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Prognostic performance of the two-step clinical care pathway in metabolic dysfunction-associated steatotic liver disease

Yip TC 1 , Lee HW 2 , Lin H 3 , Tsochatzis E 4 , Petta S 5 , Bugianesi E 6 Show all authors , Yoneda M 7 , Zheng MH 8 , Hagström H 9 , Boursier J 10 , Calleja JL 11 , Goh GB 12 , Chan WK 13 , Gallego-Durán R 14 , Sanyal AJ 15 , de Lédinghen V 16 , Newsome PN 17 , Fan JG 18 , Castéra L 19 , Lai M 20 , Fournier-Poizat C 16 , Wong GL 1 , Pennisi G 5 , Armandi A 6 , Nakajima A 7 , Liu WY 21 , Shang Y 22 , de Saint-Loup M 23 , Llop E 11 , Teh KKJ 12 , Lara-Romero C 14 , Asgharpour A 15 , Mahgoub S 24 , Chan MS 16 , Canivet CM 10 , Romero-Gomez M 14 , Kim SU 25 , Wong VW 26

Affiliations 

  • 1 Medical Data Analytics Centre, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China; State Key Laboratory of Digestive Disease, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China
  • 2 Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Republic of Korea
  • 3 Department of Gastroenterology and Hepatology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • 4 University College London Institute for Liver and Digestive Health, Royal Free Hospital and UCL, London, United Kingdom
  • 5 Section of Gastroenterology, PROMISE, University of Palermo, Italy
  • 6 Department of Medical Sciences, Division of Gastroenterology, A.O.U. Città della Salute e della Scienza di Torino, University of Turin, Turin, Italy
  • 7 Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan
  • 8 MAFLD Research Center, Department of Hepatology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
  • 9 Department of Medicine, Huddinge, Karolinska Institutet, Sweden; Division of Hepatology, Department of Upper GI Diseases, Karolinska University Hospital, Huddinge, Stockholm, Sweden
  • 10 Hepato-Gastroenterology and Digestive Oncology Department, Angers University Hospital, Angers, France; HIFIH Laboratory, SFR ICAT 4208, Angers University, Angers, France
  • 11 Department of Gastroenterology and Hepatology, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid, Spain
  • 12 Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore
  • 13 Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
  • 14 UCM Digestive Diseases, Virgen del Rocio University Hospital, SeLiver Group, Institute of Biomedicine of Seville, Ciberehd, Department of Medicine, University of Seville, Seville, Spain
  • 15 Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University School of Medicine, Richmond, VA, USA
  • 16 Echosens, Paris, France
  • 17 Roger Williams Institute of Liver Studies, School of Immunology & Microbial Sciences, Faculty of Life Sciences and Medicine, King's College London, Foundation for Liver Research and King's College Hospital, London, United Kingdom
  • 18 Department of Gastroenterology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Key Lab of Pediatric Gastroenterology and Nutrition, Shanghai, China
  • 19 Université Paris Cité, UMR1149 (CRI), INSERM, Paris, France, Service d'Hépatologie, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris (AP-HP), Clichy, France
  • 20 Division of Gastroenterology & Hepatology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
  • 21 Department of Endocrinology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
  • 22 Department of Medicine, Huddinge, Karolinska Institutet, Sweden
  • 23 Hepato-Gastroenterology and Digestive Oncology Department, Angers University Hospital, Angers, France
  • 24 National Institute for Health Research, Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham, Birmingham, United Kingdom
  • 25 Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: KSUKOREA@yuhs.ac
  • 26 Medical Data Analytics Centre, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China; State Key Laboratory of Digestive Disease, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. Electronic address: wongv@cuhk.edu.hk
J Hepatol, 2025 Jan 23.
PMID: 39863175 DOI: 10.1016/j.jhep.2025.01.014

Abstract

BACKGROUND & AIMS: Current guidelines recommend a two-step approach for risk stratification in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) involving Fibrosis-4 index (FIB-4) followed by liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) or similar second-line tests. This study aimed to examine the prognostic performance of this approach.

METHODS: The VCTE-Prognosis study was a longitudinal study of patients with MASLD who had undergone VCTE examinations at 16 centres from the US, Europe and Asia with subsequent follow-up for clinical events. The primary endpoint was incident liver-related events (LREs), defined as hepatic decompensation and/or hepatocellular carcinoma.

RESULTS: Of 12,950 patients (mean age 52 years, 41% female, 12.1% LSM >12 kPa), baseline FIB-4, at cut-offs of 1.3 (or 2.0 for age ≥65) and 2.67, classified 66.3% as low-risk and 9.8% as high-risk, leaving 23.9% in the intermediate-risk zone. After classifying intermediate FIB-4 patients as low-risk if LSM was <8.0 kPa and high-risk if LSM was >12.0 kPa, 81.5%, 4.6%, and 13.9% of the full cohort were classified as low-, intermediate-, and high-risk, respectively. At a median (IQR) follow-up of 47 (23-72) months, 248 (1.9%) patients developed LREs. The 5-year cumulative incidence of LREs was 0.5%, 1.0% and 10.8% in the low-, intermediate- and high-risk groups, respectively. Replacing LSM with Agile 3+, Agile 4, and FAST did not reduce the intermediate-risk zone or improve event prediction. Classifying intermediate FIB-4 patients by LSM <10 kPa (low-risk) and >15 kPa (high-risk) reduced the intermediate-risk zone while maintaining predictive performance.

CONCLUSIONS: The non-invasive two-step approach of FIB-4 followed by LSM is effective in classifying patients at different risks of LREs.

IMPACT AND IMPLICATIONS: Metabolic dysfunction-associated steatotic liver disease (MASLD) is emerging as one of the leading causes of cirrhosis and hepatocellular carcinoma worldwide, but only a minority of patients will develop these complications. Therefore, it is necessary to use non-invasive tests instead of liver biopsy for risk stratification. Additionally, as most patients with MASLD are seen in primary care instead of specialist settings, cost and availability of the tests should be taken into consideration. In this multicentre study, the use of the Fibrosis-4 index followed by liver stiffness measurement by vibration-controlled transient elastography effectively identified patients who would later develop liver-related events. The results support current recommendations by various regional guidelines on a clinical care pathway based on non-invasive tests to diagnose advanced liver fibrosis.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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