Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation
A Randomized Controlled Trial
- David J. Wilber, MD;
- Carlo Pappone, MD, PhD;
- Petr Neuzil, MD;
- Angelo De Paola, MD;
- Frank Marchlinski, MD;
- Andrea Natale, MD;
- Laurent Macle, MD;
- Emile G. Daoud, MD;
- Hugh Calkins, MD;
- Burr Hall, MD;
- Vivek Reddy, MD;
- Giuseppe Augello, MD;
- Matthew R. Reynolds, MD, MSc;
- Chandan Vinekar, MS;
- Christine Y. Liu, MPH;
- Scott M. Berry, PhD;
- Donald A. Berry, PhD
- for the ThermoCool AF Trial Investigators
- Author Affiliations: Cardiovascular Institute, Department of Medicine, Loyola University Medical Center, Maywood, Illinois (Dr Wilber); Department of Medicine, Hospital San Raffaele, Milan, Italy (Drs Pappone and Augello); Department of Medicine, Na Homolce Hospital, Prague, Czech Republic (Drs Neuzil and Reddy); Department of Medicine, Hospital Sao Paulo/UNIFESP, Sao Paulo, Brazil (Dr De Paola); Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia (Dr Marchlinski); Department of Medicine, Cleveland Clinic Foundation, Cleveland, Ohio (Dr Natale); Department of Medicine, Montreal Heart Institute, Montreal, Quebec, Canada (Dr Macle); Department of Medicine, Ohio State University, Columbus (Dr Daoud); Department of Medicine, Johns Hopkins Hospital, Baltimore, Maryland (Dr Calkins); Department of Medicine, University of Rochester Medical Center, Rochester, New York (Dr Hall); Harvard Clinical Research Institute, Boston, Massachusetts (Dr Reynolds); Biosense Webster, Diamond Bar, California (Mr Vinekar and Ms Liu); Berry Consultants, College Station, Texas (Dr S. Berry); and University of Texas M.D. Anderson Cancer Center, Houston (Dr D. Berry).
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 clinicaltrials.gov Identifier: NCT00116428
