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Can carotid artery stenting achieve comparable outcomes to endarterectomy in symptomatic extracranial carotid stenosis?: towards an individualized revascularization strategy: a multicenter randomized clinical trial

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Background: Carotid revascularization is a key component in the secondary prevention of stroke in patients with symptomatic extracranial carotid stenosis. Carotid endarterectomy (CEA) has traditionally been considered the gold-standard treatment, based on evidence from randomized controlled clinical trials demonstrating a lower periprocedural neurological risk compared to Carotid artery stenting (CAS). However, advances in stent technology, cerebral protection devices (EPDs), operator experience, and peri-procedural management may have substantially improved the safety profi le of CAS, warranting a re-evaluation of its role in contemporary clinical practice. Objective : The aim of this study is to assess whether CAS is non-inferior to CEA in terms of early safety outcomes, specifi cally the risk of stroke or death within 30 days after the procedure, in patients with symptomatic extracranial carotid stenosis. Methods : This is a multicenter, randomized, controlled, non inferiority clinical trial conducted across eight hospitals in Spain. Patients admitted with ischemic stroke or transient ischemic attack (TIA) including amaurosis fugax attributable to a symptomatic extracranial carotid stenosis greater than 50% will be randomly assigned to undergo either CEA or CAS. All procedures will be performed by experienced multidisciplinary teams using contemporary techniques and standardized cerebral protection strategies. The primary endpoint is the composite outcome of stroke or death within 30 days following carotid revascularization. Expected impact : By generating high-quality evidence using modern revascularization techniques, this study aims to support a more balanced evidence-based selection of carotid revascularization strategies. Demonstrating non-inferiority of CAS compared with CEA could promote a safer, more equitable, and broader application of both techniques in patients with symptomatic extracranial carotid stenosis, optimizing individualized patient care

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