From the Guidelines
Tenecteplase is not proven for wake-up stroke treatment, and its use in this context is not recommended outside of a clinical trial. The most recent guidelines from the American Heart Association/American Stroke Association, published in 2018 1, state that the benefit of IV fibrinolytic agents other than alteplase is unproven, and their administration is not recommended outside a clinical trial. While tenecteplase has been compared to alteplase in several trials, it has not been proven to be superior or noninferior to alteplase, and its use in wake-up strokes lacks robust evidence from large randomized trials.
Some key points to consider when evaluating the use of tenecteplase for wake-up stroke include:
- The lack of robust evidence from large randomized trials to support its use in this context
- The potential advantages of tenecteplase, including single-bolus administration and potentially better fibrin specificity
- The importance of advanced imaging to identify salvageable brain tissue in wake-up strokes
- The need for treatment decisions to be made within a comprehensive stroke center with imaging capabilities
The 2018 guidelines also discuss the use of imaging criteria to select patients for treatment with IV alteplase, and recommend that multimodal CT and MRI, including perfusion imaging, should not delay administration of IV alteplase 1. However, the guidelines do not provide specific recommendations for the use of tenecteplase in wake-up strokes.
In clinical practice, the use of tenecteplase for wake-up stroke would be considered off-label, and clinicians should exercise caution and carefully consider the potential benefits and risks before making a treatment decision. If tenecteplase is considered, it would typically be used at a dose of 0.25-0.4 mg/kg (maximum 40mg) as a single IV bolus, and should only be used within a comprehensive stroke center with imaging capabilities to select appropriate patients.
From the Research
Tenekteplase for Wake-Up Stroke
- The use of tenekteplase for wake-up stroke is still being investigated, with some studies suggesting its potential efficacy and safety in this setting 2, 3, 4, 5.
- However, the evidence is not yet conclusive, and further studies are needed to determine the optimal dosage and treatment window for tenekteplase in wake-up stroke patients 2, 5.
- Some studies have shown that tenekteplase may be non-inferior to alteplase in terms of safety and efficacy for acute ischemic stroke treatment within 4.5 hours of symptom onset, but its use in wake-up stroke patients is still considered off-label 4, 5.
- Ongoing clinical trials are investigating the use of tenekteplase for extended applications, including wake-up stroke, and may provide more definitive answers on its efficacy and safety in this setting 3, 5.
Current Guidelines and Recommendations
- Current guidelines favor tenekteplase over alteplase due to its logistical advantages, but retention of alteplase for off-label indications, including wake-up stroke, is not recommended 4.
- The use of tenekteplase for wake-up stroke is not yet supported by conclusive evidence, and its use in this setting should be approached with caution 2, 5.
Ongoing Research and Future Directions
- Further studies are needed to investigate the efficacy and safety of tenekteplase for wake-up stroke, including its optimal dosage and treatment window 2, 3, 5.
- Ongoing clinical trials may provide more definitive answers on the use of tenekteplase for wake-up stroke and other extended applications 3, 5.