Carotid angioplasty with stenting versus endarterectomy: 10-year randomized trial in a community hospital.

ABSTRACT

OBJECTIVES: This single-center, randomized, clinical trial was designed to determine the 10-year comparative efficacy and durability of carotid angioplasty and stenting (CAS) versus carotid endarterectomy (CEA) in preventing ipsilateral ischemic stroke in symptomatic and asymptomatic patients with high-grade carotid artery stenosis. BACKGROUND: Modern clinical trials with short-term follow-up indicate CAS and CEA are equivalent in reducing the risk for ipsilateral ischemic stroke secondary to carotid stenosis. A paucity of data exists regarding long-term outcomes. METHODS: Patients of all surgical risks with symptomatic and asymptomatic carotid stenosis (>70%) were randomly selected for CEA or CAS and followed a minimum of 10 years. RESULTS: Long-term follow-up was achieved in 173 patients (91%). Eighty-seven (50.2%) died within this period, most commonly of nonvascular causes. No difference in the risk of stroke ipsilateral to the treated artery was noted among treatment groups (p > 0.05). Restenosis determined by sequential ultrasound was assessed only in the CAS group (3.3%) and remained asymptomatic. The combined risk of fatal or nonfatal heart attack over the 10-year period was highest in individuals with symptomatic versus asymptomatic stenosis (27.5% vs. 11.0%; hazard ratio [HR] 2.32, 95% confidence interval [CI] 1.298 to 4.146, p = 0.005) and was higher in all patients treated with CEA (HR 2.27, 95% CI 1.35 to 3.816, p = 0.002). CONCLUSIONS: Long-term protection against ipsilateral stroke provided by CAS and CEA did not differ in this trial. The 10-year risk of fatal/nonfatal myocardial infarction was highest in all patients harboring symptomatic carotid stenosis at enrollment. The risk of fatal/nonfatal heart attack was significantly more prevalent in those symptomatic or asymptomatic patients randomized to CEA.