Regional differences in outcomes with ablation versus drug therapy for atrial fibrillation: Results from the CABANA trial.

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2024-04

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Abstract

Background

The finding of unexpected variations in treatment benefits by geographic region in international clinical trials raises complex questions about the interpretation and generalizability of trial findings. We observed such geographical variations in outcome and in the effectiveness of atrial fibrillation (AF) ablation versus drug therapy in the Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial. This paper describes these differences and investigates potential causes.

Methods

The examination of treatment effects by geographic region was a prespecified analysis. CABANA enrolled patients from 10 countries, with 1,285 patients at 85 North American (NA) sites and 919 at 41 non-NA sites. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Death and first atrial fibrillation recurrence were secondary endpoints.

Results

At least 1 primary endpoint event occurred in 157 patients (12.2%) from NA and 33 (3.6%) from non-NA sites over a median 54.9 and 40.5 months of follow-up, respectively (NA/non-NA adjusted hazard ratio (HR) 2.18, 95% confidence interval (CI) 1.48-3.21, P < .001). In NA patients, 78 events occurred in the ablation and 79 in the drug arm, (HR 0.91, 95% CI 0.66, 1.24) while 11 and 22 events occurred in non-NA patients (HR 0.51, 95% CI 0.25,1.05, interaction P = .154). Death occurred in 53 ablation and 51 drug therapy patients in the NA group (HR 0.96, 95% CI 0.65,1.42) and in 5 ablation and 16 drug therapy patients in the non-NA group (HR 0.32, 95% CI 0.12,0.86, interaction P = .044). Adjusting for baseline regional differences or prognostic risk variables did not account for the regional differences in treatment effects. Atrial fibrillation recurrence was reduced by ablation in both regions (NA: HR 0.54, 95% CI 0.46, 0.63; non-NA: HR 0.44, 95% CI 0.30, 0.64, interaction P = .322).

Conclusions

In CABANA, primary outcome events occurred significantly more often in the NA group but assignment to ablation significantly reduced all-cause mortality in the non-NA group only. These differences were not explained by regional variations in procedure effectiveness, safety, or patient characteristics.

Clinical trial registration

ClinicalTrials.gov Identifier: NCT0091150; https://clinicaltrials.gov/study/NCT00911508.

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Journal article

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CABANA Investigators, Humans, Atrial Fibrillation, Heart Arrest, Recurrence, Hemorrhage, Anti-Arrhythmia Agents, Catheter Ablation, Treatment Outcome, Stroke

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https://hdl.handle.net/10161/31113

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https://creativecommons.org/licenses/by-nc/4.0

Published Version (Please cite this version)

10.1016/j.ahj.2024.01.009

Publication Info

Cappato, Riccardo, Daniel B Mark, Adam P Silverstein, Peter A Noseworthy, Gianluca Bonitta, Jeanne E Poole, Jonathan P Piccini, Tristram D Bahnson, et al. (2024). Regional differences in outcomes with ablation versus drug therapy for atrial fibrillation: Results from the CABANA trial. American heart journal, 270. pp. 103–116. 10.1016/j.ahj.2024.01.009 Retrieved from https://hdl.handle.net/10161/31113.

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Scholars@Duke

Bahnson

Tristram Dan Bahnson

Professor of Medicine
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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