Safety and efficacy of intravenous tirofiban in progressive stroke patients out of thrombolytic window and without large arterial occlusion

Abstract Background: Progressive stroke is common in acute ischemic stroke (AIS) patients and is associated with the poor functional result; however, there is no effective treatment for progressive stroke patients out of the thrombolytic window and without substantial arterial occlusion. In our study, we aimed to investigate the safety and efficacy of intravenous tirofiban in patients with progressive stroke who missed the thrombolytic window and had no significant arterial occlusion. Method and Results: This is aprospective, open-label, cohort study that is based on historical controls, 15 progressive stroke patients (with the NIHSS deterioration ≥ 2 points or ≥ 1 point for limb paresis within 24 h after admission) who missed the thrombolytic window and had no large arterial occlusion in tirofiban group (T-group) were treated by intravenous tirofiban at 0.4 µg/kg/min for 30 min followed by 0.1 µg/kg/min infusion for 48 h followed by regular treatment or to receive regular antiplatelet treatment (aspirin plus clopidogrel) . The historical control group treated with regular antiplatelet agents (aspirin plus clopidogrel) was selected from a local cohort. The safety outcomes were assessed by the incidence of symptomatic intracerebral hemorrhage (sICH), systematic bleeding, and thrombocytopenia. The primary outcome was the proportion of excellent outcomes at 90 days [defifined as the modifified Rankin Scale (mRS) score of 0–1]. The secondary outcomes included the NIHSS score at 7 days. Results: After 90 days, more patients reached a excellent outcome (mRS 0–1) compared with control group (80 vs. 33.3%; unadjusted odds ratio 8.0; 95% CI: 1.275–2.858; P < 0.01). At seven days, the NIHSS score in the tirofiban group was lower than in the control group (2.8 vs. 4.5, p = 0.02). In both patient groups, neither sICH nor systemic bleeding nor thrombocytopenia occurred. Conclusions: In our study, intravenous tirofiban appears to be a potentially effective and safe therapy for progressive stroke patients who missed the thrombolytic window and had no large arterial occlusion. However, it is just a non-randomized study with a historical control group, so randomized studies are required to assess the tirofiban's safety and efficacy in this population of acute ischemic stroke patients.