Stent Angioplasty for Cervical Carotid Artery Stenosis in

High-Risk Symptomatic NASCET-Ineligible Patients

Adel M. Malek, MD, PhD; Randall T. Higashida, MD; Constantine C. Phatouros, MD;
Todd E. Lempert, MD; Philip M. Meyers, MD; Wade S. Smith, MD;
Christopher F. Dowd, MD; Van V. Halbach, MD
Background and PurposeAlthough the North American Symptomatic Carotid Endarterectomy Trial (NASCET) has
shown carotid endarterectomy (CEA) to be protective compared with medical therapy alone, its stringent eligibility
criteria excluded patients with severe medical, angiographic, and neurological risk factors. We sought to determine the
safety and efficacy of stent angioplasty in this high-risk subset for whom the perioperative morbidity and mortality of
surgery are elevated.
MethodsTwenty-eight consecutive symptomatic NASCET-ineligible patients (10 female; median age, 72.2 years)
underwent microcatheter-based carotid stent angioplasty. Half of the patients had sustained a previous stroke.
Classification of surgical risk by Sundt criteria yielded no patients in grade 1, 3 patients in grade 2 (10.7%), 8 in grade
3 (28.6%), and 17 (60.7%) in grade 4. Stratification of stroke risk for medical therapy according to the European Carotid
Surgery Trial (ECST) 5-point score showed 8 patients with a score of 3 (28.6%), 12 with 4 (42.8%), and 8 with 5
(28.6%). Follow-up was obtained in all patients at a median of 14 months.
ResultsThe procedure was technically successful in all cases (100%), with immediate stenosis reduction from a mean
of 80.3% to 2.7%. There were no periprocedural deaths, 1 major stroke (3.6%), no minor strokes, and 3 transient
ischemic attacks (10.7%). In-hospital complications included 2 nonfatal myocardial infarctions, 1 case of acute renal
failure, and 1 groin hematoma requiring transfusion. There were 5 deaths during the follow-up period, all beyond 30
days after the procedure: 3 from cardiac causes, 1 from lung cancer, and 1 following unrelated surgery. The patient with
major stroke died at 7.8 months during rehabilitation. No surviving patients had further strokes, and all except 1 (95.5%)
remained asymptomatic. Anatomic follow-up in 20 patients showed occlusion in 2 (10%) (1 symptomatic, 1
asymptomatic) and intimal hyperplasia in 3 asymptomatic patients (15%).
ConclusionsThe clinical results and sustained freedom from symptoms and stroke during the short available follow-up
period suggest that stent angioplasty may be useful in the treatment of symptomatic cervical carotid stenosis in high-risk
patients despite a notable incidence of restenosis. (Stroke. 2000;31:3029-3033.)
Key Words: angioplasty carotid endarterectomy carotid stenosis endovascular therapy stents

he North American Symptomatic Carotid Endarterectomy Trial (NASCET)1 and the European Carotid Surgery
trial (ECST)2 have demonstrated that surgical carotid endarterectomy (CEA) offers durable protection relative to medical
therapy in patients with symptomatic cervical stenosis 70%
provided that the combined morbidity and mortality is kept
below 6%.3 The need to maximize the sensitivity and specificity of the comparison with medical treatment and to
minimize confounding factors dictated a set of stringent
restrictions for eligibility in NASCET that excluded patients
with severe clinical risk factors.1 Currently no prospective
randomized data exist to help guide optimal therapy of
symptomatic high-risk patients who fail eligibility criteria set
forth in the major trials.1,2 It has been postulated that the

potential additional morbidity incurred in the treatment of

high-risk patients may invalidate the documented benefit of
carotid revascularization.4 The analysis of Sundt et al5,6
resulted in the formulation of a predictive instrument for
estimating the risk of procedural morbidity of CEA. Medical
risk factors increased the periprocedural risk of stroke and
death from CEA from 0.9% (Sundt grade 1) to 1.7% (grade
2), while angiographic risk factors increased the rate to 3.7%
(grade 3), and neurological instability further increased the
rate to 8.1% (grade 4). Patients with multiple comorbid
conditions may be denied surgical revascularization because
of elevated periprocedural risk in favor of medical therapy,
which may carry a higher cumulative risk of stroke.4,7
Recently, stent angioplasty has been proposed as an endovas-

