6/28/23, 12:49 AM AVB-TIPS Pathway Feedback Search Clinical Topics Home Studies AVB TIPS AVB TIPS Disease Disease Disease Hepatic encephalopathy Liver cirrhosis Portal hyp 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 N = 129 67.0% male 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) https://web.pathway.md/studies/recJt1NhXKkkbuSSC 1/2 6/28/23, 12:49 AM AVB-TIPS Pathway Primary outcome Death or liver transplantation 36.0 % 36 27.0 % 20 18.0 % Significant decrease 9.0 % NNT = 6 0.0 % Early transjugular intrahepatic portosystemic shunt Standard care 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. Open reference URL https://web.pathway.md/studies/recJt1NhXKkkbuSSC 2/2