Results using a self-expanding stent alone in the treatment of severe symptomatic carotid bifurcation stenosis.

Object: Conventional endovascular therapy for carotid stenosis involves placement of an embolic protection device followed by stent insertion and angioplasty. A simpler approach may be placement of a stent alone. The authors determined how often this approach could be used to treat patients with carotid stenosis, and assessed which factors would preclude this approach.

Methods: Over a period of 6 years, 97 patients with symptomatic carotid stenosis were treated with the intention of using a "stent-only" approach. Arteries in 77 patients (79%) were treated with stents alone, 13 required preinsertion balloon dilation, 6 postinsertion dilation, and 1 both pre- and postinsertion dilation.

Results: The mean stenosis according to North American Symptomatic Carotid Endarterectomy Trial criteria was reduced from 82 to 40% in the stent-only group and from 89 to 37% in the stent and balloon angioplasty group. The 30-day stroke and death rate was 7.2%. Patients were followed for a mean of 15 months. In the stent-alone group, the mean preoperative Doppler peak systolic velocity (PSV) was 409 cm/second, with an internal carotid artery/common carotid artery (ICA/CCA) ratio of 7.2. At follow-up review, the PSV decreased to 153 cm/second and the ICA/CCA ratio to 2.1. In the angioplasty group the mean preoperative PSV was 496 cm/second and the ICA/CCA ratio was 9.2, decreasing to 163 cm/second and 2, respectfully, at follow-up evaluation. Restenosis occurred in 12.8% of patients at 6 months and in 15.9% at 1 year. One stroke occurred during the follow-up period in each group. Using multivariable analysis, factors precluding the "stent-only" approach were as follows: severity of stenosis, circumferential calcification, and no history of hyperlipidemia.

Conclusions: Balloons may not be required to treat all patients with carotid stenosis. A stent alone was feasible in 79% of patients, and 79% of patients were alive and free from ipsilateral stroke or restenosis at 1 year. Restenosis rates with this approach are higher than with conventional angioplasty and stent insertion. Carotid arteries with very severe stenoses (> 90%) and circumferential calcification may be more successfully treated with angioplasty combined with stent placement.