Thrombectomy for patients with a large infarct core: a study-level meta-analysis with trial sequential analysis.

Abstract

Background: The effectiveness and safety of endovascular treatment compared with medical management alone regarding outcomes for patients with a large infarct core remain uncertain.

Objectives: To juxtapose the clinical outcomes of thrombectomy versus the best medical care in patients with a large infarct core.

Design: Systematic review and meta-analysis.

Data sources and methods: We conducted searches in PubMed, Cochrane, and Embase for articles published up until November 8, 2023. Randomized trials were selected for inclusion if they encompassed patients with large vessel occlusion and sizable strokes receiving thrombectomy. The primary outcome was functional outcomes at 3 months after pooling data using random-effects modeling. Safety outcomes included mortality at 3 months, symptomatic intracranial hemorrhage (SICH), and decompressive craniectomy. We performed a trial sequential analysis to balance type I and II errors.

Results: From 904 citations, we identified six randomized trials, involving a cohort of 1897 patients with a large ischemic region. Of these, 953 individuals underwent endovascular thrombectomy. At 3 months, thrombectomy was significantly correlated with better neurological prognosis, as evidenced by the increased odds of good functional outcomes (odds ratio (OR), 2.90; 95% confidence interval (CI), 2.08-4.05) and favorable functional outcomes (OR, 2.40; 95% CI, 1.86-3.09). Mortality rates did not demonstrably diminish as a consequence of the endovascular management (OR, 0.78; 95% CI, 0.58-1.06). However, the incidence of SICH was greater in the thrombectomy group compared to those with only medical treatment (5.5% vs 3.2%; OR, 1.77; 95% CI, 1.11-2.83). The application of trial sequential analysis yielded definitive evidence regarding favorable function outcomes and a shift in the distribution of modified Rankin scale scores at 3 months; however, others remained inconclusive.

Conclusion: The results from most of the included trials display consistency. Meta-analysis of these six randomized trials offers high-quality evidence that thrombectomy significantly mitigates disability in patients with a large infarction, while also increasing the risk of SICH.

Trial registration: PROSPERO, CRD42023480359.