RU2532340C2 - Method for prediction of probability of restenosis progression following coronary stenting - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine. Substance of the method for the prediction of a probability of a restenosis progression taking into account a stent localisation in the right coronary artery and the circumflex artery consists in the patient's blood sampling at the moment of stenting and recording a prothrombin ratio, an atherogenic index, very little density lipoproteins, high-density lipoproteins in physical values, and a stenosis value S is calculated. That is followed by calculating a probability factor of the restenosis R progression according to the predicted restenosis value 6 months later by formula. An adequacy of the restenosis prediction value 6 months after stenting is provided for the following intervals: if the stenosis is localised in the circumflex artery, 0<R<40; if the stenosis is localised in the obtuse marginal artery, 0<R<50, 90<R<100; if the stenosis is localised in the right coronary artery, 0<R<50; if the stenosis is localised in the anterior interventricular artery, 0<R<100.

EFFECT: using the declared method enables the early prediction of recurrent cardiovascular complications, particularly the restenosis progression, recurrent cardiovasoconstriction following the stenting in the right coronary artery, the circumflex artery, the anterior interventricular artery, and the obtuse marginal artery.

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Description

The invention relates to medicine, namely to cardiology, and can be used for early prediction of relapse of cardiovascular complications, in particular the development of restenosis, repeated narrowing of the heart vessels after stenting of the coronary arteries.

A known method for predicting the development of restenosis after stenting the coronary arteries with stents without drug coating (patent RU No. 2395091, published on July 20, 2010). Why genotypes of Glu298Asp polymorphisms of the endothelial synthase gene of nitric oxide (eNOS) and Prol98Leu genes of the glutathione peroxidase-1 gene (GPx-1) are determined. If the patient reveals only the Glu298 and Pro 198 alleles of the Glu298Asp polymorphisms of the eNOS gene and Prol98Leu of the GPx-1 gene, a low risk of restenosis is predicted. If either the 298Asp allele of the Glu298Asp polymorphism of the eNOS gene or the 198Leu allele of the Prol98Leu polymorphism of the GPx-1 gene is detected in the genotype, the average risk of restenosis is predicted. If the 298Asp allele of the Glu298Asp polymorphism of the eNOS gene and the 198Leu allele of the Prol98Leu polymorphism of the GPx-1 gene are detected, a high risk of restenosis is predicted. The method does not allow to quantify the likelihood of developing restenosis.

A known method for predicting restenosis of stents in the coronary arteries in the early stages after endovascular myocardial revascularization (patent RU No. 2349919 published March 20, 2009). To implement the method, an immune inflammatory response is evaluated by determining the dynamics of the expression of the cytokine IL-1. To do this, determine its concentration before and one day after stenting, and if the blood levels of IL-1 increase one day after endovascular revascularization by 25%, stent restenosis in coronary arteries is predicted. The method does not allow to quantify the likelihood of developing restenosis.

The closest in technical essence is a method for predicting the development of restenosis in the stent in working-age men with primary uncomplicated myocardial infarction (patent RU No. 2410019, published January 27, 2011), which consists in calculating the prognostic probability of developing restenosis in the stent according to the mathematical formula, taking into account localization of the stent in the anterior descending artery, the right coronary artery, the envelope of the artery, the diagonal branch, as well as indicators of the stress test, the presence of an anginal attack, horiz ontal depression of the ST segment on an ECG during a VEM test, repetition of hospitalization.

The main disadvantage of the prototype is the limited use, because this method can be used only for men and in the case of a limited range of possible clinical situations, as well as insufficiently high reliability of the prognosis due to the fact that there is no connection between the magnitude of the narrowing and the value of the prognostic coefficient of the probability of developing restenosis in the stent. The mentioned disadvantage of the prototype is due to the fact that when calculating the likelihood of developing stent restenosis, such indicators as the results of biochemical analyzes, stenosis and localization of the stent in the anterior interventricular artery, branches of the blunt edge are not taken into account.

The objective of the invention is to create a method for predicting the likelihood of developing restenosis for an extended range of possible clinical situations after stenting of the coronary arteries for various categories of patients.

The technical result consists in increasing the reliability of the prediction of the likelihood of developing restenosis for a period of up to 6 months for various categories of patients by taking into account at the time of stenting the results of biochemical analyzes, the magnitude of stenosis and an expanded spectrum of possible clinical situations, namely the localization of the stent in the anterior interventricular artery and branches blunt edge, while the prognosis of the development of restenosis by the proposed method allows to obtain a quantitative assessment of a possible repeated narrowing.

