Advances in Clinical and Experimental Medicine

Title abbreviation: Adv Clin Exp Med
5-Year IF – 2.0, IF – 1.9, JCI (2024) – 0.43
Scopus CiteScore – 4.3
Q1 in SJR 2024, SJR score – 0.598, H-index: 49 (SJR)
ICV – 161.00; MNiSW – 70 pts
Initial editorial assessment and first decision within 24 h

ISSN 1899–5276 (print), ISSN 2451-2680 (online)
Periodicity – monthly

Download original text (EN)

Advances in Clinical and Experimental Medicine

2015, vol. 24, nr 6, November-December, p. 995–1000

doi: 10.17219/acem/42147

Publication type: original article

Language: English

Download citation:

  • BIBTEX (JabRef, Mendeley)
  • RIS (Papers, Reference Manager, RefWorks, Zotero)

Effects of Rivaroxaban Therapy on ROTEM Coagulation Parameters in Patients with Venous Thromboembolism

Krzysztof Chojnowski1,A,C,D,E,F, Tomasz Górski1,A,B,C,D,E,F, Marta Robak1,B,E, Jacek Treliński1,A,B,C,D,E,F

1 Department of Hematology, Medical University of Lodz, Poland

Abstract

Background. Rivaroxaban (Xarelto) does not require routine coagulation monitoring; however, in certain clinical situations (overdose, drug accumulation, urgent surgery) measurement of its plasma concentration is highly recommended. Currently, there is no single hemostasis test that shows a direct correlation between rivaroxaban plasma levels and anticoagulant efficacy.
Objectives. This study was intended to assess the value of ROTEM in determining rivaroxaban administration.
Material and Methods. Thirteen patients with venous thromboembolism and 13 healthy volunteers were compared with regard to certain ROTEM parameters and anti-FXa activity. The tests were done before the administration of 20 mg rivaroxaban (i.e. 24 h after previous administration) and 2.5 h afterwards.
Results. The study group demonstrated residual activity of rivaroxaban in plasma (20 ± 11.3 ng/mL) 24 h following the previous administration, which did not cause marked changes in clotting assays compared to controls. In the group, 2.5 h after rivaroxaban administration, prolongation of PT (PTratio 1.51 ± 0.22), APTT (APPTratio: 1.30 ± 0.14) and ROTEM CT (CTratio – EXTEM: 2.45 ± 1.06, CTratio – INTEM: 1.32 ± 0.21) were observed. The cut-off values for particular tests were created to determine if the patient had achieved desirable anticoagulant effect after rivaroxaban administration. The mean anti-FXa values were significantly lower in patients before rivaroxaban dosing than after.
Conclusion. PT demonstrated better diagnostic value than APTT in rivaroxaban administration. The ROTEM clotting time (CT) according to EXTEM may be used to determine the anticoagulation effect of rivaroxaban, but is not sensitive enough to measure the residual activity of this drug.

Key words

ROTEM, anti-FXa method, PT, APTT

References (18)

  1. Mueck W, Stampfuss J, Kubitza D, Becka M: Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban. Clin Pharmacokinet 2014, 53, 1–16.
  2. Bayer Pharma AG: Xarelto (rivaroxaban) Summary of Product Characteristics; 2013. http://www.ema.europa. eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108.pdf (Accessed 14 March 2015).
  3. Jannsen Pharmaceuticals Inc. Xarelto (rivaroxaban) Prescribing Informaton 2013. http://www.accesdata.fda.gov/ /drugsatda_docs/label/2013/022406s004lbl.pdf (Accessed 14 March 2015).
  4. Samama MM: Which test to use to measure the anticoagulant effect of rivaroxaban: the anti-factor Xa assay. J Thromb Haemost 2013, 11, 579–580.
  5. Lindhoff-Last E, Ansell J, Spiro T, Samama MM: Laboratory testing of rivaroxaban in routine clinical practice: when, how, and which assays. Ann Med 2013, 45, 423–429.
  6. Vanassche T, Vandenbriele C, Peerlinck K, Verhamme P: Pharmacotherapy with oral Xa inhibitors for venous thromboembolism. Expert Opin Pharmacother 2015, 16, 645–658.
  7. Theusinger OM, Nürnberg J, Asmis LM, Seifert B, Spahn DR: Rotation thromboelastometry (ROTEM) stability and reproducibility over time. Eur J Cardiothorac Surg 2010, 37, 677–683.
  8. Müller MC, Meijers JC, Vroom MB, Juffermans NP: Utility of thromboelastography and/or thromboelastometry in adults with sepsis: a systematic review. Crit Care 2014, 18, 30.
  9. Lang T, von Depka M: Possibilities and limitations of thrombelastometry/-graphy. Hamostaseologie 2006, 26, 20–29.
  10. Treliński J, Misiewicz M, Robak M, Smolewski P, Chojnowski K: Assessment of rotation thromboelastometry (ROTEM) parameters in patients with multiple myeloma at diagnosis. Thromb Res 2014, 133, 667–670.
  11. Luddington RJ: Thrombelastography/thromboelastometry. Clin Lab Haematol 2005, 27, 81–90.
  12. Lang T, Bauters A, Braun SL, Pötzsch B, von Pape KW, Kolde HJ, Lakner M: Multi-centre investigation on reference ranges for ROTEM thromboelastometry. Blood Coagul Fibrinolysis 2005, 16, 301–310.
  13. Kozek-Langenecker S: Management of massive operative blood loss. Minerva Anestesiol 2007, 73, 401–415.
  14. Casutt M, Konrad C, Schuepfer G: Effect of rivaroxaban on blood coagulation using the viscoelastic coagulation test ROTEM™. Anaesthesist 2012, 61, 948–953.
  15. Adelmann D, Wiegele M, Wohlgemuth RK, Koch S, Frantal S, Quehenberger P, Scharbert G, Kozek-Langenecker S, Schaden E: Measuring the activity of apixaban and rivaroxaban with rotational thrombelastometry. Thromb Res 2014, 134, 918–923.
  16. Oswald E, Velik-Salchnera C, Innerhofera P, Taubera H, Auckenthalerb T, Ulmerc H, Streifd W: Results of rotational thromboelastometry, coagulation activation markers and thrombin generation assays in orthopedic patients during thromboprophylaxis with rivaroxaban and enoxaparin: a prospective cohort study. Blood Coagul Fibrinolysis 2015, 26, 136–144.
  17. Barrett YC, Wang Z, Frost C, Shenker A: Clinical laboratory measurement of direct factor Xa inhibitors: anti-Xa assay is preferable to prothrombin time assay. Thromb Haemost 2010, 104, 1263–1271.
  18. Lindhoff-Last E, Samama MM, Ortel TL, Weitz JI, Spiro TE: Assays for measuring rivaroxaban: their suitability and limitations. Ther Drug Monit 2010, 32, 673–679.
© Wroclaw Medical University