Original Investigation 

August 9, 2022

Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial

RESCUE BT Trial Investigators

JAMA. 2022;328(6):543-553. doi:10.1001/jama.2022.12584

Key Points

Question  Among patients with large vessel occlusion acute ischemic stroke, does administration of intravenous tirofiban before endovascular thrombectomy improve functional outcomes?

Findings  In this randomized clinical trial that included 948 patients, treatment with tirofiban, compared with placebo, before endovascular thrombectomy resulted in no significant difference in disability severity between groups as measured by the overall distribution of the modified Rankin Scale score at 90 days (adjusted common odds ratio for a lower level of disability, 1.08).

Meaning  The findings do not support use of intravenous tirofiban before endovascular treatment for acute ischemic stroke.

Abstract

Importance  Tirofiban is a highly selective nonpeptide antagonist of glycoprotein IIb/IIIa receptor, which reversibly inhibits platelet aggregation. It remains uncertain whether intravenous tirofiban is effective to improve functional outcomes for patients with large vessel occlusion ischemic stroke undergoing endovascular thrombectomy.

Objective  To assess the efficacy and adverse events of intravenous tirofiban before endovascular thrombectomy for acute ischemic stroke secondary to large vessel occlusion.

Design, Setting, and Participants  This investigator-initiated, randomized, double-blind, placebo-controlled trial was implemented at 55 hospitals in China, enrolling 948 patients with stroke and proximal intracranial large vessel occlusion presenting within 24 hours of time last known well. Recruitment took place between October 10, 2018, and October 31, 2021, with final follow-up on January 15, 2022.

Interventions  Participants received intravenous tirofiban (n = 463) or placebo (n = 485) prior to endovascular thrombectomy.

Main Outcomes and Measures  The primary outcome was disability level at 90 days as measured by overall distribution of the modified Rankin Scale scores from 0 (no symptoms) to 6 (death). The primary safety outcome was the incidence of symptomatic intracranial hemorrhage within 48 hours.

Results  Among 948 patients randomized (mean age, 67 years; 391 [41.2%] women), 948 (100%) completed the trial. The median (IQR) 90-day modified Rankin Scale score in the tirofiban group vs placebo group was 3 (1-4) vs 3 (1-4). The adjusted common odds ratio for a lower level of disability with tirofiban vs placebo was 1.08 (95% CI, 0.86-1.36). Incidence of symptomatic intracranial hemorrhage was 9.7% in the tirofiban group vs 6.4% in the placebo group (difference, 3.3% [95% CI, −0.2% to 6.8%]).

Conclusions and Relevance  Among patients with large vessel occlusion acute ischemic stroke undergoing endovascular thrombectomy, treatment with intravenous tirofiban, compared with placebo, before endovascular therapy resulted in no significant difference in disability severity at 90 days. The findings do not support use of intravenous tirofiban before endovascular thrombectomy for acute ischemic stroke.

Trial Registration  Chinese Clinical Trial Registry Identifier: ChiCTR-IOR-17014167