After a successful atrial fibrillation (AF) ablation, the need to maintain long-term anticoagulation (AC) remains uncertain, especially considering the very low residual embolic risk and the bleeding risks associated with prolonged AC use. The OCEAN study also incorporated brain magnetic resonance imaging (MRI) to detect instances of “silent” stroke.
This was a multicenter, international, prospective, randomized, open-label study conducted across 56 centers in 6 countries. It enrolled patients without AF recurrence for at least 1 year after ablation (verified by 24–48-hour monitoring) and with a CHA₂DS₂-VASc score ≥1 (≥2 in women or subjects with vascular disease).
The goal was to assess whether rivaroxaban 15 mg/day compared with aspirin (ASA) 70–120 mg/day could prevent embolic events. To detect clinical and subclinical stroke, brain MRIs were performed at baseline and at 3 years (analyzed by a central core lab).
The primary endpoint (PEP) was the occurrence of clinical stroke, systemic embolism, or silent stroke at 3 years. Event incidence was very low in both arms, with no significant reduction in the PEP with rivaroxaban vs. aspirin (p=0.28). In terms of safety, the rates for major bleeding were similar, but minor bleeding was significantly higher with AC (hazard ratio [HR] 3.51).
Conclusions: In stable patients after successful AF ablation, embolic risk was very low and did not justify continued anticoagulation. Treatment with rivaroxaban did not reduce the composite endpoint and increased non-major bleeding episodes.
Presented by Atul Verma during the Late-Breaking Science session at AHA 2025, New Orleans, USA.
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