Quantifying the benefit of non-selective beta-blockers in the prevention of hepatic decompensation: A Bayesian re-analysis of the PREDESCI trial

BACKGROUND AND AIMS: Beta-blockers have been studied for the prevention of variceal bleeding and, more recently, for the prevention of all cause decompensation. Some uncertainties regarding the benefit of beta-blockers for the prevention of decompensation remain. Bayesian analyses enhance the interpretation of trials. The purpose of this study was to provide clinically meaningful estimates of both the probability and magnitude of benefit with beta-blocker treatment across a range of patient types.

APPROACH AND RESULTS: We undertook a Bayesian re-analysis of PREDESCI incorporating three priors (moderate neutral, moderate optimistic, and weak pessimistic). The probability of clinical benefit was assessed considering the prevention of all cause decompensation. Microsimulation analyses were done to determine the magnitude of benefit. In the Bayesian analysis the probability that beta-blockers reduce all cause decompensation was >0.93 for all priors. The Bayesian posterior hazard ratios (HR) for decompensation ranged from 0.50 (optimistic prior, 95% credible interval 0.27-0.93) to 0.70 (neutral prior, 95% credible interval 0.44-1.12). Exploring the benefit of treatment using microsimulation highlights substantial treatment benefit. For the neutral prior derived posterior HR and a 5% annual incidence of decompensation, at 10 years an average of 497 decompensation-free years per 1000 patients were gained with treatment. In contrast, at 10 years 1639 years per 1000 patients were gained from the optimistic prior derived posterior HR and a 10% incidence of decompensation.

CONCLUSIONS: Beta-blocker treatment is associated with a high probability of clinical benefit. This likely translates to a substantial gain in decompensation-free life years at the population level.