Received May 11, 2000; final revision received August 24, 2000; accepted August 24, 2000.
From the Departments of Radiology, Division of Interventional Neurovascular Radiology (A.M.M., R.T.H., C.C.P., T.E.L., P.M.M., C.F.D., V.V.H.),
Neurology (W.S.S.), and Neurosurgery (R.T.H., C.F.D., V.V.H.), University of California at San Francisco.
Correspondence to Adel M. Malek, MD, PhD, Department of Neurosurgery, Brigham & Womens and Childrens Hospitals, Bader 3, 300 Longwood
Ave, Boston, MA 02115. E-mail amalek@partners.org
2000 American Heart Association, Inc.
Stroke is available at http://www.strokeaha.org

3029
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3030

Stroke

December 2000

cular technique for carotid revascularization that may be

beneficial in certain patient subsets.8 12 To clarify the possible contribution of endovascular intervention to the treatment
of carotid atherosclerosis, we present in this retrospective
study the results and clinical outcome obtained in symptomatic NASCET-ineligible high-risk patients who were referred
for stent angioplasty after consideration for surgical
endarterectomy.

TABLE 1. Demographic Characteristics, Medical Conditions,

Risk Features, and Presenting Symptoms of the
Patient Population
Age, y
Mean

70.92.1

Median

72.2

Range

4687

Distribution

Subjects and Methods

Patient Selection
Twenty-eight patients with symptomatic carotid atherosclerotic stenosis who were ineligible by NASCET criteria were referred by a
neurologist or vascular surgeon after evaluation for CEA and were
treated consecutively between July 1996 and June 1999. Detailed
informed consent was obtained from the patient or the patients legal
guardian after disclosure of the procedural status in accordance with
institutional guidelines. Patients who underwent stent angioplasty
primarily for treatment of carotid dissection, pseudoaneurysm, intracranial or intrathoracic atherosclerosis, or thrombolytic therapy for
recanalization of acute carotid occlusion were excluded from the
present analysis.

70 y

11 (39.3%)

7079 y

11 (39.3%)

80 y

6 (21.4%)

Sex
Male

18 (64.2%)

Female

10 (35.7%)

Medical conditions
Hypertension

22 (78.6%)

Coronary artery disease

17 (60.7%)

Hypercholesterolemia

16 (57.1%)

Smoking

13 (46.4%)

Procedure

Previous CABG

11 (39.3%)

Twenty-four patients (86%) underwent light intravenous neuroleptic

sedation, and the remainder had general endotracheal anesthesia
(n4, 14%) because of poor ability to cooperate (n2) or because of
the need for intracranial navigation (n2). All patients were monitored by placement of transthoracic electrodes (Zoll Medical) in case
of bradycardia or asystole during angioplasty. Patients were administered intravenous heparin (bolus of 70 U/kg) followed by either an
hourly dose (bolus of 35 U/kg) or continuous infusion (15 U/kg per
hour) to ensure an activated clotting time greater than twice baseline.
After a complete diagnostic angiographic study, the stenotic lesion
was treated with an angioplasty balloon catheter (predilatation) to
enable subsequent passage of a balloon-mounted (Palmaz, Johnson
& Johnson; GFX, AVE/Medtronic) or self-expanding stent (Wallstent, Schneider; S.M.A.R.T. stent, Cordis). In 7 cases (25%),
primary stenting was performed without resorting to predilatation.
Postdeployment high-pressure balloon angioplasty (12 to 21 atm)
was then performed to achieve apposition of the stent interstices to
the luminal surface of the artery. The patient was maintained on
heparin for 12 hours and placed on an oral regimen of ticlopidine
(250 mg PO BID) or clopidogrel (75 mg PO QD) for 6 weeks and on
daily aspirin (325 mg PO QD) indefinitely.

