Medical Management and Revascularization for Asymptomatic Carotid Stenosis
Thomas G Brott1, George Howard2, Brajesh K Lal3
1Department of Neurology, Mayo Clinic, Jacksonville, FL.
Insights
For asymptomatic carotid stenosis, carotid artery stenting significantly reduced stroke risk compared to medical management alone. Carotid endarterectomy showed no significant benefit over intensive medical therapy in this patient group.
Area of Science:
- Neurology
- Vascular Surgery
- Clinical Trials
Background:
- Advances in medical therapy, carotid stenting, and endarterectomy necessitate re-evaluation of asymptomatic carotid stenosis management.
- The comparative benefit of revascularization plus intensive medical management versus medical management alone remains unclear.
Purpose of the Study:
- To compare the efficacy of carotid artery stenting plus intensive medical management versus intensive medical management alone for high-grade asymptomatic carotid stenosis.
- To compare the efficacy of carotid endarterectomy plus intensive medical management versus intensive medical management alone for high-grade asymptomatic carotid stenosis.
Main Methods:
- Two parallel, observer-blinded clinical trials enrolled patients with high-grade (≥70%) asymptomatic carotid stenosis across 155 centers.
- The primary outcome was a composite of stroke or death within 44 days, or ipsilateral ischemic stroke up to 4 years.
Main Results:
- In the stenting trial, the 4-year event rate was 2.8% for stenting plus medical management vs. 6.0% for medical management alone (P=0.02).
- In the endarterectomy trial, the 4-year event rate was 3.7% for endarterectomy plus medical management vs. 5.3% for medical management alone (P=0.24).
- Perioperative stroke/death rates were higher in the stenting and endarterectomy groups compared to the medical-therapy group within 44 days.
Conclusions:
- Carotid artery stenting, when added to intensive medical management, significantly reduced the risk of stroke or death in patients with high-grade asymptomatic carotid stenosis.
- Carotid endarterectomy did not demonstrate a significant benefit over intensive medical management alone in this patient population.
Background:
Improvements in medical therapy, carotid-artery stenting, and carotid endarterectomy call into question the preferred management of asymptomatic carotid stenosis. Whether adding revascularization to intensive medical management would provide greater benefit than intensive medical management alone is unclear.
Methods:
We conducted two parallel, observer-blinded clinical trials that enrolled patients with high-grade (≥70%) asymptomatic carotid stenosis across 155 centers in five countries. The stenting trial compared intensive medical management alone (medical-therapy group) with carotid-artery stenting plus intensive medical management (stenting group); the endarterectomy trial compared intensive medical management alone (medical-therapy group) with carotid endarterectomy plus intensive medical management (endarterectomy group). The primary outcome was a composite of any stroke or death, assessed from randomization to 44 days, or ipsilateral ischemic stroke, assessed during the remaining follow-up period up to 4 years.
Results:
A total of 1245 patients underwent randomization in the stenting trial and 1240 in the endarterectomy trial. In the stenting trial, the 4-year incidence of primary-outcome events was 6.0% (95% confidence interval [CI], 3.8 to 8.3) in the medical-therapy group and 2.8% (95% CI, 1.5 to 4.3) in the stenting group (P = 0.02 for the absolute difference). In the endarterectomy trial, the 4-year incidence of primary-outcome events was 5.3% (95% CI, 3.3 to 7.4) in the medical-therapy group and 3.7% (95% CI, 2.1 to 5.5) in the endarterectomy group (P = 0.24 for the absolute difference). From day 0 to 44, in the stenting trial, no strokes or deaths occurred in the medical-therapy group and seven strokes and one death occurred in the stenting group; in the endarterectomy trial, three strokes occurred in the medical-therapy group and nine strokes occurred in the endarterectomy group.
Conclusions:
Among patients with high-grade stenosis without recent symptoms, the addition of stenting led to a lower risk of a composite of perioperative stroke or death or ipsilateral stroke within 4 years than intensive medical management alone. Carotid endarterectomy did not lead to a significant benefit. (Funded by the National Institute of Neurological Disorders and Stroke and others; CREST-2 ClinicalTrials.gov number, NCT02089217.).
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