ASCVD stands for atherosclerotic cardiovascular disease, which is caused by narrowing and hardening of blood vessels (atherosclerosis). ASCVD is defined as severe atherosclerosis in the blood vessels of the heart, brain and outer regions of the body such as legs, which manifest in events such as heart attack and stroke. Clinical studies have shown that people with established ASCVD are at increased risk of having heart and vascular disease, such as heart attack or stroke, and death. This risk depends on the location of the ASCVD, the presence of past heart and vascular disease events, and other diseases like diabetes. People with a condition called Heterozygous Familial Hypercholesterolemia (HeFH), which is an inherited genetic disorder that causes dangerously high cholesterol levels, are also at high risk of heart and vascular disease. However, information on the risk of heart and vascular disease in patients with ASCVD or HeFH is not well established in routine clinical practice. Therefore, this study will report the demographic and clinical characteristics of these high-risk patients, assess how frequent major heart and vascular disease events are, and investigate what the risk factors for heart and vascular disease events. This information is important for identifying which ASCVD and HeFH patients are at highest risk of future heart and vascular disease events, and for understanding the impact of these patients on public health measures.
The risk of cardiovascular (CV) events in individuals with established atherosclerotic cardiovascular disease (ASCVD) is not well described in the real-world. Data from randomized clinical trials suggest that CV event rates in this population are influenced by the type of ASCVD (e.g. coronary vs. peripheral disease), the timing since past events, and concurrent comorbid conditions such as diabetes mellitus. This study will assess the patterns of CV risk in the patients with ASCVD or Heterozygous Familial Hypercholesterolemia (HeFH) using primary care data from the UK (CPRD). Patients with ASCVD or HeFH diagnoses recorded in the 2 years before the index date of 1st January 2010 will be identified. A 2-year baseline period before index will be used to establish patient demographic, clinical and medication characteristics. Patients will be followed for CV events over time until the end of the available data, with censoring at death or transfer out, first occurrence of underlying individual component or end of data availability. Descriptive summary statistics, Kaplan-Meier analysis, and a Cox proportional hazards regression model adjusted for potential confounders will be applied to evaluate one-year event rates of CV events and predictors of CV risk. Results of this study will be useful for understanding the public health burden of ASCVD and identification of individuals who are at highest risk for future events.
Outcomes of this study will be one-year event rates of the primary and secondary CV endpoints, the frequency of demographic, clinical and medication characteristics, and predictors of CV risk.
Primary Endpoint:
Composite of: nonfatal myocardial infarction (MI), unstable angina (UA) with hospitalization, elective coronary revascularization, nonfatal ischemic stroke, and CV death
Secondary Endpoints:
Composite of: nonfatal MI, UA with hospitalization, elective coronary revascularization, nonfatal ischemic stroke, and all-cause-death
Individual components of the primary and secondary endpoints: nonfatal MI, UA with hospitalization, elective coronary revascularization, nonfatal ischemic stroke, CV death, and all-cause death
Naomi Boxall - Chief Investigator - IQVIA Ltd ( UK )
Zainab Mohamoud - Corresponding Applicant - IQVIA Ltd ( UK )
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Jessica Lundbom - Collaborator - IQVIA Ltd ( UK )
Silvia Narduzzi - Collaborator - IQVIA
Abi Mawer - Corresponding Applicant - IQVIA - UK
Jessica Lundbom - Collaborator - IQVIA Ltd ( UK )
Rachel Tham - Collaborator - IQVIA Ltd ( UK )
ONS Death Registration Data