Preliminary Safety Outcomes of Single-vs-Dual Antiplatelet Therapy Combined with the Pipeline Flex Embolization Device with Shield Technology for Intracranial Aneurysm Treatment: A Retrospective Single-Center Analysis

BACKGROUND AND PURPOSE: Flow diversion for intracranial aneurysm treatment traditionally requires dual antiplatelet therapy, creating a clinical dilemma balancing between ischemic and hemorrhagic risks, particularly for those with increased hemorrhagic risks such as ruptured aneurysms. Novel surface-modified flow diversion devices, such as the Pipeline Flex Embolization Device with Shield Technology, reduce thrombogenicity. This technology offers the opportunity to use a de-escalated antiplatelet therapy regimen. However, robust clinical evidence about the safety of this approach on the Pipeline Shield is lacking. Therefore, we compared the safety of single versus dual antiplatelet therapy in patients with intracranial aneurysms treated with this device. MATERIALS AND METHODS: We performed a retrospective single-center comparative study of patients treated with either single or dual antiplatelet therapy. The primary endpoint was major ischemic stroke (NIHSS score increase of ≥4 points for >24 hours) within 1 year. Secondary endpoints included minor and transient ischemic events, in-stent stenosis, major hemorrhagic events, and aneurysm occlusion rates. The primary endpoint data were analyzed using the Kaplan–Meier method. RESULTS: A total of 172 patients were included, with 91 in the single antiplatelet therapy group and 81 in the dual antiplatelet therapy group. The main drug used for single antiplatelet therapy was clopidogrel (95.6%). The single antiplatelet therapy group included a significantly greater proportion of patients with aneurysms in higher-risk, non-ICA locations (16.0% vs. 4.4%; P = .004). Despite this baseline imbalance, the estimated 1-year risk of major ischemic stroke did not differ significantly between groups (2.2% [2/91; 95% CI, 0–5.2%] vs. 1.3% [1/81; 95% CI, 0–3.7%]; P = .62). The rates of minor or transient ischemic events, major hemorrhage, in-stent stenosis, and complete aneurysm occlusion were comparable between the groups. CONCLUSIONS: In this exploratory study, no statistically significant difference was observed between the safety profiles of clopidogrel-based single and dual antiplatelet therapies for patients treated with the Pipeline Shield, despite the higher-risk baseline characteristics in the single-therapy cohort. These preliminary findings suggest that clopidogrel monotherapy might be a feasible alternative in select patients, potentially simplifying treatment and reducing DAPT-associated hemorrhagic complications.