Carotid artery stenting in a community setting: experience outside of a clinical trial

Carotid artery angioplasty and stenting (CAS) currently represents a less invasive percutaneous alternative to conventional endarterectomy for the treatment of carotid occlusive disease. We report here the results and complication rates of CAS performed by a team of interventionalists at a non-clinical trial center utilizing a standardized CAS protocol. CAS was attempted in 51 arteries in 48 patients (mean age 71 +/- 9 years, range 53-90). Fifteen (29%) of 48 patients were symptomatic. Indications for CAS were previous ipsilateral endarterectomy (15/51, 29%), previous neck radiation therapy (1/51, 2%), or significant coronary artery disease (30/51, 59%). SMART((R)) stents were deployed via percutaneous femoral artery access, with anticoagulation (heparin, abciximab, aspirin, clopidogrel) and temporary transvenous cardiac pacemakers employed in all patients. Neuroprotection was not used. Neurological examination and duplex scans were performed in follow-up. CAS was successfully performed in 96% of cases (49 lesions/46 patients) with angiographic stenoses of 88 +/- 8%. Neurological complications included one (2%) minor stroke that occurred 12 hr after CAS. There were no periprocedural mortalities. Clinically significant bradycardia or asystole occurred in 11/49 (22%) procedures, necessitating short-term ventricular pacing. All stented vessels remained patent during 12.2 +/- 10.1 (range 1-37) months follow-up period. One asymptomatic restenosis (>70%) occurred at 3 months, which was successfully reangioplastied; we thus had 1-year angiographic restenosis rate of 2%. Patients selected for CAS may represent a subset of patients with carotid disease who have considerable comorbidities or unfavorable anatomy compared to those undergoing conventional endarterectomy. CAS may be performed safely outside of a clinical trial with results similar to those of published series from trial centers using a standardized protocol.