Has the balloon really burst? Analysis of "the UK-REBOA randomized clinical trial"

Abstract

Background: Uncontrolled hemorrhagic shock is a leading cause of early death after injury. Resuscitative endovascular balloon occlusion of the aorta (REBOA) represents a paradigm shift in achieving hemodynamic stability and its implementation still remain controversial in different settings. The recently published UK-REBOA Randomized Clinical Trial aimed to determine the effectiveness of REBOA in patients with hemorrhagic shock, concluding its increased mortality compared with standard care alone.

Methods: An adjustment of the statistical analysis was performed and a comprehensive analysis was proposed to address the study's limitations and demonstrate that these conclusions cannot be considered as benchmarks.

Results: Primary and secondary outcomes were analyzed using Bayesian logistic regression and generalized linear models suitable for the outcome distribution. No statistically significant differences were observed between the two groups for the primary outcome (p-value 0.3341) nor in most of the secondary outcomes. The results of the principal stratum analyses (to account for intercurrent events) also did not show significant differences after the statistical analysis tests.

Conclusion: It cannot be stated that REBOA increases mortality compared with standard care alone in trauma patients with exsanguinating hemorrhage. Further studies and adequate simulation training programs in REBOA are critical to its successful implementation within a trauma system and to identify the optimum settings and patients.

Keywords: Emergency medicine; Non-compressible hemorrhage; REBOA; Resuscitative endovascular balloon occlusion of the aorta; UK-REBOA trial.