Verma A et al.: Antithrombotic Therapy after Successful Catheter Ablation for Atrial Fibrillation. NEJM 8.11.2025. DOI: 10.1056/NEJMoa2509688
BACKGROUND
Whether successful catheter ablation for atrial fibrillation eliminates the need for
long-term oral anticoagulant therapy is unknown.
METHODS
We conducted an international, open-label, randomized, blinded-outcome-assess-
ment trial involving 1284 patients who had undergone successful catheter ablation
for atrial fibrillation at least 1 year earlier and had a CHA2DS2-VASc score (scores
range from 0 to 9, with higher scores indicating a higher risk of stroke) of 1 or
more (or ≥2 for women or for patients in whom vascular disease was a risk factor).
Patients were randomly assigned to receive either aspirin (at a dose of 70 to 120
mg daily, depending on availability in the local jurisdiction) or rivaroxaban (at a
dose of 15 mg) and followed for 3 years. Magnetic resonance imaging (MRI) of
the head was performed after enrollment and at 3 years. The primary outcome was
a composite of stroke, systemic embolism, or new covert embolic stroke (defined
by ≥1 new infarct measuring ≥15 mm on MRI) at 3 years.
RESULTS
A total of 641 patients were assigned 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 group and in 9 patients (0.66 events per 100 patient-years) in
the aspirin group (relative risk, 0.56; 95% confidence interval [CI], 0.19 to 1.65; abso-
lute risk difference at 3 years, −0.6 percentage points; 95% CI, −1.8 to 0.5; P=0.28).
New cerebral infarcts measuring less than 15 mm occurred in 22 of 568 patients
(3.9%) in the rivaroxaban group and in 26 of 590 patients (4.4%) in the aspirin group
(relative risk, 0.89; 95% CI, 0.51 to 1.55). Fatal or major bleeding (the composite
primary safety outcome) had occurred in 10 patients (1.6%) with rivaroxaban and
in 4 patients (0.6%) with aspirin (hazard ratio, 2.51; 95% CI, 0.79 to 7.95) at 3 years.
CONCLUSIONS
Among patients who had had successful catheter ablation for atrial fibrillation at
least 1 year earlier and had risk factors for stroke, treatment with rivaroxaban did
not result in a significantly lower incidence of a composite of stroke, systemic
embolism, or new covert embolic stroke than treatment with aspirin. (Funded by
Bayer and others; OCEAN ClinicalTrials.gov number, NCT02168829.)