Washington D.C., October 23, 2007 - Two carotid stenting trials examining patient outcomes demonstrated results that are comparable to guidelines established by the American Heart Association (AHA) for patients treated with carotid artery surgery. The results of these studies were presented today at the Cardiovascular Research Foundation's 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium by William A. Gray, M.D., FACC, associate professor of clinical medicine at Columbia University College of Physicians and Surgeons and director of Endovascular Services at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York. Dr. Gray is the director of Endovascular Services at the Cardiovascular Research Foundation.
An interim analysis of patients treated with carotid stents in Abbotts CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) and EXACT (Emboshield and Xact Post Approval Carotid Stent Trial) post-marketing trials, which enrolled 4,111 patients in over 150 sites, demonstrated 30 day patient outcome results consistent with longstanding AHA guidelines for patients with a severe carotid stenosis but who do not have symptoms. These guidelines recommend that rates of complications for carotid artery surgery to prevent stroke be less than 3 percent for patients without symptoms of stroke (asymptomatic) and 6 percent for patients with symptoms of stroke (symptomatic).
In these two well-conducted carotid artery stenting studies, carotid stenting has achieved outcomes comparable guidelines established for patients who undergo carotid surgery, and has done so in a population of patients who are at high risk for experiencing adverse events from surgery, said Dr. Gray. This is a significant report because this is the first time that these guidelines have been achieved by any revascularization therapy in a large, multi-center exa
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Columbia University Medical Center