Covered TIPS versus endoscopic band ligation plus propranolol for the prevention of variceal rebleeding in cirrhotic patients with portal vein thrombosis: a randomised controlled trial.

Abstract

OBJECTIVE:

Limited data are available on the prevention of variceal rebleeding in cirrhotic patients with portal vein thrombosis (PVT). This study aimed to compare transjugular intrahepatic portosystemic shunt (TIPS) with covered stents versus endoscopic band ligation (EBL) plus propranolol for the prevention of variceal rebleeding among patients with cirrhosis and PVT.

DESIGN:

Consecutive cirrhotic patients (94% Child-Pugh class A or B) with PVT who had variceal bleeding in the past 6 weeks were randomly assigned to TIPS group (n=24) or EBL plus propranolol group (EBL+drug, n=25), respectively. Primary endpoint was variceal rebleeding. Secondary endpoints included survival, overt hepatic encephalopathy (OHE), portal vein recanalisation and rethrombosis, other complications of portal hypertension and adverse events.

RESULTS:

During a median follow-up of 30 months in both groups, variceal rebleeding was significantly less frequent in the TIPS group (15% vs 45% at 1 year and 25% vs 50% at 2 years, respectively; HR=0.28, 95% CI 0.10 to 0.76, p=0.008), with a significantly higher portal vein recanalisation rate (95% vs 70%; p=0.03) and a relatively lower rethrombosis rate (5% vs 33%; p=0.06) compared with the EBL+drug group. There were no statistically significant differences in survival (67% vs 84%; p=0.152), OHE (25% vs 16%; p=0.440), other complications of portal hypertension and adverse events between groups.

CONCLUSION:

Covered TIPS placement in patients with PVT and moderately decompensated cirrhosis was more effective than EBL combined with propranolol for the prevention of rebleeding, with a higher probability of PVT resolution without increasing the risk of OHE and adverse effects, but this benefit did not translate into improved survival.

TRIAL REGISTRATION NUMBER:

ClinicalTrials.gov: NCT01326949.

• Authors: Yong Lv, Xingshun Qi, Chuangye He, Zhengyu Wang, Zhanxin Yin, Jing Niu, Wengang Guo, Wei Bai, Hongbo Zhang, Huahong Xie, Liping Yao, Jianhong Wang, Tao Li, Qiuhe Wang, Hui Chen, Haibo Liu, Enxing Wang, Dongdong Xia, Bohan Luo, Xiaomei Li, Jie Yuan, Na Han, Ying Zhu, Jielai Xia, Hongwei Cai, Zhiping Yang, Kaichun Wu, Daiming Fan, Guohong Han, PVT-TIPS Study Group.
• Journal: Gut (Gut) Vol. 67 Issue 12 Pg. 2156-2168 (12 2018) ISSN: 1468-3288 [Electronic] England
• PMID: 28970291 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Chemical References

• Vasodilator Agents
• Propranolol

Topics

• Adult
• Combined Modality Therapy
• Esophageal and Gastric Varices (complications)
• Female
• Follow-Up Studies
• Gastrointestinal Hemorrhage (etiology, prevention & control)
• Hepatic Encephalopathy (etiology)
• Humans
• Kaplan-Meier Estimate
• Ligation (adverse effects, methods)
• Liver Cirrhosis (complications)
• Male
• Middle Aged
• Portal Vein
• Portasystemic Shunt, Transjugular Intrahepatic (adverse effects, methods)
• Propranolol (therapeutic use)
• Recurrence
• Secondary Prevention
• Vasodilator Agents (therapeutic use)
• Venous Thrombosis (complications)