S. S. Yakushin

OUTPATIENT REGISTER OF CARDIOVASCULAR DISEASES IN THE RYAZAN REGION (RECVASA): PRINCIPAL TASKS, EXPERIENCE OF DEVELOPMENT AND FIRST RESULTS

Aim. To estimate risk factors and comorbidity structure, cardiovascular diseases outcomes, evaluate their diagnostics and treatment quality in real outpatient practice using a register of patients with arterial hypertension (HT), ischemic heart disease (IHD), chronic heart failure (CHF) and atrial fibrillation (AF) in the Ryazan Region – the territorial subject ofRussian Federation with high cardiovascular mortality rate. Material and methods. The total of 1000 HT, IHD, CHF, AF patients, applied for general practitioners or cardiologists of theRyazan outpatient clinics in March-May of 2012 were sequentially enrolled in the outpatient REgister of CardioVAscular diseases (RECVASA). Results. According to outpatient cards data HT, IHD, CHF and AF were diagnosed in 99.0%; 70.9%; 74.8% and 13.7% of the 1000 cases, respectively. 820 (82%) patients revealed a concomitant cardiovascular pathology (cardiac comorbidity), at that the most frequent was combination of HT with IHD and CHF (50.4%). Diabetes mellitus was diagnosed in 209 (20.9%) patients. 770 (77%) patients were assessed on their total cholesterol level; smoking status and family history of heart diseases were estimated in 28 (2.8%) and 49 (4.9%) patients, respectively. Exercise tolerance test (stress-test) was carried out in 2% of the patients (including 2.8% of the IHD patients), 24-hour blood pressure (BP) and ECG monitoring – in 0.7% and 5.5%, respectively; echocardiography and ultrasound of brachiocephalic arteries (BCA) – in 25.6% and 8.6%, respectively; coronary angiography – in 1.6% (which includes 2.3% of the IHD patients). The following drug groups were prescribed most frequently: antiplatelet agents – in 60.4% of the cases (584 patients received acetylsalicylic acid and 20 – clopidogrel), ACE inhibitors – in 62.9%, β-blockers – in 43.9% of the patients. Target BP level was achieved in 245 of 956 cases (25.6%). 50.6% of IHD patients and 51.1% of hypercholesterolemic patients received statins. Conclusion. The pilot stage of the RECVASA study revealed a high incidence rate of cardiac comorbidity (82%) in patients with hypertension, IHD, CHF and AF, insufficient estimation of cardiovascular risk factors, inadequate frequency of stress-tests, 24-hour BP and ECG monitoring, echocardiography, BCA sonography, coronary angiography use, as well as a scarce prescription of warfarin in AF and statins in hypercholesterolemic patients. Improvement of correspondence to national guidelines is the main reserve for enhancement of diagnostics and treatment quality in patients with HT, IHD, CHF, AF and hypercholesterolemia.

DIAGNOSIS AND TREATMENT OF PATIENTS WITH SEVERE HYPERCHOLESTEROLEMIA IN REAL OUTPATIENT PRACTICE (ACCORDING TO THE RECVASA REGISTRY)

Hypercholesterolemia is a proven risk factor for atherosclerotic cardiovascular diseases and for their complications. Aim. To assess the quality of diagnosis and treatment of patients with severe hypercholesterolemia (total cholesterol >6.2 mmol/L) in the real outpatient practice. Material and methods. All patients with a diagnosis of arterial hypertension, ischemic heart disease, chronic heart failure, atrial fibrillation applied to primary care physicians or cardiologists in one of the randomly selected out-patient clinic of Ryazan in March-May 2012 and included into the RECVASA registry were enrolled into the study group (n=1642). Results. The group of patients with severe hypercholesterolemia consisted of 561 (44%) patients at the age of 67 (59-75) years [Me (25% -75%)]. At that, diagnosis of hyperlipidemia was indicated only in 9% of outpatient cards. Data of one or more blood chemistries including low density cholesterol (LDC) levels were presented only in 7% of outpatient cards. 83.7% of patients with severe hypercholesterolemia were classified as patients at high or very high cardiovascular risk, but statins were recommended only to 17.8% of them. Statins were mainly recommended in moderate doses; only one patient took atorvastatin 40 mg per day. Blood LDC levels were examined only in 5% of patients during statins therapy; nobody of them reached target LDC levels. Conclusion. The study data revealed the presence of a high prevalence of severe hypercholesterolemia in patients with cardiovascular diseases and poor quality of diagnosis and treatment in these patients in the real outpatient practice.

