Abstract Body: Purpose: Two previous randomized controlled trials focusing on vertebral artery stenting, the Vertebral Artery Stenting Trial (VAST) and the Vertebral Artery Ischaemia Stenting Trial (VIST), were underpowered because they failed to reach expected recruitment, and they found no difference in stroke prevention between stenting and medical treatment alone. Drug-eluting stents have shown better performance than bare metal stents. To further determine the effect of drug-eluting stenting in reducing stroke in patients with extracranial vertebral artery stenosis, we designed this study.
Materials and Methods: Multicenter, randomized, open-label, outcome assessor-blinded trial will be conducted at 31 centers in China. Patients with extracranial vertebral artery (V1-2) 70% to 99% stenosis and transient ischemic attack or ischemic stroke within the past 3 months will be recruited (first patient enrollment: Sep 15, 2023).
Results: A total of 472 patients will be enrolled. Patients will be randomized (1:1) to drug-eluting stenting plus medical therapy or medical therapy alone. Medical treatment includes dual antiplatelet (aspirin 100mg per day + clopidogrel 75mg per day or ticagrelor 90mg twice per day) for 6 months. The primary outcome is any fatal or non-fatal stroke within 30 days, or ischemic stroke in the targeted area within 30 days to 1 year. Secondary outcomes include stroke, death, crescendo TIA in the targeted area within 1 year.
Conclusion: The study has been registered on ClinicalTrials.gov (Identifier: NCT05885932) and enrollment is ongoing. This trial aims to reveal whether drug-eluting stenting is safe and effective in vertebral artery stenosis.