Timing of intracranial stent placement and one month stroke and/or death rates in patients with high-grade symptomatic intracranial stenosis: pooled analysis of SAMMPRIS and VISSIT trials.

Abstract

A critical evaluation of the US Food and Drug Administration (FDA) recommendation to avoid intracranial stent placement (ICAS) within 7 days of a qualifying cerebral ischemic event. This evaluation compared the rates of 1 month stroke and/or death associated with ICAS performed within 7 days and more than 7 days after a qualifying cerebral ischemic event in patients with high-grade (70-99% in severity) intracranial stenosis in two randomized controlled trials. A logistic regression analysis was performed to identify the impact of time interval strata between the qualifying cerebral ischemic event and ICAS on 1 month stroke and/or death rate (independent ascertainment). The rates of 1 month stroke and/or death were 14 of 112 (12.5%) and 33 of 172 (19.2%) in patients treated within 7 days and more than 7 days after a qualifying cerebral ischemic event, respectively (P=0.071). There was no difference in the 1 month stroke and/or death rate in patients who were treated within 7 days and those treated after 7 days after a qualifying cerebral ischemic event (OR 1.0004, 95% CI 0.55 to 1.84) after adjusting for age, gender, severity of stenosis strata, qualifying cerebral ischemic event type (transient ischemic attack or minor ischemic stroke), and stent used (self-expanding vs balloon expandable stents). This analysis did not show any increased risk of 1 month stroke and/or death in patients who underwent ICAS within 7 days compared with those treated more than 7 days after the qualifying cerebral ischemic event. Delaying the ICAS according to current FDA recommendations may not be necessary when ICAS is indicated.