rpcardioRational Pharmacotherapy in CardiologyРациональная Фармакотерапия в Кардиологии1819-64462225-3653«SILICEA-POLIGRAF» LLC10.20996/1819-6446-2020-04-17rpcardio-2168Research ArticlePOINT OF VIEWТОЧКА ЗРЕНИЯThe Risk of Myocardial Infarction in Patients with Atrial Fibrillation Taking a Direct Thrombin Inhibitor: Myths and RealityРиск инфаркта миокарда у пациентов с фибрилляцией предсердий, принимающих прямой ингибитор тромбина: мифы и реальностьТатарскийБ. А.TatarskyB. A.

Татарский Борис Алексеевич – доктор медицинских наук, профессор, заведующая научно-исследовательской лабораторией клинической аритмологии

197341, Санкт-Петербург, ул. Аккуратова, 2

Tatarsky B. Alekseevich – MD, PhD, Professor, Head of Clinical Arrhythmology Research Laboratory

Akkuratova ul. 2, St. Petersburg, 197341

btat@mail.ruКазенноваН. В.KazennovaN. V.

Казеннова Наталья Владимировна – кандидат медицинских наук, научный сотрудник, научно-исследовательская лаборатория клинической аритмологии

197341, Санкт-Петербург, ул. Аккуратова, 2

Natalia V. Kazennova – MD, PhD, Researcher, Clinical Arrhythmology Research Laboratory

Akkuratova ul. 2, St. Petersburg, 197341

НапалковД. А.NapalkovD. A.

Напалков Дмитрий Александрович – доктор медицинских наук, профессор, кафедра факультетской терапии №1

119991, Москва, ул. Трубецкая, 8 стр. 2

Napalkov D. Alexandrovich – MD, PhD, Professor, Chair of Faculty Therapy №1

Trubetskaya ul. 8-2, Moscow, 119991

Национальный медицинский исследовательский центр им. В.А. АлмазоваРоссияAlmazov National Medical Research CentreRussian FederationПервый Московский государственный медицинский университет им. И.М. Сеченова (Сеченовский Университет)РоссияI.M. Sechenov First Moscow State Medical University (Sechenov University)Russian Federation202027042020162301306Copyright © Tatarsky B.A., Kazennova N.V., Napalkov D.A., 20202020Татарский Б.А., Казеннова Н.В., Напалков Д.А.Tatarsky B.A., Kazennova N.V., Napalkov D.A.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/2168

The purpose of this review is to analyze the results of randomized clinical trials, meta-analyses of cohort and observational studies in real clinical practice on the influence of dabigatran etexilate on the risk of myocardial infarction in patients with atrial fibrillation. A pivotal RE-LY study on dabigatran use in patients with atrial fibrillation did not show statistically significant differences in the frequency of myocardial infarction between any of the doses of dabigatran and warfarin, and the risk of coronary events did not depend on the presence of coronary heart disease or myocardial infarction in the patient's history. Subsequently, a number of meta-analyses have reported an increased risk of myocardial infarction when dabigatran was administered to patients with atrial fibrillation. In general, these studies were characterized by conflicting data, which did not allow to draw any definite conclusions regarding the use of dabigatran in relation to the risk of myocardial infarction. Two FDA cohort observational studies were published in 2014 and 2017, and the former was significantly criticized by experts, and the results of the second study did not provide a definitive answer to the question about the importance of the effect of dabigatran on the development of myocardial infarction in patients with atrial fibrillation. Even more "confusing" the problem arose after the publication of meta-analyses of randomized trials, which showed that the risk of myocardial infarction was increased in patients treated with direct oral anticoagulants compared to patients treated with warfarin. This review provides high quality evidence for the efficacy of dabigatran in preventing myocardial infarction and other vascular complications in patients with atrial fibrillation.

Целью данного аналитического обзора является анализ результатов рандомизированных клинических исследований, проведенных мета-анализов наблюдательных когортных и обсервационных исследований реальной практики влияния дабигатрана этексилата на риск развития инфаркта миокарда у пациентов с фибрилляцией предсердий. В ключевом исследовании RE-LY по применению дабигатрана у пациентов с фибрилляцией предсердий не было отмечено статистически значимой разницы в частоте инфаркта миокарда какой-либо из доз дабигатрана в сравнении с варфарином, а риск коронарных событий не зависел от наличия у пациента ишемической болезни сердца, либо инфаркта миокарда в анамнезе. Впоследствии в ряде проведенных мета-анализов были представлены результаты, свидетельствовавшие о повышении риска развития инфаркта миокарда при назначении дабигатрана пациентам с фибрилляцией предсердий. Эти работы в основном характеризовались наличием противоречивых данных, что не позволяло сделать какие-либо определенные выводы по поводу риска развития инфаркта миокарда при использовании дабигатрана. Из двух наблюдательных когортных исследований FDA, опубликованных в 2014 и 2017 гг., первое подверглось значимой критике со стороны экспертов, а результаты второго исследования не дали окончательного ответа на вопрос о значимости влияния дабигатрана на развитие риска инфаркта миокарда у пациентов с фибрилляцией предсердий. Еще большая «запутанность» обсуждаемой проблемы возникла после публикации результатов мета-анализов рандомизированных исследований, где было показало, что риск инфаркта миокарда был повышен у лиц при лечении прямыми пероральными антикоагулянтами по сравнению с пациентами, получавшими варфарин. В обзоре предоставлены высококачественные доказательства эффективности дабигатрана в отношении профилактики инфаркта миокарда и других сосудистых осложнений у пациентов с фибрилляцией предсердий.

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