Balloon-mounted stents are not superior to antiplatelet therapy for symptomatic intracranial stenosis
The VISSIT trial examined the safety and efficacy of intracranial stenting versus antiplatelet medical therapy for symptomatic intracranial atherosclerotic disease (ICAD), similar to the SAMMPRUS trial. Target lesions included stenosis greater than 70%; primary endpoint was the secondary prevention of a stroke or hard TIA in the reference vascular distribution. In contrast to the self-expanding Wingspan stent used in SAMMPRIS, the Vitesse stent used in this trial was balloon-mounted and therefore exerted greater radial force and required more precise sizing. The investigators halted their trial for futility after the conclusion of the negative SAMMPRIS trial. Both symptomatic TIA / stroke (24.1% versus 9.8%, p= 0.05) and intracranial hemorrhage (8.6% versus 0%, p =0.06) were inferior in the stenting arm versus medical therapy. The VISSIT study does not therefore support the use of balloon-mounted stents for secondary prevention of stroke for symptomatic ICAD.