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Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care

Slide: 19 of 36

Overview of Comparative Effectiveness of rFVIIa for Spontaneous Intracranial Hemorrhage

These studies yielded moderate strength of evidence with good applicability for treatment use in the population targeted by the randomized controlled trials—those with spontaneous intracerebral hemorrhage who were not on anticoagulation therapy. Comparative analysis of patients with spontaneous intracerebral hemorrhage revealed that there was no effect of rFVIIa on mortality or rate of poor functional status; an increased rate of arterial thromboembolic events exists for medium- (41–119 μg/kg) and high-dose (≥120 μg/kg) groups; however, the low-dose group (≤40 μg/kg) may not have been powered to detect a difference; rFVIIa was associated with a decrease in the percent hematoma expansion; therefore, the evidence suggests that neither benefits nor harms exceed each other for rFVIIa use in spontaneous intracranial hemorrhage.