The required technical result in solving the problem is achieved using the proposed method for predicting the likelihood of developing restenosis after stenting of the coronary arteries, which consists in calculating the prognostic coefficient of the likelihood of developing restenosis taking into account the localization of the stent in the right coronary artery enveloping the artery, in contrast to the prototype containing new signs:

1. The prognostic coefficient of the likelihood of developing restenosis corresponds to the predicted value of restenosis after 6 months.

2. Take into account the extended range of localization of the stent, namely, additionally take into account the localization in the anterior interventricular artery and branches of the obtuse margin.

3. At the time of stenting:

- carry out the blood sampling of the patient and record in physical quantities the values of the prothrombin index, atherogenic coefficient, very low density lipoproteins, high density lipoproteins;

- calculate the value of the stenosis S of the patient in accordance with

ratio: S = (d _s / d ₀ ) * 100%, where

d _s is the diameter of the affected vessel,

d ₀ - the diameter of the lumen of the vessel.

4. Calculate the prognostic coefficient of the likelihood of developing restenosis R according to the formula:

+K₁₀*BC₂*S+К₁₁*ВС₃*S+K₁₂*BC₄*S+K₁₃*BС₁*ВС₂+К₁₄*ВС₁*ВС₃+К₁₅*ВС₃*ВС_4, R = K ₀ + K ₁ * S + K ₂ * BC ₁ + K ₃ * BC ₂ + K ₄ * BC ₃ + K ₅ * BC ₄ + K ₆ * S ² + $$K_7*B{C}_{\mathrm{one}}^2+K_8*B{C}_2^2+K_9*B{C}_{\mathrm{four}}^2$$

+ K ₁₀ * BC ₂ * S + K ₁₁ * BC ₃ * S + K ₁₂ * BC ₄ * S + K ₁₃ * BC ₁ * BC ₂ + K ₁₄ * BC ₁ * BC ₃ + K ₁₅ * BC ₃ * BC _four,

Where

BC ₁ - prothrombin index PTI,

BC ₂ - atherogenic coefficient,

BC ₃ - very low density lipoproteins (VLDL),

BC ₄ - high density lipoproteins (HDL),

K _i - coefficient, the value of which depends on the localization of stenosis, where index i takes values from 1 to 15.

The invention is as follows.

At the time of stenting, a patient is sampled and the values of the prothrombin index, atherogenic coefficient, very low density lipoproteins, high density lipoproteins are recorded in physical quantities. The stenosis S value of the patient is calculated in accordance with the ratio: S = (d _s / d ₀ ) * 100%, where

d _s is the diameter of the affected vessel,

d ₀ - the diameter of the lumen of the vessel.

Calculate the prognostic coefficient of the likelihood of developing restenosis after 6 months, taking into account the localization of the stent in the right coronary artery, envelope artery, anterior interventricular artery and branches of the obtuse margin according to the formula:

R = K ₀ + K ₁ * S + K ₂ * BC ₁ + K ₃ * BC ₂ + K ₄ * BC ₃ + K ₅ * BC ₄ + K ₆ * S ² + K ₇ * BC ₁ ² + K ₈ * BC ₂ ² + K ₉ * BC ₄ ² + K ₁₀ * BC ₂ * S + K ₁₁ * BC ₃ * S + K ₁₂ * BC ₄ * S + K ₁₃ * BC ₁ * BC ₂ + K ₁₄ * BC ₁ * BC ₃ + K ₁₅ * BC ₃ * BC ₄ ,

Where

BC ₁ - prothrombin index PTI,

BC ₂ - atherogenic coefficient,

BC ₃ - very low density lipoproteins (VLDL),

BC ₄ - high density lipoproteins (HDL),

K _i - coefficient, the value of which depends on the localization of stenosis, where index i takes values from 1 to 15.

When stenosis is localized in the branches of a blunt edge, the coefficients take the following values:

K ₀ = -1007.3013; K ₁ = 7.8604; K ₂ = 18.4524;

K ₃ = -18.4524; K ₄ = 0; K ₅ = 491.274;

K ₆ = 0; K ₇ = 0; K ₈ = 0; K ₉ = 0

K ₁₀ = 0; K ₁₁ = 0; K ₁₂ = -6.5503; K ₁₃ = 0;

K ₁₄ = 0; K ₁₅ = 0.

With the localization of stenosis in the envelope of the artery, the coefficients take the following values:

K ₀ = -3670.7068; K ₁ = -168.876; K ₂ = 177.2463;

K ₃ = 944.4897; K ₄ = -40.4895; K ₅ = 0;

K ₆ = 1.1258; K ₇ = -0.7408; K ₈ = 0; K ₉ = 0;

K ₁₀ = 0; K ₁₁ = 0; K ₁₂ = 0;

K ₁₃ = -10.0989; K ₁₄ = 0; K ₁₅ = 0.

