J Neurol. 2022 Oct 5. doi: 10.1007/s00415-022-11413-3. Online ahead of print.
ABSTRACT
BACKGROUND AND PURPOSE: This study investigated clinical outcomes after direct endovascular thrombectomy (EVT) compared to bridging therapy (EVT with prior intravenous alteplase) in acute stroke within 4.5 h after onset.
METHODS: PubMed and Embase were searched for eligible randomized controlled trials. The primary outcome was the rates of neurological functional independence defined as modified Rankin scale score 0-2 at 90 days, whose non-inferiority margin was set at – 15%, – 10%, – 6.5%, – 5%, and – 1.3% for its risk difference (RD).
RESULTS: We included six studies enrolling 2334 participants. The crude cumulative rates of functional independence were 49.0% with direct EVT vs 50.9% with bridging therapy, without significant difference (Odd ratio [OR] = 0.93, 95% confidence interval [CI] 0.79-1.09) between two groups, where the pooled RD was – 2% (95% CI – 6 to 2%) whose lower 95% CI bound fell within non-inferiority margins of – 15%, – 10%, -6.5%, but not – 5% and – 1.3%. Between the two groups, no significant difference was found in excellent function rate (30.2% vs 30.6%, OR = 0.99, 95% CI 0.82-1.18) with RD of 0% (95% CI – 3 to 4%), mortality rate (16.0% vs 15.0%, OR = 1.08, 95% CI 0.86-1.35) with RD of 1% (95% CI – 2 to 4%), and symptomatic intracranial hemorrhage rate (4.3% vs 5.0%, OR = 0.86, 95% CI 0.58-1.27) with RD of 0% (95% CI – 2 to 1%).
CONCLUSIONS: No statistical difference was found in functional and safety outcomes between direct EVT and bridging therapy groups in acute stroke within 4.5 h after symptom onset. EVT alone was non-inferior to bridging therapy for several, but not the more stringent, non-inferiority margins.
PMID:36197568 | DOI:10.1007/s00415-022-11413-3
