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(Stroke. 1996;27:197-198.)
© 1996 American Heart Association, Inc.

Articles

Concern About Safety of Carotid Angioplasty

Hugh G. Beebe, MD; Joseph P. Archie, MD; William H. Baker, MD; Robert W. Barnes, MD; Gary J. Becker, MD; Eugene F. Bernstein, MD¹; Bruce Brener, MD; G. Patrick Clagett, MD; Alexander W. Clowes, MD; John P. Cooke, MD, PhD; Mark A. Creager, MD; Jack L. Cronenwett, MD; Michael Dake, MD; James A. DeWeese, MD; Thomas J. Fogarty, MD; Julie A. Freischlag, MD; Jerry Goldstone, MD; Lazar J. Greenfield, MD; Norman R. Hertzer, MD; Robert W. Hobson, MD; John W. Joyce, MD; Barry T. Katzen, MD; Frank W. LoGerfo, MD; J.P. Mohr, MD; Wesley S. Moore, MD; Hassan Najafi, MD; John J. Ricotta, MD; Thomas S. Riles, MD; Ernest J. Ring, MD; James Robertson, MD; Robert B. Rutherford, MD; Thomas Sos, MD; James C. Stanley, MD; D. Eugene Strandness, MD; David S. Sumner, MD; James Toole, MD; Jonathan B. Towne, MD; Frank J. Veith, MD; Anthony D. Whittemore, MD; James S.T. Yao, MD Christopher K. Zarins, MD

Correspondence to Hugh G. Beebe, MD, Jobst Vascular Center, 2109 Hughes Dr, Suite 400, Toledo, OH 43606.

Key Words: angioplasty • carotid artery diseases • carotid endarterectomy • risk factors

	Introduction

 
Stroke risk reduction for the large majority of patients with high-grade carotid stenosis is presently best accomplished by carotid endarterectomy. When properly applied according to clearly identified standards and guidelines, this treatment is effective, safe, and durable.^{1 2} The results of recent large randomized trials demonstrate conclusively not only the effectiveness of surgical therapy for symptomatic and asymptomatic patients in reducing stroke incidence but also the importance of careful studies in providing definitive information.^{3 4}

With this background of hard-won experience, we view with concern the application of catheter-based angioplasty techniques to carotid artery bifurcation and internal carotid artery disease. Reports of such techniques can be found in small published series characterized by lack of complete descriptive information and absent or limited outcome and follow-up data.^{5 6 7 8 9 10 11 12 13 14 15 16 17 18} Carotid angioplasty with or without stenting has also been promoted widely in continuing education programs, suggesting that it is an established procedure when in fact it is an experimental procedure.

Legal and ethical considerations require that any patient subjected to unproven therapy be completely informed about its experimental nature and the availability and expected outcomes of proven safe and effective alternatives. Only then can a patient freely choose an experimental therapy with unknown safety or efficacy and acknowledge informed consent. Currently, carotid artery dilatation is not an approved indication for percutaneous transluminal angioplasty catheters. Carotid angioplasty applied with devices not authorized for such use in an experimental setting requires documentation of approval by oversight authorities, including an institutional review board.

We are in favor of well-controlled, . . . [Full Text of this Article]

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