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Long-term efficacy of catheter ablation as first-line therapy for paroxysmal atrial fibrillation: 5-year outcome in a randomised clinical trial.
Aarhus Univ Hosp, Aarhus, Denmark .
Gentofte University Hospital, Copenhagen, Denmark.
Tampere University Hospital, Tampere, Finland .
Leipzig University Hospital, Leipzig, Germany.
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2017 (English)In: Heart, ISSN 1355-6037, E-ISSN 1468-201X, Vol. 103, no 5, 368-376 p.Article in journal (Refereed) Published
Abstract [en]

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, χ(2) 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.

Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2017. Vol. 103, no 5, 368-376 p.
Keyword [en]
Catheter ablation
National Category
Cardiac and Cardiovascular Systems
Research subject
Cardiology
Identifiers
URN: urn:nbn:se:oru:diva-57434DOI: 10.1136/heartjnl-2016-309781ISI: 000395671900011PubMedID: 27566295Scopus ID: 2-s2.0-84984653811OAI: oai:DiVA.org:oru-57434DiVA: diva2:1090797
Note

Funding agencies

Danish Heart Foundation, grant no:  05-4-B284-A466-22237 

Biosense Webster

Available from: 2017-04-25 Created: 2017-04-25 Last updated: 2017-10-18Bibliographically approved

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