title: Long-term efficacy of catheter ablation as first-line therapy for paroxysmal atrial fibrillation: 5-year outcome in a randomised clinical trial.
abstract: The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial compared radiofrequency catheter ablation (RFA) with antiarrhythmic drug therapy (AAD) as first-line treatment for paroxysmal atrial fibrillation (AF). Endpoint of ablation was elimination of electrical activity inside pulmonary veins. We present the results of the 5-year follow-up.
  
  
  
  This pre-specified 5-year follow-up included assessment of any AF and symptomatic AF burden by one 7-day Holter recording and quality of life (QoL) assessment, using SF-36 questionnaire physical and mental component scores. Analysis was intention-to-treat. Imputation was used to compensate for missing Holter data.
  
  
  
  245 of 294 patients (83%) randomised to RFA (n=125) or AAD (n=120) attended the 5-year follow-up, 227 with Holter recording. Use of class I or III AAD was more frequent in AAD group (N=61 vs 13, p<0.001). More patients in the RFA group were free from AF (126/146 (86%) vs 105/148 (71%), p=0.001, relative risk (RR) 0.82; 95% CI 0.73 to 0.93) and symptomatic AF (137/146 (94%) vs 126/148 (85%), p=0.015, χ2test, RR 0.91; 95% CI 0.84 to 0.98) in 7-day Holter recording. AF burden was significantly lower in the RFA group (any AF: p=0.003; symptomatic AF: p=0.02). QoL scores did not differ between randomisation groups. QoL scores remained improved from baseline (both components p<0.001), and did not differ from 2-year scores.
  
  
  
  At 5 years, the occurrence and burden of any AF and symptomatic AF were significantly lower in the RFA group than in the AAD group. Improved QoL scores observed after 2 years persisted after 5 years without between-group differences.
  
  
  
  NCT00133211; Results.
authors: Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.
authors: Jens Cosedis
authors: JC
authors: Nielsen
authors: Gentofte University Hospital, Copenhagen, Denmark.
authors: Arne
authors: A
authors: Johannessen
authors: Heart Center Co. Tampere University Hospital, Tampere, Finland.
authors: Pekka
authors: P
authors: Raatikainen
authors: Leipzig University Hospital, Leipzig, Germany.
authors: Gerhard
authors: G
authors: Hindricks
authors: Department of Cardiology, Linköping University, Linköping, Sweden.|Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
authors: Håkan
authors: H
authors: Walfridsson
authors: Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen, Denmark.
authors: Steen Michael
authors: SM
authors: Pehrson
authors: Department of Medicine, University Hospital, Örebro, Sweden.
authors: Anders
authors: A
authors: Englund
authors: Kuopio University Hospital, Kuopio, Finland.
authors: Juha
authors: J
authors: Hartikainen
authors: UNI-C, Danish Information Technology Centre for Education and Research, Aarhus, Denmark.
authors: Leif Spange
authors: LS
authors: Mortensen
authors: Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.
authors: Peter Steen
authors: PS
authors: Hansen
mesh_terms: D000200:Action Potentials; D000368:Aged; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects; D016009:Chi-Square Distribution; D003718:Denmark; D018572:Disease-Free Survival; D015716:Electrocardiography, Ambulatory; D005260:Female; D006339:Heart Rate; D006801:Humans; D008297:Male; D008875:Middle Aged; D011667:Pulmonary Veins / Q000503:physiopathology / Q000601:surgery*; D011788:Quality of Life; D012008:Recurrence; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: Catheter ablation