• European heart journal · Jul 2016

    Randomized Controlled Trial

    Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial.

    • Heinrich P Mattle, Stefan Evers, David Hildick-Smith, Werner J Becker, Helmut Baumgartner, Jeremy Chataway, Marek Gawel, Hartmut Göbel, Axel Heinze, Eric Horlick, Iqbal Malik, Simon Ray, Adam Zermansky, Oliver Findling, Stephan Windecker, and Bernhard Meier.
    • Department of Neurology, Bern University Hospital, Bern 3010, Switzerland heinrich.mattle@bluewin.ch.
    • Eur. Heart J. 2016 Jul 7; 37 (26): 2029-36.

    AimsMigraine 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.MethodsMigraine 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.ResultsOne 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.ConclusionIn patients with refractory migraine with aura and PFO, PFO closure did not reduce overall monthly migraine days.Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

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