Stent-Assisted Angioplasty in Symptomatic Intracranial Stenosis without Adjacent Branch Atheromatous Disease: A
Bonaventure Y Ip1,2,3,4, Sze Ho Ma1, Wai Ting Lui1
1Division of Neurology, Department of Medicine and Therapeutics, The Prince of Wales Hospital, Shatin, Hong Kong, China.
Insights
For symptomatic intracranial atherosclerotic stenosis (ICAS) without branch atheromatous disease (BAD), intracranial stenting did not reduce stroke or death compared to medical therapy. Excluding patients with BAD did not alter the primary endpoint outcomes in this trial.
Area of Science:
- Neurology
- Interventional Neuroradiology
- Cardiovascular Research
Background:
- Previous trials indicated harm from stenting for symptomatic intracranial atherosclerotic stenosis (ICAS), with perforator stroke as a complication.
- The role of excluding patients with concurrent branch atheromatous disease (BAD) to mitigate perforator jailing remained unclear.
- This study investigated stenting versus medical therapy in high-grade symptomatic ICAS, specifically excluding adjacent BAD.
Purpose of the Study:
- To compare the safety and efficacy of intracranial stenting versus medical therapy in patients with high-grade symptomatic ICAS.
- To determine if excluding patients with adjacent branch atheromatous disease (BAD) influences outcomes, particularly perforator jailing.
Main Methods:
- A single-center, prospective, randomized, open-label, blinded end-point trial (2006-2022) involving 150 participants with severe symptomatic ICAS (70%-99%).
- Participants were randomized to receive either intracranial stenting or medical therapy within 6 weeks of a qualifying event (TIA or ischemic stroke).
- Three-dimensional rotational angiography (3DRA) was used for assessment, and patients with severe adjacent BAD were excluded. The primary endpoint included TIA, ischemic stroke, intracranial hemorrhage, and death within 30 days, or any ischemic stroke up to 1 year.
Main Results:
- No significant difference was observed in the cumulative incidence of the primary endpoint between the stenting group (16%) and the medical therapy group (24%) (HR, 0.66; P = .26).
- Secondary endpoints, including same artery territory events (SIT) and any strokes at 1 year, also showed no significant between-group differences.
- However, the percentage of stenosis at 1 year was significantly lower in the stenting group (33% ± 22) compared to the medical therapy group (67% ± 18) (P < .001).
Conclusions:
- In patients with symptomatic ICAS but without adjacent BAD, intracranial stenting did not reduce the incidence of stroke or death compared to medical therapy.
- Exclusion of patients with adjacent BAD did not alter the primary endpoint outcomes in this specific trial population.
- While stenting reduced stenosis percentage, it did not translate to improved clinical outcomes regarding stroke or death within the study's timeframe.
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.
