RU2722986C1 - Method for prediction of additional risk of thromboembolic complications in senile patients with atrial fibrillation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, cardiology, gerontology. Age is determined in the patients, collect data of anamnesis on the presence of atrial fibrillation (AF), arterial hypertension, diabetes mellitus, ischemic heart disease – acute myocardial infarction, peripheral arterial atherosclerosis, congestive chronic cardiac failure (CCF), thromboembolic complications (TEC), including cerebral strokes. Diagnosing the presence of AF by analyzing the recorded electrocardiogram (ECG) or the Holter ECG monitoring results, the presence of atherosclerotic plaques by duplex scanning of the arteries; reduction of ejection fraction (EF) in patients with CCF symptoms accompanying echocardiography. Prescription/non-prescription of oral anticoagulants (OAC) is assessed. Using the questionnaire, the patient's adherence to the recommended OAC intake is determined. According to the declared mathematical formula additional risk index of TEC (TEC ARI) is calculated. Value ARI TEC shows the low risk – if the value is up to 0.2, the average risk is 0.3–0.6, the high risk is 0.7–0.9 and the ARI TEC is more than 1.0 – a very high additional risk of TEC.

EFFECT: method provides a universal and accurate assessment of the additional risk of TEC in elderly patients suffering AF, by determining the total risk of TEC, evaluating the conducted anticoagulant therapy, as well as diagnosing adherence of the patients to the recommended treatment.

1 cl, 1 tbl, 4 ex

Description

Atrial fibrillation (AF) is a common rhythm disorder, one of the leading complications of which is various thromboembolism, thromboembolic complications (TEO), in particular thromboembolic ischemic cerebral stroke (MI) (cerebral infarction), acute myocardial infarction (AMI), kidney infarction, intestinal infarction, etc. [2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J (2016) 37 (38): 2893-2962. DOI: https://doi.org/10.1093/eurheartj/ehw210].

F et al. Adherence to non-vitamin-K-antagonist oral anticoagulant medications based on the Pharmacy Quality Alliance measure. Curr Med Res Opin. 2015;31(12):2167-73. doi: 10.1185/03007995.2015.1096242]. Диагностика приверженности к лечению затруднена из-за отсутствия надежного метода «золотого стандарта». Наиболее часто используются опросники по оценке приверженности пациентов к лечению. Большинство таких опросников определяют только общую поведенческую реакцию в отношении приема всех лекарственных препаратов, без конкретизации. В частности, к ним относятся 4- и 8-вопросные шкалы Мориски, широко применяемые в клинических исследованиях различного дизайна [Morisky D. E., Green L. W., Levine D. M.Concurrent and predictive validity of a self-reported measure of medication adherence. Med. Care. 1986, 24(1): 67-74; Morisky DE,Ang A, Krousel-Wood M,Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008; 10(5): 348-354]. В связи с этим нередко упускается из внимания факт, что у одних и тех же пациентов может быть разная приверженность к различным лекарственным препаратам: так в случае профилактики ТЭО у больных ФП наиболее значимой является именно приверженность к приему ОАК.The main preventive method for reducing the risk of feasibility study is anticoagulant therapy, which is mainly based on the use of oral anticoagulants (OAC). A common problem for all UACs is the strict need for regular intake of drugs to ensure effective and safe therapy, i.e. treatment adherence issue [McHorney CA, Crivera C,

F et al. Adherence to non-vitamin-K-antagonist oral anticoagulant medications based on the Pharmacy Quality Alliance measure. Curr Med Res Opin. 2015; 31 (12): 2167-73. doi: 10.1185 / 03007995.2015.1096242]. Diagnosis of adherence to treatment is difficult due to the lack of a reliable gold standard method. Patient adherence questionnaires are most commonly used. Most of these questionnaires determine only the general behavioral response in relation to taking all drugs, without specifying. In particular, these include 4- and 8-question Moriski scales, widely used in clinical trials of various designs [Morisky DE, Green LW, Levine DM Concurrent and predictive validity of a self-reported measure of medication adherence. Med. Care 1986, 24 (1): 67-74; Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008; 10 (5): 348-354]. In this regard, the fact that the same patients may have different adherence to different drugs is often overlooked: so in the case of the prevention of feasibility studies in patients with AF, the most significant is the adherence to receiving OAK.

