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Radiofrequency Ablation vs Antiarrhythmic Drugs as First-line Treatment of Symptomatic Atrial Fibrillation: A Randomized Trial
Abstract
CONTEXT: Treatment with antiarrhythmic drugs and anticoagulation is considered first-line therapy in patients with symptomatic atrial fibrillation (AF). Pulmonary vein isolation (PVI) with radiofrequency ablation may cure AF, obviating the need for antiarrhythmic drugs and anticoagulation. OBJECTIVE: To determine whether PVI is feasible as first-line therapy for treating patients with symptomatic AF. DESIGN, SETTING, AND PARTICIPANTS: A multicenter prospective randomized study conducted from December 31, 2001, to July 1, 2002, of 70 patients aged 18 to 75 years who experienced monthly symptomatic AF episodes for at least 3 months and had not been treated with antiarrhythmic drugs. INTERVENTION: Patients were randomized to receive either PVI using radiofrequency ablation (n=33) or antiarrhythmic drug treatment (n=37), with a 1-year follow-up. MAIN OUTCOME MEASURES: Recurrence of AF, hospitalization, and quality of life assessment. RESULTS: Two patients in the antiarrhythmic drug treatment group and 1 patient in the PVI group were lost to follow-up. At the end of 1-year follow-up, 22 (63%) of 35 patients who received antiarrhythmic drugs had at least 1 recurrence of symptomatic AF compared with 4 (13%) of 32 patients who received PVI (P<.001). Hospitalization during 1-year follow-up occurred in 19 (54%) of 35 patients in the antiarrhythmic drug group compared with 3 (9%) of 32 in the PVI group (P<.001). In the antiarrhythmic drug group, the mean (SD) number of AF episodes decreased from 12 (7) to 6 (4), after initiating therapy (P = .01). At 6-month follow-up, the improvement in quality of life of patients in the PVI group was significantly better than the improvement in the antiarrhythmic drug group in 5 subclasses of the Short-Form 36 health survey. There were no thromboembolic events in either group. Asymptomatic mild or moderate pulmonary vein stenosis was documented in 2 (6%) of 32 patients in the PVI group. CONCLUSION: Pulmonary vein isolation appears to be a feasible first-line approach for treating patients with symptomatic AF. Larger studies are needed to confirm its safety and efficacy.
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“Fewer data are available reporting the effectiveness and safety of catheter ablation in patients with persistent or long-standing persistent AF, but all point to lower recurrence rates after catheter ablation compared to antiarrhythmic drug therapy with or without cardioversion.185,717,[723][724][725][726]1039”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [723]
In the citing paper
“Fewer data are available reporting the effectiveness and safety of catheter ablation in patients with persistent or long-standing persistent AF, but all point to lower recurrence rates after catheter ablation compared to antiarrhythmic drug therapy with or without cardioversion.185,717,[723][724][725][726]1039”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [723]
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Catheter Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation
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“Structural heart disease, n (%) 10 (19) 14 (24) 24 (26)”
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“We hoped (1) to provide accurate and broadly representative estimates of the relative safety and efficacy of these 2 treatment options; (2) to gain insights into how the development of new ablation technologies and strategies may have affected the outcomes of catheter ablation over time; and (3) to highlight the size,…”
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“5% [15]), heart failure hospitalization (1 year: 0.”
Mont, L., Bisbal, F., Hernández-Madrid, A., Pérez-Castellano, N., Viñolas, X., Arenal, A., Arribas, F., Fernández-Lozano, I., Bodegas, A., Cobos, A., et al. (2014) · European Heart Journal · doi:10.1093/eurheartj/eht457 · Cited by 394
“Ablation is a well-established treatment for symptomatic drug-refractory paroxysmal AF, supported by a consistent body of evidence.(1,2,9,10) Moreover, a recentpublicationsuggests thepotential benefit of CA as first-line therapy in this population.”
ResultWann, L. S., Curtis, A. B., Ellenbogen, K. A., Estes, N. A. M., Ezekowitz, M. D., Jackman, W. M., January, C. T., Lowe, J. E., Page, R. L., Slotwiner, D. J., et al. (2011) · Heart Rhythm · doi:10.1016/j.hrthm.2011.01.032 · Cited by 394
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Complications of Catheter Ablation of Atrial Fibrillation
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“Indeed, selected patients may benefit from ablation as first-line therapy.(5) A recent study reporting the outcomes of 2 meta-analyses found a 77% success rate for catheter ablation versus 52% for antiarrhythmic drugs.”
BackgroundClinical Outcomes of Catheter Substrate Ablation for High-Risk Patients With Atrial Fibrillation
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Pulmonary Vein Isolation for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
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Complications of Catheter Ablation for Atrial Fibrillation: Incidence and Predictors
SPRAGG, D. D., Dalal, D., Cheema, A., SCHERR, D., Chilukuri, K., Cheng, A., Henrikson, C. A., Marine, J. E., Berger, R. D., Dong, J., et al. (2008) · Journal of Cardiovascular Electrophysiology · doi:10.1111/j.1540-8167.2008.01181.x · Cited by 286
Antiarrhythmic Drugs for Maintaining Sinus Rhythm After Cardioversion of Atrial Fibrillation
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New antiarrhythmic drugs for treatment of atrial fibrillation
Dobrev, D., & Nattel, S. (2010) · The Lancet · doi:10.1016/s0140-6736(10)60096-7 · Cited by 284
Shah, R. U., Freeman, J. V., Shilane, D. A., Wang, P. J., Go, A. S., & Hlatky, M. A. (2012) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2011.08.068 · Cited by 281
“Randomized controlled trials have reported AF recurrence in 13% to 44% of AF ablation recipients (12,13), and a worldwide survey of centers offering AF ablation reported recurrence in 48% to 57% of recipients at a median of 12 months’ follow-up (4).”
