TherapyTherapyТерапия2412-40362713-1823Bionika Media28821810.18565/therapy.2021.4.101-113ArticlesСтатьиResearch ArticleDirect oral anticoagulants - a new standard in the treatment of diseases associated with thrombosisПрямые оральные антикоагулянты - новый стандарт лечения тромбоз-ассоциированных состоянийBoevaOlga I.БоеваОльга Игоревна

MD, PhD, DMSci., associate professor, professor of the Department of therapy, cardiology and functional diagnostics with the course of nephrology

д.м.н., доцент, профессор кафедры терапии, кардиологии и функциональной диагностики с курсом нефрологии

box0271@mail.ruKokorinValentin A.КокоринВалентин Александрович

MD, PhD, DMSci., associate professor, professor of the Department of hospital therapy named after acad. P.E. Lukomsky

д.м.н., доцент, профессор кафедры госпитальной терапии им. акад. П.Е. Лукомского лечебного факультета

valentinkokorin@yahoo.comCentral State Medical Academy of Department of Presidential AffairsФГБУ ДПО «Центральная государственная медицинская академия» Управления делами Президента РФN.I. Pirogov Russian National Research Medical University of the Ministry of Healthcare of RussiaФГАОУ ВО «Российский национальный исследовательский медицинский университет имени Н.И. Пирогова» Минздрава России1504202174VOL 7, NO4 (2021)ТОМ 7, №4 (2021)10111326022023Copyright ©; 2021, Bionika MediaCopyright ©; 2021, ООО «Бионика Медиа»2021Bionika MediaООО «Бионика Медиа»https://journals.eco-vector.com/2412-4036/article/view/288218

In the present review, the focus of the attention is on the chronicle of the anticoagulation therapy for the treatment and prevention of thrombosis and thromboembolism; innovations associated with the widespread introduction of direct oral anticoagulants into practice are highlighted.

В представленной обзорной работе в фокусе анализа - хроника применения антикоагулянтов для лечения и профилактики тромбозов и тромбоэмболий с акцентом на инновации, связанные с широким внедрением в практику прямых оральных антикоагулянтов.

