Key result
Adding CRP and IL-6 to SCORE2 fails to improve subclinical atherosclerosis detection.
Why the study?
Low-grade chronic inflammation is a recognized contributor to cardiovascular disease, yet the incremental value of inflammatory biomarkers like CRP and IL-6 for atherosclerosis stratification beyond the SCORE2 risk algorithm remained uncertain.
Does adding circulating CRP and IL-6 levels to the SCORE2 risk score improve subclinical atherosclerosis stratification in a primary prevention population?
RCT (n=1,000)
Randomized
Yes
Does adding circulating CRP and IL-6 levels to the SCORE2 risk score improve subclinical atherosclerosis stratification in a primary prevention population?
Although CRP and IL-6 are associated with traditional cardiovascular risk factors and carotid/femoral intima-media thickness, adding them to the SCORE2 algorithm does not improve stratification for subclinical atherosclerosis in primary prevention.
Adding CRP/IL-6 to SCORE2 does not improve subclinical atherosclerosis stratification; leaves open their incremental value beyond traditional risks in primary prevention.
Background Low-grade chronic inflammation is increasingly recognized as a key contributor to cardiovascular disease, yet its incremental value in risk stratification beyond established clinical scores remains uncertain. Purpose To evaluate the association between inflammatory biomarkers and cardiovascular risk factors, and to determine whether inflammatory markers improve atherosclerosis stratification beyond the SCORE2 risk algorithm. Methods Circulating levels of C-reactive protein (CRP) and interleukin-6 (IL-6) were measured in 1,000 participants enrolled in the Italian CV-PREVITAL study, a multicentre randomized clinical trial designed to compare the effectiveness of an educational mobile health (mHealth) intervention with usual care in reducing cardiovascular risk in a primary prevention population. Associations between CRP and IL-6 levels and classical cardiovascular risk factors, including dyslipidaemia, hypertension, and body mass index (BMI), among others, were analysed. Subclinical atherosclerosis was assessed by carotid and femoral echo-Doppler measurement of intima-media thickness (IMT). The incremental value of inflammatory markers over the SCORE2 risk score for atherosclerosis stratification was evaluated. Results Both CRP and IL-6 levels were significantly associated with adverse cardiometabolic profiles, including dyslipidaemia, elevated BMI, and hypertension. A significant correlation between inflammatory markers and IMT was also observed. Higher inflammatory burden was associated with increased estimated cardiovascular risk according to SCORE2. However, the addition of CRP and IL-6 to SCORE2 did not significantly improve discrimination or reclassification for subclinical atherosclerosis compared with SCORE2 alone, without modifying their potential role in event prediction. Conclusions Although low-grade chronic inflammation is closely associated with traditional cardiovascular risk factors and overall estimated risk, inflammatory biomarkers do not provide incremental value for atherosclerosis stratification beyond SCORE2 in a primary prevention setting.
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D'Aiello et al. (2026) conducted an RCT in Subclinical atherosclerosis and cardiovascular risk in primary prevention (n=1,000). Circulating C-reactive protein (CRP) and interleukin-6 (IL-6) added to SCORE2 risk score vs. SCORE2 risk score alone was evaluated on Discrimination or reclassification for subclinical atherosclerosis (assessed by carotid and femoral intima-media thickness). Adding CRP and IL-6 to the SCORE2 risk score in 1,000 primary prevention participants did not significantly improve discrimination or reclassification for subclinical atherosclerosis.
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