Congestive heart failure

8 (28.6%)

Diabetes mellitus

8 (28.6%)

Severe PVD

6 (21.4%)

Risk Stratification
Patients were classified according to the Sundt grading system on the
basis of angiographic, medical, and neurological risk factors5 and
grouped according to risk of stroke with medical treatment as
validated in the ECST7 on the basis of cerebral versus ocular
symptoms, plaque surface irregularity, neurological event in past 2
months, and percentage of stenosis.

Clinical Outcome Measures

Members of the neurology department performed initial inpatient
neurological examinations and clinical management, with initial
postprocedural care in a neurological intensive care setting.
Follow-up neurological examinations and ultrasonography were
performed by the neurology team or at the patients referring
institution and were supplemented by telephone interviews with a
clinical nurse.

Quantitative Analysis and Statistics

Severity of stenosis was computed by the NASCET method with
interconversion to ECST values as previously described.13 Statistical
analysis was performed with software from SAS Institute. ANOVA

Previous myocardial infarction

6 (21.4%)

Previous CEA

5 (17.9%)

Previous cervical irradiation

4 (14.3%)

Presentation
Previous stroke

14 (50.0%)

Bruit

9 (32.1%)

Hemispheric symptoms
Retinal symptoms

26 (92.9%)
2 (7.1%)

Symptomatic

28 (100%)

NASCET ineligible

28 (100%)

Values are number of patients (percentage) unless indicated otherwise.

CABG indicates coronary artery bypass graft; PVD, peripheral vascular disease.

was used to compare outcome scores versus presentation and

treatment characteristics, and a Pearsons 2 test was used to
determine marginal homogeneity among nominal variables. A P
value of 0.05 was considered statistically significant.

Results
Patient Demographics and Clinical Presentation
The demographic characteristics and comorbid medical conditions of the patient population are described in Table 1. The
criteria for exclusion from NASCET eligibility appear in
Table 2; some patients satisfied 1 criterion for exclusion,
but a single disqualifying condition is shown. Half of the
patients (14/28 patients, 50%) had suffered a previous clinically significant stroke in the territory of the treated vessel.
Five patients (5/28 patients, 17.9%) had recurrent stenosis
after CEA, and 4 patients (4/28, 14.3%) had radiation
therapyinduced stenosis. The majority of patients fulfilled
the criteria for medical (23/28 patients, 82.1%), radiographic
(23/28, 82.1%), and neurological risk (17/28 patients, 60.7%)

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Malek et al

Stent Angioplasty in High-Risk NASCET-Ineligible Patients

TABLE 2. Conditions Leading to Exclusion of Patients From

NASCET Eligibility1
NASCET Ineligibility Criteria
Age 80 y*

6 (21.4%)

Intracranial atherosclerosis worse

than cervical lesion

5 (17.9%)

TABLE 3. Stratification of Patient Population With Respect to

Surgical Risk of CEA According to Surgical Risk Classification
of Sundt5 and With Respect to 5-Year Risk of Stroke Based on
Medical Risk Score Defined by Rothwell in the ECST7
Patient Stratification by Risk of Surgical Treatment According to Sundt5
Sundt Risk
Grade

Unstable neurological examination

4 (14.3%)

Surgically inaccessible cervical lesion

3 (10.7%)

Previous CEA

3 (10.7%)

Cancer with life expectancy 5 y

3 (10.7%)

Unstable congestive heart failure

1 (3.6%)

Unstable angina

1 (3.6%)

Failure to visualize both intracranial

carotid arteries

1 (3.6%)

Patient Stratification by Risk of Medical Treatment

Other intracranial vascular pathology

1 (3.6%)

Rothwell/ECST
Score

Values are number of patients (percentage).

*The age exclusion criterion applies to the first part of NASCET (before 1991)
and was eliminated after the report of the initial results1 to reflect the practice
in North America.

as defined by Sundt et al.5 The stratification by surgical risk

according to Sundt grade and by medical risk according to the
ECST7 score is presented in Table 3.

