Drug-coated Balloon for Endovascular Treatment of Symptomatic Intracranial Stenotic Disease: A Multicenter Randomized Controlled Trial

Radiology. 2026 Jan;318(1):e250893. doi: 10.1148/radiol.250893.

Abstract

Background Restenosis is a major cause of stroke recurrence after bare-metal stent (BMS) placement in patients with symptomatic intracranial atherosclerotic disease (ICAD). Observational studies have shown that drug-coated balloon (DCB) angioplasty can reduce restenosis rates. Purpose To compare the efficacy and safety of DCB angioplasty with that of BMS placement in individuals with symptomatic ICAD with high-grade stenosis. Materials and Methods Eligible patients with symptomatic ICAD at 14 Chinese tertiary hospitals were prospectively and randomly assigned (1:1 ratio) to the DCB and BMS groups. The primary outcome was 6-month restenosis assessed with digital subtraction angiography. Secondary and safety outcomes included 6-month symptomatic restenosis, 30-day to 1-year recurrent ischemic event, and 30-day stroke or death. Between-group differences in outcomes were tested using generalized linear and Cox regression models. Results Between July 2021 and March 2023, 209 participants (median age, 59 years [IQR, 52-66 years]; 157 men), 103 and 106 in the DCB and BMS groups, respectively, were included in the intention-to-treat analysis. A total of 164 participants completed the 6-month digital subtraction angiography follow-up, and 203 participants completed the 1-year clinical follow-up. The 6-month angiographic restenosis rate was lower in the DCB group than in the BMS group (11% vs 29%; risk ratio, 0.38 [95% CI: 0.19, 0.78]; P = .006). The DCB group also had a lower 6-month symptomatic restenosis rate (1% vs 10%; risk ratio, 0.13 [95% CI: 0.02, 0.96]; P = .02) and lower 30-day to 1-year recurrent ischemic event rate (4% vs 13%; hazard ratio, 0.31 [95% CI: 0.10, 0.94]; P = .04). The 30-day stroke or death rate was similar in the DCB and BMS groups (6% vs 5%; hazard ratio, 1.24 [95% CI: 0.38, 4.05]; P = .73). Conclusion In individuals with symptomatic ICAD with high-grade stenosis, DCB angioplasty reduced the 6-month risks of angiographic restenosis and symptomatic restenosis and 30-day to 1-year recurrent ischemic event rate compared with BMS placement. Chinese Clinical Trial Registry no. ChiCTR2100046829 © RSNA, 2026 Supplemental material is available for this article. See also the editorial by Wojak in this issue.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Angiography, Digital Subtraction
  • Angioplasty, Balloon* / methods
  • Endovascular Procedures* / methods
  • Female
  • Humans
  • Intracranial Arteriosclerosis* / diagnostic imaging
  • Intracranial Arteriosclerosis* / surgery
  • Intracranial Arteriosclerosis* / therapy
  • Male
  • Middle Aged
  • Prospective Studies
  • Stents
  • Treatment Outcome

Associated data

  • ChiCTR/ChiCTR2100046829