СТЕПЕНЬ СЛЕДОВАНИЯ КЛИНИЧЕСКИМ РУКОВОДСТВАМ ПРИ ОСТРОМ КОРОНАРНОМ СИНДРОМЕ БЕЗ ПОДЪЕМА ST: СВЯЗЬ С ИСХОДАМИ, ПРЕДИКТОРЫ «ПЛОХОГО» ЛЕЧЕНИЯ (РЕЗУЛЬТАТЫ РЕГИСТРА «РЕКОРД-3»)

The registries of acute coronary syndrome (ACS) are significant tools of obtaining objective data on triage and management of patients in clinical practice.Purpose. To assess the compliance with clinical practice guidelines and its association with clinical outcomes in patients with non ST-segment elevation acute coronary syndrome (NSTE-ACS) in Russian hospitals, participating in the ACS registry RECORD-3.Materials and methods. The analysis was conducted based on the data of the Russian ACS Registry RECORD-3, which included 47 hospitals from 37 Russian cities. 2370 consecutive patients with ACS admitted to participating hospitals in the period from March to April, 2015 were enrolled in the registry. Out of those, 1502 (63.4 %) patients were present with NSTE-ACS. The compliance with clinical guidelines was assessed using the following criteria: the implementation of the class I-A or I-B recommendations from 2015 European Society of Cardiology guidelines. The number of recommendations used by physicians (from 8 to 15) was calculated for each patient. The number of implemented recommendations was calculated and presented as percentage.Results. 100 % implementation rate of the class I-A or I-B recommendations was determined in 1.4 % of patients. Over 75 % of the recommendations were implemented in 19% of patients, and less than 50 % – in 14.6 % of patients. The median implementation rate of clinical guidelines was 63.6 % (the first-third quartiles of 54.5–72.7 %). The proportion of patients with the first and the second quartiles of implemented clinical practice guidelines (poor management) was 54.0 %. The proportion of patients with the third and the fourth quartiles (good management) was 46.0 %. The mortality rate in the group of patients with good physician compliance with clinical practice guidelines was 1.0 %, whereas in patients with poor physician compliance, it was 3.7 % (p=0.0015). The independent predictors of poor physician compliance with clinical practice guidelines were identified and included Killip class IV congestive heart failure, admission to a “non-invasive” hospital, as well as self/family referrals to the hospital, positive history of atrial fibrillation, the absence of ST-segment depression and elevated troponin levels, non-use of acetylsalicylic acid and angiotensin-converting enzyme / sartana, initial blood glucose levels ≤6 mmol / l.Conclusion. 75 % of clinical guidelines for the management of patients with NSTE-ACS were implemented by physicians only in 19 % of patients; the in-hospital mortality in patients assigned to poor physician management was significantly higher than in patients with good management (3.7 % vs. 1.0 %, p=0.0015); the independent predictors of poor physician management were determined, allowing defining a group of ACS patients, who require active and complete implementation of clinical practice guidelines by physiciansРегистры острого коронарного синдрома (ОКС) – значимый инструмент получения объективной информации о ведении пациентов в реальной клинической практики.Цель. Оценить степень следования положениям клинических руководств и ее связь с клиническими исходами у пациентов с ОКС без подъемов ST (ОКСбпST) в российских стационарах – участниках регистра ОКС «РЕКОРД-3».Материалы и методы. Проведен анализ на основании данных российского регистра ОКС «РЕКОРД-3», который проводился в 47 стационарах 37 городов России. В регистр включено 2 370 последовательно поступивших пациентов с ОКС, госпитализированных в стационары-участники регистра в марте – апреле 2015 года, из них у 1 502 (63,4 %) был ОКСбпST. Критериями, по которым оценивалась степень следования клиническим руководствам, были рекомендации IА или IB класса руководств Европейского общества кардиологов 2015 года. В результате для каждого пациента было рассчитано число применимых к нему руководств (от 8 до 15), а также определено число выполненных рекомендаций, рассчитанное в процентах.Результаты. Рассчитанная частота выполнения 100 % клинических руководств IА или IВ класса была у 1,4 % пациентов. Более 75 % клинических руководств выполнено у 19 %, а менее 50 % – у 14,6 % пациентов. Медиана выполнения клинических руководств составила 63,6 % (1–3-й квартили – 54,5–72,7 %). Доля пациентов с 1-м и 2-м квартилями выполнения клинических руководств («плохое») составила 54,0 %, доля пациентов с 3-м и 4-м квартилями выполнения руководств («хорошее») – 46,0 %. В группе пациентов с «хорошим» следованием клиническим руководствам госпитальная летальность составила 1,0 %, а среди больных с «плохим» следованием – 3,7 % (р=0,0015). Выявлены независимые предикторы «плохого» следования клиническим руководствам: класс IV острой сердечной недостаточности по Killip, госпитализация в «неинвазивный» стационар, а также госпитализация, минуя скорую медицинскую помощь, фибрилляция предсердий в прошлом, отсутствие депрессий сегмента ST и повышения уровня тропонина, неиспользование ацетилсалициловой кислоты, а также ингибитора ангиотензинпревращающего фермента /сартана, исходный уровень глюкозы крови ≤6 ммоль/л.Выводы. Лишь для 19 % пациентов было выполнено 75 % руководств по ведению пациентов с ОКСбпST; госпитальная летальность у пациентов, относящихся к группе «плохого» лечения, была достоверно выше, чем у пациентов с «хорошим» лечением – 3,7% против 1,0 % (р=0,0015); выявлены независимые предикторы «плохого» лечения, позволяющие определить группу пациентов с ОКС, у которых необходимо добиваться максимально полного выполнения клинических руководств

