Purpose: To evaluate the safety and efficacy of carotid artery stenting (CAS) performed without an embolic protection device (EPD) in a selected group of asymptomatic patients with primary internal carotid artery (ICA) stenosis or restenosis after carotid endarterectomy (CEA).
Materials and methods: Between May 2015 and May 2018, 77 patients (mean age 77 years; 60 men) underwent CAS without any embolic protection device. Forty-seven (61%) patients had primary ICA stenosis and were excluded from CEA because of high surgical risk; the other 30 (39%) patients had post-CEA restenosis (n=26) or a distal ICA flap after eversion CEA (n=4). The mean ICA stenosis was 82%. All procedures were performed from a femoral artery access. Pre- and/or postdilation were used in 64 patients. The primary outcome was the incidence of major complications (death, stroke, or myocardial infarction) during the procedure and within 30 days; the secondary outcome was the incidence of restenosis in follow-up.
Results: No relevant bradycardia was encountered during CAS. The combined rate of stroke, death, or myocardial infarction at 30 days was 1.3%. The single stroke patient recovered fully after 2 months. Over a follow-up that ranged to 3 years (mean 24±18 months), no further neurological events were recorded. One (1.3%) patient had a >70% restenosis after 6 months; the lesion was dilated, successfully restoring the lumen contour.
Conclusion: In our series, endovascular treatment of carotid stenosis without the use of protection devices in patients with primary stenosis or postsurgical restenosis can achieve satisfactory safety and efficacy outcomes. The choice of performing CAS without using EPDs should follow a tailored approach based on the appropriate patient anatomy and specific clinical parameters to minimize neurological complications.
Keywords: carotid artery stenting; cerebral protection; complications; embolic protection device; mortality; stent; stroke; transient ischemic attack.