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Clinical Evidence
Trials on PFO closure have been published around the world
PFO closure has been intensively studied in several randomized controlled trials. These trials were designed and conducted to compare PFO closure to medical management to see if there was a greater benefit to patients to have their PFO closed to prevent another stroke.
Read on to learn more.
The RESPECT Trial¹
Patent Foramen Ovale Closure or Medical Therapy After Stroke
The RESPECT Trial focused on the long-term outcomes of patent foramen ovale closure as compared to medical therapy after stroke. This trial was conducted in the United States and studied 980 patients who had a recent cryptogenic stroke and were found to have a PFO. The trial compared two groups of patients and followed them for a median of 5.9 years. One group underwent PFO closure plus antiplatelet medication; the other group received antithrombotic medication only (antiplatelets or anticoagulants). The study results showed that PFO closure, with an antiplatelet regimen, was associated with a lower rate of recurrent stroke than taking antithrombotic medication alone.
The RESPECT Trial - National Center for Biotechnology Information
The RESPECT Trial – New England Journal of Medicine
REDUCE Trial²
The REDUCE Trial focused on patent foramen ovale closure as compared to antiplatelet therapy for cryptogenic stroke. This was a multinational trial that studied 664 patients with a recent cryptogenic stroke and a PFO from Canada, Denmark, Finland, Norway, Sweden, and the United States. The trial compared two groups of patients and followed them for a median of 3.2 years. One group of patients had their PFO closed and took antiplatelet medication, while the other group only took antiplatelet medication. The study results showed that PFO closure was associated with a lower rate of recurrent stroke than antiplatelet medication alone.
CLOSE Trial³
The CLOSE Trial studied patent foramen ovale closure and compared it to antiplatelet medication alone and anticoagulation medication alone. This study was conducted in France and Germany and studied 663 recent cryptogenic stroke patients who had a PFO. Patients were split into three groups: PFO closure and antiplatelet medication, antiplatelet medication alone, or anticoagulants alone. Patients were followed for a median of 5.3 years. The study results showed that patients who underwent PFO closure and took antiplatelet medication had a lower rate of stroke recurrence than patients who only took antiplatelet medication. There were not enough data to draw a conclusion between PFO closure and anticoagulation medication.
- Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017; 377: 1022-32.
- Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017; 377: 1033-42.
- Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017; 377: 1011-21