Article Impact Level: HIGH Data Quality: STRONG Summary of New England Journal of Medicine https://doi.org/10.1056/NEJMoa2509688 Dr. Atul Verma et al.
Points
- The study investigated whether successful atrial fibrillation catheter ablation negates the need for long-term oral anticoagulant therapy.
- One thousand two hundred eighty-four patients with successful ablation and stroke risk factors were randomized to rivaroxaban or aspirin.
- Primary outcome events occurred in five patients (0.31 events/100 patient-years) in the rivaroxaban group.
- Nine patients (0.66 events/100 patient-years) experienced primary outcome events in the aspirin group.
- Rivaroxaban did not significantly reduce the incidence of stroke, systemic embolism, or new covert embolic stroke compared to aspirin.
Summary
This international, open-label, randomized, blinded-outcome-assessment trial investigated whether successful catheter ablation for atrial fibrillation (AF) could eliminate the requirement for long-term oral anticoagulant therapy. The study enrolled 1284 patients who had undergone successful AF ablation at least one year prior and possessed a CHA2DS2-VASc score of ≥1 (or ≥2 for women or those with vascular disease as a risk factor). Participants were randomized to receive either aspirin (70–120 mg daily) or rivaroxaban (15 mg) and were followed for three years, with head magnetic resonance imaging performed at enrollment and three years.
The primary outcome comprised a composite of stroke, systemic embolism, or new covert embolic stroke (defined as ≥1 new infarct measuring ≥15 mm on MRI) at three years. A total of 641 patients were allocated to the rivaroxaban group and 643 to the aspirin group. A primary outcome event occurred in 5 patients (0.31 events per 100 patient-years) in the rivaroxaban arm, compared to 9 patients (0.66 events per 100 patient-years) in the aspirin arm. The relative risk was 0.56 (95% confidence interval [CI], 0.19 to 1.65), with an absolute risk difference at three years of –0.6 percentage points (95% CI, –1.8 to 0.5; P = 0.28).
New cerebral infarcts measuring <15 mm were observed in 22 of 568 patients (3.9%) in the rivaroxaban group and 26 of 590 patients (4.4%) in the aspirin group (relative risk, 0.89; 95% CI, 0.51 to 1.55). Regarding safety, the composite primary safety outcome of fatal or major bleeding occurred in 10 patients (1.6%) with rivaroxaban versus 4 patients (0.6%) with aspirin (hazard ratio, 2.51; 95% CI, 0.79 to 7.95) at three years. The study concluded that, among patients with successful catheter ablation and existing stroke risk factors, rivaroxaban did not yield a significantly lower incidence of the primary composite endpoint compared to aspirin.
Link to the article: https://www.nejm.org/doi/10.1056/NEJMoa2509688
References
Verma, A., Birnie, D. H., Jiang, C., Heidbüchel, H., Hindricks, G., Kirchhof, P., Healey, J. S., Wang, Y., Dagres, N., Deyell, M. W., Sanders, P., Pathak, R. K., Koopman, P., Nuyens, D., Novak, P., Amit, G., Dussault, C., Makanjee, B., Quinn, F. R., … Wells, G. A. (2025). Antithrombotic therapy after successful catheter ablation for atrial fibrillation. New England Journal of Medicine, NEJMoa2509688. https://doi.org/10.1056/NEJMoa2509688
