Eur J Vasc Endovasc Surg 20, 250253 (2000)

doi:10.1053/ejvs.2000.1170, available online at http://www.idealibrary.com on

Carotid Endarterectomy Without Angiography:

a Prospective Randomised Pilot Study
G. P. Deriu, D. Milite, N. Damiani, D. Mercurio, C. Bonvicini, S. Lepidi and F. Grego
Department of Vascular Surgery, University of Padua School of Medicine, Padua, Italy
Objectives: to determine whether duplex ultrasonography alone is an adequate examination prior to carotid endarterectomy.
Design: prospective, randomised, single centre study.
Material and Methods: all patients with carotid bifurcation stenosis greater than 70% based on duplex scanning
were randomised to arteriography followed by carotid surgery (Group A; n=96) or cartid surgery alone (Group B; n=
90). Study endpoints were neurological complications or death occurring between the day of randomisation and until 30
days after surgery.
Results: major neurological complications of death in 1 (1%) vs 3 (3.3%) patients in group A and B, respectively (n.s.).
Minor neurological complications (only TIA) were observed in 0 and 3 (3.3%) patients, respectively.
Conclusions: complication rates were low in both groups and within the generally accepted rate after carotid surgery in
asymptomatic and symptomatic patients.
Key Words: Atherosclerosis; Carotid endarterectomy; Duplex scanning; Stroke.

Introduction
Carotid duplex is increasingly replacing angiography
as the investigation of choice prior to carotid endarterectomy. Duplex scanning showed a sensitivity
of 98%, a specificity of 96%, positive predictive value
96%, negative predictive value 98% and accuracy 97%
compared with angiography for both symptomatic
and asymptomatic carotid disease.1 Duplex scanning
also showed a better correlation (r=80, p<0.001) with
ex vivo atheroma measurements than angiography (r=
0.56; p<0.05) and magnetic resonance imaging (0.76;
p<0.001).2 Several studies,1,38 suggest that carotid endarterectomy can be performed safely without intraarterial digital subtraction angiography (IADSA).
However, no randomised trial has compared neurological complications and mortality in patients undergoing CEA with and without angiography.

Materials and Methods

From February 1998 to July 1999, 396 symptomatic and
asymptomatic patients underwent CEA. All patients
Please address all correspondence to: G. P. Deriu, Department of
Vascular Surgery, University of Padua, Via Giustiniani 2, 35125
Padua, Italy.
10785884/00/090250+04 $35.00/0 2000 Harcourt Publishers Ltd.

underwent colour-coded duplex scanning (CCDS),

performed by the same qualified and experienced
personnel using an ESAOTE Idea AU 4, provided with
a 7.5 MHz linear probe. B-mode images and pulsed
Doppler signals were obtained. The indication to CEA
was a greater than 70% carotid stenosis for both symptomatic and asymptomatic patients.9,10 The degree of
stenosis was assessed by a combination of velocity
(peak systolic velocity: PSV >2 m/s and PSVic/PSVcc
>3.2) and morphological B-mode criteria (the greatest
reduction in area or diameter on multiple longitudinaland cross-section scans).11
Patients excluded from the study shared (suspected)
thrombosis of one carotid artery, unclear images, and
(suspected) associated lesions of the distal and proximal arteries.35 Patients provided informed consent.
Patients were randomised into two groups according to whether the last digit of the unique patient
admission code, provided by the centralised hospital
administration office, was odd (A) or even (B).
Group A patients underwent IADSA via femoral
artery puncture and the stenosis was measured according to the NASCET criteria.10 All patients underwent cerebral computed tomography (CT). All CCDS,
IADSA and cerebral CT were performed within 14
days of surgery.
Surgery was performed under general anaesthesia

Carotid Endarterectomy Without Angiography

251

Table 1. Demographic characteristics and risk factors.

N. pts.
Males (%)
Mean age
CAD
Hypertension
Diabetes mellitus
Smoking

Group A (IADSA)

Group B (No-IADSA)

96
69 (72%)
71 (5985)
39%
69%
23%
62%

90
53 (59%)
73 (5684)
39%
59%
17%
50%

CAD=coronary artery disease.

with continuous EEG perioperative monitoring, systemic heparinisation, and routine insertion of a PruittInahara shunt and the routine closure of the arteriotomy with a PTFE patch.12,13
Where there was a significant kinking of the internal
carotid artery excision of the internal carotid artery,
eversion endarterectomy and proximal reanastomosis
on the homolateral common carotid artery was performed.14
Total clamp time, the presence of EEG alterations
after clamping, the recovery of EEG alterations after
shunt insertion, the total shunt time, and the length
of the second clamp time from extraction of the shunt to
completion of the suture were recorded. Neurological
examination was performed upon awakening, every
3 h during the first postoperative day, daily until discharge and finally at day 30 after surgery. Study endpoints were disabling and fatal stroke, non-disabling
stroke, TIA, and non-cerebrovascular mortality from
the day of randomisation until day 30 after surgery.
Results are presented as mean, incidence rate and 95%
confidence interval (CI). A local ethical committee
approved the trial protocol according to national laws.

