RU2749485C1 - Method for predicting cardiovascular complications within 12 months after elective endovascular myocardial revascularization in patients with ischemic heart disease - Google Patents

Abstract

FIELD: medicine.SUBSTANCE: invention relates to medicine, namely to cardiology, and can be used to predict adverse cardiovascular events within 12 months after planned endovascular myocardial revascularization. The method includes determining the level of endothelin-1 in the blood and the ratio of the waist to the thighs before the planned endovascular myocardial revascularization. Then, the risk of developing adverse cardiovascular events p is calculated using the formula p = 1/1 + exp (-z), where p is the probability of developing cardiovascular complications, exp is the exponent, z is the value of the discriminant function, and the value of the discriminant function is determined by the formula z=ax1+bx2, where x1-x2are the values of the variables corresponding to the indicators under consideration, the coefficients a, b are the weight coefficients of the corresponding indicators, x1is the concentration of endothelin-1, x1= 1 - if the concentration of endothelin-1 is greater than 0.75, x1= 2 - if the concentration of endothelin-1 is less than or equal to 0.751, a = 4.591 is a constant, x2is the ratio of the waist to the thighs, x2= 1 - if the ratio of the waist to the thighs is less than or equal to 1.0495, x2= 2 - if the ratio of the waist to the thighs is greater than 1.0495, b = -2.006 is a constant. If p is less than 0.995, the development of cardiovascular complications is predicted.EFFECT: use of the invention makes it possible to predict the onset of unfavorable cardiovascular events within 12 months after planned endovascular myocardial revascularization, to obtain an individual risk profile of a particular patient with coronary heart disease with low invasiveness and a high level of sensitivity - 88% and specificity - 92%.1 cl, 1 dwg, 3 tbl, 2 ex

Description

The invention relates to medicine and can be used in cardiology, cardiac surgery.

Despite significant advances in the development of stents and improving approaches to drug management of patients undergoing endovascular myocardial revascularization, frequent development of cardiovascular complications is recorded during the first year after percutaneous coronary revascularization (PCI), and subsequently their frequency steadily decreases over the course of subsequent observation period. Therefore, predicting restenosis processes, the development of nonfatal myocardial infarction, unstable angina pectoris, and stent thrombosis during the first year after elective 4KB is of paramount importance for providing effective outpatient care for this category of patients.

Thus, the search for predictors of unfavorable cardiovascular events with the aim of individualizing optimal pharmacotherapy and correcting patient management tactics is an urgent task of modern cardiology.

A known method for predicting a one-year risk of adverse cardiovascular events after stenting coronary arteries in patients with coronary artery disease (CHD) with metabolic syndrome without insulin resistance, which consists in the fact that patients are identified risk factors: hyperhomocysteinemia, the fact of smoking, the presence of two or more coronary arteries stenosis, narrowing the lumen of the vessel by at least 75% [1].

The disadvantage of this method is its narrow focus: the method is focused only on patients with coronary artery disease with metabolic syndrome without insulin resistance and underwent coronary stenting and does not apply to patients with diabetes mellitus.

A known method for predicting the risk of adverse cardiovascular and cerebrovascular events within 6 years after planned endovascular myocardial revascularization [2], which consists in determining the following clinical characteristics of the patient: the presence or absence of a hereditary predisposition to the development of cardiovascular diseases; conducting 4KB while taking statins with the recommendation of their subsequent continuous use upon discharge from the hospital or not taking statins; baseline level of postprandial blood glucose in mmol / l; presence or absence of a high risk of developing contrast-induced nephropathy.

The method makes it possible to predict the onset of unfavorable cardiovascular and cerebrovascular events within 6 years after planned endovascular myocardial revascularization. The primary combined endpoint of the study was only large adverse cardiovascular events, including death from cardiovascular causes, acute coronary syndrome (ACS), cerebrovascular events. In our method, the concept of adverse cardiovascular events includes not only these events, but also the development of non-fatal myocardial infarction, repeated revascularization due to stent restenosis and / or progression of atherosclerosis.

In the analyzed patent and medical scientific literature, an adequate prototype of the proposed method for predicting cardiovascular complications within 12 months after planned endovascular myocardial revascularization in patients with coronary heart disease was not found. Nowhere in the analyzed literature has the proposed combination of predictors been used to predict long-term outcomes after elective PCI.

