1–Thrombolysis in myocardial infarction

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Transcription de la présentation:

1–Thrombolysis in myocardial infarction SEPIA ACSI-TIMI 42 Study program to evaluate the prevention of ichsemia with direct anti-Xa inhibition (SEPIA) in acute coronary syndromes (ACS) 1–Thrombolysis in myocardial infarction (TIMI) 42 Sabatine M. et al.

SEPIA ACSI-TIMI 42 Méthodologie Objectif Etude Critères d’inclusion Comparer l’otamixaban* et l’HNF iv + anti-GP IIbIIIa iv (eptifibatide) dans le traitement des syndromes coronaires aigus (SCA) sans sus décalage de ST (ST-) Etude Étude de doses (phase II), internationale, multicentrique, randomisée, double insu Critères d’inclusion Patients SCA ST- SEPIA ACSI-TIMI 42 * Otamixaban : anti-Xa direct, iv, synthétique, sélectif, avec une ½ vie de 30 minutes Sabatine M. et al.

Otamixaban : 5 posologies après DC* HNF iv + Eptifibatide iv Schéma de l’étude Critère de jugement principal 1er évènement grave à 7 jours (décès toutes causes, IDM, récidive SCA nécessitant revasc. en urgence ou anti-GP IIbIIIa) Otamixaban : 5 posologies après DC* (n = 2792) SCA ST- ATL + Tt conv. (n = 3241) SEPIA ACSI-TIMI 42 R HNF iv + Eptifibatide iv (n = 449) * Otamixaban : dose de charge (DC) = 0,08 mg/kg mg puis 0,035 à 0,175 mg/kg/h Sabatine M. et al.

Critère principal (DC,IDM,récidive SCA) Résultats efficacité Critère principal (DC,IDM,récidive SCA) OTAM 0,035 OTAM 0,070 OTAM 0,105 OTAM 0,140 OTAM 0,175 UFH+ eptifi 1 2 3 4 5 6 7 8 7,2 4,6 3,8 3,6 4,3 6,2 Événements (%) 1,16 (0,56-2,33) 0,74 (0,45-1,21) 0,61 (0,36-1,02) 0,58 (0,34-0,996) 1,69 (0,42-1,15) RR 0,6 (IC95 : 0,38-0,94) p = 0,02 RR vs UFH (IC95) 125 n : 676 662 658 671 449 SEPIA ACSI-TIMI 42 Sabatine M. et al.

Tolérance (hémorragies mineures et majeures) Résultats Tolérance Tolérance (hémorragies mineures et majeures) 0,61 (0,14-2,70) 0,61 (0,27-1,38) 1,15 (0,57-2,32) 1,26 (0,63-2,52) 2,02 (1,07-3,85) RR vs UFH (IC95) 1,6 3,1 3,4 5,4 2,7 OTAM 0,035 OTAM 0,070 OTAM 0,105 OTAM 0,140 OTAM 0,175 UFH+ eptifi 1 2 3 4 5 6 Hémorragies (%) 125 n : 676 662 658 671 449 p = 0,0001 entre les bras Tt SEPIA ACSI-TIMI 42 Sabatine M. et al.

SEPIA ACSI-TIMI 42 Conclusion Aux posologies comprises entre 0,105 et 0,140 mg/kg/h, Otamixaban représente une alternative à l’association HNF-eptifibatide pour les syndromes coronaires aigus sans sus décalage de ST traités par angioplastie transluminale Les posologies inférieures sont inefficaces Les posologies supérieures exposent au risque hémorragique SEPIA ACSI-TIMI 42 Sabatine M. et al.