Host-ASSURE Adjunctive Cilostazol vs double dose clopidogrel after PCI with drug eluting stent Hyo-Soo K et al. ACC 2012.

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Host-ASSURE Adjunctive Cilostazol vs double dose clopidogrel after PCI with drug eluting stent Hyo-Soo K et al. ACC 2012

Host-ASSURE Méthodologie Objectif Etude Critères d’inclusion Etudier l’efficacité du cilostazol* en complément d’une bithérapie conventionnelle (aspirine, clopidogrel) versus une bithérapie renforcée (aspirine, clopidogrel double dose) en post-ATL coronaire Etude Étude randomisée, en simple insu, de non infériorité, multicentrique (40 sites) réalisée en République coréenne Critères d’inclusion Patients programmés pour une ATL coronaire avec pose de stent actif Host-ASSURE * Cilostazol : anti-agrégant plaquettaire (AAP) et vasodilatateur, inhibiteur des phosphodiestérases III (agréé au Japon, aux USA et en Europe depuis 2008 dans la claudication intermittente) Hyo-Soo K et al. ACC 2012

Host-ASSURE Schéma de l’étude R Tri-thérapie AAP Aspirine 100 mg + Clopidogrel 75 mg + Cilostazol 100 mg * (n = 1879) Critère principal de jugement Mortalité CV SCA non mortel AVC Hémorragies majeures** ATL coronaire programmée n = 3755 Host-ASSURE R Bi-thérapie AAP Aspirine 100 mg + Clopidogrel 150 mg (n = 1876) ) Suivi : 1 mois * Après dose de charge Cilostazole 200 mg ** Selon classification PLATO Hyo-Soo K et al. ACC 2012

Caractéristiques patients TriTt BiTt Âge (ans) 62,8 ± 10,7 63,7 ± 10,9 Hommes 69,8% 67% Diabète 31,8% 31,3% Tabagisme actif 32,8% 30,8% FEVG 60,3 ± 10,3% 59,9 ± 10,3% Host-ASSURE Hyo-Soo K et al. ACC 2012

Résultats Critère principal Host-ASSURE Hyo-Soo K et al. ACC 2012

Résultats Tolérance Host-ASSURE Hyo-Soo K et al. ACC 2012

Host-ASSURE Conclusion La trithérapie AAP (cilostazol, aspirine, clopidogrel) est au moins aussi efficace que la bithérapie renforcée (aspirine, clopidogrel double dose) pour prévenir les évènements graves post-ATL coronaire (stents actifs), sans surcroît de risque hémorragique. Les limites de l’étude : - surestimation du risque d’évènements dans le groupe bithérapie (3% attendus, puissance statistique insuffisante pour une analyse de non-infériorité) - observance imparfaite : . TriTt AAP = 91,6% . BiTt AAP = 86,5% Host-ASSURE Hyo-Soo K et al. ACC 2012