Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation - OCEAN

Nov 08, 2025

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Author/Summarized by Author:
Bridget G Lee, DO; Michael Gurin, MD
Summary Reviewer:
Fred M. Kusumoto, MD, FACC
Original Posted Date:
11/08/2025
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Contribution To Literature:

The OCEAN trial found that rivaroxaban did not result in a significantly lower incidence of stroke, systemic embolism or new covert embolic stroke compared with aspirin among patients at high risk for stroke who had undergone a catheter ablation for atrial fibrillation (AFib) at least one year prior.

Study Design:

Design: Prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication (PROBE design).

  • Randomization: 1:1
  • Sites: 56 centers, 6 countries
  • Total randomized patients: 1,284
  • Duration of follow-up: 3 years
  • Mean patient age: 66.3±7.3 (rivaroxaban group), 66.3±7.6 (aspirin group)
  • Demographics: 71.5% male (rivaroxaban group), 71.4% male (aspirin group)
  • Inclusion Criteria: At least one year after successful AFib ablation(s), at least one 24-hour Holter 2-6 months post-ablation, 24-hour Holter >6 months, and 48-hour Holter prior to enrollment, with absence of atrial arrhythmia >30 seconds. A CHA2DS2-VASc score of 1 or more, or 2 or more if female sex or vascular disease.
  • Exclusion Criteria: age >85, CrCl <30mL/min, prior disabling stroke within one year, any prior stroke within 14 days, hypercoagulability disorder, intracranial vascular anomaly, valvular AFib associated with rheumatic mitral valve or mechanical valve replacement, and any contraindication to anticoagulation, antiplatelet therapy, or MRI.
  • Interventional Model: Patients were randomized (1:1) with blinded endpoint adjudication and administered rivaroxaban (15mg) or aspirin (70-120mg). An MRI head with stroke protocols were obtained for a baseline, then again at 3 years for comparison.

Principal Findings:

Primary Outcome:

  • A composite of stroke, systemic embolism, or new covert embolic stroke defined as ≥1 new cerebral infarct ≥15 mm on MRI at 3 years occurred in 5 of 641 patients (0.8%; 0.31 events per 100 patient-years) on rivaroxaban and in 9 of 643 patients (1.4%; 0.66 events per 100 patient-years) on aspirin (relative risk, 0.56; 95% confidence interval [CI], 0.19-1.65; absolute risk difference, -0.6 percentage points; 95% CI, -1.8 to 0.5; P=0.28).

Secondary Outcomes:

  • Stroke or systemic embolism occurred in 0.8% of patients in the rivaroxaban group and 1.1% of patients in the aspirin group (relative risk, 0.72; 95% CI, 0.23–2.25).
  • New covert embolic stroke (≥15 mm) was not observed in the rivaroxaban group and occurred in 0.3% of patients in the aspirin group.
  • New cerebral infarcts <15 mm were detected in 22 of 568 patients (3.9%) receiving rivaroxaban and in 26 of 590 patients (4.4%) receiving aspirin (relative risk, 0.89; 95% CI, 0.51–1.55).

Safety outcomes: Fatalities, major and minor bleeding events.

  • Fatal or major bleeding occurred in 10 patients (1.6%) in the rivaroxaban group and in 4 patients (0.6%) in the aspirin group (hazard ratio, 2.51; 95% CI, 0.79–7.95).
  • Clinically relevant nonmajor bleeding occurred more frequently with rivaroxaban than with aspirin (5.5% vs 1.6%; hazard ratio, 3.51; 95% CI, 1.75–7.03).
  • Minor bleeding was also more common in the rivaroxaban group (11.5% vs 3.1%).

Interpretation:

Among patients who remained free of recurrent atrial arrhythmia for at least 1 year after apparently successful AFib ablation, rivaroxaban did not significantly reduce the composite of stroke, systemic embolism, or new covert embolic stroke compared with aspirin, but was associated with higher rates of nonmajor and minor bleeding.

These findings suggest that selected patients after successful ablation may be candidates for de-escalation of antithrombotic therapy, although applicability to patients at very high stroke risk remains uncertain and extended rhythm monitoring was not mandated.

References

Verma A, Birnie D, Jiang C, et al. Antithrombotic therapy after successful catheter ablation for atrial fibrillation. N Engl J Med. 2026;394:323-332. doi:10.1056/NEJMoa2509688.

Presented by Atul Verma, MD, FACC, at the American Heart Association Scientific Sessions (AHA 2025), New Orleans, LA, Nov. 8, 2025.

Resources

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Noninvasive Imaging, Anticoagulation Management and Atrial Fibrillation, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Magnetic Resonance Imaging

Keywords: AHA Annual Scientific Sessions, AHA25, Fibrinolytic Agents, Embolic Stroke, Catheter Ablation, Atrial Fibrillation, Mitral Valve, Magnetic Resonance Imaging, Hemorrhage, Embolism, Cerebral Infarction, Anticoagulants