Alexandre Y Poppe1, Grégory Jacquin2, Christian Stapf2, Nicole Daneault2, Yan Deschaintre2, Laura C Gioia2, Céline Odier2, Marilyn Labrie3, Ahmad Nehme3, Lorena Nico4, Daniel Roy5, Alain Weill5, Jean Raymond5. 1. Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Department of Neurosciences, Faculté de Médecine, Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada. Electronic address: alexandre.poppe.chum@ssss.gouv.qc.ca. 2. Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Department of Neurosciences, Faculté de Médecine, Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada. 3. Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada. 4. Department of Radiology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada. 5. Department of Radiology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.
Abstract
BACKGROUND AND PURPOSE: The 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 METHODS: The 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. RESULTS: Of 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. CONCLUSIONS: This 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 REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02157532.
RCT Entities:
BACKGROUND AND PURPOSE: The 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 METHODS: The 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. RESULTS: Of 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. CONCLUSIONS: This 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 REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02157532.