Прямые оральные антикоагулянты при антифосфолипидном синдроме
Аннотация
Антифосфолипидный синдром — приобретенная аутоиммунная тромбофилия, характеризующаяся развитием рецидивирующих тромбозов сосудов любого калибра и типа или акушерской патологией и обязательным выявлением стойко позитивных антифосфолипидных антител. Основным препаратам в курации больных с антифосфолипидным синдромом является варфарин. Роль прямых оральных антикоагулянтов в терапии антифосфолипидного синдрома остается противоречивой. В статье рассмотрены современные данные о месте прямых оральных антикоагулянтов в лечении антифосфолипидного синдрома.
Об авторах
Т. М. Решетняк
ФГБНУ Научно-исследовательский институт ревматологии им. В.А. Насоновой; ФГБОУ ДПО Российская медицинская академия непрерывного профессионального образования Минздрава России
Россия
Конфликт интересов: нет
Россия
Решетняк Татьяна Магомедалиевна – доктор медицинских наук, профессор, заведующая лабораторией сосудистой ревматологии.
115522, Москва, Каширское шоссе, 34А; 125993, Москва, ул. Баррикадная, 2/1, стр. 1
Конфликт интересов: нет
К. С. Нурбаева
ФГБНУ Научно-исследовательский институт ревматологии им. В.А. Насоновой
Россия
Конфликт интересов: нет
Россия
Нурбаева Камила Сериковна - ординатор 2 года.
115522, Москва, Каширское шоссе, 34А
Конфликт интересов: нет
Список литературы
1. Насонов ЕЛ. Антифосфолипидный синдром. М.: Изд-во «Литтера»; 2004:454.
2. Решетняк ТМ. Антифосфолипидный синдром: диагностика и клинические проявления (лекция). Научно-практическая ревматология. 2014;52(1):56-71. DOI: 10.14412/1995-4484-2014-56-71
3. Garcia D, Erkan D. Diagnosis and management of the antiphospholipid syndrome. N Engl J Med. 2018;378(21):2010-2021. DOI: 10.1056/NEJMra1705454
4. Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006;4(2):295-306. DOI: 10.1111/j.1538-7836.2006.01753.x
5. Pengo V, Ruffatti A, Legnani C, et al. Clinical course of high risk patients diagnosed with antiphospholipid syndrome. J Thromb Haemost. 2010;8(2):237-242. DOI: 10.1111/j.1538-7836.2009.03674.x
6. Volkov I, Seguro L, Leon EP, et al. Profiles of criteria and noncriteria anti-phospholipid autoantibodies are associated with clinical phenotypes of the antiphospholipid syndrome. Auto Immun Highlights. 2020;11(1):8. DOI: 10.1186/s13317-020-00131-3
7. Tektonidou MG., Andreoli L, Limper M, et al. EULAR recommendations for the management of antiphospholipid syndrome in adults. Ann Rheum Dis. 2019;78(10):1296-1304. DOI: 10.1136/annrheumdis-2019-215213
8. Kearon C, Parpia S, Spencer FA, et al. Antiphospholipid antibodies and recurrent thrombosis after a first unprovoked venous thromboembolism. Blood. 2018;131(19):2151-2160. DOI: 10.1182/blood-2017-09-805689
9. Taraborelli M, Reggia R, Dall’Ara F, et al. Long-term outcome of patients with primary antiphospholipid syndrome: A retrospective multicenter study. J Rheumatol. 2017;44(8):1165-1172. DOI: 10.3899/jrheum.161364
10. Tincani A, Andreoli L, Casu C, Cattaneo R, Meroni P. Antiphospholipid antibody profile: implications for the evaluation and management of patients. Lupus. 2010;19(4):432-435. DOI: 10.1177/0961203310361491
11. Pengo V, Ruffatti A, Legnani C, et al. Incidence of a first thromboembolic event in asymptomatic carriers of high-risk antiphospholipid antibody profile: A multicenter prospective study. Blood. 2011;118(17):4714-4718. DOI: 10.1182/blood-2011-03-340232
12. Asherson RA. New subsets of the antiphospholipid syndrome in 2006: “PRE-APS” (probable APS) and microangiopathic antiphospholipid syndromes (“MAPS”). Autoimmun Rev. 2006;6(2):76-80. DOI: 10.1016/j.autrev.2006.06.008
13. Jackson WG, Oromendia C, Unlu O, et al. Antiphospholipid syndrome alliance for clinical trials and international networking. Recurrent thrombosis in patients with antiphospholipid antibodies and arterial thrombosis on antithrombotic therapy. Blood Adv. 2017;1(25):2320-2324. DOI: 10.1182/bloodadvances.2017008185
14. Cervera R, Serrano R, Pons-Estel GJ, et al. Morbidity and mortality in the antiphospholipid syndrome during a 10-year period: A multicentre prospective study of 1000 patients. Ann Rheum Dis. 2015;74(6):1011-1018. DOI: 10.1136/annrheumdis-2013-204838
