BARCELONA, Spain — Thrombolysis with tenecteplase led to earlier reperfusion and improved functional outcomes at 90 days without any significant safety issues in selected patients with basilar artery occlusion stroke presenting up to 24 hours after symptom onset in the TRACE-5 trial.

“The trial is very important in our field. It supports the use of tenecteplase up to 24 hours in basilar artery occlusion stroke in both endovascular capable or endovascular limited settings,” lead investigator Yunyun (Carol) Xiong, MD, Beijing Tiantan Hospital, Beijing, China, said.

The results of the TRACE-5 trial were presented on October 22 at the 17th World Stroke Congress (WSC) 2025.

Most Devastating Type of Stroke

Basilar artery occlusion accounts for about 1% of all strokes but is among the most devastating, with mortality and disability rates reaching 80%-90% without recanalization.

Thrombolysis is recommended for patients presenting within 4.5 hours, and endovascular therapy (EVT) benefits select cases in the extended window. However, immediate EVT access is often limited.

The recent EXPECTS trial showed that alteplase administered 4.5 to 24 hours after stroke onset could benefit patients with posterior circulation stroke, but the trial population primarily included patients with mild stroke, and those with planned thrombectomy were excluded.

The TRACE-5 trial investigated whether tenecteplase thrombolysis, with or without EVT, could improve outcomes vs standard care in select basilar artery occlusion strokes presenting up to 24 hours after symptom onset.

Patients with intracerebral hemorrhage, extensive ischemic changes (posterior circulation Acute Stroke Prognosis Early CT score, < 6), significant cerebellar mass effect, acute hydrocephalus, clear hypodensity on noncontrast CT, or bilateral extensive brainstem ischemia were excluded from the trial based on baseline imaging.

A total of 452 Chinese individuals were randomized to receive tenecteplase or standard of care, which served as the control group. Control patients could receive anticoagulation such as heparin infusion or antiplatelets as per standard care and alteplase if eligible. EVT therapy was performed according to local practice and availability.

The primary efficacy endpoint was the proportion of patients achieving an excellent functional outcome, defined as a modified Rankin scale score of 0-1 at 90 days. This was achieved in 37.6% of the tenecteplase group vs 28.6% of the control group (P = .014).

Early reperfusion on initial angiography occurred in 15.4% of the tenecteplase patients vs 7.3% in the control group.

Safety outcomes were similar between the groups, with no signs of increased symptomatic intracranial hemorrhage, major bleeding, or death in the tenecteplase group.

New Hope

Bastian Cheng, MD, stroke neurologist at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany, who was not involved in the study said the findings, said “give the treatment physician the hope that not everything is lost in basilar artery occlusion, and that we should be treating these patients.”

Cheng pointed out that the outcomes were surprisingly good, given that basilar artery occlusion is the most catastrophic type of stroke, and especially as the Chinese population has high rates of stroke caused by intracranial atherosclerosis.

Xiong responded that the impressive early recanalization rate with tenecteplase would have helped patients achieve good functional outcomes.

Cheng asked how generalizable the findings are to other populations, such as western patients, where strokes are more often caused by embolism rather than atherosclerosis.

Xiong noted that atrial fibrillation (AF) is more prevalent in the Caucasian population.

“Previous studies have shown that if patients have AF they are more likely to have a distal occlusion, so we should see similar or even better results from tenecteplase in Caucasian patients,” she said.

‘A Major Achievement’

Commenting on the study for Medscape Medical News, Raul Nogueira, MD, professor of neurology and neurosurgery, University of Pittsburgh School of Medicine, Pittsburgh, said he thought this was an important trial, with broad application.

“Basilar artery occlusion stroke is a particular problem. It is worse than any other type of stroke. We have recently established that endovascular therapy can help selected patients out to 24 hours, but this is not available everywhere, so now we have an option for these patients who cannot get endovascular treatment. I would say this is a major achievement,” he said.

The TRACE-5 trial was supported by the Non-communicable Chronic Diseases National Science and Technology Major Project, the Beijing Municipal Science Fund for Distinguished Young Scholars, the National Natural Science Foundation of China, and China Shijiazhuang Pharmaceutical Company Recomgen Pharmaceutical. Xiong reported having no disclosures.