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Updated: Feb 23, 2026

Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke
Jean-Louis Mas1, Geneviève Derumeaux1, Benoît Guillon1
1From the Department of Neurology, Sainte-Anne Hospital, INSERM 894, Département Hospitalo-Universitaire (DHU) NeuroVasc Sorbonne Paris-Cité (J.-L.M., G.T.), and the Department of Neurology, Saint-Joseph Hospital (M.Z.), Paris Descartes University, the Department of Neurology and Stroke Unit (C.G.) and the Department of Cardiology (J.-M.J.), Bichat Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), INSERM 1148, DHU FIRE (Fibrosis Inflammation and Remodeling in Cardiovascular, Renal, and Respiratory Diseases) Sorbonne Paris-Cité, the Department of Neurology, Saint-Antoine Hospital, AP-HP, Pierre et Marie Curie University (P.F.), the Department of Neurology, Lariboisière Hospital, DHU NeuroVasc Sorbonne Paris-Cité, Paris Diderot University (P.R.), and the Epidemiology and Clinical Research Unit, Georges Pompidou European Hospital, AP-HP, INSERM Centre d'Investigation Clinique 1418 (A.C.-N., G.C.), Paris, the Departments of Physiology (G.D.), Neurology (H.H.), and Cardiology (J.-L.D.-R.), Henri Mondor Hospital, AP-HP, University Paris Est Creteil, Creteil, the Departments of Neurology (B.G.) and Cardiology (P. Guérin), Centre Hospitalier Universitaire (CHU) Nantes, Nantes, the Department of Neurology, University Hospital, Rouen (E.M.), the Stroke Department (L.M.) and the Departments of Interventional Cardiology (R.R.) and Cardiovascular Investigations (M.B.), Pierre Wertheimer and Louis Pradel Hospitals, Lyon University, Lyon, the Department of Neurology, Gui de Chauliac Hospital, INSERM 894 (C.A.), and the Department of Interventional Cardiology, Clinique du Millénaire, INSERM 1191 (C.P.), Montpellier University, Montpellier, the Department of Neurology, Dijon Stroke Registry, EA 7460 (Y.B.), and the Department of Cardiology (J.-C.E.), University Hospital, Burgundy University, Dijon, the Departments of Neurology (F.V., T.M.) and Cardiology (N.M.), Jean Minjoz University Hospital, Franche-Comté University, Besançon, the Departments of Neurology (O.D.) and Cardiology (B.B.), Michallon Hospital, Grenoble Alpes University, Grenoble, the Department of Neurology and Stroke Unit (S.C.) and the Department of Cardiology (L.L.), University Hospital, Jules Verne Picardie University, Amiens, the Department of Neurology, Yves le Foll Hospital, Saint Brieuc (C.V.), the Department of Neurology and Stroke Unit (N.D.-P.) and the Department of Cardiology and Congenital Heart Disease (F.G.), Centre Hospitalier Régional Universitaire (CHRU) Lille, Lille Nord de France University, Lille, the Department of Neurology and Stroke Unit (I.S.) and the Department of Congenital Cardiac Diseases (J.-B.T.), CHU Bordeaux, Bordeaux University, Bordeaux, the Department of Neurology, University Hospital, INSERM 1059, Lyon University, Saint-Etienne (P. Garnier), the Departments of Neurology (A.F.) and Cardiology (J.-R.L.), University Hospital, Clermont-Ferrand, the Department of Neurology and Stroke Unit, Cavale Blanche Hospital, INSERM 1078, University of Western Brittany, Brest (S.T.), the Department of Neurology, La Timone Hospital, Aix-Marseille University, Marseille (E.R.-B.), the Department of Neurology, Saint-Jean Hospital, Perpignan (D.S.), the Department of Neurology and Stroke Unit, Central Hospital, Nancy (J.-C.L.), the Departments of Neurology (J.-F.P.) and Cardiology and Vascular Diseases (J.-M.S.), Pontchaillou Hospital, Rennes University, Rennes, the Department of Neurology, Caen University Hospital, Caen (M.A.), the Department of Neurology, Docteur Schaffner Hospital, Lens (C.L.) - all in France; the Stroke Center, Department of Neurology, Vaudois University Hospital, Lausanne University, Lausanne, Switzerland (P.M.); the Department of Cardiology, CHU Sart Tilman, Liege University, Liege, Belgium (L.P.); and the Department of Neurology, University Hospital, Duisburg-Essen University, Duisberg-Essen, Germany (C.W.).
Patent foramen ovale (PFO) closure significantly reduced stroke recurrence in patients with cryptogenic stroke and specific PFO features. However, PFO closure increased the risk of atrial fibrillation.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Recurrent stroke prevention via patent foramen ovale (PFO) closure remains inconclusive.
- Investigated PFO closure versus anticoagulation for cryptogenic stroke with high-risk PFO features.
Purpose of the Study:
- To determine if PFO closure or anticoagulation benefits patients with cryptogenic stroke and echocardiographic risk factors.
- Compared PFO closure with antiplatelet therapy and anticoagulation with antiplatelet therapy.
Main Methods:
- Multicenter, randomized, open-label trial with 663 patients (16-60 years old).
- Assigned patients to PFO closure + antiplatelet, antiplatelet alone, or anticoagulation.
- Primary outcome: stroke occurrence; followed for 5.3 years.
Main Results:
- PFO closure group had no strokes (vs. 14 in antiplatelet-only group; HR 0.03).
- Higher atrial fibrillation rate in PFO closure group (4.6% vs. 0.9%).
- No significant difference in serious adverse events.
Conclusions:
- PFO closure plus antiplatelet therapy significantly reduced stroke recurrence in high-risk patients.
- PFO closure is associated with an increased risk of atrial fibrillation.
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