Publications
529 results found
Laufs U, Ballantyne CM, Banach M, et al., 2022, Efficacy and safety of bempedoic acid in patients not receiving statins in phase 3 clinical trials, JOURNAL OF CLINICAL LIPIDOLOGY, Vol: 16, Pages: 286-297, ISSN: 1933-2874
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- Citations: 15
Gunn LH, Mckay A, Ray K, 2022, IS SAFEHEART 'SAFE' TO EXTEND TO OTHER POPULATIONS?: ASSESSMENT OF SAFEHEART RISK PREDICTION MODEL EXTERNAL VALIDITY AMONG AN ENGLISH COHORT OF ROUTINE FAMILIAL HYPERCHOLESTEROLAEMIA PARTICIPANTS, Publisher: ELSEVIER SCIENCE INC, Pages: 1634-1634, ISSN: 0735-1097
McKay AJ, Gunn LH, Ference BA, et al., 2022, Is the SMART risk prediction model ready for real-world implementation? A validation study in a routine care setting of approximately 380 000 individuals, European Journal of Preventive Cardiology, Vol: 29, Pages: 654-663, ISSN: 2047-4873
AIMS: Reliably quantifying event rates in secondary prevention could aid clinical decision-making, including quantifying potential risk reductions of novel, and sometimes expensive, add-on therapies. We aimed to assess whether the SMART risk prediction model performs well in a real-world setting. METHODS AND RESULTS: We conducted a historical open cohort study using UK primary care data from the Clinical Practice Research Datalink (2000-2017) diagnosed with coronary, cerebrovascular, peripheral, and/or aortic atherosclerotic cardiovascular disease (ASCVD). Analyses were undertaken separately for cohorts with established (≥6 months) vs. newly diagnosed ASCVD. The outcome was first post-cohort entry occurrence of myocardial infarction, stroke, or cardiovascular death. Among the cohort with established ASCVD [n = 244 578, 62.1% male, median age 67.3 years, interquartile range (IQR) 59.2-74.0], the calibration and discrimination achieved by the SMART model was not dissimilar to performance at internal validation [Harrell's c-statistic = 0.639, 95% confidence interval (CI) 0.636-0.642, compared with 0.675, 0.642-0.708]. Decision curve analysis indicated that the model outperformed treat all and treat none strategies in the clinically relevant 20-60% predicted risk range. Consistent findings were observed in sensitivity analyses, including complete case analysis (n = 182 482; c = 0.624, 95% CI 0.620-0.627). Among the cohort with newly diagnosed ASCVD (n = 136 445; 61.0% male; median age 66.0 years, IQR 57.7-73.2), model performance was weaker with more exaggerated risk under-prediction and a c-statistic of 0.559, 95% CI 0.556-0.562. CONCLUSIONS: The performance of the SMART model in this validation cohort demonstrates its potential utility in routine healthcare settings in guiding both population and individual-level decision-making for secondary prevention patients.
