A randomized pilot study of patients with tandem carotid lesions undergoing thrombectomy

Abstract

Background and purposeThe optimal management of patients with tandem lesions (TL), or cervical internal carotid artery (c-ICA) steno-occlusive pathology and ipsilateral intracranial occlusion, who are undergoing endovascular thrombectomy (EVT) remains unknown. We sought to establish the feasibility of a trial designed to address this question. Materials and methodsThe Endovascular Acute Stroke Intervention (EASI) study was a single-centre randomized trial comparing EVT to medical therapy for large-vessel occlusion stroke. Patients with TL receiving EVT were randomly allocated to acute c-ICA stenting or no stenting. The primary outcome was the proportion of patients with a modified Rankin Scale (mRS) score of 0–2 at 90 days. Safety outcomes were symptomatic intracranial hemorrhage (sICH) at 24hours and mortality at 90 days. ResultsOf 301 patients included in EASI between 2013 and 2018, 24 (8.0%) with TL were randomly allocated to acute stenting (n=13) or no stenting (n=11). Baseline characteristics were balanced. Eight (61.5%; 95% CI 35.5%–82.3%) and 7 (63.6%; 95% CI 35.4%–84.9%) patients, respectively, had a favorable outcome (mRS 0–2; P=1.0). One non-stented patient had a symptomatic intracerebral hemorrhage. ConclusionsThis pilot trial of patients with TL undergoing EVT suggests that a sufficiently powered larger TL trial comparing acute c-ICA stenting to no stenting is feasible. Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT02157532.