1. Influence of atrial fibrillation type on outcomes of ablation vs. drug therapy: results from CABANA.
- Author
-
Monahan KH, Bunch TJ, Mark DB, Poole JE, Bahnson TD, Al-Khalidi HR, Silverstein AP, Daniels MR, Lee KL, and Packer DL
- Subjects
- Aged, Anti-Arrhythmia Agents adverse effects, Humans, Quality of Life, Recurrence, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation drug therapy, Atrial Fibrillation surgery, Catheter Ablation adverse effects, Catheter Ablation methods, Stroke complications
- Abstract
Aims: Influence of atrial fibrillation (AF) type on outcomes seen with catheter ablation vs. drug therapy is incompletely understood. This study assesses the impact of AF type on treatment outcomes in the Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)., Methods and Results: CABANA randomized 2204 patients ≥65 years old or <65 with at least one risk factor for stroke to catheter ablation or drug therapy. Of these, 946 (42.9%) had paroxysmal AF (PAF), 1042 (47.3%) had persistent AF (PersAF), and 215 (9.8%) had long-standing persistent AF (LSPAF) at baseline. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Symptoms were measured with the Mayo AF-Specific Symptom Inventory (MAFSI), and quality of life was measured with the Atrial Fibrillation Effect on Quality of Life (AFEQT). Comparisons are reported by intention to treat. Compared with drug therapy alone, catheter ablation produced a 19% relative risk reduction in the primary endpoint for PAF {adjusted hazard ratio [aHR]: 0.81 [95% confidence interval (CI): 0.50, 1.30]}, and a 17% relative reduction for PersAF (aHR: 0.83, 95% CI: 0.56, 1.22). For LSPAF, the ablation relative effect was a 7% reduction (aHR: 0.93, 95% CI: 0.36, 2.44). Ablation was more effective than drug therapy at reducing first AF recurrence in all AF types: by 51% for PAF (aHR: 0.49, 95% CI: 0.39, 0.62), by 47% for PersAF (aHR: 0.53, 95% CI: 0.43,0.65), and by 36% for LSPAF (aHR 0.64, 95% CI 0.41,1.00). Ablation was associated with greater improvement in symptoms, with the mean difference between groups in the MAFSI frequency score favouring ablation over 5 years of follow-up in all subgroups: PAF had a clinically significant -1.9-point difference (95% CI: -1.2 to -2.6); PersAF a -0.9 difference (95% CI: -0.2 to -1.6); LSPAF a clinically significant difference of -1.6 points (95% CI: -0.1 to -3.1). Ablation was also associated with greater improvement in quality of life in all subgroups, with the AFEQT overall score in PAF patients showing a clinically significant 5.3-point improvement (95% CI: 3.3 to 7.3) over drug therapy alone over 5 years of follow-up, PersAF a 1.7-point difference (95% CI: 0.0 to 3.7), and LSPAF a 3.1-point difference (95% CI: -1.6 to 7.8)., Conclusion: Prognostic treatment effects of catheter ablation compared with drug therapy on the primary and major secondary clinical endpoints did not differ consequentially by AF subtype. With regard to decreases in AF recurrence and improving quality of life, ablation was more effective than drug therapy in all three AF type subgroups., Clinicaltrials.gov Identifier: NCT00911508., Competing Interests: Conflict of interest: K.H.M. reports grants from the NIH/NHLBI, St. Jude Foundation and Corporation, Biosense Webster, Inc., Medtronic, Inc., and Boston Scientific Corp., during the conduct of the study; consulting without compensation from Biosense Webster, Inc.; and personal fees from Thermedical outside the submitted work. T.J.B. reports research grants from Boston Scientific, Altathera, Boehringer Ingelheim, no personal compensation received. D.B.M. reports grants from the NIH/NHLBI and Mayo Clinic during the conduct of the study; grants from Merck and HeartFlow; and personal fees from Novartis outside the submitted work. J.E.P. reports research grants paid directly to the University of Washington from Biotonik, Kestra Medical and AtriCure. T.D.B. reports grants from the NIH/NHLBI and Mayo Clinic during the conduct of the study; grants from St. Jude Medical, Inc, Abbott Medical, Biosense Webster Inc, Johnson & Johnson, and Boston Scientific Corp and consulting from Cardiofocus, Inc, outside of the submitted work. H.R.A.-K. reports grants from the NIH/NHLBI and Mayo Clinic during the conduct of the study. A.P.S. and M.R.D. report no disclosures during the conduct of the study. K.L.L. reports grants from the NIH/NHLBI and Mayo Clinic, as well as Data and Safety Monitoring Board service on studies funded by Astra-Zeneca, Medtronic, Merck, Amgen, and the Cardiovascular Research Foundation during the conduct of the study. D.L P. in the past 12 months has provided consulting services for Abbott, AtriFix, Biosense Webster, Inc., Cardio Syntax, EBAmed, Johnson & Johnson, MediaSphere Medical, LLC, MedLumics, Medtronic, NeuCures, St. Jude Medical, Siemens, Spectrum Dynamics, Centrix, Thermedical, and Xenter, Inc. D.L.P. received no personal compensation for these consulting activities, unless noted. D.L.P. receives research funding from Abbott, Biosense Webster, Boston Scientific/EPT, CardioInsight, EBAmed, Medtronic, Inc., NeuCures, Siemens, St. Jude Medical, Inc, Thermedical, Inc., NIH, Robertson Foundation, Vital Project Funds, Inc., Xenter, Inc., Mr. and Mrs. J. Michael Cook/Fund. Mayo Clinic and D.L.P. have a financial interest in Analyze-AVW technology that may have been used to analyze some of the heart images in this research. In accordance with the Bayh-Dole Act, this technology has been licensed to commercial entities, and both Mayo Clinic and D.L.P. have received royalties greater than $10 000, the federal threshold for significant financial interest. In addition, Mayo Clinic holds an equity position in the company to which the AVW technology has been licensed. D.L.P. and Mayo Clinic jointly have equity in a privately held company, EBAmed. Royalties from Wiley & Sons, Oxford, and St. Jude Medical. D.L.P. has a licensing agreement with the American Heart Association for the Mayo AF Symptom Inventory (MAFSI) Survey and has contractual rights to receive future royalties under this license., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2022
- Full Text
- View/download PDF