Safety of unprotected carotid artery stent placement in symptomatic and asymptomatic patients : a retrospective analysis of 30-day combined adverse outcomes

PURPOSE: To retrospectively evaluate the outcome of carotid artery stent placement (CAS) without the use of embolic protection devices (EPDs) in a large cohort of patients. MATERIALS AND METHODS: Institutional review board approval and informed consent from all patients were obtained. Preprocedure color Doppler ultrasonography (US), magnetic resonance (MR) imaging, or computed tomography (CT) were used to evaluate stenosis severity (70% or greater). Clinical findings and combined 30-day complication rates in 400 patients (289 men, 111 women; mean age, 73 years +/- 8 [standard deviation]) who underwent unprotected CAS for asymptomatic (n = 156; 39%) or symptomatic (n = 244, 61%) stenoses were analyzed. Follow-up at 30 days included neurologic evaluation and color Doppler US. RESULTS: Self-expanding stents were successfully deployed in 397 of 400 (99.25%) patients. Among the 397 patients, nine (2.27%) major complications (all in patients with prior symptoms) had occurred at 30 days, including three (0.76%) major (all in patients who had stopped antiplatelet prophylaxis) and six (1.5%) minor strokes--three intraprocedural and three delayed. Minor complications included 16 (4%) transient ischemic attacks, four in asymptomatic and 12 in symptomatic patients. The 30-day combined adverse outcomes (transient ischemic attack, ipsilateral stroke, death) were significantly correlated with prior presence of symptoms (symptomatic, 8.6%; asymptomatic, 2.6%; P < .03). CONCLUSION: Stent placement without EPD was performed with a high technical success rate. For asymptomatic patients, the combined 30-day adverse-outcomes rate was within the limits recommended by the American Heart Association for carotid endarterectomy and compared favorably with results reported for CAS with EPD. When a transient ischemic attack is excluded, the 30-day combined death and stroke rate among patients with prior symptoms also compared favorably with published results.