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Original Articles

Thirty-Day Outcomes for Carotid Artery Stenting in 6320 Patients From 2 Prospective, Multicenter, High-Surgical-Risk Registries

William A. Gray, MD; Seemant Chaturvedi, MD; Patrick Verta, DVM, MD on behalf of the Investigators and the Executive Committees

From the Center for Interventional Vascular Therapy (W.A.G.), Columbia University, New York, NY; Department of Neurology and Stroke Program (S.C.), Wayne State University, Detroit, Mich; and Abbott Vascular (P.V.), Endovascular Global Clinical Science, Santa Clara, Calif.

Correspondence to William A. Gray, MD, Center for Interventional Vascular Therapy, Columbia University, 161 Ft Washington Ave, Fifth Floor, New York, NY 10032. E-mail wg2131{at}columbia.edu

Received September 26, 2008; accepted February 23, 2009.

Background— The American Heart Association has 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 artery stenting has not demonstrated these outcomes in multicenter, prospective assessments of high-surgical-risk patients.

Methods and Results— Data from 2 prospective, multicenter (280 US sites, 672 operators), postmarket surveillance studies in high-surgical-risk patients were analyzed: 2145 patients from the Emboshield and Xact Post Approval Carotid Stent Trial (EX) and 4175 patients from the Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events (C2). Both studies had pre- and postprocedure neurological evaluation and independent adjudication of neurological events. The overall 30-day death and stroke rate was 4.1% (95% CI, 3.3% to 5.0%) for EX and 3.4% (95% CI, 2.9% to 4.0%) for C2. In the population comparable with American Heart Association guidelines (<80 years), the combined 30-day death and stroke rate was 5.3% (95% CI, 3.6% to 7.4%) for symptomatic patients and 2.9% (95% CI, 2.4% to 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% to 16.0%) and 4.4% (95% CI, 3.3% to 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% to 8.9%) and 2.7% (95% CI, 1.3% to 4.9%) for symptomatic and asymptomatic cohorts, respectively, independent of age.

Conclusions— Outcomes for carotid artery stenting in nonoctogenarian high-surgical-risk patients have improved since the pivotal Food and Drug Administration approval trials, and have achieved American Heart Association standards in both symptomatic and asymptomatic lesions.

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

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CLINICAL PERSPECTIVE

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