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

Abstract

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.

Self‐expanding versus balloon expandable stent for intracranial arterial stenosis: A systematic review and meta‐analysis

“…44 In two subsequent randomized clinical trials, the 30-day rate of stroke and/or death was 14.7% in the SES-treated group in Stenting vs. January 2019 and December 2021 using Resolute (R) Onyx DES reported the rate of 3.03% for 30-day stroke and/or death which was lower than the 15.6% rate in a matched cohort of patients in SAMM-PRIS treated with SES and 6.6% rate in the medical management in SAMMPRIS. 15…”

“…Several small studies have compared the short-and mid-term results of the SES and BES in the treatment of intracranial arterial stenosis, [9][10][11][12][13] particularly recent studies. 14,15 We performed this meta-analysis to provide a more precise treatment effect of BES compared with SES than be derived from considering each study with a small sample size individually. Since a previous meta-analysis, 9 more studies specifically regarding drugeluting stents (DES), a subtype of BES, have been published.…”

Randomized Secondary Prevention Trials in Participants With Symptomatic Intracranial Atherosclerotic Stenosis

“…Multiple smaller studies have begun to study the safety and efficacy of utilizing other novel drug-eluting coronary stent systems for ICAS. 39,40 If these findings show promise, DES will need to be tested in RCTs against medical management to determine their effectiveness in treating ICAS.…”

Future of Endovascular and Surgical Treatments of Atherosclerotic Intracranial Stenosis

“…35 Similarly, a multicenter study of 132 patients comprising data collected from 8 stroke centers demonstrated lower 30-day stroke and death rate in a propensity-score matched comparison to the stenting arm of SAMMPRIS (3.0% versus 15.6%;). 49 However, long-term and prospective comparative data are needed to test the efficacy of these emerging endovascular technologies. Notably, the implementation of all currently available DESs in the intracranial vasculature is off-label usage.…”