Statement regarding carotid angioplasty and stenting☆☆☆

Article Outline

 

The performance of carotid angioplasty and stenting has been advocated as an alternative treatment to carotid endarterectomy for patients who have carotid artery bifurcation stenosis. Recently, some investigators have called for a prospective randomized clinical trial to compare the two treatment methods. Several contemporary prospective randomized clinical trials of patients both with symptomatic and with asymptomatic carotid stenosis have clearly demonstrated that carotid endarterectomy is superior to the best medical therapy, provided that surgical complication rates are within well-defined limits. The surgery-related stroke/death rate should be lower than 6% for symptomatic patients and lower than 3% for asymptomatic patients who have severe carotid stenosis. Published results of carotid angioplasty and stenting procedures reveal significantly higher stroke/death rates than those that have been achieved with carotid endarterectomy. Of particular concern is the unacceptably high complication rate reported with the use of this new experimental technology in patients who have asymptomatic carotid bifurcation stenosis.

The Society for Vascular Surgery (SVS) and the International Society for Cardiovascular Surgery, North American Chapter (ISCVS-NA) support the investigation, evaluation, and development of new and promising treatment methods for patients who have carotid artery disease. The safety of any new therapy, however, must be clearly established in controlled and adequately monitored clinical trials under Institutional Review Board (IRB) and Food and Drug Administration (FDA) guidelines for such therapy. When such clinical trials can demonstrate that carotid angioplasty and stenting procedures have a treatment-related risk that is comparable with that of carotid endarterectomy, a prospective randomized trial should be conducted to determine the relative efficacy of the two treatment methods. Until the safety and efficacy of carotid angioplasty and stenting can be proved, the widespread clinical application of this technology is not justified.

For the Joint Council of the Society for Vascular Surgery (SVS) and the International Society for Cardiovascular Surgery, North American Chapter (ISCVS-NA):

SVS

James C. Stanley, MD William M. Abbott, MD Jonathan B. Towne, MD Christopher K. Zarins, MD Jack L. Cronenwett, MD Thomas J. Fogarty, MD Norman R. Hertzer, MD Frank J. Veith, MD Bruce J. Brener, MD

ISCVS-NA

Robert B. Smith III, MD William H. Baker, MD Anthony D. Whittemore, MD Alexander W. Clowes, MD William H. Pearce, MD Jerry Goldstone, MD Robert B. Rutherford, MD Ronald J. Stoney, MD George Johnson, Jr., MD