(Stroke. 2000;31:1439.)
© 2000 American Heart Association, Inc.
Comments, Opinions, and Reviews |
Systematic Comparison of the Early Outcome of Angioplasty and Endarterectomy for Symptomatic Carotid Artery Disease
From the Department of Vascular Surgery, Imperial College School of Medicine, Charing Cross Hospital, London, UK.
Correspondence to J. Golledge, Department of Vascular Surgery, Charing Cross Hospital, Fulham Palace Road, London, W6 8RF UK. E-mail J.Golledge{at}tesco.net
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Abstract |
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Background and Purpose—Endoluminal treatment is being increasingly used for carotid artery disease. The aim of this study was to compare the stroke and death risk within 30 days of endovascular treatment or endarterectomy for symptomatic carotid artery disease.
Methods—A systematic comparison of the 30-day outcome of angioplasty with or without stenting and endarterectomy for symptomatic carotid artery disease reported in single-center studies, published since 1990, was performed.
Results—Thirty-three studies (13 angioplasty and 20 carotid endarterectomy) were included in this analysis. Carotid stents were deployed in 44% of angioplasty patients. Mortality within 30 days of angioplasty was 0.8% compared with 1.2% after endarterectomy (OR 0.68, 95% CI 0.43 to 1.05; P=0.6). The stroke rate was 7.1% for angioplasty and 3.3% for endarterectomy (OR 2.22, CI 1.62 to 3.04; P<0.001), while the risk of fatal or disabling stroke was 3.2% and 1.6%, respectively (OR 2.09, CI 1.3 to 3.33; P<0.01). The risk of stroke or death was 7.8% for angioplasty and 4% for endarterectomy (OR 2.02, CI 1.49 to 2.75; P<0.001), while disabling stroke or death was 3.9% after angioplasty and 2.2% after endarterectomy (OR 1.86, CI 1.22 to 2.84; P<0.01).
Conclusions—In the treatment of symptomatic carotid artery disease, the risk of stroke is significantly greater with angioplasty than carotid endarterectomy. At present, carotid angioplasty is not recommended for the majority of patients with symptomatic carotid artery disease.
Key Words: angioplasty • carotid endarterectomy • carotid stenosis
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Introduction |
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Randomized controlled trials have demonstrated the value of carotid endarterectomy in patients with transient ischemic attack (TIA) or stroke with good recovery and severe carotid artery stenosis, with a reduction in risk of major stroke or death of
2-fold compared with medical treatment
alone.1 2 Carotid surgery can be associated with other
morbidity, including myocardial infarction or other cardiac
complications (1%), cranial nerve palsy (7%), and wound
infection or hematoma (5%).2 3 Over the last decade,
endovascular treatment of carotid disease has been introduced as an
alternative to endarterectomy. Initially,
angioplasty alone was used; more recently, stent placement has been
employed with increasing frequency. Endovascular treatment has the
advantage over endarterectomy of avoiding a neck
incision and dissection of the carotid bifurcation. However, for
angioplasty of a tight carotid stenosis, a guidewire must be
passed across the narrowing and the plaque dilated or stented. This
process is associated with a high frequency of cerebral embolization
demonstrated on transcranial Doppler insonation of the
middle cerebral artery.4
A number of randomized trials have been commenced to compare the
results of endoluminal therapy and endarterectomy
for carotid stenosis.5 The findings of only 1
trial have been published.6 This trial was stopped after
only 17 patients had received their treatment allocation, because the
complications of carotid angioplasty were so high: 5 of the 7 patients
who underwent carotid angioplasty had strokes, 3 of which were
disabling at 30 days. In contrast, there were no complications after
the 10 carotid endarterectomies.6 Another trial, the
Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS),
has been completed, and limited data have been presented in
abstract form.7 In contrast to the findings of the
Leicester trial, CAVATAS reported equivalent combined stroke and
mortality rate for angioplasty and endarterectomy
of 10% at 30 days.7 Although the results of CAVATAS
have not yet been published in a full manuscript, the trial has already
received criticism for its method of patient selection.8
On the basis of the presented results to date, some authors
have argued that angioplasty is a worthwhile alternative to
endarterectomy,9 while others feel
that widespread use of endovascular therapy for carotid artery disease
should await the results of further randomized trials.10
To address the debate regarding the role of angioplasty in carotid artery disease, a systematic comparison of the reported results of angioplasty and endarterectomy has been performed. Because sufficient data are not yet available from randomized trials, the results from single-center reports from 1990 to 1999 have been used to carry out a meta-analysis.
