Drug-coated Balloon for Endovascular Treatment of Symptomatic Intracranial Stenotic Disease: A Multicenter Randomized
Sheng Guan1, Xu Tong2, Xiaoqing Li2
1Department of Neurointervention, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Insights
Drug-coated balloon (DCB) angioplasty significantly reduced restenosis rates compared to bare-metal stent (BMS) placement in patients with intracranial atherosclerotic disease. This indicates DCB is a safer and more effective treatment option for preventing stroke recurrence.
Area of Science:
- Interventional Neurology
- Cardiovascular Research
- Medical Technology
Background:
- Restenosis post-bare-metal stent (BMS) placement is a primary driver of stroke recurrence in symptomatic intracranial atherosclerotic disease (ICAD).
- Drug-coated balloon (DCB) angioplasty has emerged as a potential alternative to reduce restenosis rates.
Purpose of the Study:
- To prospectively compare the efficacy and safety of DCB angioplasty versus BMS placement.
- To evaluate outcomes in patients with symptomatic ICAD and high-grade stenosis.
Main Methods:
- A prospective, randomized controlled trial involving 209 patients across 14 Chinese hospitals.
- Patients were randomized (1:1) to receive either DCB angioplasty or BMS placement.
- Primary outcome was 6-month angiographic restenosis; secondary outcomes included symptomatic restenosis and recurrent ischemic events.
Main Results:
- The 6-month angiographic restenosis rate was significantly lower in the DCB group (11%) compared to the BMS group (29%) (RR, 0.38; P = .006).
- DCB angioplasty also demonstrated lower rates of symptomatic restenosis (1% vs. 10%; P = .02) and recurrent ischemic events (4% vs. 13%; P = .04).
- No significant difference in 30-day stroke or death rates was observed between the groups (6% vs. 5%; P = .73).
Conclusions:
- DCB angioplasty is superior to BMS placement in reducing 6-month angiographic and symptomatic restenosis in patients with symptomatic high-grade ICAD.
- DCB angioplasty significantly lowers the risk of recurrent ischemic events from 30 days to 1 year post-procedure.
- DCB angioplasty represents a promising therapeutic strategy for managing symptomatic ICAD, offering improved outcomes over BMS.
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.
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