Регистр пациентов с семейной гиперхолестеринемией и пациентов очень высокого сердечно-сосудистого риска с недостаточной эффективностью проводимой гиполипидемической терапии (РЕНЕССАНС)

Aim. To assess awareness of blood pressure (BP) level, adherence to therapy and achievement of target BP in residents of Russian regions as part of the 2023 hypertension (HTN) screening campaign.Material and methods. During May 2023, 4613 participants from 23 cities of Russia took part in the screening. Participation was voluntary without restrictions on sex. All patients aged over 18 years. During screening, BP and pulse were measured three times using automatic or mechanical BP monitors, and a questionnaire about behavioral risk factors, concomitant diseases and therapy was filled out. HTN was diagnosed with systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg and/or taking antihypertensive therapy (AHT).Results. The analysis included data from 4585 respondents aged 18 to 95 years with an average age of 45 [28;59] years, of which 1729 were men (37,7%). The proportion of hypertensive patients was 49,6%. Among them, 62,8% took AHT and achieved target BP in 76,6% and 45,7% with the target BP criterion <140/90 mm Hg and <130/80 mm Hg, respectively. Most patients took dual AHT (37,4%), while monotherapy and triple therapy was registered in 27,5% and 23,4%, respectively. Initiation of therapy was performed with combination AHT in 43,7% of patients with HTN and 41,4% are currently using fixed-dose combination therapy. On-demand therapy was the most common reason for skipping medications and was more common in women, while men more often cited the high drug cost and a history of adverse reactions. Among patients with HTN, home BP measurement was associated with a higher prevalence of achieving target BP as follows: 1000 (60%) vs 100 (17%), p<0,001.Conclusion. The data obtained indicate, on the one hand, a continuing insufficient level of awareness about high BP and the use of antihypertensive drugs among the population, but there is a tendency to improve the effectiveness of the treatment of hypertension, including the use of fixed-dose combinations of antihypertensive drugs.

Aim. To assess the safety and efficacy of a single intravenous bolus of non-immunogenic staphylokinase compared with alteplase in patients with massive pulmonary embolism and hemodynamic instability. Non-immunogenic staphylokinase is a modified recombinant staphylokinase with low immunogenicity, high thrombolytic activity and fibrin selectivity.Material and methods. This multicenter, open-label, randomized, comparative clinical trial FORPE in two parallel groups was conducted in 23 clinical centers in Russia. A total of 310 patients aged 18 years and older with hemodynamic instability and computed tomography pulmonary angiography verified massive pulmonary embolism and right ventricular dysfunction were included. The patients were randomly assigned in either non-immunogenic staphylokinase (15 mg) or alteplase (100 mg) group. Both medicines were administered intravenously. An independent biostatistician created a randomization sequence using computer-generated random numbers. Randomization was performed using the envelopes. The study was open-label, and emergency unit staff, investigators, and patients were informed about the assigned drug. The primary efficacy endpoint was 7-day all-cause death after randomization. The non-inferiority margin was set at 10% for the difference in 7-day all-cause mortality after randomization between the compared groups. Non-inferiority was tested using the Welch t-test for the primary efficacy endpoint. Secondary efficacy endpoints were analyzed in both the intention-to-treat and per-protocol populations.Results. Of 348 patients screened between December 25, 2020, and July 31, 2023, 310 (89%) were included in the study. Of the total number, 155 (50%) patients were randomized to the non-immunogenic staphylokinase group and 155 (50%) to the alteplase group. In the non-immunogenic staphylokinase group, the primary efficacy endpoint, 7-day all-cause death, was 2% in the intent-to-treat population and 2% in the per-protocol population, whereas in the alteplase group it was 3% (odds ratio (OR) 0,75, 95% confidence interval (CI) 0,11-4,49; p=1,00) and 3% (OR 0,75, 95% CI 0,11-4,52; p=1,00), respectively. The difference in the primary efficacy endpoint was 0,6% (95% CI -2,8 to -4,0) in the intent-to-treat population and 0,6% (95% CI -2,9 to -4,2) in the per-protocol population. Thus, the lower limit of the 95% CI did not cross the non-inferiority margin (p<0,001). There were no cases of hemorrhagic stroke in the non-immunogenic staphylokinase group, whereas there were three cases (2%) of hemorrhagic stroke in the alteplase group (p=0,25). Serious adverse events were experienced by 11 patients (7%) in the non-immunogenic staphylokinase group compared with 12 patients (8%) in the alteplase group (p=1,00).Conclusion. Non-immunogenic staphylokinase is at least as effective as alteplase in the treatment of patients with massive pulmonary embolism with hemodynamic instability and has a higher safety profile. Future observational studies of non-immunogenic staphylokinase are needed to continue assessing its safety and efficacy. Given the high safety and efficacy of non-immunogenic staphylokinase, its use should be studied in patients with moderate-to-high risk pulmonary embolism.

