Aggressive medical management is the treatment of choice for patients with severe atherosclerotic stenosis (70%-90% ) of the arteries in their brain, according to the results of the 27-site VISSIT trial (NCT00816166) reported by Zaidat et al in the March 24 issue of JAMA. These patients are at extremely high risk of recurrent stroke, and it was hoped that reopening the artery via an endovascular intervention and using a stent to hold it open would reduce that risk. According to MUSC Health stroke neurologist Marc I. Chimowitz, MBChB, who led the earlier 50-site SAMMPRIS trial (NCT00576693) in the same population of patients, “The VISSIT trial confirms the findings from the SAMMPRIS trial that intracranial stenting for symptomatic intracranial arterial stenosis is associated with an unacceptably high risk of stroke and that aggressive medical therapy is the treatment of choice for these patients.” Aggressive medical therapy is defined as dual antiplatelet therapy, intensive risk factor management (systolic blood pressure <140 mm Hg, low-density lipoprotein <70 mg/dL), and a lifestyle modification program. Both SAMMPRIS and VISSIT were stopped early because patients in the endovascular intervention and stenting arm of the trials (who also received aggressive medical management) had a much higher-than-expected rate of both ischemic and hemorrhagic stroke and those in the aggressive medical management arm had a lower-than-expected rate. In an editorial accompanying the JAMA article by the VISSIT investigators, Chimowitz notes that some had questioned the SAMMPRIS results, attributing the increased rate of stroke to the two-pass endovascular intervention it used (on the first pass, angioplasty was performed to widen the artery and on the second pass the stent was deployed). These critics speculated that a balloon-mounted stent, which could widen the artery and deploy the stent on a single pass, would be less likely to increase the risk of stroke. Balloon-mounted stents were used in the endovascular therapy arm of the VISSIT trial, and even higher rates of stroke were seen than in SAMMPRIS, definitively establishing aggressive medical management as the safest and most effective treatment in these patients and drawing into real question whether stents will have a role in even limited subgroups of these patients in the foreseeable future.
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Second Large Trial Shows Stents Increase Stroke Rate in Patients With Severe Intracranial Atherosclerotic Stenosis
Posted by: Kimberly McGhee