title: Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  In patients with refractory migraine with aura and PFO, PFO closure did not reduce overall monthly migraine days.
authors.affiliation: Department of Neurology, Bern University Hospital, Bern 3010, Switzerland heinrich.mattle@bluewin.ch.
authors.forename: Heinrich P
authors.initials: HP
authors.lastname: Mattle
authors.affiliation: University Hospital of Münster, Münster, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Evers
authors.affiliation: Brighton and Sussex University Hospitals, Brighton, UK.
authors.forename: David
authors.initials: D
authors.lastname: Hildick-Smith
authors.affiliation: Hotchkiss Brain Institute, University of Calgary, Foothills Hospital, Calgary, AB, Canada.
authors.forename: Werner J
authors.initials: WJ
authors.lastname: Becker
authors.affiliation: University Hospital of Münster, Münster, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Baumgartner
authors.affiliation: Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, UK.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Chataway
authors.affiliation: Davisville Medical Centre, Toronto, ON, Canada.
authors.forename: Marek
authors.initials: M
authors.lastname: Gawel
authors.affiliation: Kiel Migraine and Headache Centre, Kiel, Germany.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Göbel
authors.affiliation: Kiel Migraine and Headache Centre, Kiel, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Heinze
authors.affiliation: Toronto General Hospital, Toronto, ON, Canada.
authors.forename: Eric
authors.initials: E
authors.lastname: Horlick
authors.affiliation: Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, UK.
authors.forename: Iqbal
authors.initials: I
authors.lastname: Malik
authors.affiliation: University Hospitals of South Manchester, Manchester, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Ray
authors.affiliation: Salford Royal Hospitals, Salford, UK.
authors.forename: Adam
authors.initials: A
authors.lastname: Zermansky
authors.affiliation: Department of Neurology, Bern University Hospital, Bern 3010, Switzerland.
authors.forename: Oliver
authors.initials: O
authors.lastname: Findling
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern 3010, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern 3010, Switzerland.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
mesh_terms: D054092:Foramen Ovale, Patent; D006801:Humans; D008881:Migraine Disorders; D055989:Septal Occluder Device; D016896:Treatment Outcome
keywords: Migraine; Migraine with aura; Patent foramen ovale; Patent foramen ovale closure