Low-dose rivaroxaban plus antiplatelet therapy for symptomatic intracranial atherosclerotic stenosis: A prospective cohort study.

BACKGROUND

The antithrombotic strategies for symptomatic intracranial atherosclerotic stenosis (sICAS) remains challenging. Dual pathway inhibition (DPI) has demonstrated clinical benefit in coronary and peripheral artery disease.

AIMS: This study aimed to evaluate the efficacy of DPI with low-dose rivaroxaban plus antiplatelet therapy (APT) compared with APT alone on recurrent stroke with sICAS.

METHODS

This prospective cohort study included patients with sICAS identified from the Ischemic Cerebrovascular Disease Database of the First Affiliated Hospital of Zhengzhou University between January 2019 to August 2023. Low-dose rivaroxaban was prescribed off-label to patients in the DPI group. The outcomes were ischemic stroke, transient ischemic attack (TIA), acute coronary syndrome (ACS), all-cause death and cardio-cerebrovascular death within 1 year of discharge. Cox regression with inverse probability of treatment weighting (IPTW) was applied to compare outcomes between the DPI and APT groups. The win-ratio method was used to assess the major adverse cardiovascular events (MACE), prioritized in the order of all-cause death, recurrent ischemic stroke or TIA, and ACS.

RESULTS

Among the 1217 patients with sICAS, 131 (10.8%) received DPI therapy. The recurrence rate of ischemic stroke was lower in the DPI group compared to the APT group (8/131 [6.1%] vs 136/1086 [12.5%]). DPI significantly reduced the risk of ischemic stroke recurrence (HR = 0.46, 95% CI: 0.23-0.94, p = 0.034) and the incidence of MACE (HR = 0.53, 95% CI: 0.29-0.97, p = 0.041) during the 1-year follow-up, consistent with the IPTW-based cohort (HR = 0.35, 95% CI: 0.16-0.76, p = 0.008; HR = 0.43, 95% CI: 0.22-0.83, p = 0.012). The win-ratio analysis of MACE favored DPI therapy (win ratio = 2.34, 95% CI: 1.41-3.90, p = 0.001). Symptomatic intracranial hemorrhage, fatal bleeding, and hospitalization for gastrointestinal bleeding were infrequent in this cohort.

CONCLUSIONS

DPI therapy may be associated with a lower risk of recurrent stroke compared with antiplatelet therapy alone in patients with sICAS. These findings warrant further investigation through large-scale randomized controlled trials.