PRIMA Examines Effect of Percutaneous PFO Closure on Migraine

September 16, 2014—Findings from the PRIMA trial—evaluating whether percutaneous patent foramen ovale (PFO) closure is effective in reducing migraine headaches compared to medical treatment—were reported at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

According to the press release from TCT, although 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 findings show that PFO closure does not significantly reduce total migraine days compared to medical therapy. 

In the TCT announcement, PRIMA investigator David Hildick-Smith, MD, commented, “In patients with refractory migraine with aura and a PFO, percutaneous PFO closure did not significantly reduce the overall monthly migraine days. However, the procedure did significantly reduce migraine with aura days and attacks and also improved responder rates.” Dr. Hildick-Smith is with the Sussex Cardiac Centre in Brighton, United Kingdom.
    
As summarized by TCT, the primary endpoint of PRIMA was reduction in migraine days 1 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 PFOs to undergo either PFO closure (n = 53) or medical management (n = 54). A total of 83 patients completed the 12-month follow-up. 

The PRIMA investigators reported that 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 = .17). The respective mean reduction in migraine with aura days was -2.4 days versus -0.6 days, respectively (P = .01). The monthly mean reduction of migraine with aura attacks was -2 in the device closure group compared to -0.5 the medical management group (P < .01). A reduction of migraine days ≥ 50% was achieved in 37.5% of the device closure group compared to 14.6% in the medical management group (P = .02), advised the TCT press release.