Carotid Endarterectomy and Stenting in a Chinese Population: Safety Outcome of the Revascularization of Extracranial Carotid Artery Stenosis Trial.

Carotid endarterectomy (CEA) and carotid artery stenting (CAS) have been well-established as two effective treatment modalities for carotid artery stenosis, while their clinical outcomes in real-world China are still unknown due to lack of nationwide trials. We aimed to evaluate the safety outcome profile of CEA and CAS in Chinese patients with carotid artery stenosis. The Revascularization of Extracranial Carotid Artery Stenosis trial was a multicentre, prospective cohort study of CEA or CAS in treating patients with carotid artery stenosis. We included symptomatic or asymptomatic patients with carotid artery stenosis (≥ 50%). The primary endpoint was any stroke, myocardial infarction and/or death within 1 month post-procedure. Overall, 2719 cases (1543 CAS-treated patients and 1176 CEA-treated patients) were enrolled from 36 centres. The primary outcome was 4.3% (95% CI 3.2-5.6%) and 4.7% (95%CI 3.5-6.3%) in the symptomatic and asymptomatic patients, respectively. No significant difference in the primary outcome was found between CAS and CEA in both symptomatic (p = 0.338) and asymptomatic (p = 0.890) patients. High- versus low-volume centre significantly related to lower rate of primary outcome in CEA-treated patients (OR 2.54; 95%CI 1.19-5.44; p = 0.017) and asymptomatic patients (OR 2.54; 95%CI 1.42-4.54; p = 0.002). CEA and CAS decided by surgeons' discretion have comparable risks among patients with carotid artery stenosis in China. Both CEA and CAS should be avoided in asymptomatic patients until a consistently low complication rate is showed with centre-level audits. Medical treatment for patients with carotid stenosis in China needs to be improved. Trial registration: NCT01994187 ( ClinicalTrials.gov ).