Ray KK, Reeskamp LF, Laufs U, et al., 2022, Combination lipid-lowering therapy as first-line strategy in very high-risk patients, EUROPEAN HEART JOURNAL, Vol: 43, Pages: 830-833, ISSN: 0195-668X
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- Citations: 75
Ray KK, Dhalwani N, Sibartie M, et al., 2022, Low-density lipoprotein cholesterol levels exceed the recommended European threshold for PCSK9i initiation: lessons from the HEYMANS study, European Heart Journal - Quality of Care and Clinical Outcomes, Vol: 8, ISSN: 2058-5225
Aims To describe the characteristics of patients receiving evolocumab in clinical practice across 12 European countries andsimulate the association between low-density lipoprotein cholesterol (LDL-C) reduction and cardiovascular (CV) riskreduction. .........................................................................................................................................................................................Methods andresultsThe characteristics of hyperlipidaemic patients at initiation of evolocumab and treatment patterns study—HEYMANS(n = 1952) is a prospective registry of patients ≥18 years old who initiated evolocumab from 1 August 2015 onwards.Mean (standard deviation) age was 60 (10.8), 85% had a prior CV event, 45% were diagnosed with familial hypercholesterolaemia (FH), and 60% had statin intolerance. At evolocumab initiation, 43% were receiving any statin, 16% werereceiving ezetimibe without statin, and 41% received no background lipid-lowering therapy (LLT), with LDL-C levelsreflecting local proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) reimbursement criteria. Median LDL-Cdecreased from 3.98 to 1.63 mmol/L within 3 months of evolocumab initiation and was maintained over 24 months.Overall, 58% achieved risk-based 2019 European Society of Cardiology/European Atherosclerosis Society LDL-C goalsbut that proportion was higher (68%) in patients receiving background LLT compared with those not receiving background LLT (44%). In patients with atherosclerotic cardiovascular disease without FH, the simulated relative CV riskreduction associated with evolocumab treatment was 34% (25–44%). .........................................................................................................................................................................................Conclusion Across Europe, LDL-C levels at evolocumab initiation were three times higher than recommended thresholds forPCSK9i initiation, reflec
Hageman SHJ, McKay AJ, Ueda P, et al., 2022, Estimation of recurrent atherosclerotic cardiovascular event risk in patients with established cardiovascular disease: the updated SMART2 algorithm, European Heart Journal, Vol: 43, Pages: 1715-1727, ISSN: 0195-668X
AimsThe 10-year risk of recurrent atherosclerotic cardiovascular disease (ASCVD) events in patients with established ASCVD can be estimated with the Secondary Manifestations of ARTerial disease (SMART) risk score, and may help refine clinical management. To broaden generalizability across regions, we updated the existing tool (SMART2 risk score) and recalibrated it with regional incidence rates and assessed its performance in external populations.Methods and resultsIndividuals with coronary artery disease, cerebrovascular disease, peripheral artery disease, or abdominal aortic aneurysms were included from the Utrecht Cardiovascular Cohort-SMART cohort [n = 8355; 1706 ASCVD events during a median follow-up of 8.2 years (interquartile range 4.2–12.5)] to derive a 10-year risk prediction model for recurrent ASCVD events (non-fatal myocardial infarction, non-fatal stroke, or cardiovascular mortality) using a Fine and Gray competing risk-adjusted model. The model was recalibrated to four regions across Europe, and to Asia (excluding Japan), Japan, Australia, North America, and Latin America using contemporary cohort data from each target region. External validation used data from seven cohorts [Clinical Practice Research Datalink, SWEDEHEART, the international REduction of Atherothrombosis for Continued Health (REACH) Registry, Estonian Biobank, Spanish Biomarkers in Acute Coronary Syndrome and Biomarkers in Acute Myocardial Infarction (BACS/BAMI), the Norwegian COgnitive Impairment After STroke, and Bialystok PLUS/Polaspire] and included 369 044 individuals with established ASCVD of whom 62 807 experienced an ASCVD event. C-statistics ranged from 0.605 [95% confidence interval (CI) 0.547–0.664] in BACS/BAMI to 0.772 (95% CI 0.659–0.886) in REACH Europe high-risk region. The clinical utility of the model was demonstrated across a range of clinically relevant treatment thresholds for intensified treatment options.ConclusionThe
