Background: Death rates from cardiovascular disease in Russia are among the highest in the world. In recent years, the Russian government has invested substantially in the healthcare system, with a particular focus on improving access to advanced technology, especially for acute myocardial infarction (AMI). This protocol describes a study to understand the management of AMI in different Russian regions, investigating the role of patient, clinical, and health system characteristics. Methods: A prospective observational study has recruited a representative sample of AMI patients within 16 hospitals from 13 regions across Russia. Criteria for inclusion are being aged 35-70 years with a confirmed diagnosis of AMI and surviving until the day after admission. Information being collected includes health system contacts and features of clinical management prior to the event and in the 12 months following discharge from hospital. Following initial exploration of the data to generate hypotheses, multivariate analyses will be applied to assess the role of these characteristics in both treatment decisions and any delays in time critical interventions. Between June 2015 and August 2016, 1,122 patients have been recruited at baseline and follow-up to 12 months post-discharge is scheduled to be completed by autumn 2017. The study is unique in examining patient factors, clinical management prior to admission and in hospital in the acute phase and throughout the critical first year of recovery across a diverse range of geographies and facilities. It uses standardized instruments to collect data from patients and health care providers and includes regions that are diverse in terms of geography and development of cardiology capacity. However, given the limited health services research capacity in the Russian Federation, it was not possible to obtain a sample that was truly nationally representative.

Aim      To study features of diagnosis and treatment of acute myocardial infarction (AMI) in Russian hospitals, results of the treatment, and early and late outcomes (6 and 12 months after AMI diagnosis); to evaluate the consistence of the treatment with clinical guidelines; and to evaluate patients’ compliance with the treatment.Material and methods  The program was designed for 3 years, including 24 months for recruitment of patients to the study. The study will include 10, 000 patients hospitalized with a confirmed diagnosis (I21 according to ICD-10) of ST segment elevation acute myocardial infarction (MI) (STEMI) or non-ST segment elevation MI (NSTEMI) based on criteria of the European Society of Cardiology Guidelines on Forth Universal Definition of Myocardial Infarction (2018). The follow-up period was divided into three stages: observation during the stay in the hospital and at 6 and 12 months following inclusion into the registry. The primary endpoint included cardiac death, nonfatal MI during the hospitalization and after one-year follow-up. Secondary endpoints were 6-months and one-year incidence of repeated MI, heart failure, ischemic stroke, clinically significant hemorrhage, unscheduled revascularization after discharge from the hospital, and the proportion of patients who continue on statins, antiplatelet drugs, and drugs of other groups for 6 months and 1 year.Results The inclusion of patients into the registry started in 2020 and will continue for 24 months. By the time of the article publication (June, 2021), more than 2,000 patients will be included.Conclusion      REGION-MI (Russian rEGIstry Of acute myocardial iNfarction) is a multicenter, retrospective and prospective observational cohort study that excludes any interference with the clinical practice. Results of the registry will help to analyze a real picture of medical care provided to patients with myocardial infarction and to schedule ways to improve the situation.

The current state of the Russian and foreign regulatory framework for off-label prescription of medicines is presented in the article. The existing problems of this specific drug therapy and possible solutions are described. Unfortunately, there are some gaps in the Russian legislation regarding the off-label medication use. Based on the clinical reality, in some cases, the “off-label” drugs prescription can be justified by the clinical condition of the patient, the lack of alternative approved drugs, and the availability of published scientific data that create the prerequisites for the effectiveness of this approach. When off-label drug prescribing as a forced measure, the doctor must provide a rationale for this prescription in the medical documentation, the conclusion of the consultation (with the participation of relevant specialists and the clinical pharmacologist) or the medical commission (with the participation of the administration representative), and the written informed consent of the patient or his legal representative. This information should be actively communicated to doctors in order to increase their legal literacy and prevent possible negative and legal consequences.

