rpcardioRational Pharmacotherapy in CardiologyРациональная Фармакотерапия в Кардиологии1819-64462225-3653«SILICEA-POLIGRAF» LLC10.20996/1819-6446-2023-01-02rpcardio-2882Research ArticleCURRENT QUESTIONS OF CLINICAL PHARMACOLOGYАКТУАЛЬНЫЕ ВОПРОСЫ КЛИНИЧЕСКОЙ ФАРМАКОЛОГИИValue of Safety of Anticoagulant Therapy in Elderly Patient with Atrial Fibrillation and High Risk of BleedingЗначение безопасности антикоагулянтной терапии у пожилых пациентов с фибрилляцией предсердий и высоким риском кровотечений: акцент на ривароксабанhttps://orcid.org/0000-0002-6021-7864ВоробьёваН. М.VorobyevaN. M.

Воробьёва Наталья Михайловна.

Москва

Natalya M. Vorobyeva.

Moscow

natalyavorobjeva@mail.ruhttps://orcid.org/0000-0002-4193-688XТкачёваО. Н.TkachevaO. N.

Ткачёва Ольга Николаевна.

Москва

Olga N. Tkacheva.

Moscow

Российский национальный исследовательский медицинский университет им. Н.И. ПироговаРоссияPirogov Russian National Research Medical UniversityRussian Federation202307032023191101106Copyright © Vorobyeva N.M., Tkacheva O.N., 20232023Воробьёва Н.М., Ткачёва О.Н.Vorobyeva N.M., Tkacheva O.N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.rpcardio.online/jour/article/view/2882

The review article discusses  the safety issue of anticoagulant therapy in elderly patients with atrial fibrillation and high risk of bleeding.  An evidence base is presented demonstrating the high safety of rivaroxaban in patients over 80  years of age,  with a high risk of bleeding  and cardiovascular complications,  the presence of comorbid  pathology, geriatric syndromes  and chronic kidney disease (including in combination with anemia). The problem of low adherence to treatment in elderly patients and the possibility of solving it were separately considered.

В обзорной статье подробно обсуждается проблема безопасности антикоагулянтной терапии  у пожилых пациентов с фибрилляцией предсердий  и высоким  риском  кровотечений. Представлена доказательная база,  демонстрирующая высокую  безопасность ривароксабана у больных  старше 80 лет, с высоким  риском кровотечений и сердечно-сосудистых осложнений, наличием  коморбидной патологии, гериатрических синдромов и хронической болезни почек (в т. ч. в сочетании с анемией). Отдельно  рассмотрена проблема низкой приверженности к лечению у пожилых пациентов и возможности её решения.

