TY - JOUR
T1 - Association between Age and Outcomes of Catheter Ablation Versus Medical Therapy for Atrial Fibrillation
T2 - Results from the CABANA Trial
AU - Bahnson, Tristram D.
AU - Giczewska, Anna
AU - Mark, Daniel B.
AU - Russo, Andrea M.
AU - Monahan, Kristi H.
AU - Al-Khalidi, Hussein R.
AU - Silverstein, Adam P.
AU - Poole, Jeanne E.
AU - Lee, Kerry L.
AU - Packer, Douglas L.
N1 - Funding Information:
Dr Bahnson reports grants from the National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) and Mayo Clinic during the conduct of the study; grants from St. Jude Medical, Abbott Medical, Medtronic, Biosense Webster, Johnson & Johnson, and Boston Scientific; consulting fees from Cardiofocus and Ventrix outside the submitted work; patents pending for a catheter for intracardiac imaging and intracardiac electrogram signal analysis. Dr Mark reports grants from NIH/NHLBI, HeartFlow, Merck, and Mayo Clinic. Dr Russo reports research funding from Boston Scientific, Kestra, Medilynx; consulting with compensation from Biosense Webster, Boston Scientific and Medtronic; research steering committee with compensation from Boston Scientific and Medtronic; and royalties from Up-To-Date. K. H. Monahan reports grants from NIH/NHLBI, St. Jude Foundation and Corporation, Biosense Webster, Medtronic, and Boston Scientific during conduct of the study; consulting without compensation from Biosense Webster; personal fees from Thermedical outside the submitted work. Dr Al-Khalidi reports grants from the NIH/NHLBI and Mayo Clinic. Dr Poole reports grants from KestraMedical, AtriCure, and Biotronik; payment from the University of Rochester NY for participation on a clinical events committee. Dr Lee reports DSMB service for studies funded by Medtronic and the Cardiovascular Research Foundation. Dr Packer in the past 12 months has provided consulting services for Abbott, AtriFix, Biosense Webster, Cardio Syntax, EBAmed, Johnson & Johnson, MediaSphere Medical, MedLumics, Medtronic, NeuCures, St. Jude Medical, Siemens, Spectrum Dynamics, Centrix, and Thermedical. Dr Packer received no personal compensation for these consulting activities, unless noted. Dr Packer receives research funding from the Abbott, Biosense Webster, Boston Scientific/EPT, CardioInsight, EBAmed, Medtronic, Siemens, St. Jude Medical, Thermedical, NIH, Robertson Foundation, Vital Project Funds, Mr. and Mrs. J. Michael Cook/Fund. The Mayo Clinic and Dr Packer 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 Dr Packer 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. Dr Packer and Mayo Clinic jointly have equity in a privately held company, EBAmed. Royalties from Wiley & Sons, Oxford, and St. Jude Medical. The other authors report no conflicts.
Funding Information:
This work was supported by National Institutes of Health grants U01HL89709, U01HL089786, U01HL089907, and U01HL089645. The content of this article does not necessarily represent the views of the National Heart, Lung, and Blood Institute or the Department of Health and Human Services. St Jude Drug Foundation and Corporation, Biosense Webster Inc, Medtronic Inc, and Boston Scientific Corporation.
Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.
