Higher fibrosis-4 index is associated with 2-year cardiovascular events in Vietnamese adults with type 2 diabetes mellitus: a prospective cohort study.

Abstract

Background: Cardiovascular disease is a major extrahepatic outcome in type 2 diabetes mellitus (T2DM) and metabolic fatty liver disease, but prospective data integrating transient elastography and the fibrosis-4 index (FIB-4) with observed cardiovascular events remain limited in Southeast Asia.

Methods: We conducted a prospective cohort study of adults with T2DM consecutively recruited at a Vietnamese tertiary hospital from June 2023 through January 2025 and followed for up to 24 months. Hepatic steatosis and liver stiffness were assessed by FibroScan^©, and metabolic dysfunction-associated fatty liver disease (MAFLD) was defined using the Asian Pacific Association for the Study of the Liver framework. Expanded major adverse cardiovascular events (MACE) were the principal time-to-event outcome. Sparse-event associations were estimated with Firth-penalized Cox regression.

Results: Of 452 patients screened, 301 consented and 284 entered the baseline cohort; 280 contributed follow-up. At baseline, MAFLD was present in 72.5% and significant liver fibrosis (liver stiffness measurement ≥7.0 kPa) in 23.9%. During 544.92 person-years, 11 expanded MACE and 5 conventional MACE occurred, corresponding to incidence rates of 20.19 (95% CI 10.08-36.12) and 9.18 (95% CI 2.98-21.41) per 1,000 person-years. In the main Firth model adjusted for age and MAFLD, each increase of 1 interquartile range (IQR; 0.696 units) in FIB-4 was associated with expanded MACE (adjusted hazard ratio 1.56, 95% CI 1.09-1.99; p = 0.022), whereas MAFLD was not statistically significant (adjusted hazard ratio 3.51, 95% CI 0.79-33.09; p = 0.105); the point estimate was above unity but imprecise because of the limited number of events.

Conclusion: Higher FIB-4 was associated with short-term cardiovascular events in adults with T2DM. Given the small number of events, these findings require confirmation in larger multicenter cohorts.