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Use of recombinant factor VIIa (NovoSeven((R))) in 8 patients with ongoing life-threatening bleeding treated with fondaparinux.

Author(s): Luporsi P, Chopard R, Janin S, Racadot E, Bernard Y, Ecarnot F, Seronde MF, Briand F, Guignier A, Descotes-Genon V, Meneveau N, Schiele F

Affiliation(s): Department of Cardiology, University Hospital Jean Minjoz, Etablissement Francais du Sang Bourgogne Franche-Comte, Besancon, France.

Publication date & source: 2011-06, Acute Card Care., 13(2):93-8. Epub 2011 Apr 25.

BACKGROUND: Fondaparinux has a favourable efficacy-safety profile but if major bleeding occurs, reversal of antithrombotic treatment is challenging. We present clinical and biological observations from patients treated with rFVIIa for bleeding under fondaparinux. METHODS: Fondaparinux-treated patients with bleeding (>10% haematocrit decrease) and cardiovascular collapse were eligible. Patients received a single 90 mug/kg bolus rFVIIa. Clinical success was defined as clinical bleeding control without thrombotic complication. A biological criterion of successful antagonization was defined as a >100% increase in peak thrombin generation (C(max)). RESULTS: 8 patients were treated (5 ACS, 3 VTE). Patients received aspirin and clopidogrel (n = 5), eptifibatide (n = 2), fluindione (n = 5). In addition to standard haemostatic methods, all patients received rFVIIa and transfusion. Clinical progression was favourable in 4, with bleeding clinically controlled in <6 h. 1 patient died. Biological success was observed in 4 patients with lowest baseline anti-Xa (0.67-0.92 U/L); (3/4) had clinical success. In patients with baseline anti-Xa >1.0 U/L (1.14-1.62 U/L), increase in C(max) was low; (3/4) had no clinical bleeding control. CONCLUSION: This series is the largest describing rFVIIa use to control bleeding in patients under fondaparinux. rVFIIa was considered efficient in 50%, suggesting inefficacy in the context of elevated anti-Xa.

Page last updated: 2011-12-09

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