Safety of latest-generation self-expanding stents in patients with NASCET-ineligible severe symptomatic extracranial internal carotid artery stenosis.

Abstract

Patients with symptomatic extracranial internal carotid artery stenosis (> or =70%) benefit from carotid endarterectomy when compared with medical management. However, independent risk factors can significantly increase the combined stroke and death risk after carotid endarterectomy. Carotid angioplasty and stenting (CAS) is a therapeutic option in patients who are otherwise at high risk or ineligible for carotid endarterectomy. Previous-generation self-expanding stents were hampered by length foreshortening, which limited their application in multifactorial occlusive extracranial internal carotid artery stenosis. This is a single-center, prospective, open-label, safety study of CAS with the latest-generation self-expanding stents in patients with extracranial internal carotid artery symptomatic stenosis (> or =70%). All patients included were adjudicated to be ineligible for carotid endarterectomy by a vascular surgeon and/or a neurologist according to the exclusion criteria. Primary adverse events included death and all strokes (ipsilateral and contralateral). Secondary adverse events included transient ischemic attack, myocardial infarction, stent thrombosis, need for reintervention, and presence of hematomas. All adverse events were recorded at 24 hours, 30 days, and 6 months after CAS. Between June 1, 2001, and January 30, 2003, 23 consecutive patients (14 women and 9 men; mean age, 65 years; age range, 48-85 years) underwent 24 extracranial CAS procedures with the latest-generation self-expanding stents. All patients had one or multiple criteria for ineligibility according to the North American Symptomatic Carotid Endarterectomy Trial. Extracranial CAS was successful in all patients, with average residual stenosis of less than 20%. One patient (4%) experienced a stroke by the 30-day periprocedure examination. The total number of primary adverse events at 6 months after CAS was 2 strokes (9%), 1 of which was contralateral to the stent placement; there were no deaths. Twenty-two patients were asymptomatic at 6 months, with a modified Rankin scale score of 1 or less. Of the 2 patients who had a stroke, 1 had a follow-up modified Rankin scale score of 3. Extracranial CAS with the latest-generation self-expanding stents is a valid alternative treatment in high-risk or North American Symptomatic Carotid Endarterectomy Trial-ineligible patients.