15. Кондратьева ЛВ, Решетняк ТМ. Профилактика тромбозов при антифосфолипидном синдроме. Современная ревматология. 2009;3(3):18-22. DOI: 10.14412/1996-7012-2009-552
16. Martinelli I, Abbattista M, Bucciarelli P, et al Recurrent thrombosis in patients with antiphospholipid antibodies treated with vitamin K antagonists or rivaroxaban. Haematologica. 2018;103(7):e315-e317. DOI: 10.3324/haematol.2017.185132
17. Сатыбалдыева МА, Решетняк ТМ. Новые оральные антикоагулянты в терапии антифосфолипидного синдрома. Научно-практическая ревматология. 2016;54(2):219-226. doi: 10.14412/1995-4484-2016-219-226
18. Hlavacek P, Guo JD, Rosenblatt L, et al. Safety, effectiveness, and health care cost comparisons among elderly patients with venous thromboembolism prescribed warfarin or apixaban in the United States Medicare population. Curr Med Res Opin. 2019;35(12):2043-2051. DOI: 10.1080/03007995.2019.1653067
19. Chen A, Stecker E, Warden BA. Direct oral anticoagulant use: A practical guide to common clinical challenges. J Am Heart Assoc. 2020;9(13):e017559. DOI: 10.1161/JAHA.120.017559
20. Ageno W, Gallus AS, Wittkowsky A, et al. Oral anticoagulant therapy: Antithrombotic therapy and prevention of thrombosis. 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e44S-e88S. DOI: 10.1378/chest.11-2292
21. Almarshad F, Alaklabi A, Bakhsh E, Pathan A, Imegren M. Use of direct oral anticoagulants in daily practice. Am J Blood Res. 2018;8(4):57-72. DOI: 10.1097/MBC.0000000000000247
22. Undas A, Goialczyk T. Direct oral anticoagulants in patients with thrombophilia: Challenges in diagnostic evaluation and treatment. Adv Clin Exp Med. 2016;25(6):1321-1330. DOI: 10.17219/acem/65853
23. Cohen H, Hunt BJ, Efthymiou M, et al. RAPS trial investigators. Rivaroxaban versus warfarin to treat patients with thrombotic antiphospholipid syndrome, with or without systemic lupus erythematosus (RAPS): A randomised, controlled, open-label, phase 2/3, non-inferiority trial. Lancet Haematol. 2016;3(9):e426-e436. DOI: 10.1016/S2352-3026(16)30079-5
24. Alberio L. The new direct oral anticoagulants in special indications. Rationale and preliminary data in cancer, mechanical heart valves, APS, HIT, and beyond. Semin Hematol. 2014;51(2):152-156. DOI: 10.1053/j.seminhematol.2014.03.002
25. Arachchillage DR, Mackie IJ, Efthymiou M, et al. Rivaroxaban limits complement activation compared with warfarin in antiphospholipid syndrome patients with venous thromboembolism. J Thromb Haemost. 2016;14(11):2177-2186. DOI: 10.1111/jth.13475
26. Balbi GGM, Pacheco MS, Monticielo OA, et al. Antiphospholipid Syndrome Committee of the Brazilian Society of Rheumatology position statement on the use of direct oral anticoagulants (DOACs) in antiphospholipid syndrome (APS). Adv Rheumatol. 2020;60(1):29-43. DOI: 10.1186/s42358-020-00125-9
27. Vazquez SR. Drug-drug interactions in an era of multiple anticoagulants: A focus on clinically relevant drug interactions. Blood. 2018;132(21):2230-2239. DOI: 10.1182/blood-2018-06-848747
28. Ordi-Ros J, Saerz-Comet L, Perez-Conesa M, et al. Rivaroxaban versus vitamin K antagonist in antiphospholipid syndrome: A randomized noninferiority trial. Ann Intern Med. 2019;171(10):685-694. DOI: 10.7326/M19-0291
29. Sciascia S, Breen K, Hunt BJ. Rivaroxaban use in patients with antiphospholipid syndrome and previous venous thromboembolism. Blood Coagul Fibrinolysis. 2015;26(4):476-477. DOI: 10.1097/MBC.0000000000000247
30. Resseguier AS, Pereira B, Rieu V, et al. Direct oral anticoagulants: An alternative treatment for thrombotic antiphospholipid syndrome. Lupus. 2017;26(12):1297-1303. DOI: 10.1177/0961203317701841
31. Betancur JF, Bonilla AF, Hormaza AA, et al. Direct oral anticoagulants in antiphospholipid syndrome: A real-life case series. Lupus. 2016;25(6):658-652. DOI: 10.1177/0961203315624555
32. Hatadyj E, Olesinska M. Rivaroxaban - a safe therapeutic option in patients with antiphospholipid syndrome? Our experience in 23 cases. Reumatologia. 2016;54(3):146-149. DOI: 10.5114/reum.2016.61217