Lesion Characteristics and Technique

Half of the lesions were left sided (14/28 patients, 50%). The
mean pretreatment stenosis of 80.32.8% was immediately
reduced to 2.71.2% by the procedure (P0.001). The
morphological characteristics of the plaque included presence
of an ulcerated or irregular plaque in 15 patients (15/28
patients, 53.6%), tandem lesions in 9 patients (9/28 patients,
32.1%), and evidence of a string sign in 6 patients (6/28
patients, 21.4%). Fifteen patients (15/28 patients, 53.6%) had
50% stenosis in the contralateral internal carotid artery, and
among these 9 (9/28 patients, 32.1%) had complete occlusion.
Mean stenosis in the contralateral cervical internal carotid
artery was 50.57.6%. Ten patients (10/28 patients, 35.7%)
demonstrated extracranial posterior circulation atherosclerotic disease of 60%, and 9 (9/28 patients, 32.1%) had
moderate to severe intracranial atherosclerotic disease as
defined by Kappelle et al.14
To achieve an adequately smooth hemodynamic result,
tandem stents were placed in 7 patients (7/28 patients, 25%)
with overlap of 2 or 3 stents in 4 patients (4/28 patients,
14.3%). A total of 34 stents were used, including selfexpanding Wallstent (n24) and S.M.A.R.T. (n2) stents
and balloon-mounted Palmaz (n6) and GFX (n2) stents.
Eight patients (8/28 patients, 28.6%) underwent combined
simultaneous endovascular procedures either at the time of
stent angioplasty or during the same hospital admission.
These complex procedures included unsupported and stentsupported angioplasty of the intracranial portion of the
internal carotid artery (n4), of the vertebral artery (n2), of
the left proximal common carotid artery (n1), and of the
contralateral cervical internal carotid artery (n1).

Complications
There were no perioperative deaths in this series. There was
1 major stroke event (1/28 patients, 3.6%) in a 78-year-old

3031

Count

Percent Total

Published CEA
Periprocedural Risk of
Stroke/Death5

0%

0.9%

II

10.7%

1.7%

III

28.6%

3.7%

IV

17

60.7%

8.1%

Count

Percent Total

Published 5-y
Actuarial Risk of
Stroke7

0%

0%

0%

6.0%

0%

13.1%

28.6%

20.0%

12

42.8%

45.2%

28.6%

38.1%

man (Sundt grade 4/ECST score 3) with previous stroke and

progressively worsening neurological condition. The patient
had poor angiographic hemodynamic reserve with an ulcerated left internal carotid artery lesion of 75% stenosis,
contralateral carotid and right vertebral artery occlusion, and
significant stenosis of the left vertebral artery. The procedure,
performed under general endotracheal anesthesia because of
poor cooperation, was characterized by a period of prolonged
uncontrolled hypotension before endovascular intervention.
The patient awoke with left-sided hemiparesis, and postprocedural imaging revealed infarction in the regions of the right
basal ganglia and corona radiata, consistent with a hypoperfusion insult. There were no instances of minor stroke (0%)
and 3 transient ischemic attack (TIA) episodes (3/28, 10.7%).
The TIAs were encountered in patients belonging to each of
Sundt grades 2, 3, and 4 and to each of the ECST score 3, 4,
and 5 subgroups. No significant relationship between stroke/
TIA event rate and Sundt grade or ECST score was found.
Complex procedures (8/28 patients, 28.6%) were not associated with a higher risk of stroke (0 stroke) or TIA (1 TIA)
compared with noncomplex procedures (20/28 patients,
71.4%). Primary stenting (7/28 patients, 25%) was associated
with 1 TIA and 1 major stroke, while secondary stenting
(after primary balloon angioplasty) (21/28 patients, 75%) was
associated with 2 TIAs and no stroke.
The immediate postoperative hospital course was complicated by a groin hematoma in 1 patient (1/28 patients, 3.6%)
that required blood transfusion and ultrasound-guided external compression. Two patients had postprocedural non-Qwave myocardial infarctions (2/28 patients, 7.1%), from
which they recovered before discharge, and 1 patient suffered
from acute renal failure (1/28, patients, 3.6%) with only
partial recovery.