thrombosisembolismtreatmentpreventiondirect oral anticoagulantsтромбозэмболиялечениепрофилактикапрямые оральные антикоагулянтыISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to the global disease burden. J Thromb Haemost. 2014; 12(10): 1580-90. doi: 10.1111/jth.12698.Virchow R., Faserstoff U. Thrombose u. Embolie. Gefabwand u. sept. Infekt. Gesamm. Abhandl. z. wiss. Med. 1856 (enthält zugl. mit Zusätzen die vorgenannten Arbeiten 1-8).Wendelboe AM, Raskob GE. Global Burden of Thrombosis: Epidemiologic Aspects. Circ Res. 2016; 118(9): 1340-47.Anderson F.A., Spencer F.A. Risk factors for venous thromboembolism. Circulation. 2003; 107(23 Suppl 1): 19-16. doi: 10.1161/01. CIR.0000078469.07362.E6.Bonderman D., Wilkens H., Wakounig S. et al. Risk factors for chronic thromboembolic pulmonary hypertension. Eur Respir J. 2009; 33(2): 325-31. doi: 10.1183/09031936.00087608.Fanikos J., Piazza G., Zayaruzny M., Goldhaber S.Z. Long-term complications of medical patients with hospital-acquired venous thromboembolism. Thromb Haemost. 2009; 102(4): 688-93. doi: 10.1160/TH09-04-0266.Jha A.K., Larizgoitia I., Audera-Lopez C. et al. The global burden of unsafe medical care: analytic modeling of observational studies. BMJ Qual Saf. 2013; 22(10): 809-15. doi: 10.1136/bmjqs-2012-001748.Saving Lives of Cancer Patients by Addressing Cancer-Associated Thrombosis. Available at: https://etha.eu/news-and-events/saving-lives-of-cancer-patients-by-addressing-cancer-associated-thrombosis (date of access - 02.04.2021).Spencer F.A., Gore J.M., Lessard D. et al. Patient outcomes after deep vein thrombosis and pulmonary embolism: the Worcester Venous Thromboembolism Study. Arch Intern Med. 2008; 168(4): 425-33. doi: 10.1001/archinternmed.2007.69.Heit J.A., Silverstein M.D., Mohr D.N. et al. Predictors of survival after deep vein thrombosis and pulmonary embolism: a population-based, cohort study. Arch Intern Med. 1999; 159(5): 445-53. doi: 10.1001/archinte.159.5.445.Konstantinides S.V., Meyer G., Becattini C. et al. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). The Task Force for the diagnosis and management of acute pulmonary embolism of the European Society of Cardiology (ESC). Eur Heart J. 2020; 41(4): 543-603. doi: 10.1093/eurheartj/ehz405.Dean S.M., Abraham W. Venous thromboembolic disease in congestive heart failure. Congest Heart Fail. 2010; 16(4): 164-69. doi: 10.1111/j.1751-7133.2010.00148.x.Verso M., Agnelli G., Ageno W. et al. Long-term death and recurrence in patients with acute venous thromboembolism: the MASTER registry. Thromb Res. 2012; 130(3): 369-73. doi: 10.1016/j.thromres.2012.04.003.Agnelli G., Buller H.R., Cohen A. et.al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013; 369(9):799-808. doi: 10.1056/NEJMoa1302507.Petersen P., Boysen G., Godtfredsen J. et al. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Lancet. 1989; 1(8631): 175-79. doi: 10.1016/s0140-6736(89)91200-2.Ezebowitz M.D., James K.E. Stroke prevention in atrial fibrillation II study. Lancet. 1994; 343(8911): 1508-09. doi: 10.1016/s0140-6736(94)92620-4.Segal J.B., McNamara R.L., Miller M.R. et al. Prevention of thromboembolism in atrial fibrillation. A meta-analysis of trials of anticoagulants and antiplatelet drugs. J Gen Intern Med. 2000; 15(1): 56-67. doi: 10.1046/j.1525-1497.2000.04329.x.Boos C.J., Lip G.Y.H. Ximelagatran: an eulogy. Thromb Res. 2006; 118(3): 301-04. doi: 10.1016/j.thromres.2006.02.012.Connolly S.J., Ezekowitz M.D., Yusuf S. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009; 361(12):1139-51. doi: 10.1056/NEJMoa0905561.Boehringer Ingelheim Pharmaceuticals Inc. Pradaxa® (dabigatran etexilate) Prescribing Information. 2018. Available at: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing%20Information/PIs/111Pradaxa/Pradaxa.pdf (date of access - 28.03.2018).Patel M.R., Mahaffey K.W., Garg J. et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011; 365(10):883-91. doi: 10.1056/NEJMoa1009638.Bayer A.G. Xarelto® (rivaroxaban) summary of product characteristics. 2018. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108.pdf (date of access - 21.05.2018).Granger C.B., Alexander J.H., McMurray J.J. et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011; 365(11): 981-92. doi: 10.1056/NEJMoa1107039.Connolly S.J., Eikelboom J., Joyner C. et al. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011; 364(9): 806-17. doi: 10.1056/NEJMoa1007432.Bristol-Myers Squibb, Pfizer. Eliquis® (apixaban) Summary of product characteristics. 2017. Available at: http://www.ema.europa. eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002148/WC500107728.pdf (date of access - 24.04.2018).You J.J., Singer D.E., Howard P.A. et al. Antithrombotic therapy for atrial fibrillation: Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012; 141(2 Suppl): e531S-75S. doi: 10.1378/chest.11-2304.Camm A.J., Lip G.Y.H., De Caterina R. et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012; 33(21): 2719-47. doi: 10.1093/eurheartj/ehs253.Giugliano R.P., Ruff C.T., Braunwald E. et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013; 369(22):2093-104. doi: 10.1056/NEJMoa1310907.Daiichi Sankyo Europe Gmb H. Lixiana® (edoxaban) summary of product characteristics. 2017. Available at: http://www.ema.europa. eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002629/WC500189045.pdf (date of access - 24.04.2018).Kirchhof P., Benussi S., Kotecha D. et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016; 37(38): 2893-962. doi: 10.1093/eurheartj/ehw210.Murray G.D., Best C.H. The use of heparin in thrombosis. Ann Surg. 1938; 108(2): 163-77. doi: 10.1097/00000658-193808000-00002.Galanaud J.P., Laroche J.P., Righini M. The history and historical treatments of deep vein thrombosis. J Thromb Haemost. 2013; 11(3): 402-11. doi: 10.1111/jth.12127.Hyers T.M. Management of venous thromboembolism: past, present, and future. Arch Intern Med. 2003; 163(7): 759-68. doi: 10.1001/archinte.163.7.759.Yeh C.H., Fredenburgh J.C., Weitz J.I. Oral direct factor Xa inhibitors. Circ Res. 2012; 111(8): 1069-78. doi: 10.1161/CIRCRESAHA.112.276741.GlaxoSmithKline. Arixtra (Fondaparinux sodium) Prescribing information. 2009. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021345s019lbl.pdf (date of access - 29.06.2018).Kearon C., Kahn S.R., Agnelli G. et al. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians evidence-based clinical practice guidelines (8th Edition). Chest. 2008; 133 (6 Suppl): 454S-545S. doi: 10.1378/chest.08-0658.EINSTEIN Investigators, Bauersachs R., Berkowitz S.D., Brenner B. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010; 363(26): 2499-510. doi: 10.1056/NEJMoa1007903.Bayer A.G. Xarelto® (rivaroxaban) summary of product characteristics. 2018. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108.pdf (date of access - 21.05.2018).Kearon C., Akl E.A., Comerota A.J. et al. Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012; 141(2 Suppl): e419S-e496S. doi: 10.1378/chest.11-2301.Schulman S., Kearon C., Kakkar A.K. et al. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013; 368(8): 709-18. doi: 10.1056/NEJMoa1113697.Boehringer Ingelheim International Gmb H. Pradaxa® (dabigatran etexilate) Summary of product characteristics. 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000829/WC500041059.pdf (date of access - 24.04.2018).Schulman S., Kakkar A.K., Goldhaber S.Z. et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014; 129(7): 764-72. doi: 10.1161/CIRCULATI0NAHA.113.004450.Bristol-Myers Squibb, Pfizer. Eliquis® (apixaban) Summary of product characteristics. 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/hu man/002148/WC500107728.pdf (date of access - 24.04.2018).The Hokusai-VTE Investigators, Buller H.R., Decousus H., Grosso M.A. et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013; 369(15): 1406-15. doi: 10.1056/NEJMoa1306638.Daiichi Sankyo Europe Gmb H. Lixiana® (edoxaban) Summary of Product Characteristics. 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002629/WC500189045.pdf (date of access - 24.04.2018).Weitz J.I., Lensing A.W.A, Prins M.H. et al. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Eng J Med. 2017; 376(13): 1211-22. doi: 10.1056/NEJMoa1700518.Kearon C., Akl E.A., Ornelas J. et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest. 2016; 149(2): 315-52. doi: 10.1016/j.chest.2015.11.026.Raskob G.E., van Es N., Verhamme P. et al. Edoxaban for the treatment of cancer-associated venous thromboembolism. N Engl J Med. 2018; 378(7): 615-24. doi: 10.1056/NEJMoa1711948.Young A.M., Marshall A., Thirlwall J. et al. Comparison of an oral factor Xa inhibitor with low molecular weight heparin in patients with cancer with venous thromboembolism: results of a randomized trial (SELECT-D). J Clin Oncol. 2018; 36(20): 2017-23. doi: 10.1200/jco.2018.78.8034.Marshall A., Levine M., Hill C. et al. Treatment of cancer-associated venous thromboembolism: 12-month outcomes of the placebo versus rivaroxaban randomization of the SELECT-D Trial (SELECT-D: 12m). J Thromb Haemost. 2020; 18(4): 905-15. doi: 10.1111/ jth.14752.McBane R.D., Wysokinski W.E., Le-Rademacher J.G. et al. Apixaban and dalteparin in active malignancy-associated venous thromboembolism: The ADAM VTE trial. J Thromb Haemost. 2020; 18(2): 411-21. doi: 10.1111/jth.14662.Anderson F.A., Spencer F.A. Risk factors for venous thromboembolism. Circulation. 2003; 107(23 Suppl 1): I9-16. doi: 10.1161/01.CIR.0000078469.07362.E6.Панченко Е.П., Балахонова Т.В., Данилов Н.М. с соавт. Диагностика и лечение тромбоэмболии легочной артерии: клинические рекомендации Евразийской ассоциации кардиологов для практических врачей (2021). Евразийский кардиологический журнал. 2021; 1: 44-77. doi: https://dx.doi.org/10.38109/2225-1685-2021-1-44-77.Banerjee A., Lane D., Torp-Pedersen C., Lip G. Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a ‘real world' atrial fibrillation population: A modelling analysis based on a nationwide cohort study. Thrombosis and haemostasis. 2011; 107(3): 584-89. doi: 10.1160/TH11-11-0784.Paul J.D., Cifu A.S. Management of acute pulmonary embolism. JAMA. 2020; 324(6): 597-98. doi: 10.1001/jama.2020.3905.Rivera-Caravaca J.M., Lip G.Y.H. Apixaban may have lower risk of GI bleeding compared with dabigatran and rivaroxaban in patients with atrial fibrillation. BMJ Evidence-Based Medicine 2017; 22(4): 154-55. doi: 10.1136/Ebmed-2017-110764.Huang W.-Y., Singer D.E., Wu Y.L. et al. Association of intracranial hemorrhage risk with non-vitamin K antagonist oral anticoagulant use vs aspirin use: A systematic review and meta-analysis. JAMA Neurol. 2018; 75(12): 1511-18. doi: 10.1001/jamaneurol.2018.221 5.Lopes R., Heizer G., Aronson R. et al. Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation. N Engl J Med. 2019; 380(16): 1509-24. doi: 10.1056/NEJMoa1817083.Blom J.W., Vanderschoot J.P., Oostindier M.J. et al. Incidence of venous thrombosis in a large cohort of 66,329 cancer patients: results of a record linkage study. J Thromb Haemost. 2006; 4(3): 529-35. doi: 10.1111/j.1538-7836.2006.01804.x.Marks M.A., Engels E.A. Venous thromboembolism and cancer risk among elderly adults in the United States. Cancer Epidemiol Biomarkers Prev. 2014; 23(5): 774-83. doi: 10.1158/1055-9965.Epi-13-1138.Саутина Е.В., Дементьева Г.И., Сошитова Н.П. с соавт. Возможности выявления и клиническое значение базальной гиперкоагуляции у больных с колоректальным раком. Хирург. 2018; 9-10: 35-47.Barsam S.J., Patel R., Arya R. Anticoagulation for prevention and treatment of cancer-related venous thromboembolism. Br J Haematol. 2013. 161(6): 764-77. doi: 10.1111/bjh.12314.Monreal M., Falga C., Valdes M. et al. Fatal pulmonary embolism and fatal bleeding in cancer patients with venous thromboembolism: findings from the RIETE registry. J Thromb Haemost. 2006; 4(9): 1950-56. doi: 10.1111/j.1538-7836.2006.02082.x.Key N.S., Khorana A.A., Kuderer N.M. et al. Venous thromboembolism prophylaxis and treatment in patients with cancer: ASCO clinical practice guideline update. J Clin Oncol. 2020; 38(5): 496-520. doi: 10.1200/jco.19.01461.Kirkilesis G.I., Kakkos S.K., Tsolakis I.A. Editor's choice - a systematic review and meta-analysis of the efficacy and safety of anticoagulation in the treatment of venous thromboembolism in patients with cancer. Eur J Vasc Endovasc Surg. 2019; 57(5): 685-701. doi: 10.1016/j.ejvs.2018.11.004.Lee A.Y., Levine M.N., Baker R.I. et al. