Impact of increased kidney function on clinical and biological outcomes in real-world patients treated with Direct Oral Anticoagulants.

BACKGROUND AND PURPOSE

Renal excretion of direct oral anticoagulants (DOACs) varies depending on the drug. Hypothetically, an increased glomerular filtration rate (GFR) may lead to suboptimal dosing and a higher thromboembolic events incidence. However, real-world patient data do not support the theoretical risk. The aim is to analyse DOAC outcomes in patients with normal and high (≥90 mL/min) GFR, focusing on biological parameters and thrombotic/haemorrhagic events.

METHODS

Observational prospective single-centre study and registry of patients on DOACs. Follow-up was 1,343 patient-years. A bivariate analysis was performed of baseline variables according to GFR (<90 mL/min vs ≥90 mL/min). Anti-Xa activity before and after drug intake (HemosIL, Liquid Anti-Xa, Werfen) was measured for edoxaban, apixaban, and rivaroxaban; diluted thrombin time for dabigatran (HEMOCLOT); and additionally, plasma concentrations in edoxaban (HemosIl, Liquid Anti-Xa suitably calibrated).

RESULTS

1,135 patients anticoagulated with DOACs were included and 152 patients with GFR ≥90 mL/min. Of 18 serious thrombotic complications during follow-up, 17 occurred in patients with GFR <90 mL/min, and 1 in a patient with GFR ≥90 mL/min. A higher incidence of complications was observed in patients with normal GFR, but the difference was not statistically significant (p>0.05). No statistically significant differences with clinical relevance were observed between the normal or supranormal groups in anti-Xa activity or in edoxaban plasma concentrations.

CONCLUSIONS

There was no increased incidence of thrombotic/haemorrhagic complications in our patients treated with DOACs, including 66% treated with edoxaban, and patients with GFR ≥90 mL/min. Likewise, drug anti-Xa activity and edoxaban plasma concentration did not seem to be influenced by GFR.

Informations de copyright

Copyright: © 2022 Corrochano et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Déclaration de conflit d'intérêts

I have read the journal’s policy and the authors of this manuscript have the following competing interests: “The HSCSP Haemostasis and Thrombosis and the IIB-Sant Pau receive funding from Daiichi-Sankyo to develop and maintain the MACACOD (Real-life Clinical Outcomes of Direct Oral Anticoagulants) registry, of which this study is part. Only the authors have participated in study design, data collection and analysis, and manuscript preparation. Dr Souto has received honoraria or financial support for travel, accommodation, or expenses from Laboratorios Rovi, Leo Pharma, Baxter, Sanofi, Boehringer Ingelheim, Pfizer, Bristol Myers Squibb, Roche, Daiichi-Sankyo, and Stago Laboratories. He also holds advisory position in Devicare. The remaining authors declare no conflicts of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.