L. S Janis

Intracranial Stenting SAMMPRIS

The Stenting and Aggressive Medical management for the Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial established aggressive medical management as superior to angioplasty and stenting for symptomatic intracranial atherosclerotic disease. This presentation addresses some criticisms of the trial, emphasizes key knowledge gained from the study and proposes potential new directions for research in this area. At present, the data from the trial are limited to complete 30-day outcomes for all enrolled patients and follow-up to 1 year in approximately half of the cohort.1 Enrollment was stopped early at the recommendation of the Data and Safety Monitoring Board because of higher than expected 30-day complication rates in the stenting arm and a futility analysis indicating essentially no chance that stenting would be proven superior. A total of 451 patients (59% of the target) had been enrolled, with 227 randomized to aggressive medical management alone and 224 to aggressive medical management plus stenting. Follow-up was completed in March 2013 and study close-out is underway. Presentation of the final primary results is planned for the Fall of 2013. The 30-day rate of stroke and death was 14.7% in the percutaneous transluminal angioplasty and stenting group (12.5% nonfatal stroke, 2.2% fatal stroke) and 5.8% in the medical group (5.3% nonfatal stroke, 0.4% nonstroke death; P =0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. These events were predefined primary end points and were blindly adjudicated. Mean duration of follow-up at the time of this analysis was 11.9 months. The Kaplan–Meier curves were significantly different ( P =0.009) and yield 1-year rates of the primary end point of 20.0% in the percutaneous transluminal angioplasty and stenting group and 12.2% in the medical group. We concluded that aggressive medical management was superior to angioplasty and stenting for patients …