6/28/23, 10:12 PM Early TIPS for variceal hemorrhage Pathway Feedback Search Clinical Topics Home Studies Early TIPS for variceal hemorrhage Early TIPS for variceal hemorrhage Disease Disease Disease Liver cirrhosis Portal hypertension Varicea Trial question What is the role of early use of TIPS in patients with cirrhosis who are hospitalized for acute variceal bleeding and at high risk for treatment failure? Study design Multi-center Open label RCT Population Characteristics of study participants 30.0% female N = 63 70.0% male 63 patients (19 female, 44 male) Inclusion criteria: patients with cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy Key exclusion criteria: age > 75 years, pregnancy, HCC that did not meet the Milano criteria for transplantation, previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding, previous use of a portosystemic shunt or TIPS, bleeding from isolated gastric or ectopic varices, total portal vein thrombosis, and HF Interventions N=32 early TIPS implantation (treatment with a PTFE-covered stent within 72 hours after randomization) N=31 vasoactive drugs and endoscopic band ligation (continuation of vasoactive-drug therapy, followed after 3 to 5 days by treatment with propranolol or nadolol and long-term endoscopic band ligation) https://web.pathway.md/studies/rec6tkFAqlPVXfJ2i 1/2 6/28/23, 10:12 PM Early TIPS for variceal hemorrhage Pathway Primary outcome Freedom from rebleeding or failure to control bleeding 97.0 % 97 72.8 % 50 48.5 % Significant increase 24.3 % NNT = 2 0.0 % Early TIPS implantation Vasoactive drugs and endoscopic band ligation Significant increase in freedom from rebleeding or failure to control bleeding (97% vs. 50%; ARR 47, 95% CI 25 to 69) Secondary outcomes Significant increase in the rate of 1-year actuarial survival (86% vs. 61%; ARR 25, 95% CI 2 to 48) Significant increase in days in the ICU (3.6 days vs. 8.6 days; AD 5 days, 95% CI 1.19 to 8.81) Safety outcomes No significant difference in serious adverse events. Conclusion In patients with cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy, early TIPS implantation was superior to vasoactive drugs and endoscopic band ligation with respect to freedom from rebleeding or failure to control bleeding. Reference Garcia-Pagan JC, Caca K, Bureau C et al. Early use of TIPS in patients with cirrhosis and variceal bleeding. N Engl J Med. 2010 Jun 24;362(25):2370-9. Open reference URL https://web.pathway.md/studies/rec6tkFAqlPVXfJ2i 2/2