Abstract

Background: In the RESCUE BT (Endovascular Treatment With versus Without Tirofiban for Stroke Patients with Large Vessel Occlusion) trial, enrollment in extended time window was based on non-contrast computed tomography. To assess whether tirofiban was safe and effective in the RESCUE BT trial according to advance imaging selection criteria based on current American Heart Association guidelines. Methods: This is a secondary analysis of a multicenter, double-blinded and randomized trial that was conducted at 55 centers in China and involved 950 participants with stroke with large vessel anterior circulation occlusion from October 2018 to October 2021. All randomized patients were screened according to the current guidelines and were followed up for 90 days from stroke onset. The primary outcome was the distribution of the 90-day modified Rankin scale (mRS) scores. Secondary outcomes included the rates of functional independence (mRS 0-2) and favorable outcome (mRS 0-3). Safety outcomes included the incidences of symptomatic intracranial hemorrhage (sICH) within 48 hours and 90-day mortality. Results: A total of 652 patients (319 in tirofiban group and 333 in placebo group) who met the current guidelines were included in this analysis, with median (IQR) age of 68 (58-75) years, 278 (42.6%) were women. The median 90-day mRS score was 3 (IQR, 1-4) in tirofiban group, and 3 (IQR, 1-4) in placebo group. The adjusted common odds ratio (OR) for a lower level of disability with tirofiban than placebo was 1.08 (95% confidence intervals [CI] 0.83-1.42). Incidence of sICH (10.1% vs 6.3%; adjusted OR 1.70 [95%CI 0.95-3.04]) was not different between groups. However, intravenous tirofiban might be associated with lower disability level (adjusted common OR 1.74 [95%CI 1.14-2.65]; P=0.01) in large artery atherosclerosis patients. Conclusions: There was no significant difference in severity of disability at 90 days with intravenous tirofiban compared with placebo among patients with large vessel anterior circulation occlusion undergoing endovascular therapy according to current guidelines. We observed potential benefits of tirofiban in large artery atherosclerosis patients, and further randomized controlled trials are warranted to validate the present results.

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