VAST: Vertebral Artery Stenting Trial. Protocol for a randomised safety and feasibility trial

BACKGROUND Twenty to 30 percent of all transient ischaemic attacks and ischaemic strokes involve tissue supplied by the vertebrobasilar circulation. Atherosclerotic stenosis >/= 50% in the vertebral artery accounts for vertebrobasilar stroke in at least one third of the patients. The risk of recurrent vascular events in patients with vertebral stenosis is uncertain and revascularisation of vertebral stenosis is rarely performed. Observational studies have suggested that the risk of subsequent stroke or death in patients with vertebrobasilar ischaemic events is comparable with that in patients with carotid territory events. Treatment of vertebral stenosis by percutaneous transluminal angioplasty has been introduced as an attractive treatment option. The safety and benefit of stenting of symptomatic vertebral stenosis as compared with best medical therapy alone remains to be elucidated in a randomised clinical trial. STUDY OBJECTIVES The primary aim of the Vertebral Artery Stenting Trial (VAST) is to assess whether stenting for symptomatic vertebral artery stenosis >/= 50% is feasible and safe. A secondary aim is to assess the rate of new vascular events in the territory of the vertebrobasilar arteries in patients with symptomatic vertebral stenosis >/= 50% on best medical therapy with or without stenting. DESIGN This is a randomised, open clinical trial, comparing best medical treatment with or without vertebral artery stenting in patients with recently symptomatic vertebral artery stenosis >/= 50%. The trial will include a total of 180 patients with transient ischaemic attack or non-disabling ischaemic stroke attributed to vertebral artery stenosis >/= 50%. The primary outcome is any stroke, vascular death, or non-fatal myocardial infarction within 30 days after start of treatment. Secondary outcome measures include any stroke or vascular death during follow-up and the degree of (re)stenosis after one year. DISCUSSION Improvements both in imaging of the vertebral artery and in endovascular techniques have created new opportunities for the treatment of symptomatic vertebral artery stenosis. This trial will assess the feasibility and safety of stenting for symptomatic vertebral artery stenosis and will provide sufficient data to inform a conclusive randomised trial testing the benefit of this treatment strategy. The VAST is supported by the Netherlands Heart Foundation (2007B045; ISRCTN29597900).