Tromp TR, Hartgers ML, Hovingh GK, et al., 2022, Worldwide experience of homozygous familial hypercholesterolaemia: retrospective cohort study, The Lancet, Vol: 399, Pages: 719-728, ISSN: 0140-6736
Background:Homozygous familial hypercholesterolaemia (HoFH) is a rare inherited disorder resulting in extremely elevated low-density lipoprotein cholesterol levels and premature atherosclerotic cardiovascular disease (ASCVD). Current guidance about its management and prognosis stems from small studies, mostly from high-income countries. The objective of this study was to assess the clinical and genetic characteristics, as well as the impact, of current practice on health outcomes of HoFH patients globally.Methods:The HoFH International Clinical Collaborators registry collected data on patients with a clinical, or genetic, or both, diagnosis of HoFH using a retrospective cohort study design. This trial is registered with ClinicalTrials.gov, NCT04815005.Findings:Overall, 751 patients from 38 countries were included, with 565 (75%) reporting biallelic pathogenic variants. The median age of diagnosis was 12·0 years (IQR 5·5–27·0) years. Of the 751 patients, 389 (52%) were female and 362 (48%) were male. Race was reported for 527 patients; 338 (64%) patients were White, 121 (23%) were Asian, and 68 (13%) were Black or mixed race. The major manifestations of ASCVD or aortic stenosis were already present in 65 (9%) of patients at diagnosis of HoFH. Globally, pretreatment LDL cholesterol levels were 14·7 mmol/L (IQR 11·6–18·4). Among patients with detailed therapeutic information, 491 (92%) of 534 received statins, 342 (64%) of 534 received ezetimibe, and 243 (39%) of 621 received lipoprotein apheresis. On-treatment LDL cholesterol levels were lower in high-income countries (3·93 mmol/L, IQR 2·6–5·8) versus non-high-income countries (9·3 mmol/L, 6·7–12·7), with greater use of three or more lipid-lowering therapies (LLT; high-income 66% vs non-high-income 24%) and consequently more patients attaining guideline-recommended LDL cholesterol goals (high-income 21% vs non-h
Krzemien P, Kasperczyk S, Banach M, et al., 2022, Analysis of the impact of sex and age on the variation in the prevalence of antinuclear autoantibodies in Polish population: a nationwide observational, cross-sectional study, RHEUMATOLOGY INTERNATIONAL, Vol: 42, Pages: 261-271, ISSN: 0172-8172
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- Citations: 1
Alsayed N, Almahmeed W, Alnouri F, et al., 2022, Consensus clinical recommendations for the management of plasma lipid disorders in the Middle East: 2021 update., Atherosclerosis, Vol: 343, Pages: 28-50, ISSN: 0021-9150
BACKGROUND AND AIMS: Disorders of plasma lipids remain key risk factors for the development of atherosclerotic cardiovascular disease (ASCVD) in the Middle East and are estimated to increase more dramatically in the next decade than in any other global region except Africa. This statement is an update to the 2016 consensus clinical recommendations for the management of plasma lipid disorders in the Middle East, following the evaluation of newer cholesterol-lowering agents in randomised controlled cardiovascular outcome trials, as well as the publication of revised international guidelines. METHODS: A multidisciplinary panel of regional experts was convened to update the consensus clinical recommendations for the management of plasma lipids in the Middle East. The recommendations constructed in 2016 were reviewed against emerging research since publication. RESULTS: Newly developed Middle East ASCVD risk categories were established using the multiple risk group categories from the recently updated international guidelines and the epidemiological evidence from the Gulf Region. These consensus recommendations support a more intensive reduction of LDL-C across cardiovascular risk categories. Alongside low-density lipoprotein cholesterol, we recommend non-high-density lipoprotein cholesterol as a primary treatment target. Lifestyle modifications remain the first-line treatment recommendation for all patients. The first-line pharmacological treatment in patients with dyslipidaemia is statin therapy, with a number of second-line agents available. The selection of a second lipid-lowering agent for combination therapy with statin should be based on the lipid-lowering target of the patient. Guidance is also provided on the management of underlying conditions and special populations; of particular pertinence in the region are familial hypercholesterolaemia, diabetes and metabolic dyslipidaemia. New therapies have emerged from research that found positive outcomes in reducing l
