Abstract
Background and aims
Bridging therapy failed to show additional benefit to direct endovascular treatment (EVT) in proximal middle cerebral artery (MCA) in the late time window when EVT is immediately available. We aimed to explore whether the duration between randomization and artery revascularization after EVT influences the effect of bridging thrombolytic on patient outcomes in the late time window for patients with acute ischemic stroke due to proximal MCA occlusion.
Methods
We performed a secondary analysis using data from the endovascular treatment with or without preceding intravenous Tenecteplase in Patients with Late-window acUte ischemic Stroke due to middle cerebral artery occlusion (TNK-PLUS) trial (NCT06221371), a phase 3, multicenter, prospective, randomized, open-label, blinded-endpoint trial, which enrolled 391 patients from 40 centers in China with MCA M1 or proximal M2 occlusion, presenting within 4.5 to 24 hours after symptom onset. Participants were randomly allocated 1:1 to receive either intravenous tenecteplase prior to EVT (intervention) or direct EVT (control). The primary outcome was modified Rankin Scale score of 0-2 at 90 days. We included 374 patients from the TNK-PLUS population who achieved artery revascularization after EVT, and assessed whether efficacy of tenecteplase bridging EVT versus direct EVT could be modified by time from randomization to revascularization.
Results
We have finished the TNK-PLUS main results analysis, and will have the subgroup results by ESOC.
Conclusions
The TNK-PLUS subgroup analysis of randomization to revascularization time may improve understanding of the role of bridging therapy in the late time window and may facilitate patient selection for transfer trials.