The closure of the Foramen Ovale (PFO) patent resulted in a decrease in monthly migraine days and attacks or a complete cessation. These results from a pooled analysis of 2 randomized trials were published in the Journal of the American College of Cardiology.
The researchers of the study pooled data from the PRIMA study (Percutaneous Closure of Patent Foramen Ovale in migraine with aura) and the prospective randomized investigation to evaluate the incidence of headache reduction in patients with migraine and PFO using the Amplatzer PFOluder compared to the PREMIUM – Study (Medical Management) for this analysis. The primary endpoint for the PRIMA study was the reduction in monthly migraine days 10 to 12 months after randomization compared to a 3-month baseline. For the PREMIUM study, the primary endpoint was a reduction in monthly migraines by at least 50% from the 2-month baseline to the 10- to 12-month follow-up.
A total of 176 patients underwent PFO closure and 161 were controls. Patients in the intervention and control arms had a mean age of 43.1 and 43.2 years, 88.1% and 87.0% were women, 10.2% and 11.3% had a history of head trauma, and 75, 6% and 77.0% had migraines with aura.
The mean reduction in monthly migraine days was 1.2 days higher in the intervention group than in the control cohort (-3.1 ± 4.5 days versus -1.9 ± 4.2 days; P = 0.02). Similarly, the mean migraine attacks were more reduced in the intervention group (-2.0 ± 2.0 versus -1.4 ± 1.9 attacks; P = 0.01). A total of 14 (9%) who received a PFO occlusion reported complete migraine cessation, compared with only 1 (0.7%) of the control subjects (P <0.001).
The reduction in migraine attacks by at least 50% was not significantly higher in the PFO group (38%) compared to the controls (29%; P = 0.13).
Stratified by aura, patients with aura in the intervention arm reported fewer migraine days compared to controls (-3.2 ± 4.8 versus -1.8 ± 4.4 days; P = 0.03). This difference was not significant in patients without aura compared to controls (-2.8 ± 3.4 versus -2.2 ± 4.0; P = 0.53). 11% of intervention recipients reported complete termination in patients with aura compared to 0.9% of controls (P = 0.002). Among intervention recipients without aura, 5% reported stopping compared to 0% of controls (P = 0.16).
Patients with frequent aura (50% of seizures) reported a greater reduction in monthly migraine days (P = 0.002) and a significant response rate (50% reduction; P = 0.005) after PFO occlusion compared to control patients.
Few adverse events were observed during the PFO procedure (hematoma: n = 2; hypotension: n = 2; tachycardia: n = 2; access site bleeding: n = 1; arm phlebitis: n = 1; vasovagal episode: n = 1).
This pooled analysis may have been limited by the different primary endpoints of the two studies examined.
The study’s researchers concluded that their results indicated that “the PFO closure was safe and significantly reduced the average number of monthly migraine days and monthly attacks, and increased the number of migraine days [patients] who have experienced a complete cessation of migraines. “Patients with aura migraines would benefit from a PFO closure, which had a decrease in monthly migraine days and attacks, likely with a 9% chance of complete migraine cessation.
Disclosure: Several authors have stated that they are part of the pharmaceutical industry. For a full list of details, see the original article.
Mojadidi MK, Kumar P, Mahmoud AN, et al. Pooled analysis of PFO occluder device trials in patients with PFO and migraines. J Am Coll Cardiol. 2021; 77 (6): 667- 676. doi: 10.1016 / j.jacc.2020.11.068