PROTECT Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation : a randomised.

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Transcription de la présentation:

PROTECT Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation : a randomised multicentre open-label controlled trial. Camenzind E, et al. ESC 2012

PROTECT Méthodologie Objectif Etude Critères d’inclusion Évaluation du risque de thrombose de 2 endoprothèses coronaires actives (stents actifs) Etude Première grande étude prospective, randomisée, multicentrique, internationale (196 sites, 5 continents) Critères d’inclusion Population de coronariens représentative des situations cliniques quotidiennes Sténoses mono et pluritronculaires Aucune limitation sur le nombre de lésions par vaisseau PROTECT Camenzind E, et al. ESC 2012

Zotarolimus stent Endeavour® n = 4357 Schéma de l’étude Zotarolimus stent Endeavour® n = 4357 Sirolimus stent Cypher® n = 4352 n = 8709 PROTECT 30 j 6 mois 12 mois 18 mois 24 mois 30 mois 3 ans 4 ans 5 ans Camenzind E, et al. ESC 2012

PROTECT Résultats Critère Principal : Thrombose de Stent certaine ou probable à 3 ans 5% PROTECT 2,5% Cypher® Sirolimus 1,79% p = 0,224 Endeavor® Zotarolimus 1,42% 1 2 3 Délai après ATL initiale (ans) Camenzind E, et al. ESC 2012

Résultats Thrombose de Stent certaine ou probable avant et à 1 an 5% PROTECT 2,5% p = 0,06 Cypher® Sirolimus 1,1% p < 0,001 Endeavor® Zotarolimus 0,3% 1 2 3 Délai après ATL initiale (ans) Camenzind E, et al. ESC 2012

Conclusion Aucune différence significative entre les 2 endoprothèses (stents) actifs pour les thromboses certaines ou probables après 3 ans de suivi. L’analyse détaillée fait apparaître néanmoins une fréquence croissante des thromboses au cours du temps, ce qui conforte le principe d’un suivi prolongé. PROTECT Camenzind E, et al. ESC 2012