Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results From the CABANA Trial.

Abstract

Background

In patients with heart failure and atrial fibrillation (AF), several clinical trials have reported improved outcomes, including freedom from AF recurrence, quality of life, and survival, with catheter ablation. This article describes the treatment-related outcomes of the AF patients with heart failure enrolled in the CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation).

Methods

The CABANA trial randomized 2204 patients with AF who were ≥65 years old or <65 years old with ≥1 risk factor for stroke at 126 sites to ablation with pulmonary vein isolation or drug therapy including rate or rhythm control drugs. Of these, 778 (35%) had New York Heart Association class >II at baseline and form the subject of this article. The CABANA trial's primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest.

Results

Of the 778 patients with heart failure enrolled in CABANA, 378 were assigned to ablation and 400 to drug therapy. Ejection fraction at baseline was available for 571 patients (73.0%), and 9.3% of these had an ejection fraction <40%, whereas 11.7% had ejection fractions between 40% and 50%. In the intention-to-treat analysis, the ablation arm had a 36% relative reduction in the primary composite end point (hazard ratio, 0.64 [95% CI, 0.41-0.99]) and a 43% relative reduction in all-cause mortality (hazard ratio, 0.57 [95% CI, 0.33-0.96]) compared with drug therapy alone over a median follow-up of 48.5 months. AF recurrence was decreased with ablation (hazard ratio, 0.56 [95% CI, 0.42-0.74]). The adjusted mean difference for the AFEQT (Atrial Fibrillation Effect on Quality of Life) summary score averaged over the entire 60-month follow-up was 5.0 points, favoring the ablation arm (95% CI, 2.5-7.4 points), and the MAFSI (Mayo Atrial Fibrillation-Specific Symptom Inventory) frequency score difference was -2.0 points, favoring ablation (95% CI, -2.9 to -1.2).

Conclusions

In patients with AF enrolled in the CABANA trial who had clinically diagnosed stable heart failure at trial entry, catheter ablation produced clinically important improvements in survival, freedom from AF recurrence, and quality of life relative to drug therapy. These results, obtained in a cohort most of whom had preserved left ventricular function, require independent trial verification. Registration: URL: https://www.clinicaltrials.gov/ct2/show/NCT00911508; Unique identifier: NCT0091150.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1161/circulationaha.120.050991

Publication Info

Packer, Douglas L, Jonathan P Piccini, Kristi H Monahan, Hussein R Al-Khalidi, Adam P Silverstein, Peter A Noseworthy, Jeanne E Poole, Tristram D Bahnson, et al. (2021). Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results From the CABANA Trial. Circulation, 143(14). pp. 1377–1390. 10.1161/circulationaha.120.050991 Retrieved from https://hdl.handle.net/10161/31125.

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Scholars@Duke

Piccini

Jonathan Paul Piccini

Professor of Medicine

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.

Al-Khalidi

Hussein Rashid Al-Khalidi

Professor of Biostatistics & Bioinformatics

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.


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