There was no difference in outcome between tenecteplase and standard care for patients with mild stroke based on their baseline vessel occlusion status.
Key Findings
Results
Tenecteplase showed no benefit over standard care in patients with no visible occlusion (focal perfusion abnormality only).
Adjusted RR 1.03 (95% CI, 0.90–1.18) for the primary outcome of return to pre-stroke neurological functioning or better at 90 days
130 patients in the control arm and 123 in the tenecteplase arm had no visible occlusion
Primary outcome assessed using 90-day modified Rankin Scale (mRS)
Results
Tenecteplase showed no benefit over standard care in patients with near occlusion (revised arterial occlusive lesion score 1).
Adjusted RR 0.85 (95% CI, 0.71–1.01) for the primary outcome
102 patients in the control arm and 92 in the tenecteplase arm had near occlusion
The confidence interval slightly crosses 1.0, indicating no statistically significant benefit
Results
Tenecteplase showed no benefit over standard care in patients with complete occlusion (revised arterial occlusive lesion score 0).
Adjusted RR 1.00 (95% CI, 0.89–1.12) for the primary outcome
218 patients in the control arm and 216 in the tenecteplase arm had complete occlusion
This was the largest subgroup among the three occlusion categories
Methods
The study population of 881 patients was divided into three subgroups based on baseline vessel occlusion status.
Complete occlusion: 218 control and 216 tenecteplase patients
Near occlusion: 102 control and 92 tenecteplase patients
No visible occlusion (focal perfusion abnormality present): 130 control and 123 tenecteplase patients
This was a secondary analysis of the randomised, controlled, blinded TEMPO-2 trial (NCT02398656)
Results
There were baseline imbalances between treatment arms within some occlusion subgroups.
Longer treatment delays were observed in the control arm among patients with near occlusion
In the complete occlusion subgroup, the tenecteplase arm had older age, more hypertension, and higher creatinine levels
Analyses were adjusted for age, sex, onset-to-randomisation time, and baseline stroke severity using a generalised linear model
Background
The overall TEMPO-2 trial enrolled patients with minor ischaemic stroke (NIHSS ≤ 5) and intracranial occlusion or focal perfusion abnormality within 12 hours of onset.
The trial compared intravenous tenecteplase to non-thrombolytic standard care
The primary outcome was return to pre-stroke neurological functioning or better, assessed with 90-day mRS
The parent trial found no overall benefit of tenecteplase compared to standard care
What This Means
This research examined whether a clot-dissolving drug called tenecteplase might benefit certain subgroups of patients who had mild strokes, specifically based on how severely the blood vessels in their brain were blocked. The TEMPO-2 trial had already shown that tenecteplase did not help mild stroke patients overall compared to standard care, but researchers wondered if patients with different degrees of vessel blockage — complete occlusion, near-occlusion, or no visible blockage but abnormal blood flow — might respond differently to the treatment.
Among 881 patients divided into these three groups, the study found no meaningful difference in outcomes between tenecteplase and standard care in any of the subgroups. Whether patients had a completely blocked vessel, a nearly blocked vessel, or just abnormal blood flow without a visible clot, tenecteplase did not improve the likelihood of returning to their pre-stroke level of functioning at 90 days.
This research suggests that the degree of vessel blockage at the time of treatment does not identify a subgroup of mild stroke patients who would benefit from tenecteplase. This adds to existing evidence that thrombolytic therapy with tenecteplase may not be the right approach for patients with mild strokes, regardless of their imaging findings, and highlights the ongoing challenge of finding effective treatments for this common and clinically important patient population.
Räty S, Strbian D, Singh N, Vatanpour S, Tomppo L, Ganesh A, et al.. (2026). Tenecteplase versus standard care for minor ischaemic stroke according to the baseline occlusion status in TEMPO-2 trial.. European stroke journal. https://doi.org/10.1093/esj/aakag111