Translating the VICTORION-1 PREVENT criteria to a real-world population

May 2026

Applying the VICTORION-1 PREVENT eligibility criteria to a real-world population indicates that up to one in six individuals will meet these criteria.

Wang N, Bhatt DL, Xhaard C, et al. Associations of VICTORION-1 PREVENT eligibility with subclinical cardiovascular and inflammatory damage in a European population-based cohort. Am J Prevent Cardiol 2026; doi:10.1016/j.ajpc.2026.101524.

STUDY SUMMARY

Objective

VICTORION-1 PREVENT (NCT05739383) is an ongoing, randomized, double-blind, placebo-controlled Phase III trial which is evaluating the efficacy of inclisiran versus placebo in preventing cardiovascular events in primary prevention patients at high-risk for atherosclerotic cardiovascular disease (ASCVD). The current study investigated whether the trial’s eligibility criteria based on Pooled Cohort Equations (PCE) and Predicting Risk of Cardiovascular Disease Events (PREVENT) equations were associated with subclinical cardiovascular and inflammatory abnormalities in a real-world, healthy European population.

 

 

Study design

This report was based on a real-world single-centre cohort study (STANISLAS) in France.  

 

 

Study population

The VICTORION-1 PREVENT inclusion criteria included evidence of non-obstructive coronary artery disease on computer tomography or invasive coronary angiogram, an elevated coronary artery calcium score or high predicted ASCVD risk (≥20 % over 10 years or 7.5–20 % with at least two risk enhancing factors) with low-density lipoprotein cholesterol (LDL-C) between 70–190 mg/dL. The STANISLAS cohort included individuals who attended for the fourth visit between 2011–2016. Eligible subjects were aged 40–79 years with LDL-C between 70–189 mg/dL and had no clinical ASCVD (defined as coronary artery disease, angina, myocardial infarction, or stroke) or liver disease (defined as alanine aminotransferase or aspartate aminotransferase ≥150 U/L) .

 

 

Main study variables

VICTORION-1 PREVENT eligibility was confirmed by estimated 10-year predicted ASCVD risk based on PCE and PREVENT equations.

 

 

Methods

Subjects were categorized according to estimated 10-year ASCVD risk as ineligible, eligible for VICTORION-1 PREVENT by PCE only (PCE group), or eligible for VICTORION-1 PREVENT by both PCE and PREVENT (PCE+PREVENT group). Linear regression analyses were used to assess the association between VICTORION-1 PREVENT eligibility with vascular indices, echocardiographic variables and cardiac and inflammatory biomarkers.

 

Key results

Data from 848 subjects in the STANISLAS cohort (mean age 60 years, 51% female) were evaluated. Overall, 133 (15.7%) were eligible with PCE criteria, of whom 60 (7.1%) were also eligible with PREVENT criteria. For eligible subjects, the mean PCE 10-year ASCVD risk was 21% (PCE+PREVENT) and 17% (PCE only); the mean PREVENT 10-year ASCVD risk was 11% (PCE+PREVENT) and 8% (PCE only).

 

Almost twice as many subjects eligible for VICTORION-1 PREVENT had evidence of carotid plaque(s) (32% for PCE and 30% for PCE+PREVENT) compared with those who were ineligible (17%). In addition, subjects eligible for VICTORION-1 PREVENT had evidence of greater subclinical cardiac and vascular abnormalities than those who were ineligible. These included increased intima medial thickness (p<0.001); increased mean pulse wave velocity (p<0.001); elevated inflammatory markers (1.6-fold higher interleukin-6, p<0.001 and up to 2-fold higher high sensitivity C-reactive protein, p<0.001); and higher circulating troponin levels (p=0.015) compared with subjects who were ineligible.

Author conclusions

A large proportion of asymptomatic individuals without known cardiovascular disease would be eligible for the VICTORION-1 PREVENT trial based on both PCE and PREVENT equations. VICTORION-1 PREVENT eligible participants had evidence of subclinical cardiovascular and inflammatory abnormalities.

Comment

Based on this analysis of a European cohort free from cardiovascular disease, one in six individuals would be eligible for the VICTORION-1 PREVENT trial based on PCE criteria and one in 14 based on PREVENT criteria. These findings imply that the VICTORION-1 PREVENT criteria are generalizable to a high prevalence of seemingly healthy Europeans.

Several limitations to this report should be considered. First, the study did not assess eligibility for the VICTORION-1 PREVENT trial based on coronary artery calcium score or evidence of non-obstructive coronary disease on angiography, both of which are included in the trial inclusion criteria.  Thus, the prevalence of VICTORION-1 PREVENT eligibility may have been underestimated in this report. Additionally, the cohort was relatively small and from one geographic region, which may limit generalizability to wider European populations. Despite this, the 10-year ASCVD risk of subjects eligible for VICTORION-1 PREVENT was comparable with that reported for a U.S. study which assessed primary prevention patients who met the trial eligibility (21% by PCE and 12% by PREVENT) (1).

These study findings suggest basing ASCVD preventive strategies on personalized cardiovascular risk rather than differentiating by evidence of prior ASCVD events. Indeed, further support for this approach is provided by another study which showed that individuals without a prior event with a coronary artery calcium score >300 are at similar cardiovascular risk as those with established ASCVD (2).

The implications of the study are that the VICTORION-1 PREVENT results may be applicable to a potentially large population of seemingly healthy individuals. If borne out in the trial, this may prompt rethinking cardiovascular disease prevention strategies.  

 

References

  1. Aggarwal R, Bhatt DL, Bonaca MP, et al. Generalizability of VICTORION-1 PREVENT enrollment criteria to the United States population. Am J Prevent Cardiol 2025;22:100957.
  2. Budoff MJ, Kinninger A, Gransar H, et al. When does a calcium score equate to secondary prevention? JACC Cardiovasc Imaging 2023;16:1181–9.

Key words: VICTORION-1 PREVENT eligibility; primary prevention; personalized cardiovascular risk