Cardiovascular (CV) disease is the leading cause of morbidity and mortality globally. Low-density lipoprotein cholesterol (LDL-C) is an important modifiable risk factor of major adverse cardiovascular events. Patients without prior myocardial infarction (MI) or stroke but with established risk factors and elevated LDL-C may benefit from intensive lipid-lowering therapy (LLT); however, the size and potential healthcare burden of this population globally are not known. The benefits of evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, in these patients, are currently being studied in the phase 3 Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV) trial. To characterise the high-risk pre–CV-event (VESALIUS-CV–like) individuals in the real world, an observational study is being conducted across multiple countries.

This retrospective cohort study will use a common protocol and an analytical common data model approach to characterise VESALIUS-CV–like individuals in the real world across different geographical regions and healthcare settings. The study period will be from 2010 to 2022, subject to data availability in study sites. Patients aged 50 years and older at high risk of CV disease but without prior MI or stroke will be included in this study. VESALIUS-CV–like individuals are defined through a combination of the following: (1) one diagnosis of coronary artery disease, cerebrovascular disease, peripheral artery disease or diabetes with microvascular complications or chronic insulin use; (2) an elevated LDL-C measurement and (3) other high-risk factors. The objectives of this study are to estimate the prevalence of VESALIUS-CV–like individuals, describe their characteristics and care pathways and estimate their incidence rates of CV events and healthcare costs. The prevalence of VESALIUS-CV–like individuals will be expressed as annual prevalence; patient characteristics at index date will be presented using summary statistics; care pathways will be summarised as LLT prescription across time; and the incidence of defined CV events will be expressed as events per person-years as well as at certain time periods. Healthcare costs will be presented as CV-related costs in different time periods.

Approvals of the study protocol were obtained from relevant local ethics and regulatory frameworks for each participating database. The results of the study will be submitted to peer-reviewed scientific publications and presented at scientific conferences.

To review the available evidence of screening for atherosclerosis in adults in a primary prevention setting with coronary artery calcium scoring (CACS) on the impact on cardiovascular (CV) risk factor control, health behaviour and clinical events.

Systematic review, reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

We searched MEDLINE, Embase and Cochrane Central Register of Controlled Trials through 22 January 2025.

We included randomised controlled trials (RCTs) and prospective cohorts, without language restrictions, comparing adults without cardiovascular diseases undergoing CACS to a control group that either did not undergo CACS or where the participants and physicians were blinded to its result. Outcomes included changes in CV risk factor control, CV therapy, changes in health behaviour at follow-up and clinical events (all-cause and CV mortality and non-fatal CV events).

Two independent reviewers extracted data and assessed the risk of bias. Due to substantial heterogeneity among the included studies, a quantitative analysis was not possible.

We identified seven RCTs and one observational study, with participants ranging from 56 to 43 447 with a total of 51 554. Populations were heterogeneous with a mean age range of 42–64 years, % women ranging from 21% to 100% and mean baseline CACS from 1.37 to >100 Agatston units. Interventions following CACS were also heterogeneous, ranging from simply communicating results to participants to initiating statin therapy for detectable CACS. One RCT demonstrated improvement regarding blood pressure (BP) (n=2137; change in systolic BP: CACS: –5 mm Hg; control: –7 mm Hg; p=0.02), several an improvement in blood lipids between groups (five studies, n=3693; eg, low-density lipoprotein (LDL) cholesterol: range –6.0 to –4.9 mg/dL). Results regarding CV medication (seven studies, n=51 104) were more discrepant, with some studies showing a decrease and others an increase in indication for or usage of CV medication. Three trials (n=3338) investigated adherence to CV medication, with only one showing increased adherence to statins (CACS: 63.3%; control: 45.6%; p=0.03). Five trials (n=3692) investigated behavioural changes, with one showing an increased motivation to change lifestyle (CACS: 94%; control: 62.8%; p=0.002) and another a higher adherence in self-reported physical activity (CACS: 96%; control: 59%; p

CACS screening with a CACS-guided intervention might have a favourable effect on CV risk factor control and potentially on adherence to CV medication and increased motivation to change lifestyle in populations at intermediate to high risk. The available evidence is insufficient to determine whether screening asymptomatic patients with CACS has an impact on all-cause mortality or CV events. Despite its known strengths in predicting outcomes in individual patients, more evidence regarding the impact on clinical outcomes is needed to determine the clinical use of CACS for screening purposes in asymptomatic patients.

CRD42022377727.