Next-generation Onyx DES for elective intracranial atherosclerosis: A meta-analysis

Abstract

Background: Intracranial atherosclerotic disease (ICAD) is a growing cause of ischemic stroke globally, with a disproportionately high burden in Asian, Black, and Hispanic populations. Despite advances in medical therapy, ICAD remains associated with high rates of recurrent stroke, prompting interest in durable endovascular solutions. This study aims to systematically evaluate the current evidence on the safety and efficacy of elective intracranial stenting in adult patients with symptomatic ICAD using Onyx drug-eluting balloon-mounted stents (Onyx DES). Methods: A meta-analysis was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Five studies were initially identified, with one excluded due to overlapping cohorts, resulting in four final studies included for analysis. Meta-analysis was conducted utilizing random-effects models for pooled event rates (95% CIs) and weighted means. Results: Of 153 articles initially identified, four high-quality studies encompassing 314 patients met inclusion criteria. The mean (±SD) age was 64.6 (±12.4) years, with a predominance of males (70.7%) and common vascular comorbidities such as hypertension (85.7%) and diabetes (60.0%). Lesions were nearly equally distributed between the anterior and posterior circulations. Periprocedural complications were infrequent (1.0%), including one hemorrhagic stroke and one fatal aneurysm rupture. The 30-day complication rate remained low at 5%, involving strokes, deaths, and TIAs. However, follow-up at six months and beyond revealed rising rates of strokes, TIAs, and in-stent restenosis, reaching 9% at six months and persisting through one year. Conclusion: This descriptive meta-analysis suggests that Onyx DES may offer promising results in the treatment of symptomatic ICAD, with lower early complication rates reported. However, larger prospective studies are needed to confirm these observations and evaluate long-term efficacy and safety.