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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">medsovet</journal-id><journal-title-group><journal-title xml:lang="ru">Медицинский Совет</journal-title><trans-title-group xml:lang="en"><trans-title>Meditsinskiy sovet = Medical Council</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2079-701X</issn><issn pub-type="epub">2658-5790</issn><publisher><publisher-name>REMEDIUM GROUP Ltd.</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.21518/2079-701X-2019-5-6-12</article-id><article-id custom-type="elpub" pub-id-type="custom">medsovet-2908</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>Антитромботическая терапия</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>Antithrombotic therapy</subject></subj-group></article-categories><title-group><article-title>Прямые оральные антикоагулянты: ПЕРВАЯ «ПОДУШКА БЕЗОПАСНОСТИ»</article-title><trans-title-group xml:lang="en"><trans-title>Direct oral anticoagulants: first airbag</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Соколова</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Sokolova</surname><given-names>A. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Соколова Анастасия Андреевна – к.м.н., ассистент кафедры факультетской терапии №1 лечебного факультета. </p><p>119991, Москва, ул. Трубецкая, 8, стр. 2.</p></bio><bio xml:lang="en"><p> Sokolova Anastasiya Andreevna – Cand. of Sci. (Med.), Assistant Professor of Chair of Intermediate Level Therapy No. 1, Faculty of General Medicine.</p><p>8, Trubetskaya Street, Moscow, 119991.</p></bio><email xlink:type="simple">sokolovastasya@rambler.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Скрипка</surname><given-names>А. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Skripka</surname><given-names>A. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Скрипка Алена Игоревна – аспирант кафедры факультетской терапии №1 лечебного факультета.</p><p>119991, Москва, ул. Трубецкая, 8, стр. 2.</p></bio><bio xml:lang="en"><p> Skripka Alena Igorevna – a post-graduate student, Chair of Intermediate Level Therapy No. 1, Faculty of General Medicine.</p><p>8, Trubetskaya Street, Moscow, 119991.</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский университет).</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation (Sechenov University.</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2019</year></pub-date><pub-date pub-type="epub"><day>02</day><month>04</month><year>2019</year></pub-date><volume>0</volume><issue>5</issue><fpage>6</fpage><lpage>12</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Соколова А.А., Скрипка А.И., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Соколова А.А., Скрипка А.И.</copyright-holder><copyright-holder xml:lang="en">Sokolova A.N., Skripka A.I.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.med-sovet.pro/jour/article/view/2908">https://www.med-sovet.pro/jour/article/view/2908</self-uri><abstract><p>Профиль безопасности пероральных антикоагулянтов (ПОАК) был подтвержден в крупномасштабных исследованиях, вероятность развития геморрагических событий все же существует, что может быть обусловлено характером сопутствующей патологии пациента, возникшей травмой или потребностью в проведении экстренного хирургического вмешательства. Такие мероприятия для восстановления коагуляционного каскада, как использование концентратов протромбинового комплекса или гемодиализ, широко не использовались в клинической практике для прекращения антикоагулянтного эффекта ПОАК и не имеют доказательной базы. На сегодняшний день единственным зарегистрированным в РФ специфическим антагонистом к ПОАК является идаруцизумаб (Праксбайнд) – нейтрализующий агент, который взаимодействует со свободным и тромбин-связанным дабигатраном, не влияя при этом на другие факторы свертывания крови и функцию тромбоцитов. В исследовании RE-VERSE AD у пациентов, получающих терапию дабигатраном, и у которых развивалось жизнеугрожающее кровотечение, было продемонстрировано, что введение идаруцизумаба обеспечивало полную нейтрализацию антикоагулянтного эффекта дабигатрана в течение 4 ч, а уже через 1,5 ч выполнялось экстренное хирургическое лечение, добиваясь при этом нормального периоперационного гемостаза в 93,4% случаев. Наличие специфического нейтрализующего агента у конкретного ПОАК может служить одним из аргументов в пользу выбора данного препарата для больных, у которых очевиден высокий риск геморрагического события, экстренного хирургического вмешательства или тромболизиса.</p></abstract><trans-abstract xml:lang="en"><p>The safety profile of oral anticoagulants (DOACs) was confirmed in the large-scale studies, the increased risk of hemorrhagic events does still exist, which may be caused by the nature of the patient’s concomitant pathology, the resulting injury or the need for emergency surgical procedures. Such measures to restore the coagulation cascade as the use of prothrombin complex concentrates or hemodialysis have not been widely used in the clinical practice to stop the anti-coagulant effect of DOACs and do not have an evidence base. Today, idarutsizumab (Praxbind) is the only specific antagonist to DOACs registered in the Russian Federation, a neutralizing agent that interacts with free and thrombin-related dabigatran, without affecting other blood coagulation factors and platelet function. RE-VERSE AD study showed that administration of idarucizumab in patients receiving dabigatran therapy and who developed life-threatening bleeding provided complete neutralization of the anti-coagulant effect of dabigatran for 4 hours, and after 1.5 hours emergency surgical treatment was performed, achieving at the same time, normal perioperative hemostasis in 93.4% of cases. The availability of a specific neutralizing agent for a specific DOAC could be identified as arguments in favour of choosing this drug for patients who have a high risk of a hemorrhagic event, emergency surgery or thrombolysis.