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BOTTOM LINE
Compared to standard medical therapy for symptomatic carotid artery stenosis, patients with stenosis of
70-99% benefit significantly from carotid endarterectomy (CEA) to prevent ipsilateral stroke. Patients with
moderated stenosis of (50-69%) may benefit from CEA in preventing ipsilateral stroke and risk factors
should be considered. Patients with (< 50%) stenosis do not benefit from CEA compared to medical therapy.
MAJOR POINTS
CEA is durable procedure that provides significant benefit for patient with 70-99% carotid artery stenosis
CEA provides no benefit compared to medical therapy in patients with < 50% stenosis
CRITICISM
The study did not include patients older than 80 years old.
Males benefited greater than females from CEA. Females may benefit less from CEA because of decreased
general overall stroke risk compare to males.
Degree of stenosis was measured with angiography and noninvasive measurement modalities may not be
equally applicable.
Study design
MULTICENTER, PARALLEL-GROUP, RANDOMIZED CONTROLLED TRIAL
N=2226
Randomized to CEA (N=1,108) or medical therapy (N= 1,118)
Time: 1987-1991
INCLUSION CRITERIA
EXCLUSION CRITERIA
Intracranial stenosis that was more clinically significant than the cervical lesion
Cerebral infarction that eliminated useful function in the affected arterial territory,
nonatherosclerotic carotid disease, cardiac lesions likely to cause cardioembolism, and a
history of ipsilateral endarterectomy.
Purpose
Previous studies demonstrated that patients with symptomatic carotid stenosis ( 70-99%)
benefit up to two years following carotid endarterectomy procedure.
Assess the benefit of CEA in patients with symptomatic moderate carotid stenosis (50-69%)
and mild stenosis (< 50%) at an average follow up of 5 years.
Assess the durability of CEA in patients with severe stenosis (70-99%) at eight years follow
up.
Intervention
Of the 2226 eligible patients with carotid stenosis of 70% or less, 1118 were
randomly assigned to the medical therapy group while the remaining 1108 were
randomly assigned to the surgical group.
Both groups were treated with aspirin, anti-hypertensives, and anti-lipids.
Patients in the surgical group underwent CEA in addition to the medical therapy.
Centers were required to demonstrate that their participating surgeons had a
perioperative rate of stroke and death of <6% in a minimum of 50 consecutive cases
accumulated over 2 years. In centers with >1 surgeon, the number of patients could
represent the aggregate experience of participating surgeons in the center, with a
minimum of 30 personal cases for any single surgeon.
Surgical technique was left to the discretion of the surgeon.
Neurologic assessment at entry, at 1, 3, 6, 9, and 12 months, and every 4 months for
underlying causes of all deaths and the territory, type, severity, and duration of
strokes.
Average follow up was 5 years for all patients.
Outcome
Outcome
For the primary outcome of ipsilateral stroke, five year failure rate for patients with a 50-69%
stenosis was 22.2% for those medically treated versus 15.7 % for those undergoing CEA
(P=0.045). The relative risk reduction was 6.5%, and NNT was 15 which is twice that for
patients with stenosis of 70 percent or more.
For the primary outcome of ipsilateral stroke , five year failure rate for patients with < 50%
stenosis was 18.7% for those medically treated and 14.4% surgically treated with CEA
(P=0.16). There was no significant difference between the surgically treated group versus the
medically treated group.
CEA provided durable benefit for patients with severe >70 % stenosis with 6.7% rate of death
or disabling ipsilateral stroke at 8 year follow-up.
Credits
SUMMARY BY:
sirweb.org