Generalizability of VICTORION-1 PREVENT enrollment criteria to the United States population

Background: VICTORION-1 PREVENT (V-1P) is an ongoing trial evaluating inclisiran for lipid lowering in patients with high cardiovascular (CV) risk without established atherosclerotic CV disease (ASCVD). This study evaluates the generalizability of V-1P enrollment criteria to the US population and their clinical comorbidity and CV risk factor burden. Methods: Data from National Health and Nutrition Examination Surveys (2015-March 2020) were used to determine nationally representative estimates. Inclusion criteria were low-density lipoprotein cholesterol (LDL-C) of 70–189 mg/dL and a 10-year ASCVD risk of ≥20% or 7.5%-19.9% with two CV risk enhancers. The pooled cohort equations (PCE) was used to stratify ASCVD risk in primary analysis. Estimates of the US population were compared with the V-1P eligible population. Results: The V-1P eligible population included 23,837,940 adults. Compared with US adults ages 40-79 years, V-1P eligible adults had higher mean 10-year ASCVD risk by PCE (21.1% [95% CI: 20.1%-22.2%] vs 10.0% [95% CI: 9.4%-10.6%]). The V-1P eligible population also had higher rates of hypertension (85.4% [95% CI: 81.6%-89.1%] vs 59.4% [95% CI: 56.7%-62.2%], diabetes (35.6% [95% CI: 31.3%-40.0%] vs 18.7% [95% CI: 16.9%- 20.5%]) and metabolic syndrome (81.6% [95% CI: 78.4%-84.7%] vs 51.1% [48.3%- 53.9%]). Adults meeting V-1P eligibility had high levels of LDL-C (117.8 mg/dL [95% CI: 114.3 mg/dL-121.2 mg/dL]) and low statin use (36.7% [95% CI: 31.9%-41.5%]). Conclusions: Many primary prevention patients have high CV risk, significant comorbidity burden, and are eligible for lipid-lowering therapy, yet rates of treatment are low. Public health interventions to improve CV risk factor management are necessary.