Efficacy of the Route 92 reperfusion system in acute ischemic stroke due to large vessel occlusion: a systematic review and meta-analysis
摘要
Super large-bore aspiration catheters have emerged as promising tools for endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) due to large vessel occlusion (LVO). The Route 92 Reperfusion System utilizes super large-bore catheters with specialized delivery mechanisms to maximize first-pass effect (FPE) and reperfusion rates. To evaluate the efficacy and safety of the Route 92 super large bore reperfusion System in treating AIS-LVO. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we searched five databases from inception through December 2025. Studies evaluating Route 92 Reperfusion System outcomes in AIS-LVO patients were included. Primary outcomes were FPE and functional independence (modified Rankin Scale (mRS) 0–2). Secondary outcomes included successful reperfusion (modified thrombolysis in cerebral infarction (mTICI) scores), symptomatic intracranial hemorrhage (sICH), mortality, and adverse events. Random-effects models were used for all analyses. Seven studies comprising 490 patients were included. In comparative analyses, Route 92 (0.088”) demonstrated significantly higher FPE rates (risk difference (RD): 0.18, number needed to treat (NNT) = 6, p = 0.001) and near-complete reperfusion (RD: 0.23, NNT = 4, p = 0.0005) compared to other techniques. Single-arm analyses showed 56% achieved FPE, 94% achieved near-complete to complete reperfusion, and 43% achieved functional independence at follow-up. The system demonstrated favorable safety with 3% sICH rate and 20% mortality. National Institutes of Health Stroke Scale (NIHSS) scores improved significantly (mean difference (MD): -9.55, p < 0.00001). The Route 92 Reperfusion System achieves high rates of FPE and successful reperfusion with acceptable safety profiles. Future RCTs is warranted to support these findings.