PY - 2022/3/15
Y1 - 2022/3/15
N2 - Background: Observational data suggest that catheter ablation may be safe and effective to treat younger and older patients with atrial fibrillation. No large, randomized trial has examined this issue. This report describes outcomes according to age at entry in the CABANA trial (Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation). Methods: Patients with atrial fibrillation ≥65 years of age, or <65 with ≥1 risk factor for stroke, were randomly assigned to catheter ablation versus drug therapy. The primary outcome was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Secondary outcomes included all-cause mortality, the composite of mortality or cardiovascular hospitalization, and recurrence of atrial fibrillation. Treatment effect estimates were adjusted for baseline covariables using proportional hazards regression models. Results: Of 2204 patients randomly assigned in CABANA, 766 (34.8%) were <65 years of age, 1130 (51.3%) were 65 to 74 years of age, and 308 (14.0%) were ≥75 years of age. Catheter ablation was associated with a 43% reduction in the primary outcome for patients <65 years of age (adjusted hazard ratio [aHR], 0.57 [95% CI, 0.30-1.09]), a 21% reduction for 65 to 74 years of age (aHR, 0.79 [95% CI, 0.54-1.16]), and an indeterminate effect for age ≥75 years of age (aHR, 1.39 [95% CI, 0.75-2.58]). Four-year event rates for ablation versus drug therapy across age groups, respectively, were 3.2% versus 7.8%, 7.8% versus 9.6%, and 14.8% versus 9.0%. For every 10-year increase in age, the primary outcome aHR increased (ie, less favorable to ablation) an average of 27% (interaction P value=0.215). A similar pattern was seen with all-cause mortality: for every 10-year increase in age, the aHR increased an average of 46% (interaction P value=0.111). Atrial fibrillation recurrence rates were lower with ablation than with drug therapy across age subgroups (aHR 0.47, 0.58, and 0.49, respectively). Treatment-related complications were infrequent for both arms (<3%) regardless of age. Conclusions: We found age-based variations in clinical outcomes for catheter ablation compared with drug therapy, with the largest relative and absolute benefits of catheter ablation in younger patients. No prognostic benefits for ablation were seen in the oldest patients. No differences were found by age in treatment-related complications or in the relative effectiveness of catheter ablation in preventing recurrent atrial arrhythmias. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00911508.
AB - Background: Observational data suggest that catheter ablation may be safe and effective to treat younger and older patients with atrial fibrillation. No large, randomized trial has examined this issue. This report describes outcomes according to age at entry in the CABANA trial (Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation). Methods: Patients with atrial fibrillation ≥65 years of age, or <65 with ≥1 risk factor for stroke, were randomly assigned to catheter ablation versus drug therapy. The primary outcome was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Secondary outcomes included all-cause mortality, the composite of mortality or cardiovascular hospitalization, and recurrence of atrial fibrillation. Treatment effect estimates were adjusted for baseline covariables using proportional hazards regression models. Results: Of 2204 patients randomly assigned in CABANA, 766 (34.8%) were <65 years of age, 1130 (51.3%) were 65 to 74 years of age, and 308 (14.0%) were ≥75 years of age. Catheter ablation was associated with a 43% reduction in the primary outcome for patients <65 years of age (adjusted hazard ratio [aHR], 0.57 [95% CI, 0.30-1.09]), a 21% reduction for 65 to 74 years of age (aHR, 0.79 [95% CI, 0.54-1.16]), and an indeterminate effect for age ≥75 years of age (aHR, 1.39 [95% CI, 0.75-2.58]). Four-year event rates for ablation versus drug therapy across age groups, respectively, were 3.2% versus 7.8%, 7.8% versus 9.6%, and 14.8% versus 9.0%. For every 10-year increase in age, the primary outcome aHR increased (ie, less favorable to ablation) an average of 27% (interaction P value=0.215). A similar pattern was seen with all-cause mortality: for every 10-year increase in age, the aHR increased an average of 46% (interaction P value=0.111). Atrial fibrillation recurrence rates were lower with ablation than with drug therapy across age subgroups (aHR 0.47, 0.58, and 0.49, respectively). Treatment-related complications were infrequent for both arms (<3%) regardless of age. Conclusions: We found age-based variations in clinical outcomes for catheter ablation compared with drug therapy, with the largest relative and absolute benefits of catheter ablation in younger patients. No prognostic benefits for ablation were seen in the oldest patients. No differences were found by age in treatment-related complications or in the relative effectiveness of catheter ablation in preventing recurrent atrial arrhythmias. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00911508.
KW - age groups
KW - anti-arrhythmia agents
KW - atrial fibrillation
KW - catheter ablation
KW - pulmonary veins
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U2 - 10.1161/CIRCULATIONAHA.121.055297
DO - 10.1161/CIRCULATIONAHA.121.055297
M3 - Article
C2 - 34933570
AN - SCOPUS:85125533572
VL - 145
SP - 796
EP - 804
JO - Circulation
JF - Circulation
SN - 0009-7322
IS - 11
ER -