TIPS Is Superior to SEMS in the Management of Refractory VARICEAL Bleed in Advanced Cirrhosis Patients (TIPSEMS‐VB Trial)

ABSTRACT Background Refractory upper GI bleed is seen in up to 15%–20% of the patients with acute variceal bleed. There are no data comparing the efficacy of oesophageal self‐expandable metal stent (SEMS) placement with TIPS in refractory acute variceal bleed in cirrhosis patients. Patients and Methods In an open‐label randomised controlled trial (RCT), cirrhosis with refractory oesophageal variceal bleed or post‐endoscopic variceal band ligation (EVL) ulcer bleed, and who were not controlled by endoscopic endotherapy or rebled after therapy, were randomised to TIPS ( n = 20) or SEMS ( n = 21) placement. Response to treatment, risk of rebleed and 6‐week mortality were calculated. Results Baseline characteristics, mean CTP {9.45 ± 1.9 vs. 9.40 ± 1.7, p = NS} MELD {18.2 ± 2.5 vs. 17.4 ± 3.2, p = NS} score and hepatic venous pressure gradient (HVPG) {19.3 ± 3.9 vs. 19.8 ± 3.2, p = NS} were comparable at baseline in both the arms. 10/21 (52.4%) patients died in the SEMS group (Group 1) while 2/20 (10%) in the TIPS group (Group 2) during 6 weeks ( p = 0.015). The risk of very early rebleeding (< 48 h) and rebleeding (48 h‐5 days) was higher in the SEMS group as compared to the TIPS group {5/21 (23.8%) vs. 1/20 (5%), p = 0.07; 4/21 (22.22) vs. 0/20 (0%), p = 0.03 respectively}. Adverse events limiting the use of drugs were comparable. The incidence of new onset sepsis was higher in the SEMS arm {10/21(47.6%) vs. 3/20 (15%), p = 0.04}; though the incidence of hepatic encephalopathy (≥grade 2) {2/21 (9.5%) in SEMS group vs. 4/20 (20%) in TIPS group ( p = 0.40)} and ischaemic hepatitis {1/21(4.76%) vs. 4/20 (20%), p = 0.34} were comparable. Conclusion In patients with advanced liver disease with failure to control bleed or very early rebleed, placement of TIPS is more effective than placement of SEMS in the control of bleeding and improves 6‐week survival. Trial Registration NCT03827681