Recent developments in stroke care have shown promising results in expanding the time window for thrombolysis, a critical treatment for eligible stroke patients. The TIMELESS trial, led by Gregory W. Albers, MD, has demonstrated the safety of tenecteplase in later-window poststroke patients, opening new possibilities for treatment.
Intravenous thrombolytic therapy with alteplase has been the standard care for eligible patients within 4.5 hours after the onset of ischemic stroke. However, the TIMELESS trial sought to extend the time window for thrombolysis by testing the hypothesis that intravenous tenecteplase, initiated 4.5 to 24 hours after stroke onset, would provide a benefit in patients with specific conditions.
The trial, which enrolled 458 patients with ischemic stroke, focused on those with a large-vessel occlusion of the internal carotid artery or specific segments of the middle cerebral artery, and evidence of salvageable ischemic brain tissue identified on CT perfusion or MRI perfusion. The majority of the enrolled patients subsequently underwent thrombectomy prior to receiving either tenecteplase or placebo.
At 90 days, the trial results showed no significant differences in modified Rankin Scale scores between the group that received tenecteplase and the placebo group. While the primary outcome of efficacy was not statistically significant, the trial provided valuable insights into the safety of treating later-window poststroke patients with tenecteplase.
Gregory W. Albers, MD, the professor of neurology and director of the Stanford Stroke Center, emphasized the significance of the trial’s findings. He noted that the ability to identify a subgroup of patients who can be treated safely is a crucial advancement, despite the challenges posed by the short time available for the drug to dissolve the clot.
The findings from the TIMELESS trial have sparked discussions within the medical community about the potential implications for stroke care. While the trial did not achieve statistical significance in its primary outcome, the safety demonstrated in treating later-window poststroke patients with tenecteplase is a notable development. As stroke care continues to evolve, these findings contribute to the ongoing efforts to improve treatment options and outcomes for stroke patients.