This Article Full Text Full Text (PDF) All Versions of this Article: 38/6/1993    most recent STROKEAHA.107.484352v1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Qureshi, A. I. Search for Related Content PubMed PubMed Citation Articles by Qureshi, A. I. Related Collections Anticoagulants

(Stroke. 2007;38:1993.)
© 2007 American Heart Association, Inc.

Emerging Therapies

Carotid Angioplasty and Stent Placement after EVA-3S Trial

From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis, Minn.

Correspondence to Adnan I. Qureshi, MD, Department of Neurology, University of Minnesota, MMC 295, 420 Delaware St SE, Minnesota, MN 55455. E-mail aiqureshi@hotmail.com

Marc Fisher MD Kennedy Lees MD Section Editors

Key Words: angioplasty • stent placement • carotid stenosis • carotid artery • carotid endarterectomy

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

A clinical trial is an endeavor where every attempt is made to optimize the quality and quantity of learning before venturing into the unknown".¹ Recently, the Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial² investigators reported the results of a multicenter, randomized, noninferiority trial comparing stent placement with endarterectomy in patients with symptomatic carotid stenosis of 60%. Patients were eligible if they experienced a hemispheric or retinal transient ischemic attack or a nondisabling stroke (or retinal infarct) within 120 days before enrollment. Endarterectomy or stent placement was to be performed within 2 weeks after randomization. The primary end point was the occurrence of any stroke or death within 30 days after treatment. The trial started recruiting in November 2000. In January 2003, the safety committee recommended mandatory use of distal protection devices because of a higher risk of stroke in patients treated without distal protection. Although initially recruiting patients with stenosis of 70%, the trial started recruiting patients with stenosis of 60% in October 2003. In September 2005, the safety committee recommended stopping enrollment after 527 patients (intended target recruitment of 872 patients) had been randomized. On the basis of the observed 30-day risk of stroke or death after endarterectomy, >4000 patients were required to test the noninferiority of stent placement. Given the observed 30-day risks of stent placement, the committee considered it to be extremely unlikely that the trial would reach its objectives despite further enrollment.

The 30-day incidence of any stroke or death was . . . [Full Text of this Article]

This article has been cited by other articles:

				M. A. Mansour Carotid Artery Stenting in the SPACE and EVA-3S Trials: Analysis and Update Perspectives in Vascular Surgery and Endovascular Therapy, March 1, 2008; 20(1): 11 - 14. [Abstract] [PDF]

				J. Golledge Carotid Intervention in Asymptomatic Patients Stroke, January 1, 2008; 39(1): e17 - e17. [Full Text] [PDF]

				J.-L. Mas, G. Chatellier, and for the EVA3S investigators Carotid Angioplasty and Stenting Stroke, January 1, 2008; 39(1): e19 - e20. [Full Text] [PDF]