Safety and efficacy of elective carotid artery stenting in high-risk patients

Objectives. We sought to evaluate the safety and efficacy of carotid artery stenting (CAS) in high risk patients. Background. Carotid endarterectomy (CE) has been shown to be more effective than medical therapy, but it has limitations. Carotid artery stenting may be a reasonable alternative, particularly in high-risk patients. Methods. We prospectively evaluated the safety and efficacy of CAS in 170 consecutive patients who underwent the procedure in 192 carotid arteries. Of the patients enrolled, 129 (76%) would have been excluded from the major trials of CE and 54 (32%) were referred by vascular surgeons. This series represents a very high-risk group that included patients with unstable angina, previous ipsilateral CE, contralateral carotid artery occlusion and other severe comorbid illnesses. Only 25 (24%) of 104 symptomatic patients would have met the North American Symptomatic Carotid Endarterectomy Trial (NASCET) entry criteria. The patients' mean age was 73 ± 8 years (95 confidence interval [CI] 57 to 89), and 42 patients (25%) were ≥80 years old. Patients had an independent neurologic examination before and after the procedure. Results. The procedural success rate was 99%, including 73 patients who had a coronary intervention. Mean carotid artery stenosis was 78 ± 10% before (95 CI 58 to 98) and 2 ± 3% after the procedure (95 CI -4 to 8). During the initial hospital period and 30 days after CAS, there was one major and two category 2 minor strokes, as well as two category 1 minor strokes (total 30-day stroke rate was 2.9% for treated patients or 2.6% for treated arteries). There were no myocardial infarctions or deaths during or within 30 days of CAS. None of the NASCET-eligible patients had a stroke. At a mean follow-up of 19 ± 11 months, three patients (2%) had asymptomatic restenosis. No other major strokes or neurologic deaths occurred. Conclusions. Carotid artery stenting is feasible, can be performed even in high-risk patients and is associated with a low restenosis rate. (C) 2000 by the American College of Cardiology.