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Study in JAMA Shows Patients Treated With Abbott's XIENCE™ V Drug Eluting Stent Experience Better Outcomes Than Patients Treated With Market-Leading Drug Eluting Stent
SPIRIT III Results Demonstrate Superior Reduction in In-Segment Late Loss, Non-Inferiority in Target Vessel Failure and Low Rates of MACE with XIENCE V Compared to TAXUS
Study in JAMA Shows Patients Treated With Abbott's XIENCE™ V Drug
Eluting Stent Experience Better Outcomes Than Patients Treated With Market-Leading
Drug Eluting Stent
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April 22, 2008 -- Abbott Park, Illinois --
A study published in today's Journal of the American Medical Association
(JAMA) demonstrated that use of Abbott's XIENCE™ V Everolimus
Eluting Coronary Stent System in patients with coronary artery disease
resulted in a significant 50 percent reduction in vessel renarrowing
(in-segment late loss) at eight months, non-inferior rates of target
vessel failure (TVF) at nine months, and an observed 42 percent reduction
in major adverse cardiac events (MACE) at one year compared to the
TAXUS® Paclitaxel-Eluting Coronary Stent System. The SPIRIT III study
is a 1,002-patient, prospective, multi-center, randomized clinical
trial designed to evaluate the safety and efficacy of the XIENCE V
stent system compared to the TAXUS stent system.
"SPIRIT III is the first large-scale clinical trial to show that patients have a lower risk of experiencing a heart attack, cardiac death or re-treatment when treated with a new stent, XIENCE V, compared to the most widely used drug eluting stent TAXUS," said Gregg W. Stone, M.D., of the Columbia University Medical Center; chairman, Cardiovascular Research Foundation, New York; and principal investigator of the SPIRIT III clinical trial. "With a significant reduction in angiographic in-segment late loss, non-inferiority in target vessel failure and a clinical advantage in the composite rate of MACE compared to TAXUS, XIENCE V represents an important advance in improving the lives of patients with coronary artery disease."
The SPIRIT III clinical trial demonstrated the following key results for XIENCE V:
- Statistical superiority to TAXUS on
the study's primary endpoint of in-segment late loss at eight
months. XIENCE V demonstrated a
statistically significant 50 percent reduction in late loss compared
to TAXUS (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS).
- Statistical
non-inferiority to TAXUS in the major secondary (co-primary)
endpoint of target vessel failure (TVF) at nine months.
XIENCE V demonstrated an observed 20 percent reduction in TVF compared
to TAXUS (7.2 percent for XIENCE V vs. 9.0 percent for TAXUS). TVF
is a composite clinical measure of safety and efficacy outcomes
defined as
cardiac death, heart attack (myocardial infarction or MI) or target
vessel revascularization (TVR).
- An observed 43 percent reduction
in the pre-specified secondary endpoint of major adverse cardiac
events (MACE) at nine months
(4.6 percent for XIENCE V vs. 8.1 percent for TAXUS) and an observed
42 percent reduction in MACE at one year (6.0 percent for XIENCE
V vs. 10.3 percent for TAXUS) compared to TAXUS. MACE is an
important composite clinical measure of safety and efficacy outcomes
for
patients, defined as cardiac death, heart attack (MI), or
ischemia-driven target lesion revascularization (TLR driven by
lack of
blood supply).
"The low rate of MACE seen with XIENCE V in the SPIRIT III trial can be directly
attributed to fewer patients experiencing heart attacks or re-treatment, and
is consistent with data from previous trials," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. "Superior efficacy combined with increased flexibility and deliverability reinforce that XIENCE V is a significant advancement in stent technology that will be a welcome addition to the field of interventional cardiology."
Additional Results from SPIRIT III
There were no significant differences between XIENCE V and TAXUS in
the rates of stent thrombosis either early (less than or equal to 30
days) or late (> 30 days), whether analyzed per protocol or by the Academic Research Consortium (ARC) definition. Rates of definite/probable late stent thrombosis at one year under the ARC definition were 0.5 percent for XIENCE V and 0.6 percent for TAXUS. The ARC definition of late stent thrombosis was developed to eliminate variability in the definitions across various drug eluting stent trials.
In addition, the reduction in in-segment late loss at eight months
with XIENCE V compared to TAXUS was consistent across a variety of
subgroups in the SPIRIT III trial; however, the SPIRIT III trial was
underpowered to measure statistical differences in any of the subgroups.
The SPIRIT III nine-month results were previously reported in March
2007 at the American College of Cardiology's 56th Annual Scientific
Session, and the one-year results were previously reported in October
2007 at the Transcatheter Cardiovascular Therapeutics scientific symposium.
The SPIRIT III two-year results will be presented in mid-May at EuroPCR
2008 in Barcelona, Spain.
About the SPIRIT III Trial
SPIRIT III is a prospective, multi-center, randomized, single-blind,
controlled clinical trial comparing XIENCE V to TAXUS in 1,002 patients
(669 XIENCE V patients, 333 TAXUS patients) with either one or two
de novo native coronary artery lesions. The trial was conducted across
65 academic and community-based centers in the United States between
June 22, 2005 and March 15, 2006. The primary endpoint was in-segment
late loss at eight months and the major secondary (co-primary) endpoint
was TVF at nine months. An additional pre-specified secondary endpoint
included MACE at nine months and one year.
About XIENCE V
The XIENCE V stent system utilizes everolimus, which has been shown
to reduce tissue proliferation in the coronary vessels following stent
implantation, and is based upon the highly deliverable and proven MULTI-LINK
VISION® coronary stent platform.
XIENCE V was launched in Europe and other international markets in
late 2006. XIENCE V is an investigational device in the United States
and Japan, and is currently under review for approval by the U.S. Food
and Drug Administration.
Abbott also supplies a private-label version of XIENCE V to Boston
Scientific called the PROMUS™ Everolimus-Eluting Coronary Stent System. PROMUS is designed, studied and manufactured by Abbott and supplied as part of a distribution agreement between the two companies.
Everolimus is licensed to Abbott by Novartis for use on its drug eluting
stents.
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.
About Abbott
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
more than 68,000 people and markets its products in more than 130 countries.
Source: Abbott
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