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003; 349(2): 146-53. doi: 10.1056/NEJMoa025313.Khorana A.A., McCrae K.R., Milentijevic D. et al. Current practice patterns and patient persistence with anticoagulant treatments for cancer-associated thrombosis. Res Pract Thromb Haemost. 2017; 1(1): 14-22. doi: 10.1002/rth2.12002.Agnelli G., Becattini C., Meyer G. et al. Apixaban for the treatment of venous thromboembolism associated with cancer. N Engl J Med. 2020; 382(17): 1599-607. doi: 10.1056/NEJMoa1915103.Лобастов К.В., Счастливцев И.В. Актуальный статус прямых оральных антикоагулянтов при лечении венозных тромбоэмболических осложнений у онкологических больных. Рациональная фармакотерапия в кардиологии. 2020; 2: 286-295. doi: https://dx.doi.org/10.20996/1819-6446-2020-04-10.Khorana A.A., Noble S., Lee A.Y.Y. et al. Role of direct oral anticoagulants in the treatment of cancer-associated venous thromboembolism: guidance from the SSC of the ISTH. J Thromb Haemost. 2018; 16(9): 1891-94. doi: 10.1111/jth.14219.NCCN.org. Cancer-assotiated venous thrombotic disease. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidlines) 2019. Version 1.2019 - February 2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/vte.pdf (date of access -02.04.2021).Deng Y., Liu W., Liu K. et al. Clinical characteristics of fatal and recovered cases of coronavirus disease 2019 in Wuhan, China: a retrospective study. Chin Med J (Engl). 2020; 133(11): 1261-57. doi: 10.1097/CM9.0000000000000824.Li T., Lu H., Zhang W. Clinical observation and management of COVID-19 patients. Emerg Microb Infect. 2020; 9(1): 687-90. doi: 10.1080/22221751.2020.1741327.Thachil J., Tang N., Gando S. et al. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020; 18(5): 1023-26. doi:10.1111/jth.14810.American Society of Hematology. COVID-19 and coagulopathy: frequently asked questions (Version 7.0; last updated January 29, 2021). Available at: https://www.hematology.org/covid-19/covid-19-and-coagulopathy (date of access - 02.04.2021).Tang N., Li D., Wang X., Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020; 18(4): 844-47. doi: 10.1111/jth.14768.Guan W., Ni Z., Hu Y. et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med. 2020; 382(18): 1708-20. doi: 10.1056/NEJMoa2002032.Wu C., Chen X., Cai Y. et al. Risk factors associated with acute respiratory distress syndrome and death in patients with coronavirus disease 2019 pneumonia in Wuhan, China. JAMA Intern Med. 2020; 180(7): 934. doi: 10.1001/jamainternmed.2020.0994.Kunutsor S.K., Laukkanen J.A. Incidence of venous and arterial thromboembolic complications in COVID-19: A systematic review and meta-analysis. Thromb Res. 2020; 196: 27-30. doi: 10.1016/j.thromres.2020.08.022.Yale School of Medicine. COVID-19 treatment algorithm. Updated 10/27/20. Available at: https://medicine.yale.edu/intmed/COVID-19%20TREATMENT%20ADULT%20Algorithm%203.8.2021%20v.23a_401118_5_v6.pdf (date of access - 02.04.2021).Временные методические рекомендации Министерства здравоохранения РФ по профилактике, диагностике и лечению новой коронавирусной инфекции (COVID-19). Версия 9 от 26.10.2020. Доступ: https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/052/548/original/MP_COVID-19_%28v.9%29.pdf (дата обращения - 02.04.2021)Mount Sinai Hospital COVID-19 Anticoagulation Protocol. Available at: https://www.mountsinai.org/files/MSHealth/Assets/HS/About/Coronavirus/COVID-19-Anticoagulation-Algorithm.pdf (date of access - 02.04.2021).Testa S., Prandoni P., Paoletti O. et al. Direct oral anticoagulant plasma levels' striking increase in severe COVID-19 respiratory syndrome patients treated with antiviral agents: The Cremona experience. J Thromb Haemost. 2020; 18(6): 1320-23. doi: 10.1111/jth.14871.Bikdeli B., Madhavan M.V., Jimenez D. et al. COVID-19 and thrombotic or thromboembolic disease: implications for prevention, antithrombotic therapy, and follow-up. J Am Coll Cardiol. 2020; 75(23): 2950-73. doi: 10.1016/jjacc.2020.04.031.Detailed recommendations for interactions with experimental COVID-19 antiviral therapies. Updated 24 September 2020. University of Liverpool. Available at: https://www.covid19-druginteractions.org/prescribing-resources (date of access - 02.04.2021).