Catapano AL, Ray KK, Tokgozoglu L, 2022, Prevention guidelines and EAS/ESC guidelines for the treatment of dyslipidaemias: A look to the future, ATHEROSCLEROSIS, Vol: 340, Pages: 51-52, ISSN: 0021-9150
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- Citations: 2
Cainzos-Achirica M, Anugula D, Mszar R, et al., 2022, Rationale and pathways forward in the implementation of coronary artery calcium-based enrichment of randomized trials, AMERICAN HEART JOURNAL, Vol: 243, Pages: 54-65, ISSN: 0002-8703
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- Citations: 2
Krzemien P, Kasperczyk S, Banach M, et al., 2022, Relationship Between Anti-DFS70 Autoantibodies and Oxidative Stress, BIOMARKER INSIGHTS, Vol: 17, ISSN: 1177-2719
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- Citations: 1
Ray KK, Ference BA, Severin T, et al., 2022, World Heart Federation Cholesterol Roadmap 2022, GLOBAL HEART, Vol: 17, ISSN: 2211-8160
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- Citations: 18
Bedlington N, Abifadel M, Beger B, et al., 2022, The time is now: Achieving FH paediatric screening across Europe - The Prague Declaration., GMS Health Innov Technol, Vol: 16
Familial hypercholesterolaemia (FH) is the most common inherited metabolic disorder characterized by high cholesterol and if left untreated leads to premature cardiovascular disease, such as heart attacks. Treatment that begins early in life, particularly in childhood, is highly efficacious in preventing cardiovascular disease and cost-effective, thus early detection of FH is crucial. However, in Europe, less than 10% of people living with FH are diagnosed and even less receive life-saving treatment. The Prague Declaration is a call to action for national and European Union policymakers and decision-makers and a result of the Czech EU Presidency meeting on FH Paediatric Screening (early detection of inherited high cholesterol) at the Czech Senate in Prague on 6th September 2022. It builds on a considerable body of evidence which was discussed at the Technical Meeting under the auspices of the Slovenian EU Presidency in October 2021. The Prague meeting addressed the outstanding barriers to the systematic implementation of FH paediatric screening across Europe. In this article, we present the key points from the Prague meeting and concrete actions needed to move forward.
Wright RS, Kallend D, Ray KK, et al., 2021, Evaluation of LDL-C reductions by siRNA treatment with inclisiran in patients with diabetes mellitus, metabolic syndrome or neither, 82nd National Congress of the Italian-Society-of-Cardiology (SIC), Publisher: OXFORD UNIV PRESS, ISSN: 1520-765X
Ray KK, Wright RS, 2021, Clinical Update on Novel Lipid-Lowering Therapies to Reduce Cardiovascular Risk, JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, Vol: 326, Pages: 2205-2205, ISSN: 0098-7484
Nishikido T, Ray KK, 2021, The power of lipid registries for cardiovascular disease prevention, CURRENT OPINION IN LIPIDOLOGY, Vol: 32, Pages: 342-348, ISSN: 0957-9672
Studziński K, Tomasik T, Windak A, et al., 2021, The differences in the prevalence of cardiovascular disease, its risk factors, and achievement of therapeutic goals among urban and rural primary care patients in Poland: results from the LIPIDOGRAM 2015 study, Journal of Clinical Medicine, Vol: 10, ISSN: 2077-0383
A nationwide cross-sectional study, LIPIDOGRAM2015, was carried out in Poland in the years 2015 and 2016. A total of 438 primary care physicians enrolled 13,724 adult patients that sought medical care in primary health care practices. The prevalence of hypertension, diabetes mellitus, dyslipidaemia, and CVD were similar in urban and rural areas (49.5 vs. 49.4%; 13.7 vs. 13.1%; 84.2 vs. 85.2%; 14.4 vs. 14.2%, respectively). The prevalence of obesity (32.3 vs. 37.5%, p < 0.01) and excessive waist circumference (77.5 vs. 80.7%, p < 0.01), as well as abdominal obesity (43.2 vs. 46.4%, p < 0.01), were higher in rural areas in both genders. Mean levels of LDL-C (128 vs. 130 mg/dL, p = 0.04) and non-HDL-C (147 vs. 148 mg/dL, p = 0.03) were slightly higher in rural populations. Altogether, 14.3% of patients with CVD from urban areas and 11.3% from rural areas reached LDL <70 mg/dL (p = 0.04). There were no important differences in the prevalence of hypertension, diabetes, dyslipidaemia, and CVD, or in mean levels of blood pressure, cholesterol fractions, glucose, and HbA1c between Polish urban and rural primary care patient populations. A high proportion of patients in cities and an even-higher proportion in rural areas did not reach the recommended targets for blood pressure, LDL-C, and HbA1c, indicating the need for novel CVD-prevention programs.
