Direct Thrombectomy vs. Combined Treatment With Intravenous Thrombolysis in the Extended Time Window: A Target Trial...

Area of Science:

• Neurology
• Interventional Neuroradiology
• Stroke Medicine

Background:

• Mechanical thrombectomy (MT) is a key treatment for large vessel occlusion (LVO) stroke.
• Its efficacy in extended time windows (beyond 4.5 hours) compared to intravenous thrombolysis (IVT) plus MT remains uncertain.

Purpose of the Study:

• To assess the non-inferiority of direct MT versus IVT plus MT for LVO stroke patients presenting beyond 4.5 hours or at wake-up.
• To evaluate functional outcomes and recanalization rates in these treatment arms.

Main Methods:

• Emulation of a non-inferiority trial using real-world data for patients with anterior circulation LVO.
• Comparison of direct MT versus IVT plus MT in patients treated between 4.5 and 24 hours.
• Inverse probability weighting (IPW) was used to adjust for covariates, with 90-day modified Rankin Scale (mRS) 0-2 as the primary outcome.

Main Results:

• Direct MT was not non-inferior to IVT plus MT, as the risk difference confidence interval crossed the non-inferiority margin.
• Successful recanalization rates were lower in the direct MT group compared to the IVT plus MT group (adjOR 0.38).
• Rates of 90-day mRS 0-1, symptomatic intracerebral hemorrhage (sICH), and mortality were similar between groups.

Conclusions:

• Direct MT is not non-inferior to IVT plus MT for LVO stroke presenting beyond 4.5 hours or at wake-up.
• Preceding IVT enhances successful recanalization rates when combined with MT in extended time windows.