Purpose: To report the results of a multicenter safety trial of percutaneou
s carotid stenting performed by vascular surgeons.
Methods: Symptomatic or asymptomatic patients greater than or equal to 65 y
ears of age with internal carotid artery (ICA) stenoses greater than or equ
al to 70% and less than or equal to 2-cm long were eligible for enrollment.
The procedures were performed in an operating room with the choice of anes
thesia and the percutaneous access site at the discretion of the surgeon. O
nly Palmaz stents were used.
Results: From January 1, 1996 to December 31, 1997, 99 patients (74 men, me
an age 70 years, range 51 to 94) were enrolled in the study. More than half
(57 of 99 patients) were asymptomatic. The direct cervical approach was us
ed predominantly (97%). Three (3%) cases were converted to surgery for inab
ility to access the artery or deploy the stent (technical success 97%). No
perioperative death or myocardial infarction was reported. Six (6%) procedu
ral complications included 1 reversible arterial spasm, 2 dissections, 1 ce
rvical hematoma, and 2 residual stenoses. One neurological event reversed w
ithin 7 days (1% minor stroke rate) and 4 (4%) transient ischemic attacks r
esolved within 24 hours. One (1%) asymptomatic early occlusion occurred 2 d
ays postoperatively.
No neurological event was observed in the 1- to 24-month follow-up (mean 13
months). Two (2%) patients died of nonprocedurally related causes. No sten
t compression was seen, but 1 asymptomatic occlusion and 3 asymptomatic, no
n-flow-limiting restenoses (2 < 40%, 1 at 60%) were found within 1 year (3%
restenosis rate on an intention-to-treat basis). Patency was 98% at 1 year
.
Conclusions: The results of this trial support the contention that carotid
stenting of short ICA lesions can be performed with a low neurological comp
lication rate.