Jean-Louis Mas1, Benoît Guillon2, Anaïs Charles-Nelson3, Valérie Domigo1, Laurent Derex4, Evelyne Massardier5, Caroline Arquizan6, Fabrice Vuillier7, Serge Timsit8, Yannick Béjot9, Olivier Detante10, Denis Sablot11, Céline Guidoux12, Igor Sibon13, Nelly Dequatre-Ponchelle14, Emmanuel Touzé15, Sandrine Canaple16, Sonia Alamowitch17, Pierre Aubry18, Emmanuel Teiger19, Geneviève Derumeaux20, Gilles Chatellier3. 1. Stroke Unit, Department of Neurology, Sainte-Anne Hospital, Paris Descartes University, INSERM 1226, Paris, France. 2. Stroke Unit, Department of Neurology, University Hospital of Nantes, Nantes, France. 3. Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges-Pompidou, Unité de Recherche Clinique, Centre d'Investigations Cliniques 1418 (CIC1418), Paris, France. 4. Stroke Unit, Department of Neurology, Hospices Civils de Lyon, EA 7425 HESPER, Claude Bernard Lyon 1 University, Lyon, France. 5. Stroke Unit, Department of Neurology, CHU Rouen, Rouen, France. 6. Department of Neurology, Gui de Chauliac Hospital, INSERM 1226, Montpellier, France. 7. Stroke Unit, Department of Neurology, CHU Besançon, Besançon, France. 8. Stroke Unit, Department of Neurology, CHRU Brest, Bretagne Occidentale University, INSERM 1028, Brest, France. 9. Stroke Unit, Department of Neurology, Dijon Stroke Registry, CHU Dijon, EA7460 Pathophysiology and Epidemiology of Cerebro-Cardiovascular diseases (PEC2), University of Burgundy, Dijon, France. 10. Stroke Unit, CHU Grenoble, INSERM 836-UJF-CEA-CHU, Grenoble, France. 11. Stroke Unit, Department of Neurology, Perpignan Hospital, Perpignan, France. 12. Stroke Unit, Department of Neurology, Bichat Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France. 13. Stroke Unit, Department of Neurology, University Hospital, Bordeaux University, CNRS 5287, Bordeaux, France. 14. Stroke Unit, Department of Neurology, Univ-Lille, INSERM U1171, CHU Lille, Lille, France. 15. Normandie Université, Université Caen Normandie, CHU Caen Normandie, INSERM U1237, Caen, France. 16. Stroke Unit, Department of Neurology, Laboratoire de Neurosciences Fonctionnelles et Pathologies, Centre Hospitalier Régional et Universitaire, Amiens, France. 17. Service de Neurologie, Hôpital Saint-Antoine, AP-HP, Sorbonne Université, INSERM, UMRS 938, Paris, France. 18. Department of Cardiology, Bichat Hospital, Paris, France. 19. Department of Cardiology, Henri Mondor Hospital, AP-HP, UPEC, Créteil, France. 20. Department of Physiology, Henri Mondor Hospital, APHP, INSERM U955, Créteil, France.
Abstract
BACKGROUND AND PURPOSE: The efficacy of patent foramen ovale (PFO) closure to reduce the frequency of migraine attacks remains controversial. METHODS: This was a planned sub-study in migraine patients enrolled in a randomized, clinical trial designed to assess the superiority of PFO closure plus antiplatelet therapy over antiplatelet therapy alone to prevent stroke recurrence in patients younger than 60 years with a PFO-associated cryptogenic ischaemic stroke. The main outcome was the mean annual number of migraine attacks in migraine patients with aura and in those without aura, as recorded at each follow-up visit by study neurologists. RESULTS: Of 473 patients randomized to PFO closure or antiplatelet therapy, 145 (mean age 41.9 years; women 58.6%) had migraine (75 with aura and 70 without aura). Sixty-seven patients were randomized to PFO closure and 78 to antiplatelet therapy. During a mean follow-up of about 5 years, there were no differences between antiplatelet-only and PFO closure groups in the mean annual number of migraine attacks, both in migraine patients with aura (9.2 [11.9] vs. 12.0 [19.1], p = 0.81) and in those without aura (12.1 [16.1] vs. 11.8 [18.4], p > 0.999). There were no differences between treatment groups regarding cessation of migraine attacks, migraine-related disability at 2 years and use of migraine-preventive drugs during follow-up. CONCLUSIONS: In young and middle-aged adults with PFO-associated cryptogenic stroke and migraine, PFO closure plusantiplatelet therapy did not reduce the mean annual number of migraine attacks compared to antiplatelet therapy alone, in migraine patients both with and without aura.
RCT Entities:
BACKGROUND AND PURPOSE: The efficacy of patent foramen ovale (PFO) closure to reduce the frequency of migraine attacks remains controversial. METHODS: This was a planned sub-study in migrainepatients enrolled in a randomized, clinical trial designed to assess the superiority of PFO closure plus antiplatelet therapy over antiplatelet therapy alone to prevent stroke recurrence in patients younger than 60 years with a PFO-associated cryptogenic ischaemic stroke. The main outcome was the mean annual number of migraine attacks in migrainepatients with aura and in those without aura, as recorded at each follow-up visit by study neurologists. RESULTS: Of 473 patients randomized to PFO closure or antiplatelet therapy, 145 (mean age 41.9 years; women 58.6%) had migraine (75 with aura and 70 without aura). Sixty-seven patients were randomized to PFO closure and 78 to antiplatelet therapy. During a mean follow-up of about 5 years, there were no differences between antiplatelet-only and PFO closure groups in the mean annual number of migraine attacks, both in migrainepatients with aura (9.2 [11.9] vs. 12.0 [19.1], p = 0.81) and in those without aura (12.1 [16.1] vs. 11.8 [18.4], p > 0.999). There were no differences between treatment groups regarding cessation of migraine attacks, migraine-related disability at 2 years and use of migraine-preventive drugs during follow-up. CONCLUSIONS: In young and middle-aged adults with PFO-associated cryptogenic stroke and migraine, PFO closure plus antiplatelet therapy did not reduce the mean annual number of migraine attacks compared to antiplatelet therapy alone, in migrainepatients both with and without aura.