There are several ways to stratify the risk of feasibility studies (mainly MI) in patients with AF.

So in a method for predicting the risk of developing ischemic stroke in patients with coronary heart disease and a constant form of atrial fibrillation [RU 2481058, IPC A61B 5/00, publ. 05/10/2013 Bull. No. 13] to assess the risk of developing ischemic MI, an additional assessment of hemostasiological indicators is proposed, which partially characterize the effectiveness of anticoagulant therapy with warfarin. The most significant drawback of the proposed method is its loss of universality in connection with the introduction, in addition to warfarin, of direct UAC drugs, for which the efficacy of anticoagulant warfarin therapy is not informative. In addition, the indicated method does not take into account the already proven risk factors of ischemic MI and other feasibility studies, in connection with which the risk assessment of the feasibility study with its help cannot be recognized as sufficiently accurate.

The basis of most currently known methods for assessing the risk of feasibility studies (special scales) is CHADS2 [Gage BF, Waterman AD, Shannon W, et al. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. J Am Med Assoc 2001; 285: 2864-2862.], ACCP 1, 2 [Laupacis A, Albers G, Dalen J, et al. Antithrombotic therapy in atrial fibrillation. Chest 1998; 114 (5 Suppl): 579S-589S; Singer DE, Albers GW, Dalen JE, et al. Antithrombotic Therapy in Atrial Fibrillation: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126 (3 Suppl): 429S-456S.], Framingham [Wang TJ, Massaro JM, Levy D, et al. A risk score for predicting stroke or death in individuals with new onset atrial fibrillation in the community: the Framingham Heart Study. J Am Med Assoc 2003; 290: 1049-1056], AFI I-III [Lip GY, Lowe GD. ABC of atrial fibrillation. Antithrombotic treatment for atrial fibrillation. Br Med J 1996; 312: 45-49. van Walraven C, Hart RG, Wells GA, et al. A clinical prediction rule to identify patients with atrial fibrillation and a low risk for stroke while taking aspirin. Arch Int Med 2003; 163: 936-943.], SPAF I-III [Hart RG, Pearce LA, McBride R, et al. Factors associated with ischemic stroke during aspirin therapy in atrial fibrillation: analysis of 2012 participants in the SPAF I-III clinical trials. The Stroke Prevention in Atrial Fibrillation (SPAF) Investigators. Stroke 1999; 30: 1223-1229] and others, - the scoring of various risk factors for the feasibility study and MI lies. Among the considered (in different combinations) risk factors include female gender, age (> 65 or> 75 years), the duration of AF, the presence of diabetes mellitus (DM), coronary heart disease (CHD), arterial hypertension (AH), thyrotoxicosis, transferred a history of acute cerebrovascular accident (stroke) or transient ischemic attack (TIA) [Hughes M, Lip GY; Guideline Development Group, National Clinical Guideline for Management of Atrial Fibrillation in Primary and Secondary Care, National Institute for Health and Clinical Excellence. Stroke and thromboembolism in atrial fibrillation: a systematic review of stroke risk factors, risk stratification schema and cost effectiveness data. Thromb Haemost. 2008; 99 (2): 295-304. doi: 10.1160 / TH07-08-0508]. A significant drawback of these methods is the incomplete accounting of all significant risk factors for feasibility studies and MI in each of them, in particular, in patients with AF, which reduces the prognostic value of these scales.

