Endovascular Acute Stroke Intervention-Tandem Occlusion (EASI-TOC) study: protocol and rationale

Area of Science:

• Neurology
• Interventional Cardiology
• Vascular Surgery

Background:

• Tandem lesions, characterized by intracranial occlusion and high-grade cervical internal carotid artery (ICA) stenosis or occlusion, affect 15%-20% of patients undergoing endovascular therapy (EVT) for stroke.
• Optimal management strategies for cervical ICA in tandem lesions remain unclear.
• This study hypothesizes that acute carotid artery stenting, in conjunction with EVT, may enhance functional outcomes compared to EVT alone.

Purpose of the Study:

• To evaluate the efficacy and safety of acute carotid artery stenting in addition to EVT for patients with tandem carotid lesions.
• To address a critical knowledge gap in the acute management of complex stroke cases involving both intracranial and cervical arterial occlusions.
• To determine if combined stenting and EVT improves functional recovery at 90 days post-stroke.

Main Methods:

• The Endovascular Acute Stroke Intervention-Tandem Occlusion (EASI-TOC) trial is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled study.
• Eligible participants are adult patients experiencing disabling acute anterior circulation stroke with salvageable brain tissue, confirmed atherosclerotic carotid tandem lesions, and undergoing EVT within 24 hours of symptom onset.
• Patients are randomized 1:1 to receive either acute carotid stenting plus EVT or EVT alone.

Main Results:

• Primary outcome: proportion of patients achieving favorable functional outcome (modified Rankin Scale 0-2) at 90 days.
• Secondary outcomes: 12-month mRS, recanalization rates, 90-day rates of recurrent ipsilateral stroke or retinal ischemia, ICA thrombosis, cognitive function (90-day MoCA score), and quality of life.
• Safety outcomes: incidence of intracranial hemorrhage (ICH), severe ICH (sICH), all-cause mortality, and procedural complications.

Conclusions:

• The EASI-TOC trial is designed as a pragmatic study to fill a significant gap in acute stroke care for patients with tandem carotid lesions.
• It will provide crucial evidence on whether incorporating acute carotid stenting into EVT offers functional benefits.
• The findings will guide clinical decision-making for managing these challenging stroke presentations.