Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation: results on health-related quality of life and symptom burden. The MANTRA-PAF trial

Europace. 2015 Feb;17(2):215-21. doi: 10.1093/europace/euu342. Epub 2015 Jan 6.

Abstract

Aims: The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial assessed the long-term efficacy of an initial strategy of radiofrequency ablation (RFA) vs. antiarrhythmic drug therapy (AAD) as first-line treatment for patients with PAF. In this substudy, we evaluated the effect of these treatment modalities on the Health-Related Quality of Life (HRQoL) and symptom burden of patients at 12 and 24 months.

Methods and results: During the study period, 294 patients were enrolled in the MANTRA-PAF trial and randomized to receive AAD (N = 148) or RFA (N = 146). Two generic questionnaires were used to assess the HRQoL [Short Form-36 (SF-36) and EuroQol-five dimensions (EQ-5D)], and the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) was used to evaluate the symptoms appearing during the trial. All comparisons were made on an intention-to-treat basis. Both randomization groups showed significant improvements in assessments with both SF-36 and EQ-5D, at 24 months. Patients randomized to RFA showed significantly greater improvement in four physically related scales of the SF-36. The three most frequently reported symptoms were breathlessness during activity, pronounced tiredness, and worry/anxiety. In both groups, there was a significant reduction in ASTA symptom index and in the severity of seven of the eight symptoms over time.

Conclusion: Both AAD and RFA as first-line treatment resulted in substantial improvement of HRQoL and symptom burden in patients with PAF. Patients randomized to RFA showed greater improvement in physical scales (SF-36) and the EQ-visual analogue scale.

Clinical trial registration: URL http://www.clinicaltrials.gov. Unique identifier: NCT00133211.

Keywords: Antiarrhythmic drug treatment; Atrial fibrillation; Catheter ablation; First-line therapy; Quality of life.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anti-Arrhythmia Agents / therapeutic use*
  • Atrial Fibrillation / therapy*
  • Catheter Ablation*
  • Cost of Illness
  • Female
  • Flecainide / therapeutic use
  • Health Status*
  • Humans
  • Male
  • Middle Aged
  • Propafenone / therapeutic use
  • Quality of Life*
  • Treatment Outcome

Substances

  • Anti-Arrhythmia Agents
  • Propafenone
  • Flecainide

Associated data

  • ClinicalTrials.gov/NCT00133211