Another common drawback of these methods for scoring the risk of feasibility studies and MI in patients with AF is the leveling of the possibility of anticoagulant therapy to reduce this risk, which is realized only if the patient has a satisfactory adherence to the prescribed treatment with anticoagulants. In addition, currently in clinical practice, in addition to warfarin, preparations of new (direct) UACs (rivaroxaban, dabigatran, apixaban) have been introduced, which have a number of features. These drugs have similar feasibility as compared to warfarin for the prevention of feasibility studies, a better safety profile, but the lack of sufficiently informative indicators of anticoagulant activity, which nevertheless necessitates laboratory monitoring of the international normalized ratio, which is mandatory for warfarin therapy.

A method that provides the most accurate assessment of the main risk of a feasibility study and MI, as well as the need for the appointment of UAC, is described in Lip GYH et al. [Lip GYH, Nieuwlaat R, Pisters R, Lane DA, Crijns HJGM. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: The Euro Heart Survey on Atrial Fibrillation. Chest 2010; 137: 263-72]. It also represents a point scale (CHA2DS2VASc) and includes the determination of gender-age indicators, the presence / absence of hypertension, diabetes, signs of systolic chronic heart failure (CHF) with an ejection fraction (EF) of less than 40%, peripheral arterial atherosclerosis, AMI, arterial Feasibility study in history, ischemic MI, TIA; and superior in accuracy to risk stratification than previous counterparts [Zhu WG, Xiong QM, Hong K. Meta-analysis of CHADS2 versus CHA2DS2VASc for predicting stroke and thromboembolism in atrial fibrillation patients independent of anticoagulation. Tex Heart Inst J. 2015; 42 (1): 6-15. doi: 10.14503 / THIJ-14-4353]. Age over 75 years (“senile” by the World Health Organization) in patients with AF or a history of previous MI, TIA, or arterial thromboembolism, according to this scale, are high risk factors for feasibility study and are an obligatory indication for receiving OAC, which included in the provisions of the clinical guidelines for the management of patients with AF [2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J (2016) 37 (38): 2893-2962. DOI: https://doi.org/10.1093/eurheartj/ehw210].

The latter method is the closest to the claimed and therefore taken as a prototype. However, the disadvantages of the prototype include the unaccountedness of prescribing KLA to patients who have mandatory indications for taking these drugs (in particular, senile age), as well as the lack of assessment of patient adherence to the implementation of medical recommendations (BP) for the treatment of KLA.

The technical result of the claimed method is a universal and accurate assessment of the additional risk of feasibility study in patients with AF, performed on the basis of determining the total risk of feasibility study (according to CHA2DS2VAS with the categorization of the scale modified by the inventors) [Lip GYH, Nieuwlaat R, Pisters R, Lane DA, Crijns HJGM. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: The Euro Heart Survey on Atrial Fibrillation. Chest 2010; 137: 263-72], evaluation of anticoagulant therapy, as well as diagnosis of the degree of patient adherence to the recommended treatment according to the questionnaire - scale of adherence of the National Society of Evidence-Based Pharmacotherapy (NODF) developed by the inventors.

The universality of the claimed method is due to its applicability in any patient of senile age suffering from AF, and therefore in need of mandatory prescription and strictly regular administration of KLA, which are evaluated by the proposed method and on this basis allow stratification of patients into groups at an additional risk of feasibility study.

The accuracy of the additional risk assessment of the feasibility study is justified and confirmed by the results of a statistical analysis of the data of 78 senile patients with AF - building a model of multivariate logistic regression, which included the components of the invention as an indicator of UAC assignment, adherence to therapy on the NODF scale, and a score on the categorized scale CHA2DS2VASc. The results of multivariate logistic regression analysis revealed a statistically significant (p <0.05) proportional increase in the risk of feasibility study in such patients, depending on the degree of decrease in adherence (diagnosed on the NODF adherence scale), on an increase in the main risk of feasibility study, with no UAC (table).

