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

Abstract Background Patients with stroke due to symptomatic intracranial occlusion and concurrent symptomatic high-grade cervical internal carotid artery (ICA) stenosis (≥70%) or occlusion constitute 15%–20% of patients undergoing EVT. The optimal management of the cervical ICA in these tandem lesions remains unknown. We hypothesise that acute carotid artery stenting in addition to EVT will improve functional outcomes when compared with EVT alone. Study design Endovascular Acute Stroke Intervention–Tandem Occlusion (EASI-TOC) is a multicentre, prospective, randomised, open-label, blinded end-point (PROBE) controlled trial. Adult patients with a disabling acute anterior circulation stroke (intracranial carotid, M1 or M2 segment occlusion) and salvageable brain tissue who undergo EVT within 24 h of onset, are eligible for enrolment if they have an angiographically confirmed atherosclerotic carotid tandem lesion. Patients are randomised 1:1 to acute carotid stenting or no stenting during EVT. Study endpoints The primary outcome is the proportion of patients achieving a favourable functional outcome (mRS 0–2) at 90 days. Secondary outcomes include 12-month mRS, recanalisation, the 90-day rate of recurrent ipsilateral stroke or retinal ischaemia, the proportion of patients with ICA thrombosis, 90-day Montreal Cognitive Assessment score and quality of life. Safety outcomes include any ICH, sICH, all-cause mortality and procedural complications. Summary Endovascular Acute Stroke Intervention—Tandem Occlusion is a pragmatic trial addressing a critical gap in the acute management of patients with tandem carotid lesions by evaluating whether acute carotid stenting provides a functional benefit over no stenting in patients undergoing EVT. Trial registration ClinicalTrials.gov NCT04261478.