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Radiofrequency Ablation as Initial Therapy in Paroxysmal Atrial Fibrillation

Nielsen, Jens Cosedis; Johannessen, Arne; Raatikainen, Pekka; Hindricks, Gerhard; Walfridsson, Hakan; Kongstad Rasmussen, Ole LU ; Pehrson, Steen; Englund, Anders; Hartikainen, Juha and Mortensen, Leif Spange, et al. (2012) In New England Journal of Medicine 367(17). p.1587-1595
Abstract
Background There are limited data comparing radiofrequency catheter ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation. Methods We randomly assigned 294 patients with paroxysmal atrial fibrillation and no history of antiarrhythmic drug use to an initial treatment strategy of either radiofrequency catheter ablation (146 patients) or therapy with class IC or class III antiarrhythmic agents (148 patients). Follow-up included 7-day Holter-monitor recording at 3, 6, 12, 18, and 24 months. Primary end points were the cumulative and per-visit burden of atrial fibrillation (i.e., percentage of time in atrial fibrillation on Holter-monitor recordings). Analyses were performed on an... (More)
Background There are limited data comparing radiofrequency catheter ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation. Methods We randomly assigned 294 patients with paroxysmal atrial fibrillation and no history of antiarrhythmic drug use to an initial treatment strategy of either radiofrequency catheter ablation (146 patients) or therapy with class IC or class III antiarrhythmic agents (148 patients). Follow-up included 7-day Holter-monitor recording at 3, 6, 12, 18, and 24 months. Primary end points were the cumulative and per-visit burden of atrial fibrillation (i.e., percentage of time in atrial fibrillation on Holter-monitor recordings). Analyses were performed on an intention-to-treat basis. Results There was no significant difference between the ablation and drug-therapy groups in the cumulative burden of atrial fibrillation (90th percentile of arrhythmia burden, 13% and 19%, respectively; P = 0.10) or the burden at 3, 6, 12, or 18 months. At 24 months, the burden of atrial fibrillation was significantly lower in the ablation group than in the drug-therapy group (90th percentile, 9% vs. 18%; P = 0.007), and more patients in the ablation group were free from any atrial fibrillation (85% vs. 71%, P = 0.004) and from symptomatic atrial fibrillation (93% vs. 84%, P = 0.01). One death in the ablation group was due to a procedure-related stroke; there were three cases of cardiac tamponade in the ablation group. In the drug-therapy group, 54 patients (36%) underwent supplementary ablation. Conclusions In comparing radiofrequency ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation, we found no significant difference between the treatment groups in the cumulative burden of atrial fibrillation over a period of 2 years. (Funded by the Danish Heart Foundation and others; MANTRA-PAF ClinicalTrials.gov number, NCT00133211.) (Less)
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New England Journal of Medicine
volume
367
issue
17
pages
1587 - 1595
publisher
Massachusetts Medical Society
external identifiers
  • wos:000310131700005
  • scopus:84867815907
ISSN
0028-4793
DOI
10.1056/NEJMoa1113566
language
English
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yes
id
a239b4f1-b3b4-4a6b-9cdf-e91ab73a676d (old id 3174040)
date added to LUP
2012-12-03 06:53:31
date last changed
2017-11-12 03:02:49
@article{a239b4f1-b3b4-4a6b-9cdf-e91ab73a676d,
  abstract     = {Background There are limited data comparing radiofrequency catheter ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation. Methods We randomly assigned 294 patients with paroxysmal atrial fibrillation and no history of antiarrhythmic drug use to an initial treatment strategy of either radiofrequency catheter ablation (146 patients) or therapy with class IC or class III antiarrhythmic agents (148 patients). Follow-up included 7-day Holter-monitor recording at 3, 6, 12, 18, and 24 months. Primary end points were the cumulative and per-visit burden of atrial fibrillation (i.e., percentage of time in atrial fibrillation on Holter-monitor recordings). Analyses were performed on an intention-to-treat basis. Results There was no significant difference between the ablation and drug-therapy groups in the cumulative burden of atrial fibrillation (90th percentile of arrhythmia burden, 13% and 19%, respectively; P = 0.10) or the burden at 3, 6, 12, or 18 months. At 24 months, the burden of atrial fibrillation was significantly lower in the ablation group than in the drug-therapy group (90th percentile, 9% vs. 18%; P = 0.007), and more patients in the ablation group were free from any atrial fibrillation (85% vs. 71%, P = 0.004) and from symptomatic atrial fibrillation (93% vs. 84%, P = 0.01). One death in the ablation group was due to a procedure-related stroke; there were three cases of cardiac tamponade in the ablation group. In the drug-therapy group, 54 patients (36%) underwent supplementary ablation. Conclusions In comparing radiofrequency ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation, we found no significant difference between the treatment groups in the cumulative burden of atrial fibrillation over a period of 2 years. (Funded by the Danish Heart Foundation and others; MANTRA-PAF ClinicalTrials.gov number, NCT00133211.)},
  author       = {Nielsen, Jens Cosedis and Johannessen, Arne and Raatikainen, Pekka and Hindricks, Gerhard and Walfridsson, Hakan and Kongstad Rasmussen, Ole and Pehrson, Steen and Englund, Anders and Hartikainen, Juha and Mortensen, Leif Spange and Hansen, Peter Steen},
  issn         = {0028-4793},
  language     = {eng},
  number       = {17},
  pages        = {1587--1595},
  publisher    = {Massachusetts Medical Society},
  series       = {New England Journal of Medicine},
  title        = {Radiofrequency Ablation as Initial Therapy in Paroxysmal Atrial Fibrillation},
  url          = {http://dx.doi.org/10.1056/NEJMoa1113566},
  volume       = {367},
  year         = {2012},
}