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Original article
Long-term efficacy of catheter ablation as first-line therapy for paroxysmal atrial fibrillation: 5-year outcome in a randomised clinical trial
  1. Jens Cosedis Nielsen1,
  2. Arne Johannessen2,
  3. Pekka Raatikainen3,
  4. Gerhard Hindricks4,
  5. Håkan Walfridsson5,6,
  6. Steen Michael Pehrson7,
  7. Anders Englund8,
  8. Juha Hartikainen9,
  9. Leif Spange Mortensen10,
  10. Peter Steen Hansen1
  11. for the MANTRA-PAF Investigators
  1. 1 Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark
  2. 2 Gentofte University Hospital, Copenhagen, Denmark
  3. 3 Heart Center Co. Tampere University Hospital, Tampere, Finland
  4. 4 Leipzig University Hospital, Leipzig, Germany
  5. 5 Department of Cardiology, Linköping University, Linköping, Sweden
  6. 6 Department of Medical and Health Sciences, Linköping University, Linköping, Sweden
  7. 7 Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen, Denmark
  8. 8 Department of Medicine, University Hospital, Örebro, Sweden
  9. 9 Kuopio University Hospital, Kuopio, Finland
  10. 10 UNI-C, Danish Information Technology Centre for Education and Research, Aarhus, Denmark
  1. Correspondence to Jens Cosedis Nielsen, Department of Cardiology, Aarhus University Hospital, Skejby, Palle Juul-Jensens Boulevard 99, Aarhus N 8200, Denmark; jenniels{at}rm.dk

Abstract

Objective 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.

Methods 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.

Results 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, χ2 test, 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.

Conclusions 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.

Trial registration number NCT00133211; Results.

  • Catheter ablation

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