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.
Aim: to measure the echogenicity of atherosclerotic plaques (AP) of carotid arteries to assess the dynamics of atherosclerosis and risk of cardiovascular outcomes (CVO) in patients with different CVD risk. Materials and methods. The study included 223 patients: 80 patients (47 males) with moderate CVD risk (mean age: 53 years, range: 39-66) (Group 1) and 143 patients (123 males) with acute coronary syndrome (ACS) and high CVD risk (mean age: 57, range: 32-83) years (Group 2). All patients were examined at the Chazov National Medical Research Center of Cardiology. Patients underwent a standard clinical examination, biochemical blood test with lipid profile determination, and ultrasound duplex scanning. Patients with ACS were re-examined after 1-1.5 years and patients with moderate CVD risk were re-examined after 1 and 7 years. Results. We analyzed 181 APs in Group 1 and 378 APs in Group 2. Analysis of gray-scale median (GSM) at the first and second visit showed a significant increase in GSM in both groups: from 67.02 [54.13; 82.85] to 73.5 [59.5; 88.7] (p<0.0001) in Group 1, and from 49.3 [39.73;63.64] to 50.7 [40.04;66.54] (p<0.05) in Group 2. An increase in GSM was observed in 79% of patients in Group 1, in 53% of patients in Group 2. Unfavorable CVO (CVO+) developed after 7 years in 7 (8.8%) patients in Group 1, and after 1 year in 23 (23%) patients in Group 2. In Group 1, an increase in GSM was observed only in patients with favorable prognosis (CVO-): from 67.7[52.13; 79.0] to 77.5[64.12; 91.0] (n=148 AP, p<0.05), in patients with CVO+, GSM increased non-significantly from 60.1[53.5; 66.5] to 66.5[55.0; 71.6] (n=18 AP, p=NS). In Group 2, a significant increase in GSM was observed in patients with CVO-: from 48.7[39.0; 63.4] to 51.3[40.0; 67.4] (n=141 AP, p<0.01), in patients with CVO+, GSM decreased from 51.6[42.9; 72.5] to 50.2[40.4; 65.0] (n=43 AP, p=NS). In Group 2, GSM significantly increased by 2.75 (6.05%) from the initial value (p<0.05) in patients with CVO-, while patients with CVO+ showed a significant decrease in the average GSM of AP by 3.33 (7.8%) (p<0.05). Using ROC analysis, a Δ% GSM value of 6.96% was found (area under the curve 0.628 ± 0.0465 [95% CI 0.556 - 0.696], p = 0.0058). According to Cox regression analysis, the risk of CVO increased by 2.16 times with a decrease in GSM AP in the carotid arteries over time by ≥ 6.96% (НR=2.16; 95% CI=1.331 – 3.507); p=0.009. Conclusion. The ultrasound method of measuring the echogenicity of an atherosclerotic plaque of the carotid artery using GSM parameter can be effective for assessing the dynamics of atherosclerosis and prognosis of adverse cardiovascular events in patients with high and moderate CVD risk
Aim. To study the relationship between the presence and size of microvascular obstruction (MVO) and the prognosis of patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) within one year.Material and methods. The study included 50 patients with a first STEMI who underwent PPCI on the infarct-related artery. After 3-7 days and 12 months, contrast-enhanced cardiac magnetic resonance imaging was performed to assess left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), and MVOs. After 12 months, patients were rehospitalized and prognosis was assessed based on data on cardiovascular events.Results. Patients with MVO had a significantly lower LVEF in the acute period of MI (44,1±10,6%) compared to patients without MVO (52,9±10,5%), p=0,0209, as well as during reassessment after a year (44,8±11,1%) compared with patients without MVO (58,9±8,0%), p=0,0004. A significant inverse correlation was found between LVEF in the initial and repeat examination and MVO size in the initial examination as follows: ρ=-0,42 (95% confidence interval (CI): -0,66 — -0,12, p=0,008) and ρ=-0,61 (95% CI: -0,78 — -0,34, p=0,0001). There was also a significant inverse correlation between LVEF and MVO size at reassessment, ρ=-0,40 (95% CI: -0,65 — -0,07, p=0,0205). A significant direct correlation was identified between MVO size in the acute MI period and LVEDV one year later, ρ=0,35 (95% CI: 0,02-0,62, p=0,0409). The development of a left ventricular (LV) aneurysm was registered in 40% of patients with MVO during the initial study and was not registered among patients without MVO (p=0,0039).Conclusion. MVOs was associated with post-infarction LV aneurysm. An increase in MVO size correlated with a decrease in LVEF and an increase in LVEDV both in the acute period and one year after MI.
