Stenting for symptomatic vertebral artery stenosis: The Vertebral Artery Ischaemia Stenting Trial

$\textbf{Objective:}$ To compare in the Vertebral Artery Ischaemia Stenting Trial (VIST) the risks and benefits of vertebral angioplasty and stenting with best medical treatment (BMT) alone for symptomatic vertebral artery stenosis. $\textbf{Methods:}$ VIST was a prospective, randomized, open-blinded endpoint clinical trial performed in 14 hospitals in the United Kingdom. Participants with symptomatic vertebral stenosis ≥50% were randomly assigned (1:1) to vertebral angioplasty/stenting plus BMT or to BMT alone with randomization stratified by site of stenosis (extracranial vs intracranial). Because of slow recruitment and cessation of funding, recruitment was stopped after 182 participants. Follow-up was a minimum of ≥1 year for each participant. $\textbf{Results:}$ Three patients did not contribute any follow-up data and were excluded, leaving 91 patients in the stent group and 88 in the medical group. Mean follow-up was 3.5 (interquartile range 2.1-4.7) years. Of 61 patients who were stented, stenosis was extracranial in 48 (78.7%) and intracranial in 13 (21.3%). No periprocedural complications occurred with extracranial stenting; 2 strokes occurred during intracranial stenting. The primary endpoint of fatal or nonfatal stroke occurred in 5 patients in the stent group vs 12 in the medical group (hazard ratio 0.40, 95% confidence interval 0.14-1.13, p = 0.08), with an absolute risk reduction of 25 strokes per 1,000 person-years. The hazard ratio for stroke or TIA was 0.50 (p = 0.05). $\textbf{Conclusions:}$ Stenting in extracranial stenosis appears safe with low complication rates. Large phase 3 trials are required to determine whether stenting reduces stroke risk. $\textbf{ISRCTNCOM identifier}$: ISRCTN95212240. $\textbf{Classification of evidence:}$ This study provides Class I evidence that for patients with symptomatic vertebral stenosis, angioplasty with stenting does not reduce the risk of stroke. However, the study lacked the precision to exclude a benefit from stenting.The run in phase with recruitment of the first 100 patients was supported by a grant from the Stroke Association. Recruitment after patient 100 was supported by a grant from the NIHR Health Technology Assessment. Recruitment was supported by the NIHR Clinical Research Network. Hugh S Markus is supported by an NIHR Senior Investigator award and his work is supported by the Cambridge University Hospitals Trust NIHR Comprehensive Biomedical Research Centre. Peter M Rothwell is supported by Wellcome Trust and NIHR Senior Investigator awards and his work is supported by the NIHR Biomedical Research Centre, Oxford