К вопросу о выполнении рекомендованных лечебных мероприятий у больных острым коронарным синдромом в кардиологических учреждениях на территории Российской Федерации

Objective: to assess the clinical and economic feasibility of ticagrelor in combination with acetylsalicylic acid (ASA) in comparison with clopidogrel in combination with ASA in patients with acute coronary syndrome (ACS), including both those who underwent, and those who did not undergo percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); and new oral anticoagulants (NOACs) in combination with clopidogrel in comparison with warfarin in combination with clopidogrel and ASA in patients with atrial fibrillation (AF) who underwent PCI; to identify the impact of the above strategies of antithrombotic therapy on the targets of the State Health Care Program of the Russian Federation (RF) “Development of Health Care” and the Federal Project “Cardiovascular Diseases Control”.Material and methods. The clinical and economic study (CES) of ticagrelor in combination with ASA in ACS patients was based on a costbenefit analysis. A combined model, including a decision tree and Markov model was developed. The horizon period of the analysis was 5 years. Quality-adjusted life year (QALY) was used as an efficiency criterion and only the direct medical costs associated with the conditions identified in the modeling were taken into account. A discount rate of 5% was taken into account during the CES. The application of NOACs in combination with clopidogrel was studied in the CES using a cost minimization analysis considering the costs per patient characterized by the presence of AF regardless of the presence of ACS and a history of PCI.Results. We used a decision tree and Markov modeling in adult patients with ACS, who had or had not undergone PCI or CABG, in the horizon period of 5 years considering the discount rate of the added quality-adjusted life year (incremental cost-effectiveness ratio (ICER) per QALY). The result for ticagrelor in combination with ASA compared to clopidogrel in combination with ASA was 605,199 rubles, which was significantly lower than the willingness-to-pay threshold (2,235,201 rubles). Assessment of the impact of the therapy regimen including ticagrelor in combination with ASA on the target indicators of the State Health Care Program of the RF “Development of Healthcare” and the Federal Project “Cardiovascular Diseases Control” showed that the use of this therapy regimen will reduce mortality from myocardial infarction (MI) and cardiovascular causes by 2.45 cases per 100 thousand population provided that 100% of patients with MI and unstable angina in the RF are transferred from clopidogrel + ASA scheme to ticagrelor + ASA. The potential contribution of ticagrelor in combination with ASA compared to clopidogrel in combination with ASA in patients with ACS in achieving the target reduction of mortality from circulatory diseases will be 6.48% by 2023. In all simulated scenarios, in the group of patients with AF who had undergone PCI, pharmacotherapy regimens containing NOACs (dabigatran etexilate, rivaroxaban, apixaban) were more costly than therapy regimens containing warfarin (with not significantly different effectiveness).Conclusion. The results of the evaluation of clinical and economic feasibility of antiplatelet therapy strategies demonstrated the costeffectiveness of ticagrelor in combination with ASA compared to clopidogrel in combination with ASA in patients with ACS, including those who had undergone PCI or CABG and those who had not. The strategy of ticagrelor + ASA showed a favorable effect on the rates of mortality from MI, as well as from circulatory diseases. The results of the clinical and economic evaluation of the four strategies of antithrombotic drug therapy in patients with AF who had undergone PCI showed higher costs of the regimens containing NOACs with a presumed zero effect on the mortality from circulatory diseases.

Cardiovascular diseases remain a common cause of morbidity and mortality in populations around the world, varying in incidence by age and gender. Every year, more than 7 million people around the world are diagnosed with acute coronary syndrome, which may be the first clinical manifestation of coronary heart disease. In the ranking of mortality causes in the Russian Federation, diseases of the circulatory system occupy a leading place. The purpose of the review was to analyze the clinical characteristics and spectrum of coronary lesions of patients with acute coronary syndrome depending on age and gender. Thus, according to the results of coronary angiography, young patients with myocardial infarction were rarely accompanied by multivessel or ostial lesions of the coronary arteries, in contrast to the elderly patients. It was revealed that multivessel lesions of the coronary arteries more often characterize males, and singlevessel lesions more often characterize females. It is obvious that the prognosis of patients with acute coronary syndrome will largely depend not only on age and gender, but also on the outcome of the syndrome, the quality and scope of diagnostic and treatment procedures. This is especially important since most patients under 60 years of age are exposed to some form of systematic work load in their field of activity. The influence of polypathy, characteristic of modern cardiac patients, can be expressed to varying degrees depending on the gender and age of the patient with acute coronary syndrome. The article presents data on the short-term and long-term prognosis of patients with acute coronary syndrome, taking into account gender and age periods, including depending on the tactics of their management. Determining the clinical characteristics of patients of different ages allows to take them into account for selecting effective and safe therapy, preventing wave-like atherosclerosis as the main cause of coronary heart disease, thereby improving prognosis and survival.