Table

Results of multivariate logistic regression analysis (dependent variable - feasibility study)

Factors Included in the Logistic Regression Model Odds Ratio (OR)
(Exp (B) 95% Confidence Interval for OSH (for (Exp (B) The statistical significance of p Bottom line Upper bound Non-commitment (according to the NODF scale) - reference category - committed 4.83 1.72 13.57 0.004 Partially committed (0.4) 1.22 0.95 13.77 0.06 Partially Uncommitted (0.6) 3.85 0.93 15.89 0.08 Uncommitted (0.8) 5.34 1.09 16.36 0,03 Totally unassailable 7.36 1.90 18.57 0.01 Unassigned UAC (reference category - UAC appointment) 5.51 1.86 11.41 0.002 CHA2S2VASc (categorized) 3.05 1.21 7.74 0.02

Predictive value of the constructed model of logistic regression (percentage of correctly predicted results) = 84.9%, sensitivity = 91.1%, specificity = 75.6%. According to the logistic regression model, factors of non-adherence to KLA, non-appointment of these drugs and the maximum score on the categorized CHA2S2VASc scale statistically significantly increase the risk of feasibility study at 4.83; 5.51 and 3.05 times, respectively.

Thus, the task to which the invention is directed is achieved due to the fact that the method determines the age of the patients, collects anamnesis data on the presence of AF, hypertension, diabetes, coronary heart disease (AMI), peripheral arterial atherosclerosis, congestive heart failure, on feasibility study including MI. Diagnose the presence of AF by analyzing the registered electrocardiogram (ECG) or the results of ECG monitoring by Holter; the presence of atherosclerotic plaques by duplex scanning of the arteries of a compromised (according to history) vascular pool; decreased PV in patients with symptoms of heart failure. Appointment / nonappointment of UAC is assessed by determining the UAC assignment coefficient, then using the NODF adherence scale developed by the inventors, the patient’s adherence to the recommended UAC is determined by assessing the adherence index on the NODF scale. In the case of unsatisfactory adherence, the leading factor that violates it is diagnosed. After that, it is determined by the number of points scored on the CHA2DS2VASc [Lip GYH, Nieuwlaat R, Pisters R, Lane DA, Crijns HJGM. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: The Euro Heart Survey on Atrial Fibrillation. Chest 2010; 137: 263-72] the main risk of a feasibility study. Then, according to the formula, the additional risk index of the feasibility study is calculated as

Feasibility study IDR = (UAC assignment coefficient + NODF adherence index) x Principal risk of the feasibility study,

where UAC Assignment Ratio:

= 0 - when prescribing KLA to a patient with AF;

= 1 - in the absence of a recommendation for KLA to a patient with AF,

NODF Scale of Commitment Index:

0 - in the case of the coefficient of assignment UAC = 1;

0.2 - with absolute (full) commitment and compliance with all BP when taking UAC;

0.4 - with an involuntary partial commitment (omissions in taking UAC due to forgetfulness);

0.6 - with intentional partial commitment (independent change of BP for UAC reception - change in dose, time and frequency of admission, omissions);

0.8 - with partial non-adherence and cessation of UAC;

1,0 - with absolute (complete) non-adherence - refusal to start receiving UAC,

The main risk of feasibility study is determined by the number of points scored on the CHA2DS2VASc scale (1 point is awarded to the female gender, the presence of hypertension, diabetes, ischemic heart disease, AMI or peripheral arterial atherosclerosis, congestive heart failure with PV less than 40%; 2 points are awarded to all senile patients age (over 75 years) and patients undergoing MI, TIA). For the corresponding risk, the following points are awarded:

2-3 points on the CHA2DS2VASс scale (risk <4%) - 1.0 point;

4-5 points on the CHA2DS2VASc scale (risk 4-7%) - 1.5 points;

6-7 points on the CHA2DS2VASс scale (risk 7-9%) - 2.0 points;

8-9 points on the CHA2DS2VASc scale (risk> 10%) - 2.5 points

according to the value of the feasibility study IDRs, the feasibility risk is predicted low - with a value of up to 0.2, medium - with 0.3-0.6, high - with 0.7-0.9 or very high additional risk - with a value of more than 1.0.