Aim. Based on data from the Russian REGION-MI registry, to characterize patients with myocardial infarction (MI) hospitalized in Russian hospitals, describe their historical, demographic, and clinical characteristics, and compare the results with the data of previous Russian and international registries of acute coronary syndrome.Material and methods. REGION-MI is a multicenter prospective observational study. The follow-up period was divided into three stages: during the hospital stay, at 6 and 12 months after the inclusion in the registry. Demographic and historic data and information about the present case of MI were entered into the patient’s individual record card.Results. The median age of all patients was 63 years; 68% of patients were men. The mean age of women was older than that of men. Among all MI cases, 70% were ST-segment elevation myocardial infarction (STEMI). Patients with non-ST-segment elevation myocardial infarction (NSTEMI) were older and had more comorbidities than patients with STEMI. The median time from the first symptoms to ECG recording was two hours, and from the first symptoms to CAG 7 hours. CAG was performed in 91% of patients with STEMI and 84% of patients with NSTEMI. Stenting was performed in 69% of patients. Although many patients had a complicated cardiovascular history, at the time of admission only 31.5% of patients were taking at least one drug from the groups of antiplatelets, oral anticoagulants, statins, and beta-blockers.Conclusion. Patients with MI in the Russian Federation are younger than patients with MI in European countries. Among the clinical and historical characteristics, conspicuous is the presence of modifiable risk factors in many patients, as well as the presence of a previous diagnosis of ischemic heart disease. Furthermore, a small proportion of patients took statins, antiplatelet agents or anticoagulants at the outpatient stage, which indicates a great reserve of both primary and secondary prevention of cardiovascular diseases in the Russian Federation. The delayed seeking medical help is also noticeable, which indicates the need for increasing the public awareness of the symptoms of MI and the importance of timely hospitalization.
Aim. To study the features of the appointment of beta-blockers (BB) therapy in the early stages of acute myocardial infarction without ST segment elevation (nonSTEMI) in real clinical practice in the Russian Federation according to the REGION registry, to analyze the frequency and use cases of Intravenous forms (IVF).Material and methods. REGION-IM is a multicenter prospective Russian registry of acute myocardial infarction (AMI). The database records demographic, anamnestic, clinical characteristics of patients, results of laboratory and instrumental examinations. The patient’s recruitment was carried out from 01.11.2020 to 30.06.2023. Overall, 10,884 patients with AMI were included in the MI REGION, of which 3252 patients with non-STEMI and 7631 — with acute myocardial infarction with ST segment elevation (STEMI), information on the appointment or refusal of IV therapy on the first day of hospitalization is present for 7597 patients with STEMI.Results. On the first day after hospitalization, 1.2% (n=91) of patients with STEMI received IVF therapy. In all cases, metoprolol was used at an average daily dose of 4.43 mg. The majority of patients (61.5%, n=56) were transferred to oral administration of BB on the first day, another 33% of patients (n=30) — the next day, 4.4% (n=4) received only intravenous BB, one (1.1%) information is missing due to the transfer to another hospital. The most common relative and absolute contraindications to the appointment of BB — acute heart failure (AHF), including Killip II, and systolic blood pressure less than 120 mmHg. They were observed in less than 20% of all patients with STEMI and in 13% and 12% of patients who received IVF. 74% of patients received oral medications on the first day. Oral forms of BB were used to initiate therapy 61 times more often than IVF of BAB (p<0.0001). Hospital mortality among all patients with STEMI was 4.3% (n=328). Of these, 3.3% (n=249) — cardiac death, 0.7% (n=58) — non-cardiac cause of death, 0.3% (n=21) — the cause of death is not specified. In the group of patients who received IVF, 2.2% died (n=2, of which 1 was a cardiac cause, 1 was not indicated), 4.3% did not receive it (n=326, 76% was a cardiac cause). There was no statistically significant difference in hospital mortality in patients treated with IVF and those who did not receive IVF.Conclusion. The results of the REGION-IM registry demonstrate an unreasonably rare frequency of IVF use in the early stages of the disease in patients with STEMI. Intravenous administration of metoprolol at an average total dose of about 4-5 mg on the first day of hospitalization with further transition to oral administration of BAB was safe. There was no significant difference in the frequency of deaths in the hospital, cases of AHF, cardiogenic shock, severe conduction disorders in the form of grade II-III AV block between the groups of patients who received and did not receive IVF.
