Stent-Assisted Angioplasty in Symptomatic Intracranial Stenosis without Adjacent Branch Atheromatous Disease: A Randomized Trial with Patients Selected by Using Three-Dimensional Rotational Angiography.

Abstract

Background Use of stents for symptomatic intracranial atherosclerotic stenosis (ICAS) was found to be harmful in previous randomized trials, in which perforator stroke was a notable procedural complication. It was unclear if excluding patients with concurrent branch atheromatous disease (BAD) adjacent to the target intracranial stenosis may reduce perforator jailing. Purpose To compare the safety and efficacy of intracranial stent placement (hereafter, stenting) versus medical therapy in participants with high-grade symptomatic ICAS and adjacent BAD excluded with three-dimensional rotational angiography (3DRA). Materials and Methods In this single-center, prospective, randomized, open-label, blinded end-point trial conducted in Hong Kong from 2006 to 2022, participants with transient ischemic attack (TIA) or ischemic stroke attributed to severe ICAS (70%-99%) were randomized to intracranial stenting under local anesthesia or medical therapy within 6 weeks of a qualifying event. Participants underwent 3DRA, and participants with severe BAD adjacent to the target stenosis were excluded. The primary end point was a composite of TIA, ischemic stroke, intracranial hemorrhage, and death within 30 days or any ischemic stroke from 30 days to 1 year. The secondary end points were ischemic stroke or TIA in the same artery territory (SIT), any strokes, and percentage of stenosis at 1 year. Cumulative incidences of end points were compared using Cox proportional hazard models. Results A total of 150 participants (mean age, 61 years ± 9.5 [SD], 45 female participants) were randomized into stenting (n = 74) and medical therapy (n = 76) groups. There was no evidence of between-group differences in the cumulative incidence of the primary end point (stenting vs medical therapy, respectively: 12 of 74 [16%] vs 18 of 76 [24%]; hazard ratio [HR], 0.66 [95% CI: 0.32, 1.36]; P = .26), SIT (nine of 74 [12%] vs 15 of 76 [20%]; HR, 0.59 [95% CI: 0.26, 1.35]; P = .21), or any strokes at 1 year (10 of 74 [14%] vs 17 of 76 [22%]; HR, 0.57 [95% CI: 0.27, 1.24]; P = .16). Percentage stenosis at 1 year was lower with intracranial stenting (33% ± 22 vs 67% ± 18, respectively; P < .001). Conclusion In participants with symptomatic ICAS without BAD adjacent to the target stenosis, intracranial stenting did not result in a reduction in the cumulative incidence of stroke or death at 30 days or stroke from 30 days to 1 year. Center for Clinical Research and Biostatistics Clinical Trial Registry (The Chinese University of Hong Kong)/Chinese Clinical Trials Registry Identifier: CUHK-CCT00116 Published under a CC BY 4.0 license. Supplemental material is available for this article. See also the editorial by Wojak in this issue.