Assessment of Evidence Regarding Minimally Invasive Surgery vs. Conservative Treatment on Intracerebral Hemorrhage: A Trial Sequential Analysis of Randomized Controlled Trials

Abstract

Introduction: The recent publication of a trial failed to prove the efficacy of minimally invasive surgery (MIS) in patients with intracerebral hemorrhage. The aim of this study was to answer the question: Do we need more trials to compare MIS vs. conservative treatment in these patients? Methods: Databases were searched for relevant randomized trials on MIS (endoscopic surgery or stereotactic evacuation) vs. conservative treatment. The primary outcome was significant neurological debilitation or death at the follow-up, and the secondary outcome was death. Both conventional meta-analysis and trial sequential analysis (TSA) were performed. Results: Twelve trials with 2,049 patients were included. In the conventional meta-analysis, the risk ratios of MIS vs. conservative treatment were 0.82 [95% confidence interval (CI), 0.72–0.94] and 0.74 (95% CI, 0.62–0.88) for the primary and secondary outcomes, respectively. In TSA, the cumulative z curve crossed the superiority boundary, which confirmed an 18.8% relative risk reduction of MIS vs. conservative treatment for the primary outcome. It was also highly likely that MIS would reduce mortality by 24.3%. Several sensitivity analyses suggested the robustness of our results, including different prior settings, including only trials with blind outcome assessment, and the assumption of future trials to be futile. Conclusions: Minimally invasive surgery seems to be more effective than conservative treatment in patients with intracerebral hemorrhage in reducing both morbidity and mortality. Repeating a clinical trial with similar devices, design, and outcomes is unlikely to change the current evidence.