Aim. To characterize patients with acute non-ST elevation myocardial infarction (NSTEMI) hospitalized in Russian hospitals, study their anamnestic, demographic and clinical characteristics, treatment features and hospital outcomes, as well as compare data from previous Russian and foreign registries of acute coronary syndrome.Material and methods. Russian Registry of Acute Myocardial Infarction (REGION-IM) is a multicenter prospective observational study. The case report form contains demographic and anamnestic data, as well as the following information about the present MI: timing of symptom onset, first contact with medical personnel and admission to the hospital; data from coronary angiography (CAG) and percutaneous coronary intervention (PCI), therapy, hospitalization outcomes.Results. In total, for the period from November 1, 2020 to June 30, 2023, the study included 3253 patients with STEMI from 73 hospitals (30 vascular surgery departments, 17 of which are equipped with angiographic system, and 43 regional vascular surgery centers) from 45 constituent entities of the Russian Federation. There were 55% of high-risk patients. CAG was performed in 83,73% of patients. In 81%, CAG was performed ≤24 hours from hospitalization. PCI was performed in 62% of patients with NSTEMI. Median onset-to-balloon time was 27 hours [10;77]. The median door-to-balloon time was 5 hours [1;20]. Inhospital mortality was 3%. In the group with CAG, compared with the group without CAG, inhospital mortality was lower (2% and 6%, respectively; p<0,05). In patients with a higher risk according to the GRACE, CRUSADE and ARC-HBR scales, CAG was performed less frequently.Conclusion. In patients with NSTEMI in Russian regions, there is a high frequency of CAG and PCI, including in the early stages. Inhospital mortality is low, especially in the invasive treatment group, and corresponds to data from international registries. In severely ill patients, revascularization is performed less frequently than in low-risk patients. There is room for increasing the prescription rate of modern effective anticoagulants and antiplatelet agents. In general, the quality of treatment for NSTEMI patients has improved in recent years.
Aim. To analyze the frequency, indications, and outcomes of using glycoprotein IIb/IIIa inhibitors in patients with acute myocardial infarction (AMI) in Russia based on data from a multicenter registry.Material and methods. This work is part of the REGION-MI (Russian Registry of Acute Myocardial Infarction) multicenter retrospective-prospective observational study, which included patients admitted to hospitals in 45 regions of Russia with a diagnosis of AMI from 2020 to 2023. The decision to prescribe glycoprotein IIb/IIIa inhibitors was made by physicians. The observation period was 12 months, the following outcomes were recorded: cardiovascular events (relapse/repeated AMI, stent thrombosis, revascularisation), hemorrhagic complications, and in-hospital and all-cause mortality during the entire observation period. The study is conducted on the "Quinta" platform. Statistical data processing was performed using IBM SPSS Statistics ver.24.Results. A total of 10,884 patients were included in the registry, glycoprotein IIb/IIIa inhibitors were prescribed to 114 patients (1%), all of whom underwent percutaneous coronary intervention (PCI), while among patients with non-ST elevation myocardial infarction, the frequency of IIb/IIIa inhibitors was 0.5%, among ST-segment elevation myocardial infarction patients — 1.3%. Eptifibatide was used most often (67.5%), tirofiban was prescribed in 28.9% of cases, abciximab — 2.6%, framon — 0.9%. The most common indication for prescribing drugs were complications of PCI, in particular — distal embolism. There was a higher incidence of cardiogenic shock and multivessel revascularization in the glycoprotein IIb/IIIa inhibitor group. In-hospital mortality and adverse events within 180 days (death, cardiovascular events) did not differ between patients who did and did not receive glycoprotein IIb/IIIa inhibitors. The use of glycoprotein IIb/IIIa inhibitors in this study was associated with an increased risk of all in-hospital bleeding (odds ratio 9.656, confidence interval 2.859-3,894, p <0.001). Other predictors of in-hospital bleeding were: prescription of glycoprotein IIb/IIIa inhibitors, chronic kidney disease with glomerular filtration rate <60 ml/min/1.73 m2, body weight less than 60 kg.Conclusion. We observed a very low frequency of glycoprotein IIb/IIIa inhibitors usage in Russia, while these drugs are used mainly for complications of PCI in the group of patients with the highest risk — with cardiogenic shock, multivessel revascularisation, and complications of the procedure, which can have impact on the outcomes. Further research is needed to develop an optimal protocol for glycoprotein IIb/IIIa inhibitors administration in AMI.
