Standard-Dose Tenecteplase vs Low-Dose Alteplase for Acute Ischemic Stroke From Large-Vessel Occlusion: A Randomized...

Area of Science:

• Neurology
• Cardiovascular Medicine
• Pharmacology

Background:

• Acute ischemic stroke treatment relies on timely reperfusion.
• Low-dose alteplase (0.6 mg/kg) is standard in Japan and Asia, despite tenecteplase's advantages.
• Mechanical thrombectomy is crucial for large-vessel occlusions.

Purpose of the Study:

• To compare standard-dose tenecteplase (0.25 mg/kg) with low-dose alteplase (0.6 mg/kg) for reperfusion rates in acute ischemic stroke patients undergoing mechanical thrombectomy.
• To generate evidence supporting potential regulatory approval of tenecteplase in Japan.

Main Methods:

• Investigator-initiated, multicenter, randomized, open-label, superiority trial.
• 221 patients with large-vessel occlusion stroke, eligible for thrombolysis within 4.5 hours, were randomized 1:1.
• Primary outcome: substantial reperfusion (mTIC 2b-3) on initial angiogram.

Main Results:

• Substantial reperfusion occurred in 10.3% of the tenecteplase group vs. 3.6% of the alteplase group (absolute difference 6.5%).
• 90-day functional outcomes showed a trend favoring tenecteplase (OR 1.47).
• Symptomatic intracranial hemorrhage and 90-day mortality rates were similar between groups.

Conclusions:

• Standard-dose tenecteplase significantly increases early reperfusion rates compared to low-dose alteplase in acute ischemic stroke patients.
• Tenecteplase demonstrates comparable safety and functional outcomes, presenting a viable alternative to low-dose alteplase.
• This study supports tenecteplase as a potential new standard of care in regions currently using low-dose alteplase.