Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke

Détails

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Etat: Serval
Version: Final published version
ID Serval
serval:BIB_0D2246A81D77
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke
Périodique
New England Journal of Medicine
Auteur(s)
Mas Jean-Louis, Derumeaux Geneviève, Guillon Benoît, Massardier Evelyne, Hosseini Hassan, Mechtouff Laura, Arquizan Caroline, Béjot Yannick, Vuillier Fabrice, Detante Olivier, Guidoux Céline, Canaple Sandrine, Vaduva Claudia, Dequatre-Ponchelle Nelly, Sibon Igor, Garnier Pierre, Ferrier Anna, Timsit Serge, Robinet-Borgomano Emmanuelle, Sablot Denis, Lacour Jean-Christophe, Zuber Mathieu, Favrole Pascal, Pinel Jean-François, Apoil Marion, Reiner Peggy, Lefebvre Catherine, Guérin Patrice, Piot Christophe, Rossi Roland, Dubois-Randé Jean-Luc, Eicher Jean-Christophe, Meneveau Nicolas, Lusson Jean-René, Bertrand Bernard, Schleich Jean-Marc, Godart François, Thambo Jean-Benoit, Leborgne Laurent, Michel Patrik, Pierard Luc, Turc Guillaume, Barthelet Martine, Charles-Nelson Anaïs, Weimar Christian, Moulin Thierry, Juliard Jean-Michel, Chatellier Gilles
ISSN
0028-4793
1533-4406
Statut éditorial
Publié
Date de publication
14/09/2017
Peer-reviewed
Oui
Volume
377
Numéro
11
Pages
1011-1021
Langue
anglais
Résumé
BACKGROUND Trials of patent foramen ovale (PFO) closure to prevent recurrent stroke have been inconclusive. We investigated whether patients with cryptogenic stroke and echocardiographic features representing risk of stroke would benefit from PFO closure or anticoagulation, as compared with antiplatelet therapy. METHODS In a multicenter, randomized, open-label trial, we assigned, in a 1:1:1 ratio, patients 16 to 60 years of age who had had a recent stroke attributed to PFO, with an associated atrial septal aneurysm or large interatrial shunt, to transcatheter PFO closure plus long-term antiplatelet therapy (PFO closure group), antiplatelet therapy alone (antiplatelet-only group), or oral anticoagulation (anticoagulation group) (randomization group 1). Patients with contraindications to anticoagulants or to PFO closure were randomly assigned to the alternative noncontraindicated treatment or to antiplatelet therapy (randomization groups 2 and 3). The primary outcome was occurrence of stroke. The comparison of PFO closure plus antiplatelet therapy with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 2, and the comparison of oral anticoagulation with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 3. RESULTS A total of 663 patients underwent randomization and were followed for a mean (+/- SD) of 5.3 +/- 2.0 years. In the analysis of randomization groups 1 and 2, no stroke occurred among the 238 patients in the PFO closure group, whereas stroke occurred in 14 of the 235 patients in the antiplatelet-only group (hazard ratio, 0.03; 95% confidence interval, 0 to 0.26; P<0.001). Procedural complications from PFO closure occurred in 14 patients (5.9%). The rate of atrial fibrillation was higher in the PFO closure group than in the antiplatelet-only group (4.6% vs. 0.9%, P = 0.02). The number of serious adverse events did not differ significantly between the treatment groups (P = 0.56). In the analysis of randomization groups 1 and 3, stroke occurred in 3 of 187 patients assigned to oral anticoagulants and in 7 of 174 patients assigned to antiplatelet therapy alone. CONCLUSIONS Among patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. PFO closure was associated with an increased risk of atrial fibrillation.
Mots-clé
General Medicine
Pubmed
Web of science
Création de la notice
09/10/2017 17:36
Dernière modification de la notice
03/03/2018 13:39
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