PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years

Inclusion Criteria:

• Man or woman aged 60 to 80 years.

• Recent (≤ 6 months) ischemic stroke confirmed by cerebral imaging regardless ofsymptom duration.

• Absence of a more probable cause of stroke than PFO after a standardized etiologicalwork-up (see addenda).

• Presence of a PFO with at least 1 of the 2 following characteristics:

• PFO with large shunt > 20 microbubbles appearing in the left atrium during atleast one of the 3 cardiac cycles after opacification of the right atrium,detected spontaneously or during provocative manoeuvers, on contrasttransthoracic (TTE) or transoesophageal (TOE) echocardiography. The diagnosisof PFO by contrast TEE must be confirmed by contrast TOE showing aright-to-left passage of the contrast material across the PFO.

• PFO with ASA on transoesophageal echocardiography: excursion >10 mm

• Affiliation to a French Health Insurance system. Informed consent.

Exclusion Criteria:

• Life expectancy < 4 years.

• Contraindication to both experimental treatments (PFO closure, oral anticoagulanttherapy) or to the reference treatment (antiplatelet therapy) (see paragraph 20.5).

• Indication to long-term anticoagulant therapy.

• mRS >= 3.

• Presence of other medical conditions that would lead to inability to complete thestudy or interfere with the assessment of outcomes.

• Previous surgical or transcatheter treatment of PFO or ASA. Expected impossiblefollow-up or poor compliance.

• Patient unable to understand the informed consent form. Patient under tutorship,curatorship, or legal protection.