Aim. To describe the characteristics of the patient with MI who is admitted to a hospital and to characterize the main diagnostic and treatment interventions in clinic. Material and methods. This study is observational and the part of big international project. It includes a representative sample of patients with MI admitted to 16 clinics in 13 regions of Russian Federation (Arkhangelsk region, Belgorod region, Bryansk region, Tver region, Saratov region, Rostov region, Samara region, the Republic of Tatarstan, Perm region, Tyumen region, Khanty-Mansiysk Autonomous district, Kemerovo region, Altai region). Patients were selected at random from among those experiencing a MI that were alive on the next morning after hospitalization. Enrollment took place from June 2015 to August 2016. Results. Of 1,128 patients included in the study, 872 were male (77.3%) and 256 females. 21.4% of patients had a previous MI, 8.3% had undergone PCI, and 2.2% CABG. Turning to cardiovascular risk factors, 46.2% of patients smoked prior to hospitalization, 34.6% were obese and 52.1% had a high cholesterol level. Only 40.0% of patients had no contact with the health care system within 12 months before the MI. Every fourth patient (25.1%) had undergone dispensarisation within 12 months before MI, women significantly often than men (33.5% and 22.6%, p<0.001). Initial revascularization was performed in 73.2% of patients, PCI was the initial revascularization attempt in 49.4% of patients, and PCI with stenting in 46.7%. Conclusion. Patient with a MI in Russian clinics is likely to have had a history of cardiovascular disease, and to have regular contact with the health care system within 12 months before the development of cardiovascular event. We demonstrated the high rates of appropriate MI treatment, without significant gender and age difference (except for thrombolysis), however, there is a reserve for increasing the proportion of patients who are undergoing revascularization.

В третьем номере журнала «Сердце» за 2016 г. опу-бликована статья О. П. Творун с соавт. «Тяжелая легочная гипертензия при врожденном пороке сердца у долгожителя» [1]. Авторами подробно представлен редкий клинический случай (врожденный порок сердца с тяжелыми гемодинамическими нарушениями у паци-ента 92 лет) и на его основе рассмотрена одна из рас-пространенных кардиологических патологий -легочная гипертензия. На наш взгляд, данный случай наглядно иллюстрирует еще одну проблему, которая в последнее время все чаще встречается в клинической практике -назначение завышенной дозы ривароксабана пожилым больным с фибрилляцией предсердий (ФП).Как следует из статьи, 92-летнему пациенту в свя-зи с наличием постоянной формы ФП ривароксабан был назначен в дозе 20 мг / сут. Основанием для выбо-ра полной дозы препарата послужило то, что по дан-ным анализа крови расчетная скорость клубочковой фильтрации (СКФ) по формуле MDRD оказалась равна 77,82 мл / мин / 1,73 м 2 . При этом содержание креатинина в сыворотке крови составляло 84,9 мкмоль / л, а масса тела пациента -54,4 кг [1].С учетом приведенных данных (мужчина 92 лет с мас-сой тела 54,4 кг и креатинином сыворотки 84,9 мкмоль / л) рассчитаем клиренс креатинина (КлКр) Резюме На примере клинического случая пациента 92 лет рассмотрена одна из распространенных в гериатрической практике оши-бок -назначение ривароксабана по 20 мг в сутки больным с фибрилляцией предсердий (ФП) и нарушенной функцией почек (при клиренсе креатинина менее 50 мл / мин). Показано, что главной причиной ошибки является выбор дозы ривароксабана на основе расчетной скорости клубочковой фильтрации (СКФ), которая у пожилых больных, как правило, выше расчетного клиренса креатинина (КлКр). Рассмотрены возможные неблагоприятные последствия применения завышенной дозы риварок-сабана у лиц старше 75 лет. Подчеркнуто приоритетное значение формулы Кокрофта-Голта для расчета КлКр при выборе дозы ривароксабана в данной возрастной группе.Bel'diev S. N., Platonov D. Ju. Russian Heart Journal. 2017;16 (3):207-212 Summary Using as an example a clinical case of 92-year old patient, the article reviews one of common mistakes in geriatric practice, prescribing rivaroxaban 20 mg daily to patients with atrial fibrillation (AF) and impaired kidney function (creatinine clearance <50 ml / min). It was shown that the main cause of this mistake is choosing the rivaroxaban dose based on calculated glomerular filtration rate (GFR), which is usually higher than the calculated creatinine clearance (CrCl) in elderly patients. The authors reviewed possible adverse consequences of overdosing rivaroxaban in patients older than 75 and stressed the priority significance of the Cockcroft-Gault equation for calculating CrCl to select the rivaroxaban dose for this age group.

