Tenecteplase compared to alteplase in real-world outcome: A Swedish Stroke Register study

Area of Science:

• Neurology
• Cardiovascular Medicine
• Pharmacology

Background:

• Tenecteplase is increasingly used off-label for ischemic stroke thrombolysis as an alternative to alteplase.
• Real-world data is crucial for evaluating the safety of tenecteplase compared to alteplase.

Purpose of the Study:

• To evaluate the safety and efficacy of tenecteplase versus alteplase in a large, real-world cohort of acute ischemic stroke patients.
• To compare key clinical outcomes, including symptomatic intracerebral hemorrhage, death, and functional status.

Main Methods:

• A comparative study using data from the Swedish Stroke Register (2018-2020).
• Inclusion of adult patients with acute ischemic stroke treated with either alteplase or tenecteplase.
• Primary outcome: symptomatic intracerebral hemorrhage or in-hospital death. Secondary outcomes: 90-day mortality, modified Rankin Scale at 90 days, and door-to-needle time (DNT).

Main Results:

• No significant differences in baseline characteristics between the alteplase (6,560 patients) and tenecteplase (888 patients) groups.
• Tenecteplase was associated with a higher risk of symptomatic intracerebral hemorrhage or in-hospital death (13.2% vs. 10.7%).
• No significant differences in 90-day functional outcomes or mortality, but tenecteplase demonstrated a reduced mean DNT (by 9 minutes).

Conclusions:

• Tenecteplase was not non-inferior to alteplase regarding safety outcomes (hemorrhage or death).
• Despite safety concerns, tenecteplase showed a benefit in reducing door-to-needle time.
• Ongoing scrutiny of safety outcomes is essential, especially as clinical trials investigate tenecteplase's functional non-inferiority.