Prognostic Impact of Sinus Rhythm in Atrial Fibrillation Patients: Separating Rhythm Outcomes From Randomized Strategy Findings From the CABANA Trial.
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2024-05
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Abstract
Background
Clinically detected atrial fibrillation (AF) is associated with a significant increase in mortality and other adverse cardiovascular events. Since the advent of effective methods for AF rhythm control, investigators have attempted to determine how much these adverse prognostic AF effects could be mitigated by the restoration of sinus rhythm (SR) and whether the method used mattered.Methods
The CABANA trial (Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) randomized 2204 AF patients to ablation versus drug therapy, of which 1240 patients were monitored in follow-up using the CABANA ECG rhythm monitoring system. To assess the prognostic benefits of SR, we performed a prespecified analysis using Cox survival modeling with heart rhythm as a time-dependent variable and randomized treatment group as a stratification factor.Results
In the 1240 patient study cohort, 883 (71.2%) had documented AF at some point during their postblanking follow-up. Among the 883 patients, 671 (76.0%) experienced AF within the first year of postblanking follow-up, and 212 (24.0%) experienced their first AF after ≥1 year of postblanking follow-up. The primary CABANA end point (death, disabling stroke, serious bleeding, or cardiac arrest) occurred in 95 (10.8%) of the 883 patients with documented AF and in 29 (8.1%) of the 357 patients with no AF recorded during follow-up. In multivariable time-dependent analysis, the presence of SR (compared with non-SR) was associated with a significantly reduced risk of the primary end point (adjusted hazard ratio, 0.57 [95% CI, 0.38-0.85]; P=0.006; independent of treatment strategy [ablation versus drugs]). Corresponding results for all-cause mortality were adjusted hazard ratio of 0.59 [95% CI, 0.35-1.01]; P=0.053).Conclusions
In patients in the CABANA trial with detailed long-term rhythm follow-up, increased time in SR was associated with a clinically consequential decrease in mortality and other adverse prognostic events. The predictive value of SR was independent of the therapeutic approach responsible for reducing the burden of detectable AF.Registration
URL: https://clinicaltrials.gov; Unique Identifier: NCT00911508.Type
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Bunch, T Jared, Jeanne E Poole, Adam P Silverstein, Kerry L Lee, Hussein R Al-Khalidi, Gerhard Hindricks, Alexander Romanov, Alexander Romanov, et al. (2024). Prognostic Impact of Sinus Rhythm in Atrial Fibrillation Patients: Separating Rhythm Outcomes From Randomized Strategy Findings From the CABANA Trial. Circulation. Arrhythmia and electrophysiology, 17(5). p. e012697. 10.1161/circep.123.012697 Retrieved from https://hdl.handle.net/10161/31134.
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Scholars@Duke
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.
Tristram Dan Bahnson
Jonathan Paul Piccini
Jonathan P. Piccini, MD, MHS, FACC, FAHA, FHRS is a clinical cardiac electrophysiologist and Professor of Medicine and Population Health at Duke University Hospital and the Duke Clinical Research Institute. He is the Director of the Cardiac Electrophysiology section at the Duke Heart Center. His focus is on the care of patients with atrial fibrillation and complex arrhythmias, with particular emphasis on catheter ablation, pacing, and lead extraction. His research interests include the development and evaluation of innovative cardiovascular interventions for the treatment of heart rhythm disorders. He serves on the Board of Trustees of the Heart Rhythm Society, is an Associate Editor at JACC: Clinical Electrophysiology, and is an elected member of the American Society for Clinical Investigation. Dr. Piccini has more than 600 publications in the field of heart rhythm medicine and has been the recipient of several teaching and mentorship awards.
Daniel Benjamin Mark
Dr. Mark is a clinical cardiologist with the rank of Professor of Medicine (with tenure) as well as Vice Chief for Academic Affairs in the Division of Cardiology, Department of Medicine at Duke University Medical Center. He is also the Director of Outcomes Research at the Duke Clinical Research Institute. He has been on the full-time faculty at Duke since 1985. Prior to that he completed his cardiology fellowship at Duke, his residency and internship at the University of Virginia Hospital, and received his medical degree from Tufts University and his Master’s degree from Harvard. In 1998, he was given the honor of being elected to the American Society for Clinical Investigators and in 2002 he was honored by election to the Association of American Physicians. These organizations are the two most prestigious honor societies in academic medicine. In 2009, Dr. Mark was awarded the American College of Cardiology Distinguished Scientist Award.
Dr. Mark's major research interests include medical economics and quality of life outcomes, outcomes research, and quality of medical care. Currently, Dr. Mark is directing a number of outcomes analyses for ongoing clinical trials including PROMISE (anatomic versus functional testing for coronary artery disease, NIH), CABANA (catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation, NIH), ISCHEMIA (percutaneous coronary intervention versus optimal medical therapy for moderate-severe ischemia), and STICH (CABG +/- ventricular reconstruction versus medical therapy for ischemic heart disease, NIH). He was the principal author of the AHCPR Unstable Angina Guidelines and is a co-author of both the American College of Cardiology Guideline on Exercise Testing and their Coronary Stent Consensus Guideline. He is also the Editor of the American Heart Journal. Dr. Mark has published over 270 peer-reviewed articles, two books, and 80 book chapters. He lectures widely in the US, as well as in Canada, South America, and Europe.
Keywords: cost-effectiveness analysis, disease management, quality of life assessment, resource use.
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