Data from the CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) study were published today in The New England Journal of Medicine. In this trial, stenting and surgery had similar initial safety and longer-term outcomes for symptomatic and asymptomatic men and women. Adverse event rates of death, stroke and heart attack were also similar for both therapies. Abbott's ACCULINK® Carotid Stent System and ACCUNET® Embolic Protection System were used in the study, which was sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), and partially funded by Abbott.
"As the worldwide market leader in the interventional treatment of carotid artery disease, we are proud of our long-standing commitment to expanding treatment options for patients and to advancing clinical evidence in the field, including our support of the landmark CREST study," said Robert Hance, senior vice president, vascular, Abbott. "Based on the strength of the CREST data, we plan to file an application in the U.S. by the end of this year seeking an expanded indication for the ACCULINK Carotid Stent System to treat patients with carotid artery disease who are at standard risk for surgery."
All carotid stent systems in the United States are currently indicated only for patients who are considered to be at high risk for surgical treatment due to anatomical factors, age or other considerations. The majority of patients with carotid artery disease are not part of this high-risk group, and therefore are not within the current U.S. Food and Drug Administration (FDA) indications for carotid stenting.
Abbott will submit the results of a pre-agreed-upon analysis of the CREST data to the FDA in an application seeking an expanded indication for the ACCULINK Carotid Stent System as a treatment option for patients at standard surgical risk (those patients not considered to be at high risk for surgery). Abbott will seek Medicare coverage for standard-risk patients if the FDA approves the treatment for this broader patient group.
"As a neurosurgeon who has performed both carotid surgeries and carotid stenting procedures, I am pleased to see that carotid stenting and carotid surgery had comparable outcomes for a majority of standard-risk patients in this trial," said L. Nelson "Nick" Hopkins III, M.D., chairman of Neurosurgery, professor of Radiology, and director of the Toshiba Stroke Research Center at the University at Buffalo, State University of New York. "Both therapies met the American Heart Association guidelines for patients with carotid narrowing. Experience, training and patient selection will continue to be of paramount importance in determining success for both treatments."
CREST demonstrated results consistent with long-standing American Heart Association (AHA) guidelines for outcomes in patients with a severe carotid stenosis. These guidelines state that rates of death and stroke for carotid artery surgery within 30 days of the procedure be less than 3 percent for asymptomatic patients and less than 6 percent for symptomatic patients.
In addition to CREST, Abbott is currently enrolling patients in ACT I – an additional randomized clinical trial of patients at standard risk for surgical treatment, which will include up to 1,658 asymptomatic patients under the age of 80. This multi-center study compares carotid surgery to Abbott's second carotid stent and embolic protection system – the Xact® Rapid Exchange Carotid Stent System and the Emboshield family of embolic protection systems.
Abbott is the only company with two distinct carotid stent and embolic protection systems approved by the FDA and on the market in the United States. Abbott also has the most comprehensive clinical trial program studying the benefits of carotid artery stenting. To date, approximately 25,000 patients have been enrolled in nine clinical trials evaluating Abbott's carotid stent systems.
Since the first carotid stent approval in Europe in 1999, more than 100,000 patients have been treated with Abbott's carotid stents and embolic protection systems throughout the world.
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