title: Migraine Intervention With STARFlex Technology (MIST) trial: a prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache.
abstract: BACKGROUND
  Patent foramen ovale (PFO) is prevalent in patients with migraine with aura. Observational studies show that PFO closure resulted in migraine cessation or improvement in approximately 80% of such patients. We investigated the effects of PFO closure for migraine in a randomized, double-blind, sham-controlled trial.
  
  
  RESULTS
  Patients who suffered from migraine with aura, experienced frequent migraine attacks, had previously failed > or = 2 classes of prophylactic treatments, and had moderate or large right-to-left shunts consistent with the presence of a PFO were randomized to transcatheter PFO closure with the STARFlex implant or to a sham procedure. Patients were followed up for 6 months. The primary efficacy end point was cessation of migraine headache 91 to 180 days after the procedure. In total, 163 of 432 patients (38%) had right-to-left shunts consistent with a moderate or large PFO. One hundred forty-seven patients were randomized. No significant difference was observed in the primary end point of migraine headache cessation between implant and sham groups (3 of 74 versus 3 of 73, respectively; P=0.51). Secondary end points also were not achieved. On exploratory analysis, excluding 2 outliers, the implant group demonstrated a greater reduction in total migraine headache days (P=0.027). As expected, the implant arm experienced more procedural serious adverse events. All events were transient.
  
  
  CONCLUSIONS
  This trial confirmed the high prevalence of right-to-left shunts in patients with migraine with aura. Although no significant effect was found for primary or secondary end points, the exploratory analysis supports further investigation. The robust design of this study has served as the model for larger trials that are currently underway in the United States and Europe.
authors.affiliation: The King's Headache Service, King's College Hospital, Denmark Hill, London SE5 9RS, UK. dr.dowson@btopenworld.com
authors.forename: Andrew
authors.initials: A
authors.lastname: Dowson
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mullen
authors.forename: Richard
authors.initials: R
authors.lastname: Peatfield
authors.forename: Keith
authors.initials: K
authors.lastname: Muir
authors.forename: Arif Anis
authors.initials: AA
authors.lastname: Khan
authors.forename: Christopher
authors.initials: C
authors.lastname: Wells
authors.forename: Susan L
authors.initials: SL
authors.lastname: Lipscombe
authors.forename: Trevor
authors.initials: T
authors.lastname: Rees
authors.forename: Joseph V
authors.initials: JV
authors.lastname: De Giovanni
authors.forename: W Lindsay
authors.initials: WL
authors.lastname: Morrison
authors.forename: David
authors.initials: D
authors.lastname: Hildick-Smith
authors.forename: Giles
authors.initials: G
authors.lastname: Elrington
authors.forename: W Stewart
authors.initials: WS
authors.lastname: Hillis
authors.forename: Iqbal S
authors.initials: IS
authors.lastname: Malik
authors.forename: Anthony
authors.initials: A
authors.lastname: Rickards
mesh_terms: D000328:Adult; D002305:Cardiac Tamponade / Q000209:etiology; D003951:Diagnostic Errors; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery*; D006346:Heart Septum / Q000601:surgery*; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D020325:Migraine with Aura / Q000209:etiology / Q000601:surgery*; D018579:Patient Selection; D010490:Pericardial Effusion / Q000209:etiology; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000009:adverse effects; D012187:Retroperitoneal Space; D017211:Treatment Failure; D014463:Ultrasonography