Transcatheter closure versus medical therapy for PFO in older adults

Medical Treatment With or Without Transcatheter Patent Foramen Ovale CloSure for Older Patients With CrypTogenic StrOke and Patent Foramen Ovale. The STOP Trial

This tests whether closing a patent foramen ovale (PFO) with a catheter plus usual medicines prevents another unexplained (cryptogenic) stroke in people over 60 better than medicines alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 714 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval (Academic / other)
• Locations: 2 sites (Québec, Quebec and 1 other locations)
• Trial ID: NCT05907694 on ClinicalTrials.gov

What this trial studies

This randomized interventional trial will enroll patients older than 60 who had a recent cryptogenic nonlacunar ischemic stroke and a PFO confirmed by transesophageal echocardiography with right-to-left shunt. Participants are randomized to transcatheter PFO closure plus optimal medical therapy or to optimal medical therapy alone, with follow-up for recurrent ischemic stroke events. Key exclusions include lacunar stroke, atrial fibrillation, need for chronic anticoagulation, significant extracranial or intracranial atherosclerosis, intracardiac thrombus, and uncontrolled hypertension. The primary outcome is prevention of recurrent nonlacunar ischemic stroke, with mid- to long-term follow-up to capture recurrence rates and safety events.

Who should consider this trial

Good fit: Ideal candidates are people older than 60 with a recent cryptogenic nonlacunar ischemic stroke and a documented PFO with right-to-left shunt on TEE who do not have atrial fibrillation, major atherosclerotic disease, or contraindications to antiplatelet therapy.

Not a fit: Patients with lacunar (small vessel) stroke, clinically apparent or monitored atrial fibrillation/flutter, a clear alternative cause of stroke such as significant carotid atherosclerosis, need for chronic anticoagulation, or contraindications to antiplatelet therapy are unlikely to benefit from PFO closure in this protocol.

Why it matters

Potential benefit: If successful, adding PFO closure to medical therapy could substantially reduce recurrent cryptogenic strokes and related disability in patients over 60.

How similar studies have performed: Randomized trials have shown benefit of PFO closure versus medical therapy in patients under 60, and observational data in older patients are promising though randomized evidence in those over 60 is limited.

Eligibility criteria

Inclusion Criteria:

* Cryptogenic stroke
* Age \>60 years
* Right-to-left shunt as evaluated by echocardiography (TEE).

Exclusion Criteria:

-≤60 year-old

* Lacunar (small vessel) stroke.
* Permanent or paroxysmal atrial fibrillation/flutter (clinically apparent or detected by continuous ECG monitoring).
* Need for chronic anticoagulation therapy.
* Any contraindication for antiplatelet therapy (aspirin, clopidogrel, ticagrelor).
* Presence of extracranial or intracranial atherosclerosis causing ≥50% luminal --stenosis in arteries supplying the area of ischemia.
* Presence of complex atheroma plaques at the ascending aorta-aortic arch (≥4-mm-thick, ulcerated or containing mobile thrombi) as evaluated by TEE.
* Presence of intracardiac thrombus as evaluated by TEE.
* Uncontrolled hypertension (systemic pressure values \>160/90 mmHg despite optimal medical treatment).
* History of myocardial infarction or coronary intervention. (percutaneous coronary intervention, coronary artery bypass graft).
* History of prior valve surgery or transcatheter valve repair.
* Presence of deep venous thrombosis at the time of index stroke as evaluated by Doppler ultrasonography.
* Left ventricular ejection fraction \<50% as evaluated by TTE.
* Significant (moderate or severe) valvular disease as evaluated by echocardiography.
* History of congestive heart failure.
* Severe chronic kidney dysfunction defined an estimated glomerular filtration rate \<30 ml/min/m2 or need for dialysis.
* Isolated ASD or ASD associated with PFO but with a hemodynamically significant left-to-right shunt requiring closure.
* Other specific cause of stroke identified (eg, arteritis, dissection, migraine/vasospasm, and drug abuse).
* Prior surgical or endovascular treatments of PFO or ASD.
* Rheumatic heart disease.
* Left atrial enlargement defined as a left atrial diameter \>41 mm in men and ≥39 mm in women.
* Presence of high burden of premature atrial contractions (\>500 per 24 hrs) as evaluated by continuous ECG monitoring.
* Follow-up impossible or expected poor compliance.
* Active cancer.
* Presence of an inferior vena cava filter.
* Severe pulmonary artery hypertension (systolic pulmonary pressure \>60 mmHg).
* Functional dependency as measured by a modified Rankin Scale score \>3 (unable to attend to own bodily needs without assistance and unable to walk unassisted).
* Any medical condition determining a life expectancy \<2 years.
* Participation in another randomized study.
* Failure to provide signed informed consent.

Where this trial is running

Québec, Quebec and 1 other locations

• Iucpq-Ul — Québec, Quebec, Canada (Active_not_recruiting)
• Iucpq — Québec, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: IUCPQ Rodes-Cabau, MD, PhD — Fondation IUCPQ
• Study coordinator: Josep Rodes-Cabau, MD, PhD

Conditions Patent Foramen Ovale; Cryptogenic Stroke; Older Patients; Medical Treatment; Recurrent Stroke