title: Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation.
abstract: BACKGROUND
  There are limited data comparing radiofrequency catheter ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation.
  
  
  METHODS
  We randomly assigned 294 patients with paroxysmal atrial fibrillation and no history of antiarrhythmic drug use to an initial treatment strategy of either radiofrequency catheter ablation (146 patients) or therapy with class IC or class III antiarrhythmic agents (148 patients). Follow-up included 7-day Holter-monitor recording at 3, 6, 12, 18, and 24 months. Primary end points were the cumulative and per-visit burden of atrial fibrillation (i.e., percentage of time in atrial fibrillation on Holter-monitor recordings). Analyses were performed on an intention-to-treat basis.
  
  
  RESULTS
  There was no significant difference between the ablation and drug-therapy groups in the cumulative burden of atrial fibrillation (90th percentile of arrhythmia burden, 13% and 19%, respectively; P=0.10) or the burden at 3, 6, 12, or 18 months. At 24 months, the burden of atrial fibrillation was significantly lower in the ablation group than in the drug-therapy group (90th percentile, 9% vs. 18%; P=0.007), and more patients in the ablation group were free from any atrial fibrillation (85% vs. 71%, P=0.004) and from symptomatic atrial fibrillation (93% vs. 84%, P=0.01). One death in the ablation group was due to a procedure-related stroke; there were three cases of cardiac tamponade in the ablation group. In the drug-therapy group, 54 patients (36%) underwent supplementary ablation.
  
  
  CONCLUSIONS
  In comparing radiofrequency ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation, we found no significant difference between the treatment groups in the cumulative burden of atrial fibrillation over a period of 2 years. (Funded by the Danish Heart Foundation and others; MANTRA-PAF ClinicalTrials.gov number, NCT00133211.).
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. jenniels@rm.dk
authors.forename: Jens
authors.initials: J
authors.lastname: Cosedis Nielsen
authors.forename: Arne
authors.initials: A
authors.lastname: Johannessen
authors.forename: Pekka
authors.initials: P
authors.lastname: Raatikainen
authors.forename: Gerhard
authors.initials: G
authors.lastname: Hindricks
authors.forename: Håkan
authors.initials: H
authors.lastname: Walfridsson
authors.forename: Ole
authors.initials: O
authors.lastname: Kongstad
authors.forename: Steen
authors.initials: S
authors.lastname: Pehrson
authors.forename: Anders
authors.initials: A
authors.lastname: Englund
authors.forename: Juha
authors.initials: J
authors.lastname: Hartikainen
authors.forename: Leif Spange
authors.initials: LS
authors.lastname: Mortensen
authors.forename: Peter Steen
authors.initials: PS
authors.lastname: Hansen
mesh_terms: D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000188:drug therapy / Q000601:surgery*; D001282:Atrial Flutter / Q000175:diagnosis; D017115:Catheter Ablation / Q000009:adverse effects; D017281:Cost of Illness; D015716:Electrocardiography, Ambulatory; D005260:Female; D005424:Flecainide / Q000009:adverse effects / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D011405:Propafenone / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents; D011405:Propafenone; D005424:Flecainide