.8%) treated with ADT and 5 of 103 patients (4.9%) treated with catheter ablation. Mean quality of life scores improved significantly in patients treated by catheter ablation compared with ADT at 3 months; improvement was maintained during the course of the study.
  
  
  CONCLUSIONS
  Among patients with paroxysmal AF who had not responded to at least 1 antiarrhythmic drug, the use of catheter ablation compared with ADT resulted in a longer time to treatment failure during the 9-month follow-up period.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00116428.
authors.affiliation: Cardiovascular Institute, Department of Medicine, Loyola University Medical Center, 2160 S First Ave, Bldg 110, Room 6232, Maywood, IL 60153, USA. dwilber@lumc.edu
authors.forename: David J
authors.initials: DJ
authors.lastname: Wilber
authors.forename: Carlo
authors.initials: C
authors.lastname: Pappone
authors.forename: Petr
authors.initials: P
authors.lastname: Neuzil
authors.forename: Angelo
authors.initials: A
authors.lastname: De Paola
authors.forename: Frank
authors.initials: F
authors.lastname: Marchlinski
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
authors.forename: Laurent
authors.initials: L
authors.lastname: Macle
authors.forename: Emile G
authors.initials: EG
authors.lastname: Daoud
authors.forename: Hugh
authors.initials: H
authors.lastname: Calkins
authors.forename: Burr
authors.initials: B
authors.lastname: Hall
authors.forename: Vivek
authors.initials: V
authors.lastname: Reddy
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Augello
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Reynolds
authors.forename: Chandan
authors.initials: C
authors.lastname: Vinekar
authors.forename: Christine Y
authors.initials: CY
authors.lastname: Liu
authors.forename: Scott M
authors.initials: SM
authors.lastname: Berry
authors.forename: Donald A
authors.initials: DA
authors.lastname: Berry
mesh_terms: D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D017211:Treatment Failure
chemical_list: D000889:Anti-Arrhythmia Agents