SAMMPRIS trial halted after high risk of stroke/death found

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The SAMMPRIS trial, initiated to compare aggressive medical therapy alone to aggressive medical management plus angioplasty combined with stenting in patients with symptomatic high-grade stenosis (70 to 99 percent) of a major intracranial artery to prevent stroke, has been halted.

According to the National Institutes of Health, the trial was stopped by the National Institute of Neurological Disorders and Stroke (NINDS) after the researchers reported that five stroke-related deaths had occurred within the 30-day enrollment in the stenting arm. In fact, the most recent review by the Data Safety Monitoring Board found that 14 percent of the patients within the angioplasty and stenting group experienced a stroke or died within the first 30 days of enrollment. In comparison, this rate of stroke or death in the patient arm that was medically managed was 5.8 percent.

The SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis) committee, along with the NINDS and Data Safety Monitoring Board, has determined that medical therapy alone is superior to angioplasty with stenting for these patients.

The trial enrolled 59 percent (451 patients) of the planned 763 patients who experienced a TIA or non-disabling stroke attributed to intracranial arterial stenosis within 30 days of trial enrollment. The patients received medical management that included 325 mg/day of aspirin through follow-up, 75 mg/day of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis) for 90 days after enrollment and the patients also underwent intensive management of vascular risk factors including blood pressure and lifestyle modifications during the trial period.

Patients randomized to receive angioplasty underwent stenting with the Gateway-Wingspan system.

“The 30-day rate in the stented patients is substantially higher than the estimated rate of 5.2 percent and 9.6 percent based on registry data,” NINDS wrote. Additionally, the 30-day rate of stroke or death in the intensive medical treatment arm was significantly lower than the estimated 10.7 percent in historical controls.

“Beyond 30 days, the rates of stroke in the territory of the stenotic artery are similar in the two groups, but fewer than half the patients have been followed for one year,” the statement read. “As such, follow-up of currently enrolled patients and comprehensive analysis of the total trial data set will be important in the final interpretation of this study.”