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

Prior treatment

• Contraindication to both experimental treatments (PFO closure, oral anticoagulant therapy) or to the reference treatment (antiplatelet therapy) (see paragraph 20.5).
• Indication to long-term anticoagulant therapy.
• Previous surgical or transcatheter treatment of PFO or ASA. Expected impossible follow-up or poor compliance.

Other illness

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

Age

• Life expectancy \< 4 years.

Other

• mRS \> 3.
• PFO associated with an atrial septal defect (ASD) requiring closure (significant shunt with impact on the right cavities, elevation of pulmonary pressures or QP/QS\>2)
• Patient unable to understand the informed consent form. Patient under tutorship, curatorship, or legal protection.

• Man or woman aged 60 to 80 years.
• Recent (≤ 6 months) ischemic stroke confirmed by cerebral imaging regardless of symptom duration.
• Absence of a more probable cause of stroke than PFO after a standardized etiological work-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 at least one of the 3 cardiac cycles after complete opacification of the right atrium, detected either spontaneously or during provocative manoeuvers, on contrast transthoracic (TTE) or transoesophageal (TOE) echocardiography. The diagnosis of PFO by contrast TEE must be confirmed by contrast TOE showing a right-to-left passage of the contrast material across the PFO.
  • PFO associated with an ASA on transoesophageal echocardiography: excursion \>10 mm
• Affiliation to a French Health Insurance system. Informed consent.