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Methods |
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Studies for comparison were identified from PUBMED with the advanced search option. The terms used were "carotid artery," "angioplasty," "stent," and "endarterectomy." Studies were included if the following criteria were fulfilled: (1) number of strokes occurring within 30 days of carotid endarterectomy or endoluminal treatment were reported for patients with symptomatic carotid stenosis; (2) the report was a single-center study, since very few multicenter angioplasty series have been published; (3) the study was published between 1990 and 1999; and (4) only 1 series from any center was included unless there was clearly no overlap in cases.
For each study, the presenting symptom of the patient, the
frequency of any stroke, disabling or fatal stroke, death, and TIA per
operation was recorded. The risk of stroke and/or death and TIA
were calculated using the OR, with 95% CIs, and the
2 test.11
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Results |
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Thirteen studies of angioplasty with or without stenting6 12 13 14 15 16 17 18 19 20 21 22 23 and 20 endarterectomy studies fulfilled our inclusion criteria.24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43
Presenting Symptoms
Most studies did not state separately the number of patients
presenting with amaurosis fugax and cortical TIA, despite the
differing results of endarterectomy in these
groups.34 Two of the angioplasty studies and 2 of the
endarterectomy series did not separate patients
presenting with TIA and stroke.12 21 27 28 Excluding
these studies, 58% of patients treated by angioplasty compared with
70% of patients undergoing endarterectomy
presented with a TIA (Tables 1
and 3;
2=8.49, P<0.01). Because a
previous systematic review44 has shown no difference
in the outcome of endarterectomy for patients with
cortical TIA and stroke (OR 1.01) the ORs for stroke and death were not
adjusted. A small number of patients presented with symptoms of
vertebrobasilar insufficiency in both angioplasty and
endarterectomy series.
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Angioplasty Series
In early series angioplasty alone was
performed,19 20 21 22 23 while in more recent studies primary
stent placement has become more common.6 14 15 16 17 18 For ease,
the endovascular treatment studies will be referred to as the
angioplasty series. Overall, 44% of patients were stented (Table 1
). A distal internal carotid cerebral protection balloon was
used in 2 studies (11% of patients). Technical success was defined in
most studies as balloon dilatation of the carotid stenosis so
that a residual stenosis of <50% remained. With these
criteria, technical failure occurred in 37 cases (7%); most of these
patients went on to have an endarterectomy,
although the morbidity associated with this extra procedure has not
been stated in most publications. The technical failures included some
patients in whom it was not possible to cross the stenosis with
a guidewire, in addition to cases in which a residual stenosis
was present.
Comparison of Complications of Angioplasty and
Endarterectomy
The odds of stroke, death, and TIA within 30 days of procedure are
compared for angioplasty and endarterectomy in
Table 4. There was a >2-fold increased risk of stroke, whether
minor or major, within 30 days of angioplasty compared with
endarterectomy (any stroke
2=26.5, P<0.001; fatal/disabling
stroke 2=8.8, P<0.01). Death
within 30 days of the procedure was less common after angioplasty
(0.8%) than after endarterectomy (1.2%), but this
difference was not significant (95% CI 0.4 to 1.1;
2=0.57, P=0.6). Combined stroke or
death was 7.8% following angioplasty and 4% after
endarterectomy (2=20.6,
P<0.001). TIA was reported in only 7 of the 20
endarterectomy series, thus making comparison with
the endovascular series very difficult (Tables 3 and 4).
There is no clear relationship between the year of publication of the
angioplasty series and the reported complications (Table 2).
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Discussion |
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Principally, 3 mechanisms have been implicated in stroke complicating carotid endarterectomy.37 First, cerebral embolization during dissection of the carotid arteries and from the endarterectomy surface45 ; second, stroke as a result of hypoperfusion during clamping of the carotid arteries46 ; and third, stroke due to cerebral hemorrhage following clamp release and hyperperfusion.47 During carotid angioplasty, while the risk of hypoperfusion is likely to be less, the frequency of embolization has been demonstrated to be much greater.22 The findings of our systematic review suggest that this increased frequency of embolization is associated with a much greater risk of a perioperative neurological event. The risk of stroke is 2-fold greater after angioplasty than after endarterectomy for patients with symptomatic carotid artery disease (Table 4
).
