Clinical characteristics of patients with direct oral anticoagulant (DOAC) levels outside expected ranges: A retrospective chart study
Background: Routine monitoring direct oral anticoagulants (DOAC) is not recommended, yet DOAC levels are frequently measured in clinical practice. Interpretation of levels, especially those outside expected ranges, is challenging. Until now it's unclear which patients are at risk for these leve...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-05-01
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| Series: | Thrombosis Update |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S266657272300010X |
| _version_ | 1827941648391208960 |
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| author | Dionne C.W. Braeken Roisin Bavalia Yvonne M.C. Henskens Hugo ten Cate Rutger C.C. Hengeveld Barbara A. Hutten Saskia Middeldorp Michiel Coppens An K. Stroobants |
| author_facet | Dionne C.W. Braeken Roisin Bavalia Yvonne M.C. Henskens Hugo ten Cate Rutger C.C. Hengeveld Barbara A. Hutten Saskia Middeldorp Michiel Coppens An K. Stroobants |
| author_sort | Dionne C.W. Braeken |
| collection | DOAJ |
| description | Background: Routine monitoring direct oral anticoagulants (DOAC) is not recommended, yet DOAC levels are frequently measured in clinical practice. Interpretation of levels, especially those outside expected ranges, is challenging. Until now it's unclear which patients are at risk for these levels. Aim: Identify clinical characteristics of patients with DOAC levels outside expected ranges. Methods: Patients of 2 Dutch academic medical centers with a DOAC concentration measured between 2012 and 2019 were included. DOAC levels above upper limit peak and below lower limit trough ranges, based on DOAC registration trials, were assigned outside expected range. Differences between patients were evaluated using Chi-square, independent sample-T tests and multivariable logistic regression analysis. Results: Of 597 patients with DOAC measurement, 108 (18.1%) had levels outside expected ranges. Compared to patients with levels within range, patients with levels above range (n = 64) were older (71.1 vs. 60.6 years), more often had creatinine clearance <50 ml/min (32.8% vs. 13.9%). and used more often interacting (17.2% vs. 6.7%) and/or antiplatelet co-medication (25.0% vs. 13.1%). Patients with levels above (62.5%) and below range (61.4%) more often had atrial fibrillation as DOAC indication versus patients with levels within range (39.1%). Age (OR 1.046 [1.025–1.068]) was associated with levels above range, while dabigatran versus apixaban was associated with levels below range (OR 6.060 [1.836–19.996]). Conclusion: Particularly older aged patients with additional comorbidity and co-medication had DOAC levels outside expected ranges. Prospective studies are essential to investigate whether identification of patients with levels outside expected ranges is necessary to reduce the risk of clinically relevant adverse events. |
| first_indexed | 2024-03-13T09:40:52Z |
| format | Article |
| id | doaj.art-c4ae03be940740b2917334958497aeae |
| institution | Directory Open Access Journal |
| issn | 2666-5727 |
| language | English |
| last_indexed | 2024-03-13T09:40:52Z |
| publishDate | 2023-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Thrombosis Update |
| spelling | doaj.art-c4ae03be940740b2917334958497aeae2023-05-25T04:25:24ZengElsevierThrombosis Update2666-57272023-05-0111100139Clinical characteristics of patients with direct oral anticoagulant (DOAC) levels outside expected ranges: A retrospective chart studyDionne C.W. Braeken0Roisin Bavalia1Yvonne M.C. Henskens2Hugo ten Cate3Rutger C.C. Hengeveld4Barbara A. Hutten5Saskia Middeldorp6Michiel Coppens7An K. Stroobants8Maastricht University Medical Center, Thrombosis Expertise Centre, Maastricht, the Netherlands; Corresponding author. MUMC+, TEC, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands.Amsterdam University Medical Center, University of Amsterdam, Department of Vascular Medicine, Amsterdam, the Netherlands; Amsterdam University Medical Center, Amsterdam Cardiovascular Sciences, Pulmonary Hypertension & Thrombosis, Amsterdam, the NetherlandsMaastricht University Medical Center, Department of Clinical Chemistry, Maastricht, the NetherlandsMaastricht University Medical Center, Thrombosis Expertise Centre, Maastricht, the Netherlands; Maastricht University Medical Center, Department of Internal Medicine, Maastricht, the NetherlandsAmsterdam University