Low-dose tenecteplase safe, effective up to 24 hours after ischemic stroke onset
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Administration of low-dose IV tenecteplase in the 4.5 to 24 hours after stroke symptom onset seemed to be safe and effective in the reperfusion and recanalization of occluded large cerebral vessels, a speaker reported.
According to the results of a phase 2a trial presented at the International Stroke Conference, low-dose tenecteplase (TNKase, Genentech) was more effective in achieving the primary outcome of major reperfusion without symptomatic intracranial hemorrhage at 24 to 48 hours after thrombolysis compared with higher-dose tenecteplase.
The lower dose of tenecteplase was chosen for the phase 2b study.
As Healio previously reported, in the EXTEND-IA TNK trial, tenecteplase was associated with more frequent reperfusion and improved outcomes compared with alteplase (Activase, Genentech) in patients with acute ischemic stroke selected for thrombectomy.
“The stroke burden continues to grow across the world, and particularly in China where stroke is the leading cause of death,” Xin Cheng, MD, PhD, associate professor of neurology at the Huashan Hospital of Fudan University and the National Center for Neurological Disorders in Shanghai, said in a press release. “There are two major limitations in thrombolysis [treatment to dissolve dangerous clots and restore blood flow] with alteplase: the restricted time window of 4.5 hours and a low rate of success in reopening arteries and restoring blood flow when a large brain vessel is blocked.”
Therefore, Cheng and colleagues conducted the present trial to evaluate whether tenecteplase administered in the 4.5 to 24 hours from time of last known well for patients with ischemic stroke would be efficacious and safe.
Researchers enrolled 86 patients with ischemic stroke admitted at 13 hospitals in China. All participants had head and neck CT angiography between 4.5 and 24 hours after last known well; anterior large vessel occlusion or severe stenosis; and penumbral mismatch on CT perfusion imaging. Researchers randomly assigned participants to low-dose tenecteplase (0.25 mg/kg; mean age, 68 years; 58% men) or higher-dose tenecteplase (0.32 mg/kg; mean age, 67 years; 72% men).
The primary outcome was achieving major reperfusion without symptomatic intracranial hemorrhage at 24 to 48 hours after thrombolysis with tenecteplase.
The researchers found 32.6% of participants assigned to low-dose tenecteplase and 23.3% of those assigned to a higher dose achieved the primary outcome.
The rates of modified Rankin Scale score of 0 to 1 at 90 days were 27.9% in the low-dose group and 48.8% in the higher-dose group, whereas the rates of modified Rankin Scale score of 0 to 2 at 90 days were 46.5% in the low-dose group and 60.5% in the higher-dose group, Cheng said during a press conference.
The rate of recanalization at 4 to 6 hours was 43.9% in both groups.
Symptomatic intracranial hemorrhage occurred in 11.6% of the low-dose group and 9.3% of the higher-dose group, whereas the rates of modified Rankin Scale score of 5 or 6 at 90 days were 25.6% in the low-dose group and 16.3% in the higher-dose group, Cheng said.
“These results are the first to be reported as thrombolysis with [tenecteplase] in the extended time window,” Cheng said during the press conference. “It seems feasible to extend the time window of intravenous thrombolysis to 24 hours after last known well through perfusion imaging selection. [Tenecteplase] seems safe and more potent in the reperfusion of hypoperfused brain at risk for infarction and the recanalization of the occluded large cerebral vessels.”
Reference:
- Newer clot-busting medication may someday increase time for stroke treatment. newsroom.heart.org/news/newer-clot-busting-medication-may-someday-increase-time-for-stroke-treatment. Published Feb. 10, 2022. Accessed Feb. 10, 2022.
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Cheng X, et al. LB7. Presented at: International Stroke Conference; Feb. 9-11, 2022; New Orleans (hybrid meeting).
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