Improved Outcomes with Tenecteplase in Stroke Beyond 4.5 Hours: Study finds

Tenecteplase given between 4.5 to 24 hours after stroke onset resulted in less disability and similar survival rates compared to regular treatment in the trial involving Chinese patients with ischemic stroke due to large-vessel occlusion, most of whom did not undergo endovascular thrombectomy. 

A stroke is considered an emergency where blood flow to the brain is blocked due to blood clots, plaque deposits, embolism, or thrombus. Tenecteplase is an effective thrombolytic agent for the management of stroke within 4.5 hours of onset. However, there is limited information on how effective tenecteplase is when administered after 4.5 hours.

To fill this knowledge gap, Yunyun Xiong, From the Department of Neurology, China and colleagues conducted a study where they randomly assigned patients with blockages in the middle cerebral artery or internal carotid artery, who had viable brain tissue identified through perfusion imaging and no access to endovascular thrombectomy, to receive tenecteplase(at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or standard medical treatment 4.5 to 24 hours after the time that the patient was last known to be well (including after stroke on awakening and unwitnessed stroke).

The main goal was to measure the absence of disability, defined as a score of 0 or 1 on the modified Rankin scale (which ranges from 0 to 6, with higher scores indicating more severe disability), 90 days after treatment. The primary safety concerns were the occurrence of symptomatic brain bleeding and death.

The researchers reported the following findings:

• 516 patients were recruited, in which 264 were randomly assigned to receive tenecteplase and 252 to receive standard medical treatment.
• Fewer than 2% of the patients (4 in the tenecteplase group and 5 in the standard treatment group) underwent rescue endovascular thrombectomy.
• Treatment with tenecteplase led to a higher percentage of patients achieving a modified Rankin scale score of 0 or 1 at 90 days compared to standard medical treatment (33.0% vs. 24.2%).
• The 90-day mortality rate was 13.3% for those treated with tenecteplase and 13.1% for those receiving standard medical treatment. Symptomatic intracranial hemorrhage within 36 hours after treatment occurred in 3.0% of the tenecteplase group and 0.8% of the standard treatment group.

“Although tenecteplase performed better overall, the incidence of symptomatic intracranial hemorrhage was higher,” researchers reported.

Reference: Xiong Y, Campbell BCV, Schwamm LH, Meng X, Jin A, Parsons MW, Fisher M, Jiang Y, Che F, Wang L, Zhou L, Dai H, Liu X, Pan Y, Duan C, Xu Y, Xu A, Zong L, Tan Z, Ye W, Wang H, Wang Z, Hao M, Cao Z, Wang L, Wu S, Li H, Li Z, Zhao X, Wang Y; TRACE-III Investigators. Tenecteplase for Ischemic Stroke at 4.5 to 24 Hours without Thrombectomy. N Engl J Med. 2024 Jul 18;391(3):203-212. doi: 10.1056/NEJMoa2402980. Epub 2024 Jun 14. PMID: 38884324