Medical Center, University of Amsterdam, Department of Clinical Chemistry, Amsterdam, the NetherlandsAmsterdam University Medical Center, University of Amsterdam, Department of Epidemiology and Data Science, Amsterdam Cardiovascular Sciences, Amsterdam, the NetherlandsAmsterdam University Medical Center, University of Amsterdam, Department of Vascular Medicine, Amsterdam, the Netherlands; Radboud University Medical Center, Department of Internal Medicine & Radboud Institute of Health Sciences (RIHS), Nijmegen, the NetherlandsAmsterdam University Medical Center, University of Amsterdam, Department of Vascular Medicine, Amsterdam, the Netherlands; Amsterdam University Medical Center, Amsterdam Cardiovascular Sciences, Pulmonary Hypertension & Thrombosis, Amsterdam, the NetherlandsRadboud University Medical Center, Department of Clinical Chemistry, Nijmegen, the NetherlandsBackground: Routine monitoring direct oral anticoagulants (DOAC) is not recommended, yet DOAC levels are frequently measured in clinical practice. Interpretation of levels, especially those outside expected ranges, is challenging. Until now it's unclear which patients are at risk for these levels. Aim: Identify clinical characteristics of patients with DOAC levels outside expected ranges. Methods: Patients of 2 Dutch academic medical centers with a DOAC concentration measured between 2012 and 2019 were included. DOAC levels above upper limit peak and below lower limit trough ranges, based on DOAC registration trials, were assigned outside expected range. Differences between patients were evaluated using Chi-square, independent sample-T tests and multivariable logistic regression analysis. Results: Of 597 patients with DOAC measurement, 108 (18.1%) had levels outside expected ranges. Compared to patients with levels within range, patients with levels above range (n = 64) were older (71.1 vs. 60.6 years), more often had creatinine clearance <50 ml/min (32.8% vs. 13.9%). and used more often interacting (17.2% vs. 6.7%) and/or antiplatelet co-medication (25.0% vs. 13.1%). Patients with levels above (62.5%) and below range (61.4%) more often had atrial fibrillation as DOAC indication versus patients with levels within range (39.1%). Age (OR 1.046 [1.025–1.068]) was associated with levels above range, while dabigatran versus apixaban was associated with levels below range (OR 6.060 [1.836–19.996]). Conclusion: Particularly older aged patients with additional comorbidity and co-medication had DOAC levels outside expected ranges. Prospective studies are essential to investigate whether identification of patients with levels outside expected ranges is necessary to reduce the risk of clinically relevant adverse events.http://www.sciencedirect.com/science/article/pii/S266657272300010XFactor Xa inhibitorsThrombin inhibitorsAnti-Xa levelAnti-IIa levelDOAC concentrationsLevels outside expected range |
| spellingShingle | Dionne C.W. Braeken Roisin Bavalia Yvonne M.C. Henskens Hugo ten Cate Rutger C.C. Hengeveld Barbara A. Hutten Saskia Middeldorp Michiel Coppens An K. Stroobants Clinical characteristics of patients with direct oral anticoagulant (DOAC) levels outside expected ranges: A retrospective chart study Thrombosis Update Factor Xa inhibitors Thrombin inhibitors Anti-Xa level Anti-IIa level DOAC concentrations Levels outside expected range |
| title | Clinical characteristics of patients with direct oral anticoagulant (DOAC) levels outside expected ranges: A retrospective chart study |
| title_full | Clinical characteristics of patients with direct oral anticoagulant (DOAC) levels outside expected ranges: A retrospective chart study |
| title_fullStr | Clinical characteristics of patients with direct oral anticoagulant (DOAC) levels outside expected ranges: A retrospective chart study |
| title_full_unstemmed | Clinical characteristics of patients with direct oral anticoagulant (DOAC) levels outside expected ranges: A retrospective chart study |
| title_short | Clinical characteristics of patients with direct oral anticoagulant (DOAC) levels outside expected ranges: A retrospective chart study |
| title_sort | clinical characteristics of patients with direct oral anticoagulant doac levels outside expected ranges a retrospective chart study |
| topic | Factor Xa inhibitors Thrombin inhibitors Anti-Xa level Anti-IIa level DOAC concentrations Levels outside expected range |
| url | http://www.sciencedirect.com/science/article/pii/S266657272300010X |
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