THE CONTROL OF INTERNATIONAL NORMALISED RATIO IN PATIENTS WITH ATRIAL FIBRILLATION TREATED WITH WARFARIN IN OUTPATIENT AND HOSPITAL SETTINGS: DATA FROM RECVASA REGISTRIES

Am. To study in the RECVASA registers the availability of data about the international normalized ratio (INR) indicator and achievement of its target values in outpatient and hospital practice in patients with atrial fibrillation (AF) receiving anticoagulant therapy with warfarin. Material and methods . Data about the INR control and the frequency of achievement of its target values at the outpatient and hospital stages were analyzed in RECVASA (Ryazan) and RECVASA FP – Yaroslavl outpatient registries, as well as in the hospital registers RECVASA FP (Moscow, Kursk, Tula) in 817 patients (46.9% of men, age 68.5±9.6 years) with AF and the prescribed anticoagulant therapy with warfarin. Results . INR was determined in 689 (84.3%) of 817 patients. The values of INR were monitored during therapy with warfarin in RECVASA (Ryazan) and RECVASA FP –Yaroslavl outpatient registries in 73.7% and 77.7% of patients, respectively, and in RECVASA FP hospital registers: 95.8% (Moscow); 81.3% (Tula) and 93.5% (Kursk). The target level of INR (2.0-3.0) was achieved in a minority of patients with AF during treatment with warfarin: inRyazan – in 26.3% of cases;Yaroslavl – 38.3%;Kursk – 34.8%;Moscow – 39.5%; Tule – 26.3%. Control of INR in hospital registries during warfarin therapy in patients with AF significantly more often (p<0.05) was performed at the hospital stage, compared with prehospital (in Kursk –2.3 times more often in Moscow – 2.6 times, in Tula – in 1,8 times). The target level of INR in the hospital was achieved significantly more often (p<0.05) than before hospitalization (Moscow andKursk), but no significant differences were found in the RECVASA FP –Tula register (p=0.08). The INR was monitored by 94.9% of the patients; however, the target values of this indicator were achieved only in 33% of cases in the sample study in the RECVASA FP –Moscow registry according to a survey of 39 patients with AF who continued to receive warfarin after 2.6±0.8 years after discharge from the hospital. Conclusion . INR was monitored in 74-96% of patients with AF treated with warfarin and included in the RECVASA and RECVASA FP registries. Target levels of INR were achieved only in 26-39% of patients. INR was monitored with achievement of its target levels more often at the hospital stage of treatment than before hospitalization and more often than in outpatient registries. In practical public health in patients with AF treated with warfarin, it is fundamentally important to monitor INR and increase the frequency of achieving its target values, at which the risk of cardioembolic stroke and other thromboembolic complications is proven to be reduced.

ASSESSMENT OF ADHERENCE TO TREATMENT AND FACTORS AFFECTING IT IN PATIENTS WITH STABLE ISCHEMIC HEART DISEASE DURING THERAPY WITH NICORANDIL