Бельдиев С. Н. к.м.н., доцент, кафедра терапии и кардиологии Егорова И. В. к.м.н., ассистент, кафедра терапии и кардиологии Гавриленко Н. Г. к.ф.н., доцент, кафедра иностранных и латинского языков Березина Е. И. к.м.н., доцент, кафедра терапии и кардиологии Медведева И. В. к.м.н., доцент, кафедра терапии и кардиологии Платонов Д. Ю. д.м.н., заведующий, кафедра терапии и кардиологии ФГБОУ ВО «Тверской государственный медицинский университет» Минздрава России

According to the results of several short-term randomized controlled trials (RCTs), nicorandil is not inferior in its antianginal efficacy to beta-blockers (BB), calcium channel blockers (CCB) and long-acting nitrates (LAN). At the same time, in some short-term RCTs, as well as in the long-term RCT IONA (2002), it was shown that antianginal efficacy of nicorandil as monotherapy or in combination with other antianginal drugs did not differ from placebo. Ability of nicorandil to reduce the risk of adverse cardiovascular events, demonstrated in the RCT IONA, requires confirmation in a long-term trial with a stronger primary endpoint and concomitant treatment that would meet the current guidelines for the management of patients with chronic coronary syndromes. In this regard, and also taking into account the proven ability of nicorandil to cause gastrointestinal ulcerations, European experts currently consider nicorandil as a drug that is inferior in priority of choice to the first-line antianginal drugs (BB, CCB) and, in some cases, to the second-line drugs (LAN, ivabradine, ranolazine, trimetazidine).

ВведениеВ четвертом номере журнала «Рациональная фар-макотерапия в кардиологии» за 2016 г. опубликована статья Ю.А. Бунина и С.В. Миклишанской «Клиническое значение новых пероральных антикоагулянтов в про-филактике тромбоэмболических осложнений у боль-ных с фибрилляцией предсердий: не все мечты сбы-ваются» [1]. По мнению авторов, в настоящее время це-лесообразно говорить о дифференцированном подходе к назначению новых оральных антикоагулянтов (НОАК), а не сравнивать их по принципу «лучше-хуже», так как подобные оценки являются некорректными. В число факторов, которые необходимо учитывать при диф-ференцированном подходе, авторы включают взаи-модействие НОАК с другими лекарствами и поясняют данное положение следующим образом: «Надо иметь в виду, что такие антиаритмические препараты как амио-дарон, верапамил и дронедарон, используемые при лечении фибрилляции предсердий (ФП), существен-но увеличивают плазменную концентрацию дабигатрана (на 12-60%, 12-180% и 70-100%, соответственно). В то же время они в значительно меньшей степени влияют на концентрацию ривароксабана. Практически нет данных об их воздействии на концентрацию апик-сабана. Дилтиазем не влияет на концентрацию даби-гатрана, немного увеличивает ее при приеме рива-роксабана и приводит к довольно существенному воз- В некоторых отечественных публикациях высказывается мнение о том, что ривароксабан обладает наиболее благоприятным профилем ле-карственного взаимодействия по сравнению с другими новыми оральными антикоагулянтами (НОАК). Основой для подобных суждений стала сводная таблица лекарственных взаимодействий НОАК из рекомендаций Европейской ассоциации сердечного ритма 2015 г. по при-менению НОАК у пациентов с неклапанной фибрилляцией предсердий. В настоящей работе обсуждаются содержащиеся в таблице некорректные качественные формулировки и несоответствующие первоисточ-никам количественные данные о лекарственных взаимодействиях НОАК, а также приводятся уточненные и дополненные сведения об из-менениях плазменных концентраций НОАК при совместном приеме с препаратами других групп. На основе представленных данных ав-торы приходят к заключению о том, что по профилю лекарственного взаимодействия ривароксабан существенно не отличается от других НОАК.Ключевые слова: дабигатран, апиксабан, ривароксабан, эдоксабан, лекарственные взаимодействия. The opinion is expressed in some domestic publications that rivaroxaban has the most favorable profile of drug interaction in comparison with other new oral anticoagulants (NOAC). The basis for such judgments is the summary table of drug interaction from the Guidelines of the European Heart Rhythm Association 2015 on the use of NOAC in patients with non-valvular atrial fibrillation. The paper discusses the issue that the abovementioned table contains some incorrect qualitative statements and quantitative data inconsistent with primary source of information of NOAC drug interactions, and provides the updated and extended information on changes in NOAC plasma concentrations when co-administered with drugs from the other groups. O...