Press Release
Real-World Studies of Carotid Artery Stenting Demonstrate Results Comparable to Guidelines for Patients Treated with Surgery
Washington, October 23, 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)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 (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.
About Abbott's CAPTURE 2 and EXACT Post-Marketing Clinical
Studies
The CAPTURE 2 study included 1,987 patients and utilized Abbott's ACCULINK™
Carotid Stent System and ACCUNET™ Embolic Protection System. The EXACT study
included 2,124 patients and utilized Abbott's Xact Rapid Exchange Carotid Stent
System and Emboshield BareWire™ 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 percent and 3.0 percent combined stroke and death in CAPTURE 2 and EXACT patients without symptoms under age
80
- 6.0 percent and 7.3 percent combined stroke and death in CAPTURE 2 and EXACT patients with symptoms under age
80
- 3.8 percent and 4.0 percent 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.
About Stroke
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 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.
Learn more about Abbott
Vascular.
About Abbott
Abbott 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.
References
1 Circulation 1998;97;501-509
Media:
Karin Bauer Aranaz |
(650) 868-2999 |
Financial:
Tina Ventura |
(847) 935-9390 |