The objective of the invention is to create a method for predicting cardiovascular complications within 12 months after planned endovascular myocardial revascularization in patients with ischemic heart disease.

The task is solved by determining the following factors in patients: the concentration of endothelin-1 (ET-1) in blood serum and calculating the ratio of waist volume (OT) / hip volume (OB), after which, to calculate the risk of developing adverse cardiovascular events, a mathematical processing of numerical values according to the proposed formula:

where p is the likelihood of adverse events;

exp - exponent;

z is the value of the discriminant function,

and the value of the discriminant function is determined by the formula:

where x ₁ -x ₂ are the values of the variables corresponding to the indicators under consideration, the coefficients a, b are the weight coefficients of the corresponding indicators.

x ₁ - concentration of ET-1

x ₁ = 1 - if the concentration of ET-1 is more than 0.751

x ₁ = 2 - if the concentration of ET-1 is less than or equal to 0.751

a = 4.591

x ₂ - ratio FROM / OB

x ₂ = 1 - if the ratio FROM / OBL is less than or equal to 1.0495

x ₂ = 2 - if the ratio OT / OB is more than 1.0495

b = -2.006

The conditional border dividing patients into 2 groups (development of adverse events and without them), according to the results of the ROC curve analysis, was defined as 0.995. Thus, if the probability of developing unfavorable cardiovascular events, calculated by this method, is less than 0.995, result 1 (unfavorable) is predicted, if the obtained value is greater than 0.995, result 0 (favorable) is predicted.

The total percentage of correctly classified results (coefficient of concordance) is 89.6%. The sensitivity of the model is 88%, the specificity is 92%.

The statistical significance of the method is high: chi-square = 88.959, p <0.001. The quality of the fit is good (Hosmer-Lemeshev test: chi-square = 0.7, p = 0.698). The share of total variance is high - Nigelkirk's R = 0.695.

New in the proposed method is the identification of the main factors that have a significant impact on the development of cardiovascular complications within 12 months after planned endovascular myocardial revascularization, a formula for determining the likelihood of cardiovascular complications within 12 months after planned endovascular myocardial revascularization, the specific p value is less than 0.995, allowing predict the development of cardiovascular complications.

Finding suitable cardiometabolic biomarkers is a priority in the field of cardiovascular medicine. This is due to the fact that traditional factors cannot always predict the risk of developing adverse cardiovascular events [3].

The proposed method for predicting the risk of unfavorable cardiovascular events is based on the fact that it is based on taking into account the influence of the most significant and sensitive factors in the pathogenesis of atherosclerosis progression, hyperproliferation of the vascular intima inside stents and thrombosis. These factors are taken into account by quantifying the level of ET-1 in the blood and calculating the OT / OB ratio.

In the study of A.P. Golikov. et al. (2017) established the most significant predictors influencing the development of unfavorable outcomes during a year of follow-up in diabetic patients with acute coronary syndrome without ST segment elevation, which turned out to be: multifocal atherosclerosis, a decrease in left ventricular ejection fraction of less than 51% and an ET-1 level of more than 0 , 87 fmol / ml [4].

The level of ET-1 in blood plasma was previously identified as a new marker of disease severity and clinical outcome in patients with coronary artery disease [5] and is associated with an increased risk of adverse events in patients with stable coronary artery disease [6; 7].

It was noted that the expression of ET-1 increases immediately after stent implantation. Along with the ability to influence vascular tone, overexpression of ET-1 can lead to vasoconstriction and a decrease in coronary blood flow, which can induce or aggravate myocardial ischemia. Second, ET-1 can reduce nitric oxide (NO) production and enhance NO degradation, leading to an imbalance) between NO and ET-1 and subsequent endothelial dysfunction [8]. Third, ET-1 may increase oxidative stress and inflammatory cell infiltration, which contribute to the formation, progression, and rupture of atherosclerotic plaques [9]. Compared to traditional biomarkers of myocardial injury (troponin I), cardiac stress (NT-proBNP), and inflammation (highly sensitive C-reactive protein), ET-1 may reflect endothelial function, which is also important for the development of atherosclerosis [10].

