Abstract

Background: The efficacy and safety of tirofiban, as an adjuvant medication of endovascular therapy (EVT), in patients with large vessel occlusion due to atherosclerotic thrombosis was still unclear. Methods: The Endovascular Treatment With versus Without Tirofiban in Stroke (RESCUE BT) trial was a randomized, double-blinded, placebo-controlled trial that was performed at 55 centers in China from October 10, 2018 to October 31, 2021. This was a post hoc exploratory analysis of the RESCUE BT trial and 435 patients were included in the intention-to-treat analysis. The primary outcome was the proportion of functional independence (defined as modified Rankin Scale 0-2) at 90 days. We estimated the efficacy and safety of EVT plus placebo versus EVT plus tirofiban using binary logistic regression analysis. A causal mediation analysis was also performed to assess the potential mediators of tirofiban on functional outcome. Results: This study included 435 patients, including 197 patients assigned to the tirofiban group and 238 patients assigned to the placebo group. The median age was 65 [IQR, 56-72] years, and 311 (71.5%) patients were men. Tirofiban was associated with higher rates of functional independence at 90 days compared with the placebo (adjusted odds ratio with 95% CI, 1.68 [1.11–2.56], P = 0.014). There was no significant difference in mortality and symptomatic intracranial hemorrhage between the two groups, thought the rate of intracranial hemorrhage was numerically higher in the tirofiban group (29.1% versus 23.2%, P = 0.165). Tirofiban was also associated with fewer number of thrombectomy passes (beta, -0.48; 95% CI, -0.62 to -0.34; P < 0.001). Treatment-reduced passes explains 20.0% (95% CI, 4-76) of the beneficial effect of tirofiban on functional independence. Conclusion: Tirofiban plus EVT might be an effective and well-tolerated option for patients with anterior large vessel occlusion due to atherosclerosis. These findings are needed to be confirmed in future trials.

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