Percutaneous closure of patent foramen ovale did not significantly lessen the frequency of migraines in patients with episodic migraines, according to a study published yesterday in the Journal of the American College of Cardiology.
Although the Premium trial missed its primary endpoint, the study met the secondary endpoint of reducing migraine days after PFO closure.
A sub-group analysis also found that patients with frequent aura experienced a significant reduction in migraine attacks with PFO closure. One of the trial’s investigators told Medscape that there is validity to right-to-left shunt closure, as long as researchers can identify the subset of patients who are most likely to respond.
The 230-patient trial focused on patients with six to 14 migraine days per month. The participants also had failed at least three migraine preventive medications and showed significant right-to-left shunt in ultrasonography scans. Researchers randomized patients to receive medication with a sham procedure or medication and PFO with St. Jude Medical‘s Amplatzer PFO Occluder.
The primary efficacy endpoint was met in 45 of 117 patients in the PFO group and 33 of 103 patients in the control group. Data from the study also showed that 10 patients in the PFO group experienced complete cessation of migraine attacks for one year compared to one patient in the control group.
Patients in the PFO group had 3.4 fewer migraine days per month compared to baseline, while participants in the control group had two fewer migraine days per month.
Although previous work has shown an association between patients with migraines and the presence of PFO, there is still an ongoing debate whether PFO closure can lessen the frequency of migraine attacks. The mixed results of the Premium trial underscore that debate and some see it as highlighting the need to focus PFO-closure trials on patients with frequent aura.
In a subgroup analysis of patients with aura as a consistent feature of their migraines, 49% of patients in the PFO group saw a >50% reduction in migraine days compared to 23% of patients in the control group.
“Because this subgroup was not prespecified, these observations can be used only to generate the hypothesis that a future clinical trial of PFO closure might be beneficial in subjects where aura is a frequent component (>50%) of the migraine episodes,” the researchers wrote.
“In 2015, St. Jude Medical (prior to Abbott’s acquisition of the company) made the decision to discontinue the Premium study, including long-term follow-up, and not pursue U.S. regulatory approval of the Amplatzer PFO Occluder for the treatment of migraines. Studies have shown an association between migraines and patent foramen ovales (PFOs), frequently referred to as a hole in the heart, but their role in the disorder remains unknown. Although the Amplatzer PFO Occluder is a safe and effective device approved for the closure of a PFO, the PREMIUM trial did not show that PFO closure reduced the incidence of migraines compared to medical therapy. However, Abbott remains focused on PFO closure to prevent strokes,” an Abbott spokesperson told MassDevice.
This story was updated on Dec. 11 to include a statement from Abbott regarding the discontinued Premium study.