Mixed migraine results for PFO closure study

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 i...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Neurological Wall Street Beat stjudemedical Source Type: news