There are many exclusion criteria in early randomized control trials for intravenous recombinant tissue plasminogen activator use in acute ischemic stroke, thus, many patients were not eligible for the treatment.Objective:
This study aimed to compare the safety and short-term treatment outcome between those who fulfilled the criteria and those who did not.Methods:
All acute ischemic stroke patients treated with intravenous thrombolysis from 2004 to 2015 in Tuen Mun hospital were recruited. They were divided into an on-label group if they did not have any of the contraindications and an off-label group if contraindication existed. Primary outcome of symptomatic hemorrhage, and secondary outcome of early neurological change, 3-month mortality and functional outcome were measured. Multivariate analysis with logistic regression with adjustment of baseline characteristics was done.Results:
Totally, 323 patients received intravenous thrombolysis and 162 (50.2%) had at least one contraindication. None of the contraindications were associated with symptomatic intracranial hemorrhage. Patients with previous stroke and diabetes mellitus performed similarly in all outcome measures. Patients with minor stroke had less early neurological deterioration and better functional outcome. Old age and high blood pressure were shown to have less early neurological improvement and less good functional outcome. Severe stroke was related to increased mortality and none had a good functional outcome.Conclusions:
This study demonstrated that the off-label group had comparable symptomatic intracranial hemorrhagic risk which gave ground for further study into its safety. However, some subgroups had less favorable outcome, including high blood pressure, severe stroke, and old age. This may be due to underlying comorbidities and limited rehabilitation potential rather than thrombolysis per se.