Therapeutic Applications of Drug-Coated Balloons in Symptomatic Intracranial Arterial Stenosis: A Systematic Review and Quantitative Meta-Analysis
Author(s)
Ying Tao, Bachelor, Dunming Xiao, Master, Yingyao Chen, Ph.D., Shimeng Liu, Ph.D.;
Fudan University, Shanghai, China
Fudan University, Shanghai, China
Presentation Documents
OBJECTIVES: Intracranial atherosclerotic stenosis (ICAS) represents a major cause of ischemic stroke, with endovascular treatments like stenting facing challenges such as restenosis and complications. Drug-coated balloons (DCBs) provide a promising alternative by delivering targeted drug without permanent implants. This review systematically evaluates the efficacy and safety of DCBs for symptomatic ICAS, providing evidence-based insights to guide clinical practice.
METHODS: Databases were searched from inception to October 16, 2023, to identify studies on DCB therapy for symptomatic ICAS. Two independent researchers screened the literature and extracted data. A meta-analysis was performed using the Freeman-Tukey double arcsine transformation with random or fixed effects models to assess perioperative safety and restenosis rates. Heterogeneity and publication bias were evaluated.
RESULTS: The analysis included six controlled studies and 16 single-arm studies involving 1,308 patients with ≥70% stenosis. In single-arm studies, the pooled restenosis rate for DCBs was 7.34% (95% CI: 0.05-0.10, I²=44%, P=0.04), with perioperative stroke and mortality rate of 5.75% (95% CI: 0.04-0.08, I²=25%, P=0.18). Follow-up stroke and transient ischemic attack rate was 1.26% (95% CI: 0.00-0.03, I²=33%, P=0.11). In controlled studies, DCBs significantly reduced restenosis rates compared to conventional balloons (OR=0.24, P=0.003) and stents (OR=0.20, P<0.001), without increasing perioperative adverse events.
CONCLUSIONS: DCBs show significant potential as an effective and safe therapeutic option for symptomatic ICAS in clinical practice, with lower restenosis rates compared to conventional endovascular approaches and comparable safety profiles. However, further larger-scale, high-quality prospective studies are essential to validate these findings and establish standardized protocols for their application.
METHODS: Databases were searched from inception to October 16, 2023, to identify studies on DCB therapy for symptomatic ICAS. Two independent researchers screened the literature and extracted data. A meta-analysis was performed using the Freeman-Tukey double arcsine transformation with random or fixed effects models to assess perioperative safety and restenosis rates. Heterogeneity and publication bias were evaluated.
RESULTS: The analysis included six controlled studies and 16 single-arm studies involving 1,308 patients with ≥70% stenosis. In single-arm studies, the pooled restenosis rate for DCBs was 7.34% (95% CI: 0.05-0.10, I²=44%, P=0.04), with perioperative stroke and mortality rate of 5.75% (95% CI: 0.04-0.08, I²=25%, P=0.18). Follow-up stroke and transient ischemic attack rate was 1.26% (95% CI: 0.00-0.03, I²=33%, P=0.11). In controlled studies, DCBs significantly reduced restenosis rates compared to conventional balloons (OR=0.24, P=0.003) and stents (OR=0.20, P<0.001), without increasing perioperative adverse events.
CONCLUSIONS: DCBs show significant potential as an effective and safe therapeutic option for symptomatic ICAS in clinical practice, with lower restenosis rates compared to conventional endovascular approaches and comparable safety profiles. However, further larger-scale, high-quality prospective studies are essential to validate these findings and establish standardized protocols for their application.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO203
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy
Disease
SDC: Neurological Disorders, STA: Personalized & Precision Medicine