Clinical utility of the FIB-4 index for predicting cardiovascular outcomes in patients with metabolic dysfunction-associated steatotic liver disease: a 10-year retrospective cohort study

Abstract Background/Introduction Metabolic dysfunction-associated steatotic liver disease (MASLD) is rapidly increasing and a global problem. It is associated with significant liver disease and hepatocellular carcinoma. Patients with fatty liver with metabolic risks, particularly those with advanced liver fibrosis, exhibit a higher prevalence of subclinical cardiovascular disease (CVD) and are associated with increased all-cause mortality. The fibrosis-4 (FIB-4) index is a standard noninvasive biomarker for fibrosis prediction and has been widely utilized for fibrosis screening in MASLD. Nonetheless, its role in classifying cardiovascular risk remains uncertain. Purpose This study evaluates individuals with MASLD identified with vibration-controlled transient elastography (FibroScan@) and investigates the clinical value of the FIB-4 index in forecasting long-term cardiovascular outcomes. Methods This retrospective cohort study evaluates patients with MASLD diagnosed with a controlled attenuation parameter (CAP) of 260 dB/m. and followed for 10 years period. Participants with excessive alcohol consumption were excluded. The FIB-4 index is categorized into two groups: low (1.3) and immediate to high risk (≥ 1.3) for fibrosis. The primary endpoint was a composite outcome of major adverse cardiovascular events (MACEs), including myocardial infarction, heart failure hospitalization, new-onset atrial fibrillation (AF), stroke, and all-cause mortality. Cox proportional hazard models and multivariate analysis were used to assess the composite outcomes of MACEs. Results The study included 1,169 participants with a mean age of 55.3 ± 10.4 years and a median FIB-4 index of 1.25 (interquartile range 0.83–1.97). The median follow-up duration is 4.93 years (interquartile range 2.63–6.47). Diabetes was present in 256 participants (21.9%). The average body weight index (BMI) is 27.16 ± 3.69 kg/m2. The primary outcome was a composite of MACEs, occurring in 50 participants (4.28%). This comprised 12 participants (1.03%) with myocardial infarction, 5 (0.43%) with heart failure hospitalizations, 18 (1.54%) with new-onset AF, 8 (0.68%) with strokes, and 7 (0.60%) with all-cause deaths. The FIB-4 index was a significant predictor of MACEs (adjusted hazard ratio aHR 2.16, 95% confidence interval CI 1.09–5.36, p = 0.030). Conclusion(s) The FIB-4 score is a simple, non-invasive biomarker that effectively classifies the extent of liver fibrosis and forecasts long-term cardiovascular consequences. A moderate to high FIB4 score is significantly associated with an increased risk of adverse cardiovascular events over ten years.FIB4 index group and MACEs