Association Between Age and Outcomes of Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: Results From the CABANA Trial.
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2022-03
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Abstract
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.Type
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Bahnson, Tristram D, Anna Giczewska, Daniel B Mark, Andrea M Russo, Kristi H Monahan, Hussein R Al-Khalidi, Adam P Silverstein, Jeanne E Poole, et al. (2022). Association Between Age and Outcomes of Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: Results From the CABANA Trial. Circulation, 145(11). pp. 796–804. 10.1161/circulationaha.121.055297 Retrieved from https://hdl.handle.net/10161/31128.
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Scholars@Duke
Tristram Dan Bahnson
Hussein Rashid Al-Khalidi
My research interest includes design and analysis of cardiovascular clinical trials, medical devices, survival analysis, group-sequential analysis, time-to-recurrent or multiple events, continuous-time Markov models, stochastic process, linear model, dose-response modeling, design of experiments and adaptive designs.
Kerry L. Lee
As a faculty-level biostatistician, my research activities are focused on the statistical and data coordination aspects of several large multicenter clinical trials, and on statistical issues in the design and analysis of collaborative clinical research projects associated with the Duke University Cardiovascular Disease Database. I am currently the principal investigator of the statistical and data coordinating center for two NIH-sponsored multicenter randomized clinical trials, namely (1) the Pacemaker Mode Selection Trial, a 2000 patient study of dual chamber versus single chamber pacing in patients with sinus node dysfunction, and (2) the Sudden Cardiac Death in heart Failure Trial a 2,500 patient, three-arm randomized trial of implantable defibrillator therapy or amiodarone versus conventional therapy in patients with class II or III congestive heart failure. During the past year my colleagues and I have completed a third trial sponsored by the NIH for which I was the principal investigator of the data coordinating center. This trial assessed the efficiency of electrophy siologic-guided antiarrhythmic therapy in patients at risk for sudden cardiac death. I also serve as the statistical director and principal statistician for the following major clinical trials:
(1) Symphony II, a 7,000 patient randomized trial of long-term oral platelet inhibition therapy in patients following an acute coronary syndrome, sponsored by Hoffman-LaRoche.
(2) PARAGON B, a 5,200 patient trial of platelet inhibition therapy in patients with unstable angina, also sponsored by Hoffman-LaRoche.
Methodologically, my research activities are focused on the analytic and design issues associated with clinical trials, on regression modeling strategies for risk assessment with logistic and proportional hazards regression models, and on methods for validating prognostic models and assessing probabilistic predictions.
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