Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation A Randomized Controlled Trial

Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation A Randomized Controlled Trial

Author Wilber, David J. Google Scholar
Pappone, Carlo Google Scholar
Neuzil, Petr Google Scholar
De Paola, Angelo Autor UNIFESP Google Scholar
Marchlinski, Frank Google Scholar
Natale, Andrea Google Scholar
Macle, Laurent Google Scholar
Daoud, Emile G. Google Scholar
Calkins, Hugh Google Scholar
Hall, Burr Google Scholar
Reddy, Vivek Google Scholar
Augello, Giuseppe Google Scholar
Reynolds, Matthew R. Google Scholar
Vinekar, Chandan Google Scholar
Liu, Christine Y. Google Scholar
Berry, Scott M. Google Scholar
Berry, Donald A. Google Scholar
ThermoCool AF Trial Investigators Google Scholar
Institution Loyola Univ
Hosp San Raffaele
Na Homolce Hosp
Universidade Federal de São Paulo (UNIFESP)
Hosp Univ Penn
Cleveland Clin Fdn
Montreal Heart Inst
Ohio State Univ
Johns Hopkins Univ Hosp
Univ Rochester
Harvard Clin Res Inst
Biosense Webster
Berry Consultants
Univ Texas MD Anderson Canc Ctr
Abstract Context Antiarrhythmic drugs are commonly used for prevention of recurrent atrial fibrillation (AF) despite inconsistent efficacy and frequent adverse effects. Catheter ablation has been proposed as an alternative treatment for paroxysmal AF.Objective To determine the efficacy of catheter ablation compared with antiarrhythmic drug therapy (ADT) in treating symptomatic paroxysmal AF.Design, Setting, and Participants A prospective, multicenter, randomized (2: 1), unblinded, Bayesian-designed study conducted at 19 hospitals of 167 patients who did not respond to at least 1 antiarrhythmic drug and who experienced at least 3 AF episodes within 6 months before randomization. Enrollment occurred between October 25, 2004, and October 11, 2007, with the last follow-up on January 19, 2009.Intervention Catheter ablation (n = 106) or ADT (n = 61), with assessment for effectiveness in a comparable 9-month follow-up period.Main Outcome Measures Time to protocol-defined treatment failure. the proportion of patients who experienced major treatment-related adverse events within 30 days of catheter ablation or ADT was also reported.Results At the end of the 9-month effectiveness evaluation period, 66% of patients in the catheter ablation group remained free from protocol-defined treatment failure compared with 16% of patients treated with ADT. the hazard ratio of catheter ablation to ADT was 0.30 (95% confidence interval, 0.19-0.47; P < .001). Major 30-day treatment-related adverse events occurred in 5 of 57 patients (8.8%) treated with ADT and 5 of 103 patients (4.9%) treated with catheter ablation. Mean quality of life scores improved significantly in patients treated by catheter ablation compared with ADT at 3 months; improvement was maintained during the course of the study.Conclusion Among patients with paroxysmal AF who had not responded to at least 1 antiarrhythmic drug, the use of catheter ablation compared with ADT resulted in a longer time to treatment failure during the 9-month follow-up period.Trial Registration Identifier: NCT00116428 JAMA. 2010;303(4):333-340
Language English
Sponsor Biosense Webster
Boston Scientific
St Jude Medical
Johnson Johnson
Cyrocath Technologies
Hansen Medical
Bristol-Myers Squibb
GE Healthcare
CryoCath Technologies
Endosense Hansen Medical
Grant number NIH: BARI 2D
Date 2010-01-27
Published in Jama-Journal of the American Medical Association. Chicago: Amer Medical Assoc, v. 303, n. 4, p. 333-340, 2010.
ISSN 0098-7484 (Sherpa/Romeo, impact factor)
Publisher Amer Medical Assoc
Extent 333-340
Access rights Closed access
Type Article
Web of Science ID WOS:000273952800021

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