The proposed method was tested in a group of 78 patients older than 75 years with AF.

The inventive method is as follows: in all patients older than 75 years, with AF who came on an outpatient visit, an ECG is recorded and / or Holter ECG is monitored daily to confirm the diagnosis of AF.

Anamnesis data are collected on the presence of hypertension, diabetes, heart failure, coronary heart disease (AMI), peripheral arterial atherosclerosis, transferred TEO, including MI.

If there is a history of peripheral arterial atherosclerosis, patients undergo a duplex scan of the arteries of the compromised pool (brachiocephalic arteries (BCA), renal arteries, etc.) to confirm the presence of atherosclerotic plaques.

Patients with symptoms of congestive heart failure have an echocardiographic study (ECHO-KG) with the definition of PV.

All patients are assessed for prescription / nonassignment of UAC, then using the NODF scale of adherence, the degree of patient adherence to receiving the recommended UAC is diagnosed.

Patients are observed once every six months.

During the one-year follow-up period, the outcomes of the disease are recorded (cardiovascular events: ischemic MI, AMI and other feasibility studies; deaths as a result of these events, adverse effects of drug therapy or the absence of changes in the patient’s status).

The main risk of feasibility study is determined on the CHA2DS2VASс scale, for which data are collected on the risk factors included in this scale and the points are summed for each of them: in the presence of hypertension, diabetes mellitus, coronary heart disease (AMI) or signs of peripheral arterial atherosclerosis, symptoms of congestive heart failure (with PV less than 40%), as well as in the case of the female field, 1 point is awarded for each indicator, 2 points are added to all patients due to senile age, an additional 2 points increase on the CHA2DS2VASc scale in patients who underwent MI, TIA, and TEO. Then determine the modified categorized score indicator of the main risk of the feasibility study, used for subsequent calculations: the risk is less than 4% (2-3 points according to CHA2DS2VASc) = 1.0 point; the risk of 4-6% (4-5 points for CHA2DS2VASc) = 1.5 points; the risk is 7-9% (6-7 points on CHA2DS2VASc) = 2.0 points, and the risk is more than 10% (high, corresponding to 8-9 points on the CHA2DS2VASc scale) = 2.5 points on the modified categorized scale.

Next, they evaluate the appointment of UAC, which is mandatory for such patients, and patient compliance with BP for UAC, diagnosed using the NODF adherence scale developed by the inventors. The NODF commitment scale includes 3 questions:

1. Did the attending physician recommend you to take one of the following oral anticoagulant medications (OACs): Warfarin, Xarelto, Elikvis, Pradaksa

1) Yes (indicate which of the following) ________________________________

2) No (poll completed)

2. Do you take the prescribed medication (OAC) as recommended by your healthcare provider:

1) Yes, I take it strictly according to the doctor’s recommendations

2) Sometimes I forget to take the drug

3) I take the medicine irregularly, take breaks in taking the medicine myself, or change the dose, time, frequency of taking the drug

4) Stopped taking the drug

5) Did not start taking the drug

3. If you did not start or stop taking the prescribed drug, indicate the leading reason for this.

1) I am afraid of side effects, harm to health with long-term medication

2) There were side effects of the drug

3) Lack of tangible effect (improvement) from treatment

4) I take a lot of different drugs

5) I have a very complicated medication regimen (many times a day, many tablets)

6) The high price of the drug

7) I doubt the correctness of the treatment prescribed to me

8) I do not want to take medicine constantly for a long time

9) Other (specify) _____________________________________

The answer to the first question allows us to estimate the coefficient of prescription of UAC equal to 0 in the presence of BP for the administration of UAC to a patient with AF and equal to 1 in the absence of such VR.