The study of the phenomenon of visceral obesity as one of the most significant risk factors for CC3 and the need for a simple, affordable and reliable method for assessing the amount of abdominal adipose tissue led many researchers to use the OT parameter and the OT / O ratio. The OT score is the simplest way to measure the abdominal distribution of adipose tissue.

Despite the close relationship between OT and body mass index (BMI), measurement of OT, in contrast to the determination of BMI, allows us to assess not only the degree of deviation of body weight from the norm, but also the severity of abdominal obesity. This is evidenced by a high correlation between RT, on the one hand, and visceral adipose tissue (r = 0.696) and subcutaneous adipose tissue (r = 0.828), on the other hand, according to the results of a study using computed tomography of the abdominal region [11].

However, OT is a surrogate parameter that does not provide information on the prevalence of subcutaneous or intra-abdominal components of adipose tissue. In this regard, the OT / O ratio seems to be more preferable. characterizing the distribution of subcutaneous tissue at the level of the thigh and waist and, thereby, determining the severity of the visceral depot.

The use of OT and OT / O allows to distinguish a group of "metabolically fat" patients from among those with a normal BMI.

The possibilities of verifying abdominal obesity using OT and OT / O determine the importance of these anthropometric methods for stratification of the risk of cardiovascular diseases and metabolic syndrome. In a number of studies, a 10-fold increase in the risk of developing diabetes mellitus was noted in individuals with a high OT value. an increase in the relative risk of coronary artery disease by 1.5-2.5 times when comparing patients with high and low values of OT, the association of a high cardiometabolic risk with an increase in OT / OV ratio regardless of BMI, including in patients after myocardial infarction [12].

The technical result is achieved by determining immediately before stenting two indicators: the level of endothelin-1, measuring OT and OT and calculating the OT / OT ratio and then calculating the risk of developing adverse cardiovascular events according to the proposed formula.

A feature of the method obtained in this study is that. that it is easy to use, it involves a small number of input factors, which simplifies its practical use.

The essential features characterizing the invention have shown in the claimed aggregate new properties that do not explicitly follow from the prior art and are not obvious to a specialist.

The advantages of the proposed method are:

1) minimally invasive (single venous blood sampling);

2) determination of only 1 indicator of endothelial dysfunction and 1 anthropometric indicator (OT / O ratio), which is a routine method and is determined in all cardiac patients;

3) pathogenetic validity of the combination of the selected indicators as factors influencing the development of unfavorable cardiovascular events in patients with coronary artery disease;

4) availability, low cost and simplicity in the research setting;

5) high level of sensitivity - 88% and specificity - 92%.

The method can be used in cardiological and therapeutic departments, at outpatient appointments to determine the tactics of management and dispensary observation of patients with coronary artery disease after planned PCI.

The importance of practical health care for a doctor is that the method makes it possible to:

1) get an individual risk profile of a particular patient with coronary artery disease;

2) to form comparatively homogeneous risk groups of patients according to the prognosis;

3) carry out secondary prevention in order to prevent complications of cardiovascular diseases, including the most complete correction of risk factors and the use of more aggressive patient management tactics. The main mechanisms for the implementation of secondary prevention are: dispensary observation of patients who have undergone coronary revascularization in the conditions of primary medical care by cardiologists or doctors of the district service, medical rehabilitation and sanatorium treatment;

5) plan individual treatment tactics and organize long-term adequate treatment at the stages of assistance (hospital stage, outpatient stage, sanatorium and rehabilitation stage).

Such a step-by-step individualized assessment of the risk of subsequent adverse cardiovascular events (CVD) in patients with previous myocardial revascularization will improve the outpatient management tactics of identified individuals with a high risk of cardiovascular complications, enhance the motivation of the patients themselves, and apply more intensive secondary preventive therapy regimens.

The essential features characterizing the invention have shown in the claimed aggregate new properties that do not explicitly follow from the prior art and are not obvious to a specialist. An identical set of features was not found in the patent and medical scientific literature.

Based on the foregoing, the method proposed as an invention should be considered as corresponding to the conditions of patentability "Novelty". "Inventive level", "Industrial applicability".

The invention will be clear from the following description and the accompanying figure.