AIM:Based on data from the Russian REGION-IM registry, to study the features of reperfusion therapy in patients with ST-segment elevation myocardial infarction (STEMI) in real-life clinical practice.MATERIAL AND METHODS:REGION-IM is a multicenter prospective observational study. The observational period is divided into 3 stages: during the stay in the hospital and at 6 and 12 months after inclusion in the registry. The patient's records contain demographic and history data; information about the present case of MI, including the time of the first symptom onset, first contact with medical personnel, and admission to the hospital; coronary angiography (CAG) data, percutaneous coronary intervention (PCI) data, and information about the thrombolytic therapy (TLT).RESULTS:Reperfusion therapy was performed in 88.9 % of patients with STEMI. Primary PCI (pPCI) was performed in 60.6 % of patients. The median time from the onset of symptoms to pPCI was 315 minutes [195; 720]. The median time from ECG to pPCI was 110 minutes [84;150]. Isolated TLT was performed in 7.4 %, pharmaco-invasive treatment tactics were used only in 20.9 % of cases. The median time from ECG to TLT (prehospital and in-hospital) was 30 minutes [10; 59], whereas the median time from ECG to prehospital TLT was 18 minutes [10; 39], and in 63 % of patients, TLT was performed more than 10 minutes after diagnosis. PCI followed TLT in 73 % of patients.CONCLUSION:The frequency of reperfusion therapy for STEMI in the Russian Federation has increased considerably in recent years. The high frequency of pPCI is noteworthy, but the timing of pPCI does not always comply with clinical guidelines. The results of this registry confirm the high demand for pharmaco-invasive strategies in real-life clinical practice. Taking into account geographical and logistical features, implementing timely myocardial reperfusion requires prehospital TLT. However, the TLT frequency in the Russian Federation is still insufficient despite its proven maximum effectiveness in the shortest possible time from the detection of acute MI.
Introduction . The presence of diabetes mellitus in patients with acute infarction significantly worsens short- and long-term prognosis, but the features of the course of the infarction in this category of patients have not been fully studied. Objective . To compare clinical, functional and structural myocardial characteristics of patients with acute ST-segment elevation myocardial infarction with and without diabetes mellitus. Materials and methods . The study included 91 patients with revascularized ST-segment elevation myocardial infarction (41 patients with diabetes mellitus). All patients underwent cardiac MRI with contrast, including myocardial T1 mapping, tissue analysis of left ventricular myocardium with determination of infarct zone, heterogeneous zone, edema zone, pre- and post-contrast T1 values, extracellular volume values of healthy myocardium and infarct zone. Results . The presence of diabetes in patients with AMI was associated with increased EDV LV: 153 ± 38 and 181 ± 58 ml (p = 0.007), increased ESV LV: 76 ml [54–93] and 87 ml [71–122] (p = 0.035). Infarct size was significantly larger in patients with diabetes than in those without diabetes: 37 ± 15 g (95% CI: 33–41) and 47 ± 21 g (95% CI: 40–53), p = 0.017. Patients with acute infarction and diabetes mellitus had higher extracellular volume values in both healthy myocardium: 24% [22–27] and 28% [24–30], p = 0.002, and in the infarct zone: 48% [40–58] and 58% [50–61], p = 0.016. Conclusions . In patients with ST-segment elevation myocardial infarction with diabetes mellitus, the infarct size, the edema area, and the value of the extracellular volume fraction both in the infarct area and in the preserved myocardium were larger than in patients without diabetes, which may underlie the development of myocardial dysfunction and further progression of heart failure.