With the localization of stenosis in the right coronary artery, the coefficients take the following values:

K ₀ = -129.2103; K ₁ = 2.1992; K ₂ = -4.1480;

K ₃ = 303.8618; K ₄ = -522,1097; K ₅ = -619.0743;

K ₆ = 0; K ₇ = 0.0269; K ₈ = -10.6126;

K ₉ = 0; K ₁₀ = 19.3059; K ₁₁ = 6.3003;

K ₁₂ = 0; K ₁₃ = 0; K ₁₄ = 0; K ₁₅ = 42.9024.

With the localization of stenosis in the anterior interventricular artery, the coefficients take the following values:

K ₀ = 6434.5551; K ₁ = -170.2915; K ₂ = 2.6731;

K ₃ = -466.8056; K ₄ = 1484.8251; K ₅ = 0;

K ₆ = 0; K ₇ = 0; K ₈ = 0; K ₉ = 0;

K ₁₀ = 6.2234; K ₁₁ = -14.9416; K ₁₂ = 0;

K ₁₃ = 0; K ₁₄ = -3.8507; K ₁₅ = 0.

All coefficients were obtained using reverse stepwise regression using the Statistica 7.0 statistical analysis software package. The adequacy of the predicted value of restenosis 6 months after stenting with a significance level of p = 0.05 according to the Fisher test is provided for the following intervals:

- with localization of stenosis in the envelope of the artery 0 <R <40;

- with localization of stenosis in the branches of the obtuse margin 0 <R <50, 90 <R <100;

- with localization of stenosis in the right coronary artery 0 <R <50;

- with localization of stenosis in the anterior interventricular artery 0 <R <100.

Examples of specific implementation.

1. Patient No. 9 at the time of stenting had the following indicators: localization of stenosis - located in a vessel of branches of a blunt edge, the value of stenosis S = 70%; physical values of biochemical analyzes - BC ₁ = 80 (PTI), BC ₂ = 5.1 (atherogenic coefficient), BC ₃ = 1.7 (VLDL), BC ₄ = 0.9 (HDL).

R = -1007.3013 + 7.8604 * 70-1.4578 * 80 + 18.4524 * 5.1 + 491.274 * 0.9-6.5503 * 70 * 0.9 = 40.3592

Thus, at the time of stenting, the predicted value of restenosis after 6 months was 40.3592%.

6 months after the stenting operation, examination of the patient revealed restenosis in the stent of a branch of the blunt edge with an overlap of the lumen of the vessel of 40%.

2. Patient No. 23 at the time of stenting had the following indicators: localization of stenosis - located in the envelope of the artery, stenosis S = 80%; physical values of biochemical analyzes - BC ₁ = 101 (PTI), BC ₂ = 3.9 (atherogenic coefficient), BC ₃ = 1.2 (VLDL), BC ₄ = 1.0 (HDL).

R = -3670.7068-168.876 * 80 + 177.2463 * 101 + 944.4897 * 3.9-40.4895 * 1.2 + 1.1258 * 802-0.7408 * 1012-10.0989 * 101 * 3.9 = 39.0847

Thus, at the time of stenting, the predicted value of restenosis after 6 months was 39.0847%.

6 months after the stenting operation, a patient examination revealed restenosis in the artery of the envelope of the artery with a 40% overlap in the lumen of the vessel.

3. Patient No. 5 at the time of stenting had the following indicators: localization of stenosis - located in the right coronary artery, stenosis S = 80%; physical quantities of biochemical analyzes BC ₁ = 52 (PTI), BC ₂ = 4.3 (atherogenic coefficient), BC ₃ = 0.7 (VLDL), BC ₄ = 0.9 (HDL).

R = -129.2103 + 2.1992 * 80-4.1480 * 52 + 303.8618 * 40.3-522.1097 * 0.7-619.0743 * 0.9 + 0.0269 * 52 ² - 10.6126 * 4.3 ² + 19.3059 * 0.9 ² -2.7230 * 4.3 * 80 + 6.3003 * 0.7 * 80 + 42.9024 * 0.7 * 0.9 = 31,6268

Thus, at the time of stenting, the predicted value of restenosis after 6 months was 31.6268%.

6 months after the stenting operation, a patient examination revealed restenosis in the stent of the right coronary artery with a 40% overlap in the lumen of the vessel.

4. Patient No. 20 at the time of stenting had the following indicators: localization of stenosis - located in the anterior interventricular artery, stenosis S = 70%, physical values of biochemical analyzes BC ₁ = 100 (IPT), BC ₂ = 4.3 (atherogenicity coefficient) , BC ₃ = 1.6 (VLDL), BC ₄ = 1.6 (HDL).