Vallejo-Vaz AJ, Stevens CAT, Lyons ARM, et al., 2021, Global perspective of familial hypercholesterolaemia: a cross-sectional study from the EAS Familial Hypercholesterolaemia Studies Collaboration (FHSC), The Lancet, Vol: 398, Pages: 1713-1725, ISSN: 0140-6736
BackgroundThe European Atherosclerosis Society Familial Hypercholesterolaemia Studies Collaboration (FHSC) global registry provides a platform for the global surveillance of familial hypercholesterolaemia through harmonisation and pooling of multinational data. In this study, we aimed to characterise the adult population with heterozygous familial hypercholesterolaemia and described how it is detected and managed globally.MethodsUsing FHSC global registry data, we did a cross-sectional assessment of adults (aged 18 years or older) with a clinical or genetic diagnosis of probable or definite heterozygous familial hypercholesterolaemia at the time they were entered into the registries. Data were assessed overall and by WHO regions, sex, and index versus non-index cases.FindingsOf the 61 612 individuals in the registry, 42 167 adults (21 999 [53·6%] women) from 56 countries were included in the study. Of these, 31 798 (75·4%) were diagnosed with the Dutch Lipid Clinic Network criteria, and 35 490 (84·2%) were from the WHO region of Europe. Median age of participants at entry in the registry was 46·2 years (IQR 34·3–58·0); median age at diagnosis of familial hypercholesterolaemia was 44·4 years (32·5–56·5), with 40·2% of participants younger than 40 years when diagnosed. Prevalence of cardiovascular risk factors increased progressively with age and varied by WHO region. Prevalence of coronary disease was 17·4% (2·1% for stroke and 5·2% for peripheral artery disease), increasing with concentrations of untreated LDL cholesterol, and was about two times lower in women than in men. Among patients receiving lipid-lowering medications, 16 803 (81·1%) were receiving statins and 3691 (21·2%) were on combination therapy, with greater use of more potent lipid-lowering medication in men than in women. Median LDL cholesterol
Brandts J, Ray KK, 2021, Familial Hypercholesterolemia JACC Focus Seminar 4/4, JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, Vol: 78, Pages: 1831-1843, ISSN: 0735-1097
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- Citations: 19
Ray K, Molemans B, Schoonen WM, et al., 2021, EU-wide cross-sectional observational study of lipid-modifying therapy use in secondary and primary care: the DA VINCI study, European Journal of Preventive Cardiology, Vol: 28, Pages: 1279-1289, ISSN: 2047-4873
AimsTo provide contemporary data on the implementation of European guideline recommendations for lipid-lowering therapies (LLTs) across different settings and populations and how this impacts low-density lipoprotein cholesterol (LDL-C) goal achievement.Methods and resultsAn 18 country, cross-sectional, observational study of patients prescribed LLT for primary or secondary prevention in primary or secondary care across Europe. Between June 2017 and November 2018, data were collected at a single visit, including LLT in the preceding 12 months and most recent LDL-C. Primary outcome was the achievement of risk-based 2016 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) LDL-C goal while receiving stabilized LLT; 2019 goal achievement was also assessed. Overall, 5888 patients (3000 primary and 2888 secondary prevention patients) were enrolled; 54% [95% confidence interval (CI) 52–56] achieved their risk-based 2016 goal and 33% (95% CI 32–35) achieved their risk-based 2019 goal. High-intensity statin monotherapy was used in 20% and 38% of very high-risk primary and secondary prevention patients, respectively. Corresponding 2016 goal attainment was 22% and 45% (17% and 22% for 2019 goals) for very high-risk primary and secondary prevention patients, respectively. Use of moderate–high-intensity statins in combination with ezetimibe (9%), or any LLT with PCSK9 inhibitors (1%), was low; corresponding 2016 and 2019 goal attainment was 53% and 20% (ezetimibe combination), and 67% and 58% (PCSK9i combination).ConclusionGaps between clinical guidelines and clinical practice for lipid management across Europe persist, which will be exacerbated by the 2019 guidelines. Even with optimized statins, greater utilization of non-statin LLT is likely needed to reduce these gaps for patients at highest risk.
