Publications by authors named "Nina Gotcheva"

20 Publications

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Potential for optimizing management of obesity in the secondary prevention of coronary heart disease.

Eur Heart J Qual Care Clin Outcomes 2021 Jul 27. Epub 2021 Jul 27.

Department of Medicine, Solna, Karolinska Institutet, FoU - Tema Hjärta och Kärl, S1:02, Karolinska Universitetssjukhuset/Solna, SE-171 76, Stockholm, Sweden.

Aims: Prevention guidelines have identified the management of obese patients as an important priority to reduce the burden of incident and recurrent cardiovascular disease. Still, studies have demonstrated that over 80% of patients with coronary heart disease (CHD) fail to achieve their weight target. Here, we describe advice received and actions reported by overweight CHD patients since being discharged from hospital and how weight changes relate to their risk profile.

Methods And Results: Based on data from 10 507 CHD patients participating in the EUROASPIRE IV and V studies, we analysed weight changes from hospital admission to the time of a study visit ≥6 and <24 months later. At hospitalization, 34.9% were obese and another 46.0% were overweight. Obesity was more frequent in women and associated with more comorbidities. By the time of the study visit, 19.5% of obese patients had lost ≥5% of weight. However, in 16.4% weight had increased ≥5%. Weight gain in those overweight was associated with physical inactivity, non-adherence to dietary recommendations, smoking cessation, raised blood pressure, dyslipidaemia, dysglycaemia, and lower levels of quality of life. Less than half of obese patients was considering weight loss in the coming month.

Conclusions: The management of obesity remains a challenge in the secondary prevention of CHD despite a beneficial effect of weight loss on risk factor prevalences and quality of life. Cardiac rehabilitation programmes should include weight loss interventions as a specific component and the incremental value of telehealth intervention as well as recently described pharmacological interventions need full consideration.
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http://dx.doi.org/10.1093/ehjqcco/qcab043DOI Listing
July 2021

Primary prevention efforts are poorly developed in people at high cardiovascular risk: A report from the European Society of Cardiology EURObservational Research Programme EUROASPIRE V survey in 16 European countries.

Eur J Prev Cardiol 2021 May;28(4):370-379

National Institute for Prevention and Cardiovascular Health, National University of Ireland-Galway, Republic of Ireland.

Background: European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) V in primary care was carried out by the European Society of Cardiology EURObservational Research Programme in 2016-2018. The main objective was to determine whether the 2016 Joint European Societies' guidelines on cardiovascular disease prevention in people at high cardiovascular risk have been implemented in clinical practice.

Methods: The method used was a cross-stional survey in 78 centres from 16 European countries. Patients without a history of atherosclerotic cardiovascular disease either started on blood pressure and/or lipid and/or glucose lowering treatments were identified and interviewed ≥ 6 months after the start of medication.

Results: A total of 3562 medical records were reviewed and 2759 patients (57.6% women; mean age 59.0 ± 11.6 years) interviewed (interview rate 70.0%). The risk factor control was poor with 18.1% of patients being smokers, 43.5% obese (body mass index ≥30 kg/m2) and 63.8% centrally obese (waist circumference ≥88 cm for women, ≥102 cm for men). Of patients on blood pressure lowering medication 47.0% reached the target of <140/90 mm Hg (<140/85 mm Hg in people with diabetes). Among treated dyslipidaemic patients only 46.9% attained low density lipoprotein-cholesterol target of <2.6 mmol/l. Among people treated for type 2 diabetes mellitus, 65.2% achieved the HbA1c target of <7.0%.

Conclusion: The primary care arm of the EUROASPIRE V survey revealed that large proportions of people at high cardiovascular disease risk have unhealthy lifestyles and inadequate control of blood pressure, lipids and diabetes. Thus, the potential to reduce the risk of future cardiovascular disease throughout Europe by improved preventive cardiology programmes is substantial.
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http://dx.doi.org/10.1177/2047487320908698DOI Listing
May 2021

Patient perceptions of anticoagulant treatment with dabigatran or a vitamin K antagonist for stroke prevention in atrial fibrillation according to region and age: an exploratory analysis from the RE-SONANCE study.

J Thromb Thrombolysis 2021 Apr 30. Epub 2021 Apr 30.

Faculty of Medicine in Hradec Kralove, Charles University and Edumed s.r.o, Broumov, Czech Republic.

Background: The oral anticoagulant dabigatran offers an effective alternative to vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF), yet patient preference data are limited. The prospective observational RE-SONANCE study demonstrated that patients with AF, newly initiated on dabigatran, or switching to dabigatran from long-term VKA therapy, reported improved treatment convenience and satisfaction compared with VKA therapy. This pre-specified sub-study aimed to assess the impact of country and age on patients' perceptions of dabigatran or VKA therapy in AF.

Methods: RE-SONANCE was an observational, prospective, multi-national study (NCT02684981) that assessed treatment satisfaction and convenience in patients switching from VKAs to dabigatran (Cohort A), or newly diagnosed with AF receiving dabigatran or VKAs (Cohort B), using the PACT-Q questionnaire. Pre-specified exploratory outcomes: variation in PACT-Q2 scores by country and age (< 65, 65 to < 75, ≥ 75 years) (both cohorts); variation in PACT-Q1 responses at baseline by country and age (Cohort B).

