Reasons for exclusion from intravenous thrombolysis in stroke patients admitted to the Stroke Unit

Abstract

Intravenous (IV) thrombolysis is the treatment in ischemic stroke, but only the minority of patients receive this medication. The primary objective of this study was to explore the reasons associated with the decision not to offer IV thrombolysis to stroke patients admitted to the Stroke Unit (SU). We conducted a retrospective analysis based on data collected from 876 consecutive stroke patients admitted to the SU <12 h of symptoms onset, treated or not with IV thrombolysis at the discretion of the treating neurologist. Of the 876 patients, 449 were thrombolysed and 427 non-thrombolysed. Stroke onset >4.5 h (p = 0.001) and unknown time of onset (or stroke present on awakening) (p = 0.004) were reasons listed in the current SPC of Actilyse reasons for exclusion even they occurred singly, whereas mild deficit (or rapidly improving symptoms) (p < 0.001), extra-cranial conditions with increased risk of bleeding (p = 0.004), and history of SNC diseases (p = 0.001) only when they occurred in combination. Severe pre-stroke disability (p = 0.003) was extra-SPC reason for exclusion even when it occurred singly, whereas early CT hypodensity (p < 0.001) only when it occurred in combination. After stratification for intra-SPC reasons for exclusion, early CT hypodensity was associated with decision not offer IV thrombolysis in patients with mild deficit (p < 0.001), age >80 years (p < 0.001), stroke onset >4.5 h (p = 0.005), and unknown time of onset (p = 0.037), while severe pre-stroke disability (p = 0.025) and admission under non-stroke specialist neurologist assessment (p = 0.018) in patients with age >80 years. There are often unjustified reasons for exclusion from IV thrombolysis in SU.

Keywords: Contraindications; Ischemic stroke; Off-label; Reasons for exclusion; Thrombolysis; rt-PA.