A longitudinal assessment of cardiovascular risk for NASH/MASH patients enrolled in TARGET-NASH.

Challenge

Cardiovascular risk prediction models used in clinical practice were not validated in MASH, and whether cirrhotic MASH patients face meaningfully higher CV event rates than non-cirrhotic MASH patients—after adjustment for traditional CV risk factors—was unknown in a real-world US cohort.

Solution

The TARGET-NASH cohort was used to calculate Framingham and PCE 10-year CV risk estimates by disease phenotype and compare observed CV event rates using Fine-Gray subdistribution hazard models adjusted for traditional CV risk factors, stratified by cirrhosis status.

Impact

Establishing that cirrhotic MASH patients have higher predicted and observed CV risk—even after adjusting for traditional risk factors—supports the regulatory case for MASH as an independent CV risk modifier and provides evidence for CV endpoint design in MASH development programs.