- Question
- To determine whether long-term oral anticoagulation can be avoided after successful catheter ablation of atrial fibrillation in patients with stroke risk factors, comparing rivaroxaban with aspirin.
- Design
- International, randomized, open-label trial with blinded outcome assessment, including 1284 patients followed for 3 years. Head MRI was performed at enrollment and at 3 years.
- Population
- Patients who had undergone successful catheter ablation for atrial fibrillation at least 1 year earlier and had a CHA2DS2-VASc score of 1 or more (or 2 or more for women or when vascular disease was the risk factor).
- Intervention
- Rivaroxaban 15 mg daily (641 patients).
- Control
- Aspirin 70 to 120 mg daily, depending on local availability (643 patients).
- Primary outcome
- Composite of stroke, systemic embolism, or new covert embolic stroke (at least one new infarct of 15 mm or more on MRI) at 3 years.
- Results
- A primary-outcome event occurred in 5 patients on rivaroxaban (0.31 events per 100 patient-years) and 9 on aspirin (0.66 per 100 patient-years): relative risk 0.56 (95% CI, 0.19 to 1.65; P = 0.28), not statistically significant. New cerebral infarcts smaller than 15 mm occurred in 3.9% with rivaroxaban and 4.4% with aspirin.
- Safety
- Fatal or major bleeding occurred in 10 patients (1.6%) on rivaroxaban and 4 (0.6%) on aspirin (HR 2.51; 95% CI, 0.79 to 7.95).
- Conclusion
- In patients with successful ablation and stroke risk factors, rivaroxaban did not significantly reduce the composite of stroke, systemic embolism, or covert embolic stroke compared with aspirin.
- Why it matters
- The trial provides randomized evidence on whether long-term anticoagulation is needed after successful ablation, a question previously lacking a clear answer. It suggests aspirin may be an alternative, although the low event rate limits the precision of the estimate.
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 14, 2026