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>фибрилляция предсердий</kwd><kwd>антикоагулянтная терапия</kwd><kwd>прямые оральные антикоагулянты</kwd><kwd>специфический антагонист</kwd><kwd>дабигатран</kwd><kwd>идаруцизумаб</kwd><kwd>тромбоэмболические осложнения</kwd><kwd>геморрагические осложнения</kwd></kwd-group><kwd-group xml:lang="en"><kwd>atrial fibrillation</kwd><kwd>anticoagulant therapy</kwd><kwd>direct oral anticoagulants</kwd><kwd>neutralizing agent</kwd><kwd>dabigatran</kwd><kwd>idarucizumab</kwd><kwd>thromboembolic complications</kwd><kwd>hemorrhagic complications</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">2018 EHRA/ Executive summary. Europace. 2018;20(1).</mixed-citation><mixed-citation xml:lang="en">2018 EHRA/ Executive summary. Europace. 2018;20(1).</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Connolly S.J. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-51.</mixed-citation><mixed-citation xml:lang="en">Connolly S.J. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-51.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Eikelboom J. et al; Emergency care of patients receiving non-vitamin K antagonist oral anticoagulants. British Journal of Anaesthesia. 2018;120(4):645–656.</mixed-citation><mixed-citation xml:lang="en">Eikelboom J. et al; Emergency care of patients receiving non-vitamin K antagonist oral anticoagulants. British Journal of Anaesthesia. 2018;120(4):645–656.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Fordyce C.B. et al. On-Treatment Outcomes in Patients With Worsening Renal Function With Rivaroxaban Compared With Warfarin: Insights From ROCKET AF. Circulation 2016;134(1):37-47.</mixed-citation><mixed-citation xml:lang="en">Fordyce C.B. et al. On-Treatment Outcomes in Patients With Worsening Renal Function With Rivaroxaban Compared With Warfarin: Insights From ROCKET AF. Circulation 2016;134(1):37-47.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Graham D.J. et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015;131(2):157-64.</mixed-citation><mixed-citation xml:lang="en">Graham D.J. et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015;131(2):157-64.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Graham D.J. et al., Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation. JAMA Intern Med. 2016;176(11):1662-1671.</mixed-citation><mixed-citation xml:lang="en">Graham D.J. et al., Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation. JAMA Intern Med. 2016;176(11):1662-1671.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Hijazi Z. et al. Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation in Relation to Renal Function Over Time: Insights From the ARISTOTLE Randomized Clinical Trial. JAMA Cardiol. 2016;1(4):451-60.</mixed-citation><mixed-citation xml:lang="en">Hijazi Z. et al. Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation in Relation to Renal Function Over Time: Insights From the ARISTOTLE Randomized Clinical Trial. JAMA Cardiol. 2016;1(4):451-60.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Huisman M.V. et al. Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry. Am Heart J. 2018;198:55-63.</mixed-citation><mixed-citation xml:lang="en">Huisman M.V. et al. Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry. Am Heart J. 2018;198:55-63.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Kirchhof P. et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS: The Task Force for the 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 ESCEndorsed by the European Stroke Organisation (ESO). Eur Heart J. 2016;37(38):2893–2962.</mixed-citation><mixed-citation xml:lang="en">Kirchhof P. et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS: The Task Force for the 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 ESCEndorsed by the European Stroke Organisation (ESO). Eur Heart J. 2016;37(38):2893–2962.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Larsen T.B. et al. Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ. 2016;353:i3189.</mixed-citation><mixed-citation xml:lang="en">Larsen T.B. et al. Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ. 2016;353:i3189.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Pollack C.V. Evidence supporting idarucizumab for the reversal of dabigatran. American Journal of Emergency Medicine. 2016;34:33–38.</mixed-citation><mixed-citation xml:lang="en">Pollack C.V. Evidence supporting idarucizumab for the reversal of dabigatran. American Journal of Emergency Medicine. 2016;34:33–38.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Pollack C.V., Jr., Reilly P.A., van Ryn J, et al. Idarucizumab for Dabigatran Reversal – Full Cohort Analysis. The New England journal of medicine. 2017;377:431-41.</mixed-citation><mixed-citation xml:lang="en">Pollack C.V., Jr., Reilly P.A., van Ryn J, et al. Idarucizumab for Dabigatran Reversal – Full Cohort Analysis. The New England journal of medicine. 2017;377:431-41.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Seeger J.D. et al. Propensity Score Weighting Compared to Matching in a Study of Dabigatran and Warfarin. Drug Saf. 2017;40(2):169-181.</mixed-citation><mixed-citation xml:lang="en">Seeger J.D. et al. Propensity Score Weighting Compared to Matching in a Study of Dabigatran and Warfarin. Drug Saf. 2017;40(2):169-181.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Villines T.C. et al. A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system. Thromb Haemost. 2015;114(6):1290-8.</mixed-citation><mixed-citation xml:lang="en">Villines T.C. et al. A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system. Thromb Haemost. 2015;114(6):1290-8.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Ревишвили А.Ш., Шляхто Е.В., Замятин М.Н. и соавт. Особенности оказания экстренной и неотложной медицинской помощи пациентам, получающим прямые оральные антикоагулянты: согласительный документ междисциплинарной группы экспертов. Вестник аритмологии. 2018;92:59-72.</mixed-citation><mixed-citation xml:lang="en">Revishvili A.Sh., Shlyakhto E.V., Zamyatin M.N., et al. Features of urgent and emergency medical care for patients receiving direct oral anticoagulants: consensus statement of an interdisciplinary group of experts. Vestnik Aritmologii. 2018; 92: 59-72.] (In Russ).</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