Results: Patients from 12 countries (Europe/Israel) were enrolled in Cohort A (n = 4103) or B (n = 5369). In Cohort A, mean (standard deviation) PACT-Q2 score increase was highest in Romania (convenience: 29.6 [23.6]) and Hungary (satisfaction: 26.0 [21.4]) (p < 0.001). In Cohort B, mean (standard error) increase in PACT-Q2 scores between dabigatran and VKAs was highest in Romania (visit 3: 29.0 [1.3]; 24.5 [0.9], p < 0.001). Mean PACT-Q2 score increase by age (all p < 0.001) was similar across ages. PACT-Q1 responses revealed lowest expectations of treatment success in Romania and greatest concerns about payment in Estonia, Latvia, and Romania, but were similar across ages.

Conclusions: Treatment satisfaction and convenience tended to favor dabigatran over VKAs. Regional differences in treatment expectations exist across Europe.

Trial And Clinical Registry: Trial registration number: ClinicalTrials.gov NCT02684981. Trial registration date: February 18, 2016.
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http://dx.doi.org/10.1007/s11239-021-02450-2DOI Listing
April 2021

Prediction of recurrent event in patients with coronary heart disease: the EUROASPIRE Risk Model.

Eur J Prev Cardiol 2020 Dec 29. Epub 2020 Dec 29.

Department of Public Health and Primary Care, Ghent University, C. Heymanslaan 10, 9000 Gent, Belgium.

Aims: Most patients with established atherosclerotic cardiovascular disease (CVD) are at very high risk for developing recurrent events. Since this risk varies a lot between patients there is a need to identify those in whom an even more intensive secondary prevention strategy should be envisaged. Using data from the EUROASPIRE IV and V cohorts of coronary heart disease (CHD) patients from 27 European countries, we aimed at developing and internally and externally validating a risk model predicting recurrent CVD events in patients aged < 75 years.

Methods And Results: Prospective data were available for 12 484 patients after a median follow-up time of 1.7 years. The primary endpoint, a composite of fatal CVD or new hospitalizations for non-fatal myocardial infarction (MI), stroke, heart failure, coronary artery bypass graft, or percutaneous coronary intervention (PCI), occurred in 1424 patients. The model was developed based on data from 8000 randomly selected patients in whom the association between potential risk factors and the incidence of the primary endpoint was investigated. This model was then validated in the remaining 4484 patients. The final multivariate model revealed a higher risk for the primary endpoint with increasing age, a previous hospitalization for stroke, heart failure or PCI, a previous diagnosis of peripheral artery disease, self-reported diabetes and its glycaemic control, higher non-high-density lipoprotein cholesterol, reduced renal function, symptoms of depression and anxiety and living in a higher risk country. The model demonstrated excellent internal validity and proved very adequate in the validation cohort. Regarding external validity, the model demonstrated good discriminative ability in 20 148 MI patients participating in the SWEDEHEART register. Finally, we developed a risk calculator to estimate risks at 1 and 2 years for patients with stable CHD.

Conclusion: In patients with CHD, fatal and non-fatal rates of recurrent CVD events are high. However, there are still opportunities to optimize their management in order to prevent further disease or death. The EUROASPIRE Risk Calculator may be of help to reach this goal.
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http://dx.doi.org/10.1093/eurjpc/zwaa128DOI Listing
December 2020

Patient perception of anticoagulant treatment for stroke prevention (RE-SONANCE study).

Open Heart 2020 24;7(1):e001202. Epub 2020 Mar 24.

Department of Cardiology, General Hospital Celje, Celje, Slovenia.

Objective: We evaluated atrial fibrillation (AF) patients' perceptions of anticoagulation treatment with dabigatran or a vitamin K antagonist (VKA) for stroke prevention, according to accepted indications.

Methods: The RE-SONANCE observational, prospective, multicentre, international study used the validated Perception on Anticoagulant Treatment Questionnaire (PACT-Q) to assess patients with AF already taking a VKA who were switched to dabigatran (cohort A), and newly diagnosed patients initiated on either dabigatran or a VKA (cohort B). Visit 1 (V1) was at baseline, and visit 2 (V2) and visit 3 (V3) were at 30-45 and 150-210 days after baseline, respectively. Primary outcomes were treatment satisfaction and convenience in cohort A at V2 and V3 versus baseline, and in cohort B for dabigatran and a VKA at V2 and V3.

Results: The main analysis set comprised 4100 patients in cohort A and 5365 in cohort B (dabigatran: 3179; VKA: 2186). In cohort A, PACT-Q2 improved significantly (p<0.001 for all) for treatment convenience (mean change V1 vs V2=20.72; SD=21.50; V1 vs V3=24.54; SD=22.85) and treatment satisfaction (mean change V1 vs V2=17.60; SD=18.76; V1 vs V3=21.04; SD=20.24). In cohort B, mean PACT-Q2 scores at V2 and V3 were significantly higher (p<0.001 for all) for dabigatran versus a VKA for treatment convenience (V2=18.38; SE =0.51; V3=23.34; SE=0.51) and satisfaction (V2=15.88; SE=0.39; V3=19.01; SE=0.41).

Conclusions: Switching to dabigatran from long-term VKA therapy or newly initiated dabigatran is associated with improved patient treatment convenience and satisfaction compared with VKA therapy.
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http://dx.doi.org/10.1136/openhrt-2019-001202DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7103803PMC
June 2020

Primary prevention efforts are poorly developed in people at high cardiovascular risk: A report from the European Society of Cardiology EURObservational Research Programme EUROASPIRE V survey in 16 European countries.

