Drug-coated balloons (DCB) for symptomatic intracranial atherosclerotic stenosis: a systematic review and meta-analysis

Background: Intracranial atherosclerosis is a major cause of ischemic stroke, with high restenosis rates following angioplasty and stenting. Drug-coated balloons (DCBs) offer a potential alternative by delivering antiproliferative drugs to reduce restenosis. This systematic review and meta-analysis aimed to evaluate the restenosis rate and effectiveness of DCBs in treating intracranial atherosclerosis.

Methods: PubMed, EMBASE, and Cochrane CENTRAL were searched from inception to April 13, 2025 (date of search). Eligible studies included randomized trials, and prospective and retrospective cohort studies evaluating DCBs in patients with symptomatic intracranial atherosclerosis. The primary outcomes were restenosis rate and degree of stenosis post-DCB treatment. Pooled proportions and odds ratios (ORs) with 95% confidence interval (CI) were calculated. Heterogeneity was assessed using the I² statistic, and risk of bias with the Newcastle-Ottawa Scale.

Results: Twenty-six studies involving 1,489 patients were included. The pooled restenosis rate after DCB treatment was 11% (95% CI: 9–13%; I²=26.8%). The pooled mean degree of stenosis after treatment was 34.34% (95% CI: 29.85–38.84%; I²=93.9%). In comparative studies, DCB was associated with a significantly lower restenosis rate than non-DCB treatment (OR =0.26; 95% CI: 0.16–0.44; P<0.001; I²=0%). No significant difference was observed in post-treatment stenosis between groups (mean difference =14.58; 95% CI: −5.98 to 35.14; P=0.17; I²=92.5%).

Conclusions: Restenosis rates post-DCB treatment are low, and are significantly lower than with non-DCB treatments. Because most included studies were retrospective cohort studies, which inherently provide lower-quality evidence, the current findings should be interpreted cautiously. High-quality prospective studies, ideally randomized controlled trials, are warranted in the future.