ЦЕЛЬ ИССЛЕДОВАНИЯ Оценить комплаентность пациентов с гетерозиготной семейной гиперхолестеринемией (геСГХС) в течение 5-летнего периода работы регистра РЕНЕССАНС (Регистр пациентов с СГХС и пациентов очень высокого сЕрдечно-Сосудистого риска с недоСтАточной эффективНоСтью, проводимой гиполипидемической терапии). МАТЕРИАЛ И МЕТОДЫ РЕНЕССАНС является открытым, национальным, наблюдательным исследованием и включает больных с СГХС. Проводилась оценка факторов риска атеросклероза, анамнеза сердечно-сосудистых заболеваний (ССЗ), интенсивности гиполипидемической терапии (ГЛТ). Каждому пациенту определены уровни общего холестерина, триглицеридов, холестерина липопротеидов высокой плотности в сыворотке крови. Содержание холестерина липопротеидов низкой плотности (ХС ЛНП) рассчитывали по формуле Фридвальда. РЕЗУЛЬТАТЫ В исследование включено 2317 пациентов с геСГХС, из которых 58% — женщин. При включении в регистр 59% больных относились к категории высокого сердечно-сосудистого риска. Динамический визит проведен у 47% пациентов, период наблюдения составил 24 [11; 42] мес. Больные с динамическим визитом чаще имели определенный диагноз геСГХС и отягощенный наследственный анамнез по ССЗ, были моложе и им в более раннем возрасте диагностировали СГХС (p<0,05). У пациентов без динамического визита были распространены модифицируемые факторы риска (p<0,001). Среди пациентов высокого сердечно-сосудистого риска 54% больных получали ГЛТ, очень высокого — 86%. За время наблюдения в регистре доля принимающих ГЛТ пациентов увеличилась с 59 до 78%, в том числе статинами в режиме высокой интенсивности с 36 до 54%, в комбинации с эзетимибом — с 15 до 34%, ингибиторами PCSK9 — с 4 до 14% (p<0,001 для всех). Целевого уровня ХС ЛНП достигли 13% пациентов. Данные симуляционного анализа продемонстрировали, что для адекватного контроля уровня ХС ЛНП, не менее 92,5% больных с геСГХС в регистре должны получать трехкомпонентную ГЛТ со статинами, эзетимибом и ингибиторами PCSK9. ЗАКЛЮЧЕНИЕ 5-летнее наблюдение за участниками регистра РЕНЕССАНС демонстрирует увеличение использования многокомпонентных схем лечения, но недостаточное для адекватного контроля ХС ЛНП.

Non-compact right ventricular myocardium is a rare type of cardiomyopathy, it usually results from arrested myocardial development during embryogenesis. This disease can be characterized by excessive prominent trabeculations and deep inter-trabecular recesses in the ventricular wall. It might be a component of biventricular non-compact cardiomyopathy or an isolated form. The article presents a review of the literature on the clinic and radiation diagnostics of non-compact right ventricular myocardium with the presentation of the issues of differential diagnosis.

Aim. The study of the structural and functional properties of arteries in patients after a coronavirus disease 2019.Material and methods. The study included 113 people: 45 people who were examined before the start of the COVID-19 pandemic, healthy individuals who had COVID-19 (n=44), 24 patients with hypertension (HTN) in combination with prior COVID-19. In the individuals included in the study, the blood tests were performed, while the carotid arteries were evaluated using high-RF signal technology, applanation tonometry, volume sphygmography, and a test with post-occlusive reactive hyperemia were performed.Results. According to the study of carotid arteries, significant differences were registered between groups of healthy individuals (with and without a history of COVID-19) and HTN patients after COVID-19. According to the applanation tonometry in patients with hypertension and COVID-19 in history, aortic pressure and carotid-femoral pulse wave velocity significantly exceeded those in cohorts of individuals without cardiovascular diseases. According to the results of volume sphygmography in the group of patients after COVID-19, signs of early vascular aging were revealed, and the maximum values of these indicators were recorded in the group of hypertensive patients.Conclusion. The results obtained in the course of this study make it possible to state an increase in the arterial stiffness in people after COVID-19, which can be regarded as a sign of early vascular aging.