Eur J Prev Cardiol 2020 Mar 20:2047487320908698. Epub 2020 Mar 20.

National Institute for Prevention and Cardiovascular Health, National University of Ireland-Galway, Republic of Ireland.

Background: European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) V in primary care was carried out by the European Society of Cardiology EURObservational Research Programme in 2016-2018. The main objective was to determine whether the 2016 Joint European Societies' guidelines on cardiovascular disease prevention in people at high cardiovascular risk have been implemented in clinical practice.

Methods: The method used was a cross-sectional survey in 78 centres from 16 European countries. Patients without a history of atherosclerotic cardiovascular disease either started on blood pressure and/or lipid and/or glucose lowering treatments were identified and interviewed ≥ 6 months after the start of medication.

Results: A total of 3562 medical records were reviewed and 2759 patients (57.6% women; mean age 59.0 ± 11.6 years) interviewed (interview rate 70.0%). The risk factor control was poor with 18.1% of patients being smokers, 43.5% obese (body mass index ≥30 kg/m) and 63.8% centrally obese (waist circumference ≥88 cm for women, ≥102 cm for men). Of patients on blood pressure lowering medication 47.0% reached the target of <140/90 mm Hg (<140/85 mm Hg in people with diabetes). Among treated dyslipidaemic patients only 46.9% attained low density lipoprotein-cholesterol target of <2.6 mmol/l. Among people treated for type 2 diabetes mellitus, 65.2% achieved the HbA1c target of <7.0%.

Conclusion: The primary care arm of the EUROASPIRE V survey revealed that large proportions of people at high cardiovascular disease risk have unhealthy lifestyles and inadequate control of blood pressure, lipids and diabetes. Thus, the potential to reduce the risk of future cardiovascular disease throughout Europe by improved preventive cardiology programmes is substantial.
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http://dx.doi.org/10.1177/2047487320908698DOI Listing
March 2020

Alirocumab Reduces Total Hospitalizations and Increases Days Alive and Out of Hospital in the ODYSSEY OUTCOMES Trial.

Circ Cardiovasc Qual Outcomes 2019 11 11;12(11):e005858. Epub 2019 Nov 11.

Division of Cardiology, University of Colorado School of Medicine, Aurora, CO (G.G.S.).

Background: In ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), alirocumab was compared with placebo, added to high-intensity or maximum tolerated statin treatment after acute coronary syndrome in 18 924 patients. Alirocumab reduced first occurrence of the primary composite end point-coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or hospitalization for unstable angina-as well as total nonfatal cardiovascular events and all-cause deaths. The present analysis determined whether alirocumab reduced total (first and subsequent) hospitalizations and death and increased days alive and out of hospital (DAOH) and percent DAOH in ODYSSEY OUTCOMES.

Methods And Results: In prespecified analyses, hazard functions for total hospitalizations and death were jointly estimated by a semiparametric model, while in post hoc analyses, DAOH and percent DAOH were compared between treatment groups with Poisson regression and one-inflated beta regression, respectively. With 16 629 total hospitalizations and 726 deaths, 331 fewer hospitalizations, and 58 fewer deaths were observed with alirocumab compared with placebo, translating to 15.6 total hospitalizations or deaths avoided with alirocumab per 1000 patient-years of assigned treatment. Alirocumab reduced total hospitalizations (hazard ratio, 0.96 [95% CI, 0.92-1.00]; =0.04) and increased DAOH relative to placebo (rate ratio, 1.003 [95% CI, 1.000-1.007]; =0.05), primarily through a reduction in days dead (rate ratio, 0.847 [95% CI, 0.728-0.986]; =0.03). Patients randomized to alirocumab were also more likely to survive to the end of the study without hospitalization (odds ratio, 1.06 [95% CI, 1.00-1.13]; =0.03).

Conclusions: Alirocumab reduced total hospitalizations with corresponding small increases in DAOH and percent DAOH. These outcomes provide alternative patient-centered metrics to capture the totality of alirocumab clinical efficacy after acute coronary syndrome.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01663402.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.119.005858DOI Listing
November 2019

Blood pressure distribution and control in coronary patients from 24 European countries in the European Society of Cardiology EURoObservational Research Programme European survey of cardiovascular disease prevention and diabetes. EUROASPIRE IV Registry.

J Hypertens 2019 10;37(10):2015-2023

Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.

Background: Hypertension is the most prevalent major independent risk factor for developing coronary heart disease (CHD). The present analysis aimed to assess blood pressure (BP) distribution and factors associated with insufficient BP control in coronary patients from 24 countries participating in the European Society of Cardiology (ESC) EURoObservational Research Programme (EORP) EUROASPIRE IV survey.

Methods: EUROASPIRE IV is a cross-sectional study conducted in 2012-2013 in patients aged 80 years or less hospitalized for CHD with a follow-up visit at a median of 16 months later. Logistic regression analysis was applied to confirm factors associated with BP control defined as less than 140/90 mmHg for nondiabetic patients and less than 140/85 mmHg for diabetic patients.

