Therapeutic applications of drug coated balloons in symptomatic intracranial arterial stenosis: systematic review and quantitative meta-analysis.

Abstract

Background: Intracranial atherosclerotic stenosis (ICAS) represents a major cause of ischemic stroke, with endovascular treatments, such as 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 DCBs 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 also evaluated.

Results: The analysis included six controlled studies and 16 single arm studies involving 1308 patients with ≥70% stenosis. In single arm studies, the pooled restenosis rate for DCBs was 7.34% (95% CI 0.05 to 0.10, I²=44%, P=0.04), with a perioperative stroke and mortality rate of 5.75% (95% CI 0.04 to 0.08, I²=25%, P=0.18). The follow-up stroke and transient ischemic attack rate was 1.26% (95% CI 0.00 to 0.03, I²=33%, P=0.11). In controlled studies, DCBs significantly reduced restenosis rates compared with conventional balloons (OR=0.24, P=0.003) and stents (OR=0.20, P<0.001), without increasing perioperative adverse events.

Conclusions: In this study, DCBs showed significant potential as an effective therapeutic option for symptomatic ICAS in clinical practice, offering lower restenosis rates compared with conventional endovascular approaches while maintaining comparable safety profiles. However, further larger scale, high quality prospective studies are essential to validate these findings and establish standardized protocols for their application.