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Protected carotid stenting in high-surgical-risk patients: the ARCHeR results
William A Gray1, L Nelson Hopkins, Sanjay Yadav
1Columbia University Medical Center, New York, NY 10032, USA. wg2131@columbia.edu
Insights
Carotid artery stenting with embolic protection is a safe and effective alternative for high-risk patients. The ARCHeR trial showed stenting is not inferior to carotid endarterectomy for severe carotid artery disease.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Neurology
Background:
- Carotid endarterectomy is standard for severe carotid bifurcation disease.
- Safety and efficacy in high-surgical-risk patients remain unclear.
- The ARCHeR trial investigated carotid artery stenting as an alternative.
Purpose of the Study:
- To determine if carotid artery stenting with embolic protection is safe and effective.
- To compare stenting outcomes to carotid endarterectomy in high-risk patients.
Main Methods:
- Prospective, multicenter, nonrandomized studies (ARCHeR trial).
- 581 high-surgical-risk patients with severe carotid stenosis enrolled.
- ACCULINK stent and ACCUNET filter used in most patients.
Main Results:
- 30-day death/stroke/myocardial infarction rate was 8.3%.
- 30-day major/fatal stroke rate was 1.5%.
- 1-year composite endpoint was 9.6%, below the 14.4% historical control.
Conclusions:
- Carotid artery stenting with embolic filter protection is not inferior to endarterectomy.
- Stenting is a safe, durable, and effective option for high-surgical-risk patients.
Background:
Carotid endarterectomy is the standard of care for most patients with severe extracranial carotid bifurcation disease. However, its safety and efficacy in patients with significant surgical risk are unclear. The ARCHeR (ACCULINK for Revascularization of Carotids in High-Risk patients) trial was performed to determine whether carotid artery stenting with embolic protection is a safe and effective alternative to endarterectomy in high-surgical-risk patients.
Methods:
The ARCHeR trial is a series of three sequential, multicenter, nonrandomized, prospective studies. Forty-eight sites enrolled 581 high-surgical-risk patients between May 2000 and September 2003. Patients with severe carotid artery stenosis (angiographically defined, symptomatic > or =50%, or asymptomatic > or =80%) had an ACCULINK nitinol stent implanted. The ACCUNET filter embolic protection system was added to the procedure in the final 2 studies (422 patients). The primary efficacy end point was a composite of periprocedural (< or =30 days) death, stroke, and myocardial infarction, plus ipsilateral stroke between days 31 and 365.
Results:
The 30-day rate of death/stroke/myocardial infarction was 8.3% (95% confidence interval [CI], 6.2%-10.8%), and that of stroke/death was 6.9% (95% CI, 5.0%-9.3%). Most (23/32) strokes were minor, of which more than half (12/23) returned to baseline National Institutes of Health Stroke Scale scores within 30 days. The 30-day major/fatal stroke rate was 1.5% (95% CI, 0.7%-2.9%). No hemorrhagic strokes were observed in the study. Ipsilateral cerebrovascular accident occurred in 1.3% between 30 days and 1 year, thus giving a primary composite end point of 30-day death/stroke/myocardial infarction plus ipsilateral stroke at 1 year of 9.6% (95% CI, 7.2%-12.0%), which is below the 14.4% historical control comparator. Target lesion revascularization at 12 months and 2 years was 2.2% and 2.9%, respectively.
Conclusions:
The ARCHeR results demonstrate that extracranial carotid artery stenting with embolic filter protection is not inferior to historical results of endarterectomy and suggest that carotid artery stenting is a safe, durable, and effective alternative in high-surgical-risk patients.