Cause of Death and Predictors of All-Cause Mortality in Anticoagulated Patients With Nonvalvular Atrial Fibrillation : Data From ROCKET AF

M. Kaste on työryhmän ROCKET AF Steering Comm jäsen.Background-Atrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all-cause mortality may guide interventions. Methods and Results-In the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose-adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all-cause mortality in the 14 171 participants in the intention-to-treat population. The median age was 73 years, and the mean CHADS(2) score was 3.5. Over 1.9 years of median follow-up, 1214 (8.6%) patients died. Kaplan-Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all-cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33-1.70, P= 75 years (hazard ratio 1.69, 95% CI 1.51-1.90, P Conclusions-In a large population of patients anticoagulated for nonvalvular atrial fibrillation, approximate to 7 in 10 deaths were cardiovascular, whereasPeer reviewe

Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes

BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. RESULTS: During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to -0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P<0.001). Rates of hospitalization for heart failure did not differ between the two groups (hazard ratio, 1.00; 95% CI, 0.83 to 1.20; P = 0.98). There were no significant between-group differences in rates of acute pancreatitis (P = 0.07) or pancreatic cancer (P = 0.32). CONCLUSIONS: Among patients with type 2 diabetes and established cardiovascular disease, adding sitagliptin to usual care did not appear to increase the risk of major adverse cardiovascular events, hospitalization for heart failure, or other adverse events

Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease

BACKGROUND: The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high-density lipoprotein (HDL) cholesterol level, reduces the low-density lipoprotein (LDL) cholesterol level, and enhances cellular cholesterol efflux capacity. We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high-risk vascular disease. METHODS: In a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, we enrolled 12,092 patients who had at least one of the following conditions: an acute coronary syndrome within the previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease. Patients were randomly assigned to receive either evacetrapib at a dose of 130 mg or matching placebo, administered daily, in addition to standard medical therapy. The primary efficacy end point was the first occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina. RESULTS: At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo. After 1363 of the planned 1670 primary end-point events had occurred, the data and safety monitoring board recommended that the trial be terminated early because of a lack of efficacy. After a median of 26 months of evacetrapib or placebo, a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91). CONCLUSIONS: Although the cholesteryl ester transfer protein inhibitor evacetrapib had favorable effects on established lipid biomarkers, treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high-risk vascular disease. (Funded by Eli Lilly; ACCELERATE ClinicalTrials.gov number, NCT01687998 .)

