Published Online
on March 6, 2009

A more recent version of this article appeared on June 1, 2009

This Article Full Text (PDF) All Versions of this Article: 2/3/159    most recent CIRCINTERVENTIONS.108.823013v1 Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal 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 Gray, W. A. Articles by Verta, P. Search for Related Content PubMed Articles by Gray, W. A. Articles by Verta, P. Related Collections Catheter-based coronary interventions: stents Carotid Stenosis Carotid endarterectomy Angioplasty and Stenting Related Article

Original Article

30-Day Outcomes for Carotid Artery Stenting in 6,320 Patients From Two Prospective, Multicenter, High Surgical Risk Registries

William A. Gray^1,4; Seemant Chaturvedi² and Patrick Verta³

¹ Columbia University;
² Wayne State University;
³ Abbott Vascular, Endovascular Global Clinical Science

⁴ E-mail: wgray{at}crf.org

Background—The American Heart Association (AHA) established guidelines for acceptable 30-day death and stroke rates for patients with severe carotid disease undergoing standard risk carotid endarterectomy: <3% for asymptomatic lesions and <6% for symptomatic lesions. To date, carotid stenting (CAS) has not demonstrated these outcomes in multicenter, prospective assessments of high surgical risk patients.

Methods and Results—Data from two prospective, multicenter (280 United States sites, 672 operators), post-market surveillance studies in high-surgical risk patients were analyzed: 2145 patients from EXACT (EX) and 4175 patients from CAPTURE 2 (C2). Both studies had pre- and post-procedure neurologic evaluation and independent adjudication of neurologic events. The overall 30-day death and stroke rate was 4.1% [95% CI: 3.3%, 5.0%] for EX and 3.4% [95% CI: 2.9%, 4.0%] for C2. In the population comparable to AHA guidelines (<80 years), the combined 30-day death and stroke rate was 5.3% [95% CI: 3.6%, 7.4%] for symptomatic patients and 2.9% [95% CI: 2.4%, 3.4%] for asymptomatic patients, independent of unfavorable risk factors (anatomic or physiologic); in patients 80 years, this rate was 10.5% [95% CI: 6.3%, 16.0%] and 4.4% [95% CI: 3.3%, 5.7%], respectively. In subjects with anatomic features unfavorable for surgery, the 30-day death and stroke rates were 1.7% [95% CI: 0.0%, 8.9%] and 2.7% [95% CI: 1.3%, 4.9%] for symptomatic and asymptomatic cohorts respectively, independent of age.

Conclusions—Outcomes for CAS in non-octogenarian high-surgical risk patients have improved since the pivotal FDA approval trials; they achieved AHA standards in both symptomatic and asymptomatic lesions.

Key Words: carotid arteries • stenosis • stents • stroke • outcomes

Author contributions: Submitted on behalf of the investigators and the Executive Committees of Abbott Vascular.

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				M. Roffi, D. Mukherjee, and D. G. Clair Carotid artery stenting vs. endarterectomy Eur. Heart J., November 2, 2009; 30(22): 2693 - 2704. [Abstract] [Full Text] [PDF]