Migraine Headache and Patent Foramen Ovale: Observational Studies, the Randomized Clinical Trials, and the GORE RELIEF Clinical Study

Robert J Sommer; Barbara T Robbins

doi:10.1016/j.ccl.2024.01.007

Migraine Headache and Patent Foramen Ovale: Observational Studies, the Randomized Clinical Trials, and the GORE RELIEF Clinical Study

Cardiol Clin. 2024 Nov;42(4):497-507. doi: 10.1016/j.ccl.2024.01.007. Epub 2024 Feb 29.

Authors

Robert J Sommer¹, Barbara T Robbins²

Affiliations

¹ Department of Medicine, Division of Interventional Cardiology, Columbia University Medical Center, 161 Fort Washington Avenue, Room 624, New York, NY 10032, USA. Electronic address: [email protected].
² Department of Medicine, Division of Interventional Cardiology, Columbia University Medical Center, 161 Fort Washington Avenue, Room 624, New York, NY 10032, USA.

PMID: 39322340
DOI: 10.1016/j.ccl.2024.01.007

Abstract

The pathophysiology of migraine remains poorly understood. Like most migraine preventive therapies, patent foramen ovale (PFO) closure was never intended for the treatment of migraine. After closure of PFO for other reasons, migraine symptom reduction/elimination was noted in some patients. Subsequent small trials failed to prove its benefit. There is significant evidence suggesting a platelet-mediated mechanism linking migraines to PFO. The GORE RELIEF Clinical Study is a randomized, blinded, placebo- and sham-controlled trial, currently enrolling. The study design is meant to optimize patient selection using thienopyridine responsiveness as an inclusion criterion.

Keywords: Migraine headache; P2Y12 inhibition; Patent foramen ovale; Platelets; Trials.

Publication types

Review

MeSH terms

Foramen Ovale, Patent* / complications
Foramen Ovale, Patent* / surgery
Foramen Ovale, Patent* / therapy
Humans
Migraine Disorders* / prevention & control
Observational Studies as Topic
Randomized Controlled Trials as Topic*