AVB-TIPS
Trial question
What is the role of early placement of TIPSs in patients with advanced cirrhosis and acute variceal bleeding?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 129
129 patients (42 female, 87 male)
Inclusion criteria: patients with advanced cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy
Key exclusion criteria: uncontrolled bleeding before randomization; spontaneous recurrent hepatic encephalopathy; HCC or other extrahepatic malignancy; previous treatments with a surgical shunt
Interventions
N=84 early TIPS (done within 72 hours after initial endoscopy)
N=45 standard care (vasoactive drugs continued to day 5, followed by propranolol plus endoscopic band ligation, with TIPS as rescue therapy as needed)
Primary outcome
Death or liver transplantation
20
36
36.0 %
27.0 %
18.0 %
9.0 %
0.0 %
Early transjugular intrahepatic portosystemic shunt
Standard care
Significant decrease ▼
NNT = 6
Significant decrease in death or liver transplantation (20% vs. 36%; HR 0.5, 95% CI 0.25 to 0.98)
Secondary outcomes
Significant decrease in failure to control bleeding or rebleeding (13% vs. 38%; HR 0.26, 95% CI 0.12 to 0.55)
Significant decrease in new or worsening ascites (17% vs. 44%; HR 0.28, 95% CI 0.14 to 0.55)
No significant difference in overt hepatic encephalopathy (35% vs. 36%; HR 0.89, 95% CI 0.48 to 1.64)
Safety outcomes
No significant differences in hepatic hydrothorax, SBP, hepatorenal syndrome, HCC, other serious adverse events or non-serious adverse events.
Conclusion
In patients with advanced cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy, early TIPS was superior to standard care with respect to death or liver transplantation.
Reference
Yong Lv, Zhiping Yang, Lei Liu et al. Early TIPS with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial. Lancet Gastroenterol Hepatol. 2019 Aug;4(8):587-598.
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