BackgroundDAGRES, N., HINDRICKS, G., KOTTKAMP, H., SOMMER, P., GASPAR, T., BODE, K., ARYA, A., HUSSER, D., RALLIDIS, L. S., KREMASTINOS, D. T., et al. (2009) · Journal of Cardiovascular Electrophysiology · doi:10.1111/j.1540-8167.2009.01493.x · Cited by 279
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Poole, J. E., Bahnson, T. D., Monahan, K. H., Johnson, G. W., Rostami, H., Silverstein, A. P., Al‐Khalidi, H. R., Rosenberg, Y., Mark, D. B., Lee, K. L., et al. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.04.065 · Cited by 275
“[2,4,5] The difficulties in detecting recurrent AF episodes, particularly when asymptomatic, led to a long period of controversy regarding the actual durability of AF suppression after ablation.”
BackgroundSantangeli, P., Zado, E. S., Hutchinson, M. D., Riley, M. P., Lin, D., Frankel, D. S., Supple, G. E., Garcia, F. C., Dixit, S., Callans, D. J., et al. (2015) · Heart Rhythm · doi:10.1016/j.hrthm.2015.10.023 · Cited by 265
Guidelines for Pharmacotherapy of Atrial Fibrillation (JCS 2013):– Digest Version –
JCSJointWorkingGroup (2014) · Circulation · Cited by 261
Catheter ablation for atrial fibrillation: current indications and evolving technologies
Parameswaran, R., Al‐Kaisey, A., & Kalman, J. M. (2020) · Nature Reviews Cardiology · doi:10.1038/s41569-020-00451-x · Cited by 261
Long-Term Quality of Life After Ablation of Atrial Fibrillation
Wokhlu, A., Monahan, K. H., Hodge, D. O., Asirvatham, S. J., Friedman, P. A., Munger, T. M., Bradley, D. J., Bluhm, C. M., Haroldson, J. M., & Packer, D. L. (2010) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2010.01.040 · Cited by 242
Electronic sensor and actuator webs for large-area complex geometry cardiac mapping and therapy
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Management of atrial fibrillation
Lip, G. Y., & Tse, H.-F. (2007) · The Lancet · doi:10.1016/s0140-6736(07)61300-2 · Cited by 229
Dong, J., Dickfeld, T. M., Dalal, D., Cheema, A., Vasamreddy, C. R., Henrikson, C. A., Marine, J. E., Halperin, H. R., Berger, R. D., Lima, J. A. C., et al. (2006) · Journal of Cardiovascular Electrophysiology · doi:10.1111/j.1540-8167.2006.00425.x · Cited by 227
Catheter Ablation Versus Medical Therapy for Atrial Fibrillation
Asad, Z. U. A., Yousif, A., Khan, M. S., Al‐Khatib, S. M., & Stavrakis, S. (2019) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.119.007414 · Cited by 226
“…study 2014 RFA 98 55 78 6 61 0/100 3 MT 48 55 77 4 61 0/100 2 Stabile et al 2006 RFA 68 62 54 53 63 59 62/38 46 4 MT 69 69 64 49 62 58 73/27 45 7 Wazni et al 2005 RFA 33 53 25 53 97/3 41 MT 37 54 28 54 95/5 42 Wilber et al 2010 RFA 106 56 69 2 10 49 10 62 100/0 40 MT 61 56 62 3 12 50 15 63…”
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Metadata
- Authors
- Wazni, O. M., Marrouche, N. F., Martin, D. O., Verma, A., Bhargava, M., Saliba, W., Bash, D., Schweikert, R., Brachmann, J., Gunther, J., Gutleben, K., Pisano, E., Potenza, D., Fanelli, R., Raviele, A., Themistoclakis, S., Rossillo, A., Bonso, A., & Natale, A.
- Affiliations
- Cleveland Clinic (US)
- Corresponding author
- Natale, Andrea
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2005-06-01
- Volume
- 293
- Issue
- 21
- Pages
- 2634
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2154269490
- Cited by
- 1,121
- References
- 39
- Citations by year
- 2026: 18 · 2025: 31 · 2024: 38 · 2023: 29 · 2022: 61 · 2021: 52 · 2020: 45 · 2019: 36 · 2018: 53 · 2017: 40 · 2016: 44 · 2015: 52 · 2014: 69 · 2013: 75 · 2012: 78
- FWCI
- 43.53
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- 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
- atrial fibrillation, radiofrequency ablation, pulmonary vein isolation, antiarrhythmic drugs, first-line therapy, atrial fibrillation recurrence, hospitalization, quality of life, pulmonary vein stenosis, anticoagulation, thromboembolic events, Short Form 36 Health Survey, randomized trial comparison, cost-effectiveness, patient satisfaction
- MeSH terms
- Anti-Arrhythmia Agents, Atrial Fibrillation, Humans, Middle Aged, Pilot Projects, Prospective Studies, Pulmonary Veins, Quality of Life, Survival Analysis, Treatment Outcome, Catheter Ablation
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