ECST
Trial question
What is the role of carotid endarterectomy in adult patients with carotid stenosis who experienced at least one ischemic vascular event in the distribution of one or both carotid arteries in the previous 6 months?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 3018
3018 patients (850 female, 2168 male).
Inclusion criteria: adult patients with carotid stenosis with ≥ 1 ischemic vascular event in the distribution of one or both carotid arteries in the previous 6 months.
Key exclusion criteria: doctors reasonably certain surgery is indicated or not indicated, embolism from the heart to the brain or eye, or more severe disease of the distal than of the proximal ICA.
Interventions
N=1807 carotid endarterectomy (within 1 year of randomization).
N=1211 no routine surgical intervention (surgery to be avoided for as long as possible).
Primary outcome
Major stroke or death at 3 years, in patients with stenosis > 80%
14.9%
26.5%
26.5 %
19.9 %
13.3 %
6.6 %
0.0 %
Carotid
endarterectomy
No routine surgical
intervention
Significant
increase ▲
NNH = 8
Significant increase in major stroke or death at 3 years, in patients with stenosis > 80% (14.9% vs. 26.5%; ARD 11.6, 95% CI 4.72 to 18.48).
Conclusion
In adult patients with carotid stenosis with ≥ 1 ischemic vascular event in the distribution of one or both carotid arteries in the previous 6 months, carotid endarterectomy was superior to no routine surgical intervention with respect to major stroke or death at 3 years, in patients with stenosis > 80%.
Reference
European Carotid Surgery Trialists' Collaborative Group. Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST). Lancet. 1998 May 9;351(9113):1379-87.
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