Key result
PFO closure reduces monthly migraine days by ~1.2 more than medical therapy.
Why the study?
Does percutaneous PFO closure reduce migraine frequency in patients with PFO and episodic migraine?
Meta-Analysis (n=337)
randomized by blocks
Does percutaneous PFO closure reduce migraine frequency in patients with PFO and episodic migraine?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“What this [study] will do is increase people's interest and whet their appetite for the next clinical trial, but it's not going to have an immediate practical, clinical effect. People aren't going to go out and start closing PFOs for migraine. I hope if anything it will stimulate interest in the patient population to participate in the RELIEF PFO trial [because] this shows the good justification for why PFO closure may be beneficial in a certain subset.”
“In the latter 2 studies, after PFO closure with the Amplatzer PFO Occluder, some patients demonstrated dramatic headache reductions. But neither study met its primary endpoint, in part because of the small sizes of the trials and limited statistical power, although both had secondary endpoints that were positive.”
“This patient level meta-analysis is worthwhile as it reinvigorates the question of whether PFO closure could be a viable therapeutic option to reduce the burden of migraines in some patients”
Pooled patient-level data from two RCTs suggests that PFO closure safely and significantly reduces migraine frequency and increases the rate of complete migraine cessation in patients with PFO and episodic migraine.
BACKGROUND Although observational studies have shown percutaneous patent foramen ovale (PFO) closure to be a safe means of reducing the frequency and duration of migraine, randomized clinical trials have not met their primary efficacy endpoints. OBJECTIVES The authors report the results of a pooled analysis of individual participant data from the 2 randomized trials using the Amplatzer PFO Occluder to assess the efficacy and safety of percutaneous device closure as a therapy for episodic migraine with or without aura. METHODS The authors analyzed individual patient-level data from 2 randomized migraine trials (the PRIMA [Percutaneous Closure of Patent Foramen Ovale in Migraine With Aura] and PREMIUM [Prospective Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects with Migraine and PFO Using the Amplatzer PFO Occluder Compared to Medical Management] studies). Efficacy endpoints were mean reduction in monthly migraine days, responder rate (defined as ≥50% reduction in monthly migraine attacks), mean reduction in monthly migraine attacks, and percentage of patients who experienced complete cessation of migraine. The safety endpoint was major procedure- and device-related adverse events. RESULTS Among 337 subjects, 176 were randomized by blocks to device closure and 161 to medical treatment only. At 12-month follow-up, the analysis met 3 of the 4 efficacy endpoints: mean reduction of monthly migraine days (-3.1 days vs. -1.9 days; p = 0.02), mean reduction of monthly migraine attacks (-2.0 vs. -1.4; p = 0.01), and number of subjects who experienced complete cessation of migraine (14 [9%] vs. 1 [0.7%]; p < 0.001). For the safety analysis, 9 procedure-related and 4 device-related adverse events occurred in 245 subjects who eventually received devices. All events were transient and resolved. CONCLUSIONS This pooled analysis of patient-level data demonstrates that PFO closure was safe and significantly reduced the mean number of monthly migraine days and monthly migraine attacks, and resulted in a greater number of subjects who experienced complete migraine cessation.
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Mojadidi et al. (2021) conducted a meta-analysis in Episodic migraine with or without aura and patent foramen ovale (n=337). Percutaneous device closure using the Amplatzer PFO Occluder vs. Medical treatment only was evaluated on Mean reduction in monthly migraine days (p=0.02). Percutaneous PFO closure significantly reduced mean monthly migraine days (-3.1 vs. -1.9 days; p=0.02) and increased complete migraine cessation (9% vs. 0.7%; p<0.001) compared to medical therapy.
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