WASHINGTON, Oct. 23 /PRNewswire-FirstCall/ -- 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)(1) for patients treated with carotid artery surgery. The results of these studies were presented today in a late-breaking clinical trials session at the Cardiovascular Research Foundation's 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium by William Gray, M.D., FACC, of Columbia University Medical Center in New York.
Patients treated with carotid stents in Abbott's CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) and EXACT(TM) (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% for patients without symptoms of stroke (asymptomatic) and 6% 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.
About Abbott's CAPTURE 2 and EXACT Post-Marketing Clinical Studies
The CAPTURE 2 study included 1,987 patients and utilized Abbott's ACCULINK(TM) Carotid Stent System and ACCUNET(TM) Embolic Protection System. The EXACT study included 2,124 patients and utilized Abbott's Xact(R) Rapid Exchange Carotid Stent System and Emboshield BareWire(TM) Rapid Exchange Embolic Protection System. The key objective of both trials was to determine whether carotid stenting could be performed safely in real-world clinical setting by physicians with varying levels of experience. The primary endpoints were death, stroke and MI at 30 days. The demographics of patients in both trials were similar.
The 30-day composite endpoints of stroke and death for patients in the CAPTURE 2 and EXACT studies were:
-- 3.1% and 3.0% combined stroke and death in CAPTURE 2 and EXACT patients
without symptoms under age 80
-- 6.0% and 7.3% combined stroke and death in CAPTURE 2 and EXACT patients
with symptoms under age 80
-- 3.8% and 4.0% stroke and death within 30-days of treatment for the
combined patient populations
"We are very pleased with the findings from the CAPTURE 2 and EXACT trials, which show that patients treated with Abbott's ACCULINK and XACT carotid artery stent systems can have outcomes comparable to those of patients who undergo carotid surgery," said Charles D. Foltz, vice president, Abbott Vascular. "With approximately 15,000 patients enrolled across our six carotid artery stenting trials, Abbott continues to lead both the understanding and development of less invasive treatment methods for patients with carotid artery disease, which is a cause of stroke."
Patient enrollment for the CAPTURE 2 trial is ongoing. The EXACT trial is closed and 30-day follow up has been completed.
Approximately 25 percent of strokes are caused by carotid artery disease. In carotid artery disease, arteries located on either side of the neck that supply blood to the brain become narrowed or blocked due to the deposition of fatty plaques that can lead to stroke. 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. More than 700,000 Americans will have new (500,000) or recurrent (200,000) strokes each year, and more than 150,000 will die from the events.
About Carotid Artery Stenting
Carotid artery stenting is a minimally invasive alternative treatment to surgery in which a stent is inserted into carotid arteries in the neck in order to stabilize fatty plaque deposits and re-establish adequate blood flow to the brain. Carotid stenting is usually accompanied by an embolic protection filter designed to capture and remove any debris that becomes dislodged during a carotid stenting procedure. Currently, carotid artery stenting in the United States is approved by the FDA for treating patients who are at high risk for experiencing adverse events from surgery or carotid endarterectomy -- an invasive procedure in which the artery is surgically opened and the plaque is removed. Abbott's carotid stenting devices are also being investigated in a broader group of patients who are not at high risk from surgery in two randomized clinical trials called CREST and ACT I, which are comparing stenting to surgery.
For images of Abbott's carotid stent and embolic protection systems and other information, please visit the company's online TCT newsroom at http://www.abbottvascular.com/presskit.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety and effectiveness in treating patients with vascular 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 65,000 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 http://www.abbott.com.
(1) Circulation 1998;97;501-509
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