R = 6434.5551-170.2915 * 70 + 2.6731 * 100-466.8056 * 4.3 + 1484.8251 * 1.6 + 1.0768 * 70 ² + 6.2234 * 4.3 * 70 -14.9416 * 1.6 * 70-3.8507 * 100 * 1.6 = 62.8218

Thus, at the time of stenting, the predicted value of restenosis after 6 months was 62.8218%.

6 months after the stenting operation, examination of the patient revealed restenosis in the stent of the anterior interventricular artery with overlap of the lumen of the vessel of 60%.

Claims (1)

A method for predicting the likelihood of developing restenosis after stenting the coronary arteries, which consists in calculating the likelihood of developing restenosis taking into account the localization of the stent in the right coronary artery, envelope of the artery, characterized in that the stent is also taken into account in the anterior interventricular artery and branches of the obtuse margin, at the time of stenting, blood sampling of the patient and recorded in physical quantities the values of the prothrombin index, atherogenic coefficient, lipoproteins o very low density, high density lipoproteins, calculate the stenosis value S of the patient in accordance with the ratio: S = (d _s / d ₀ ) * 100%, where
d _s is the diameter of the affected vessel,
d ₀ - the diameter of the lumen of the vessel, and then calculate the coefficient of probability of development of restenosis R, corresponding to the predicted value of restenosis after 6 months, according to the formula:
R = K ₀ + K ₁ * S + K ₂ * BC ₁ + K ₃ * BC ₂ + K ₄ * BC ₃ + K ₅ * BC ₄ + K ₆ * S ² + K ₇ * BC ₁ ² + K ₈ * BC ₂ ² + K ₉ * BC ₄ ² + K ₁₀ * BC ₂ * S + K ₁₁ * BC ₃ * S + K ₁₂ * BC ₄ * S + K ₁₃ * BC ₁ * BC ₂ + K ₁₄ * BC ₁ * BC ₃ + K ₁₅ * BC ₃ * BC _4, where
BC ₁ - prothrombin index PTI,
BC ₂ - atherogenic coefficient,
BC ₃ - very low density lipoproteins (VLDL),
BC ₄ - high density lipoproteins (HDL),
S is the value of stenosis at the time of stenting,
K _i - coefficient, the value of which depends on the localization of stenosis, where index i takes values from 1 to 15; in the case of localization of stenosis in the branches of a blunt edge, the coefficients K _i have the following meanings:
K ₀ = -1007.3013; K ₁ = 7.8604; K ₂ = 18.4524;
K ₃ = -18.4524; K ₄ = 0; K ₅ = 491.274;
K ₆ = 0; K ₇ = 0; K ₈ = 0; K ₉ = 0
K ₁₀ = 0; K ₁₁ = 0; K ₁₂ = -6.5503; K ₁₃ = 0;
K ₁₄ = 0; K ₁₅ = 0;
with localization of stenosis in the envelope of the artery, the coefficients take the following values:
K ₀ = -3670.7068; K ₁ = -168.876; K ₂ = 177.2463;
K ₃ = 944.4897; K ₄ = -40.4895; K ₅ = 0;
K ₆ = 1.1258; K ₇ = -0.7408; K ₈ = 0; K ₉ = 0;
K ₁₀ = 0; K ₁₁ = 0; K ₁₂ = 0;
K ₁₃ = -10.0989; K ₁₄ = 0; K ₁₅ = 0;
with localization of stenosis in the right coronary artery, the coefficients take the following values:
K ₀ = -129.2103; K ₁ = 2.1992; K ₂ = -4.1480;
K ₃ = 303.8618; K ₄ = -522,1097; K ₅ = -619.0743;
K ₆ = 0; K ₇ = 0.0269; K ₈ = -10.6126;
K ₉ = 0; K ₁₀ = 19.3059; K ₁₁ = 6.3003;
K ₁₂ = 0; K ₁₃ = 0; K ₁₄ = 0; K ₁₅ = 42.9024;
with localization of stenosis in the anterior interventricular artery, the coefficients take the following values:
K ₀ = 6434.5551; K ₁ = -170.2915; K ₂ = 2.6731;
K ₃ = -466.8056; K ₄ = 1484.8251; K ₅ = 0;
K ₆ = 0; K ₇ = 0; K ₈ = 0; K ₉ = 0;
K ₁₀ = 6.2234; K ₁₁ = -14.9416; K ₁₂ = 0;
K ₁₃ = 0; K ₁₄ = -3.8507; K ₁₅ = 0;
the adequacy of the predicted value of restenosis 6 months after stenting is provided for the following intervals: with localization of stenosis in the envelope of the artery 0 <R <40; with localization of stenosis in the branches of the obtuse margin 0 <R <50, 90 <R <100; with localization of stenosis in the right coronary artery 0 <R <50; with localization of stenosis in the anterior interventricular artery 0 <R <100.