Results: A total of 7998 patients (response rate, 48.7%) attended the follow-up visit. Complete data were available in 7653 participants (mean age 62.5 ± 9.6 years). The BP goal was achieved in 57.6%. Patients failing to achieve the BP goal were older, had higher BMI, had more often a history of coronary artery bypass grafting (CABG) and reported diabetes more frequently. Logistic regression confirmed the following independent significant predictors of not achieving the BP goal: a history of diabetes [odds ratio (OR) 1.75], obesity (OR 1.70 vs. normal BMI), overweight (OR 1.28 vs. normal BMI), age at least 65 years (OR 1.53) and CABG as the index event (OR 1.26 vs. acute MI).

Conclusion: EUROASPIRE IV found insufficient BP control in a large proportion of patients with stable CHD, with diabetes, increased BMI, older age and CABG as the index event being independent predictors of poor BP control.
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http://dx.doi.org/10.1097/HJH.0000000000002130DOI Listing
October 2019

Lifestyle and impact on cardiovascular risk factor control in coronary patients across 27 countries: Results from the European Society of Cardiology ESC-EORP EUROASPIRE V registry.

Eur J Prev Cardiol 2019 05 10;26(8):824-835. Epub 2019 Feb 10.

32 Department of Cardiology, Interventional Electrocardiology and Hypertension, Jagiellonian University Medical College, Krakow, Poland.

Aims: The aim of this study was to determine whether the Joint European Societies guidelines on secondary cardiovascular prevention are followed in everyday practice.

Design: A cross-sectional ESC-EORP survey (EUROASPIRE V) at 131 centres in 81 regions in 27 countries.

Methods: Patients (<80 years old) with verified coronary artery events or interventions were interviewed and examined ≥6 months later.

Results: A total of 8261 patients (females 26%) were interviewed. Nineteen per cent smoked and 55% of them were persistent smokers, 38% were obese (body mass index ≥30 kg/m), 59% were centrally obese (waist circumference: men ≥102 cm; women ≥88 cm) while 66% were physically active <30 min 5 times/week. Forty-two per cent had a blood pressure ≥140/90 mmHg (≥140/85 if diabetic), 71% had low-density lipoprotein cholesterol ≥1.8 mmol/L (≥70 mg/dL) and 29% reported having diabetes. Cardioprotective medication was: anti-platelets 93%, beta-blockers 81%, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers 75% and statins 80%.

Conclusion: A large majority of coronary patients have unhealthy lifestyles in terms of smoking, diet and sedentary behaviour, which adversely impacts major cardiovascular risk factors. A majority did not achieve their blood pressure, low-density lipoprotein cholesterol and glucose targets. Cardiovascular prevention requires modern preventive cardiology programmes delivered by interdisciplinary teams of healthcare professionals addressing all aspects of lifestyle and risk factor management, in order to reduce the risk of recurrent cardiovascular events.
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http://dx.doi.org/10.1177/2047487318825350DOI Listing
May 2019

Incidence of cardiovascular events in patients with stabilized coronary heart disease: the EUROASPIRE IV follow-up study.

Eur J Epidemiol 2019 Mar 23;34(3):247-258. Epub 2018 Oct 23.

Department of Epidemiology and Population Studies, Faculty of Health Sciences, Jagiellonian University Medical College, Kracow, Poland.

The EUROASPIRE surveys (EUROpean Action on Secondary Prevention through Intervention to Reduce Events) demonstrated that most European coronary patients fail to achieve lifestyle, risk factor and therapeutic targets. Here we report on the 2-year incidence of hard cardiovascular (CV) endpoints in the EUROASPIRE IV cohort. EUROASPIRE IV (2012-2013) was a large cross-sectional study undertaken at 78 centres from selected geographical areas in 24 European countries. Patients were interviewed and examined at least 6 months following hospitalization for a coronary event or procedure. Fatal and non-fatal CV events occurring at least 1 year after this baseline screening were registered. The primary outcome in our analyses was the incidence of CV death or non-fatal myocardial infarction, stroke or heart failure. Cox regression models, stratified for country, were fitted to relate baseline characteristics to outcome. Our analyses included 7471 predominantly male patients. Overall, 222 deaths were registered of whom 58% were cardiovascular. The incidence of the primary outcome was 42 per 1000 person-years. Comorbidities were strongly and significantly associated with the primary outcome (multivariately adjusted hazard ratio HR, 95% confidence interval): severe chronic kidney disease (HR 2.36, 1.44-3.85), uncontrolled diabetes (HR 1.89, 1.50-2.38), resting heart rate ≥ 75 bpm (HR 1.74, 1.30-2.32), history of stroke (HR 1.70, 1.27-2.29), peripheral artery disease (HR 1.48, 1.09-2.01), history of heart failure (HR 1.47, 1.08-2.01) and history of acute myocardial infarction (HR 1.27, 1.05-1.53). Low education and feelings of depression were significantly associated with increased risk. Lifestyle factors such as persistent smoking, insufficient physical activity and central obesity were not significantly related to adverse outcome. Blood pressure and LDL-C levels appeared to be unrelated to cardiovascular events irrespective of treatment. In patients with stabilized CHD, comorbid conditions that may reflect the ubiquitous nature of atherosclerosis, dominate lifestyle-related and other modifiable risk factors in terms of prognosis, at least over a 2-year follow-up period.
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http://dx.doi.org/10.1007/s10654-018-0454-0DOI Listing
March 2019

Cost-effectiveness of optimized adherence to prevention guidelines in European patients with coronary heart disease: Results from the EUROASPIRE IV survey.

