Key result
PFO closure fails to improve migraine attack reduction compared to sham procedure.
Why the study?
Patent foramen ovale has been associated with migraine, but its role and the efficacy of percutaneous PFO closure as a therapy for migraine remain poorly understood.
Does percutaneous PFO closure reduce migraine attacks in patients with frequent migraine, PFO, and failure of prior preventive medications?
RCT (n=230)
Double-blind
Does percutaneous PFO closure reduce migraine attacks in patients with frequent migraine, PFO, and failure of prior preventive medications?
Absolute Event Rate: 38.5% vs 32%
In patients with frequent migraine and PFO, percutaneous PFO closure did not significantly improve the responder rate for migraine reduction compared to medical therapy and a sham procedure.
BACKGROUND: Migraine is a prevalent and disabling disorder. Patent foramen ovale (PFO) has been associated with migraine, but its role in the disorder remains poorly understood. OBJECTIVES: This study examined the efficacy of percutaneous PFO closure as a therapy for migraine with or without aura. METHODS: The PREMIUM (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management) was a double-blind study investigating migraine characteristics over 1 year in subjects randomized to medical therapy with a sham procedure (right heart catheterization) versus medical therapy and PFO closure with the Amplatzer PFO Occluder device (St. Jude Medical, St. Paul, Minnesota). Subjects had 6 to 14 days of migraine per month, had failed at least 3 migraine preventive medications, and had significant right-to-left shunt defined by transcranial Doppler. Primary endpoints were responder rate defined as 50% reduction in migraine attacks and adverse events. Secondary endpoints included reduction in migraine days and efficacy in patients with versus without aura. RESULTS: Of 1,653 subjects consented, 230 were enrolled. There was no difference in responder rate in the PFO closure (45 of 117) versus control (33 of 103) groups. One serious adverse event (transient atrial fibrillation) occurred in 205 subjects who underwent PFO closure. Subjects in the PFO closure group had a significantly greater reduction in headache days (-3.4 vs. -2.0 days/month, p = 0.025). Complete migraine remission for 1 year occurred in 10 patients (8.5%) in the treatment group versus 1 (1%) in the control group (p = 0.01). CONCLUSIONS: PFO closure did not meet the primary endpoint of reduction in responder rate in patients with frequent migraine. (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management [PREMIUM]; NCT00355056).
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Tobis et al. (2017) conducted an RCT in Migraine with or without aura (n=230). Percutaneous PFO closure with the Amplatzer PFO Occluder device vs. Medical therapy with a sham procedure (right heart catheterization) was evaluated on Responder rate defined as 50% reduction in migraine attacks. Percutaneous PFO closure did not significantly increase the responder rate for a 50% reduction in migraine attacks compared to a sham procedure (38.5% vs 32.0%).
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