Feasibility trial of carotid stenting with and without an ernbolus protection device

Purpose: To evaluate the feasibility of stenting and cerebral protection in patients with carotid bifurcation disease. Methods: Carotid stenting with self-expanding nitinol stents was evaluated in 261 patients (157 men; mean age 70.9 +/- 9.7 years, range 41-90) treated at 33 clinical sites. Among these patients, 141 (54.3%) were symptomatic, and 71 (27.2%) had postendarterectomy restenotic lesions. An embolus protection device became available in the latter third of the study. The primary endpoint of the study was the 30-day composite occurrence of major adverse clinical events (all deaths, strokes, or myocardial infarctions [MI]). At 1 year, the endpoint included all deaths, strokes, or MIs at 30 days, plus all deaths or ipsilateral strokes between 31 days and 1 year. Results: SMART stents were placed in 147 (56%) patients and Precise stents in 107 (41%); 7 (3%) patients were treated with non-study stents. Lesion success, defined as <30% post-procedural residual stenosis, was achieved in 249 (95%). An AngioGuard filter was used in 85 patients; of 90 filters employed, 78 (87%) were successfully deployed and retrieved. Visible material was noted in 42 (54%) retrieved filters. One (0.4%) stent thrombosis occurred at <30 days, and no restenotic lesions >80% were noted in up to 1 year of followup. At 30 days, stroke occurred in 16 (6.1%) patients, MI in 1 (0.4%), and 2 (0.8%) patients died. The 30-day rate of stroke, MI, or death was 6.9%. Major ipsilateral stroke occurred in 4 (1.5%) patients between 0 and 30 days; no new major ipsilateral strokes were noted up to 1 year. By Kaplan-Meier analysis, the 1-year risk of stroke, MI, or death was 10.9%+/- 2.0%. The 1-year risk of major ipsilateral stroke was significantly lower in patients treated with embolus protection devices (0.0% versus 2.3%, p=0.05). Conclusions: The use of nitinol self-expanding stents in the carotid position appears to be a safe and efficacious alternative for the treatment of carotid bifurcation disease. The addition of embolus protection devices may diminish the risk of postprocedural major ipsilateral strokes.