Percutaneous Closure of PFO in Migraine With Aura - PRIMA

Description:

Closure of a patent foramen ovale (PFO) with the STARFlex device was not effective in reducing migraine headache in the MIST trial. The goal of the present trial was to evaluate if PFO closure with the Amplatzer device would reduce headache days among individuals who have migraine with aura refractory to medical therapy compared with ongoing medical therapy.

Contribution to the Literature: The PRIMA trial failed to show that PFO closure reduced total migraine days.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Participants with migraine headache with aura
  • Migraine headache before age 50 years
  • >3 migraine attacks or 5 migraine days per month
  • <14 headache days per month
  • Failed ≥2 antimigraine medications
  • Preventative migraine medications stable for 4 weeks prior to and during screening
  • Documented right-to-left shunt (by transthoracic echo or transcranial Doppler)
  • Documented PFO (by transesophageal echo)

    Number of participants screened: 705
    Number of enrollees: 107
    Duration of follow-up: 12 months
    Mean patient age: 44 years
    Percentage female: 85%

Exclusions:

  • Age <18 years or >65 years
  • Medication overuse
  • Contraindication to aspirin and/or clopidogrel
  • Indication for aspirin, clopidogrel, or warfarin
  • Nickel allergy

Primary Endpoints:

  • Reduction in migraine days from baseline to 1 year

Secondary Endpoints:

  • Change in responder rate (≥50% reduction in number of headache days)
  • Change in the number of monthly migraine attacks
  • Change in the use of migraine medications
  • Change in MIDAS score
  • Quality of life
  • Beck Depression Inventory Score
  • Effects of antiplatelet medications
  • Completeness of PFO closure at 12 months

Drug/Procedures Used:

Participants who have migraine with aura refractory to medical therapy were randomized to closure with the Amplatzer device (n = 53 [device actually implanted in 41 participants]) versus ongoing medical therapy (n = 54).

Concomitant Medications:

Both groups received aspirin for 6 months and clopidogrel for 3 months.

Principal Findings:

The trial was terminated prematurely due to slow enrollment.

In the closure group, there was one major vascular complication and one episode of atrial fibrillation requiring DC cardioversion. Failure to eliminate right-to-left shunt occurred in 12%.

The primary outcome, mean reduction in migraine days with and without aura, was -2.9 in the closure group versus -1.7 in the medical therapy group (p = 0.17).

Secondary Outcomes:

  • Mean reduction in migraine attacks with and without aura: -2.1 in the closure group versus -1.3 in the medical therapy group (p = 0.09)
  • Days without acute migraine medication use: -13.9 in the closure group versus -8.3 in the medical therapy group (p = 0.12)
  • Mean reduction in migraine with aura days: -2.4 in the closure group versus -0.6 in the medical therapy group (p = 0.014)
  • Mean reduction in migraine with aura attacks: -2.0 in the closure group versus -0.5 in the medical therapy group (p < 0.01)

Interpretation:

Among patients with PFO and migraine headache refractory to medical therapy, PFO closure did not reduce the total migraine days compared with medical therapy. PFO closure was associated with a reduction in migraine with aura days (secondary outcome); however, this needs to be interpreted cautiously in this nonsham conducted trial. The PREMIUM trial was also negative for PFO closure. At the present time, PFO closure for prevention of migraine cannot be recommended.

References:

Mattle HP, Evers S, Hildick-Smith D, et al. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized clinical trial. Eur Heart J 2016;Feb 22:[Epub ahead of print].

Presented by Dr. David Hildick-Smith at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2014), Washington, DC, September 16, 2014.

Clinical Topics: Arrhythmias and Clinical EP, Congenital Heart Disease and Pediatric Cardiology, EP Basic Science, Congenital Heart Disease, CHD & Pediatrics and Arrhythmias

Keywords: Migraine with Aura, Electric Countershock, Epilepsy, Psychotherapy, Group, Foramen Ovale, Patent, Headache, Transcatheter Cardiovascular Therapeutics


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