The answer to the second question allows us to determine the index of adherence on the NODF scale, which is 0.2 with absolute (full) adherence and compliance with all BP when taking UAC (answer 1); 0.4 - with an involuntary partial commitment (omissions in taking UAC due to forgetfulness - answer 2); 0.6 - with intentional partial commitment (independent change of BP for UAC reception - change in dose, time and frequency of admission, omissions - answer 3); 0.8 - with partial non-adherence and cessation of UAC administration (answer 4); and 1.0 - with absolute (complete) non-adherence - refusal to start receiving UAC (answer 5 to question 2).

Based on the data obtained, the additional risk index (IDR) of the feasibility study is calculated, which is calculated by the following formula:

Feasibility study IDR = (UAC assignment coefficient + adherence index according to the NODF scale) x Principal risk of the feasibility study, where:

UAC Assignment Ratio:

= 0 - when prescribing KLA to a patient with AF;

= 1 - in the absence of a recommendation for KLA to a patient with AF.

NODF Scale of Commitment Index:

0 - in the case of the coefficient of assignment UAC = 1;

0.2 - with absolute (full) commitment and compliance with all BP when taking UAC;

0.4 - with an involuntary partial commitment (omissions in taking UAC due to forgetfulness);

0.6 - with intentional partial commitment (independent change of BP for UAC reception - change in dose, time and frequency of admission, omissions);

0.8 - with partial non-adherence and cessation of UAC;

1,0 - with absolute (complete) non-adherence - refusal to start receiving UAC.

Principal risk of feasibility study

determined by the number of points scored on the CHA2DS2VASc scale (1 point is awarded for female gender, the presence of hypertension, diabetes, coronary heart disease, AMI or peripheral arterial atherosclerosis, congestive heart failure with EF less than 40%; 2 points are awarded to all patients of old age (older 75 years) and patients who underwent MI, TIA). For the corresponding risk, the following points are awarded:

2-3 points on the CHA2DS2VASс scale (risk <4%) - 1.0 point;

4-5 points on the CHA2DS2VASc scale (risk 4-7%) - 1.5 points;

6-7 points on the CHA2DS2VASс scale (risk 7-9%) - 2.0 points;

8-9 points on the CHA2DS2VASc scale (risk> 10%) - 2.5 points.

Stratification into additional risk groups for the development of a feasibility study is carried out depending on the value of the feasibility study IDR. In case of a feasibility study IDR:

up to 0.2 - low additional risk

0.3 - 0.6 - average additional risk

0.7 - 0.9 - high additional risk

more than 1.0 - very high additional risk

In response to the third question on the NODF scale of adherence, the leading cause of patient non-adherence to receiving the recommended UAC (if there is such an appointment) is diagnosed, which is corrected by informing the patient about the need for strictly constant administration of UAC, replacing or prescribing UAC (in the absence of such BP earlier).

To assess the effectiveness of eliminating the causes of non-adherence and re-diagnosing the degree of BP fulfillment for receiving UAC (adherence), repeated visits to the doctor are recommended with a frequency of 6 months after the visit, on which the assessment of the feasibility study IDR is carried out, information training and correction of therapy are carried out.

The method allows to reliably predict the additional risk of developing a feasibility study in elderly patients with AF, to adjust treatment and adherence to taking the recommended anticoagulant, depending on the identified leading factor of non-adherence.

Using the proposed method, 78 patients, over 75 years old, with AF were examined.

Clinical example No. 1

Patient K., 84 years old, came to see a cardiologist. From the anamnesis: the patient for a long time suffers from hypertension, coronary heart disease, CHF. The ECG confirmed the diagnosis of AF, a constant form. According to the performed echocardiography FV = 34%. The number of points according to CHA2DS2VASс = 5 points (age (2) + AH (1) + IHD (1) + CHF (1)). The patient was previously prescribed warfarin (OAC), but the patient refused to take the drug (response 5 on the NODF adherence scale)

According to the proposed method:

Feasibility study IDR = (0 (warfarin) + 1.0 (absolutely not committed)) x 1.5 (5 points CHA2DS2VASс) = 1.5

The patient is diagnosed with a very high additional risk of feasibility study.

