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Radiofrequency Ablation vs Antiarrhythmic Drugs as First-Line Treatment of Paroxysmal Atrial Fibrillation (RAAFT-2): A Randomized Trial
Open accessAbstract
IMPORTANCE: Atrial fibrillation (AF) is the most common rhythm disorder seen in clinical practice. Antiarrhythmic drugs are effective for reduction of recurrence in patients with symptomatic paroxysmal AF. Radiofrequency ablation is an accepted therapy in patients for whom antiarrhythmic drugs have failed; however, its role as a first-line therapy needs further investigation. OBJECTIVE: To compare radiofrequency ablation with antiarrhythmic drugs (standard therapy) in treating patients with paroxysmal AF as a first-line therapy. DESIGN, SETTING, AND PATIENTS: A randomized clinical trial involving 127 treatment-naive patients with paroxysmal AF were randomized at 16 centers in Europe and North America to received either antiarrhythmic therapy or ablation. The first patient was enrolled July 27, 2006; the last patient, January 29, 2010. The last follow-up was February 16, 2012. INTERVENTIONS: Sixty-one patients in the antiarrhythmic drug group and 66 in the radiofrequency ablation group were followed up for 24 months. MAIN OUTCOMES AND MEASURES: The time to the first documented atrial tachyarrhythmia of more than 30 seconds (symptomatic or asymptomatic AF, atrial flutter, or atrial tachycardia), detected by either scheduled or unscheduled electrocardiogram, Holter, transtelephonic monitor, or rhythm strip, was the primary outcome. Secondary outcomes included symptomatic recurrences of atrial tachyarrhythmias and quality of life measures assessed by the EQ-5D tool. RESULTS: Forty-four patients (72.1%) in the antiarrhythmic group and in 36 patients (54.5%) in the ablation group experienced the primary efficacy outcome (hazard ratio [HR], 0.56 [95% CI, 0.35-0.90]; P = .02). For the secondary outcomes, 59% in the drug group and 47% in the ablation group experienced the first recurrence of symptomatic AF, atrial flutter, atrial tachycardia (HR, 0.56 [95% CI, 0.33-0.95]; P = .03). No deaths or strokes were reported in either group; 4 cases of cardiac tamponade were reported in the ablation group. In the standard treatment group, 26 patients (43%) underwent ablation after 1-year. Quality of life was moderately impaired at baseline in both groups and improved at the 1 year follow-up. However, improvement was not significantly different among groups. CONCLUSIONS AND RELEVANCE: Among patients with paroxysmal AF without previous antiarrhythmic drug treatment, radiofrequency ablation compared with antiarrhythmic drugs resulted in a lower rate of recurrent atrial tachyarrhythmias at 2 years. However, recurrence was frequent in both groups. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00392054.
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“As first-line treatment for paroxysmal AF, randomized trials showed only modestly improved rhythm outcome with catheter ablation compared to antiarrhythmic drug therapy.585,[721][722][723]”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [722]
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“Complication rates were similar, but ablation was performed in expert centres, justifying catheter ablation as first-line therapy in selected patients with paroxysmal AF who ask for interventional therapy.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [722]
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Hindricks, G., Potpara, T., Dagres, N., Arbelo, E., Bax, J. J., Blomström‐Lundqvist, C., Boriani, G., Castella, M., Dan, G.-A., Dilaveris, P., et al. (2020) · European Heart Journal · doi:10.1093/eurheartj/ehaa612 · Cited by 10,550
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January, C. T., Wann, L. S., Alpert, J. S., Calkins, H. G., Cigarroa, J. E., Cleveland, J. C., CONTI, J. B., Ellinor, P. T., Ezekowitz, M. D., Field, M. E., et al. (2014) · Circulation · doi:10.1161/cir.0000000000000041 · Cited by 7,145
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P. F., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castellà, M., Diener, H., Heidbüchel, H., Hendriks, J., et al. (2016) · EP Europace · doi:10.1093/europace/euw295 · Cited by 6,438
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castella, M., Diener, H.-C., Heidbuchel, H., Hendriks, J., et al. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehw210 · Cited by 6,418
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Metadata
- Authors
- Morillo, C. A., Verma, A., Connolly, S. J., Kuck, K. H., Nair, G. M., Champagne, J., Sterns, L. D., Beresh, H., Healey, J. S., Natale, A., & RAAFT-2 Investigators
- Affiliations
- Population Health Research Institute (CA)
- Southlake Regional Health Center (CA)
- Asklepios Klinik St Georg, Hamburg, Germany
- Ottawa Heart Institute (CA)
- Université Laval (CA)
- Victoria Cardiac Arrhythmia Trials Inc, Victoria, Canada
- McMaster University, Population Health Research Institute, Hamilton Health Sciences, Hamilton, Canada
- St David's Medical Center (US)
- Corresponding author
- Morillo, Carlos A.
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2014-02-19
- Volume
- 311
- Issue
- 7
- Pages
- 692
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2125891322
- Cited by
- 667
- References
- 31
- Citations by year
- 2026: 23 · 2025: 50 · 2024: 58 · 2023: 44 · 2022: 60 · 2021: 68 · 2020: 63 · 2019: 47 · 2018: 45 · 2017: 56 · 2016: 63 · 2015: 48 · 2014: 37
- FWCI
- 46.73
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Biosense Webster
- 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, first-line therapy, atrial tachyarrhythmia recurrence, atrial flutter, atrial tachycardia, quality of life, treatment-naive patients, bleeding risk
- MeSH terms
- Adult, Aged, Anti-Arrhythmia Agents, Atrial Fibrillation, Atrial Flutter, Female, Heart Atria, Humans, Male, Middle Aged, Recurrence, Tachycardia, Treatment Outcome, Catheter Ablation
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