Purpose: Although the current guidelines recommend bridging thrombolysis (BT) therapy, which is intravenous thrombolysis (IVT) followed by endovascular thrombectomy (EVT), for patients with acute ischemic stroke from large vessel occlusion (AIS-LVO), the effectiveness and safety of IVT remain controversial. We performed a meta-analysis to demonstrate the non-inferiority of direct EVT alone (DEVT) compared to BT for the efficacy and safety in patients with AIS-LVO who were eligible for IVT.
Methods: The literature was searched in big databases between 1 January 1990 and 1 April 2021. The search included both randomized clinical trials (RCTs) and nonrandomized studies (NRSs) that compared DEVT with BT for patients with AIS-LVO who were eligible for IVT (time from stroke onset ≤ 4.5 h). Only NRSs with good intergroup variable matching were included in the study. Outcomes measured included 90-day functional independence, mortality, symptomatic intracranial hemorrhage (sICH), and successful recanalization. The noninferiority margin for risk difference was set at 5% from the literature review.
Results: Three RCTs (n = 1094) and four NRSs (n = 1366) were included in the meta-analysis. There were 1227 patients (49.9%) in the DEVT group and 1233 patients (50.1%) in the BT group. A statistically significant noninferiority of DEVT compared to BT was concluded in 90-day functional independence, mortality and successful reperfusion. Even in the sICH rate, DEVT group showed a superiority (risk difference, -2%; 95% confidence interval, -4 to -0.002%).
Conclusion: Evidence from RCTs and observational NRSs supports the use of DEVT (without IVT) as the first choice for treatment of patients with AIS-LVO within a time span of 4.5 h or less from stroke onset.
Keywords: Brain ischemia; Meta-analysis; Stroke; Thrombectomy; Thrombolysis.
© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.