фибрилляция предсердийпожилой пациентривароксабанбезопасностьвысокий риск кровотеченийatrial fibrillationelderly patientrivaroxabansafetyhigh risk of bleedingReferencesWolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991;22(8):983-88. DOI:10.1161/01.str.22.8.983.Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991;22(8):983-88. DOI:10.1161/01.str.22.8.983.Hindricks G, Potpara T, Dagres N, et al. ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2020;00:1-126. DOI:10.1093/eurheartj/ehaa612.Hindricks G, Potpara T, Dagres N, et al. ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2020;00:1-126. DOI:10.1093/eurheartj/ehaa612.Patel MR, Mahaffey KW, Garg J, et al. ROCKET AF Investigators. Rivaroxaban versus warfarin in non-valvular atrial fibrillation. N Engl J Med. 2011;365(10):883-91. DOI:10.1056/NEJMoa1009638.Patel MR, Mahaffey KW, Garg J, et al. ROCKET AF Investigators. Rivaroxaban versus warfarin in non-valvular atrial fibrillation. N Engl J Med. 2011;365(10):883-91. DOI:10.1056/NEJMoa1009638.Марцевич С.Ю., Навасардян А.Р., Захарова Н.А., Лукьянов М.М. Новые оральные антикоагулянты: можно ли результаты международных контролируемых исследований с этими препаратами переносить на российских больных? Кардиоваскулярная Терапия и Профилактика. 2015;14(5):48-52. DOI:10.15829/1728-8800-2015-5-48-52.Martsevich SYu, Navasardian AR, Zakharova NA, Lukianov ММ. New oral anticoagulants: is that plausible to implement the data from international trials to russian population? Cardiovascular Therapy and Prevention. 2015;14(5):48-52 (In Russ.) DOI:10.15829/1728-8800-2015-5-48-52.Halperin JL, Hankey GJ, Wojdyla DM, et al. ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Circulation. 2014;130(2):138-46. DOI:10.1161/CIRCULATIONAHA.113.005008.Halperin JL, Hankey GJ, Wojdyla DM, et al. ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Circulation. 2014;130(2):138-46. DOI:10.1161/CIRCULATIONAHA.113.005008.Hanon O, Chaussade E, David JP, et al. SAFIR cohort: One-year prospective follow-up of very old and frail patients treated with direct oral anticoagulant, rivaroxaban. Arch Cardiovasc Dis Suppl. 2020;12(1):115. DOI:10.1016/j.acvdsp.2019.09.250.Hanon O, Chaussade E, David JP, et al. SAFIR cohort: One-year prospective follow-up of very old and frail patients treated with direct oral anticoagulant, rivaroxaban. Arch Cardiovasc Dis Suppl. 2020;12(1):115. DOI:10.1016/j.acvdsp.2019.09.250.Hanon O, Vidal JS, Pisica-Donose G, et al. SAFIR study group. Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation. Heart. 2021;107(17):1376-82. DOI:10.1136/heartjnl-2020-317923.Hanon O, Vidal JS, Pisica-Donose G, et al. SAFIR study group. Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation. Heart. 2021;107(17):1376-82. DOI:10.1136/heartjnl-2020-317923.Deitelzweig S, Keshishian A, Kang A, et al. Burden of major gastrointestinal bleeding among oral anticoagulant-treated non-valvular atrial fibrillation patients. Therap Adv Gastroenterol. 2021;14:1756284821997352. DOI:10.1177/1756284821997352.Deitelzweig S, Keshishian A, Kang A, et al. Burden of major gastrointestinal bleeding among oral anticoagulant-treated non-valvular atrial fibrillation patients. Therap Adv Gastroenterol. 2021;14:1756284821997352. DOI:10.1177/1756284821997352.Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955-62. DOI:10.1016/S0140-6736(13)62343-0.Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955-62. DOI:10.1016/S0140-6736(13)62343-0.Mihalkanin L, Stancak B. The Impact of Novel Anticoagulants on the Upper Gastrointestinal Tract Mucosa. Medicina (Kaunas). 2020;56(7):363. DOI:10.3390/medicina56070363.Mihalkanin L, Stancak B. The Impact of Novel Anticoagulants on the Upper Gastrointestinal Tract Mucosa. Medicina (Kaunas). 2020;56(7):363. DOI:10.3390/medicina56070363.Консенсус экспертов по снижению риска желудочно-кишечных кровотечений у пациентов, получающих оральные антикоагулянты. Терапия. 