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(Stroke. 2005;36:1314.)
© 2005 American Heart Association, Inc.

Comments, Opinions, and Reviews

Carotid Artery Stenting

Meeting the Recruitment Challenge of a Clinical Trial

Robert W. Hobson, II, MD; Thomas G. Brott, MD; Gary S. Roubin, MD, PhD; Frank L. Silver, MD Henry J.M. Barnett, MD

From CREST, UMDNJ-New Jersey Medical School (R.W.H.), Newark, NJ; CREST, Mayo Clinic (T.G.B.), Jacksonville, Fla; CREST, Intervention (Cardiology), and Interventional Cardiology (G.S.R.), Lenox Hill, New York, NY; CREST Canada and, UHN Stroke Program (F.L.S.), Toronto Western Hospital, Toronto, ON, Canada; Robarts Research Institute (H.J.M.B.), London, ON, Canada.

Correspondence to Robert W. Hobson II, MD, UMDNJ-New Jersey Medical School ADMC, Bldg. 6, Room 620 30 Bergen Street Newark, NJ 07101. E-mail hobsonrw@umdnj.edu

Key Words: carotid endarterectomy • carotid stenosis • randomized controlled trials • stents

An extract of the first 250 words of the full text is provided, because this article has no abstract.

Clinical efficacy of carotid endarterectomy (CEA), when combined with best medical care and compared with optimal medical management alone, was established in rigorous clinical trials for symptomatic^1–4 and asymptomatic^5,6 extracranial carotid occlusive disease. Enrollment was slow for each, and so reporting of results occurred years after the first randomizations. Nonetheless, increases in the numbers of CEAs in the US and Canada occurred soon after these results became available.⁷ These increases indicated that physicians were exercising restraint while the trials were in progress and then increased referrals for and performance of CEA in response to the positive results.

Carotid artery stenting (CAS) has been recommended as a less invasive but potentially equally effective treatment for carotid disease. Physicians and patients are eager for information comparing CEA and CAS. Data derived from previous and current attempts at randomized clinical trials^8–12 and registries^9,12 (P.L. Whitlow et al, personal communication, 2003) have raised the question of comparability of CEA and CAS, particularly in high-risk patients. None of these trials was powered to compare efficacy of CEA and CAS in symptomatic patients, in which the evidence for CEA is the strongest.^1–4 Fortunately, larger clinical trials are currently underway in North America¹³ and Europe.^10,14 Recruitment into these trials will also be slow and the data may not be available for next 2 to 3 years.

As was recommended previously for CEA, caution should be exercised in the use of CAS, pending reports from these rigorous randomized comparisons of CEA to CAS. We ask that specialists in . . . [Full Text of this Article]

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