Andexanet alfa: hét antidotum voor factor Xa-remmers?

Wat is de waarde voor de Nederlandse praktijk?
Commentaar
10-07-2019
F.A. (Erik) Klok en Menno V. Huisman

Tot voor kort waren er geen specifieke geneesmiddelen beschikbaar die de werking van bepaalde directe orale antistollingsmiddelen – de zogenoemde factor Xa-remmers – kunnen antagoneren. Het huidige beleid is om bij patiënten die factor Xa-remmers gebruiken en een ernstige bloeding krijgen, protrombinecomplex-concentraat (PCC) toe te dienen. Daar lijkt verandering in te komen nu het Europees Geneesmiddelen Agentschap (EMA) andexanet alfa heeft goedgekeurd als middel om de antistolling door factor Xa-remmers om te keren.

Andexanet alfa: the best antidote for factor Xa inhibitors?

Andexanet alfa (andexanet) was specifically developed to reverse factor Xa inhibitors. Its effect on patients who are experiencing major bleeding while being treated with an oral Xa inhibitor or low molecular weight heparin was studied in the ANNEXA 4 study. The main outcome of this study was that anti-factor Xa activity decreased during the 2-hour infusion with andexanet, and that 82% of patients had excellent or good haemostatic efficacy after 12 hours according to pre-specified criteria. Although andexanet is the only specific antidote for factor Xa inhibitors available, an alternative treatment may be high-dose prothrombin concentrate (PCC). With the recent approval by the European Medicines Agency (EMA) but unknown Dutch reimbursement status, the role of andexanet for daily clinical practice in the Netherlands remains to be determined. Notably, and importantly, when treating patients with anticoagulant-associated major bleeding, local haemostatic control and–if relevant–adequate fluid resuscitation are at least as important as choosing the optimal anticoagulation antidote.

Conflict of interest and financial support: potential conflicts of interest have been reported for this article. ICMJE forms provided by the authors are available online along with the full text of this article.