Laboratory assessment of the compliance to direct oral anticoagulants: 615.273.53:616-08-07

Abstract

Summary. Background. For prolonged prophylaxis of thrombosis after surgery, of atrial fibrillation, therapy of deep vein thrombosis and/or pulmonary embolism, direct oral anticoagulants (DOACs) are widely used. It is believed that DOACs lack the deficiencies inherent in antagonists of vitamin K (AVK), have predictable pharmacokinetic and pharmacodynamic effects, and therefore do not require routine laboratory monitoring to adjust and select the dose of the drug. We pay special attention to the issue of adherence to DOACs therapy. Objectives: to assess compliance to therapy with direct oral factor Xa inhibitors by determining plasma DOACs concentration. Patients/Methods. A prospective clinical and laboratory study was performed, 50 patients with prolonged anti- thrombotic therapy by DOACs were included. To assess compliance to therapy, the peak concentration of direct factor Xa inhibitors was determined by the chromogenic method. Results. In real clinical practice up to 10% of patients did not take the prescribed antithrombotic therapy and hid this fact from the doctor. Thus, by determining the concentration of direct factor Xa inhibitors by the chromogenic method, it is possible to identify a lack of compliance to therapy. Conclusions. Determination of plasma DOACs concentration allows assessing the patient’s adherence to anticoagulant therapy with direct factor Xa inhibitors and the efficacy and safety of prolonged antithrombotic therapy.

References:

1. Passport of the national project “Healthcare” (approved by the Presidium of the Council under the President of Russian Fede‐ ration for Strategic Development and National Projects, protocol from 24.12.2018 N 16). Konsul’tant Plyus. 55 рр. (In Russ.). Available at: http://www.consultant.ru/document/cons_doc_LAW_319209. 

2. Medical and demographic indicators of the Russian Federation in 2018. 2019: Statistical data book. Moscow: Ministry of Health of Russia, 2019. 253 pp. (In Russ.). 

3. LaberkoL.A.The optimal duration of anticoagu‐ lant therapy: balancing between risks. Hirurg. 2017;(9–12):33–46. (In Russ.). 

4. Bogachev V. Yu. Warfarin. Death is delayed. RMZh. 2013;21(15):797– 803. (In Russ.).
5. Dale B.J., Chan N.C., Eikelboom J.W. Laboratory measurement of the direct oral anticoagulants. Br J Haematol. 2016;172(3):315–36. DOI: 10.1111/bjh.13810. 

6. Douxfils J., Gosselin R.C. Laboratory assessment of direct oral anti‐ Thromb Haemost. 2017;43(3):277–90. DOI: 10.1055/ s‐0036–1597296. 

7. Voskresenskaya T.V., Azizova A.G., Zubritskaya S.A. et al. Experi‐ ence in the use of oral anticoagulants in outpatient clinics. Medi- cinskij sovet. 2017;(12):134–7. DOI: 10.21518/2079–701X‐2017–12– 134–137. (In Russ.). 

8. Heidbuchel H., Verhamme P., Alings M. et al. European Heart Rhythm Association Practical Guide on the use of new oral anti‐ coagulants in patients with non‐valvular atrial fibrillation. Euro- pace. 2013;15(5):625–51. DOI: 10.1093/europace/eut083. 

9. Zabolotskih I.B., Kirov M. Yu., Bozhkova S.A. et al. Perioperative management of patients receiving longterm antithrombotic the‐ Clinical guidelines. Regionarnaya anesteziya i lechenie ostroj boli. 2014;8(4):50–66. (In Russ.).
10. ZabolotskikhI.B., Kirov M.Yu., AfonchikovV.S. et al. Periopera‐ tive management of patients receiving long‐term antithrombotic therapy. Russian Federation of anesthesiologists and reanimatol‐ ogists guidelines. Vestnik intensivnoj terapii imeni A.I. Saltanova. 2019;(1):7–19.DOI: 10.21320/1818–474X‐2019–1–7–19
11. Steffel J., Verhamme P., Potpara T.S. et al. The 2018 European Heart Rhythm Association Practical Guide on the use of non‐vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018;39(16):1330–93. DOI: 10.1093/eurheartj/ehy136.
12. 
Mamaev A.N., Kudlay D.A. Statistical methods in medicine. Mos- cow: Prakticheskaya medicina, 2021. 136 pp.
13. SkirdenkoJ.P., NikolaevN.A.New approaches to individualized choice of oral anticoagulants in patients with atrial fibrillation. Racional’naya farmakoterapiya v kardiologii. 2018;14(1):58–64. DOI: 10.20996/1819–6446–2018–14–1–58–64. (In Russ.).
14. Gosselin R.C., Adcock D.M., Bates S.M. et al. Recommendations for laboratory measurement of direct oral anticoagulants. Thromb Haemost. 2018;118(3):437–50. DOI: 10.1055/s‐0038–1627480.
15. Melkumyan A.L., Berkovsky A.L., Kishinets R.S., Kozlov A.A. Moni‐ toring the effeciency of direct anticoagulants. Gematologiya i trans- fuziologiya. 2013;58(1):32–8. (In Russ.).