Lipid management in high cardiovascular risk patients without prior myocardial infarction or stroke - preliminary data from the VESALIUS-REAL global burden study

Abstract Background Early intervention with lipid lowering therapy (LLT) in patients with high cardiovascular (CV) risk who have not yet had myocardial infarction or stroke may have substantial public health benefits, despite being perceived as less urgent. The effect of LLT is being investigated in this population in a clinical trial (VESALIUS-CV: Effect of EVolocumab in PatiEntS at High CArdiovascuLar RIsk WithoUt Prior Myocardial Infarction or Stroke – CardioVascular, NCT03872401). We conducted an observational study to examine the global burden of VESALIUS-CV-like population in the REAL-World ("VESALIUS-REAL") across 11 regions/countries. Purpose To describe the characteristics of VESALIUS-CV like population and their lipid management patterns in US, Germany, UK, Japan and South Korea. Methods Using the eligibility criteria aligned with VESALIUS-CV, patients aged ≥ 50 years with elevated low density lipoprotein cholesterol (LDL-C, ≥2.3 mmol/L ≥90 mg/dL), coronary artery disease (CAD), cerebrovascular disease (CeVD), peripheral artery disease (PAD), or high-risk diabetes (DM), and another high CV risk factor were identified in (a) medical and pharmacy claims: HealthVerity (US), German Disease Analyzer (Germany), DeSC (Japan) and National Health Insurance Service-Health Screening Cohort (South Korea); or (b) electronic medical records: Clinical Practice Research Datalink Aurum (UK) between 2017 and 2022. Index date was defined as the earliest date when patients met all eligibility criteria. Patient characteristics and LLT use at index, patterns of LDL-C testing and results during 1-year post-index are summarized. Results Overall, 917,558 VESALIUS-CV like patients were included. Across the 5 countries, median age ranged from 64-71 years, 38-50% had CAD, 15-35% had CeVD, 9-17% had PAD and 25-39% had high-risk DM (Table). A majority of patients were not on LLT. Background LLT use ranged from 28% (South Korea) to 49% (UK). Moderate-intensity statins were the most commonly-used therapy in all countries except Japan, in which low-intensity statins were most commonly used. The percentage of patients with LDL-C recording during the 1-year follow-up ranged from 7% to 52%. Most of these patients had LDL-C 1.8 mmol/L (70 mg/dL) (84%, 89%, 65%, 97% and 83% in US, Germany, UK, Japan and South Korea, respectively) (Figure). Conclusion Despite having high CV risk, a large proportion of VESALIUS-CV like patients were receiving no LLT at index and did not have a recorded LDL-C during 1 year of follow-up. For those with follow-up LDL-C records, most exceeded the 1.8 mmol/L (70 mg/dL) threshold for high risk patients. Variation between countries may reflect differences in treatment or data collection practices and lipid management guidelines. These results highlight a missed opportunity to optimize lipid control in this high CV-risk population and prevent major ischemic events.