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Updated: Jun 23, 2026
A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Long-term results of carotid stenting versus endarterectomy in high-risk patients
Hitinder S Gurm1, Jay S Yadav, Pierre Fayad
1University of Michigan School of Medicine, Ann Arbor, USA.
Insights
Carotid artery stenting with emboli-protection devices is as effective as endarterectomy for severe carotid stenosis over 3 years. Long-term outcomes show no significant difference in major adverse events between the two procedures.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Neurology
Background:
- Previous reports indicated carotid stenting with emboli-protection devices is non-inferior to endarterectomy at 30 days and 1 year.
- This study presents the 3-year follow-up results of the randomized trial.
Purpose of the Study:
- To compare the long-term efficacy and safety of carotid artery stenting with emboli-protection devices versus endarterectomy in patients with severe carotid artery stenosis and increased surgical risk.
Main Methods:
- A randomized trial involving 334 patients with symptomatic (≥50% stenosis) or asymptomatic (≥80% stenosis) carotid artery disease at increased risk for endarterectomy complications.
- The primary endpoint was a composite of death, stroke, or myocardial infarction within 30 days, or death or ipsilateral stroke between 31 days and 3 years.
Main Results:
- At 3 years, follow-up data were available for 260 patients (77.8%).
- The cumulative incidence of the major secondary endpoint was 24.6% for stenting and 26.9% for endarterectomy (absolute difference: -2.3%; 95% CI: -11.8 to 7.0).
- There were 15 strokes in each group, with 11 ipsilateral strokes in the stenting group and 9 in the endarterectomy group.
Conclusions:
- In patients with severe carotid artery stenosis and elevated surgical risk, carotid artery stenting with an emboli-protection device demonstrated no significant difference in long-term outcomes compared to endarterectomy.
- Both interventions offer comparable long-term safety and efficacy for this patient population.
Background:
We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy for the treatment of carotid artery disease at 30 days and at 1 year. We now report the 3-year results.
Methods:
The trial evaluated carotid artery stenting with the use of an emboli-protection device as compared with endarterectomy in 334 patients at increased risk for complications from endarterectomy who had either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%. The prespecified major secondary end point at 3 years was a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and 1080 days (3 years).
Results:
At 3 years, data were available for 260 patients (77.8%), including 85.6% of patients in the stenting group and 70.1% of those in the endarterectomy group. The prespecified major secondary end point occurred in 41 patients in the stenting group (cumulative incidence, 24.6%; Kaplan-Meier estimate, 26.2%) and 45 patients in the endarterectomy group (cumulative incidence, 26.9%; Kaplan-Meier estimate, 30.3%) (absolute difference in cumulative incidence for the stenting group, -2.3%; 95% confidence interval, -11.8 to 7.0). There were 15 strokes in each of the two groups, of which 11 in the stenting group and 9 in the endarterectomy group were ipsilateral.
Conclusions:
In our trial of patients with severe carotid artery stenosis and increased surgical risk, no significant difference could be shown in long-term outcomes between patients who underwent carotid artery stenting with an emboli-protection device and those who underwent endarterectomy. (ClinicalTrials.gov number, NCT00231270 [ClinicalTrials.gov].).