Int J Cardiol 2018 Dec 28;272:20-25. Epub 2018 Jun 28.

Department of Public Health, Ghent University, Ghent, Belgium.

Background: This study aims to assess the cost-effectiveness of optimized guideline adherence in patients with a history of coronary heart disease.

Methods: An individual-based decision tree model was developed using the SMART risk score tool which estimates the 10-year risk for recurrent vascular events in patients with manifest cardiovascular disease (CVD). Analyses were based on the EUROASPIRE IV survey. Outcomes were expressed as an incremental cost-effectiveness ratio (ICER).

Results: Data from 4663 patients from 13 European countries were included in the analyses. The mean estimated 10-year risk for a recurrent vascular event decreased from 20.13% to 18.61% after optimized guideline adherence. Overall, an ICER of 52,968€/QALY was calculated. The ICER lowered to 29,093€/QALY when only considering high-risk patients (≥20%) with decreasing ICERs in higher risk patients. Also, a dose-response relationship was seen with lower ICERs in older patients and in those patients with higher risk reductions. A less stringent LDL target (<2.5 mmol/L vs. <1.8 mmol/L) lowered the ICER to 32,591€/QALY and intensifying cholesterol treatment in high-risk patients (≥20%) instead of high-cholesterol patients lowered the ICER to 28,064€/QALY. An alternative method, applying risk reductions to the CVD events instead of applying risk reductions to the risk factors lowered the ICER to 31,509€/QALY.

Conclusion: Depending on the method used better or worse ICERs were found. In addition, optimized guidelines adherence is more cost-effective in higher risk patients, in patients with higher risk reductions and when using a less strict LDL-C target. Current analyses advice to maximize guidelines adherence in particular patient subgroups.
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http://dx.doi.org/10.1016/j.ijcard.2018.06.104DOI Listing
December 2018

Lifestyle and risk factor management in people at high risk of cardiovascular disease. A report from the European Society of Cardiology European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) IV cross-sectional survey in 14 European regions.

Eur J Prev Cardiol 2016 12 27;23(18):2007-2018. Epub 2016 Sep 27.

1 European Society of Cardiology, Sophia Antipolis, France.

Background European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) IV in primary care was a cross-sectional survey carried out by the European Society of Cardiology, EURObservational Research Programme in 2014-2015 in 71 centres from 14 European countries. The main objective was to determine whether the 2012 Joint European Societies' guidelines on cardiovascular disease (CVD) prevention in people at high CVD risk have been followed in clinical practice. Methods Patients without a history of atherosclerotic disease started on either blood pressure and/or lipid and/or glucose-lowering treatments were identified and interviewed at least six months after the start of medication. Results Medical notes of 6700 patients were reviewed, and 4579 patients (58.7% women; mean age 58.8 (standard deviation (SD) 11.3) years) interviewed (interview rate 68.3%). Overall, 16.6% were smokers, 39.9% were overweight (body mass index (BMI)≥25 and <30 kg/m), 43.5% obese (BMI ≥30 kg/m) and 63.9% centrally obese (waist circumference of ≥88 cm for women, ≥102 cm for men). The medical risk factor control was very poor, with less than half (42.8%) of the patients on blood pressure lowering medication reaching the target of <140/90 mm Hg (<140/80 mm Hg in people with self-reported diabetes). Among treated dyslipidaemic patients only 32.7% attained the low-density lipoprotein (LDL)-cholesterol target of <2.5 mmol/l. Among people treated for type 2 diabetes mellitus, 58.5% achieved the glycated haemoglobin (HbA1c) target of <7.0%. Conclusion The EUROASPIRE IV survey shows that large proportions of patients at high CVD risk have unhealthy lifestyle habits and uncontrolled blood pressure, lipids and diabetes. The present data make it clear that more efforts must be taken to improve cardiovascular prevention in people at high CVD risk.
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http://dx.doi.org/10.1177/2047487316667784DOI Listing
December 2016

Lifestyle and risk factor management in people at high cardiovascular risk from Bulgaria, Croatia, Poland, Romania and the United Kingdom who participated in both the EUROASPIRE III and IV primary care surveys.

Eur J Prev Cardiol 2016 10 15;23(15):1618-27. Epub 2016 Apr 15.

European Society of Cardiology, Sophia Antipolis Cedex, France International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, UK.

Objective: The objective of this study was to determine time trends in the implementation of European guidelines on the management of cardiovascular disease prevention in people at high cardiovascular risk.

Methods: Cardiovascular disease prevention as reflected in the primary care arms of the EUROASPIRE III and IV surveys were compared in centres from Bulgaria, Croatia, Poland, Romania and the United Kingdom that participated in both surveys. All patients were free of cardiovascular disease but considered at high cardiovascular disease risk since they had been started on blood pressure and/or lipid and/or glucose lowering treatments. They were interviewed and examined by means of standardized methods ≥6 months after the start of therapy.

