Durability of Drug-Eluting Balloon-Mounted Stents in Symptomatic ICAD: A Propensity-Matched Landmark Analysis of RO-ZES Versus Wingspan or Medical Management Beyond 24 Months.

Abstract

Background: Symptomatic intracranial atherosclerotic disease can be managed with medical therapy, risk factor control, angioplasty, and stenting. The Wingspan stent demonstrated limited efficacy and higher adverse outcomes than medical management in the SAMMPRIS trial (Stenting Versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis). Drug-eluting stents, including the Resolute Onyx Zotarolimus-eluting stent, have demonstrated superior outcomes beyond 1 year. This study assessed outcomes at ≥24 months after stenting.

Methods: This retrospective multicenter study compared patients diagnosed with severe symptomatic intracranial atherosclerotic disease who underwent Resolute Onyx Zotarolimus-eluting stent stenting between March 2018 and May 2021 with patients from the percutaneous angioplasty and stenting and the aggressive medical management arms of the SAMMPRIS trial. Individuals who remained alive, stroke-free, and under follow-up at 24 months were included. Propensity score matching was used to align the 3 arms, and landmark analysis using inverse probability weighting, accounting for differential survival to 24 months, was used as complementary sensitivity analysis. The primary outcomes measured were postlandmark (ie, 24 months) stroke recurrence, intracranial hemorrhage, and all-cause mortality.

Results: After applying the 24-month landmark and propensity score matching, 204 patients (68 per arm) were eligible (median follow-up, 36 months). Unweighted rates of stroke (P=0.147), intracranial hemorrhage (P=0.362), and mortality (P=0.168) did not differ significantly among groups. Weighted multivariable logistic and Cox regression analyses, adjusting for residual postmatch differences, similarly showed no significant differences in stroke recurrence. Kaplan-Meier analysis did not demonstrate a significant difference in overall survival across the 3 arms (log-rank P=0.139).

Conclusions: Although previous studies have demonstrated the superiority of the Resolute Onyx Zotarolimus-eluting stent compared with the Wingspan system and aggressive medical management for the treatment of severe symptomatic intracranial atherosclerotic disease, the present landmark analysis suggests that these benefits may not consistently extend beyond 24 months. One speculative explanation is that the drug elution-related benefit of the Resolute Onyx Zotarolimus-eluting stent may attenuate over time, but this was not directly assessed in the present study. Prospective, controlled trials are necessary to confirm the implications of our long-term findings.