Background Studies from countries with high public health expenditure (PHE) have reported a decline of the rates of mortality from cardiovascular disease (CVD).Given that most mortality from CVD occurs in countries with low and middle PHE, there is a need for broader information on the relationship between variability in disease burden and outcomes in such countries. Purpose The aim of this study was to evaluate the relation among risk factors, revascularization therapies and short-term mortality from acute coronary syndromes (ACS) in patient admitted to hospitals in middle versus low PHE countries. Methods Data were derived from 18,704 patients admitted to 41 hospitals referring data to the ISACS-TC registry (NCT0128776). Patients were divided in two groups:low and middle PHE. Bosnia and Herzegovina,Croatia,Hungary,Italy,and Serbia have high PHE values, whereas Macedonia, Romania, Lithuania, Russian Federation, Kosovo,Moldova, and Montenegro, have low values. Main outcome measure was 30-day mortality. We used logistic-regression models to assess the effect of variables on the associations of interest. Results There were 18,704 patients admitted to hospital for an ACS. Of these patients, 45% were in the low PHE group and 55% in the middle PHE group. Patients in middle PHE group were older (64% vs 61%), had higher prevalence of traditional risk factors, namely hypertension (75% vs 66%), hypercholesterolemia (55% vs 31%), diabetes (28.58% vs 23.10%), and positive family history of coronary artery disease (45.66% vs 17.56) as compared with patients in the low PHE group.Furthermore, patients in the middle PHE group had more frequently history of prior ischemic heart disease and higher rate of ST segment elevation myocardial infarction (STEMI) as clinical presentation (63.91 vs 61.98). The crude 30-day mortality rate was 6.97% in the middle PHE and 5,82% in the low PHE group. After multivariable adjustment for comorbidities and treatment covariates, patients in the middle PHE group had a better outcome compared with those in the low PHE group (OR 0.64; 95% CI 0.45–0.93).As most patients presented to hospital with STEMI we performed separate analyses for such patients and stratified outcomes in function of time to hospital presentation from initial symptom onset. The odds of mortality were still lower in patients in the middle PHE group (OR 0.41; 95% CI 0.22–0.76) if they presented within 6 hours from symptom onset.In contrast there were no difference in outcomes between middle and low PHE groups (OR 0.69; 95% CI 0.34–1.44) in patients with delayed presentation.This held true even in patients undergoing primary percutaneous intervention (OR 1.02; 95% CI 0.43–2.39). Conclusions There are significant costs and infrastructure limitations that prohibit most countries with low PHE from having timely admission to hospital of patients with suspected ACS. Currently, many of the Eastern European countries are facing an enormous burden of mortality from CVD. Funding Acknowledgement Type of funding source: None

Timely and accurate diagnosis and early start of the treatment can improve the prognosis and clinical course of acute coronary syndrome. In some cases (in the absence of persistent ST-segment elevation, non-specific ECG changes, bundle brunch blocks, atypical presentations of the disease) differential diagnosis between acute myocardial infarction and unstable angina is difficult. The currently applied markers of myocardial necrosis — heart troponins and CK-MB are not effective enough in the early stages of AMI. On results of the multicentre study ISPOLIN, which included 1049 patients in 17 cities of the Russian Federation, the new domestic express-test for the qualitative determination of cardiac fatty acid binding protein, has more sensitivity, accuracy and predictive value compared with the test of the troponin I in the first 12 h of AMI and can be recommended for wide application in practice.

Circulatory System Diseases (CSD) are the leading causes of high morbidity and mortality of the adult population in many countries, including in the Russian Federation and largely determine public health status. The aim of the work is to analyze the dynamics of the general and primary morbidity of CSD and coronary heart disease (CHD) in the adult population of the Moscow Region for 2008–2016. We used the data of Rosstat for 2008–2016. The indicators of the total and primary morbidity of CSD and CHD of the adult population were determined. A high level and dynamics of an increase in the morbidity of CSD and CHD in the Moscow Region for the 2008 – 2016 period, which determine the high need for endovascular care, especially for patients with acute coronary syndrome, have been established.

