Migraine Intervention With STARFlex Technology (MIST) Trial

Migraine with aura often correlates with the presence of patent foramen ovale, or PFO. Closure of PFO has shown promising results in observational studies, with 80% of patients improving. This study aimed to evaluate the effectiveness of PFO closure through a randomized trial. The trial involved patients who frequently experienced migraines but had not responded to multiple treatments. Participants were assigned to receive either PFO closure with STARFlex or a sham procedure. After six months, the main goal was to see if migraines ceased. Among 432 patients, 38% had PFOs. Ultimately, there was no significant difference in migraine cessation between groups. Secondary goals also did not achieve significance. However, exploratory analysis indicated fewer migraine days in the implant group. The implant group experienced more serious adverse events, though all were transient. This study highlights the prevalence of PFOs in migraine patients and encourages further research. Clinical relevance: This research suggests that PFO closure may not significantly alleviate migraines, prompting further studies.