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.
Summary Background and Aims Carvedilol reduces rates of variceal bleeding and rebleeding by lowering portal pressure. However, an associated pleiotropic survival benefit has been proposed. We aimed to assess long‐term survival in a cohort of patients previously randomised to receive either carvedilol or endoscopic band ligation (EBL) following oesophageal variceal bleeding (OVB). Methods The index study randomised 64 cirrhotic patients with OVB between 2006 and 2011 to receive either carvedilol or EBL. Follow‐up was undertaken to April 2020 by review of electronic patient records. The primary outcome was survival. Other outcomes including variceal rebleeding and liver decompensation events were compared. Results 26 out of 33 participants received carvedilol in the follow‐up period and 28 out of 31 attended regular EBL sessions. The median number of follow‐up days for all patients recruited was 1459 (SE = 281.74). On the intention to treat analysis, there was a trend towards improved survival in the carvedilol group (p = 0.09). On per‐protocol analysis, carvedilol use was associated with improved long‐term survival (p = 0.005, HR 3.083, 95% CI 1.397–6.809), fewer liver‐related deaths (0% vs 22.57%, p = 0.013, OR ∞, 95%CI 1.565–∞) and fewer admissions with decompensated liver disease (12% vs 64.29%, p = 0.0002, OR 13.2, 95% CI 3.026–47.23) compared to the EBL group. There was no statistically significant difference in variceal rebleeding rates. Conclusion Following OVB in cirrhotic patients, carvedilol use is associated with survival benefit, fewer liver‐related deaths and fewer hospital admissions with decompensated liver disease. Further studies are needed to validate this finding.
Summary Background Pre‐emptive transjugular intrahepatic portosystemic shunt (pTIPSS) should be considered within 72 hours following acute oesophageal variceal bleeding. However, recent studies highlight the difficulty in providing pTIPSS within this narrow timeframe. Delaying pTIPSS beyond 72 hours has not been studied. Aim To determine if the time taken to perform pTIPSS alters patient outcome. Method Patients referred to 4 UK tertiary centres for pTIPSS between 01 January 2010 and 31 December 2018 were included. Time from endoscopy to pTIPSS was recorded and pre‐defined clinically relevant outcomes were observed relative to two groups: early pTIPSS (<72 h) and late pTIPSS (72 h–28 days). The primary outcome was transplant‐free survival at 1‐year. Follow‐up was until 31 December 2020. Results A total of 83 patients received early pTIPSS and 88 received late pTIPSS. Baseline characteristics were similar with no requirement for propensity score‐matched analysis. There was no difference between early and late pTIPSS groups for patient outcomes; 1‐year transplant‐free survival rate (69.9% vs 71.6%, p = 0.73, HR 0.91, 95% CI 0.52–1.58), long‐term survival (p = 0.52, HR 1.132, 95% CI 0.77–1.65), variceal rebleeding (4.82% vs 11.36%, p = 0.09, HR 0.411, 95% CI 0.14–1.17), hepatic encephalopathy (43.93% vs 34.61%, p = 0.26) and new or worsening ascites (16.6% vs 13.46%, p = 0.79). Death due to liver failure was significantly more prevalent in those undergoing early pTIPSS compared to late pTIPSS (44% vs 16%, p = 0.046, HR 2.79, 95%CI 1.02–8.32). Conclusion Placement of pTIPSS within 72 hours offered similar short‐ and long‐term survival benefits compared to pTIPSS placed between 72 hours and 28 days. Early pTIPSS may be associated with an increased risk of liver failure‐related mortality. Further large, randomised studies are required to evaluate these findings.
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