Anticoagulation With an Inhibitor of Factors XIa and XIIa During Cardiopulmonary Bypass.


Journal

Journal of the American College of Cardiology
ISSN: 1558-3597
Titre abrégé: J Am Coll Cardiol
Pays: United States
ID NLM: 8301365

Informations de publication

Date de publication:
29 10 2019
Historique:
received: 08 07 2019
accepted: 01 08 2019
entrez: 26 10 2019
pubmed: 28 10 2019
medline: 9 6 2020
Statut: ppublish

Résumé

Exposure of blood to polyanionic artificial surfaces, for example, during cardiopulmonary bypass (CPB), induces a highly procoagulant condition requiring strong anticoagulation. Unfractionated heparin (UFH) is currently used during CPB but can lead to serious bleeding complications or development of a hypercoagulable state culminating in life-threatening thrombosis, highlighting the need for safer antithrombotics. Ixodes ricinus contact phase inhibitor (Ir-CPI) is a protein expressed by I. ricinus ticks, which specifically inhibits both factors XIIa and XIa, 2 factors contributing to thrombotic disease while playing a limited role in hemostasis. This study assessed the antithrombotic activity of Ir-CPI in animal contact phase-initiated thrombosis models, including CPB. The safety of Ir-CPI also was evaluated. The authors evaluated the antithrombotic activity of Ir-CPI by using in vitro catheter-induced clotting assays and rabbit experimental models of catheter occlusion and arteriovenous shunt. During CPB with cardiac surgery in sheep, the clinical applicability of Ir-CPI was investigated and its efficacy compared to that of UFH using an uncoated system suitable for adult therapy. Taking advantage of the similar hemostatic properties of pigs and humans, the authors performed pig liver bleeding assays to evaluate the safety of Ir-CPI. Ir-CPI prevented clotting in catheter and arteriovenous shunt rabbit models. During CPB, Ir-CPI was as efficient as UFH in preventing clot formation within the extracorporeal circuit and maintained physiological parameters during and post-surgery. Unlike UFH, Ir-CPI did not promote bleeding. Preclinical animal models used in this study showed that Ir-CPI is an effective and safe antithrombotic agent that provides a clinically relevant approach to thrombosis prevention in bypass systems, including highly thrombogenic CPB.

Sections du résumé

BACKGROUND
Exposure of blood to polyanionic artificial surfaces, for example, during cardiopulmonary bypass (CPB), induces a highly procoagulant condition requiring strong anticoagulation. Unfractionated heparin (UFH) is currently used during CPB but can lead to serious bleeding complications or development of a hypercoagulable state culminating in life-threatening thrombosis, highlighting the need for safer antithrombotics. Ixodes ricinus contact phase inhibitor (Ir-CPI) is a protein expressed by I. ricinus ticks, which specifically inhibits both factors XIIa and XIa, 2 factors contributing to thrombotic disease while playing a limited role in hemostasis.
OBJECTIVES
This study assessed the antithrombotic activity of Ir-CPI in animal contact phase-initiated thrombosis models, including CPB. The safety of Ir-CPI also was evaluated.
METHODS
The authors evaluated the antithrombotic activity of Ir-CPI by using in vitro catheter-induced clotting assays and rabbit experimental models of catheter occlusion and arteriovenous shunt. During CPB with cardiac surgery in sheep, the clinical applicability of Ir-CPI was investigated and its efficacy compared to that of UFH using an uncoated system suitable for adult therapy. Taking advantage of the similar hemostatic properties of pigs and humans, the authors performed pig liver bleeding assays to evaluate the safety of Ir-CPI.
RESULTS
Ir-CPI prevented clotting in catheter and arteriovenous shunt rabbit models. During CPB, Ir-CPI was as efficient as UFH in preventing clot formation within the extracorporeal circuit and maintained physiological parameters during and post-surgery. Unlike UFH, Ir-CPI did not promote bleeding.
CONCLUSIONS
Preclinical animal models used in this study showed that Ir-CPI is an effective and safe antithrombotic agent that provides a clinically relevant approach to thrombosis prevention in bypass systems, including highly thrombogenic CPB.

Identifiants

pubmed: 31648711
pii: S0735-1097(19)37465-0
doi: 10.1016/j.jacc.2019.08.1028
pii:
doi:

Substances chimiques

Anticoagulants 0
Blood Proteins 0
Fibrinolytic Agents 0
factor XIIa inhibitor 0
Heparin 9005-49-6
Factor XIa EC 3.4.21.27
Factor XIIa EC 3.4.21.38

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2178-2189

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

Auteurs

Valérie Pireaux (V)

Bioxodes S.A., Marche-en-Famenne, Belgium.

Joël Tassignon (J)

Bioxodes S.A., Marche-en-Famenne, Belgium.

Stéphanie Demoulin (S)

Bioxodes S.A., Marche-en-Famenne, Belgium.

Sandrine Derochette (S)

Bioxodes S.A., Marche-en-Famenne, Belgium.

Nicolas Borenstein (N)

IMM Recherche, Institut Mutualiste Montsouris, Paris, France.

Angélique Ente (A)

IMM Recherche, Institut Mutualiste Montsouris, Paris, France.

Laurence Fiette (L)

IMM Recherche, Institut Mutualiste Montsouris, Paris, France.

Jonathan Douxfils (J)

QUALIblood S.A., Namur, Belgium.

Patrizio Lancellotti (P)

GIGA Cardiovascular Sciences, Department of Cardiology, University Hospital of Liège, CHU Sart Tilman, Liège, Belgium.

Michel Guyaux (M)

Bioxodes S.A., Marche-en-Famenne, Belgium.

Edmond Godfroid (E)

Bioxodes S.A., Marche-en-Famenne, Belgium. Electronic address: edmond.godfroid@bioxodes.com.

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Classifications MeSH