Coagulation Test Interpretation in a Patient Taking Direct Oral Anticoagulant Therapy

Sholzberg, Michelle; Xu, Yan

doi:10.1001/jama.2018.13998

Cited by 5 publications

(4 citation statements)

References 11 publications

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“…Although there is substantial variability in assay sensitivity, similar result was reported by Sholzberg and Xu 22 who presented a clinical case in which the patient presented a PT value of 18.5 seconds and a rivaroxaban level of 167.5ng/mL, a subtherapeutic level.…”

Section: Discussionsupporting

confidence: 78%

Routine Coagulation Tests in Patients With Nonvalvular Atrial Fibrillation Under Dabigatran and Rivaroxaban Therapy: An Affordable and Reliable Strategy?

Silva

Scanavacca

Darrieux

et al. 2019

Clin Appl Thromb Hemost

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Dabigatran and rivaroxaban, direct oral anticoagulants (DOACs), affect coagulation tests, and knowledge of their effects is important for therapeutic monitoring. Our aim was to examine the association between DOAC levels and routine coagulation tests in patients with nonvalvular atrial fibrillation. Samples from patients receiving dabigatran (150 mg) and patients receiving rivaroxaban (20 mg) were collected 2 hours after drug intake. Direct oral anticoagulant concentrations were determined using direct Hemoclot thrombin inhibitor (HTI) assay (HTI test) and a direct Xa inhibitor (Anti Xa-Riva). The routine coagulation measured included activated partial thromboplastin time (aPTT) and prothrombin time (PT). The median plasmatic dabigatran was 128.3 ng/mL (95% confidence interval [CI]: 93.7-222.6 ng/mL). The HTI exhibited a good correlation with aPTT ( R 2 = 0.74; P < .0001). The median plasmatic rivaroxaban was 223.9 ng/mL (95% CI: 212.3-238.9 ng/mL). Anti-Xa-Riva correlated with PT ( R 2 = 0.69, P < .0001) and aPTT (R 2 = 0.36, P < .001), but prolonged PT results were obtained, even below the rivaroxaban therapeutic range (20%). The routine coagulation tests were able to identify out of therapeutic range concentrations for dabigatran and rivaroxaban. We suggest the use of these screening tests to better understand and monitor the subtherapeutic concentrations of these DOACs.

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Section: Discussionsupporting

confidence: 78%

Routine Coagulation Tests in Patients With Nonvalvular Atrial Fibrillation Under Dabigatran and Rivaroxaban Therapy: An Affordable and Reliable Strategy?

Silva

Scanavacca

Darrieux

et al. 2019

Clin Appl Thromb Hemost

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“…Due to their direct anti‐activated factor II (FIIa) or anti‐Xa activity, DOACs interfere with most clot‐based haemostasis tests (Gosselin et al , ), although not in a consistent manner. The knowledge of the impact that DOACs have on coagulation testing is vital to avoid misinterpretation of laboratory test results that may result in mismanagement, and every effort should be made to educate clinicians on this important area that directly impacts on patient care (Gosselin et al , ; Sholzberg & Xu, ). Assessment of drug exposure without knowing the exact DOAC concentration can be useful in determining the course of clinical management in certain scenarios.…”

Section: What Monitoring Is Possible?mentioning

confidence: 99%

Progress in the monitoring of direct oral anticoagulant therapy

et al. 2019

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Summary The availability of direct oral anticoagulants (DOACs) has led to a paradigm shift in the field of anticoagulation, with DOACs increasingly being prescribed for patients in preference to vitamin K antagonists and low molecular weight heparin. Despite good experience with the use of these agents at fixed doses, there are clinical scenarios where monitoring is recommended. Data from phase III studies of the DOACs and small real‐world studies suggest a relationship between DOAC concentration and clinical events. The DOACs have differing impacts on the common tests of haemostasis and it is important that clinicians are familiar with the sensitivity of the reagents used in their laboratory to individual DOACs. The specific DOAC drug concentrations can be assayed in the laboratory, when required, to guide appropriate clinical decision‐making. Studies from the real world with sufficient numbers evaluating the association of DOAC concentrations with outcomes should be a research priority in order to understand if we could do better through dose individualisation.

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“…Our findings are in line with the general understanding that PT and aPTT are not indicators to predict the therapeutic or supratherapeutic effects of rivaroxaban. 18 Therefore, rivaroxaban therapy cannot be adjusted based on aPTT/PT results alone. In contrast, abrupt interruption of anticoagulation therapy carries a great risk of recurrent thromboembolic events and even leads to a fatal outcome.…”

Section: Discussionmentioning

confidence: 99%

“…[7][8][9][10][11][12][13][14][15] Nevertheless, a prolonged PT and/or aPTT in a patient with known DOACs exposure should be expected and is likely to be drug related. [16][17][18] In the past, studies have explored the influence of DOACs on routine coagulation assays, or the relationship between drug concentration and coagulation test results. 19,20 However, little is known about the clinical characteristics of patients with prolonged PT and/or aPTT while receiving the standard pharmacotherapy of DOACs such as rivaroxaban.…”

Section: Introductionmentioning

confidence: 99%

Activated Partial Thromboplastin Time or Prothrombin Time Prolongation During Rivaroxaban Administration: Clinical Risk Factors and Outcomes Analysis

Yao

Qiu

2023

Clin Appl Thromb Hemost

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Activated partial thromboplastin time (aPTT) or prothrombin time (PT) is often detected after rivaroxaban administration, and it is known that aPTT or PT can be prolonged or normal. However, the clinical risk factors and outcomes of prolongation were unknown. In a single-center, retrospective case-control study, adult inpatients who had aPTT/PT tested before and after administration of rivaroxaban during a designated 12-month period were eligible for inclusion. Depending on whether their aPTT/PT was prolonged, patients were allocated to the prolonged case or normal control group. Demographics, rivaroxaban indications and daily dose, and laboratory values were compared. Multivariate logistic regression was used to identify independent risk factors. The changes in laboratory values and clinical outcomes were analyzed. A total of 155 patients were included in the study among which 54 (34.84%) were reported to have either or both aPTT/PT prolonged. The average prolongation time of PT was between 0.8 and 0.9 s, and 1.8 and 3.5 s for aPTT. Multivariable regression modeling showed that height (odds ratio [OR] 1.12, 95% confidence interval [CI] 1.02-1.22, P = .02) and human albumin replacement (OR 3.19, 95% CI 1.05-9.74, P = .04) were independent risk factors for aPTT/PT prolongation. The incidence of bleeding events and changes in laboratory values were similar between the groups. Patient height and receiving human albumin replacement were independent risk factors for aPTT/PT mild prolongation caused by rivaroxaban. The prolongation was not associated with an increased occurrence of bleeding events.

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Coagulation Test Interpretation in a Patient Taking Direct Oral Anticoagulant Therapy

Cited by 5 publications

References 11 publications

Routine Coagulation Tests in Patients With Nonvalvular Atrial Fibrillation Under Dabigatran and Rivaroxaban Therapy: An Affordable and Reliable Strategy?

Routine Coagulation Tests in Patients With Nonvalvular Atrial Fibrillation Under Dabigatran and Rivaroxaban Therapy: An Affordable and Reliable Strategy?

Progress in the monitoring of direct oral anticoagulant therapy

Activated Partial Thromboplastin Time or Prothrombin Time Prolongation During Rivaroxaban Administration: Clinical Risk Factors and Outcomes Analysis

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