Working Group of the NIKEA Program. Ekaterinburg: Akulina E.N.; Izhevsk: Shinkareva S. E., Grebnev S.A.; Krasnodar: Kudryashov E.A., Fendrikova A.V.; Krasnoyarsk: Nemik D.B., Pitaev R.R., Altaev V.D., Samokhvalov E.V., Stolbikov Y.Y.; Moscow: Dmitrieva N.A., Zagrebelnyy A.D., Zakharova A.V., Balashov I.S., Leonov A.S., Sladkova T.A., Zelenova T.I., Shestakova G.N., Kolganova E.V., Maksimova M.A.; Novosibirsk: Moskalenko I.V., Shurkevich A.A.; Omsk: Loginova E.N., Gudilin V.A.; Orel: Zhuravleva L.L., Lobanova G.N., Luneva M.M.; Orenburg: Kondratenko V.Y.; Rostov-on-Don: Kalacheva N.M., Kolomatskaia O.E., Dubishcheva N.F., Romadina G.V., Chugunova I.B., Skarzhinskaia N.S.; Ryazan: Bulanov A.V., Trofimova Y.M., Nikolaeva A.S.; St. Petersburg: Savinova E.B., Ievskaia E.V., Vasileva L.B.; Tula: Zubareva L.A., Berberfish L.D., Gorina G.I., Nadezhkina K.N., Iunusova K.N., Nikitina V.F., Dabizha V.G., Renko I.E., Soin I.A. Aim. To study the adherence to treatment and the factors that affect it in patients with stable coronary heart disease during the treatment with nicorandil. Material and methods . The use of nicorandil in addition to standard antianginal therapy was recommended to patients (n=590) in a prospective, observational, multicenter NIKEA study. Patients completed original questionnaires on adherence, including a Morisky-Green test at the enroll visit. The questionnaires were filled by 423 patients (73% response). The factors that influence adherence were studied. Results. All patients were divided into 3 groups, depending on the adherence to the use of nicorandil: immediately refused to take the drug (n=150; group 1); started, but stopped taking nicorandil in the first 3 months of observation (n=75; group 2); who took nicorandil for 3 months (n=327; group 3). Potentially adherents (intention to treat) were 582 out of 590 (98.6%) patients, and actually adherents – only 327 of 552 (59.2%) patients. The main reason for non-adherence to the beginning of therapy is polypharmacy; to the continuation of the treatment that had just started – adverse events; for termination of long-term therapy – polypharmacy, adverse events and insufficient effectiveness of treatment. Group 3 had initially more severe angina pectoris: more number of angina attacks (p=0.014) and the need of short-acting nitrates (p<0.0001). Patients of the group 1 compared to the patients of group 3 did not visit the doctors more often or attended them only when necessary, violated the medical prescriptions for taking medications (p<0.05). According to the results of the Morisky-Green test, 150 patients (36.2%) were not are committed to medical recommendations, 264 (63.8%) – are committed. Women were more adherent than men (p=0.47); patients with class I angina were more adherent than patients with class III angina (p=0.027), and patients who regularly attended the treating physician (more often than once a month) were more committed to medical recommendations than patients, not visiting the treating physician (p=0.004). С onclusion . The levels of overall adherence according to Morisky-Green test, the potential adherence according to the survey and the actual adherence of patients to treatment vary considerably. The leading cause of non-adherence at the beginning of therapy is polypharmacy, for the continuation of the recently started treatment – the adverse events; for long-term sustained treatment – equally polypharmacy, drug adverse events and the lack of treatment efficacy.

DRUG TREATMENT OF PATIENTS WITH THE HISTORY OF ACUTE STROKE: DATA OF THE PILOT PHASE OF THE OUTPATIENT REGISTRY «REGION»

Aim. To study the pharmacological treatment of patients with acute stroke (AS) within the prospective outpatient registries. Material and methods. In the pilot phase of the study, conducting on the base of one of the out-patient clinic in Ryazan city, 200 and 115 patients were included into the outpatient registry of patients with AS history of any remoteness (AS-AR registry), and outpatient registry of the first apply (AS-FA registry) to the out-patient clinic after stroke, respectively. The correspondence of the prescribed and actually taken drug therapy to clinical recommendations, its continuity, and the adherence of patients to treatment were assessed during the prospective observation. Results . Most patients did not receive adequate therapy to reduce the risk of AS and other cardiovascular complications in the outpatient stage, especially in the period prior to the reference AS. Drugs with a proven beneficial effect on the prognosis in the post-stroke period were prescribed significantly (p and after 2 years – in the AS-FA registry, the frequency of the therapy was not significantly different from the frequency of prescribing at the stage of inclusion in the registers, with the exception of statins (they were taken 1.7 and 1.5 times less frequently). Prognostically significant prescriptions of the inclusion phase were performed in the long-term follow-up period in 49% and 70% of patients (on average 58%), respectively; however, the frequency of first-time therapy was 44% and 19% of the total number of prescriptions in this period, respectively. Adherence to treatment, according to the Morisky-Green questionnaire, was revealed in 17.7 and 51.7% of patients, respectively Conclusion. The results of the pilot phase of the REGION study (AS-AR and AS-FA outpatient registries) showed that the quality of the prescribed drug therapy of patients in out-patient clinic is inadequate. A comparison of the data of AS-AR and AS-FA registries allows to make a preliminary conclusion that over the 5-year period separating the remoteness of AS development in these registries, the quality of patient treatment has significantly improved, although not enough. The proportion of previously performed prognostically significant prescriptions averaged only about 60% at the stage of the further prospective follow-up. In general, during the observation period, taking into account newly made prescriptions, the frequency of adequate drug therapy during the observation period decreased only for statins. Most patients were not sufficiently committed to pharmacological treatment according to the Morisky-Green questionnaire.

