Randomised clinical trial: standard of care versus early‐transjugular intrahepatic porto‐systemic shunt (TIPSS) in patients with cirrhosis and oesophageal variceal bleeding

Abstract

Summary Background Early‐transjugular intrahepatic porto‐systemic shunt (TIPSS) has been recommended in international guidelines for high‐risk patients with oesophageal variceal bleeding. Aim To validate the results of a previous randomised control trial which supports use of early‐TIPSS. Methods In a two‐centre open‐label parallel‐group randomised control trial, patients with cirrhosis and acute variceal bleeding were recruited following haemostasis with vaso‐active drugs and endoscopic band ligation. Participants were randomised to standard of care or early‐TIPSS. The primary outcome was 1‐year survival, secondary outcomes included early and late rebleeding, and complications of portal hypertension. Results Fifty‐eight patients (58 ± 11.12 years; 32.7% female) were randomised. After one year, seven patients died in the standard of care group and six in the early‐TIPSS group, a 1‐year survival of 75.9% vs 79.3% respectively (P = 0.79). Variceal rebleeding occurred in eight patients in the standard of care group compared with three patients in the early‐TIPSS group (P = 0.09). Not all participants randomised to early‐TIPSS received the intervention in time. For those receiving TIPSS per‐protocol, variceal rebleeding rates were reduced (0% vs 27.6%, P = 0.04) but this had no effect on survival (76.9% vs 75.9%, P = 0.91). Serious adverse events were similar in both treatment groups, except that rates of hepatic encephalopathy were higher in patients receiving TIPSS (46.1% vs 20.7%, P < 0.05). Conclusions Early‐TIPSS reduced variceal rebleeding, increased encephalopathy but had no effect on survival in high‐risk patients with oesophageal variceal bleeding. Early‐TIPSS may not be feasible in many centres however, larger studies are needed. ClinicalTrials.gov reference: NCT02377141.

Letter: TIPSS improves muscle mass indices in patients with cirrhosis and severe portal hypertension

“…The median MELD and Child‐Pugh scores for the entire cohort were 11.4 and 8, respectively, whereas 15 (17.6%) and 32 (37.64%) of the GIB cohort had MELD score above 13 and 18, respectively. The authors have attributed the similar survival in the GIB and ascites groups to their consideration of early and salvage TIPSS, which is contradicted by a recent RCT 5 and multi‐centre study, which found that early TIPSS was only beneficial in Child C patients 6 . In the present study, we noticed poor muscle mass in the ascites group and higher MELD score in GIB group.…”

Editorial: early TIPSS in patients with cirrhosis and acute variceal bleeding—the plot thickens!

“…Dunne et al 9 attempted to address this important clinical conundrum. Fifty‐eight patients with a Child‐Pugh score of 8‐13, without previous treatment for portal hypertension related bleeding were included, regardless of active bleeding.…”

“…Despite this RCT being underpowered, there are some important messages from the current e‐TIPSS studies. One‐year survival in patients with acute variceal bleed has improved in recent years owing to improved SOC management 9 . Second, clinical efficacy of e‐TIPSS previously demonstrated 2 has not translated into clinical effectiveness in all patient groups 5‐7 .…”

Transjugular intrahepatic portosystemic shunt in cirrhosis: An exhaustive critical update

“…Therefore, antiviral therapy could have influenced the outcome. Another recent RCT from the United Kingdom reported that early-TIPS reduced rebleeding without survival benefit and higher incidence of HE in those undergoing early TIPS[ 21 ]. However, out of the 29 patients enrolled in the TIPS-arm of this study, only 13 underwent TIPS stent placement within 72 h of index bleeding, making it underpowered to derive any conclusions.…”