Territorial Stroke in SAMMPRIS: Critical Analyses of Stroke Prevention in Intracranial Atherosclerosis.

backgroundCurrent guidelines do not support the addition of stenting to maximal medical therapy (MMT) for severe symptomatic intracranial atherosclerotic disease as first-line treatment. This is largely due to the SAMMPRIS trial (Stenting and Aggressive Medical Management Therapy for Preventing Recurrent Stroke in Intracranial Arterial Stenosis) results, which featured a high periprocedural stroke rate. In this study, we examined the rates of ischemic stroke in the territory of the qualifying artery (stroke in territory [SIT]) over time between MMT alone and stent+MMT.

methodsThe primary outcome was SIT. Periprocedural stroke was considered <7 days from stent placement. Log-rank analysis, Cox proportional hazards models, and Kaplan-Meier survival curves compared time to SIT between MMT and stent+MMT (day of stenting considered day 0).

resultsIn total, 435 patients were included (MMT: n=227; stent+MMT: n=208). The SIT event rate was 15.6% (68 events-MMT: n=31/227 (13.7%); stent+MMT: n=37/208 (17.8%). Twenty of the 37 stented patients had periprocedural SIT (7 early; 13 delayed). When periprocedural SIT was excluded, there were zero SIT events in the stent+MMT arm at 30 and 60 days, which was significantly lower than the MMT arm (

conclusionsContrary to Food and Drug Administration recommendations, periprocedural SIT rates did not vary by time of stenting after qualifying ischemic event. Most SIT was periprocedural, and the rate of SIT over the study period was higher in MMT when excluding periprocedural strokes. These findings are exploratory but may suggest that MMT alone may not be the most effective treatment for intracranial atherosclerotic disease and that with improvements in periprocedural safety, intracranial stenting may remain a viable treatment option. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00576693.