Results: EUROASPIRE III comprised 2604 and EUROASPIRE IV 3286 subjects whereof 76% and 56% were interviewed. There were no major differences between the two surveys in age, gender, centres and reasons for inclusion. The prevalence of smoking was similar between EUROASPIRE III and IV. The proportion of smokers who did not intend to quit was significantly greater in EUROASPIRE IV compared with III. The prevalence of overweight or obesity was high and identical in both surveys. No significant differences were observed in physical activity. In participants not on blood pressure lowering treatment an elevated blood pressure was observed in 47% in both EUROASPIRE III and IV. In participants not on lipid lowering drugs the low-density lipoprotein cholesterol was ≥2.5 mmol/l in 87% and 88% in EUROASPIRE III and IV respectively. In participants free from known diabetes fasting plasma glucose was ≥7 mmol/l in 12% and 18% in EUROASPIRE III and IV. In subjects with known arterial hypertension blood pressure was at or below guideline recommended targets in 28% in EUROASPIRE III and 35% in IV. In participants on lipid lowering drugs the low-density lipoprotein cholesterol was < 2.5 mmol/l in 28% and 37% in EUROASPIRE III and IV. Glycated haemoglobin was < 7.0% in participants with known diabetes in 62% and 60% in EUROASPIRE III and IV.

Conclusions: The results from EUROASPIRE III and IV clearly demonstrate that the control of modifiable risk factors in people at high cardiovascular disease risk remains poor.
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http://dx.doi.org/10.1177/2047487316645474DOI Listing
October 2016

Suboptimal Control of Lipid Levels: Results from 29 Countries Participating in the Centralized Pan-Regional Surveys on the Undertreatment of Hypercholesterolaemia (CEPHEUS).

J Atheroscler Thromb 2016 May 2;23(5):567-87. Epub 2015 Dec 2.

General Clinical Research Center, Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University.

Aim: Five multicentre, cross-sectional Centralized Pan-Regional Surveys on the Undertreatment of Hypercholesterolaemia (CEPHEUS) were conducted in 29 countries across Asia, Western Europe, Eastern Europe, the Middle East, and Africa. The surveys assessed the current use and efficacy of lipid-lowering drugs (LLDs) worldwide and identified possible patient and physician characteristics associated with failure to attain low-density lipoprotein cholesterol (LDL-C) goals. The aim of this analysis was to consolidate the global results from these surveys.

Methods: The surveys involved patients aged ≥18 years who had been prescribed LLDs for at least 3 months without dose changes for at least 6 weeks. A single visit was scheduled for data collection, including fasting plasma lipid and glucose levels. Cardiovascular risk profile and LDL-C goal attainment were assessed according to the 2004 updated US National Cholesterol Education Program Adult Treatment Panel III guidelines.

Results: In total, 35 121 patients (mean age: 60.4 years) were included, and 90.3% had been prescribed statin monotherapy. Overall, only 49.4% of patients reached their recommended LDL-C level. LDL-C goals were attained in 54.8% (5084/9273) and 22.8% (3287/14 429) of patients were at high and very high cardiovascular risk, respectively. Factors associated with an increased likelihood of LDL-C goal attainment were lower baseline cardiovascular risk; presence of diabetes mellitus, hypertension, or history of cardiovascular disease; and treatment with simvastatin, atorvastatin, or rosuvastatin (vs. all other LLDs).

Conclusion: LDL-C goal attainment in patients taking LLDs is suboptimal worldwide, particularly in patients at high and very high cardiovascular risk.
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http://dx.doi.org/10.5551/jat.31179DOI Listing
May 2016

Patients with coronary artery disease and diabetes need improved management: a report from the EUROASPIRE IV survey: a registry from the EuroObservational Research Programme of the European Society of Cardiology.

Cardiovasc Diabetol 2015 Oct 1;14:133. Epub 2015 Oct 1.

European Society of Cardiology, Les Templiers, 2035 route des Colles, CS 80179 BIOT, 06903, Sophia Antipolis Cedex, France.

Background: In order to influence every day clinical practice professional organisations issue management guidelines. Cross-sectional surveys are used to evaluate the implementation of such guidelines. The present survey investigated screening for glucose perturbations in people with coronary artery disease and compared patients with known and newly detected type 2 diabetes with those without diabetes in terms of their life-style and pharmacological risk factor management in relation to contemporary European guidelines.

Methods: A total of 6187 patients (18-80 years) with coronary artery disease and known glycaemic status based on a self reported history of diabetes (previously known diabetes) or the results of an oral glucose tolerance test and HbA1c (no diabetes or newly diagnosed diabetes) were investigated in EUROASPIRE IV including patients in 24 European countries 2012-2013. The patients were interviewed and investigated in order to enable a comparison between their actual risk factor control with that recommended in current European management guidelines and the outcome in previously conducted surveys.

Results: A total of 2846 (46%) patients had no diabetes, 1158 (19%) newly diagnosed diabetes and 2183 (35%) previously known diabetes. The combined use of all four cardioprotective drugs in these groups was 53, 55 and 60%, respectively. A blood pressure target of <140/90 mmHg was achieved in 68, 61, 54% and a LDL-cholesterol target of <1.8 mmol/L in 16, 18 and 28%. Patients with newly diagnosed and previously known diabetes reached an HbA1c <7.0% (53 mmol/mol) in 95 and 53% and 11% of those with previously known diabetes had an HbA1c >9.0% (>75 mmol/mol). Of the patients with diabetes 69% reported on low physical activity. The proportion of patients participating in cardiac rehabilitation programmes was low (≈40 %) and only 27% of those with diabetes had attended diabetes schools. Compared with data from previous surveys the use of cardioprotective drugs had increased and more patients were achieving the risk factor treatment targets.

