Arrhythmia2019Journal of the American Medical Association

CABANA

Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation

Sample Size

2,204

Study Design

Multicenter, international, randomized, open-label trial

Year Published

2019

Clinical Question

Is catheter ablation superior to drug therapy for the treatment of atrial fibrillation in reducing a composite of death, disabling stroke, serious bleeding, or cardiac arrest?

Population

Patients aged 65 or older (or younger with ≥1 stroke risk factor) with paroxysmal, persistent, or longstanding persistent atrial fibrillation at 126 sites in 10 countries.

Intervention

Catheter ablation for atrial fibrillation (primarily pulmonary vein isolation)

Control

Guideline-recommended antiarrhythmic drug therapy (rate or rhythm control)

Primary Endpoint

Composite of death, disabling stroke, serious bleeding, or cardiac arrest

Key Findings

On intention-to-treat analysis, the primary endpoint occurred in 8.0% of ablation vs 9.2% of drug therapy patients (HR 0.86; 95% CI, 0.65-1.15; p=0.30).

Per-protocol analysis (treatment received) showed a significant 33% reduction in the primary endpoint with ablation (HR 0.67; 95% CI, 0.50-0.89; p=0.006).

AF recurrence at 12 months was significantly lower with ablation (50% vs 69%; p<0.001).

The crossover rate from drug therapy to ablation was 27.5%, which significantly diluted the intention-to-treat analysis.

Quality of life improved significantly more in the ablation group across all time points.

Impact on Clinical Practice

CABANA was the largest randomized trial of catheter ablation versus drug therapy for AF, but its interpretation was complicated by a high crossover rate from the drug arm to ablation. The intention-to-treat analysis did not reach statistical significance, but the per-protocol and as-treated analyses showed significant benefits of ablation. The trial highlighted a fundamental challenge in interventional trials: when patients assigned to conservative therapy cross over to the intervention in large numbers, the true treatment effect is diluted. In CABANA, 27.5% of patients randomized to drug therapy ultimately underwent ablation, largely because of symptom burden or drug intolerance. Despite the neutral primary result on intention-to-treat, CABANA provided important supportive evidence for ablation as a first-line rhythm control strategy, particularly in younger patients and those with heart failure. Combined with CASTLE-AF and subsequent analyses, it contributed to a growing evidence base favoring early rhythm control in atrial fibrillation.

Guideline Impact

CABANA contributed to the 2020 ESC AF guideline recommendation for catheter ablation as a first-line rhythm control option (Class IIa) in selected patients with paroxysmal AF. The ACC/AHA/HRS guidelines cite CABANA in support of ablation as an alternative to antiarrhythmic drugs for rhythm control.

Limitations

The 27.5% crossover rate from drug to ablation significantly diluted the intention-to-treat analysis and complicated result interpretation.

The low overall event rate (8-9%) suggested the enrolled population was lower risk than anticipated, reducing statistical power.

Open-label design may have influenced the decision to cross over from drug therapy to ablation.

Reviewed by Sandeep M. Patel, MD

Structural & Interventional Cardiologist

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CASTLE-AF

2018 · New England Journal of Medicine

atrial fibrillation ablation vs medical therapy

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