Tenecteplase Increases Early Reperfusion vs Low-Dose Alteplase Before Thrombectomy in Acute Ischemic Stroke
KEY TAKEAWAYS
- In the randomized T-FLAVOR trial, early substantial reperfusion occurred in 10.3% of patients treated with tenecteplase vs 3.6% with low-dose alteplase before thrombectomy.
- Ninety-day functional outcomes did not differ significantly between groups, although results numerically favored tenecteplase.
- Symptomatic intracranial hemorrhage occurred in 2.8% vs 1.8%, respectively, with no significant difference in 90-day mortality.
Tenecteplase led to higher rates of early substantial reperfusion than low-dose alteplase in patients with acute ischemic stroke caused by large-vessel occlusion (LVO) who were scheduled for mechanical thrombectomy. Results from the randomized T-FLAVOR trial showed that tenecteplase met the study’s prespecified threshold for superiority on the primary outcome.
The phase 2, multicenter trial enrolled patients at 18 hospitals in Japan who were eligible for intravenous thrombolysis within 4.5 hours of stroke onset and had an internal carotid, M1, M2, or basilar artery occlusion. Investigators randomly assigned 221 patients to tenecteplase 0.25 mg/kg or alteplase 0.6 mg/kg before thrombectomy; 218 received treatment and were included in the analysis. The primary outcome was substantial reperfusion on the first angiogram, defined as modified Treatment in Cerebral Ischemia grade 2b to 3 or no retrievable thrombus.
What the Trial Revealed
- Early substantial reperfusion occurred in 10.3% with tenecteplase vs 3.6% with alteplase (difference, 6.5 percentage points; 90% CI, 0.89-12.1; P=.06).
- At 90 days, the odds of a shift toward better modified Rankin Scale outcomes did not differ significantly between groups (common OR, 1.47; 95% CI, 0.92-2.35; P=.11).
- Symptomatic intracranial hemorrhage occurred in 2.8% vs 1.8% (P=.62), while 90-day mortality was 6.5% vs 9.9% (P=.36), respectively.
The modest sample size limited the trial’s ability to detect differences in secondary clinical outcomes. Although tenecteplase increased early reperfusion compared with low-dose alteplase, the trial did not demonstrate a significant difference in 90-day functional outcomes.
Source:
Inoue M, Hirano T, Fukuda-Doi M, et al; T-FLAVOR trial Investigators. Standard-dose tenecteplase vs low-dose alteplase for acute ischemic stroke from large-vessel occlusion: a randomized clinical trial. JAMA Neurol. 2026;83(8):769-777. doi:10.1001/jamaneurol.2026.1590