Antithrombotic Therapy after Successful Catheter Ablation for Atrial Fibrillation
After successful AF ablation, rivaroxaban did not lower stroke/systemic embolism versus aspirin and increased nonmajor bleeding. International, open-label randomized, blinded-outcome-assessment trial; Level 1b (2011 OCEBM).
Background
Whether anticoagulation can be safely stopped after successful atrial fibrillation (AF) ablation is uncertain.
Patients
1284 adults ≥1 year post–successful AF ablation; mean age 66; 29% women; mean CHA2DS2-VASc 2.2 (32% ≥3). Key exclusions: CrCl <30 ml/min, MRI contraindication, age >85.
Intervention
Rivaroxaban 15 mg once daily.
Control
Aspirin 70–120 mg once daily.
Outcome
Primary efficacy: composite of stroke, systemic embolism, or new covert embolic stroke (MRI ≥15 mm) at 3 years. Primary safety: fatal or major bleeding.
Follow up period
3 years.
Results
| Outcome | Rivaroxaban | Aspirin | Effect | Absolute difference | NNT/NNH (3y) |
|---|---|---|---|---|---|
| Primary efficacy: stroke/systemic embolism/covert embolic stroke | 5/641 (0.8%) | 9/643 (1.4%) | RR 0.56 (95% CI 0.19–1.65) | −0.6% | NNT 167 |
| Stroke or systemic embolism | 5/641 (0.8%) | 7/643 (1.1%) | RR 0.72 (95% CI 0.23–2.25) | −0.3% | NNT 333 |
| New covert embolic stroke (MRI ≥15 mm) | 0 (0%) | 2 (0.3%) | — | −0.3% | NNT 333 |
| New cerebral infarcts <15 mm (imaging) | 22/568 (3.9%) | 26/590 (4.4%) | RR 0.89 (95% CI 0.51–1.55) | −0.5% | NNT 200 |
| Primary safety: fatal or major bleeding | 10/641 (1.6%) | 4/643 (0.6%) | HR 2.51 (95% CI 0.79–7.95) | +1.0% | NNH 100 |
| Clinically relevant nonmajor bleeding | 35/641 (5.5%) | 10/643 (1.6%) | HR 3.51 (95% CI 1.75–7.03) | +3.9% | NNH 26 |
| Minor bleeding | 74/641 (11.5%) | 20/643 (3.1%) | HR 3.71 (95% CI 2.29–6.01) | +8.4% | NNH 12 |
Limitations
- Low event rates; trial underpowered for modest effects.
- Open-label; early enrollment stop for futility.
- No extended rhythm monitoring; asymptomatic AF recurrence unknown.
- Moderate-risk, relatively healthy cohort; generalizability limited for very high risk.
Funding
Bayer and device companies; public agencies; potential industry bias.
Citation
Verma A, Birnie DH, Jiang C, et al. Antithrombotic Therapy after Successful Catheter Ablation for Atrial Fibrillation. N Engl J Med. 2025; Published Nov 8. DOI: 10.1056/NEJMoa2509688.