Study in JAMA Shows Patients Treated With Abbott's XIENCE(TM) V Drug Eluting Stent...

Study in JAMA Shows Patients Treated With Abbott's XIENCE(TM) 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

ABBOTT PARK, Ill., April 22 /PRNewswire-FirstCall/ -- A study published in
today's Journal of the American Medical Association (JAMA) demonstrated that
use of Abbott's XIENCE(TM) 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(R) 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(R) 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(TM) 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.
For images of Abbott's XIENCE V stent and other information, please visit
the company's online 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.
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.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com.
SOURCE Abbott

Media, Kelly Morrison, +1-847-937-3802, or Karin Bauer, +1-408-845-3887, or
Financial, John Thomas, +1-847-938-2655, or Tina Ventura, +1-847-935-9390, all
of Abbott