Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation: A Randomized Controlled Trial
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 Conclusion Among patients with paroxysmal AF who had no…
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Catheter ablation or combination therapy is often effective when antiarrhythmic drugs fail.
“Catheter ablation or combination therapy is often effective when antiarrhythmic drugs fail.226,[585][586][587]”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [586]
In patients with symptomatic paroxysmal, persistent, and probably long-standing persistent atrial fibrillation, catheter ablation is more effective than antiarrhythmic drug therapy.
“In such patients, catheter ablation is more effective than antiarrhythmic drug therapy.185,586,713,[717][718][719][720]”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [586]
Catheter ablation of atrial fibrillation is effective in restoring and maintaining sinus rhythm in patients with symptomatic paroxysmal, persistent, and probably long-standing persistent atrial fibrillation, generally as second-line treatment after failure of or intolerance to antiarrhythmic drug therapy.
“Catheter ablation of AF is effective in restoring and maintaining sinus rhythm in patients with symptomatic paroxysmal, persistent, and probably long-standing persistent AF -in general as second-line treatment after failure of or intolerance to antiarrhythmic drug therapy.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [586]
In patients who experience symptomatic recurrences of atrial fibrillation despite antiarrhythmic drug therapy, all randomized controlled trials showed better sinus rhythm maintenance with catheter ablation than on antiarrhythmic drugs.
“In patients who experience symptomatic recurrences of AF despite antiarrhythmic drug therapy, all RCTs showed better sinus rhythm maintenance with catheter ablation than on antiarrhythmic drugs.586,713,727,728”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [586]
Isthmus ablation is comparably safe and more effective than antiarrhythmic drug therapy.
“Isthmus ablation is comparably safe and more effective than antiarrhythmic drug therapy, and is recommended for recurrent atrial flutter.[585][586][587]713”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [586]
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“Major adverse events have been reported in up to 6% of patients undergoing AF ablation, including thromboembolic events, atrialesophageal fistula, cardiac perforation, phrenic nerve paralysis, and death.(12-16,24) None of these more serious complications occurred in our study.”
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- Authors
- Wilber, D. J., Pappone, C., Neuzil, P., De Paola, A., Marchlinski, F., Natale, A., Macle, L., Daoud, E. G., Calkins, H., Hall, B., Reddy, V., Augello, G., Reynolds, M. R., Vinekar, C., Liu, C. Y., Berry, S. M., Berry, D. A., & ThermoCool AF Trial Investigators, F. T.
- Affiliations
- Loyola University Medical Center (US)
- Cleveland Clinic (US)
- Université de Montréal (CA)
- The Ohio State University (US)
- Johns Hopkins University (US)
- University of Rochester (US)
- Na Homolce Hospital (CZ)
- Harvard University (US)
- Biosense Webster (United States) (US)
- Berry Consultants, LLC (United States) (US)
- The University of Texas MD Anderson Cancer Center (US)
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2010-01-27
- Volume
- 303
- Issue
- 4
- Pages
- 333
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2038456369
- Cited by
- 1,170
- References
- 4
- Citations by year
- 2026: 30 · 2025: 44 · 2024: 58 · 2023: 47 · 2022: 68 · 2021: 74 · 2020: 80 · 2019: 71 · 2018: 68 · 2017: 67 · 2016: 74 · 2015: 66 · 2014: 93 · 2013: 91 · 2012: 115
- FWCI
- 71.35
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- UNIFESP Institutional Repository (Universidade Federal de São Paulo) (submittedVersion)
- Funders
- National Cancer Institute (P30CA016672)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Arrhythmias and Treatments
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Keywords
- paroxysmal atrial fibrillation, radiofrequency catheter ablation, antiarrhythmic drugs, treatment failure, treatment-related adverse events, quality of life, refractory atrial fibrillation, treatment efficacy comparison, 30-day complications, quality-adjusted survival
- MeSH terms
- Anti-Arrhythmia Agents, Atrial Fibrillation, Female, Humans, Male, Middle Aged, Prospective Studies, Quality of Life, Catheter Ablation, Treatment Failure
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