A new randomized trial from China suggests that administering intravenous tenecteplase before endovascular thrombectomy significantly improves functional outcomes for patients with acute ischemic stroke caused by large-vessel occlusion. The study, published in the New England Journal of Medicine and presented at the European Stroke Organisation Conference in Helsinki, found that 52.9% of patients receiving combination therapy achieved functional independence at 90 days compared to 44.1% receiving thrombectomy alone.
Study Design and Patient Population
The open-label trial, led by Dr. Zhongming Qiu from the Second Affiliated Hospital of Army Medical University in Chongqing, enrolled 550 patients across China who presented within 4.5 hours of acute ischemic stroke onset due to large-vessel occlusion. Participants were randomly assigned to receive either intravenous tenecteplase followed by endovascular thrombectomy (278 patients) or endovascular thrombectomy alone (272 patients).
The primary endpoint was functional independence, defined as a score of 0 to 2 on the modified Rankin scale at 90 days, with higher scores indicating more severe disability. All patients were eligible for thrombolysis according to standard criteria.
Key Clinical Outcomes
The combination therapy group demonstrated superior outcomes with an unadjusted risk ratio of 1.20 for functional independence. Notably, 6.1% of patients in the tenecteplase-thrombectomy group achieved successful reperfusion before the thrombectomy procedure, compared to only 1.1% in the thrombectomy-alone group. Post-thrombectomy successful reperfusion rates were comparable between groups at 91.4% and 94.1%, respectively.
Safety Profile and Limitations
The safety analysis revealed slightly higher rates of symptomatic intracranial hemorrhage within 48 hours in the combination group (8.5%) compared to thrombectomy alone (6.7%). Mortality rates at 90 days were similar between groups at 22.3% and 19.9%, respectively.
The researchers acknowledged important limitations in their findings. "The lack of a consistent significant benefit across secondary outcomes makes this finding tenuous," the authors noted, suggesting that while the primary endpoint showed promise, the overall clinical benefit may be less robust than initially apparent.
Clinical Context and Implications
Current stroke treatment guidelines emphasize rapid reperfusion for large-vessel occlusion strokes, with endovascular thrombectomy established as the gold standard for eligible patients. The addition of intravenous thrombolysis before mechanical intervention has been debated, with previous studies showing mixed results.
This Chinese trial adds to the growing body of evidence supporting bridging therapy, though the authors' cautious interpretation highlights the need for additional validation. The study's focus on patients presenting within the 4.5-hour window aligns with established thrombolysis guidelines, making the results clinically relevant for emergency stroke care.
Funding and Future Directions
The research received partial funding from China Shijiazhuang Pharmaceutical Company Recomgen Pharmaceutical, which manufactures tenecteplase products. The study's findings may influence treatment protocols for acute ischemic stroke, though the researchers' measured conclusions suggest that further investigation is warranted to establish the optimal approach for bridging therapy in this patient population.
