Outcomes for IV tenecteplase treatment nonsuperior to placebo for stroke at 90 days

 Wasn't this already proven last June?

TIMELESS: Tenecteplase No Help Late After Ischemic Stroke Onset June 2023

Outcomes for IV tenecteplase treatment nonsuperior to placebo for stroke at 90 days

Key takeaways:

• The study examined 458 adults given IV tenecteplase or placebo 4.5 to 24 hours after stroke.
• At 90 days after treatment, the modified Rankin Scale score for both groups was 3.

Tenecteplase IV therapy for individuals who suffered ischemic stroke was nonsuperior to placebo, researchers wrote in the New England Journal of Medicine.

“Intravenous thrombolytic therapy with alteplase has generally been the standard care for eligible patients within 4.5 hours after the onset of ischemic stroke,” Gregory W. Albers, MD, a professor of neurosurgery at Stanford University School of Medicine, and colleagues wrote.

New research found that IV tenecteplase given 4.5 to 24 hours after stroke was nonsuperior to placebo with respect to outcomes for ischemic stroke at 90 days. Image: Adobe Stock

Researchers sought to examine whether tenecteplase, as a relatively new thrombolytic agent, would be an effective intervention from 4.5 hours to 24 hours post stroke, as little is known about efficacy in the longer term.

They conducted the multicenter, double-blind, randomized, placebo-controlled Thrombolysis in Imaging Eligible Late Window Patients to Assess the Efficacy and Safety of Tenecteplase (TIMELESS) trial at 112 locations in the United States and Canada.

A total of 458 individuals were randomized 1:1 to receive either 0.25 mg/kg IV tenecteplase up to 25 mg, or a similar dose of placebo between 4.5 and 24 hours after the last time the patient did not exhibit stroke or stroke-like symptoms. Participants were required to have evidence of occlusion of either the middle cerebral artery or internal carotid artery as well as undamaged or salvageable tissue upon perfusion imaging.

The primary outcome was score on the modified Rankin Scale (mRS) score: zero to six with higher number indicating greater disability 90 days following treatment. Secondary safety outcomes included incidence of death and symptomatic intracranial hemorrhage.

According to results, the median mRS score at 90 days for both tenecteplase and placebo groups was three, with the adjusted common odds ratio of mRS score distribution for tenecteplase compared with placebo was 1.13 (95% CI: 0.82-1.57).

Data further showed that mortality at 90 days was 19.7% for those treated with tenecteplase and 18.2% in the placebo group, with incidence of symptomatic intracranial hemorrhage 3.2% vs. 2.3%, respectively.

“We found no benefit in functional outcome with tenecteplase as compared with placebo administered 4.5 to 24 hours after symptom onset in patients with ischemic stroke,” Albers and colleagues wrote.

In a related editorial, Dana Leifer, MD, a neurology practitioner at Weill Cornell Medicine, noted that patients without large-vessel occlusions were excluded from the TIMELESS study, a population whose treatment with IV tenecteplase in future clinical trials may yield positive results.

Reference:

• Leifer D. N Engl J Med. 2024:doi:10.1056/NEJMe2314930.

Sources/Disclosures

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Source:

Albers GW, et al. N Engl J Med. 2024;doi:10.1056/NEJMoa2310392.

Disclosures: Albers reports no relevant financial disclosures. The study was supported by Genentech. Please see the study for all other authors’ relevant financial disclosures. Leifer reports no relevant financial disclosures.