Background and purpose: Angioplasty and stenting is a treatment option for patients with medically refractory symptomatic intracranial atherosclerotic disease (sICAD). Currently the Wingspan Stent System (WSS) is the only FDA approved device for this indication. We find the Resolute (R) Onyx Stent, a drug-eluting balloon mounted stent (DES), a better alternative to the WSS for treatment of sICAD. Herein, we present our findings comparing the two stents based on our single center experience.
Methods: A prospectively maintained neuro-endovascular databased was queried for patients between January 2013 to June 2021. Inclusion criteria for patients included sICAD with failed medical management, and intracranial stenting with either R-Onyx DES or WSS, including patients treated within 7 days of their last stroke. Primary outcomes were assessed via the occurrence of ischemic or hemorrhagic stroke or death within 72 h of the procedure. Secondary outcomes consisted of recurrent stroke or significant in-stent restenosis evaluated by a clinical or angiographic follow-up at 6 months.
Results: A total of 184 patients, average age 61.26 (SD = 12.53) (44% women), were eligible for analysis with 58 having R-onyx DES and 126 having WSS. Within 72 h, the primary outcome was observed in 1.7% (n = 1) of patients in the R-onyx DES group and 6.3% (n = 8) of patients in the WSS group (p = 0.089). Among 41 angiographic and clinical follow-ups in the R-onyx DES group, none had a recurrent stroke, while among 101 patients who had follow-up in the WSS group, 8.9% (n = 9) had a stroke (p = 0.024). At a 6-month angiographic follow-up, there was a significantly lower rate of symptomatic in-stent restenosis among the R-onyx DES group with 1.7% (n = 1) compared with 21.4% (n = 27) in the WSS group (p = 0.0003).
Conclusion: R-onyx DES is more effective than WSS in treating sICAD with low rates of periprocedural complications and long-term strokes and symptomatic in-stent restenosis. Future prospective randomized multicenter trials are needed.
Keywords: Intracranial stent; balloon mounted stent; restenosis.