A prospective randomized trial comparing endarterectomy to stenting in severe asymptomatic carotid stenosis.

BACKGROUND: For an asymptomatic patient with severe carotid stenosis the most important question is how to prevent an ischemic stroke. Carotid artery stenosis is the estimated cause of stroke in 8-20% of the cases. Today more than 50% of procedures for carotid stenosis are done on asymptomatic patients, but few of the randomized controlled trials comparing carotid endarterectomy and stenting examined specifically these patients.

METHODS: All patients with severe (>70%) asymptomatic carotid artery stenosis seen in the Carmel medical center vascular clinic were prospectively screened and randomized 1:1 for carotid endarterectomy (CEA) or carotid stenting (CAS). Patients eligible for both procedures were enrolled. The primary objectives of the study were: 1) periprocedural complications - stroke (CVA), transient ischemic attack (TIA), myocardial infarction (MI), and death; 2) long-term results: mortality, prevention of ipsilateral stroke or TIA, and freedom from restenosis.

RESULTS: One-hundred and thirty-six patients were treated with mean follow-up of 26 months. There was no difference in short and long term results between the two groups. Thirty day morbidity included: 1 CVA in each group with no MI. Long-term results included 4 deaths in each group; none from CVA. One TIA was noted after CAS, and 3 cases of restenosis were found in CEA and one in CAS.

CONCLUSIONS: CAS is a maturing procedure and has improved significantly over the past several years. Future developments of stents and protection devices will achieve better perioperative results. This along with our excellent long term results will promote the use of stenting for suitable patients.