Onyx frontier DES in the setting of intracranial atherosclerotic disease: multicenter retrospective insights from early clinical experience.

Abstract

Background: Intracranial atherosclerotic disease (ICAD) is a leading cause of stroke, often refractory to aggressive medical therapy. Recent advancements in drug-eluting stents (DES) show promise for improved efficacy in intracranial applications relative to traditional ICAD treatments.

Methods: We retrospectively collected all consecutive deployments of the Onyx Frontier [Medtronic, Santa Rosa, CA] stent in the setting of ICAD between August 2022 and August 2024 at six high-volume neuro-interventional centers across the US. Patients were included if their indication for stenting (eg, acute/recurrent stroke) was secondary to ICAD. Primary outcome was periprocedural stroke (<72 hours) and secondary outcomes included degree of pre- and post-stent vessel stenosis and National Institutes of Health Stroke Scale (NIHSS) scores at most recent follow-up. Secondary outcomes were assessed via paired t-tests.

Results: Among 55 patients that met our inclusion criteria, the mean age was 62, mean presentation NIHSS was 10, and 40% were female. A total of 62 devices were used. Most common occlusion locations included the middle cerebral and internal carotid arteries. The periprocedural stroke rate was 10.9%, with a mortality rate of 1.8%. Mean vessel stenosis significantly decreased from 84.90% pre-stent to 2.00% post-stent (P<0.05). Mean NIHSS score improved from 10.37 preoperatively to 3.23 at follow-up (p<0.05). Procedural failure did not occur, however complications occurred in 16.4% of cases.

Conclusion: Our findings suggest that stenting in this setting results in a lower periprocedural stroke rate than appreciated in historical trials such as SAMMPRIS and VISSIT. However, recent CASSISS and BASIS trials demonstrate far reduced periprocedural stroke rates in the context of submaximal angioplasty for ICAD. This, in conjunction with complication rate, suggest that the Onyx Frontier, while promising, may not offer a definitive solution to ICAD.