28. ICH Management Active Medical Treatment NovoSeven ® directly activates factor X on the surface of the locally activated platelets Hoffman, M, et al. Thromb Haemost 2001;85:958. t ½ = 2.6 hrs INITIATION : Tissue Factor/FVIIa interaction leads to thrombin generation AMPLIFICATION : rFVIIa activates factor X on the surface of activated platelets, leading to an enhanced thrombin burst at the site of injury FIBRIN CLOT FORMATION: Thrombin converts fibrinogen into fibrin, producing a stable clot
29.
30. Benefit of FVIIa is dose dependent ICH Volume Edema Volume ICH + IVH + Edema Volume • P<0.05 •• P<0.01 ••• P<0.005 • ••• ••• •• • ••• Absolute change in lesion volume compared to placebo (mL) p = 0.02 for trend
31. ICH Management Factor VIIa p=0.02 p=0.02, Chi Square test p=0.10 Log rank test PLACEBO 18% 29% Mortality
32. Patient Outcome with FVIIa Outcome Pl 40 80 160 NNT 7.1 5.0 6.7 ARR 16%, p = 0.004 (group) 54% P=0.023 49% P=0.008 55% P=0.018 69% mRS 4-6 0.14 73% 81% E-GOS 0.008 6.0 12.5 NIHSS 0.006 60.0 25.0 BI 0.004 53% 69% mRS 0.02 18% 29% Death P value Total Rx Placebo Variable
33. ICH Management Active Medical Treatment Factor VIIa Frequency of Thrombo-Embolic SAEs * Fisher’s Exact test Arterial events significant : 7 AMI, 7 AIS (3% early, 5% total) Venous events non-significant : 3 PE Total Thromboembolic Events Total: 7% treatment; 2% placebo Serious: 2% treatment; 2% placebo 0.12 10% 4% 6% 2% P-value* 160 µg/kg 80 µg/kg 40 µg/kg Placebo
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