Aim. This trial was aimed at comparing the efficacy and safety of sirolimus-eluting coronary stent “Calypso” (Angioline) and everolimus-eluting coronary stent “XiencePrime” (Abbott Vascular) when used for treatment of ischemic heart disease patients.Methods. The trial included patients suitable for coronary revascularization with coronary stenting. They underwent a standard revascularization procedure and were randomized in 2:1 ratio to receive “Calypso” coronary stent (Angioline) (n = 407) or “XiencePrime” coronary stent (AbbottVascular) (n = 203). The follow-up period was 12 months. In order to detect restenosis (secondary endpoint), angiographic follow-up was performed in 20% of cases at 12 months. The trial protocol had no limitations regarding the length of lesions, number of target lesions and number of implanted stents. The main exclusion criterion was STEMI. The composite primary endpoint included one-year target lesion-related complications determined as cardiogenic death, target vessel myocardial infarction, clinically indicated target lesion revascularization. The primary endpoint data were evaluated by an independent committee.Results. In the trial, 55% of patients had acute coronary syndrome with ST elevation and type C lesions were detected in 46% of cases. In “Calypso” and “XiencePrime” groups, TLF occurred in 5.4% and 6.4% respectively (absolute risk difference in TLF accounted for 1%, 95% CI [---;2.1%]; p non-inferiority = 0.017). Thus, the hypothesis of non-inferiority of “Calypso” as compared to “XiencePrime” was confirmed. The incidence of stent thrombosis (definite and probable) was relatively low and had no significant differences between “Calypso” and “XiencePrime” groups (0.73% and 0%; p>0.05). Definite stent thrombosis was noted in two cases in the “Calypso” group (0.49%), in one case the cause of thrombosis turned out to be incomplete stent expansion after implantation.Conclusion. “Calypso” sirolimus eluting stent was not inferior to “XiencePrime” everolimus-eluting stent in treating patients with coronary heart disease.Received 7 November 2017. Revised 13 November 2017. Accepted 20 November 2017.Funding: The study was funded by “Angioline Interventional Devices” (Novosibirsk, Russian Federation). The supporting source had no involvement in study design; collection, analysis and interpretation of data; writing of the report; and in the decision to submit the article for publication.Conflict of interest: The authors declare no conflict of interest.