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3032

Stroke

December 2000

Clinical Follow-Up
Clinical follow-up was obtained in all patients, with a median
duration of 14 months (range, 0.8 to 26.7 months). During the
follow-up period, there was 1 death in the patient who had the
perioperative major stroke from complications related to his
long-term rehabilitation at 7.8 months and 5 deaths that were
unrelated to the treatment. The latter included 3 cardiac
deaths (1 from fatal myocardial infarction at 4.4 months, 1
from cardiac arrest at 4.6 months, and 1 from intractable
congestive heart failure at 13.3 months); 1 death from
small-cell lung cancer (0.8 months); and 1 postoperative
death after hip surgery (14 months). The patient who had
cardiac arrest at 4.6 months was 1 of the 2 patients who had
sustained a postprocedural myocardial infarction. Overall, 24
patients (85.7%) had clinical follow-up of duration 6
months; of the 4 who did not, 3 were the result of death as
described above. Seventeen patients had clinical follow-up at
1 year.
Of the surviving 22 patients, 21 (21/22 patients, 95.5%)
remained free of new symptoms or new strokes, while 1
patient (1/22 patients, 4.5%) who underwent simultaneous
treatment of an intracranial internal carotid artery stenosis
and a cervical carotid lesion developed delayed central retinal
artery occlusion and ipsilateral ocular blindness at 2 months.
Subsequent angiography revealed occlusion of the carotid
artery at the siphon with proximal cervical carotid flow stasis
at the level of the stented segment.
Anatomic follow-up was available at 6 months after the
procedure and consisted of either ultrasonography or conventional angiography in 20 of the 28 patients (20/28 patients,
71%). Three asymptomatic patients (Sundt grade 3/ECST
score 4 in 2; Sundt grade 4/ECST score 5 in 1) developed
60% intimal hyperplasia, 2 of which (65% and 80%
restenosis) were treated successfully with further angioplasty
and reconstitution of patency. Two patients, one symptomatic
from occlusion of the ipsilateral central retinal artery (Sundt
grade 4/ECST score 5) and another asymptomatic (Sundt
grade 3/ECST score 4), showed complete occlusion at followup. Neither underwent recanalization attempts because of the
irreversible deficit in the first and the absence of related
symptoms in the other. Pretreatment stenosis in the patients
who subsequently had restenosis or occlusion (87.8%, n5)
was not significantly different from those who did not
(79.5%, n15) (P0.23).

Discussion
In the past 4 years there have been increased reports of stent
angioplasty for carotid stenosis performed in patients with
different risk profiles.8 12 These studies are difficult to
compare with each other because they were performed in
heterogeneous patient populations, they involved lesions with
variable characteristics, different endovascular techniques
were used, and outcome measures were dissimilar. Although
the patient population in the study of Yadav et al9 represented
a high proportion of patients with high-risk features, it also
included a significant proportion (41%) of asymptomatic
patients. In the series of Henry et al11 and Diethrich et al,15 the
majority of the treated population (65% and 72%, respectively) was asymptomatic. Recent analysis of carotid stent

