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Title: Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation A Randomized Controlled Trial
Authors: Wilber, David J.
Pappone, Carlo
Neuzil, Petr
De Paola, Angelo [UNIFESP]
Marchlinski, Frank
Natale, Andrea
Macle, Laurent
Daoud, Emile G.
Calkins, Hugh
Hall, Burr
Reddy, Vivek
Augello, Giuseppe
Reynolds, Matthew R.
Vinekar, Chandan
Liu, Christine Y.
Berry, Scott M.
Berry, Donald A.
ThermoCool AF Trial Investigators
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
Issue Date: 27-Jan-2010
Publisher: Amer Medical Assoc
Citation: Jama-Journal of the American Medical Association. Chicago: Amer Medical Assoc, v. 303, n. 4, p. 333-340, 2010.
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
ISSN: 0098-7484
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