In this episode, I’ll discuss tenecteplase for stroke from 4.5 to 24 hours after the time last know well.
While the use of thrombolytics for patients with acute ischemic stroke is usually done if the patient presents within 4.5 hours of the time last know well, data specifically with tenecteplase beyond the 4.5 hour window is sparse.
A group of authors recently published a randomized controlled trial in New England Journal of Medicine involving over 500 acute ischemic stroke patients to determine whether tenecteplase or standard medical treatment had better outcomes for patients presenting within 4.5 to 24 hours from the time last know to be well. The group that received tenecteplase were dosed at 0.25 mg per kilogram of body weight to a maximum dose of 25 mg, and the other group received only standard medical treatment. The trial took place at center in China.
Treatment with tenecteplase resulted in 33% of patients with good outcome as defined by a modified Rankin scale score of 0 or 1 at 90 days compared to 24.2% with standard medical treatment. This difference was statistically significant.
Mortality at 90 days was similar between groups at 13.3% with tenecteplase and 13.1% with standard medical treatment. The incidence of symptomatic intracranial hemorrhage within 36 hours after treatment was 3.0% with tenecteplase and 0.8% with standard medical care.
The authors concluded:
In this trial involving Chinese patients with ischemic stroke due to large-vessel occlusion, most of whom did not undergo endovascular thrombectomy, treatment with tenecteplase administered within 4.5 to 24 hours after stroke onset resulted in less disability and similar survival as compared with standard medical treatment, and the incidence of symptomatic intracranial hemorrhage appeared to be higher.
Because this trial could be considered to expand the usual window for thrombolytics in ischemic stroke, the journal editors invited expert commentary in the form of an editorial titled “Small Step or Giant Leap? Expanding the Acute Stroke Thrombolysis Window to 24 Hours“.
The editorialist cautions that the results of this trial need to be replicated in other populations, and for real-world implementation of the protocol used in this study, hospitals would need perfusion-imaging capability. Furthermore they state that using tenecteplase beyond 4.5 hours from time last know well in conjunction with a model that includes transfer to another facility for planned thrombectomy was not well represented in the current trial.
The editorialist concludes by saying:
Despite these limitations, the results of the trial represent an exciting advance in acute stroke care. In patients with ischemic stroke due to large-vessel occlusion who had salvageable penumbra and who did not have access to thrombectomy, treatment with tenecteplase administered up to 24 hours after the time that the patient was last known to be well was associated with higher incidences of a good functional outcome and revascularization than standard medical treatment.
To access my free download area with 20 different resources to help you in your practice, go to pharmacyjoe.com/free.
If you like this post, check out my book – A Pharmacist’s Guide to Inpatient Medical Emergencies: How to respond to code blue, rapid response calls, and other medical emergencies.
Leave a Reply