Related Experiment Video
Updated: Mar 25, 2026
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial
Heinrich P Mattle1, Stefan Evers2, David Hildick-Smith3
1Department of Neurology, Bern University Hospital, Bern 3010, Switzerland heinrich.mattle@bluewin.ch.
Aims:
Migraine with aura and patent foramen ovale (PFO) are associated. The Percutaneous Closure of PFO in Migraine with Aura (PRIMA) trial is a multicentre, randomized trial to investigate the effect of percutaneous PFO closure in patients refractory to medical treatment.
Methods:
Migraine with aura patients and PFO who were unresponsive to preventive medications were randomized to PFO closure or medical treatment. Both groups were given acetylsalicylic acid 75-100 mg/day for 6 months and clopidogrel 75 mg/day for 3 months. The primary endpoint was reduction in monthly migraine days during months 9-12 after randomization compared with a 3-month baseline phase before randomization. The committee reviewing the headache diaries were blinded to treatment assignment.
Results:
One hundred and seven patients were randomly allocated to treatment with an Amplatzer PFO Occluder (N = 53) or control with medical management (N = 54). The trial was terminated prematurely because of slow enrolment. Eighty-three patients (40 occluder, 43 control) completed 12-month follow-up. Mean migraine days at baseline were 8 (±4.7 SD) in the closure group and 8.3 (±2.4) in controls. The primary endpoint was negative with -2.9 days after PFO closure vs. -1.7 days in control group (P = 0.17). Patent foramen ovale closure caused five adverse events without permanent sequelae.
Conclusion:
In patients with refractory migraine with aura and PFO, PFO closure did not reduce overall monthly migraine days.
Insights
Percutaneous closure of patent foramen ovale (PFO) did not significantly reduce monthly migraine days in patients with refractory migraine with aura. Further research is needed to explore PFO closure for migraine treatment.
Area of Science:
- Neurology
- Cardiology
Background:
- Migraine with aura is frequently associated with patent foramen ovale (PFO).
- Medical treatment for refractory migraine with aura often proves insufficient.
Purpose of the Study:
- To investigate the efficacy of percutaneous PFO closure versus medical management in patients with refractory migraine with aura.
Main Methods:
- A multicentre, randomized trial comparing percutaneous PFO closure with medical treatment.
- Patients received antiplatelet therapy post-randomization.
- The primary endpoint was the reduction in monthly migraine days.
Main Results:
- The study was terminated early due to slow enrollment.
- PFO closure showed a trend towards reducing migraine days (-2.9 days) compared to medical management (-1.7 days), but this was not statistically significant (P = 0.17).
- Five adverse events occurred in the PFO closure group, with no permanent sequelae.
Conclusions:
- Percutaneous PFO closure did not significantly reduce monthly migraine days in patients with refractory migraine with aura.
- The findings suggest that PFO closure may not be an effective standalone treatment for this patient population.
