Thirty-Day Outcomes of Resolute Onyx Stent for Symptomatic Intracranial Stenosis: A Multicenter Propensity Score-Matched Comparison With Stenting Versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial

Background: Symptomatic intracranial atherosclerotic disease (sICAD) is estimated to cause 10% of strokes annually in the United States. However, treatment remains a challenge with several different stenting options studied in the past with unfavorable results.

Objective: To report the 30-day stroke and/or death rate associated with intracranial stent placement for sICAD using Resolute Onyx Zotarolimus-Eluting Stent (RO-ZES) and provide a comparison with the results of Stenting Versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial.

Methods: Prospectively maintained databases across 8 stroke centers were used to identify adult patients treated with RO-ZES for sICAD between January 2019 and December 2021. Primary end point was composite of 30-day stroke, intracerebral hemorrhage, and/or death. Propensity score matching was performed using age, hypertension, lipid disorder, cigarette smoking, and symptomatic target vessel to create a matched group for comparison between RO-ZES and the SAMMPRIS medical management and treatment groups (SAMMPRIS percutaneous angioplasty and stenting [S-PTAS]).

Results: A total of 132 patients met the inclusion criteria for analysis (mean age: 64.2 years). Mean severity of stenosis was 81.4% (±11.4%). A total of 4 (3.03%) stroke and/or deaths were reported within 30 days of treatment in the RO-ZES group compared with 6.6% in the SAMMPRIS medical management group (OR [odds ratio] 2.26, 95% CI 0.7-9.56, P = .22) and 15.6% in the S-PTAS group (OR 5.9, 95% CI 2.04-23.4, P < .001). Propensity score match analysis of 115 patients in each group demonstrated 30-day stroke and/or death rate of 2.6% in the RO-ZES group and 15.6% in the S-PTAS group (OR 6.88, 95% CI 1.92-37.54, P < .001).

Conclusion: Patients treated with RO-ZES had a relatively low 30-day stroke and/or death rate compared with the S-PTAS group. Further large-scale prospective studies are warranted to evaluate the safety and efficacy of RO-ZES for the treatment of sICAD.