The article describes the main methods of assessment of physiological significance of coronary artery stenoses, their use in clinical practice and future perspectives. New diagnostic methods that are currently under research are discussed.
Aim To study the prevalence of hyperlipidemia in patients with myocardial infarction (MI) in the Russian Federation; to assess the compliance with clinical practice guidelines of the lipid-lowering therapy prescribed upon discharge from the hospital; and to determine the number of patients who are indicated for the combination lipid-lowering therapy to achieve the low-density lipoprotein cholesterol (LDL-C) goal.Material and methods REGION-MI is Russian rEGIstry Of acute myocardial iNfarction, a multicenter, retrospective and prospective observational study. The observation period was divided into 3 stages: observation during the stay in the hospital and at 6 and 12 months after the inclusion in the registry. Plasma total cholesterol (TC) and LDL-C were measured in all patients on admission. Evaluation of the prescribed lipid-lowering therapy included the intensity of the treatment.ResultsThe study included 3 620 patients; 62.4 of them had hyperlipidemia on admission. Mean TC on admission was 5.29 mmol/l and LDl-C level was 3.35 mmol/l. Upon discharge, 95.4% of patients after myocardial infarction continued on or were prescribed statin therapy; ezetimibe was prescribed to 1.22% of patients. Patients with an extremely high level of LDL-C >5 mmol/l accounted for 10.7% of patients with hyperlipidemia. The target level of LDL-C ≤1.4 mmol/l cannot be achieved with the statin and ezetimibe combination therapy in these patients; drugs from the group of PCSK9 inhibitors are indicated for them.Conclusion According to the data of the Russian registry of acute myocardial infarction, REGION-MI, a high incidence of hyperlipidemia is observed in patients with acute MI. Despite multiple studies that have proven the importance of achieving a low LDL-C level and good tolerance and safety of ezetimibe and PCSK9 inhibitors, the prescription frequency of combination therapy remains unreasonably low. Results of a simulation study that was conducted in Sweden and the data of the REGION-MI registry showed that PCSK9 inhibitors as a part of the combination therapy are indicated for many patients. The combination therapy is presently the most powerful type of lipid-lowering treatment that allows, in most cases, achievement of the LDL-C goal.
Currently the incidence of congestive heart failure after ST-segment elevation myocardial infarction (STEMI) tends to increase. Reperfusion therapy is still the only effective method to reduce an infarct size. Therefore, there is a high unmet need of novel cardioprotective treatments that would improve outcomes in such patients. Recent advances in cardiovascular magnetic resonance (CMR) methods enabled the identification of certain new infarct characteristics associated with the development of heart failure and sudden cardiac death. These characteristics can help identify new groups of high risk patients and used as a targets for novel cardioprotective treatments. This part of the review summarizes novel CMR-based characteristics of myocardial infarction and their role in the prognostic stratification of STEMI patients.
Current management of patients with acute coronary syndrome (ACS) includes a dual antiplatelet therapy with acetylsalicylic acid and a platelet P2Y12 receptor inhibitor. For patients without a high risk of bleeding, prasugrel and ticagrelor are preferred, since their effect is more pronounced, less dependent on metabolism of a specific patient, and occurs faster that the effect of clopidogrel. The prescription rate of platelet glycoprotein IIb/IIIa (GP IIb / IIIa) receptor inhibitors has considerably decreased. However, these drugs remain relevant in percutaneous coronary interventions in patients with a high risk of coronary thrombosis or a massive coronary thrombus, in thrombotic complications of the procedure, and in the "no-reflow" phenomenon. The intravenous route of GP IIb / IIIa inhibitor administration provides their effectiveness in patients with difficulties of drug intake or with impaired absorption of oral medications. This review presents clinical and pharmacological characteristics of various GP IIb / IIIa inhibitors and data of randomized clinical studies and registries of recent years that evaluated results of their use in patients with ACS.