Comparison of the incidence of TIA is hampered by the lack of reporting
in the endarterectomy series; however, where this
was stated, the incidence appeared to be much greater in the
endovascular group (Tables 3 and 4). Furthermore, technical failure of
angioplasty was reported in 7% of patients, many of whom went on to
require endarterectomy. The complications of this
additional treatment are usually not included in the report. Although
many surgeons do not routinely perform imaging of the
endarterectomy site after surgery, it is very rare
for repeat surgery to be required for residual stenosis. Because angioplasty can be performed percutaneously with local anesthetic, whereas endarterectomy is often carried out under general anesthetic, it might be assumed that angioplasty would be associated with a lower risk of perioperative death. A previous systematic review has suggested the complications of endarterectomy are lower when the operation is performed under regional block.48 The mortality was slightly lower in the angioplasty series, but the difference was not statistically significant.
As with any systematic review, a number of issues must be borne in mind
when assessing the results. First, because the studies compared are not
randomized, it is possible that patients in both series are different.
For example, more unfit patients may have been selected for
angioplasty, since this technique is considered less invasive. Of note,
the frequency of TIA as a presenting symptom was more common in the
endarterectomy series. Similarly, patients with
more stable carotid stenosis may have been selected for
angioplasty; indeed, in some studies authors state that balloon
dilatation is delayed until 3 months after symptoms.19
Second, the care with which perioperative complications
were identified may have differed between the 2 series. A neurologist
was noted to have assessed the patients at follow-up in 9 of the 13
angioplasty studies (69%), whereas this was the case for only 6 of the
20 endarterectomy studies (30%). These differences
in follow-up might have allowed the detection of more subtle
neurological deficits in the angioplasty patients. However, the 2-fold
increase in fatal or disabling stroke following angioplasty support the
present superiority of carotid surgery (Table 4). Third, it
could be argued that the results reported in single-center series are
not representative of the everyday outcomes of carotid
surgery. For example, the outcomes reported in the North American
Symptomatic Carotid Endarterectomy
Trial (NASCET) and the European Carotid Surgery Trial (ECST) are
different from those reported in most of the
endarterectomy studies presented here. In
NASCET the 30-day stroke rate was 5.5% (1.8% disabling/fatal
strokes); in ECST the perioperative stroke rate was
6.6% (3.1% disabling/fatal strokes). However, this criticism is
likely to apply equally to both endarterectomy and
angioplasty studies. Fourth, endovascular treatment of carotid disease
is in a process of development, with new techniques such as primary
stenting and cerebral protection being introduced; therefore, the
results reported in Table 2 may improve with technical advances.
Finally, our comparison does not take into account complications other
than stroke or death, such as nonfatal myocardial infarction or cranial
nerve palsy, which appear too rarely in publications to be
assessed.
The best level of clinical evidence is obtained from randomized controlled trials or meta-analysis of such studies. Despite the poor outcome of carotid angioplasty in the only trial published to date,6 the frequency of angioplasty reports appears to be increasing. This may be due to the relatively small number of patients included in the Leicester trial before the study had to be stopped, and therefore the possibility that the findings may be a type 2 error. Alternatively, the findings from CAVATAS,7 which have been presented in abstract form and suggest an equivalent outcome for angioplasty and endarterectomy, may have encouraged interventionists to expand their practice. The findings of this systematic review support that of the Leicester trial. At present, angioplasty or stenting would not appear suitable for most patients presenting with a symptomatic severe carotid stenosis. In the future, it may be possible to identify certain subgroups, such as high-risk surgical patients and those with symptomatic restenoses or distally positioned stenoses, that are better suited to angioplasty than surgery. More information is also required regarding the long-term results of endovascular treatment of carotid artery disease.
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Acknowledgments |
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This project was funded by the BUPA Foundation.
Received November 8, 1999; revision received February 10, 2000; accepted March 8, 2000.
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