Background Randomized clinical trials have failed to prove that the safety and efficacy of endovascular treatment for symptomatic intracranial atherosclerotic disease (ICAD) is better than that of medical management. A recent study using a self-expandable stent showed acceptable lower rates of periprocedural complications.
Objective To study the safety and efficacy of a balloon-mounted stent (BMS) in the treatment of symptomatic ICAD.
Methods Prospectively maintained databases from 15 neuroendovascular centers between 2010 and 2020 were reviewed. Patients were included if they had severe symptomatic intracranial stenosis in the target artery, medical management had failed, and they underwent intracranial stenting with BMS after 24 hours of the qualifying event. The primary outcome was the occurrence of stroke and mortality within 72 hours after the procedure. Secondary outcomes were the occurrence of stroke, transient ischemic attacks (TIAs), and mortality on long-term follow-up.
Results A total of 232 patients were eligible for the analysis (mean age 62.8 years, 34.1% female). The intracranial stenotic lesions were located in the anterior circulation in 135 (58.2%) cases. Recurrent stroke was the qualifying event in 165 (71.1%) while recurrent TIA was identified in 67 (28.9%) cases. The median (IQR) time from the qualifying event to stenting was 5 (2–20.75) days. Strokes were reported in 13 (5.6%) patients within 72 hours of the procedure; 9 (3.9%) ischemic and 4 (1.7%) hemorrhagic, and mortality in 2 (0.9%) cases. Among 189 patients with median follow-up time 6 (3–14.5) months, 12 (6.3%) had TIA and 7 (3.7%) had strokes. Three patients (1.6%) died from causes not related to stroke.
Conclusion Our study has shown that BMS may be a safe and effective treatment for medically refractory symptomatic ICAD. Additional prospective randomized clinical trials are warranted.
Data availability statement
Anonymized data from the study are available upon reasonable request to the corresponding author.
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Contributors MHM: Study conception, design of the work, statistical analysis, interpretation of data, drafting of the manuscript. RGN: Study conception, interpretation of data, critical revision of manuscript. AEH: Study conception, design of the work, critical revision of the manuscript. Other co-authors: interpretation of data, critical revision of manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests RGN reports consulting fees for advisory roles with Stryker Neurovascular, Cerenovus, Medtronic, Phenox, Anaconda, Genentech, Biogen, Prolong Pharmaceuticals, Imperative Care and stock options for advisory roles with Brainomix, Viz-AI, Corindus Vascular Robotics, Vesalio, Ceretrieve, Astrocyte and Cerebrotech. DCH is a consultant for Stryker and Vesalio and holds stock options at Viz.AI. AEH - 1.Consultant/speaker: Medtronic, Microvention, Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera therapeutics, Proximie, NovaSignal and Vesalio. 2.Principal investigator: COMPLETE study- Penumbra, LVO SYNCHRONISE-Viz.ai. 3.Steering committee/publication committee member: SELECT, DAWN, SELECT 2, EXPEDITE II, EMBOLISE, CLEAR. 4.Proctor: Pipeline, FRED, Wingspan, and Onyx. 5.Supported by grants from: GE Healthcare. PK is on the editorial board of JNIS. The other authors report no conflicts.
Provenance and peer review Not commissioned; externally peer reviewed.
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