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

• Published in: Europace (London, England) Vol. 17; no. 2; pp. 215 - 221
• Main Authors: Walfridsson, H, Walfridsson, U, Nielsen, J Cosedis, Johannessen, A, Raatikainen, P, Janzon, M, Levin, L A, Aronsson, M, Hindricks, G, Kongstad, O, Pehrson, S, Englund, A, Hartikainen, J, Mortensen, L S, Hansen, P S
• Format: Journal Article
• Language: English
• Published: England 01-02-2015
• Subjects: Adult; Aged; Anti-Arrhythmia Agents - therapeutic use; Atrial Fibrillation - therapy; Cardiac and Cardiovascular Systems; Catheter Ablation; Clinical Medicine; Cost of Illness; Female; Flecainide - therapeutic use; Health Status; Humans; Kardiologi; Klinisk medicin; Male; Medical and Health Sciences; Medicin och hälsovetenskap; Middle Aged; Propafenone - therapeutic use; Quality of Life; Treatment Outcome; Antiarrhythmic drug treatment; First-line therapy; Atrial fibrillation; Catheter ablation; Quality of life
• ISSN: 1099-5129; 1532-2092; 1532-2092
• DOI: 10.1093/europace/euu342

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.
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.
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.
URL http://www.clinicaltrials.gov. Unique identifier: NCT00133211.