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Hamostaseologie 2023; 43(06): 398-409
DOI: 10.1055/a-2136-2391
Review Article

Grundlagen zur Anwendung von Andexanet

Basics for the Use of Andexanet
J. Koscielny
1   Charité, Universitätsmedizin Berlin, Gerinnungsambulanz mit Hämophiliezentrum, Berlin, Germany
,
I. Birschmann
2   Herz- und Diabeteszentrum Nordrhein-Westfalen, Institut für Laboratoriums- und Transfusionsmedizin, Universitätsklinik der Ruhr-Universität Bochum, Bochum, Germany
,
R. Bauersachs
3   Cardioangiologisches Centrum Bethanien, CCB, Frankfurt am Main, Germany
4   Center for Vascular Research, München, Germany
,
D. Trenk
5   Universitätsklinikum Freiburg, Universitat-Herzzentrum, Klinik für Kardiologie und Angiologie - Klinische Pharmakologie, Bad Krozingen, Germany
,
F. Langer
6   Universitätsklinikum Eppendorf, Zentrum für Onkologie, II. Medizinische Klinik und Poliklinik (Gerinnungsambulanz und Hämophiliezentrum), Hamburg, Germany
,
P. Möhnle
7   Abteilung für Transfusionsmedizin, Zelltherapeutika und Hämostaseologie, LMU Klinikum München, München, Germany
,
J. Beyer-Westendorf
8   Thromboseforschung und Gerinnungsstörungen, Universitätsklinikum Carl Gustav Carus, Med. Klinik I, Dresden, Germany
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Zusammenfassung

Hintergrund Für lebensbedrohliche oder unkontrollierbare Blutungen steht bei einer Assoziation mit dem Thrombin-Inhibitor Dabigatran das monoklonale Antikörperfragment Idarucizumab und bei einer Assoziation mit den direkten Faktor-Xa-Inhibitoren Rivaroxaban oder Apixaban das modifizierte rekombinante FXa-Protein Andexanet für eine Antagonisierung zur Verfügung. Diese spezifischen Antidote stellen Notfallpräparate dar, die typischerweise nur bei Notwendigkeit einer Antagonisierung neben oder nach der Durchführung leitlinienkonformer multimodaler Maßnahmen eingesetzt werden.

Methoden Eine interdisziplinäre Gruppe erfahrener Experten aus den Bereichen Angiologie, Hämatologie, Innerer Medizin, klinischer Pharmakologie, Labormedizin, Transfusionsmedizin, Anästhesiologie, Intensivmedizin und Hämostaseologie hat auf Basis der aktuellen wissenschaftlichen Datenlage praxisrelevante Informationen und Empfehlungen erarbeitet.

Ergebnisse Eine Antagonisierung oraler Antikoagulanzien sollte in folgenden Situationen erfolgen: (1) lebensbedrohliche Blutungen oder refraktärer hämorrhagischer Schock, (2) intrazerebrale Blutungen, oder (3) gastrointestinale endoskopisch unstillbare Blutungen. Nach erfolgreicher Blutstillung sollte die Antikoagulation (z.B. direktes orales Antikoagulanz, Vitamin-K-Antagonist, Heparin) unter Berücksichtigung des individuellen Blutungs- und Thromboembolierisikos wieder zeitnah fortgeführt werden.

Diskussion Diese Zusammenstellung soll allen beteiligten medizinischen Disziplinen helfen, den Umgang mit Andexanet zu erleichtern und damit eine optimale Versorgung der Patienten mit lebensbedrohlichen oder unkontrollierbaren Blutungen zu gewährleisten.

Abstract

Background For life-threatening or uncontrollable bleeding in association with the thrombin inhibitor dabigatran, the monoclonal antibody fragment idarucizumab is available, and for bleeding in association with the direct factor Xa inhibitors rivaroxaban or apixaban, the modified recombinant FXa protein andexanet is available for reversal. These antidotes represent emergency drugs that are typically used only after performing guideline-compliant multimodal measures.

Methods An interdisciplinary group of experienced experts in the fields of angiology, hematology, internal medicine, clinical pharmacology, laboratory medicine, transfusion medicine, anesthesiology, intensive care, and hemostaseology developed recommendations relevant to daily clinical practice based on the current scientific evidence.

Results Reversal of oral anticoagulants should be considered for severe bleeding in the following situations: (1) life-threatening bleeding or refractory hemorrhagic shock, (2) intracerebral bleeding, or (3) endoscopically unstoppable gastrointestinal bleeding. After successful hemostasis, anticoagulation (e.g., direct oral anticoagulant, vitamin K antagonist, and heparin) should be resumed promptly, taking into account individual bleeding and thromboembolic risk.

Discussion This article aims to facilitate the management of patients with andexanet by all medical disciplines involved, thereby ensuring optimal care of patients during bleeding episodes.

Schlüsselwörter

Andexanet - Apixaban - Rivaroxaban - Pharmakokinetik - Pharmakodynamik - ANNEXA-4-Studie - Labormessungen - Blutungsrisiko nach Gabe - Indikationsstellung

Keywords

andexanet - apixaban - rivaroxaban - pharmacokinetic - pharmacodynamic - ANNEXA-4 trial - measurements - bleeding risk after use - mode of indication


Publication History

Received: 26 May 2023

Accepted: 24 July 2023

Article published online:
09 October 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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