Author + information
- Received September 30, 2019
- Revision received March 9, 2020
- Accepted April 21, 2020
- Published online June 22, 2020.
- Jeanne E. Poole, MDa,∗ (, )@jepoolemd,
- Tristram D. Bahnson, MDb,
- Kristi H. Monahan, RNc,
- George Johnson, BSEEd,
- Hoss Rostami, BSMSEb,
- Adam P. Silverstein, MSb,
- Hussein R. Al-Khalidi, PhDb,
- Yves Rosenberg, MD, MPHe,
- Daniel B. Mark, MD, MPHb,
- Kerry L. Lee, PhDb,
- Douglas L. Packer, MDc,
- for the CABANA Investigators and ECG Rhythm Core Lab
- aUniversity of Washington Medical Center, Seattle, Washington
- bDuke Clinical Research Institute, Duke University, Durham, North Carolina
- cMayo Clinic, Rochester, Minnesota
- dSeattle Institute of Cardiac Research, Seattle, Washington
- eNational Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland
- ↵∗Address for correspondence:
Dr. Jeanne E. Poole, Division of Cardiology, Department of Medicine, University of Washington Medical Center, 1959 NE Pacific Street, Box 356422, Seattle, Washington 98195.
Background The CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial randomized 2,204 patients with atrial fibrillation (AF) to catheter ablation or drug therapy. Analysis by intention-to-treat showed a nonsignificant 14% relative reduction in the primary outcome of death, disabling stroke, serious bleeding, or cardiac arrest.
Objectives The purpose of this study was to assess recurrence of AF in the CABANA trial.
Methods The authors prospectively studied CABANA patients using a proprietary electrocardiogram recording monitor for symptom-activated and 24-h AF auto detection. The AF recurrence endpoint was any post–90-day blanking atrial tachyarrhythmias lasting 30 s or longer. Biannual 96-h Holter monitoring was used to assess AF burden. Patients who used the CABANA monitors and provided 90-day post-blanking recordings qualified for this analysis (n = 1,240; 56% of CABANA population). Treatment comparisons were performed using a modified intention-to-treat approach.
Results Median age of the 1,240 patients was 68 years, 34.4% were women, and AF was paroxysmal in 43.0%. Over 60 months of follow-up, first recurrence of any symptomatic or asymptomatic AF (hazard ratio: 0.52; 95% confidence interval: 0.45 to 0.60; p < 0.001) or first symptomatic-only AF (hazard ratio: 0.49; 95% confidence interval: 0.39 to 0.61; p < 0.001) were both significantly reduced in the catheter ablation group. Baseline Holter AF burden in both treatment groups was 48%. At 12 months, AF burden in ablation patients averaged 6.3%, and in drug-therapy patients, 14.4%. AF burden was significantly less in catheter ablation compared with drug-therapy patients across the 5-year follow-up (p < 0.001). These findings were not sensitive to the baseline pattern of AF.
Conclusions Catheter ablation was effective in reducing recurrence of any AF by 48% and symptomatic AF by 51% compared with drug therapy over 5 years of follow-up. Furthermore, AF burden was also significantly reduced in catheter ablation patients, regardless of their baseline AF type. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508)
- antiarrhythmic drug therapy
- atrial fibrillation
- catheter ablation
- long-standing persistent atrial fibrillation
- paroxysmal atrial fibrillation
- persistent atrial fibrillation
- pulmonary vein isolation
This study was supported by the National Institutes of Health (NIH) (U01HL89709, U01HL089786, U01HL089907, and U01HL089645), St. Jude Medical Drug Foundation and Corporation, Biosense Webster, Medtronic, and Boston Scientific Corporation. The content of this article does not necessarily represent the views of the National Heart, Lung, and Blood Institute (NHLBI) or the Department of Health and Human Services. Dr. Poole has received research funding from ATriCure, Biotronik, Medtronic, and Kestra, Inc. outside of the submitted work; has served on the Advisory Board with compensation for Boston Scientific; has served as a speaker with honoraria from Boston Scientific, Medtronic, and MediaSphere Medical; and has served on a Data and Safety Monitoring Board on a study funded by EBR Systems. Dr. Bahnson has received grants from the NIH/NHLBI and Mayo Clinic during the conduct of the study; has received grants from St. Jude Medical, Abbott Medical, Medtronic, Biosense Webster, Johnson & Johnson, NIH, and Boston Scientific; has received consulting fees from Cardiofocus and Ventrix outside of the submitted work; and has patents pending for a catheter for intracardiac imaging and intracardiac electrogram signal analysis. Dr. Monahan has received grants from the NIH/NHLBI, St. Jude Foundation and Corporation, Biosense Webster, Medtronic, and Boston Scientific during the conduct of the study; has served as a consultant without compensation for Biosense Webster; and has received personal fees from Thermedical outside of the submitted work. Dr. Al-Khalidi has received grants from the NIH/NHLBI and Mayo Clinic during the conduct of the study. Dr. Mark has received grants from the NIH/NHLBI and Mayo Clinic during the conduct of the study; has received grants from Merck, Oxygen Therapeutics, Bristol-Myers Squibb, AstraZeneca, the University of Calgary, Eli Lilly & Company, AGA Medical, St. Jude Medical, and Tufts University; and has received personal fees from CeleCor outside of the submitted work. Dr. Lee has received grants from the NIH/NHLBI, Mayo Clinic, St. Jude Medical Foundation and Corporation, Biosense Webster, Medtronic, and Boston Scientific; and has served on Data and Safety Monitoring Boards on studies funded by AstraZeneca, Medtronic, Merck, Amgen, and the Cardiovascular Research Foundation during the conduct of the study. Dr. Packer has received grants from the NIH/NHLBI, St. Jude Medical Corporation and Foundation, Biosense Webster, Medtronic, and Boston Scientific during the conduct of the study; has received grants from Abbott, Biosense Webster, Boston Scientific, CardioFocus, Medtronic, St. Jude Medical, CardioInsight, NIH, Siemens, Thermedical, Endosense, Robertson Foundation, and Hansen Medical; has served on the Advisory Board without compensation for Abbott, Biosense Webster, Boston Scientific, CardioFocus, Medtronic, St. Jude Medical, Spectrum Dynamics, Siemens, Thermedical, Johnson & Johnson, and SigNum Preemptive Healthcare Inc.; has served as a speaker with honorarium from Biotronik and MediaSphere Medical LLC; has received royalties from Wiley & Sons, Oxford, and St. Jude Medical; has equity jointly with Mayo Clinic in a privately held company, External Beam Ablation Medical Devices, outside of the submitted work; and has mapping technologies with royalties paid. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.
- Received September 30, 2019.
- Revision received March 9, 2020.
- Accepted April 21, 2020.
- 2020 American College of Cardiology Foundation
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