Aim To study specific features of administering platelet P2Y12 receptor inhibitors to patients with myocardial infarction (MI) in real-life clinical practice; to reveal a possible inconsistency of the therapy with clinical guidelines; to evaluate the patients’ compliance with the medication at the outpatient stage; and to outline major direction for improving quality of the antiplatelet treatment.Material and methods REGION-MI is a multicenter prospective, observational study. The observational period is divided into 3 stages: during the stay in the hospital and at 3 and 12 months following the inclusion into the registry. Information about the drug therapy (used at the time of hospitalization, administered before the hospitalization, received in the hospital, and prescribed at discharge from the hospital) was recorded in the patient’s individual registration card. Information about the antiplatelet treatment at 6 months following enrollment into the study was obtain by phone.Results The study included 4 553 patients. Dual antiplatelet therapy was administered after MI to 94.4 % patients: clopidogrel was administered to 52 %, ticagrelor to 42.2 %, and prasugrel to 11 patients (0.2 %). Ticagrelor was administered significantly more frequently in ST segment elevation myocardial infarction (STEMI) than in NSTEMI, 45 % and 33 %, respectively (p<0.001); clopidogrel was also administered more frequently to patients with STEMI than with NSTEMI, 59 % and 50 %, respectively. According to ARC-HBR criteria, in MI and a high risk of bleeding, clopidogrel was administered more frequently than ticagrelor (p <0.001). Ticagrelor was significantly more frequently administered to patients with MI and a low risk of bleeding than to patients with a high risk (p<0.001). In STEMI and a low risk of bleeding, ticagrelor was administered somewhat more frequently than clopidogrel, 56 % and 44 %, respectively (р<0.05). In NSTEMI and a low risk of bleeding, clopidogrel was administered more frequently than ticagrelor, 53 % and 47 %, respectively (p<0.05). At 6 months post-MI, 94 % of patients continued taking one of the P2Y12 inhibitors.Conclusion According to data of the REGION-MI registry, the frequency of administering P2Y12 inhibitors to patients with acute MI was high, and the patients’ compliance with this therapy was high at 6 months following MI. Although ticagrelor (the most available drug of all powerful platelet P2Y12 receptor inhibitors) has been prescribed more frequently in the recent years, a definite reserve exists for increasing the frequency of its administration. This is particularly important with a low risk of bleeding and the absence of requirement for anticoagulants. Thus, the prognosis for MI patients can be considerably improved.
ХАРАКТЕРИСТИКА ПОРАЖЕНИЯ КОРОНАРНЫХ АРТЕРИЙ ПО ДАННЫМ ОБЪЕМНОЙ КОМПЬЮТЕРНОЙ ТОМОГРАФИИ У ПАЦИЕНТОВ С ОСТРЫМ КОРОНАРНЫМ СИНДРОМОМКолесникова О
СРАВНЕНИЕ БЕСКОНТРАСТНОЙ МАГНИТНО-РЕЗОНАНСНОЙ ТОМОГРАФИИ СЕРДЦА (Т1-КАРТИРОВАНИЯ) И МАГНИТНО-РЕЗОНАНСНОЙ ТОМОГРАФИИ С ОТСРОЧЕННЫМ КОНТРАСТИРОВАНИЕМ В ВЫЯВЛЕНИИ ОСТРОГО ИНФАРКТА МИОКАРДА С ПОДЪЕМОМ СЕГМЕНТА ST И
The work of the national network of vascular centers of the Russian Federation (RF), based on the Clinical recommendations of the Russian Society of Cardiology and the procedure for providing medical care to patients with cardiovascular diseases, has led to significant positive results in the treatment of patients with acute coronary syndrome (ACS) in the country, although a number of targets have not yet been reached. The purpose of the publication is to demonstrate the trend in therapeutic approaches to the management of patients with ACS in 2020-2022. in Russia and analysis of their effectiveness. Quantitative and qualitative indicators of the treatment of patients with ACS for the presented analysis were obtained on the basis of monitoring data from the Russian Ministry of Health for 2018-2021. presented: Monitoring of measures to reduce mortality from coronary heart disease, letters of the Ministry of Health of Russia dated March 13, 2015 No. 17-6 / 10 / 1-177 and dated July 24, 2015 No. 17-9 / 10 / 2-4128, within which data collection carried out monthly, on the portal of the Federal State Budgetary Institution "TsNIIOIZ" of the Ministry of Health of Russia - Automated system for monitoring medical statistics and the register REGION-IM (Russian Register of Acute Myocardial Infarction) - a multicenter prospective observational cohort study for 2020-2022, organized by the Federal State Budgetary Institution "National Medical Research Center of Cardiology named after Academician E.I. Chazov" of the Ministry of Health of Russia. In Russia with a diagnosis of ACS in 