title: Radiofrequency catheter ablation and antiarrhythmic drug therapy: a prospective, randomized, 4-year follow-up trial: the APAF study.
abstract: BACKGROUND
  Information on comparative outcome between radiofrequency catheter ablation (RFA) and antiarrhythmic drugs (AADs) >1 year after randomization is important for clinical decision-making.
  
  
  RESULTS
  A total of 198 patients (age, 56 ± 10 years) with paroxysmal atrial fibrillation were randomly assigned to RFA (99 patients) or to AADs (99 patients). We evaluated efficacy of RFA or AADs in a comparable 48-month follow-up period according to intention-to-treat analysis. Cardiac rhythm was assessed with daily transtelephonic transmissions. Quality of life was also analyzed. At 4 years, among the 99 patients first assigned to RFA, the procedure was repeated because of recurrent atrial fibrillation/atrial tachycardia in 27 patients (27.3%). Among the 99 patients randomly assigned to AADs, 87 (87.9%) crossed over to undergo RFA and 4 years after random assignment only 12 (12.1%) were in sinus rhythm with AAD alone without ablation. Despite the high level of crossovers, at 4 years the intention-to-treat analysis showed that 72.7% of patients in the ablation arm and 56.5% of those initially randomly assigned to AADs were free of recurrent atrial fibrillation/atrial tachycardia (P=0.017). During the follow-up, 19.2% of AAD patients progressed to persistent atrial fibrillation before switching to RFA. RFA significantly improved quality of life (P<0.001), whereas before crossing over to RFA, patients receiving AADs showed poorer quality of life. Except for new left atrial tachycardia, there were no serious complications caused by RFA.
  
  
  CONCLUSIONS
  With follow-up extended to 4 years after randomly assigned, ablation remains superior to antiarrhythmic drug in these patients with paroxysmal atrial fibrillation.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00340314.
authors.affiliation: San Raffaele University Hospital, Milan, Italy. cpappone@gvm-vmc.it
authors.forename: Carlo
authors.initials: C
authors.lastname: Pappone
authors.forename: Gabriele
authors.initials: G
authors.lastname: Vicedomini
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Augello
authors.forename: Francesco
authors.initials: F
authors.lastname: Manguso
authors.forename: Massimo
authors.initials: M
authors.lastname: Saviano
authors.forename: Mario
authors.initials: M
authors.lastname: Baldi
authors.forename: Andrea
authors.initials: A
authors.lastname: Petretta
authors.forename: Luigi
authors.initials: L
authors.lastname: Giannelli
authors.forename: Zarko
authors.initials: Z
authors.lastname: Calovic
authors.forename: Vladimir
authors.initials: V
authors.lastname: Guluta
authors.forename: Luigi
authors.initials: L
authors.lastname: Tavazzi
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Santinelli
mesh_terms: D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects; D016009:Chi-Square Distribution; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination; D004452:Echocardiography; D015716:Electrocardiography, Ambulatory; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012008:Recurrence; D011795:Surveys and Questionnaires; D013617:Tachycardia, Supraventricular / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery*; D013686:Telemetry; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents