PRIMA: PFO Closure in Patients With Refractory Migraine With Aura
Patent foramen ovale closure (PFO) may significantly reduce migraine headaches in patients, as well as in patients who have migraines with aura refractory as compared to medical therapy, according to results from the PRIMA trial presented Sept. 16 at TCT 2014.
Led by principal investigator David Hildick-Smith, MD, the study sought to find a new means of relief for migraine headaches, which afflicts approximately 55 million people across the U.S. and Europe. Recently PFO closure had become associated with high rate of resolution of incidental migraine, leading to a hypothesis that right-to-left shunting of chemical or physical triggers could alleviate the chronic condition.
With a primary endpoint of a reduction in migraine days after one year, the trial enrolled 107 patients and randomized them into a PFO closure group (n=53) and medical therapy group (n=54). Reaching 12-months, 40 patients in the closure group and 43 in the medical group completed their follow-up. Results showed that the primary end point was not met, and the mean reduction of migraine days from closure group and medical group was -2.9 and -1.7 respectively from a baseline of 8.0 and 8.3. The mean reduction of migraines with aura days was -2.4 and -0.6 from a baseline of 4.1 and 4.0.
While interventional studies in migraine/aura patients are difficult, real and tangible benefit accrues to some migraine patients after PFO closure. The authors conclude that their trial suggests that PFO closure may be safe and that 40 percent of device closure patients had headache burden reduced by ≥50 percent, 10 percent became migraine free, and 40 percent became free of migraine with aura.
However, moving forward, larger, sham controlled confirmatory studies which are underway, are needed prior to considering PFO closure as a proven therapy for migraine.
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