Gordian J Hubert
Title: Effects of presence of off-label-criteria on door-to-needle-time in systemic thrombolysis for acute stroke treatment Background: Thrombolysis is the only approved pharmacological therapy for acute ischemic stroke. Several contraindications result from the stringent inclusion and exclusion criteria used in landmark RCTs. Nonetheless, off-label-treatment is common in acute stroke care. In previous studies most off-label criteria were not associated with higher risk of symptomatic intracerebral haemorrhage (SICH). Aim: To analyze, if presence of off-label-criteria influences door-to-needle time. Methods: We analyzed treatment protocols of all patients who received thrombolysis in the TEMPiS telestroke network between 01.01.2015 and 31.12.2017. Off-label criteria were defined according to the European licence of alteplase. Kruskal-Wallis test with Dunn’s post-hoc test and linear regression modelling with interaction terms were used for test of significance. Results: Of 2792 patients, 680 (24.4%) had at least one contraindication for thrombolysis (19.3% with one, 3.9%, 0.9%, 0.1% and 0.1% with 2-5 contraindications, respectively). Most common contraindications were history of prior stroke and concomitant diabetes (18.4%), elevated blood pressure (14.9%) and onset >4.5h or unknown (10.3%). Presence of at least one off-label-criterium led to significant delay of door-to-needle-time (47min vs. 41min; p<0.0001) with a tendency to longer delays with more contraindications. Difference was seen irrespective of whether thrombolysis was initiated via telemedicine or onsite (7min vs. 4min difference, p=0.36). Conclusion: Presence of off-label-criteria was associated with longer door-to-needle-time in patients treated with thrombolysis in the TEMPiS-network. Considering the potentially detrimental effect for patients and recently published data on SICH in off-label thrombolysis, further research evaluating the safety concerns underlying the alteplase licence criteria is needed.
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