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.
Department of Medical Statistics, Fourth Military Medical University, Xi'an 710032, China.
J Hepatol. 2017 Sep;67(3):508-516. doi: 10.1016/j.jhep.2017.05.006. Epub 2017 May 12.
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.
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.
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.
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.
目前，由于缺乏充分的证据，指南中并没有关于经颈静脉肝内门体分流术（TIPS）中支架首选直径的建议。因此，我们比较了 8mm 支架和 10mm 支架，以评估 8mm 支架是否可以实现类似的分流功能，同时减少肝性脑病（HE）的发生，并改善肝功能。
将肝硬化患者随机分配接受 8mm 或 10mm 覆盖支架的 TIPS 治疗，以预防静脉曲张再出血。主要终点是分流功能障碍。所有原因再出血、肝移植（OLT）无生存、其复合终点、显性 HE（总体和自发性）和肝功能被指定为次要终点。
2012 年 7 月至 2014 年 1 月，64 例和 63 例患者分别被分配到 8mm 组和 10mm 组。在两组均为 27 个月的中位随访期内，功能障碍率（两年时为 16% vs. 16%，p=0.62）、两年再出血率（16% vs. 17%，p=0.65）、OLT 无生存率（95% vs. 86%，p=0.37）和复合终点（p=0.62）在两组之间无统计学差异。尽管整体显性 HE 略有下降，但在两年内 8mm 组自发性显性 HE 事件明显减少（27% vs. 43%，p=0.03），风险降低 47%。值得注意的是，接受 8mm 支架的患者肝功能损害也较轻。
8mm 覆盖支架的 TIPS 显示出与 10mm 支架的 TIPS 相似的分流功能，但将自发性显性 HE 的风险降低了一半，并减少了肝功能损害。因此，对于预防肝硬化患者静脉曲张再出血，应首选 8mm TIPS 支架。
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