Residual Risk and Burden of Cardiovascular Diseases in the United Kingdom

Study type
Protocol
Date of Approval
Study reference ID
16_135
Lay Summary

Heart and blood vessel diseases known as cardiovascular diseases are the leading cause of death in England and Wales, accounting for almost 1/3 of all deaths. More than 1.7 million admissions in NHS hospitals in the UK annually are related to cardiovascular disease. The majority of risk factors for cardiovascular diseases can be modified, such as high blood cholesterol. However, despite cholesterol lowering treatment, patients still experience cardiovascular events. It is therefore important to understand factors associated with cardiovascular events such as heart attack and stroke in patients treated with cholesterol lowering treatments. The aims of this study are therefore to: assess the clinical and demographic profile of patients treated with cholesterol lowering treatments, including patterns of prescribed medications and variation in cholesterol levels; to quantify cardiovascular events in these patients and investigate risk factors for these events; and to describe healthcare resource use associated with cardiovascular disease in this population.

Technical Summary

Cardiovascular diseases (CVD) are the leading cause of death in England and Wales, accounting for almost 1/3 of all deaths and around 1.7 million episodes in NHS hospitals annually. The majority of risk factors for CVD are modifiable, such as high blood cholesterol Prescriptions of statin or other non-statin medications aiming to lower low-density lipoprotein (LDL) cholesterol are first choice in the management of patients with high CVD risk. Despite LDL cholesterol lowering, the risk of CVD remains significant. To reduce further the risk of CVD events, it is important to understand the factors associated with those events in patients treated with lipid-lowering medications. This study aims to assess clinical and demographic characteristics of patients on cholesterol lowering therapy, including patterns of prescribed medications and variation LDL levels; describe the burden of disease in terms healthcare resource use and incidence of cardiovascular events; and assess predictors of those events. This study will be primarily exploratory and hypothesis generating in nature. Descriptive analysis, and univariate and multivariate Cox regression models will be used. Subgroup analyses will be implemented for known CVD risk factors: subjects with and without familial hypercholesterolemia and with/without chronic kidney disease and diabetes.

Health Outcomes to be Measured

Composite cardiovascular event Myocardial infarction (any, fatal, and non-fatal) Stroke (ischemic, haemorrhagic, and other strokes) (any, fatal, and non-fatal) Coronary revascularization (coronary artery bypass grafting, percutaneous coronary intervention, thrombolysis) Transient ischemic attack (TIA). Unstable angina Stable angina Unstable angina-related hospitalization Unstable angina requiring revascularization Cardiovascular-related death All-cause mortality Cardiovascular-related hospitalizations

Collaborators

Dimitra Lambrelli - Chief Investigator - Evidera, Inc
Marta Pereira - Collaborator - Bristol-Myers Squibb - USA ( BMS )
Robert Donaldson - Collaborator - Evidera Ltd - UK
Selin Cooper - Collaborator - Evidera, Inc
Sharon MacLachlan - Collaborator - Evidera, Inc
Sreeram Ramagopalan - Collaborator - London School Of Economics & Political Science

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation