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

Slide: 21 of 36

Increased Risk of Arterial Thromboembolic Events With rFVIIa for Spontaneous Intracranial Hemorrhage vs. Usual Care

Meta-analysis of arterial thromboembolic events identified, with a moderate level of evidence, significantly higher rates with rFVIIa use when compared to usual care for the medium- and high-dose groups. There was also a similar, but non-significant, finding for the low-dose group (risk difference: low dose 0.025 [95% CI -0.004 to 0.053], medium dose 0.035 [95% CI 0.008 to 0.062], high dose 0.063 [95% CI 0.011 to 0.063]. These results suggest that there is an increase in arterial thromboembolic events with rFVIIa use vs. usual care at medium and high doses; however, the low -dose group may not have been powered to detect a difference. There were no differences between groups in venous thromboembolic events.