Company Plans to File Application by End of Year Seeking an Expanded Indication to Treat Standard-Surgical-Risk Patient Population
ABBOTT PARK, Ill., May 26 /PRNewswire-FirstCall/ -- 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.
For more information about Abbott's carotid stent and embolic protection systems, please visit www.carotidmediakit.com.
About the CREST Study
CREST is a randomized, multi-center clinical trial comparing outcomes of carotid artery stenting and carotid surgery in symptomatic and asymptomatic patients with carotid artery disease.
In the study, stenting and surgery had similar initial safety and longer-term outcomes for symptomatic and asymptomatic men and women. The study showed equivalent low rates of adverse events for either procedure in the 2,502 patients studied, with 6.8 percent of surgery patients and 7.2 percent of stenting patients experiencing a primary endpoint of death, stroke or heart attack event in the periprocedural period (during the procedure and within approximately 30 days thereafter) and ipsilateral strokes up to four years after the procedure (mean follow-up of 2.5 years). In the periprocedural period, 5.2 percent of surgery patients and 4.5 percent of stenting patients experienced any of these adverse events, with a rate of stroke of 2.3 percent in the surgical patients and 4.1 percent in the stenting group, and a rate of heart attack of 2.3 percent in the surgical group and 1.1 percent in the stenting group. After the periprocedural period, the incidence of ipsilateral stroke was similar for stenting (2.0 percent) and surgery (2.4 percent).
The rate of cranial nerve palsy during the periprocedural period was 4.7 percent for the surgical group and 0.3 percent for the stenting group (representing crossover stenting patients who also underwent the surgical procedure). Cranial nerve palsy refers to a temporary injury of the nerves that run close to the carotid artery, potentially causing difficulty with speaking, swallowing and facial expressions. It is not a complication of stenting.
Treatments for Carotid Artery Disease
Carotid artery disease involves the buildup of plaque in one or both carotid arteries in the neck. The carotid arteries supply vital oxygen and glucose-rich blood to the parts of the brain where thinking, speech, personality, and sensory and motor functions reside. Patients with carotid artery disease have three treatment options: carotid artery stenting – which currently is approved in the United States for high-risk patients only – carotid surgery, known as carotid endarterectomy, or medical therapy.
The traditional surgical treatment for carotid artery disease usually entails general anesthesia and involves an incision in the patient's neck and artery to remove plaque from inside the vessel wall. In contrast, during a carotid stenting procedure, an embolic protection system is positioned in the carotid artery and a stent is deployed using a catheter inserted into a small puncture in the patient's groin. The patient usually remains conscious while the stent is implanted at the site of the blockage. The embolic protection system is designed to capture and remove particles of plaque that might be dislodged during the procedure, which could potentially lead to stroke and other complications.
About Stroke and Carotid Artery Disease
Stroke is the third leading cause of death in the United States and the number one cause of disability in adults, according to the American Heart Association. Strokes can be caused by carotid artery disease. An ischemic stroke, the most common type, can occur when carotid arteries become narrowed and when small particles of atherosclerotic plaque become dislodged from the diseased artery wall. This embolic material can travel through the bloodstream and block vessels in the brain. More than 795,000 Americans will have new (610,000) or recurrent (185,000) strokes each year. On average, every four minutes someone dies of stroke.(1)
About Abbott Vascular
Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 83,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at www.abbott.com.
(1) Circulation "Heart Disease and Stroke Statistics 2010 Update. A Report From the American Heart Association." January 26, 2010