title: Use of recombinant factor VIIa (NovoSeven(®)) in 8 patients with ongoing life-threatening bleeding treated with fondaparinux.
abstract: 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 μg/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); ¾ 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; ¾ had no clinical bleeding control.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Cardiology, University Hospital Jean Minjoz, Etablissement Français du Sang Bourgogne Franche-Comté, Besançon, France.
authors.forename: P
authors.initials: P
authors.lastname: Luporsi
authors.forename: R
authors.initials: R
authors.lastname: Chopard
authors.forename: S
authors.initials: S
authors.lastname: Janin
authors.forename: E
authors.initials: E
authors.lastname: Racadot
authors.forename: Y
authors.initials: Y
authors.lastname: Bernard
authors.forename: F
authors.initials: F
authors.lastname: Ecarnot
authors.forename: M F
authors.initials: MF
authors.lastname: Séronde
authors.forename: F
authors.initials: F
authors.lastname: Briand
authors.forename: A
authors.initials: A
authors.lastname: Guignier
authors.forename: V
authors.initials: V
authors.lastname: Descotes-Genon
authors.forename: N
authors.initials: N
authors.lastname: Meneveau
authors.forename: F
authors.initials: F
authors.lastname: Schiele
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects* / Q000627:therapeutic use; D001803:Blood Transfusion; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D000077425:Fondaparinux; D006470:Hemorrhage / Q000139:chemically induced* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011134:Polysaccharides / Q000009:adverse effects* / Q000627:therapeutic use; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000188:drug therapy
chemical_list: D000925:Anticoagulants; D011134:Polysaccharides; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa; D000077425:Fondaparinux