PATIENTS WITH COMBINATION OF CHRONIC HEART FAILURE, HYPERTENSION AND HISTORY OF MYOCARDIAL INFARCTION: CLINICAL AND ANAMNESTIC CHARACTERISTICS, ADMINISTRATION OF ACE INHIBITORS, ANGIOTENSIN RECEPTOR BLOCKERS, -BLOCKERS AND ADHERENCE TO THE DRUG THERAPY (DATA OF OUTPATIENT REGISTRY RECVASA)

Aim. To assess the clinical and anamnestic characteristics, the prescription rate of angiotensin converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB) and β-blockers in the outpatient practice, adherence to drug therapy in patients with a combination of chronic heart failure (CHF), hypertension (HT) and history of myocardial infarction (MI) in the frame of Cardiovascular Disease Registry (RECVASA). Material and methods. Data analysis in groups of patients with a combination of CHF, HT and the history of MI (n=406) and patients with a combination of CHF, HT and ischemic heart disease (IHD) without history of MI (n=1897) was performed in the frame of RECVASA registry. The structure of the associated cardiovascular and concomitant non-cardiac diseases, the severity of the clinical manifestations of CHF, IHD and HT, the prescription rate of the ACEI/ARB and β-blockers, the adherence to drug therapy (according to the Morisky-Green test) were studied in groups. Results. Patients with a combination of CHF, HT and IHD with or without MI history significantly differed in the proportion of men (47.8% vs 24.9%, respectively), prevalence of atrial fibrillation (25.9% vs 20.5%, respectively), diabetes mellitus (27.3% vs 15.7%, respectively) and the stroke history (17.2% vs 10.7%, respectively). The mean age (69.9±11.0 vs 70.3±11.0 years, respectively), as well as the prevalence of the history of respiratory diseases, chronic kidney disease, digestive diseases, obesity and anemia, did not differ significantly. Patients with a combination of CHF, HT and post-infarction cardiosclerosis (PICS) compared with patients without PICS significantly more often had CHF class 3-4 NYHA (62% vs 47.9%, respectively), HT of degree 3 (92.5% vs 84.2%, respectively), stable angina class 3-4 (84.4% vs 66.4%, respectively). Patients with PICS significantly (p<0.05) more often received β-blockers (56.7% vs 42.2%, respectively), a combination of ACEI/ARB plus β-blockers (44.6% vs 35.1%, respectively), but less often – monotherapy with ACEI/ARB (73.7% vs 77.6%, respectively). The proportion of patients with adherence to treatment (4 points on the Morisky-Green scale) was greater in patients with PICS (37.2% vs 30.6%, respectively; p<0.05). Conclusion. Patients with CHF in combination with HT and PICS compared with patients without PICS had more prevalence of atrial fibrillation, diabetes mellitus and stroke history, more severe course of CHF, HT and IHD, greater prescription rate of β-blockers, combinations of ACEI/ARB plus β-blockers, but less prescription rate only ACEI/ARB, higher adherence to treatment. The prescription rate of prognostically significant ACEI/ARB and β-blockers in these patients is inadequate, and only one third of patients are adherent to treatment.

QUALITY ASSESSMENT OF ANTIHYPERTENSIVE THERAPY IN PATIENTS WITH ARTERIAL HYPERTENSION WITHOUT CONCOMITANT CARDIOVASCULAR DISEASES AS A PART OF OUTPATIENT RECVASA REGISTER

Aim. To assess the quality of arterial hypertension (HT) pharmacotherapy within the outpatient register RECVASA, emphasizing whether the choice of antihypertensive drugs (AHD) is in line with current clinical guidelines. Material and methods. Patients with HT without ischemic heart disease, chronic heart failure and atrial fibrillation (n=741) were selected from all patients (n=3690) included into the register. Among concomitant diseases were revealed the following: bronchial asthma and/or chronic obstructive pulmonary disease (COPD) – in 42 (5.7%) patients; obesity – in 93 patients, impaired glucose tolerance – in 9 patients, and diabetes mellitus – 84 patients. Prescription of AHD, their number and class were recorded at every next visit to doctor. Accuracy of AHD choice, compliance with current clinical guidelines, and other considerations were assessed through the example of beta-blockers (BBs). Results. AHD were prescribed to 641 patients, and in 13.5% of patients did not receive any AHD. 49.7% of patients received ACE inhibitors, 38.5% – diuretics, 32.5% – BBs. BBs were prescribed to the third part of patients with diabetes and obesity. Furthermore a quarter patients with COPD and the third part of patients with bronchial asthma received BBs. BBs in combination with thiazide diuretics were prescribed to 12 (41.4%) patients with diabetes mellitus and to 13 (40.6%) patients with obesity. Conclusion. Doctors do not always make AHD choice according to current clinical guidelines. Compliance of AHD choice with current clinical guidelines should be an element of treatment quality assessment.