Does preemptive transjugular intrahepatic portosystemic shunt improve survival after acute variceal bleeding? Systematic review, meta-analysis, and trial sequential analysis of randomized trials.

ABSTRACT

BACKGROUND AND AIM: A preemptive transjugular intrahepatic portosystemic shunt (p-TIPSS) after acute variceal bleeding (AVB) is advocated. However, when compared with the current standard of care, the survival benefit of p-TIPSS is questionable. We performed a systematic review, meta-analysis, and trial sequential analysis of randomized control trials (RCTs) to assess the survival benefit of p-TIPSS in patients with cirrhosis and AVB. METHODS: Comprehensive literature search of three bibliographic databases (MEDLINE, Embase, and Cochrane) was conducted from inception till May 2021. All study types evaluating the survival benefit of p-TIPSS in AVB were considered for inclusion. The relative risk (RR) of mortality and rebleeding at 6 weeks and mortality at 1 year with a random-effects model was computed. Trial sequential analysis was performed for the primary outcome of 6-week mortality. RESULTS: A total of nine studies (four RCTs and five cohort studies) comprising 2861 patients with AVB were included. The overall pooled risks of mortality at 6 weeks and 1 year were 17.9% (95% confidence interval [CI] 16.5-19.3%) and 26.7% (95% CI 25.0-28.3%), respectively. Although p-TIPSS was associated with lower 6-week rebleeding risk (RR = 0.20; 95% CI = 0.13-0.29, I2  = 0%), data from pooled RCTs showed no significant difference in mortality at 6 weeks (RR = 0.33; 95% CI = 0.08-1.36, I2  = 63%) or at 1 year (RR = 0.76; 95% CI = 0.51-1.14, I2  = 30%). Using trial sequential analysis, required sample size to detect a 20% relative risk reduction in mortality at 6 weeks with p-TIPSS was estimated to be 6317, which is beyond the total number of patients available for analysis. CONCLUSIONS: This meta-analysis found that the available data from RCTs are insufficient to confer 6-week mortality benefit with p-TIPSS compared with standard of care; thus, adequately powered RCTs are required.