Multicenter evaluation of a self-expanding carotid stent system with distal protection in the treatment of carotid stenosis.
OBJECTIVE
Carotid artery stent placement may be limited by the embolization of atheromatous material. We evaluated the safety and feasibility of the Medtronic Self-Expanding Carotid Stent (Exponent) in combination with the Medtronic Interceptor Carotid Filter System for the treatment of carotid stenosis among patients at high risk for carotid endarterectomy.


METHODS
Patients at high risk for carotid endarterectomy but amenable to percutaneous treatment with stent placement were enrolled. Clinical follow-up was performed at 30 days and 6 and 12 months postprocedure. The National Institutes of Health Stroke Scale was assessed before and within 3 days postprocedure and at 30 days and 6 months postprocedure. Angiography was performed pre- and postprocedure, and carotid duplex scans were performed at baseline and at 30 days and 6 months.


RESULTS
Fifty-two carotid procedures were performed in 51 patients (mean age, 69 years; 84% of patients were men). The major adverse event (MAE) rate (death, stroke, and myocardial infarction [MI]) at 30 days was 5.9%: 2 strokes and a single death from periprocedural MI. MAE rates after 6 and 12 months were 5.9% and 11.8%, respectively. The delivery success rate was 94.2% (49/52) for the Interceptor Filter System and 95.9% (47/49) for the Exponent Stent. The mean diameter stenosis of the target lesion was reduced from 62.4% preprocedure to 21.2% postprocedure.


CONCLUSIONS
High delivery success rates were achieved with a low rate of MAE (death, stroke, or MI) in a high-risk population. Treatment of carotid artery disease with the Exponent Carotid Stent combined with distal protection from the Interceptor Filter System is effective and safe.
Hill
M D
MD
Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.
Morrish
W
W
Soulez
G
G
Nevelsteen
A
A
Maleux
G
G
Rogers
C
C
Hauptmann
K E
KE
Bonafé
A
A
Beyar
R
R
Gruberg
L
L
Schofer
J
J
D000368:Aged; D016893:Carotid Stenosis / Q000601:surgery*; D004617:Embolism / Q000517:prevention & control; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005374:Filtration / Q000295:instrumentation; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D015607:Stents / Q000009:adverse effects