Abstract T MP17: Reduced Lesion Volume in the rtPA-Epifibatide Group in CLEAR-ER Study

Abstract

Trial Introduction/Purpose: The C ombined Approach to L ysis Utilizing E ptifibatide and r t-PA in Acute Ischemic Stroke- E nhanced R egimen (CLEAR-ER) trial demonstrated the safety of a reduced-dose rtPA regimen (0.6mg/kg rt-PA over 40 minutes) plus eptifibatide (135mcg/kg bolus followed by a two-hour infusion at 0.75mcg/kg/min), and gave evidence of potential clinical efficacy. The purpose of our study is to examine if differences in lesion volume between the 2 groups further support better clinical outcomes as an additional outcome measure in the CLEAR-ER study. Methods: Lesion volumes on 24-hour CT (n=117) and MR images (n=2) from subjects with anterior circulation ischemia in the CLEAR-ER Study were calculated using HLW/2 method. Volumes were compared using multiple regression to adjust for baseline mRS, NIHSS, age, and time to IV rtPA administration. Volumes were log transformed for analysis due to the distribution. Geometric means and 95% confidence intervals are shown. Results: Mean lesion volumes (adjusted and unadjusted) and p value are presented in Table 1. Discussion: 51.0 % smaller mean adjusted lesion volumes between the combined-treatment and rt-PA-only groups in the CLEAR-ER study supports the clinical benefit observed with combined therapy previously reported. Whereas the findings reported remain hypothesis generating, more conclusive prospective research is needed for confirming the findings of this preliminary analysis.