Figure 1 shows the determination of the sensitivity and specificity for different values of the probability of belonging to a group of patients with an unfavorable or favorable course of coronary artery disease in the examined patients (ROC-analysis): a characterological curve (ROC-curve) of the sensitivity and specificity of the values of the obtained model in the risk of developing unfavorable cardiovascular events. The abscissa shows the specificity values (%), the ordinate shows the sensitivity (%). According to the analysis, it follows that the "cut off point" - cut off, characterizing the prediction of the risk of adverse cardiovascular events with a sensitivity of this criterion of 88% with a specificity of 92%, is the value of the probability of belonging to a group of patients with an unfavorable or favorable course of coronary artery disease 0.995

The method is carried out as follows:

Material used to determine the level of endothelin-1: blood serum.

Collection and storage of samples: Freshly collected EDTA plasma or serum samples should be placed on ice immediately after blood collection and centrifuged during the day. If the samples are not analyzed during the day of taking, then they are stored at a temperature of -20 ° C, for long-term storage - at -70 ° C.

Analysis protocol:

Перед началом анализа все реагенты должны достичь комнатной температуры (18-26°С).

All reagents must reach room temperature (18-26 ° C) before starting the assay.

Маркируют положения стандартов, бланка, контролей и образцов на схеме анализа, поставляемой с набором.

Mark the positions of standards, blank, controls and samples on the assay chart supplied with the kit.

Извлекают из пакета стрипы микропланшета и помечают их согласно схеме.

Remove microplate strips from the package and label them according to the scheme.

1. Pipette 50 µl of standards (white caps) of samples and controls (yellow caps) (STD / SAMPLE / CTRL) in duplicate into the respective wells. The well for the letterhead must remain empty.

2. Add 200 µl of detecting antibodies (AB, green bottle cap) to each well, except for the blank, mix thoroughly.

3. Cover the strips with foil and incubate overnight (16-24 hours) at room temperature (18-26 ° C). The cells must be carefully sealed to prevent evaporation.

4. Remove the film from the strips. Completely remove the contents of the wells and wash them 5 times with 300 μL diluted WASHBUF. Remove the remaining liquid in the cells after the last wash by inverting the strips on filter paper.

5. Add 200 µl of Enzyme Conjugate (CONJ) to all wells.

6. Cover the strips with foil and incubate for 1 hour at room temperature (18-26 ° C).

7. Remove the film from the strips. Completely remove the contents of the wells and wash them 5 times with 300 μL diluted WASHBUF. Remove the remaining liquid in the cells after the last wash by inverting the strips on filter paper.

8. Add 200 µl of Substrate (SUB) to all wells.

9. Incubate for 30 minutes at room temperature (18-26 ° C) in the dark.

10. Add 50 µl of STOP solution to all wells, mix their contents.

11. Read the absorbance at 450 nm from a reference wavelength of 620 nm.

A calibration curve is constructed using the absorbance values obtained for the endothelin-1 standards supplied with the kit. The results are assessed using the 4PL algorithm.

OT was measured in a standing position midway between the apex of the iliac crest and the inferior lateral edge of the ribs. The measurement was carried out on exhalation, with an emphasis on both feet and with hands hanging freely along the body. The hip circumference is measured around the widest part of the buttocks, the tape is held parallel to the floor. Use a fiberglass measuring tape. The ratio is then calculated by dividing the waist circumference by the hip circumference.

Statistical processing of the research results was carried out using the SPSS 17 and R.

To identify predictors of unfavorable endpoints, we used the logistic regression method, as well as ROC analysis with the construction of characteristic curves and the calculation of the AUC (area under the curve). The area under the ROC curve exceeding 0.70 was considered significant.

To select the optimal separation threshold for mathematical models built using stepwise logistic regression (with and without covariates), the criterion of "maximum total sensitivity and specificity" was used.

Data were presented as median (Me) and quarterly range (Q25-Q75 - 25th and 75th percentiles). The critical level of significance p for all statistical analysis procedures used was taken equal to 0.05.

To achieve this goal, we analyzed the prognosis of patients with coronary artery disease who underwent planned PCI after a year of follow-up.

The study included 225 patients with coronary artery disease at an average age of 57 [51; 63] years, admitted to the hospital in order to perform elective endovascular coronary myocardial revascularization by means of stenting.

