Drug-coated balloon versus stent angioplasty in patients with intracranial atherosclerotic stenosis: A systematic review and meta-analysis

Background Intracranial Atherosclerotic Stenosis (ICAS) is one of the leading causes of ischemic stroke worldwide. Endovascular interventions such as drug-coated balloon (DCB) angioplasty and stent angioplasty (SA) have emerged as promising treatment options, particularly for patients with severe stenosis. However, the comparative efficacy and safety of these two approaches remain uncertain. This systematic review aimed to compare the efficacy and safety of DCB versus SA in patients with ICAS. Methods A comprehensive search of PubMed, Scopus, Web of Science, Embase, and the Cochrane Central was conducted through January 2026. We included randomized clinical trials and comparative cohort studies that compare DCB with SA in patients with ICAS. Results Six studies comprising 723 participants (332 DCB, 391 SA) met the inclusion criteria. The mean participant age ranged from 55.3 to 66.33 years. Compared with SA, DCB was associated with a lower overall restenosis rate (RR = 0.28, 95% CI: 0.18 to 0.44, p = 0.0007, I2 = 0.0%, τ2 = 0, PI = 0.16 to 0.48), and recurrent ischemic events (RR = 0.30, 95% CI: 0.22 to 0.42, p = 0.0002, I2 = 0.0%, τ2 = 0, PI = 0.13 to 0.72). No statistically significant difference in periprocedural complications was observed between the two strategies (RR = 0.78, 95% CI: 0.39 to 1.55, p = 0.3878, I2 = 0.0%, τ2 ≤0.0001, PI = 0.35 to 1.73). Conclusion DCB is associated with greater efficacy than SA in reducing restenosis and recurrent ischemic events in patients with ICAS without increasing procedural complications. However, interpretation of these findings is limited by the predominance of nonrandomized studies and relatively short follow-up durations. More randomized clinical trials with longer follow-up and larger sample sizes are needed.