NASCET
Trial question
Is carotid endarterectomy superior to medical care alone in patients with moderate carotid stenosis and TIAs or non-disabling strokes ipsilateral to the stenosis (within 180 days)?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 2226
2226 patients (668 female, 1558 male).
Inclusion criteria: patients with moderate carotid stenosis and TIAs or non-disabling strokes ipsilateral to the stenosis (within 180 days).
Key exclusion criteria: lack of angiographic visualization of the symptomatic artery, nonatherosclerotic carotid disease, cardiac lesions likely to cause cardioembolism, or a history of ipsilateral endarterectomy.
Interventions
N=1108 surgical therapy (carotid endarterectomy plus medical treatment).
N=1118 medical therapy (medical care alone with antiplatelet medications, antihypertensives and antilipidemics as indicated).
Primary outcome
Any ipsilateral stroke at 5 years, in patients with stenosis of 50-69%
15.7%
22.2%
22.2 %
16.6 %
11.1 %
5.5 %
0.0 %
Surgical
therapy
Medical
therapy
Significant
decrease ▼
NNT = 15
Significant decrease in any ipsilateral stroke at 5 years, in patients with stenosis of 50-69% (15.7% vs. 22.2%; RR 0.7, 95% CI 0.48 to 0.93).
Secondary outcomes
No significant difference in any ipsilateral stroke at 5 years, in patients with < 50% stenosis (14.9% vs. 18.7%; RR 0.8, 95% CI -0.31 to 1.91).
Conclusion
In patients with moderate carotid stenosis and TIAs or non-disabling strokes ipsilateral to the stenosis (within 180 days), surgical therapy was superior to medical therapy with respect to any ipsilateral stroke at 5 years, in patients with stenosis of 50-69%.
Reference
Barnett HJ, Taylor DW, Eliasziw M et al. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med. 1998 Nov 12;339(20):1415-25.
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