333 Use of recombinant factor VIIa (NovoSeven) in patients treated with fondaparinux for ongoing life-threatening bleeding

Background Recombinant factor VIIa (rFVIIa) may be used to reverse the anticoagulant effect of fondaparinux. We report a single centre experience in 8 patients with severe bleeding. Methods: Patients pretreated with fondaparinux, with life-threatening bleeding were treated with 90 μg/kg rFVIIa. Life-threatening bleeding was defined as TIMI 3 bleeding or a drop in hemoglobin > 5g or hemodynamic shock and elevated antiXa activity. Endpoints were (1) death (2) persistent bleeding (clinical or continued drop of hemoglobin) (3) uncontrolled hemodynamic shock (4) clinical arterial or venous thrombosis and (5) peak of thrombin generation. Results Between June 2008 and November 2009, among 1224 patients treated with fondaparinux, 8 presented with life-threatening bleeding (3 with venous thrombo-embolic disease, 5 acute coronary syndrome (ACS)). Patients with ACS had double (n = 2) or triple (n = 3) antiplatelet therapy. Bleedings were related to vascular access in 5, gastro-duodenal in 2 and lung in 1. Five patients had hemorrhagic shock, mean drop in hemoglobin was 6.1 g/dL. Anti-Xa activity ranged from 0.67 to 1.62, rFVIIa dose ranged from 3.6 to 7.65 mg. One patient died from uncontrolled shock, no patient had signs of persistent bleeding or thrombotic complication. In patients with the highest basal anti-Xa activity (1.14 to 1.62), the time to peak of thrombin generation remained low. Conversely, it returned to normal in the four patients with lowest baseline anti-Xa activity (0.67 to 0.92). Conclusions Use of 90 μg/kg rFVIIa in patients treated with fondaparinux and with life-threatening bleeding was associated with clinical bleeding cessation in 7/8. Lack of normalization of thrombin generation was observed in patients with the highest anti-Xa activity. Download full-size image