33. Noel N, Dutasta F, Costedoat-Chalumeau N, et al. Safety and efficacy of oral direct inhibitors of thrombin and factor Xa in antiphospholipid syndrome. Autoimmun Rev. 2015;14(8):680-685. DOI: 10.1016/j.autrev.2015.03.007
34. Malec K, Goralczyk T, Undas A. The use of direct oral anticoagulants in 56 patients with antiphospholipid syndrome. Thromb Res. 2017;152:93-97. DOI: 10.1016/j.thromres.2016.12.009
35. Kunk PR, Brown J, McShane M, et al. Direct oral anticoagulants in hypercoagulable states. J Thromb Thrombolysis. 2017;43(1):79-85. DOI: 10.1007/s11239-016-1420-x
36. Signorelli F, Nogueira F, Domingues V, et al. Thrombotic events in patients with antiphospholipid syndrome treated with rivaroxaban: A series of eight cases. Clin Rheumatol. 2016;35(3):801-805. DOI: 10.1007/s10067-015-3030-y
37. Schaefer JK, Mcbane RD, Black DF, et al. Failure of dabigatran and rivaroxaban to prevent thromboembolism in antiphospholipid syndrome: A case series of three patients. Thromb Haemost. 2014;112(5):947-950. DOI: 10.1160/TH14-03-0272
38. Win K, Rodgers GM. New oral anticoagulants may not be effective to prevent venous thromboembolism in patients with antiphospholipid syndrome. Am J Hematol. 2014;89(10):1017. DOI: 10.1002/ajh.23797
39. Pengo V, Denas G, Zoppellaro G, et al. Rivaroxaban vs warfarin in high-risk patient with antiphospholipid syndrome. Blood. 2018;132(13):1365-1371. DOI: 10.1182/blood-2018-04-848333
40. Cortes-Hernandez J, S;iez Comet L, Perez-Conesa M, et al. Rivaroxaban versus warfarin as secondary thromboprophylaxis in patients with antiphospholipid syndrome protocol: a randomized, multicenter, open-label, clinical trial. Ann Intern Med. 2019;171(10):685-694. DOI: 10.7326/M19-0291
41. Schulman S, Kearon C, Kakkar AK, et al. Extended use of dabiga-tran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013;368(8):709-718. DOI: 10.1056/NEJMoa1113697
42. Schulman S, Kakkar AK, Goldhaber SZ, et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014;129(7):764-772. DOI: 10.1161/CIRCULATIONAHA.113.004450
43. Woller SC, Stevens SM, Kaplan DA, Rondina MT. Protocol modification of apixaban for the secondary prevention of thrombosis among patients with antiphospholipid syndrome study (Letter to editor). Clin Appl Thromb Hemost. 2016;22(3):239-247. DOI: 10.1177/1076029615615960
44. ISRCTN10280992. Rivaroxaban for stroke patients with antiphospholipid syndrome. DOI: 10.1186/ISRCTN10280992
45. Dufrost V, Risse J, Reshetnyak T, et al. Increased risk of thrombosis in antiphospholipid syndrome patients treated with direct oral anticoagulants. Results from an international patient-level data meta-analysis. Autoimmun Rev. 2018;17(10):1011-1021. DOI: 10.1016/j.autrev.2018.04.0
46. Sanchez-Redondo J, Espinosa G, Varillas DD, Cervera R. Recurrent thrombosis with direct oral anticoagulants in antiphospholipid syndrome: A systematic literature review and meta-analy-sis. Clin Ther. 2019;41(9):1839-1862. DOI: 10.1016/j.clin-thera.2019.06.015
47. Elsebaie MAT, van Es N, Langston A, Buller HR, Gaddh M. Direct oral anticoagulants in patients with venous thromboembolism and thrombophilia: A systematic review and met analysis. J Thromb. Haemost. 2019;17(4):645-656. DOI: 10.1111/jth.14398
48. Dufrost V, Wahl D, Zuily S. Direct oral anticoagulants in antiphospholipid syndrome: Meta-analysis of randomized controlled trials. Autoimmun Rev. 2020;Nov 13:102711. DOI: 10.1016/j.autrev.2020.102711
49. Cerda P, Becattini C, Iriarte A, et al. Direct oral anticoagulants versus vitamin K antagonists in antiphospholipid syndrome: A meta-analysis. Eur J Intern Med. 2020;79:43-50. DOI: 10.1016/j.ejim.2020.05.012
50. Satybaldyeva MA, Seredavkina NV, Nasonov EL, Lila AM, Reshetnyak TM. Dabigatran for failed warfarin treatment in high-risk patients with antiphospholipid syndrome. ISTH 2019 Final program. 2019; PB 1097. URL: https://academy.isth.org/isth/2019/melbourne/264291/nataliya.seredavkina.dabigatran.for.failed.warfarin.treatment.in.high-risk.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Asearch%3D-Dabigatran+for+failed+warfarin+treatment+in+high-risk+patients+with+antiphospholipid+syndrome (Date accessed: 2020).
