Patent foramen ovale closure in stroke patients with migraine in the CLOSE trial. The CLOSE-MIG study

Jean-Louis Mas (1, 2) , Benoit Guillon (3) , Anais Charles-Nelson (4) , Valerie Domigo (5, 6) , Laurent Derex (7) , Evelyne Massardier (8) , Caroline Arquizan (9) , Fabrice Vuillier (10) , Serge Timsit (11) , Yannick Bejot (12, 13) , Olivier Detante (14, 15) , Denis Sablot (16, 17) , Celine Guidoux (18, 19, 20) , Igor Sibon (21) , Nelly Dequatre-Ponchelle (22) , Emmanuel Touze (23, 24) , Sandrine Canaple (25, 26) , Sonia Alamowitch (27) , Pierre Aubry (28) , Emmanuel Teiger (29) , Genevieve Derumeaux (29) , Gilles Chatellier (30, 31)

1 Hôpital Cochin [AP-HP]
2 UFR Médecine UPCité - UFR Médecine [Santé] - Université Paris Cité
3 CHU Nantes - Centre hospitalier universitaire de Nantes
4 CIC 1418 - CIC - HEGP
5 GHU Paris Psychiatrie et Neurosciences
6 IPNP - U1266 Inserm - Institut de psychiatrie et neurosciences de Paris
7 HESPER - Health Service and Performance Research
8 CHU Rouen
9 CHU Montpellier
10 CHRU Besançon - Centre Hospitalier Régional Universitaire de Besançon
11 Service de Neurologie [Brest]
12 CHU Dijon
13 Registre Dijonnais des Accidents Vasculaires Cérébraux (AVC) - Dijon Stroke Registry
14 CHU - Centre Hospitalier Universitaire [Grenoble]
15 GIN - [GIN] Grenoble Institut des Neurosciences
16 Centre Hospitalier Saint Jean de Perpignan
17 ARS Occitanie - Agence Régionale de Santé Occitanie
18 LVTS (UMR_S_1148 / U1148) - Laboratoire de Recherche Vasculaire Translationnelle
19 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
20 CHU Pitié-Salpêtrière [AP-HP]
21 INCIA - Institut de Neurosciences cognitives et intégratives d'Aquitaine
22 TCDV - Troubles cognitifs dégénératifs et vasculaires - U 1171
23 PhIND - Physiopathologie et imagerie des troubles neurologiques
24 CHU Caen
25 Service de neurologie [Amiens]
26 LNFP - Laboratoire de Neurosciences Fonctionnelles et Pathologies - UR UPJV 4559
27 Service de Neurologie [CHU Saint-Antoine]
28 CIC - CHU Bichat
29 IMRB - Institut Mondor de Recherche Biomédicale
30 UPCité - Université Paris Cité
31 HEGP - Hôpital Européen Georges Pompidou [APHP]

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 plus antiplatelet therapy did not reduce the mean annual number of migraine attacks compared to antiplatelet therapy alone, in migraine patients both with and without aura.

Domaines: Sciences du Vivant [q-bio]

Jean-Louis Mas, Benoit Guillon, Anais Charles-Nelson, Valerie Domigo, Laurent Derex, et al.. Patent foramen ovale closure in stroke patients with migraine in the CLOSE trial. The CLOSE-MIG study. European Journal of Neurology, 2021, 28 (8), pp.2700-2707. ⟨10.1111/ene.14892⟩. ⟨hal-03607030⟩