Efficacy and safety of bridging therapy and thrombectomy alone in patients with large infarcts of unrestricted size: LASTE trial post hoc analysis.

Abstract

Endovascular thrombectomy (EVT) is now the standard treatment for patients with large cerebral infarcts. However, the benefit of intravenous thrombolysis before EVT (IVT+EVT) in this setting is uncertain. We conducted a post hoc analysis of the Large Stroke Therapy Evaluation (LASTE) trial, which randomized patients with large infarcts (Alberta stroke program early CT score (ASPECTS) ≤5) to EVT plus medical care or medical care alone. Among those assigned to EVT, patients were divided into two groups: IVT+EVT and EVT alone. The main outcome was the shift analysis of the 3 month modified Rankin Scale (mRS) score. Safety outcomes included parenchymal hemorrhage (PH) and symptomatic intracranial hemorrhage (sICH). Among 159 patients allocated to EVT, 55 received IVT+EVT and 104 EVT alone. Patients in the IVT+EVT group had lower National Institutes of Health Stroke Scale (NIHSS) scores (median 19 (IQR 17-22) <i>vs</i> 22, (19-24) p=0.003), were less often anticoagulated (3.6% <i>vs</i> 27.9%, p<0.001) and shorter onset-to-imaging time (median 148 (91-280) vs 200 (123-311); P=0.024). Both groups had similar rates of ASPECTS 0-2 (50.9% vs 55.8%; P=0.56). There was no significant difference in 3 month functional outcome between IVT+EVT and EVT alone (generalized OR 1.22 (95% CI 0.85 to 1.74); P=0.28) or sICH (RR 1.72 (95% CI 0.65 to 4.48); P=0.27). Pre-EVT recanalization was higher in the IVT+EVT group (RR 15.1 (95% CI 1.9 to 117.9); P<0.001). Mortality rates did not differ significantly. In patients with very large infarcts, IVT+EVT was not associated with better functional outcome than EVT alone, despite higher pre-EVT recanalization rates. Safety outcomes were comparable. Randomized trials are warranted to clarify the role of IVT in this high-risk population. NCT03811769.