Conclusions: Despite advances in patient management there is further potential to improve both the detection and management of patients with diabetes and coronary artery disease.
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http://dx.doi.org/10.1186/s12933-015-0296-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4591740PMC
October 2015

EUROASPIRE IV: A European Society of Cardiology survey on the lifestyle, risk factor and therapeutic management of coronary patients from 24 European countries.

Eur J Prev Cardiol 2016 Apr 16;23(6):636-48. Epub 2015 Feb 16.

The European Society of Cardiology, Sophia Antipolis Cedex, France Federal Health Centre and Department of Chronic Noncommunicable Diseases Prevention, National Research Centre for Preventive Medicine, Moscow, Russia.

Aims: To determine whether the Joint European Societies guidelines on cardiovascular prevention are being followed in everyday clinical practice of secondary prevention and to describe the lifestyle, risk factor and therapeutic management of coronary patients across Europe.

Methods And Results: EUROASPIRE IV was a cross-sectional study undertaken at 78 centres from 24 European countries. Patients <80 years with coronary disease who had coronary artery bypass graft, percutaneous coronary intervention or an acute coronary syndrome were identified from hospital records and interviewed and examined ≥ 6 months later. A total of 16,426 medical records were reviewed and 7998 patients (24.4% females) interviewed. At interview, 16.0% of patients smoked cigarettes, and 48.6% of those smoking at the time of the event were persistent smokers. Little or no physical activity was reported by 59.9%; 37.6% were obese (BMI ≥ 30 kg/m(2)) and 58.2% centrally obese (waist circumference ≥ 102 cm in men or ≥88 cm in women); 42.7% had blood pressure ≥ 140/90 mmHg (≥140/80 in people with diabetes); 80.5% had low-density lipoprotein cholesterol ≥ 1.8 mmol/l and 26.8% reported having diabetes. Cardioprotective medication was: anti-platelets 93.8%; beta-blockers 82.6%; angiotensin-converting enzyme inhibitors/angiotensin receptor blockers 75.1%; and statins 85.7%. Of the patients 50.7% were advised to participate in a cardiac rehabilitation programme and 81.3% of those advised attended at least one-half of the sessions.

Conclusion: A large majority of coronary patients do not achieve the guideline standards for secondary prevention with high prevalences of persistent smoking, unhealthy diets, physical inactivity and consequently most patients are overweight or obese with a high prevalence of diabetes. Risk factor control is inadequate despite high reported use of medications and there are large variations in secondary prevention practice between centres. Less than one-half of the coronary patients access cardiac prevention and rehabilitation programmes. All coronary and vascular patients require a modern preventive cardiology programme, appropriately adapted to medical and cultural settings in each country, to achieve healthier lifestyles, better risk factor control and adherence with cardioprotective medications.
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http://dx.doi.org/10.1177/2047487315569401DOI Listing
April 2016

Comparison of the efficacy and safety of two rivaroxaban doses in acute coronary syndrome (from ATLAS ACS 2-TIMI 51).

Am J Cardiol 2013 Aug 24;112(4):472-8. Epub 2013 May 24.

TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

The dosing of anticoagulants is critical when balancing efficacy and safety. The Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Aspirin With/Without Thienopyridine Therapy in Subjects With Acute Coronary Syndrome 2-Thrombolysis In Myocardial Infarction 51 (ATLAS ACS 2-TIMI 51) trial was designed to evaluate 2 low doses of rivaroxaban compared with placebo in patients with recent acute coronary syndromes being treated with antiplatelet therapies. Because the 2 doses significantly reduced the primary efficacy end point, a further comparison of the 2 treatment strategies was deemed important. In total, 15,526 patients were randomized to twice-daily rivaroxaban 2.5 mg, rivaroxaban 5 mg, or placebo. Comparing the 2 active doses, there were no significant differences between 2.5 and 5 mg for the primary efficacy end point of cardiovascular death, myocardial infarction, or stroke (9.1% vs 8.8%, p = 0.89), myocardial infarction (6.1% vs 4.9%, p = 0.23), or stent thrombosis (2.2% vs 2.3%, p = 0.59). However, there was a divergence in cardiovascular death, which included ischemic and hemorrhagic events, with the 2.5-mg dose resulting in lower rates than the 5-mg dose (2.7% vs 4.0%, p = 0.009). Notably, with 2.5 versus 5 mg, there were fewer study drug discontinuations (p = 0.004) and fewer non-coronary artery bypass grafting TIMI major or minor bleeds (p = 0.021) and fatal bleeds (p = 0.044). Of the patients who died, 8 in the 2.5-mg group and 20 in the 5-mg group experienced non-coronary artery bypass grafting TIMI major or minor bleeding events before death. In conclusion, the 2 doses of rivaroxaban reduced cardiovascular events in patients with recent acute coronary syndromes treated with antiplatelet therapies; however, the 2.5-mg dose was associated with lower mortality and fewer bleeding complications than the 5-mg dose. Thus, the addition of rivaroxaban 2.5 mg twice daily offers a more favorable balance of efficacy and safety in patients with recent acute coronary syndromes.
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http://dx.doi.org/10.1016/j.amjcard.2013.04.011DOI Listing
August 2013

The determinants of side branch compromise after main vessel stenting in coronary bifurcation lesions.