MANAGEMENT AND OUTCOMES IN ACUTE CORONARY SYNDROME WITH ATRIAL FIBRILLATION IN “NON-INVASIVE” CLINIC

Aim. To evaluate the management and outcomes in acute coronary syndrome patients (ACS) comorbid with atrial fibrillation (AF) during in-patient period and in 12 months from ACS onset.Material and methods. Into multicenter prospective registry (CCH № 29 of Moscow), beginning December 2013, during 12 months, all consecutive patients included, with ACS, and AF on baseline ECG. Follow-up was continued during hospitalization and in 12 months from ACS (phone call).Results. Totally, 234 patients included. Mean age 72,0±11,6 y.o., 65+73,5%, females — 68,8%, anamnesis of myocardial infarction (MI) — 35,9%, diabetes — 23,9%, known AF before ACS — 65,0%, non-ST-elevation ACS — 97,9%, Killip &gt;I — 7,3%, ST depression on baseline ECG — 89,9%, high troponin level — 59,0%, GRACE risk of fatal outcome &gt;140 points. — 75,2%, median CHA2 DS2 -Vasc — 5 pts. At discharge from hospital, 44% patients received double antiplatelet treatment (DAT), 38% — aspirin with oral anticoagulant (OAC), 33% — warfarin, 23% — new OAC (NOAC). During hospitalization (median 14 days) 7 patients died (3,0%). In 12 months the outcomes were followed in 210 patients (89,8%). By 12 months from ACS onset, 18,1% patients died, and in 12 months but after discharge — 15,3%. New MI after discharge had 1,5%, stroke — 2,5%, and bleeding — 3,5% patients. The part of fatal outcomes in 12 months did not differ in DAT or aspirin with OAC groups (12,1% vs 12,8%; p=0,88). The “remained” prescription rate (i.e. adherence) in 12 months after ACS was maximum for aspirin, OAC and NOAC (71%, 58%, 63%, resp.) and minimum for DAT and aspirin with OAC (20% and 27%, resp.). The independent predictors of death after discharge from hospital up to 12 months from ACS onset were the baseline hemoglobin &lt;110 g/L (OR 16,00; 95% CI 2,57-99,50; р=0,003), non-treatment by antithrombotics before ACS (OR 7,22; 95% CI 2,20- 23,68; р=0,001), hospital risk by GRACE &gt;140 pts. (OR 6,88; 95% CI 1,44-32,80; р=0,015) and non-prescription of aspirin in discharge (OR 3,21; 95% CI 1,20-8,61; р=0,02).Conclusion. The results of observational study of ACS and AF patients, admitted to Moscow city “non-invasive” clinic, showed high rate of fatal outcomes in 12 months after ACS (18,1%), low adherence to the prescribed treatment after discharge. Also, in the group studied, there were predictors of fatal outcomes in 12 months after ACS

EARLY DISCONTINUATION OF FONDAPARINUX IN LOW-RISK PATIENTS HOSPITALIZED WITH NON-ST-ELEVATION ACUTE CORONARY SYNDROME: MARKERS OF HEMOSTASIS ACTIVATION AND IN-HOSPITAL OUTCOMES

