Abstract Body (Do not enter title and authors here): Background: VESALIUS-CV (Effect of EVolocumab in PatiEntS at High CArdiovascuLar RIsk WithoUt Prior Myocardial Infarction or Stroke – CardioVascular; NCT03872401) is an ongoing clinical trial investigating the benefits of intensified lipid-lowering therapy (LLT) in patients at high risk for a first atherosclerotic cardiovascular disease (ASCVD) event. We conducted an observational study to examine a similar population in the real world (VESALIUS-REAL) across different healthcare settings.
Aim: To examine the rate of ASCVD events across eight countries in a high-risk population similar to that of VESALIUS-CV.
Methods: Using eligibility criteria aligned with VESALIUS-CV, selected patients were aged ≥50 years, had evaluated low-density lipoprotein cholesterol (LDL-C) ≥2.3 mmol/L (≥90 mg/dL), and had coronary artery disease, cerebrovascular disease, peripheral artery disease, or high-risk diabetes in addition to another high cardiovascular risk factor, without history of myocardial infarction (MI) or stroke. Index was defined as the earliest date patients met all eligibility criteria. Patients with an index date between 2017 and 2022 were identified in medical and pharmacy claims (DeSC [Japan], German Disease Analyzer [Germany], HealthVerity [US]) or in electronic medical records (Hospital Authority [Hong Kong], PHARMO Data Network [The Netherlands], National and Regional Patient Registries [Sweden], Chang Gung Research Database [Taiwan], Clinical Practice Research Datalink Aurum [UK]). Incidence of first MI and first stroke was age and sex standardized to the 2020 global population and reported per 1,000 person-years (pys).
Results: Of 1,076,773 patients at high risk for an ASCVD event, the proportion not receiving LLT at index ranged from 38% in Hong Kong to 72% in Germany and Taiwan. The age-sex standardized incidence rates of MI ranged from 2.6 (95% confidence interval [CI], 2.5–2.8) in Japan to 13.6 (95% CI, 12.6–14.7) in Hong Kong. For stroke, incidence rates ranged from 5.6 (95% CI, 5.3–5.8) in the US to 27.7 (95% CI, 26.4–29.2) in Taiwan (Figure).
Conclusions: Despite being at high risk for a first ASCVD event, most patients in VESALIUS-REAL were not receiving LLT. Variation between countries may reflect differences in treatment. Differences in data sources and collection practices may impact incidence rates. These results highlight a missed opportunity to optimize lipid management in this high-risk population to prevent the burden of ASCVD events.