Objectives

To determine whether catheter ablation is more effective than conventional medical therapy for improving outcomes in atrial fibrillation.

Background

Atrial fibrillation (AF) is the most common cardiac tachyarrhythmia. However, it is perplexing from a clinical management perspective. Some patients with AF are symptomatic to the point of disabling decrements in quality of life, while others remain asymptomatic.

Antiarrhythmic drug therapy has been the primary treatment for AF for decades, but limited effectiveness combined with incompletely assessed risks have led to the development of other strategies to maintain sinus rhythm, such as ablation. The use of ablation has been extended to more difficult and higher-risk patients despite the lack of large randomized comparative trial evidence of improved clinical outcomes.

CABANA was designed to test the hypothesis that ablative therapy for AF is more effective than state-of-the-art drug therapy in a broad population of symptomatic and inadequately treated patients with AF.

Participants

Eligible patients were aged 65 years and older or younger than 65 years with 1 or more risk factors for stroke (hypertension, heart failure, history of stroke, diabetes, or other heart problems), had 2 or more episodes of paroxysmal AF or 1 episode of persistent AF in the prior 6 months, and were suitable for catheter-based treatment or rhythm and/or rate control drug therapy.

A total of 2204 patients were enrolled. 1108 patients were randomized to the catheter ablation group and 1096 to the medical therapy group.

Design

The CABANA study was an international open-label, multicenter, randomized trial. Eligible participants were randomized to either the catheter ablation group or the medical therapy group. Participants in the catheter ablation group underwent pulmonary vein isolation, with additional ablative procedures at the discretion of site investigators. Participants in the drug therapy group received standard rhythm and/or rate control drugs guided by contemporaneous guidelines. It was recommended that patients randomized to medical therapy receive rate control medications first. All participants received anticoagulation based on contemporaneous guidelines.

Scheduled patient follow-up occurred at 3, 6, and 12 months and then every 6 months thereafter. Collected data include events for each component of the primary end point, cardiovascular hospitalization, adverse events, and AF recurrence.

The primary end point was a composite of death, disabling stroke (irreversible physical limitation defined by a Rank in Stroke Scale score of 2 or greater), serious bleeding (bleeding accompanied by hemodynamic compromise requiring surgical intervention or a transfusion of 3 or more units of blood), or cardiac arrest.

Conclusions

Among patients with AF, the strategy of catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest.

Packer DL, Mark DB, Robb RA, et al. Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019;321(13):1261-1274. doi:10.1001/jama.2019.0693

Request Data

Please note that researchers must be registered on this site to submit a request, and you will be prompted to log in. If you are not registered on this site, you can do so via the Request button. Registration is quick, easy and free.