Fath F, Bengeser A, Barresi M, et al., 2021, FH ALERT: efficacy of a novel approach to identify patients with familial hypercholesterolemia, SCIENTIFIC REPORTS, Vol: 11, ISSN: 2045-2322
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- Citations: 1
Toth PP, Schwartz GG, Nicholls SJ, et al., 2021, Reduction in the risk of MACE with apabetalone in patients with recent acute coronary syndrome and diabetes according to NAFLD fibrosis score: exploratory analysis of the BETonMACE trial, Publisher: OXFORD UNIV PRESS, Pages: 2536-2536, ISSN: 0195-668X
Koenig W, Conde LG, Landmesser U, et al., 2021, Efficacy and Safety of Inclisiran in Patients with Polyvascular Disease: Pooled, Post Hoc Analysis of the ORION-9, ORION-10, and ORION-11 Phase 3 Randomized Controlled Trials, Publisher: SPRINGER, Pages: 2025-2025, ISSN: 0920-3206
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- Citations: 7
McEvoy JW, Jennings C, Kotseva K, et al., 2021, INTERASPIRE: an International Survey of Coronary Patients; Their Cardiometabolic, Renal and Biomarker Status; and the Quality of Preventive Care Delivered in All WHO Regions In Partnership with the World Heart Federation, European Society of Cardiology, Asia Pacific Society of Cardiology, InterAmerican Society of Cardiology, and PanAfrican Society of Cardiology., CURRENT CARDIOLOGY REPORTS, Vol: 23, ISSN: 1523-3782
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- Citations: 2
Labuz-Roszak B, Banach M, Skrzypek M, et al., 2021, Secondary Stroke Prevention in Polish Adults: Results from the LIPIDOGRAM2015 Study, JOURNAL OF CLINICAL MEDICINE, Vol: 10
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- Citations: 2
Ray KK, Haq I, Bilitou A, et al., 2021, Treatment of high- and very high-risk patients for the prevention of cardiovascular events in Europe: baseline demographics from the multinational observational SANTORINI study, Publisher: OXFORD UNIV PRESS, Pages: 2580-2580, ISSN: 0195-668X
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- Citations: 1
Ray KK, Bruckert E, Filardi P, et al., 2021, Evolocumab use in Europe: clinical guidelines vs. reimbursement thresholds - results from the HEYMANS study, Publisher: OXFORD UNIV PRESS, Pages: 2940-2940, ISSN: 0195-668X
Koenig W, Ray KK, Kallend DG, et al., 2021, Efficacy and safety of inclisiran in patients with established cerebrovascular disease: pooled, post hoc analysis of the ORION-9, ORION-10 and ORION-11, phase 3 randomised clinical trials, Publisher: OXFORD UNIV PRESS, Pages: 2026-2026, ISSN: 0195-668X
Offiah G, O'Connor C, Kennedy C, et al., 2021, THE DA VINCI STUDY: DYSLIPIDAEMIA MANAGEMENT IN IRELAND AND EUROPE, Annual Scientific Meeting and AGM of the Irish-Cardiac-Society, Publisher: BMJ PUBLISHING GROUP, Pages: A15-A16, ISSN: 1355-6037
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