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

[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 elasto...

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Autores: Yip, Terry Cheuk-Fung, Lee, Hye Won, Lin, Huapeng, Tsochatzis, Emmanuel, Petta, Salvatore, Bugianesi, Elisabetta, Yoneda, Masato, Zheng, Ming-Hua, Hagström, Hannes, Boursier, Jérôme, Calleja, José Luis, Goh, George Boon-Bee, Chan, Wah-Kheong, Gallego-Durán, Rocío, Sanyal, Arun J., Ledinghen, Victor de, Newsome, Philip N., Fan, Jian-Gao, Castéra, Laurent, Lai, Michelle, Fournier-Poizat, Céline, Wong, Grace Lai-Hung, Pennisi, Grazia, Armandi, Angelo, Nakajima, Atsushi, Liu, Wen-Yue, Shang, Ying, de Saint-Loup, Marc, Llop, Elba, Teh, Kevin Kim Jun, Lara-Romero, Carmen, Asgharpour, Amon, Mahgoub, Sara, Chan, Mandy Sau-Wai, Canivet, Clémence M., Romero-Gómez, Manuel, Kim, Seung Up, Wong, Vincent Wai-Sun
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/400656
Acceso en línea:http://hdl.handle.net/10261/400656
https://api.elsevier.com/content/abstract/scopus_id/105000575199
Access Level:acceso abierto
Palabra clave:FIB-4
Hepatocellular carcinoma
MASLD
VCTE
Hepatic decompensation
id ES_fe36e48491bcc62bb5ae8f85372def3e
oai_identifier_str oai:digital.csic.es:10261/400656
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Prognostic performance of the two-step clinical care pathway in metabolic dysfunction-associated steatotic liver disease
title Prognostic performance of the two-step clinical care pathway in metabolic dysfunction-associated steatotic liver disease
spellingShingle Prognostic performance of the two-step clinical care pathway in metabolic dysfunction-associated steatotic liver disease
Yip, Terry Cheuk-Fung
FIB-4
Hepatocellular carcinoma
MASLD
VCTE
Hepatic decompensation
title_short Prognostic performance of the two-step clinical care pathway in metabolic dysfunction-associated steatotic liver disease
title_full Prognostic performance of the two-step clinical care pathway in metabolic dysfunction-associated steatotic liver disease
title_fullStr Prognostic performance of the two-step clinical care pathway in metabolic dysfunction-associated steatotic liver disease
title_full_unstemmed Prognostic performance of the two-step clinical care pathway in metabolic dysfunction-associated steatotic liver disease
title_sort Prognostic performance of the two-step clinical care pathway in metabolic dysfunction-associated steatotic liver disease
dc.creator.none.fl_str_mv Yip, Terry Cheuk-Fung
Lee, Hye Won
Lin, Huapeng
Tsochatzis, Emmanuel
Petta, Salvatore
Bugianesi, Elisabetta
Yoneda, Masato
Zheng, Ming-Hua
Hagström, Hannes
Boursier, Jérôme
Calleja, José Luis
Goh, George Boon-Bee
Chan, Wah-Kheong
Gallego-Durán, Rocío
Sanyal, Arun J.
Ledinghen, Victor de
Newsome, Philip N.
Fan, Jian-Gao
Castéra, Laurent
Lai, Michelle
Fournier-Poizat, Céline
Wong, Grace Lai-Hung
Pennisi, Grazia
Armandi, Angelo
Nakajima, Atsushi
Liu, Wen-Yue
Shang, Ying
de Saint-Loup, Marc
Llop, Elba
Teh, Kevin Kim Jun
Lara-Romero, Carmen
Asgharpour, Amon
Mahgoub, Sara
Chan, Mandy Sau-Wai
Canivet, Clémence M.
Romero-Gómez, Manuel
Kim, Seung Up
Wong, Vincent Wai-Sun
author Yip, Terry Cheuk-Fung
author_facet Yip, Terry Cheuk-Fung
Lee, Hye Won
Lin, Huapeng
Tsochatzis, Emmanuel
Petta, Salvatore
Bugianesi, Elisabetta
Yoneda, Masato
Zheng, Ming-Hua
Hagström, Hannes
Boursier, Jérôme
Calleja, José Luis
Goh, George Boon-Bee
Chan, Wah-Kheong
Gallego-Durán, Rocío
Sanyal, Arun J.
Ledinghen, Victor de
Newsome, Philip N.
Fan, Jian-Gao
Castéra, Laurent
Lai, Michelle
Fournier-Poizat, Céline
Wong, Grace Lai-Hung
Pennisi, Grazia
Armandi, Angelo
Nakajima, Atsushi
Liu, Wen-Yue
Shang, Ying
de Saint-Loup, Marc
Llop, Elba
Teh, Kevin Kim Jun
Lara-Romero, Carmen
Asgharpour, Amon
Mahgoub, Sara
Chan, Mandy Sau-Wai
Canivet, Clémence M.
Romero-Gómez, Manuel
Kim, Seung Up
Wong, Vincent Wai-Sun
author_role author
author2 Lee, Hye Won
Lin, Huapeng
Tsochatzis, Emmanuel
Petta, Salvatore
Bugianesi, Elisabetta
Yoneda, Masato
Zheng, Ming-Hua
Hagström, Hannes
Boursier, Jérôme
Calleja, José Luis
Goh, George Boon-Bee
Chan, Wah-Kheong
Gallego-Durán, Rocío
Sanyal, Arun J.
Ledinghen, Victor de
Newsome, Philip N.
Fan, Jian-Gao
Castéra, Laurent
Lai, Michelle
Fournier-Poizat, Céline
Wong, Grace Lai-Hung
Pennisi, Grazia
Armandi, Angelo
Nakajima, Atsushi
Liu, Wen-Yue
Shang, Ying
de Saint-Loup, Marc
Llop, Elba
Teh, Kevin Kim Jun
Lara-Romero, Carmen
Asgharpour, Amon
Mahgoub, Sara
Chan, Mandy Sau-Wai
Canivet, Clémence M.
Romero-Gómez, Manuel
Kim, Seung Up
Wong, Vincent Wai-Sun
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv The Government of the Hong Kong Special Administrative Region
Chinese University of Hong Kong
Yip, Terry Cheuk-Fung [0000-0002-1819-2464]
Tsochatzis, Emmanuel [0000-0001-5069-2461]
Petta, Salvatore [0000-0002-0822-9673]
Bugianesi, Elisabetta [0000-0002-0502-4381]
Yoneda, Masato [0000-0001-7815-549X]
Zheng, Ming-Hua [0000-0003-4984-2631]
Hagström, Hannes [0000-0002-8474-1759]
Calleja, José Luis [0000-0002-5278-0163]
Goh, George Boon-Bee [0000-0001-8221-5299]
Gallego-Durán, Rocío [0000-0002-9452-1661]
Newsome, Philip N. [0000-0001-6085-3652]
Pennisi, Grazia [0000-0001-9518-4751]
Nakajima, Atsushi [0000-0002-6263-1436]
Romero-Gómez, Manuel 0000-0001-8494-8947
Kim, Seung Up 0000-0002-9658-8050
Wong, Vincent Wai-Sun 0000-0003-2215-9410
Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]
dc.subject.none.fl_str_mv FIB-4
Hepatocellular carcinoma
MASLD
VCTE
Hepatic decompensation
topic FIB-4
Hepatocellular carcinoma
MASLD
VCTE
Hepatic decompensation
description [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.
publishDate 2025
dc.date.none.fl_str_mv 2025
2025
2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
http://purl.org/coar/resource_type/c_6501
Publisher's version
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10261/400656
https://api.elsevier.com/content/abstract/scopus_id/105000575199
url http://hdl.handle.net/10261/400656
https://api.elsevier.com/content/abstract/scopus_id/105000575199
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv The underlying dataset has been published as supplementary material of the article in the publisher platform at DOI https://doi.org/10.1016/j.jhep.2025.01.014
https://doi.org/10.1016/j.jhep.2025.01.014

dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Elsevier BV
publisher.none.fl_str_mv Elsevier BV
dc.source.none.fl_str_mv reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC
instname:Consejo Superior de Investigaciones Científicas (CSIC)
instname_str Consejo Superior de Investigaciones Científicas (CSIC)
reponame_str DIGITAL.CSIC. Repositorio Institucional del CSIC
collection DIGITAL.CSIC. Repositorio Institucional del CSIC
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869425664455606272
spelling Prognostic performance of the two-step clinical care pathway in metabolic dysfunction-associated steatotic liver diseaseYip, Terry Cheuk-FungLee, Hye WonLin, HuapengTsochatzis, EmmanuelPetta, SalvatoreBugianesi, ElisabettaYoneda, MasatoZheng, Ming-HuaHagström, HannesBoursier, JérômeCalleja, José LuisGoh, George Boon-BeeChan, Wah-KheongGallego-Durán, RocíoSanyal, Arun J.Ledinghen, Victor deNewsome, Philip N.Fan, Jian-GaoCastéra, LaurentLai, MichelleFournier-Poizat, CélineWong, Grace Lai-HungPennisi, GraziaArmandi, AngeloNakajima, AtsushiLiu, Wen-YueShang, Yingde Saint-Loup, MarcLlop, ElbaTeh, Kevin Kim JunLara-Romero, CarmenAsgharpour, AmonMahgoub, SaraChan, Mandy Sau-WaiCanivet, Clémence M.Romero-Gómez, ManuelKim, Seung UpWong, Vincent Wai-SunFIB-4Hepatocellular carcinomaMASLDVCTEHepatic decompensation[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.The study was supported in part by the Noncommunicable Chronic Diseases-National Science and Technology Major Project of China (2023ZD0508700), General Research Fund by the Hong Kong SAR Government (14106923), and Direct Grant of The Chinese University of Hong Kong (2024.065).Peer reviewedElsevier BVThe Government of the Hong Kong Special Administrative RegionChinese University of Hong KongYip, Terry Cheuk-Fung [0000-0002-1819-2464]Tsochatzis, Emmanuel [0000-0001-5069-2461]Petta, Salvatore [0000-0002-0822-9673]Bugianesi, Elisabetta [0000-0002-0502-4381]Yoneda, Masato [0000-0001-7815-549X]Zheng, Ming-Hua [0000-0003-4984-2631]Hagström, Hannes [0000-0002-8474-1759]Calleja, José Luis [0000-0002-5278-0163]Goh, George Boon-Bee [0000-0001-8221-5299]Gallego-Durán, Rocío [0000-0002-9452-1661]Newsome, Philip N. [0000-0001-6085-3652]Pennisi, Grazia [0000-0001-9518-4751]Nakajima, Atsushi [0000-0002-6263-1436]Romero-Gómez, Manuel 0000-0001-8494-8947Kim, Seung Up 0000-0002-9658-8050Wong, Vincent Wai-Sun 0000-0003-2215-9410Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]202520252025info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501Publisher's versioninfo:eu-repo/semantics/publishedVersionapplication/pdfhttp://hdl.handle.net/10261/400656https://api.elsevier.com/content/abstract/scopus_id/105000575199reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)InglésThe underlying dataset has been published as supplementary material of the article in the publisher platform at DOI https://doi.org/10.1016/j.jhep.2025.01.014https://doi.org/10.1016/j.jhep.2025.01.014Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/4006562026-05-22T06:33:51Z
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