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Can a Single Measurement of Apixaban Levels Identify Patients at Risk of Overexposure? A Prospective Cohort Study

Background  Patients with atrial fibrillation (AF) are frequently treated with apixaban 2.5-mg twice daily (BID) off-label, presumably to reduce the bleeding risk. However, this approach has the potential to increase the risk of ischemic stroke. If a single measurement could reliably identify patien...

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Autores principales: de Vries, Tim A.C., Hirsh, Jack, Bhagirath, Vinai C., Ginsberg, Jeffrey S., Pisters, Ron, Hemels, Martin E.W., de Groot, Joris R., Eikelboom, John W., Chan, Noel C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Georg Thieme Verlag KG 2022
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8786560/
https://www.ncbi.nlm.nih.gov/pubmed/35088021
http://dx.doi.org/10.1055/s-0041-1740492
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author de Vries, Tim A.C.
Hirsh, Jack
Bhagirath, Vinai C.
Ginsberg, Jeffrey S.
Pisters, Ron
Hemels, Martin E.W.
de Groot, Joris R.
Eikelboom, John W.
Chan, Noel C.
author_facet de Vries, Tim A.C.
Hirsh, Jack
Bhagirath, Vinai C.
Ginsberg, Jeffrey S.
Pisters, Ron
Hemels, Martin E.W.
de Groot, Joris R.
Eikelboom, John W.
Chan, Noel C.
author_sort de Vries, Tim A.C.
collection PubMed
description Background  Patients with atrial fibrillation (AF) are frequently treated with apixaban 2.5-mg twice daily (BID) off-label, presumably to reduce the bleeding risk. However, this approach has the potential to increase the risk of ischemic stroke. If a single measurement could reliably identify patients with high drug levels, the increased stroke risk may be mitigated by confining off-label dose reduction to such patients. Objectives  This study aimed to determine whether a single high apixaban level is predictive of a similarly high level when the test is repeated in 2 months. Methods  In this prospective cohort study of clinic patients receiving apixaban 5-mg BID for AF or venous thromboembolism, peak and trough apixaban levels were measured using the STA-Liquid anti-Xa assay at baseline and 2 months. We calculated the proportions of patients with levels that remained in the upper quintile. Results  Of 100 enrolled patients, 82 came for a second visit, 55 of whom were treated with apixaban 5-mg BID. Seven (63.6%, 95% confidence interval [CI]: 35.4–84.8%) and nine (81.8%, 95% CI: 52.3–94.9%) of 11 patients with a baseline trough and peak level in the upper quintile, respectively, had a subsequent level that remained within this range. Only one (9.1%, 95% CI: 1.6–37.7%) patient had a subsequent level that fell just lower than the median. Conclusion  The trough and peak levels of apixaban in patients who have a high level on a single occasion, usually remain high when the assay is repeated in 2 months. Accordingly, the finding of a high apixaban level in patients deemed to be at high risk of bleeding, allows physicians contemplating off-label use of the 2.5-mg BID dose to limit its use to selected patients who are less likely to be exposed to an increased risk of thrombosis.
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spelling pubmed-87865602022-01-26 Can a Single Measurement of Apixaban Levels Identify Patients at Risk of Overexposure? A Prospective Cohort Study de Vries, Tim A.C. Hirsh, Jack Bhagirath, Vinai C. Ginsberg, Jeffrey S. Pisters, Ron Hemels, Martin E.W. de Groot, Joris R. Eikelboom, John W. Chan, Noel C. TH Open Background  Patients with atrial fibrillation (AF) are frequently treated with apixaban 2.5-mg twice daily (BID) off-label, presumably to reduce the bleeding risk. However, this approach has the potential to increase the risk of ischemic stroke. If a single measurement could reliably identify patients with high drug levels, the increased stroke risk may be mitigated by confining off-label dose reduction to such patients. Objectives  This study aimed to determine whether a single high apixaban level is predictive of a similarly high level when the test is repeated in 2 months. Methods  In this prospective cohort study of clinic patients receiving apixaban 5-mg BID for AF or venous thromboembolism, peak and trough apixaban levels were measured using the STA-Liquid anti-Xa assay at baseline and 2 months. We calculated the proportions of patients with levels that remained in the upper quintile. Results  Of 100 enrolled patients, 82 came for a second visit, 55 of whom were treated with apixaban 5-mg BID. Seven (63.6%, 95% confidence interval [CI]: 35.4–84.8%) and nine (81.8%, 95% CI: 52.3–94.9%) of 11 patients with a baseline trough and peak level in the upper quintile, respectively, had a subsequent level that remained within this range. Only one (9.1%, 95% CI: 1.6–37.7%) patient had a subsequent level that fell just lower than the median. Conclusion  The trough and peak levels of apixaban in patients who have a high level on a single occasion, usually remain high when the assay is repeated in 2 months. Accordingly, the finding of a high apixaban level in patients deemed to be at high risk of bleeding, allows physicians contemplating off-label use of the 2.5-mg BID dose to limit its use to selected patients who are less likely to be exposed to an increased risk of thrombosis. Georg Thieme Verlag KG 2022-01-24 /pmc/articles/PMC8786560/ /pubmed/35088021 http://dx.doi.org/10.1055/s-0041-1740492 Text en The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. ( https://creativecommons.org/licenses/by/4.0/ ) https://creativecommons.org/licenses/by/4.0/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 work is properly cited.
spellingShingle de Vries, Tim A.C.
Hirsh, Jack
Bhagirath, Vinai C.
Ginsberg, Jeffrey S.
Pisters, Ron
Hemels, Martin E.W.
de Groot, Joris R.
Eikelboom, John W.
Chan, Noel C.
Can a Single Measurement of Apixaban Levels Identify Patients at Risk of Overexposure? A Prospective Cohort Study
title Can a Single Measurement of Apixaban Levels Identify Patients at Risk of Overexposure? A Prospective Cohort Study
title_full Can a Single Measurement of Apixaban Levels Identify Patients at Risk of Overexposure? A Prospective Cohort Study
title_fullStr Can a Single Measurement of Apixaban Levels Identify Patients at Risk of Overexposure? A Prospective Cohort Study
title_full_unstemmed Can a Single Measurement of Apixaban Levels Identify Patients at Risk of Overexposure? A Prospective Cohort Study
title_short Can a Single Measurement of Apixaban Levels Identify Patients at Risk of Overexposure? A Prospective Cohort Study
title_sort can a single measurement of apixaban levels identify patients at risk of overexposure? a prospective cohort study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8786560/
https://www.ncbi.nlm.nih.gov/pubmed/35088021
http://dx.doi.org/10.1055/s-0041-1740492
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