Background: The efficacy and safety of direct oral anticoagulants (DOACs) in outpatients is closely related to patient’s adherence to therapy. Objective documentation of drug intake may be a useful tool for patients’ education and improvement of adherence to treatment.
Aims: We aim to analyze the accuracy of DOAC Dipstick TM -patient device compared to plasma concentration for evaluation of the presence of DOACs in outpatients’ urine samples treated with DOACs for venous thromboembolism.
Methods: A prospective observational ongoing cohort study is performed including outpatients on treatment with DOACs. All participants are routinely assessed for DOACs’ plasma concentration by specific chromogenic assays and for renal function by Cockroft–Gault equation. The dipstick test is performed from patients’ urine samples and trained staff evaluated colors of factor-Xa (FXA) and thrombin inhibitors (THR) pads visually according the instructions for use.
Results: Interim analysis was performed after enrolment of 72 patients (female n=40, age 56±16 years, mean±SD). standard deviation). 47 received rivaroxaban, 23 apixaban, and 2 dabigatran. All patients had normal renal function. Plasma anti Xa levels were 151.41±114.79 ng/mL (mean, SD) and anti-IIa levels 191.66±110.34 ng/mL. The color of the FXA pad was judged as positive in 69/70 patients (correct positive for DXI: 98.5%) and of THR pad as negative in all cases treated with DXI (correct negative for DTI: 100%), respectively. The pads of the 2 DTI treated patients were judged correctly as positive (THR pad) and as correctly negative (FXA pad).
Conclusions: The results show a high agreement of therapeutic plasma concentrations of DXI treated patients with presence of DXI and absence of DTI in urine samples by DOAC Dipstick test. Given the encouraging results despite the limited number of patients treated with dabigatran, the ongoing study should allow the device’s validation as an accurate ,easy-to-use assessment tool
To cite this abstract in AMA style:Papageorgiou L, Harenberg J, Auge S, Tredler L, Elalamy I, Gerotziafas G. Results of DOAC Dipstick Test in Outpatients with Venous Thromboembolic Disease Are Comparable to Plasma Levels of Direct Oral Inhibitors – An Efficient Assessment Tool [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 1). https://abstracts.isth.org/abstract/results-of-doac-dipstick-test-in-outpatients-with-venous-thromboembolic-disease-are-comparable-to-plasma-levels-of-direct-oral-inhibitors-an-efficient-assessment-tool/. Accessed September 24, 2021.
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ISTH Congress Abstracts - https://abstracts.isth.org/abstract/results-of-doac-dipstick-test-in-outpatients-with-venous-thromboembolic-disease-are-comparable-to-plasma-levels-of-direct-oral-inhibitors-an-efficient-assessment-tool/