SPREAD-STACI study: A protocol for a randomized multicenter clinical trial comparing urgent with delayed endarterectomy in symptomatic carotid artery stenosis

Rationale In patients with >50% carotid artery stenosis (as measured by North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria) suffering a transient ischemic attack or a minor ipsilateral stroke, carotid endarterectomy exerts maximum benefits, when performed within the first 15 days from the initial ischemic symptom. It is also known that the probability of a major stroke spikes within the first few days after a transient ischemic attack/minor stroke and then flattens out in the following days and weeks. It could be hypothesized that urgent carotid endarterectomy has greater benefit than delayed procedure. Aims Demonstrate that urgent carotid endarterectomy is more effective than delayed interventions. Design Centers employing neurolgist/stroke physicians and vascular surgeons will enroll TIA or minor stroke patients with >50 % carotid artery stenosis (Nascet criteria), randomized in two groups: 1) urgent carotid endarterectomy (within 48 hours) and 2) delayed carotid endarterectomy (operated between 48 hours and 15 days after onset of symptoms) Risk factors will be evaluated at enrollment. TIA will be classified by ABCD2 scoring system, and minor stroke by National Institutes of Health Stroke Scale (NIHSS) scores. The study will last 90 days per patient, starting from their initial symptom, and the follow-up will be performed by an indipendent neurologist. A total of 456 patients (228 / group) is needed to observe an absolute difference of 10% between groups. Outcomes Primary end-point is reduction in all types of stroke, AMI or death in urgent endarterectomy groupo compared to delayed ones. Secondary end-points are: - Reduction of ipsilateral ischemic stroke in group 1 with respect to Group 2 - Identification of predictive risk factors and - Confirmation of no different rate for hemorragic/ischemiccomplications between groups.