The patient is informed about the need to take a UAC, rivaroxaban is recommended.

Six months later, the patient came to visit: it turned out that the patient had not started taking rivaroxaban because of fears of side effects of the drug.

Feasibility study IDR = (0 (rivaroxaban) + 1.0 (absolutely not committed)) x 1.5 (5 points CHA2DS2VASс) = 1.5

Feasibility study IDR> 1.0 - the patient has a very high additional risk of feasibility.

The patient is once again informed about the need for strict adherence to treatment with OAK (rivaroxaban) due to the high risk of developing a feasibility study.

After 1 year, when collecting information about the patient from a relative, information was received that the patient had not started the recommended treatment, the patient had ischemic MI with a fatal outcome.

Clinical example No. 2.

A patient M., 77 years old, came to see a cardiologist. According to the anamnesis, it was found that the patient for a long time suffers from hypertension, coronary artery disease, persistent AF, suffered from AMI. Over the past 5 years, symptoms of heart failure have been noted: severe shortness of breath, edematous syndrome. The ECG confirmed the diagnosis of AF, a constant form. When ECHO-KG determined PV = 37%.

The number of points according to CHA2DS2VASс = 5 points (age (2) + AH (1) + transferred AMI (1) + congestive heart failure (1)). Apixaban is assigned to the patient, which, according to the completed questionnaire, sometimes the patient forgets to accept (0.4 points on the NODF adherence scale).

According to the proposed method, the feasibility study IDR was calculated:

TEC IDR = (0 (apixaban) + 0.4 (sometimes forgets and misses the reception)) x 1.5 (5 points CHA2DS2VASс) = 0.6

The patient is diagnosed with an average additional risk of feasibility study.

The patient is informed about the need to take the drug OAK (apixaban) in strict accordance with BP for the effective prevention of feasibility study.

Six months later, the patient came to the doctor’s visit, there are no gaps in taking apixaban: the patient takes UAC in strict accordance with BP.

Feasibility study IDR = (0 (apixaban) + 0.2 (absolutely not committed)) x 1.5 (5 points CHA2DS2VASс) = 0.3

Additional risk of feasibility study reduced from medium to low.

Clinical example No. 3.

Patient Sh., 81 years old, came to see a cardiologist. From the anamnesis: the patient for a long time suffers from hypertension, a paroxysmal form of AF (with frequent paroxysms), there are signs of carotid atherosclerosis. According to the results of ECG monitoring by Holter, paroxysms of AF were recorded, the diagnosis of AF was confirmed, and the paroxysmal form. A duplex scan of the carotid arteries was performed, atherosclerotic plaques were detected in the right carotid artery (with stenosis of the lumen up to 60%) and in the left carotid artery (stenosis of 45%).

The number of points according to CHA2DS2VASс = 5 points (age (2) + AH (1) + peripheral atherosclerosis (1) + female gender (1)). The patient was prescribed the drug OAC dabigatran, the reception of which she independently missed, reduced the dose of the drug = 0.6 (on the adherence scale NODF).

According to the proposed method defined IDR feasibility study:

Feasibility study IDR = (0 (dabigatran) + 0.6 (UAC administration with independent BP impairment)) x 1.5 (5 points CHA2DS2VASс) = 0.9

The patient is diagnosed with a high additional risk of feasibility study.

The patient is informed about the need to take the drug KLA dabigatran in strict accordance with BP.

Six months later, the patient came to the doctor’s visit, took dabigatran strictly in accordance with BP (0.2 on the NODF adherence scale)

TEC IDR = (0 (dabigatran) + 0.2 (on the NODF adherence scale)) x 1.5 (5 points CHA2DS2VASс) = 0.3

Additional risk of feasibility study reduced to a low level.