Results
CCDS exclusion criteria were met in 14 patients: four
subclavian artery stenosis, four contralateral carotid
occlusion, one associated proximal lesion, two associated distal lesion (tandem lesion) and three presented heavy calcification. Nine patients refused to
enter the protocol, and 185 patients were excluded
because they had IADSA or MR angiography prior to
admission.
One hundred and eighty-six patients were randomized to group A (96 patients) and B (90 patients).
The mean age was 71 (range: 5985) years in group
A, and 73 (range 5684) years in group B (Table 1). In
group A, IADSA always confirmed the CCDS findings.
At admission, 27 (28%) and 17 (19%) patients presented with hemispheric symptoms in group A and

B, respectively, 24 (26%), 22 (24%) patients presented

non-hemispheric symptoms, and 45 (46%) and 51 (5%)
patients were asymptomatic (n.s.).
Preoperative cerebral CT revealed significant lesions
in five (5%) and seven (8%) patients in group A and
B, respectively.
In either group, 85 patients underwent standard
carotid endarterectomy and PTFE patch. An eversion
endarterectomy of the internal carotid artery and proximal reanastomosis was performed on 11 patients of
group A and five (6%) patients of group B (n.s.). No
stroke and mortality was observed after IADSA. In
group A, RNCR was 1%. One asymptomatic patient
suffered from a major stroke: a monoparesis of the
upper controlateral limb, partially regressed during
the hospital stay.
In group B, RNCR was 3.3%. One asymtomatic
patient died as a result of massive cerebral infarct in
the contralateral hemisphere (with negative pre- and
postoperative CCDS of the controlateral carotid artery
and no complications on the operated side) and two
symptomatic patients suffered from a major homolateral stroke upon awakening, documented by serial
postoperative CT scans (Table 2). No minor stroke was
observed in both groups. No postoperative TIA was
documented in group A and 3 (3.3%) in group B.
Mortality due to noncerebrovascular causes was absent
in both groups.

Discussion
Some authors advocated the use of CCDS alone prior
to CEA,18 because IADSA entails risk,8,10,16 because it
does not provide haemodynamic or morphological
information about the plaque, and is aggressive.
Others believe that there is still no reliable alternative
to IADSA because CCDS does not provide information
about the supraortic vessels, or the intracranial circulation.
However, associated proximal and distal lesions
Eur J Vasc Endovasc Surg Vol 20, September 2000

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G. P. Deriu et al.

Table 2. Results.
Group A

Group B

Symptomatic

Asymptomatic

Total

Symptomatic

Asymptomatic

Total

N. pts.
Lethal stroke
Disabling stroke
Minor stroke
TIA

51
0
0
0
0

45
0
1
0
0

96
0
1
0
0

39
0
2
0
1

51
1
0
0
2

90
1
2
0
3

%
(95% CI)

1.0%
(0.035.5%)

3.3%
(0.68.5%)

Major complication rate.

CI=Confidence Interval.

rarely modify the management of patients with extracranial carotid stenosis.1822 In our experience of
more than 3000 patients studied by IADSA, only in
0.3% of cases did the presence of significant intracranial
lesions modify the indication to surgery. However, in
the present pilot study, two (1%) patients were excluded because of intracranial lesions suspected on
CDDS.
The inability of CCDS to distinguish subocclusive
and occlusive thrombotic lesions in some patients is
well known.2325 In our experience, therefore, a carotid
thrombosis suspected on CCDS represents an indication for IADSA.
In the evaluation of a stenotic lesion of the carotid
bifurcation, the accuracy of CCDS was comparable or
superior to IADSA.2,26
Finally, there is concern about increased perioperative CEA risks without IADSA, although several
authors have achieved good results.4,7,8,13,27
The results of this pilot study show that the perioperative rate of relevant neurological complication
and TIA are comparable in group A and B patients.
Complications in both groups for asymptomatic and
symptomatic patients are low, and below the general
accepted rate for CEA.
If we consider the costs and the reported risks of
preoperative angiography, an extended prospective
trial based on the protocol and results from this pilot
study may be justified. However, the incidence rate of
our endpoints is low, and to test the equivalence
of these in the two preoperative evaluation groups
requires a very large series of patients to draw any
statistically significant conclusion.

Acknowledgements
We thank Dr. Franco Noventa for his assistance and suggestions in
the review of the manuscript.
Eur J Vasc Endovasc Surg Vol 20, September 2000

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Accepted 13 June 2000

Eur J Vasc Endovasc Surg Vol 20, September 2000