2021;(10):23-41. DOI:10.18565/therapy.2021.10.23–41.Experts consensus on reducing the risk of gastrointestinal bleeding in patients receiving oral anticoagulants. Therapy. 2021;(10):23-41 (In Russ.) DOI:10.18565/therapy.2021.10.23–41.Cheung KS, Leung WK. Gastrointestinal bleeding in patients on novel oral anticoagulants: Risk, prevention and management. World J Gastroenterol. 2017;23(11):1954-63. DOI:10.3748/wjg.v23.i11.1954.Cheung KS, Leung WK. Gastrointestinal bleeding in patients on novel oral anticoagulants: Risk, prevention and management. World J Gastroenterol. 2017;23(11):1954-63. DOI:10.3748/wjg.v23.i11.1954.Pannach S, Goetze J, Marten S, et al. Management and outcome of gastrointestinal bleeding in patients taking oral anticoagulants or antiplatelet drugs. J Gastroenterol. 2017;52(12):1211-20. DOI: 10.1007/s00535-017-1320-7.11.Pannach S, Goetze J, Marten S, et al. Management and outcome of gastrointestinal bleeding in patients taking oral anticoagulants or antiplatelet drugs. J Gastroenterol. 2017;52(12):1211-20. DOI: 10.1007/s00535-017-1320-7.11.Польшакова И.Л., Поветкин С.В. Структура лекарственной терапии и клиническая характеристика больных с фибрилляцией предсердий по данным исследования РЕКУР-ФП. Рациональная Фармакотерапия в Кардиологии 2018;14(5):733-40. DOI:10.20996/1819-6446-2018-14-5-733-740.Polshakova IL, Povetkin SV. Drug Therapy Structure and Clinical Characteristics of Patients with Atrial Fibrillation According to Data of REKUR-AF Study. Rational Pharmacotherapy in Cardiology. 2018;14(5):733-40 (In Russ.) DOI:10.20996/1819-6446-2018-14-5-733-740.Leung KCW, MacRae JM. Anticoagulation in CKD and ESRD. Journal of Nephrology. 2019;32(5):719-31. DOI:10.1007/s40620-019-00592-4.Leung KCW, MacRae JM. Anticoagulation in CKD and ESRD. Journal of Nephrology. 2019;32(5):719-31. DOI:10.1007/s40620-019-00592-4.Hwang HS, Park MW, Yoon HE, et al. Clinical Significance of Chronic Kidney Disease and Atrial Fibrillation on Morbidity and Mortality in Patients with Acute Myocardial Infarction. Am J Nephrol. 2014;40(4):345-52. DOI:10.1159/000368422.Hwang HS, Park MW, Yoon HE, et al. Clinical Significance of Chronic Kidney Disease and Atrial Fibrillation on Morbidity and Mortality in Patients with Acute Myocardial Infarction. Am J Nephrol. 2014;40(4):345-52. DOI:10.1159/000368422.Fox KA, Piccini JP, Wojdyla D, et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J. 2011;32(19):2387-94. DOI:10.1093/eurheartj/ehr342.Fox KA, Piccini JP, Wojdyla D, et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J. 2011;32(19):2387-94. DOI:10.1093/eurheartj/ehr342.Чашкина М.И., Андреев Д.А., Козловская Н.Л. и др. Показатели безопасности ривароксабана по сравнению с варфарином у пациентов с фибрилляцией предсердий и хронической болезнью почек поздних стадий. Кардиология. 2020;60(11):94-100. DOI:10.18087/cardio.2020.11.n1322.Chashkina MI, Andreev DA, Kozlovskaya NL, et al. Safety performance of rivaroxaban versus warfarin in patients with atrial fibrillation and advanced chronic kidney disease. Kardiologiia. 2020;60(11):94-100 (In Russ.) DOI:10.18087/cardio.2020.11.n1322.Kim S, Yoon S, Choi J, et al. Clinical implication of frailty assessment in older patients with atrial fibrillation. Arch Gerontol Geriatr. 2017;70:1-7. DOI:10.1016/j.archger.2016.12.001.Kim S, Yoon S, Choi J, et al. Clinical implication of frailty assessment in older patients with atrial fibrillation. Arch Gerontol Geriatr. 2017;70:1-7. DOI:10.1016/j.archger.2016.12.001.Fried LP, Tangen CM, Walston J, et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001;56(3):146-56. DOI:10.1093/gerona/56.3.m146.Fried LP, Tangen CM, Walston J, et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001;56(3):146-56. DOI:10.1093/gerona/56.3.m146.Ткачева О.Н., Котовская Ю.В., Рунихина Н.