Intracranial stenting versus aggressive medical therapy for symptomatic intracranial stenosis: A meta-analysis of multicenter randomized controlled trials and an expert assessment of the current data

Abstract

Background Intracranial atherosclerotic stenosis (ICAS) is associated with high risk of recurrent strokes despite best medical management (MM). We aimed to synthesize the evidence from randomized studies comparing intracranial stenting plus MM versus MM alone. Methods Comprehensive search of MEDLINE database was performed until May 2023. The data were extracted and pooled as risk ratio (RR) with 95% confidence interval (95% CI). Results We included three multicenter RCTs totaling 919 patients. As compared to MM alone, intracranial stenting was associated with statistically significant higher risks of any stroke or death (RR = 2.93, 95%CI [1.80–4.78], p < 0.0001), stroke in the same territory of qualifying artery (RR = 3.56, 95%CI [1.97–6.44], p < 0.0001), any ischemic stroke (RR = 2.22, 95%CI [1.27–3.87], p = 0.005), hemorrhagic stroke (RR = 13.49, 95%CI [2.59–70.15], p = 0.0002), and death (RR = 5.43, 95%CI [1.21–24.40], p = 0.003) within 30 days of randomization. There was a persistent lack of benefit and signals of harm at the last follow up within 1–3 years: any stroke or death (RR = 1.57, 95%CI [0.92–2.67], p =  0.1), stroke in the same territory of qualifying artery (RR = 1.84, 95%CI [0.97–3.50], p =  0.06), any ischemic stroke (RR = 1.56, 95%CI [1.11–2.20], p =  0.01), death (RR = 1.61, 95%CI [0.77–3.38], p =  0.2). The cumulative rate of stroke in the same territory of qualified artery with MM alone within the 1–3-year follow up was lower than expected, with only 47 out of the 450 (10.4%) MM alone patients suffering such events. Conclusion The findings from this meta-analysis do not recommend stenting as a routine care option for the broader symptomatic ICAS patient population. The rates of recurrent strokes in ICAS patients managed with aggressive MM do not seem to be as high as anticipated. Additional multicenter RCTs including safer devices, larger sample sizes, and patients at higher risk of recurrent events are warranted.