Abstract Body: Background: The Food and Drug Administration (FDA) recommended that intracranial stenting (ICAS) not be performed within 7 days of qualifying cerebral ischemic event due to high rates of 1-month stroke and/or death observed with Wingspan intracranial stent placement in Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial. However, a detailed analysis of the relationship between timing of ICAS and 1-month stroke and/or death has not been performed.
Methods: We compared the rates of 1-month stroke and/or death associated with ICAS performed ≤7 days and those >7 days after qualifying cerebral ischemic event in patients recruited in two randomized multicenter trials (SAMMPRIS and Vitesse Intracranial Stent Study for Ischemic Stroke Therapy [VISSIT]. Both trials recruited patients aged ≥ 30 years and ≤ 80 years, who suffered from transient ischemic attack (TIA) or minor ischemic stroke related to high grade (70% to 99% in severity) stenosis in a major intracranial artery and used independent ascertainment for 1 month event rates. We performed logistic regression analysis to identify the effect of time interval strata between qualifying cerebral ischemic event and ICAS on 1-month stroke and/or death rate after adjusting for potential confounders.
Results: A total of 108 and 170 patients underwent ICAS ≤7 days and >7 days after the qualifying cerebral ischemic event, respectively. Balloon expandable stent (BES) and self-expanding stent (SES) were used in 54 and 224 patients, respectively. The rates of 1-month stroke and death were 17 of 108 (15.7%) and 30 of 170 (17.6%) in patients treated ≤7 days and those >7 days after qualifying cerebral ischemic event, respectively (p=0.729). There was no difference in the 1-month stroke and/or death rate in patients who underwent ICAS ≤7 days and those >7 days after qualifying cerebral ischemic events (odds ratio 0.074, 95% confidence interval 0.28-2.41) after adjusting for age, gender, severity of stenosis strata, qualifying cerebral ischemic event type (TIA or minor ischemic stroke), and stent used (BES versus SES).
Conclusions: We did not observe any increased risk of 1-month stroke and/or death in patients who underwent ICAS ≤7 days and those >7 days after the qualifying cerebral ischemic event. Delaying the ICAS according to current FDA recommendations may not be necessary when ICAS is indicated.