October 25, 2007 — Two carotid stenting trials examining outcomes in real-world patients demonstrated for the first time results that are comparable to guidelines established by the American Heart Association (AHA) for patients treated with carotid artery surgery, the results of which were presented by William Gray, M.D., FACC, of Columbia University Medical Center in New York at TCT 2007.
Patients treated with carotid stents in Abbott’s 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, demonstrated 30 day patient outcome results that are comparable to the AHA outcome guidelines for patients less than 80 years old who undergo carotid surgery (carotid endarterectomy). These guidelines recommend stroke and death rates that are within 3 percent for patients without symptoms of stroke (asymptomatic) and 6 percent for patients with symptoms of stroke (symptomatic).
"With these two very large, well-conducted, real-world carotid artery stenting trials, not only has carotid stenting achieved a comparable outcome to guidelines established for patients who undergo carotid surgery, but it also did so in a population of patients who are at high risk for experiencing adverse events from surgery," said Dr. Gray "This is significant because this is the first time physicians have achieved results in high surgical risk candidates that are comparable to the long-standing guidelines that were established for lower surgical risk candidates, demonstrating that stenting can provide a reliable non-surgical alternative for patients facing the difficult decision of how to manage their carotid artery disease."
In 1998, the American Heart Association published its 30 day outcome guidelines in Circulation for patients treated with carotid artery surgery. These guidelines were based on the observed stroke and death rates in patients with carotid artery disease who had undergone surgery, or carotid endarterectomy, to treat their condition. The patients who underwent carotid artery surgery were at standard risk for experiencing an adverse event from surgery. Abbott's post-marketing CAPTURE 2 and EXACT studies are the first real-world carotid artery stenting studies to demonstrate results comparable to these goals.
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