2020 and 2021 403,931 and 397,930 patients were hospitalized, respectively. The decrease in the number of patients diagnosed with ACS admitted to Russian hospitals by 22.32% was mainly due to a significant decrease in hospital admissions of patients diagnosed with non-ST elevation ACS (non-STE-ACS) (by 29.03%). At the same time, the admission of patients with ST elevation myocardial infarction (STEMI) decreased only by 6.02%. Compared to 2018-2019, in 2020-2022. increased mortality in primary percutaneous coronary intervention (PCI) (by 9.6%) and in the general STEMI group (by 12.3%); significantly increased mortality both in the general group of NSTE-ACS (by 48%) and during PCI for patients with non-STE-ACS (by 28.6%); there was an increase in the average annual number of primary PCI (by 12.6%); an absolute and relative increase in the number of PCI in non-STE-ACS was revealed (by 2.7 and 37.1%, respectively). In the country's hospitals, by the time of discharge, 95% of patients receive statins, beta-blockers – 87%, ACE inhibitors – 80%, acetylsalicylic acid – 82%, P2Y12 inhibitors – 98% of patients, regardless of the type of ACS. In Russia in 2020-2022 unfavorable tendencies in the provision of care to patients with ACS include: increased mortality in primary PCI and in the general STEMI group; increased mortality both in the general group of non-STE-ACS and during PCI for patients with non-STE-ACS. The positive results of the work of the national network of vascular centers include: absolute, relative and estimated increase in the number of primary PCI; absolute and relative increase in the number of PCI in non-STE-ACS; a high level of prescribing drugs with a proven positive effect on the prognosis.
Aim To study specific features of the parenteral anticoagulant therapy for acute myocardial infarction (MI) in the Russian Federation and to evaluate the consistency of the prescribed parenteral anticoagulant therapy with the effective clinical guidelines. Material and Methods REGION-MI, the Russian rEGIstry for acute myOcardial iNfarction, is a multicenter observational study. This registry includes all patients admitted to hospitals with a documented diagnosis of ST-elevation acute MI (STEMI) and non- ST-elevation acute MI (NSTEMI) based on the criteria of the Forth Universal Definition of MI of the European Society of Cardiology. Risk of bleeding was assessed with the Academic Research Consortium for High Bleeding Risk (ARC-HBR) scale, and risk of major bleeding in patients with NSTEMI was additionally assessed with the CRUSADE scale. Results From November 01, 2020 through April 03, 2022, 5025 patients were included into the REGIONMI registry. At primary vascular departments, 70.5 % of patients were administered unfractionated heparin (NFH); at regional vascular centers, 37.1% of patients were administered NFH, 29.6 % enoxaparin, 20,2 % NFH in combination with enoxaparin, 6.8 % fondaparinux, 4.2% NFH in combination with fondaparinux, and 1.9 % nadroparin. At the prehospital stage, NFH was used as an anticoagulant support for the thrombolytic therapy (TLT) in 84% of patients, and lowmolecular heparins (LMH) were used in 16 %. At the hospital stage, UFH was administered to 64.4 % of patients, and enoxaparin was administered to 23.9 % of patients. Among the patients who had undergone primary percutaneous coronary intervention (PCI), 40 % received NFH, 25 % enoxaparin, 22% NFH in combination with enoxaparin, 7 % fondaparinux, and 4 % NFH in combination with fondaparinux. In conservative and invasive tactics of therapy for NSTEMI, NFH was also administered more frequently (43 and 43%, respectively), followed by (according to frequency of administration) enoxaparin (36 and 34%, respectively), NFH in combination with enoxaparin (10 and 16 %, respectively), fondaparinux (7 and 6 %, respectively), and NFH in combination with fondaparinux (3 and 1%, respectively). Conclusion According to the Russian registry of acute MI, REGION-MI, with all strategies for the treatment of MI, parenteral anticoagulants are not prescribed in full consistency with clinical guidelines. The most frequently used parenteral anticoagulant is NFH. Despite the high efficacy and safety of fondaparinux, the frequency of its administration remains unjustifiably low not only in the Russian Federation but also in other countries. The same can be said about the administration of enoxaparin to patients who had received TLT. Attention should be paid to physicians' awareness of recent clinical guidelines, to minimize the prehospital treatment with parenteral anticoagulants, to limit this treatment to the TLT support, and to provide continuity between all stages of medical care.
Aim.To study the effectiveness of Fortelyzin® in subgroups with different body weights in patients with ST-segment elevation acute myocardial infarction (STEMI) in the FRIDOM1 study and real clinical practice.Material and methods.Fortelyzin® was administered in a single-bolus dose of 15 mg over 10 seconds, regardless of the body weight of patients. Metalyse® was administered in a single-bolus dose of 30-50 mg over 10 seconds, depending on body weight. The one-year results of the FRIDOM1 study were evaluated by the clinical centers using telephone contact. Monitoring of Fortelyzin® use was carried out by inpatient physicians, emergency doctors and paramedics by filling out a monitoring sheet in the period from June 2013 to December 2021 in 19243 patients with STEMI.Results.In the FRIDOM1 study, the distribution of patients depending on body weight in the Fortelyzin® (n=190) and Metalyse® (n=191) drug groups was as follows: up to 60 kg — 4 people each (p=1,00); from 60 to 70 kg — 21 and 23 (p=0,87); from 70 to 80 kg — 39 and 43 (p=0,71), from 80 to 90 kg — 63 and 47 (p=0,07); from 90 to 100 kg — 30 and 41 (p=0,19); over 100 kg — 33 people (p=1,00) in each group. The effectiveness of thrombolysis according to electrocardiographic (ECG) data in the Fortelyzin® and Metalyse® groups was as follows: up to 60 kg — 75% each (p=1,00); from 60 to 70 kg — 76% vs 83% (p=0,72); from 70 to 80 kg — 82% vs 86% (p=0,76); from 80 to 90 kg — 81% vs 77% (p=0,64); from 90 to 100 kg — 80% vs 81% (p=1,00); over 100 kg — 79% vs 76% (p=1,00); in total — 80% vs 80% (p=0,87). The effectiveness of thrombolysis according to coronary angiography (CAG) (TIMI 2-3) in the Fortelyzin® and Metalyse® groups was as follows: up to 60 kg — 100% vs 50% (p=0,43); from 60 to 70 kg — 81% vs 67% (p=0,48); from 70 to 80 kg — 74% vs 84% (p=0,41); from 80 to 90 kg — 70% vs 72% (p=1,00); from 90 to 100 kg — 67% vs 66% (p=1,00); over 100 kg — 58% vs 64% (p=0,80); in total — 70% vs 71% (p=0,76). The one-year survival rate in the FRIDOM1 study in the Fortelyzin® and Metalyse® groups was 94% (p=0,91). The administration of Fortelyzin® in patients with STEMI caused blood flow restoration according to ECG data in 14624 of 19243 patients (76%), while according to CAG (TIMI 2-3) — in 3422 of 4805 patients (71%). Inhospital mortality was 5% (n=962), while intracranial hemorrhage developed in 0,5% (n=92).Conclusion.The use of Fortelyzin® in the FRIDOM1 study and in real clinical practice in a single-bolus (10 sec) dose of 15 mg in patients with STEMI with any body weight showed its high efficacy and safety, including at the prehospital stage.