51. Bala MM, Celinska-Lowenho M, Szot W, Padjas A, et al. Antiplatelet and anticoagulant agents for secondary prevention of stroke and other thromboembolic events in people with antiphospholipid syndrome. Cochrane Database Syst Rev. 2020;10:CD012169. DOI: 10.1002/14651858.CD012169.pub3
52. European Medicines Agency (EMA). PRAC recommendations on signals. 2019 May 6; URL: https://www.ema.europa.eu/en/docu-ments/prac-recommendation/prac-recommendations-signals-ad-opted-8-11-april-2019-prac-meeting_en.pdf (Date accessed: 2020).
53. Medicines and Healthcare products Regulatory Agency. Direct-acting oral anticoagulants (DOACs): Increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome. URL: https://www.gov.uk/drug-safety-update/direct-act-ing-oral-anticoagulants-doacs-increased-risk-of-recurrent-throm-botic-events-in-patients-with-antiphospholipid-syndrome (Date accessed: 2020).
54. Arachchillage DRJ, Gomez K, Alikhan R, et al. Addendum to British Society for Haematology Guidelines on Investigation and Management of Antiphospholipid syndrome, 2012 (Br. J. Haematol. 2012; 157: 47-58): Use of direct acting oral anticoagulants. Br J Haematol. 2020;189(2):212-215. DOI: 10.1111/bjh.16308.
55. Konstantinides SV, 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). Eur Heart J. 2020;41(4):543-603. DOI: 10.1093/eurheartj/ehz405
56. Agence Nationale de Securite du Medicaments (ANSM). Anticoagulants Oraux Directs (AODs) (apixaban (Eliquis®), rivaroxaban (Xarelto®), dabigatran (Pradaxa®) et edoxaban (Lixiana®/ Roteas®) non recommandes chez les patients presentant un Syndrome des Antiphospholipides (SAPL) - Lettre aux profession-nels de sante. 2019 May 24. URL: https://ansm.sante.fr/S-informer/Informations-de-securite-Lettres-aux-professionnels-de-sante/Anticoagulants-Oraux-Directs-AODs-apixaban-Eliquis-R-rivaroxaban-Xarelto-R-dabigatran-Pradaxa-R-et-edoxaban-Lix-iana-R-Roteas-R-non-recommandes-chez-les-patients-presentant-un-Syndrome-des-Antiphospholipides-SAPL-Lettre-aux-profes-sionnels-de-sante (Date accessed: 2020).
57. Bauersachs R, Langer F, Kalka C, et al. Treatment of the antiphospholipid syndrome with direct oral anticoagulants: Position statement of German societies. Vasa. 2019;48(6):483-486. DOI: 10.1024/0301-1526/a000815
58. Zuily S, Cohen H, Isenberg D, et al. Use of direct oral anticoagulants in patients with thrombotic antiphospholipid syndrome: Guidance from the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. J Thromb Haemost. 2020;18(9):2126-2137. DOI: 10.1111/jth.1
Для цитирования:
Решетняк Т.М., Нурбаева К.С. Прямые оральные антикоагулянты при антифосфолипидном синдроме. Научно-практическая ревматология. 2020;58(6):708-715. https://doi.org/10.47360/1995-4484-2020-708-715
For citation:
Reshetnyak T.M., Nurbaeva K.S. Direct-acting oral anticoagulants in antiphospholipid syndrome. Rheumatology Science and Practice. 2020;58(6):708-715. (In Russ.) https://doi.org/10.47360/1995-4484-2020-708-715
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