Antithrombotic effect of tissue factor inhibition by inactivated factor VIIa: An ex vivo human study

Eli I. Lev, Jonathan D. Marmur, Milan Zdravkovic, Julio I. Osende, Jonathan Robbins, Jenny A. Delfin, Merwin Richard, Elisabeth Erhardtsen, Mikael S. Thomsen, A. Michael Lincoff, Juan J. Badimon

Research output: Contribution to journalArticlepeer-review

27 Scopus citations


FFR-rFVIIa is an inactivated recombinant factor VIIa (rFVIIa) that inhibits the binding of factor VIIa to tissue factor (TF). It has been shown to prevent TF-induced thrombosis in animals. The present study is a substudy of the Active Site Inhibited Seven (ASIS) trial and examines the antithrombotic effect of 3 doses of FFR-rFVIIa in 24 patients undergoing percutaneous coronary intervention (PCI). Group 1 (n=9) received 400 μg/kg FFR-rFVIIa and 40 to 50 U/kg heparin, group 2 (n=7) received 200 μg/kg FFR-rFVIIa and 100 U/kg heparin, and group 3 (n=8) received 50 μg/kg FFR-rFVIIa and 100 U/kg heparin. Blood thrombogenicity was assessed as total thrombus area and fibrin deposition on the perfusion chamber at shear rate conditions typical of mild-moderate coronary stenosis. Baseline blood thrombogenicity was evaluated a day before PCI, after heparin administration. A second perfusion chamber study was performed just before PCI, 15 minutes after the administration of heparin and FFR-rFVIIa. Thrombus formation at a high shear rate was markedly reduced in groups 1 and 2 after drug administration, by 79% to 84% and 76% to 87%, respectively (P<0.004 [group 1], P<0.04 [group 2]). In group 3, moderate thrombus reduction of 46% to 48% was achieved (P<0.04). Fibrin deposition in all 3 groups was nearly eliminated after drug administration. Our data demonstrate that FFR-rFVIIa has a potent antithrombotic effect at different shear rates and severe arterial injury conditions.

Original languageEnglish
Pages (from-to)1036-1041
Number of pages6
JournalArteriosclerosis, Thrombosis, and Vascular Biology
Issue number6
StatePublished - 29 Jun 2002
Externally publishedYes


  • Factor VIIa
  • Fibrin
  • Platelets
  • Thrombus formation
  • Tissue factor

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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