After 1 year of observation, the patient's condition is stable, no deterioration. There were no new cardiovascular events, including a feasibility study. Correction of therapy is not required.

Clinical example 4.

Patient P., 76 years old, came to visit a cardiologist. From the anamnesis it was found that for 10 years, hypertension and a constant form of AF have been suffering. An ECG was registered, on which a constant form of AF was confirmed. The number of points according to CHA2DS2VASс = 3 points (AH (1 point) and age over 75 years (2 points)). The patient takes rivaroxaban in strict accordance with BP (0.2 points on the NODF adherence scale).

According to the proposed method defined IDR feasibility study:

Feasibility study IDR = (0 (rivaroxaban) + 0.2 (because assignment coefficient = 1)) x 1 (3 points CHA2DS2VASс) = 0.2

The patient is diagnosed with a low additional risk of feasibility study. Correction of therapy is not required. It is recommended to continue taking rivaroxaban in accordance with BP.

Claims (18)

A method for predicting the additional risk of thromboembolic complications (TEO) in senile patients with atrial fibrillation (AF) by mathematical calculations, including evaluating gender-age indicators, collecting anamnesis data on the presence of AF, arterial hypertension, diabetes mellitus, coronary heart disease (acute heart attack) myocardium), peripheral arterial atherosclerosis, congestive chronic heart failure (CHF), about feasibility studies, including cerebral strokes, the diagnosis of AF by analyzing a registered electrocardiogram (ECG) or Holter ECG monitoring results, the detection of atherosclerotic plaques by duplex scanning of arteries a compromised (according to history) vascular pool; a decrease in the ejection fraction (EF) in patients with symptoms of heart failure with an echocardiographic study, characterized in that the appointment / non-appointment of oral anticoagulant (OAC) preparations is evaluated, determining the coefficient of administration of OAC; then using the questionnaire on the scale of adherence of the National Society of Evidence-Based Pharmacotherapy (NODF) determine the patient's adherence to receiving the recommended UAC - index of adherence on the NODF scale; by the number of points scored on the categorized CHA2DS2VASс scale, the main risk of the feasibility study is evaluated, after which the additional risk index of the feasibility study (feasibility study IDR) is calculated as: Feasibility study IDR = (UAC assignment coefficient + NODF adherence index) x Principal risk of the feasibility study, where the destination coefficient of the UAC: = 0 - when prescribing KLA to a patient with AF; = 1 - in the absence of a recommendation for KLA to a patient with AF, NODF adherence index: 0 - in the case of the coefficient of assignment UAC = 1; 0.2 - with absolute - full commitment and compliance with all BP when taking UAC; 0.4 - with an involuntary partial commitment - omissions in the reception of UAC due to forgetfulness; 0.6 - with intentional partial commitment - independent change of BP for receiving UAC - change in dose, time and frequency of admission, omissions; 0.8 - with partial non-adherence and cessation of UAC; 1,0 - with absolute - complete non-adherence - refusal to start receiving UAC, the main risk of the feasibility study is determined by the number of points scored on the CHA2DS2VASc scale: 1 point is awarded to the female gender, the presence of hypertension, diabetes, ischemic heart disease - transferred OI or atherosclerosis of peripheral arteries, congestive heart failure with PV less than 40%; 2 points are awarded to all patients of senile age older than 75 years and patients who have undergone MI, TIA, according to the corresponding risk, the following points are awarded: 2-3 points on the CHA2DS2VASc scale - risk <4% - 1.0 point; 4-5 points on the CHA2DS2VASc scale - risk 4-7% - 1.5 points; 6-7 points on the CHA2DS2VASc scale - risk 7-9% - 2.0 points; 8-9 points on the CHA2DS2VASc scale - risk> 10% - 2.5 points, according to the value of the feasibility study IDR, an additional feasibility study is predicted: low - at a value of up to 0.2, medium - at 0.3-0.6, high - at 0.7-0.9 and with a feasibility study IDR of more than 1.0 - very high .