Abstract 15195: Use of Recombinant Factor VII a (NovoSeven) in Patients with Ongoing Life Threatening Bleeding Treated with Fondaparinux
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 with life-threatening bleeding and pretreated with fondaparinux were treated with 90μg/kg rFVIIa. Life-threatening bleeding was defined as TIMI 3 bleeding or > 5g drop in hemoglobin or hemodynamic shock and elevated antiXa activity. Endpoints were (1) death, (2) persistent bleeding (clinical or continued drop in 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 patients had venous thrombo-embolic disease and 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 inhaemoglobin was 6.1 g/dL. AntiXa 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 antiXa 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 antiXa activity (0.67 to 0.92).
Conclusions: Use of 90μg/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.
- © 2010 by American Heart Association, Inc.