Inclusion criteria: documented ischemic heart disease, indications for planned PCI.

Exclusion criteria: less than 6 months. after acute coronary or cerebrovascular events, uncontrolled arterial hypertension. oncological, hematological and immune diseases, inflammatory diseases in the acute stage.

All patients signed informed consent to participate in the study and further prospective observation, giving the right to anonymized data processing. The study was carried out after the protocol was approved by the Local Ethics Committee of the Research Institute of Cardiology of the Tomsk NIMTs.

Immediately before stenting of the coronary arteries, the content of one of the markers of endothelial dysfunction, the level of ET-1 (fmol / ml), was determined in the blood serum using the enzyme-linked immunosorbent assay, and the OT / OB ratio was calculated.

The patients were divided into 2 groups depending on the presence or absence of adverse cardiovascular events (HCCS).

The clinical and demographic characteristics of the examined patients are presented in Table 1. There were no significant differences between the groups in terms of the main clinical and demographic indicators.

Table 1 - Clinical and demographic characteristics of the studied groups of patients, Me [Q25; Q75]

Drug therapy before and after the procedure of endovascular myocardial revascularization did not differ statistically significantly between the groups (Table 2).

After PCI, all subjects were included in a 12-month prospective observation, during which the total cardiovascular "endpoints" were recorded, which in this study were considered: deaths, frolicking as a result of any cardiovascular event and decompensation of heart failure, as well as unplanned hospitalization due to the development of acute coronary syndrome, nonfatal myocardial infarction, acute cerebrovascular accident and in connection with the onset or progression of symptoms of heart failure by 1 functional class or more (decreased exercise tolerance, the appearance and / or increased shortness of breath, the appearance and / or an increase in edema), the occurrence of cardiac arrhythmias requiring surgical correction, repeated revascularization (coronary artery bypass grafting, stenting of the coronary arteries (CA) in connection with restenosis of the primary implanted stent or the progression of CA atherosclerosis. At the final stage, patients of both groups were subjected to repeated comprehensive examination (Table 3).

A mathematical model was created to predict cardiovascular complications within 12 months after elective endovascular myocardial revascularization in patients with coronary heart disease. The resulting model was built using logistic regression analysis with stepwise inclusion of predictors. ROC analysis was used to assess the quality of the constructed model. The Area Under Curve (AUC) was 0.995. To determine the optimal cut-off threshold, the criterion of "maximum total sensitivity and specificity" was chosen. As a result, the sensitivity of the model was 88%, and the specificity was 92%.

EXAMPLE 1: Patient Ts., 60 years old, was admitted to the clinic of the Research Institute of Cardiology on January 10, 2017 with complaints of pressing pains behind the sternum during normal physical exertion, walking 350 m, while climbing three flights of stairs, stopped with nitroglycerin (up to 2 tab. / day), pain radiating to the left shoulder, accompanied by dyspnea of a mixed nature, an increase in blood pressure to 160/90 mm Hg. Suffering from type 2 diabetes mellitus for a year.

According to coronary angiography, atherosclerosis with lesions of the anterior descending artery (ANA) - 50%, the circumflex artery (OA) - 50%, 1 branch of the blunt edge (BTK) - 75%, and the right coronary artery (RCA) - 75% were revealed.

Performed myocardial revascularization: stenting of RCA stenoses 75% and 1 VTK 75% with Integrity 3.5 * 18 and Resolute Integrity 3.0 * 15 stents.

Clinical diagnosis: IHD: exertional angina FC III. Atherosclerosis of the coronary arteries (PNA50%, OA 50%, 1VTK 75%, RCA 75%). Stenting of RCA stenoses with 75% and 1 VTK% with Integrity 3.5 * 18 mm and Resolute Integrity 3.0 * 15 mm stents. Background: Hypertension stage III. Normalization of blood pressure was achieved with medication. Diabetes mellitus type 2, target glycated hemoglobin 6.5%, achieved 7%. Hypercholesterolemia. Risk 4. NC stage 1, FC II (NYHA). Concomitant diseases: Stomach ulcer, remission. Hernia of the alimentary opening of the diaphragm. Chronic duodenitis, remission.

