Characterization of patients with atherosclerotic cardiovascular disease: a descriptive study in the UK CPRD Aurum

Study type
Protocol
Date of Approval
Study reference ID
21_000518
Lay Summary

Atherosclerotic cardiovascular disease is a group of diseases that are caused by hardening of an artery due to an abnormal accumulation of material in the inner layer of the wall of an artery, which is the leading cause of death worldwide. It is important to understand the characteristics of this population and their unmet needs. However, previous studies were done decades ago, and the disease pattern has changed because of change in treatments and lifestyles. We propose to study the characteristics in patients with atherosclerotic cardiovascular disease by using routinely collected health information from the Clinical Practice Research Datalink. We will include patients diagnosed with atherosclerotic cardiovascular disease and investigate the characteristics, comorbidities (other long term conditions), treatment, risk of death, hospitalization and cardiovascular events in this population. The study will provide knowledge of characteristics of these patients and find their unmet needs to improve disease management and health outcomes.

Technical Summary

Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality worldwide and need comprehensive management. Many recent guidelines have been issued and the clinical practice may have changed over time. It is important to understand the up-to-date characteristics and unmet needs of ASCVD patients to inform future guidelines and guide the management of patients.

This study aims to characterise the patients of ASCVD. Patients diagnosed with ASCVD in UK primary care will be included for a cross-sectional study and a cohort study. In the cross-sectional study, patients diagnosed with ASCVD before 1st Jan 2016 and before 1st Jan 2021 will be included, respectively, and CPRD Aurum data and Multiple Deprivation Index data will be extracted to describe baseline characteristics (including socioeconomic status), biomarkers distribution, comorbidities prevalence, medication pattern and prior procedures. In the cohort study, patients diagnosed with ASCVD before 1st Jan 2016 will be included and will be followed up via HES Admitted Patient Care and ONS Death Registration Data to describe their long-term health outcomes (death, hospitalization), procedures and initiation of medications. Analysis will be carried out in two disjoint population: population 1 of patients with ASCVD diagnosis only from primary care, population 2 of patients with ASCVD diagnosis from both primary care and secondary care. Data will be summarized using descriptive statistics (means, medians, frequencies, rates). The study will provide knowledge of characteristics of these patients and find their unmet needs to improve disease management and their long-term outcomes.

Health Outcomes to be Measured

Cross-sectional study
Characteristics: age, sex, ethnicity, socioeconomic status, smoking

Biomarkers: BMI, C-reactive protein, serum creatinine, albumin-creatinine ratio, HbA1c, haemoglobin, blood pressure, total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, triglycerides, liver function tests (including alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], gamma-glutamyl transferase [GGT])

Comorbidities: chronic kidney disease, chronic obstructive pulmonary disease, type 2 diabetes, hypertension, heart failure, depression, atrial fibrillation, liver disease, malignancies (cancers)

Procedures: percutaneous coronary intervention, coronary artery bypass grafting, peripheral revascularisation, kidney dialysis, kidney transplant

Medications: lipid-lowering therapy, glucose-lowering therapy, ACE inhibitors, angiotensin II receptor blockers (ARB), calcium channel blockers, diuretics, beta-blockers, antiplatelet, anticoagulant, nitrates

Retrospective Cohort study
Mortality: all-cause mortality, cardiovascular death, renal death

Hospitalizations: all-cause hospitalization, cardiovascular disease, myocardial infarction, heart failure, stroke, transient ischemic attack, peripheral arterial disease, kidney disease

Procedures: percutaneous coronary intervention, coronary artery bypass grafting, peripheral revascularisation, dialysis, kidney transplant

Composite endpoint: 3- point major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke), expanded major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, coronary revascularization), major adverse limb events (severe limb ischemia leading to a peripheral revascularization or major vascular amputation)

Initiation of medications: lipid-lowering therapy, glucose-lowering therapy, ACE inhibitors, angiotensin II receptor blockers (ARB), calcium channel blockers, diuretics, beta-blockers, antiplatelet, anticoagulant, nitrates

Collaborators

Lise Lotte Nystrup Husemoen - Chief Investigator - Novo Nordisk A/S
Zewei Shen - Corresponding Applicant - Novo Nordisk A/S
Iram Faqir Muhammad - Collaborator - Novo Nordisk A/S
Kamlesh Khunti - Collaborator - University of Leicester
Mads Jeppe Tarp-Johansen - Collaborator - Novo Nordisk A/S
Naveed Sattar - Collaborator - University of Glasgow
Oscar Plunde - Collaborator - Novo Nordisk Denmark A/S
Simon Reuter - Collaborator - Novo Nordisk A/S

Former Collaborators

Christian Medom Madsen - Collaborator - Novo Nordisk A/S
Gamze Tombak - Collaborator - Novo Nordisk A/S
SADBERK LALE TOKGÖZOĞLU - Collaborator - Hacettepe University
Mads Faurby - Collaborator - Novo Nordisk A/S

Linkages

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