Highlights The comorbid course of ischemic cardiovascular diseases with indications for surgical revascularization and untimely surgical correction of blood circulation in chronic ischemic heart disease and lower limb ischemia, asymptomatic stenosis of the common/internal carotid artery ≥ 70% cause high risks of developing adverse cardiovascular outcomes – acute coronary syndrome, acute cerebrovascular accident, critical ischemia of the lower extremities and death. The improvement of the surgical stage of treatment for comorbidity of ischemic cardiovascular diseases based on the tactics of single-stage revascularization of various arterial basins using X-ray endovascular technology contributes to the timely availability of surgical care and the medical and economic efficiency of the healthcare organization. Abstract Aim. To evaluate the medical economic effectiveness of single-stage revascularization of various arterial pools (RVAP) in patients with comorbidity of chronic ischemic cardiovascular diseases (CICVD) and indications for surgical revascularization. Methods. A multicenter research (n = 6) was in 2004–2024. The research subjects were patients (n = 854) with comorbidity of chronic ischemic heart disease (CIHD) and limb ischemia (CLI) 2B-4 st., asymptomatic stenosis ≥ 70% of the common/internal carotid artery (CCA/ICA), with indications for RVAP in accordance with the clinical guidelines of the Russian Federation. The average age of patients was 74.1 ± 7.4 years. Patients of the main group A (n = 106) underwent single-stage RVAP, and patients of the control group B (n = 748) underwent two-stage RVAP, a stage interval – 3.2 ± 8.25 days. Endovascular technology was used for RVAP. To evaluate the safety, clinical, angiographic, social, financial and economic effectiveness of medical care with RVAP. The follow-up period for evaluate of results was 1 and 3 years. The methods of content analysis, statistical, mathematical, comparative analysis were applied. For statistical analysis the program Statistica 6.0 (StatSoft Inc., USA) was applied. Results. Patients in groups A and B were comparable in terms of age and sex, prevalence of CICVD with indications for RVAP and risk factors of cardiovascular complications (CVC). Indications for revascularization in 2 and 3 arterial pools were established in 94.6% (n = 808) and 5.4% (n = 46) of patients, respectively. The structure of 2-pool revascularization: for CLI 3–4 st. and CIHD (n = 539, 63.1%) – single-stage (n = 84, 15.6%) and two-stage (n = 455, 84.4%); for CLI 2B st. and CIHD (16.2%, n = 138) – single-stage (n = 5, 3.6%) and two-stage (n = 133, 96.4%); with CLI 3–4 st. and unilateral stenosis ≥ 70% of CCA/ICA (8.4%, n = 72) – single-stage (n = 8, 11.1%) and two-stage (n = 64, 88.9%); with CIHD and unilateral CCA/ICA stenosis ≥ 70% (4.1%, n = 35) – single-stage (n = 7, 20%) and two-stage (n = 28, 80%); with CLI 2B st. and unilateral stenosis ≥ 70% of CCA/ICA (1.76%, n = 15) – single-stage (n = 2, 13.3%) and two-stage (n = 15, 86.7%); with bilateral stenosis ≥ 70% of CCA/ICA (1.05%, n = 9) a two-stage endovascular procedures was performed. Three-pool revascularization tactic was performed in patients with CLI 3–4 st, CIHD and unilateral stenosis ≥ 70% of CCA/ICA (5.4%, n = 46). One-year results were assessed in all patients in group A and 89.7% (n = 670) in group B. Three-year results were assessed in all patients in group A and 81.3% (n = 608) patients in group B. In all cases, clinical and angiographic effectiveness of RVAP was achieved, there were no complications. The period of hospital treatment in patients of group A was 1.2 ± 2.6 days, group B 2.9 ± 4.15 days. In 1st year of follow-up the indications for repeated revascularization arose due to the progression of CLI in 1 patient of group A and 3 patients of group B and the return of angina pectoris to 2–3 FC in 2 patients of group B. During 3 years of follow-up the remaining patients did not have repeated revascularizations and CVC, which was facilitated by continuous controlled dispensary care according to the developed algorithm. The average bill and direct costs for one-stage RVAP were 487.4 ± 15.1 rubles and 158.6 ± 12.8 rubles, for two-stage – 634.8 ± 18.7 rubles and 196.9 ± 16.2 rubles, for three-stage – 816.8 ± 18.1 rubles and 276.1 ± 24.9 rubles, respectively. Three-year survival in both groups is 98.7%. Conclusion. The scientific practical novelty and theoretical significance of the findings on the safety, medical, social, economic and financial effectiveness of complex medical care in patients with comorbidity of CICVD with indications for surgical care and using single-stage RVAP, can become the basis for improving clinical recommendations in patients with cardiovascular diseases, with the accumulation of analytical data.

Aim . Analysis of psychosocial risk factors in coronary heart disease (CHD) patients among Russian centers of the EUROASPIRE IV study, comparing to overall study population. Material and methods . In the cross-sectional study, 24 European countries participated, including Russian Federation (3 centers). In the study, patients were included of the age 18-80 y.o., who, during the period ≥6 months to <3 years before the inclusion, had been hospitalized with myocardial infarction (MI) or other acute coronary syndromes (ACS) or for myocardial revascularization. To the study protocol, the analysis of medical charts was included, with following visit and structured interview. During the study, long-term results were evaluated, presence and level of the risk factors, including psychosocial, life quality parameters, adequacy of the acquired by patients recommendations and the grade of adherence. Prevalence of anxiety and depression symptoms was assessed with the Hospital Anxiety and Depression Scale (HADS). Results . Overall, in the Russian centers, 746 patients were included, of those to the interview visit 424 admitted (mean age 63,4±9,0 y.o., 25,2% females). Educational level of the Russian cohort was higher than of overall study population (higher education in 44,3% and 22,3%, respectively). Prevalence of the anxiety symptoms in Russian patients and in overall population almost matched: 8-10 points by HADS-A in Russia and overall had 15,7% and 15,0% of participants, respectively, the ≥11 points — 12,4% and 11,3%, respectively. Contrary, the prevalence of depression symptoms in Russia was slightly higher: 8-10 by HADS had 16,4% and 14,6%, and ≥11 — 10,9% and 7,8%, respectively. Both anxiety and depression symptoms were more common among women; depression symptoms were more common for post-MI/ ACS patients than in the re-vascularized. Conclusion . By the data from European monitoring center of EUROASPIRE IV, in Russian cohort of CHD post MI/ACS, and revascularized patients there are specific differences in comparison with overall study population in psychosocial risk factors. Prevalence of clinically significant anxiety and depression symptoms in Russian cohort of EUROASPIRE IV was significantly lower than in earlier trials, including EUROASPIRE III, and was just slightly higher than in overall study population.

Endorsed by: Research and Practical Council of the Ministry of Health of the Russian Federation.