Stenting Versus Medical Therapy for Symptomatic Intracranial Artery Stenosis: Long-Term Follow-Up of a Randomized Trial.

Whether the long-term benefit of stroke prevention when stenting is added to medical therapy (MT) over MT alone for symptomatic severe intracranial artery stenosis offsets the perioperative risks of the stenting has not been directly evaluated in a randomized trial. We aimed to compare the long-term (>3 years) effect of stenting versus MT alone in patients with symptomatic severe intracranial artery stenosis in a randomized trial. We extended the follow-up of 358 subjects enrolled in a multicenter, open-label, randomized trial conducted at 8 centers in China. Patients with transient ischemic attack or stroke attributed to severe intracranial stenosis (70% to 99%) were recruited between March 5, 2014, and November 10, 2016. The primary outcome was a composite of stroke or death within 30 days or stroke in the territory of the qualifying artery beyond 30 days. Other secondary outcomes included stroke in the territory of the qualifying artery, as well as disabling stroke or death after enrollment. A total of 358 patients (stenting 176 versus MT 182) were recruited from March 5, 2014, and followed up till January 22, 2024. The median duration of follow-up was 7.4 years (interquartile range, 6.0-8.0). The primary outcome was not significantly different (stenting 14.8% versus MT 14.3%; hazard ratio, 1.02 [95% CI, 0.58-1.77]; P=0.97). No significant difference was found between groups for the secondary outcomes: stroke in the territory of qualifying artery (14.8% versus 14.3%; hazard ratio, 1.02 [95% CI, 0.58-1.77]; P=0.97), disabling stroke or death (16.5% versus 14.3%; hazard ratio, 1.12 [95% CI, 0.66-1.91]; P=0.70), and death (9.1% versus 7.1%; hazard ratio, 1.22 [95% CI, 0.58-2.58]; P=0.60). This study provides compelling evidence that, even over prolonged observed periods, the addition of stenting to MT does not confer additional benefits to MT alone in patients with symptomatic severe intracranial artery stenosis. These results underscore the importance of MT as the cornerstone of long-term stroke prevention in this patient population. URL: https://www.clinicaltrials.gov; Unique identifier: NCT01763320.