Qiuhe Wang1, Yong Lv1, Ming Bai1, Zhengyu Wang1, Haibo Liu1, Chuangye He1, Jing Niu1, Wengang Guo1, Bohan Luo1, Zhanxin Yin1, Wei Bai1, Hui Chen1, Enxin Wang1, Dongdong Xia1, Xiaomei Li1, Jie Yuan1, Na Han1, Hongwei Cai2, Tao Li3, Huahong Xie4, Jielai Xia2, Jianhong Wang3, Hongbo Zhang4, Kaichun Wu5, Daiming Fan5, Guohong Han6. 1. Department of Liver Disease and Digestive Interventional Radiology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an 710032, China. 2. Department of Medical Statistics, Fourth Military Medical University, Xi'an 710032, China. 3. Department of Ultrasound, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an 710032, China. 4. Department of Digestive Endoscopy, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an 710032, China. 5. State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Disease and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an 710032, China. 6. Department of Liver Disease and Digestive Interventional Radiology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an 710032, China. Electronic address: hangh@fmmu.edu.cn.
Abstract
BACKGROUND & AIMS: Currently, there are no recommendations in guidelines concerning the preferred diameter of stents for transjugular intrahepatic portosystemic shunt (TIPS), owing to the lack of adequate evidence. We therefore compared 8mm stents with 10mm stents, to evaluate whether 8mm stents would achieve similar shunt function, with less hepatic encephalopathy (HE) and better liver function. METHODS:Cirrhotic patients were randomly assigned to receive TIPS with an 8mm or 10mm covered stent to prevent variceal rebleeding. The primary endpoint was shunt dysfunction. All-cause rebleeding, orthotopic liver transplantation (OLT)-free survival, their composite endpoint, overt HE (overall and spontaneous) andliver function were designated as the secondary endpoints. RESULTS:From July 2012 to January 2014, 64 and 63 patients were allocated to the 8mm and 10mm groups, respectively. During a median follow-up of 27months in both arms, dysfunction rates (16% vs. 16% at two years, p=0.62), two-year rebleeding (16% vs. 17%, p=0.65), OLT-free survival (95% vs. 86%, p=0.37), and the composite endpoint (p=0.62) were not statistically different between the groups. Despite a marginal decrease in overall overt HE, there were significantly fewer spontaneous overt HE incidents in the 8mm group within two years (27% vs. 43%, p=0.03), with a risk reduction of 47%. Notably, patients receiving 8mm stents also developed less hepatic impairment. CONCLUSIONS:TIPS with 8mm covered stents showed similar shunt function to TIPS with 10mm stents, but halved the risk of spontaneous overt HE and reduced hepatic impairment. Therefore, 8mm TIPS stents should be preferred for the prevention of variceal rebleeding in cirrhotic patients. Lay summary: The optimal diameter for transjugular intrahepatic portosystemic shunt (TIPS) remained uncertain. This study showed that TIPS with 8mm covered stents did not compromise shunt patency, or influence the efficacy of variceal rebleeding prevention compared to TIPS with 10mm stents, but reduced the risk of spontaneous overt hepatic encephalopathy and the incidence of severe encephalopathy. Moreover, liver function reserve was also better in the 8mm stents group, suggesting that 8mm TIPS stents should be preferred for the prevention of variceal rebleeding in cirrhotic patients.
RCT Entities:
BACKGROUND & AIMS: Currently, there are no recommendations in guidelines concerning the preferred diameter of stents for transjugular intrahepatic portosystemic shunt (TIPS), owing to the lack of adequate evidence. We therefore compared 8mm stents with 10mm stents, to evaluate whether 8mm stents would achieve similar shunt function, with less hepatic encephalopathy (HE) and better liver function. METHODS: Cirrhotic patients were randomly assigned to receive TIPS with an 8mm or 10mm covered stent to prevent variceal rebleeding. The primary endpoint was shunt dysfunction. All-cause rebleeding, orthotopic liver transplantation (OLT)-free survival, their composite endpoint, overt HE (overall and spontaneous) and liver function were designated as the secondary endpoints. RESULTS: From July 2012 to January 2014, 64 and 63 patients were allocated to the 8mm and 10mm groups, respectively. During a median follow-up of 27months in both arms, dysfunction rates (16% vs. 16% at two years, p=0.62), two-year rebleeding (16% vs. 17%, p=0.65), OLT-free survival (95% vs. 86%, p=0.37), and the composite endpoint (p=0.62) were not statistically different between the groups. Despite a marginal decrease in overall overt HE, there were significantly fewer spontaneous overt HE incidents in the 8mm group within two years (27% vs. 43%, p=0.03), with a risk reduction of 47%. Notably, patients receiving 8mm stents also developed less hepatic impairment. CONCLUSIONS: TIPS with 8mm covered stents showed similar shunt function to TIPS with 10mm stents, but halved the risk of spontaneous overt HE and reduced hepatic impairment. Therefore, 8mm TIPS stents should be preferred for the prevention of variceal rebleeding in cirrhotic patients. Lay summary: The optimal diameter for transjugular intrahepatic portosystemic shunt (TIPS) remained uncertain. This study showed that TIPS with 8mm covered stents did not compromise shunt patency, or influence the efficacy of variceal rebleeding prevention compared to TIPS with 10mm stents, but reduced the risk of spontaneous overt hepatic encephalopathy and the incidence of severe encephalopathy. Moreover, liver function reserve was also better in the 8mm stents group, suggesting that 8mm TIPS stents should be preferred for the prevention of variceal rebleeding in cirrhotic patients.
Authors: Caterina Cusumano; Stefano Gussago; Martina Guerra; Chloe Paul; François Faitot; Philippe Bachellier; Pietro Addeo Journal: Hepatol Int Date: 2022-08-08 Impact factor: 9.029
Authors: Justin R Boike; Bartley G Thornburg; Sumeet K Asrani; Michael B Fallon; Brett E Fortune; Manhal J Izzy; Elizabeth C Verna; Juan G Abraldes; Andrew S Allegretti; Jasmohan S Bajaj; Scott W Biggins; Michael D Darcy; Maryjane A Farr; Khashayar Farsad; Guadalupe Garcia-Tsao; Shelley A Hall; Caroline C Jadlowiec; Michael J Krowka; Jeanne Laberge; Edward W Lee; David C Mulligan; Mitra K Nadim; Patrick G Northup; Riad Salem; Joseph J Shatzel; Cathryn J Shaw; Douglas A Simonetto; Jonathan Susman; K Pallav Kolli; Lisa B VanWagner Journal: Clin Gastroenterol Hepatol Date: 2021-07-15 Impact factor: 13.576