Kardiol Pol 2012 ;70(10):989-97

Cardiac Catheterisation Laboratory, National Heart Hospital, 1309 Sofia, Bulgaria.

Background And Aim: The purpose of this analysis was to determine the factors responsible for side branch (SB) ostial stenosis after main vessel stent implantation.

Methods: Theoretical and bench-test bifurcation models with different lengths of carina were created. Bench-test experiments with a flexible bifurcation model were performed for the observation of changes in the bifurcation region after stent implantation. An angiographic analysis of 92 bifurcation lesions (84 patients) was performed to determine the role of theoretical parameters on SB compromise in practice. The theoretically predicted and actual SB compromise were compared in these patients.

Results: Bench tests revealed a complex change in the bifurcation region with carina displacement, SB lateral walls stretch and main vessel - SB proximal angle decrease after main vessel stent placement. In an angiographic analysis, actually measured SB% diameter stenosis was larger than expected in 35 (38%) lesions and the measured stenosis was smaller than expected in 49 lesions. Independent predictors of difference between theoretically predicted and observed SB stenosis were carina length mismatch (OR = 2.568, CI 1.336-4.896), main branch reference diameter (OR = 0.314, CI 0.101-0.972), and proximal main vessel - SB angle change after stenting (OR = 0.926, CI 0.870-0.985). In a plot comparing the values of carina length mismatch and deviations from the prediction in SB ostial stenosis, 30% (n = 27) of cases were located in a zone with a shorter carina and more SB compromise than expected, suggesting the role of plaque shift in these cases.

Conclusions: The degree of SB jailing seems to be determined by carina deformation, the length of the carina, and plaque shifting.
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July 2013

Cost-effectiveness of optimizing prevention in patients with coronary heart disease: the EUROASPIRE III health economics project.

Eur Heart J 2012 Nov 26;33(22):2865-72. Epub 2012 Jul 26.

Ghent University, Gent, Belgium.

Aims: The EUROASPIRE III survey indicated that the guidelines on cardiovascular disease prevention are poorly implemented in patients with established coronary heart disease (CHD). The purpose of this health economic project was to assess the potential clinical effectiveness and cost-effectiveness of optimizing cardiovascular prevention in eight EUROASPIRE III countries (Belgium, Bulgaria, Croatia, Finland, France, Italy, Poland, and the U.K.). METHODS AND RESULTS The individual risk for subsequent cardiovascular events was estimated, based on published Framingham equations. Based on the EUROASPIRE III data, the type of suboptimal prevention, if any, was identified for each individual, and the effects of optimized tailored prevention (smoking cessation, diet and exercise, better management of elevated blood pressure and/or LDL-cholesterol) were estimated. Costs of prevention and savings of avoided events were based on country-specific data. A willingness to pay threshold of €30,000/quality-adjusted life year (QALY) was used. The robustness of the results was validated by sensitivity analyses. Overall, the cost-effectiveness analyses for the eight countries showed mainly favourable results with an average incremental cost-effectiveness ratio (ICER) of €12,484 per QALY. Only in the minority of patients at the lowest risk for recurrent events, intensifying preventive therapy seems not cost-effective. Also, the single impact of intensified cholesterol control seems less cost-effective, possibly because their initial 2-year risk was already fairly low, hence the room for improvement is rather limited.

Conclusion: These results underscore the societal value of optimizing prevention in most patients with established CHD, but also highlight the need for setting priorities towards patients more at risk and the need for more studies comparing intensified prevention with usual care in these patients.
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http://dx.doi.org/10.1093/eurheartj/ehs210DOI Listing
November 2012

Enoxaparin vs. unfractionated heparin with fibrinolysis for ST-elevation myocardial infarction in elderly and younger patients: results from ExTRACT-TIMI 25.

Eur Heart J 2007 May 24;28(9):1066-71. Epub 2007 Apr 24.

Green Lane Cardiovascular Service, Auckland City Hospital, Auckland 1030, New Zealand.

Aims: To determine the effects of age on outcomes in patients with STEMI treated with a strategy of enoxaparin (ENOX) vs. unfractionated heparin (UFH).

Methods And Results: In the ExTRACT-TIMI 25 trial, 20,479 patients with STEMI were randomized in a double-blind fashion to UFH or ENOX. A novel reduced dose of ENOX was administered to patients >or=75 years, and a reduced dose in those with an estimated creatinine clearance of < 30 mL/min. Anti-Xa levels were measured in a subset of patients (n = 73). The exposure to anti-Xa over time was lower in the elderly (AUC(0-12 h) P < 0.0001; AUC(steady-state) P = 0.0046). The relative risk reduction (RR) with ENOX on the primary endpoint, i.e. death or non-fatal recurrent myocardial infarction, was greater in patients < 75 years (20%) than > 75 years (6%), but the absolute benefits were similar. When compared with UFH, ENOX was associated with an RR of 1.67 for major bleeding, but the magnitude of the excess risk tended to be lower (RR = 1.15) in patients >or= 75 years assigned to ENOX.

Conclusion: A dose reduction of ENOX in the elderly appears to be helpful in ameliorating bleeding risk. A strategy of ENOX was superior to UFH in both young and elderly patients with STEMI treated with fibrinolysis.
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http://dx.doi.org/10.1093/eurheartj/ehm081DOI Listing
May 2007
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