Feasibility trial of carotid stenting with and without an embolus protection device.
OBJECTIVE
To evaluate the feasibility of stenting and cerebral protection in patients with carotid bifurcation disease.


METHODS
Carotid stenting with self-expanding nitinol stents was evaluated in 261 patients (157 men; mean age 70.9+/-9.7 years, range 41-90) treated at 33 clinical sites. Among these patients, 141 (54.3%) were symptomatic, and 71 (27.2%) had postendarterectomy restenotic lesions. An embolus protection device became available in the latter third of the study. The primary endpoint of the study was the 30-day composite occurrence of major adverse clinical events (all deaths, strokes, or myocardial infarctions [MI]). At 1 year, the endpoint included all deaths, strokes, or MIs at 30 days, plus all deaths or ipsilateral strokes between 31 days and 1 year.


RESULTS
SMART stents were placed in 147 (56%) patients and Precise stents in 107 (41%); 7 (3%) patients were treated with non-study stents. Lesion success, defined as <30% postprocedural residual stenosis, was achieved in 249 (95%). An AngioGuard filter was used in 85 patients; of 90 filters employed, 78 (87%) were successfully deployed and retrieved. Visible material was noted in 42 (54%) retrieved filters. One (0.4%) stent thrombosis occurred at <30 days, and no restenotic lesions >80% were noted in up to 1 year of follow-up. At 30 days, stroke occurred in 16 (6.1%) patients, MI in 1 (0.4%), and 2 (0.8%) patients died. The 30-day rate of stroke, MI, or death was 6.9%. Major ipsilateral stroke occurred in 4 (1.5%) patients between 0 and 30 days; no new major ipsilateral strokes were noted up to 1 year. By Kaplan-Meier analysis, the 1-year risk of stroke, MI, or death was 10.9%+/-2.0%. The 1-year risk of major ipsilateral stroke was significantly lower in patients treated with embolus protection devices (0.0% versus 2.3%, p=0.05).


CONCLUSIONS
The use of nitinol self-expanding stents in the carotid position appears to be a safe and efficacious alternative for the treatment of carotid bifurcation disease. The addition of embolus protection devices may diminish the risk of postprocedural major ipsilateral strokes.
Ouriel
Kenneth
K
Department of Surgery, The Cleveland Foundation, OH 44195, USA. ourielk@ccf.org
Wholey
Mark H
MH
Fayad
Pierre
P
Katzen
Barry T
BT
Whitlow
Patrick
P
Frentzko
Michael
M
Kuntz
Richard E
RE
Wechsler
Lawrence
L
Hopkins
Nelson
N
Satler
Lowell
L
Mishkel
Greg
G
Yadav
Jay S
JS
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000627:therapeutic use; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation; D017536:Carotid Artery, Common / Q000000981:diagnostic imaging / Q000473:pathology*; D016893:Carotid Stenosis / Q000628:therapy*; D000077144:Clopidogrel; D005240:Feasibility Studies; D005260:Female; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011859:Radiography; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D015996:Survival Rate; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome
D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin