- Question
- Is catheter ablation more effective than conventional drug therapy for improving clinical outcomes in patients with atrial fibrillation?
- Design
- Investigator-initiated, open-label, multicenter randomized trial across 126 centers in 10 countries, enrolling 2204 patients. Median follow-up was 48.5 months.
- Population
- Symptomatic patients with atrial fibrillation who were aged 65 years or older, or younger than 65 with one or more stroke risk factors.
- Intervention
- Catheter ablation with pulmonary vein isolation, with additional ablative procedures at the discretion of site investigators.
- Control
- Standard rhythm and/or rate control drug therapy guided by contemporaneous guidelines.
- Primary outcome
- Composite of death, disabling stroke, serious bleeding, or cardiac arrest.
- Results
- In the intention-to-treat analysis, the primary end point occurred in 8.0% of the ablation group vs 9.2% of the drug therapy group (HR 0.86; 95% CI 0.65-1.15; P = .30), a nonsignificant difference. AF recurrence was 49.9% vs 69.5% (HR 0.52; 95% CI 0.45-0.60; P < .001).
- Conclusion
- Catheter ablation did not significantly reduce the primary composite end point compared with medical therapy, although interpretation is limited by lower-than-expected event rates and treatment crossovers.
- Why it matters
- The trial showed that ablation did not demonstrate superiority over medical therapy for overall hard outcomes, but it provided key evidence on its effect on arrhythmia recurrence and highlighted the importance of accounting for crossovers between groups.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026