К., и др. Клинические рекомендации «Старческая астения». Российский Журнал Гериатрической Медицины. 2020;(1):11-46. DOI:10.37586/2686-8636-1-2020-11-46.Tkacheva ON, Kotovskaya YV, Runikhina NK, et al. Clinical guidelines on frailty. Russian Journal of Geriatric Medicine. 2020;(1):11-46 (In Russ.) DOI:10.37586/2686-8636-1-2020-11-46.Martinez BK, Sood NA, Bunz TJ, Coleman CI. Effectiveness and Safety of Apixaban, Dabigatran, and Rivaroxaban Versus Warfarin in Frail Patients With Nonvalvular Atrial Fibrillation. J Am Heart Assoc. 2018;7:e008643. DOI:10.1161/JAHA.118.008643.Martinez BK, Sood NA, Bunz TJ, Coleman CI. Effectiveness and Safety of Apixaban, Dabigatran, and Rivaroxaban Versus Warfarin in Frail Patients With Nonvalvular Atrial Fibrillation. J Am Heart Assoc. 2018;7:e008643. DOI:10.1161/JAHA.118.008643.Herr M, Robine JM, Pinot J, et al. Polypharmacy and frailty: prevalence, relationship, and impact on mortality in a French sample of 2350 old people. Pharmacoepidemiol Drug Saf. 2015;24(6):637-46. DOI:10.1002/pds.3772.Herr M, Robine JM, Pinot J, et al. Polypharmacy and frailty: prevalence, relationship, and impact on mortality in a French sample of 2350 old people. Pharmacoepidemiol Drug Saf. 2015;24(6):637-46. DOI:10.1002/pds.3772.Piccini JP, Hellkamp AS, Washam JB, et al. Polypharmacy and the Efficacy and Safety of Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation. Circulation. 2015;133(4):352-60. DOI:10.1161/circulationaha.115.018544.Piccini JP, Hellkamp AS, Washam JB, et al. Polypharmacy and the Efficacy and Safety of Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation. Circulation. 2015;133(4):352-60. DOI:10.1161/circulationaha.115.018544.Gomez-Outes A, Lagunar-Ruiz J, Terleira-Fernandez AI, et al. Causes of Death in Anticoagulated Patients With Atrial Fibrillation. J Am Coll Cardiol. 2016;68(23):2508-21. DOI:10.1016/j.jacc.2016.09.944.Gomez-Outes A, Lagunar-Ruiz J, Terleira-Fernandez AI, et al. Causes of Death in Anticoagulated Patients With Atrial Fibrillation. J Am Coll Cardiol. 2016;68(23):2508-21. DOI:10.1016/j.jacc.2016.09.944.Mak KH. Coronary and mortality risk of novel oral antithrombotic agents: a meta-analysis of large randomised trials. BMJ Open. 2012;2(5):e001592. DOI:10.1136/bmjopen-2012-001592.Mak KH. Coronary and mortality risk of novel oral antithrombotic agents: a meta-analysis of large randomised trials. BMJ Open. 2012;2(5):e001592. DOI:10.1136/bmjopen-2012-001592.Loke YK, Pradhan S, Yeong JK, Kwok CS. Comparative coronary risks of apixaban, rivaroxaban and dabigatran: a meta-analysis and adjusted indirect comparison. Br J Clin Pharmacol. 2014;78(4):707-17. DOI:10.1111/bcp.12376.Loke YK, Pradhan S, Yeong JK, Kwok CS. Comparative coronary risks of apixaban, rivaroxaban and dabigatran: a meta-analysis and adjusted indirect comparison. Br J Clin Pharmacol. 2014;78(4):707-17. DOI:10.1111/bcp.12376.Деменко Т.Н., Чумакова Г.А., Чугунова Ю.В. Особенности когнитивной функции у пациентов с фибрилляцией предсердий. Анналы Аритмологии. 2015;12(4):215-24. DOI:10.15275/annaritmol.2015.4.3.Demenko TN, Chumakova GA, Chugunova YV. Features of cognitive function in patients with atrial fibrillation. Annals of Arrhythmology. 2015;12(4):215-24 (In Russ.) DOI:10.15275/annaritmol.2015.4.3.Туров А.Н., Панфилов С.В., Чиглинцева О.В. Эффективность, безопасность и приверженность при использовании новых антикоагулянтов у пациентов с фибрилляцией предсердий старше 75 лет. Рациональная Фармакотерапия в Кардиологии. 2020;16(1):10-8. DOI:10.20996/1819-6446-2020-20-07.Turov AN, Panfilov SV, Tschiglinzeva ОV. The Efficacy, Safety and Adherence to Treatment when New Anticoagulants Taking in Over 75 Years Old Patients with Atrial Fibrillation. Rational Pharmacotherapy in Cardiology. 2020;16(1):10-8. (In Russ.) DOI:10.20996/1819-6446-2020-20-07.

The authors declare that there are no conflicts of interest present.