Protected carotid stenting in high-surgical-risk patients: The ARCHeR results

Gray, William A.; Hopkins, L. Nelson; Yadav, Sanjay; Davis, Thomas; Wholey, Mark; Atkinson, Richard; Cremonesi, Alberto; Fairman, Ronald; Walker, Gary; Verta, Patrick; Popma, Jeff; Virmani, Renu; Cohen, David J.; ARCHeR Trial Collaborators,

doi:10.1016/j.jvs.2006.03.044

« Previous Next »Journal of Vascular Surgery
Volume 44, Issue 2 , Pages 258-268, August 2006

Protected carotid stenting in high-surgical-risk patients: The ARCHeR results

Presented at the American College of Cardiology Annual Scientific session, March 7–10, 2004, New Orleans, LA.

William A. Gray, MD
- Columbia University Medical Center, New York, NY
- Reprint requests: William A. Gray, MD, Center for Interventional Vascular Therapy/Columbia University Medical Center, Cardiovascular Research Foundation, New York, NY 10032
L. Nelson Hopkins, MD
- Millard Fillmore Hospital, Buffalo, NY
Sanjay Yadav, MD
- The Cleveland Clinic Foundation, Cleveland, Ohio
Thomas Davis, MD
- St John Hospital, Detroit, Mich
Mark Wholey, MD
- University of Pittsburgh, Pittsburgh, Penn
Richard Atkinson, MD
- University of California at Davis, Sacramento, Calif
Alberto Cremonesi, MD
- Villa Maria Cecilia Hospital, Cotignola (Ravenna), Ravenna, Italy
Ronald Fairman, MD
- Hospital at University of Pennsylvania, Philadelphia, Penn
Gary Walker, PhD
- Guidant Endovascular Solutions, Santa Clara
Patrick Verta, MD
- Guidant Endovascular Solutions, Santa Clara
Jeff Popma, MD
- Brigham and Women’s Hospital, Boston, Mass
Renu Virmani, MD
- Armed Forces Institute of Pathology, Bethesda, Md
David J. Cohen, MD, MSc
- Harvard Clinical Research Institute, Boston, Mass
ARCHeR Trial Collaborators
- Other collaborators of the ARCHeR trial are listed in Appendix I.

Received 11 January 2006; accepted 30 March 2006.

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 ≥50%, or asymptomatic ≥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 (≤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.

The ARCHeR trials were funded by Guidant Corporation (Santa Clara, Calif).

Competition of interest: The authors below, along with authors not listed here, may have relationships with other companies which were not deemed in conflict with the reporting of the results of this trial. Specific to the sponsor of the study, the following disclosures are made: Dr Walker, Guidant employee; Dr Verta, Guidant employee; Dr Atkinson, consultant to Guidant; Dr Fairman, research grant support from Guidant; Dr Wholey, consultant to Guidant; Dr Hopkins, research grant support from Guidant; Dr Cohen, consultant to Guidant; Dr Virmani, consultant to Guidant; and Dr Gray, consultant to Guidant.

PII: S0741-5214(06)00745-2

doi:10.1016/j.jvs.2006.03.044