September 22, 2014 — According to a new study, while it is common for patients who have migraine to have a patent foramen ovale, a procedure to repair this heart defect does not significantly reduce total migraine days compared to medical therapy. The findings were reported at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
Patent foramen ovale (PFO) is a defect between the atrial chambers of the heart. Patients who have migraine frequently have a PFO, and observational studies of PFO closure have shown a reduction in the frequency and severity of migraine attacks.
The PRIMA trial evaluated whether percutaneous PFO closure is effective in reducing migraine headaches in patients who have migraine, compared to medical treatment. The primary endpoint was reduction in migraine days one year after randomization. Secondary endpoints included reduction in migraine with aura days, reduction in migraine with aura attacks and freedom from migraines.
The multicenter trial with blinded endpoints randomized 107 patients with refractory migraine with aura and PFO to either receive either PFO closure (n=53) or medical management (n=54). A total of 83 patients completed the 12-month follow-up.
The mean reduction in migraine days was -2.9 days in the device closure group and -1.7 days in the medical management group (p=0.17). Respective mean reduction in migraine with aura days was -2.4 days versus -0.6 days, respectively (p=0.01). Monthly mean reduction of migraine with aura attacks were -2.0 in the device closure group compared to -0.5 in the medical management group (p<0.01). A reduction of migraine days greater than or equal to 50 percent was achieved in 37.5 percent of the device closure group compared to 14.6 percent in the medical management group (p=0.02).
“In patients with refractory migraine with aura and a PFO, percutaneous PFO closure did not significantly reduce the overall monthly migraine days,” said investigator David Hildick-Smith, M.D. from the Sussex Cardiac Center in Brighton, England. “However the procedure did significantly reduce migraine with aura days and attacks, and also improved responder rates.”
The PRIMA trial was funded by St. Jude Medical. Hildick-Smith reported grant support from St. Jude Medical.
For more information: www.crf.org, www.tctconference.com
November 14, 2025 