angioplasty by Mathur et al16 has identified a higher risk in

patients with advanced age, long or multiple stenoses, and
severe lesions, but long-term clinical follow-up remains
significantly shorter than that available for surgical
endarterectomy.
The decision to treat carotid stenosis relies on a costbenefit analysis that takes into account the cumulative risk of
stroke in a patient undergoing medical treatment and the
procedure-related risks of stroke and death from surgical or
endovascular revascularization. Analysis of multiple published endarterectomy studies by Rothwell et al17 has identified a significantly higher combined risk of stroke and death
in symptomatic (5.18%) than in asymptomatic (3.35%) patients, a finding confirmed by McCrory et al18 (9.5% in
symptomatic versus 2.7% in asymptomatic patients). This
difference may be the result of a higher rate of embolic
events, as suggested by the greater frequency of highintensity transient signals seen in symptomatic patients.19
Recent analysis of the NASCET surgical results has identified a greater perioperative risk in patients with hemispheric
versus retinal symptoms (2.3-fold), contralateral carotid occlusion (2.2-fold), a left-sided procedure (2.3-fold), or an
irregular/ulcerated lesion (1.5-fold).3 A similar effect of
hemispheric symptoms and plaque ulceration has also been
reported in ECST.7 In addition, available data to guide
treatment in high-risk patients who fail to qualify by
NASCET criteria are scarce. The predictive value of Sundts
grading system, initially based on retrospective analysis at a
single center,5 has been independently validated both retrospectively18,20 and prospectively in a study from the Academic Medical Center Consortium.18 Sieber et al20 found that
total morbidity and mortality from CEA increased from 2%
for Sundt grade 1 to 10% for grade 2, 11% for grade 3, and
18% for grade 4. McCrory et al18 reported total stroke or
death rates of 2.5% for grade 1, 3.1% for grade 2, 5.1% for
grade 3, and 7.9% for grade 4. Although it is impossible to
predict the risk of surgical therapy for the patients in the
present study, its computation based on the Sundt instrument
yields a rate of procedure-related death and stroke rate
ranging from 7.4%5 to 15.1%,20 which is higher than observed in this report (3.6%). Applying the ECST medical risk
score and associated actuarial stroke rate (Table 3) to the
patient population in the present study yields a predicted
5-year risk of ipsilateral stroke of 36.3%; however, direct
comparison will not be possible until longer follow-up is
available.
Even though the present series consists exclusively of
symptomatic NASCET-ineligible patients with a high proportion of Sundt grade 3 and 4, the 30-day periprocedural
combined risk of stroke and death (3.6%) is comparable to the
surgical results of NASCET3 and other series.6,20 The risk of
all in-hospital medical complications (including TIA) in this
series was 25% (7/28 patients; 2 nonfatal myocardial infarction, 1 acute renal failure, 1 groin hematoma, 3 TIAs), which
is higher than that encountered in NASCET (1% for myocardial infarction, 8.1% total medical complications excluding
TIAs).21 The rate of wound-related complications (1 groin
hematoma, 2.6%) is lower than in NASCET (9.3%), and no
instances of perioperative cranial nerve injury were encoun-

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Malek et al

Stent Angioplasty in High-Risk NASCET-Ineligible Patients

tered (8.9% in NASCET).3 Although the majority (95.4%) of

patients remained asymptomatic in the follow-up period, the
risk of 60% restenosis or occlusion in the present study
(5/20 patients, 25%) is higher than reported for the 3 to 18
months of follow-up of the 645 patients in the surgical arm of
the Asymptomatic Carotid Atherosclerosis Study (ACAS)
(7.6% to 11.4%)22 and greater than the 6- to 12-month rate
reported in other series (8%).23 Since the original goal of the
procedure was stroke prevention, the current management
was effective in 4 of the 5 patients with 60% restenosis or
occlusion for the limited length of follow-up. However, even
if one were to consider only restenosis of 80% as clinically
warranting retreatment, the rate in the present study remains
significant at 15% (3/20 patients).
In conclusion, carotid stent angioplasty can be performed
in NASCET-ineligible high-risk symptomatic patients with a
periprocedural risk of stroke and death that is comparable to
those of NASCET and other published endarterectomy series.
A significant relief from neurological symptoms and stroke
was encountered during the intermediate follow-up period
along with significant restenosis in this cohort of patients
with advanced medical and surgical risk factors.

Acknowledgments
This study was supported by the Boston Neurosurgical Foundation
(Dr Malek). We would like to thank Drs Daryl Gress, David
Bonovitch, and Clay Johnston for assistance in the clinical management of the patients in this series.

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Stent Angioplasty for Cervical Carotid Artery Stenosis in High-Risk Symptomatic

NASCET-Ineligible Patients
Adel M. Malek, Randall T. Higashida, Constantine C. Phatouros, Todd E. Lempert, Philip M.
Meyers, Wade S. Smith, Christopher F. Dowd and Van V. Halbach
Stroke. 2000;31:3029-3033
doi: 10.1161/01.STR.31.12.3029
Stroke is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231
Copyright 2000 American Heart Association, Inc. All rights reserved.
Print ISSN: 0039-2499. Online ISSN: 1524-4628

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