Current guidelines recommend use of anticoagulants (preferably fondaparinux) until hospital discharge in non-invasively treated patients (pts) with non-ST-segment elevation acute coronary syndrome (NSTEACS).  however, some evidence exists that anticoagulants may be safely stopped earlier in low-risk aspirin-treated pts. Aim. To assess markers of hemostasis activation and in-hospital events rate after very early discontinuation of fondaparinux in non-invasive treatment of low-risk pts hospitalized with NSTEACS. Material and methods. 53 pts admitted with NSTEACS at median 2,3 h after last episode of chest pain were included into prospective non-comparative study. All pts had GRACE score ≤108, negative tn t (cut-off 0,03 ng/ml), and no st-segment deviation &gt;0,1 mV. Aspirin and beta-blockers were used in all cases while clopidogrel in 35 (66,0%) only. After single subcutaneous injection of fondaparinux at presentation no anticoagulants were used. Plasma thrombin-antithrombin (tAt), d-dimer (dd), plasmin-antiplasmin (PAP) levels, plasminogen activator inhibitor-1 (PAI-1) activity and its complex with tissue plasminogen activator (tPA/PAI-1) level were measured at median 18,0 and 42,5 hours after fondaparinux. 12-lead ECG monitoring was started at median 21,2 h after fondaparinux and continued for median 38,6 h.  Treadmill stress test was performed on days 4-18 (median 9) after hospitalization. Pts were followed until hospital discharge (median 14 days). Results. Plasma  tAt ,  dd and PAP levels increased after discontinuation of  fondaparinux: medians 3,1 and 3,3 ng/l (p=0,002), 359 and 486 ng/l (p=0,002), 471 and 498 ng/l (p=0,052), respectively. Increase at least one of these markers of hemostasis activation was revealed in 49 (92,5%) pts. Ischemic  st-segment deviations on ambulatory ECg were found in 13 pts (24,5%). First episode appeared at median 51,8 hours after fondaparinux and only one was symptomatic. tAt , dd and PAP levels as well as their changes were not associated with recurrence of ischemia. Positive result of treadmill test was obtained in 12 Conclusion. While in non-invasive treatment of low-risk nstEACs pts very early discontinuation of fondaparinux was associated with activation of coagulation this laboratory finding was not related to recurrence of ischemia and clinical events rate was low. (25,0%) pts (5 with and 7 without ischemic  st-segment deviations on ambulatory ECg; p=0,25).  during hospital stay, no patient died or had myocardial infarction; 3 had recurrent angina

GENDER SPECIFICS OF CLINICAL COURSE AND IN-PATIENT STAGE OF MANAGEMENT IN ST ELEVATION ACUTE CORONARY SYNDROME PATIENTS (BY THE RUSSIAN REGISTRY OF ACUTE CORONARY SYNDROME “RECORD-3”)

Aim. To evaluate gender differences in the disease course and in treatment at inpatient stage of management of ST elevation acute coronary syndrome (STEACS) patients by the data from the Russian Registry of Acute Coronary Syndromes “RECORD-3”.Material and methods. The study was conducted based on the data from Russian registry “RECORD-3”, in 47 institutions of 37 cities of Russia. The Registry included all consequtive patients with ACS, hospitalized in the participated institutions during march-april 2015, totally 2370 ACS patients. From the general group, patients were selected with the admission diagnosis STEACS (n=864). Mean age of STEACS patients was 62,6±12,4 y. Among them, 712 (82,4%) were primarily hospitalized into centers with invasive methods available, others (n=152, 17,6%) to non-invasive. The analysis was conducted, of the in-patient stage of patients, including reperfusion methods, and analysis of medication therapy.Results. More than a half of patients (68%) with STEACS were males, and hospitalized women were 10 years older. Females with ACS were at baseline clinically more complicated with arterial hypertension (AH), angina, chronic heart failure (CHF), diabetes 2 type, and atrial fibrillation in anamnesis. Higher number of acute heart failure was found (HF) (Killip II-IV) in females with ACS. There were no gender differences by the time of onset of pain to admittance and of doorballoon time. However coronary and ventriculography (CVG), percutaneous interventions (PCI), thrombolysis were done significantly (p=0,0001) rarer in females than in males. Higher mortality was found in females with STEACS comparing to males. There was higher rate of mortality in STEACS of females comparing to males (17,5% vs. 6,3%, p=0,0001). Monofactorial analysis revealed factors related to non-direction of patients to coronary arteriography: older age (more than 60 y. o.), female gender, cardiovascular comorbidity, acute heart failure at admittance. Conclusion. By the results of data analysis of “RECORD-3”, there were special characteristics of STEACS patients revealed for females: mean age is 10 years older than males; higher rate of cardiovascular comorbidity; reperfusion performed more rare, including outpatient stage of management. All these lead to significantly worse outcomes

2020 Clinical practice guidelines for Acute coronary syndrome without ST segment elevation

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