Treatment was prescribed: clopidogrel 75 mg / day, aspirin 75 mg / day after meals. bisoprolol 2.5 mg in the morning, fosinopril 5 mg / day, rosuvastatin 20 mg at night, metformin 500 mg, 1 tablet 2 times a day

When assessing the risk of developing adverse cardiovascular events, the developed method was used:

Thus, a p value <0.995 predicts the development of cardiovascular complications. Indeed, after 10 months, against the background of the recommended treatment, angina attacks resumed, during examination (diagnostic coronary angiography was performed): the progression of OA stenosis to 75%. Previously placed stents are patentable. OA stenting with Cypher stent was performed without residual stenosis. Hemodynamic parameters: blood pressure 130/80 mm Hg, heart rate 60 beats / min. FC CHS remained at the same level - II according to NYHA.

EXAMPLE 2: Patient V., 58 years old, was admitted to the clinic of the Research Institute of Cardiology on January 15, 2018 with complaints of pressing pain in the heart area when walking 300 m, stopped by nitroglycerin (up to 1-2 tablets / day), for an increase in blood pressure to 180/100 mm Hg On examination according to echocardiography, there are signs of postinfarction cardiosclerosis.

Coronary angiography revealed atherosclerosis with PNA lesion, stenosis of 75%. On January 20, 2018, a drug-eluting stent was implanted in the PNA.

Clinical diagnosis: IHD: exertional angina FC III. Atherosclerosis of the coronary arteries (PNA stenosis 75%). PNA stenting with Xience PR 3.5 × 23 mm stent (20.01.2018). Postinfarction cardiosclerosis. NDT stage I. FC II (NYHA). Background: Hypertensive disease stage III, the target values of blood pressure have been achieved. Left ventricular hypertrophy. Atherosclerosis of the carotid arteries (in the bifurcation of the plaque, on the left is dense 30%, on the right 35%), of the femoral arteries (on the right 35-40%, on the left 20-25%). Obesity I degree. Hypercholesterolemia. Diabetes mellitus type 2, the target level of glycated] o hemoglobin 6.5%, reached 6.5%. Diabetic polyneuropathy. Risk 4. Concomitant: Chronic atrophic gastritis, remission. Chronic autoimmune thyroiditis, euthyroidism.

Treatment was prescribed: bisoprolol 5 mg / day, candesartan 16 mg once a day, aspirin 75 mg at lunchtime, torasemide 5 mg in the morning, gliclazide MB 30 mg in the morning, metformin 850 mg 2 times a day, clopidogrel 75 mg / day.

To assess the risk of developing adverse cardiovascular events, the developed method was used:

After 12 months, against the background of the recommended treatment, the follow-up examination (diagnostic coronary angiography was performed) did not reveal the progression of atherosclerosis, signs of stent restenosis. Hemodynamic parameters: blood pressure 140/80 mm Hg, heart rate 79 beats / min. FC CHS remained at the same level - II according to NYHA.

Literature

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Claims (17)

A method for predicting cardiovascular complications within 12 months after elective endovascular myocardial revascularization in patients with ischemic heart disease, characterized by the fact that the concentration of endothelin-1 in blood serum is determined in patients before the revascularization procedure and the ratio of waist volume (WT) to thigh volume (OB) is calculated , and the likelihood of developing cardiovascular complications is determined by the formula p = 1/1 + exp (-z), where p is the likelihood of developing cardiovascular complications; exp - exponent; z is the value of the discriminant function, and the value of the discriminant function is determined by the formula z = ax ₁ + bx ₂ , where x ₁ -x ₂ are the values of the variables corresponding to the indicators under consideration, the coefficients a, b are the weight coefficients of the corresponding indicators, x ₁ - concentration of endothelin-1, x ₁ = 1 - if the concentration of endothelin-1 is more than 0.751, x ₁ = 2 - if the concentration of endothelin-1 is less than or equal to 0.751, a = 4.591 is a constant, x ₂ - ratio FROM / OB, x ₂ = 1 - if the ratio FROM / OBL is less than or equal to 1.0495, x ₂ = 2 - if the ratio FROM / OBL is more than 1.0495, b = -2.006 - constant, and if p is less than 0.995, the development of cardiovascular complications is predicted.

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