XIENCE(tm) V Drug Eluting Stent from Abbott Outperforms Market-Leading Stent in Reducing Major Adverse Cardiac Events at Two Years

Released on: May 15, 2008, 11:28 pm

Press Release Author: Abbott

Industry: Healthcare

Press Release Summary: Long-term data presented for the first time yesterday from
the SPIRIT III trial, Abbott's U.S. pivotal trial studying the XIENCET V Everolimus
Eluting Coronary Stent System, demonstrated that XIENCE V continues to deliver
clinically superior benefits for patients compared to the TAXUS® paclitaxel-eluting
coronary stent system. In this trial of more than 1,000 patients, XIENCE V
demonstrated a 45 percent reduction in the risk of major adverse cardiac events
(MACE) and a 32 percent reduction in the risk of target vessel failure (cardiac
events related to the treated vessel) at two years as compared to TAXUS. The SPIRIT
III two-year results were presented by Gregg W. Stone, M.D., principal investigator
of the SPIRIT III trial, during the late-breaking clinical trials session at EuroPCR
2008.

Press Release Body: BARCELONA, Spain and NEW DELHI, India, May 14, 2008 - Long-term
data presented for the first time yesterday from the SPIRIT III trial, Abbott's U.S.
pivotal trial studying the XIENCET V Everolimus Eluting Coronary Stent System,
demonstrated that XIENCE V continues to deliver clinically superior benefits for
patients compared to the TAXUS® paclitaxel-eluting coronary stent system. In this
trial of more than 1,000 patients, XIENCE V demonstrated a 45 percent reduction in
the risk of major adverse cardiac events (MACE) and a 32 percent reduction in the
risk of target vessel failure (cardiac events related to the treated vessel) at two
years as compared to TAXUS. The SPIRIT III two-year results were presented by Gregg
W. Stone, M.D., principal investigator of the SPIRIT III trial, during the
late-breaking clinical trials session at EuroPCR 2008.

\"Not only did XIENCE V clearly differentiate itself from the TAXUS stent in the
first year after treatment, it has now demonstrated even more positive effects at
two years in the SPIRIT III trial,\" said Dr. Stone, Columbia University Medical
Center and chairman, Cardiovascular Research Foundation, New York. \"As measured by
clinically significant reductions in target vessel failure and MACE, XIENCE V
demonstrated an even greater improvement in patient outcomes compared to TAXUS at
two years than at one year, driven by numerically lower rates of heart attacks and
lower observed rates of re-intervention of the target lesion. We also saw
encouraging trends for lower observed rates of late and very late stent thrombosis
in XIENCE V-treated patients, especially in those who discontinued dual antiplatelet
therapy.\"

The SPIRIT III trial of 1,002 patients, which is the basis for the pre-market
application of XIENCE V to the U.S. Food and Drug Administration (FDA), demonstrated
the following key results for XIENCE V at two years:


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. A 45 percent reduction in the risk of major adverse cardiac events (MACE) compared
to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for TAXUS,
p-value=0.004). 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).
. A 32 percent reduction in the risk of Target Vessel Failure (TVF, cardiac events
related to the treated vessel) compared to TAXUS (10.7 percent for XIENCE V vs. 15.4
percent for TAXUS, p-value=0.04)*. 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).
. A 40 percent reduction in the risk of ischemia-driven target lesion
revascularization (ID-TLR) as compared to TAXUS (4.6 percent for XIENCE V vs. 7.5
percent for TAXUS, p-value=0.07)*.
. Low rates of stent thrombosis between one and two years, defined as very late
stent thrombosis, per Academic Research Consortium (ARC) definition of
definite/probable stent thrombosis (0.3 percent for XIENCE V and 1.0 percent for
TAXUS) and per the SPIRIT III protocol (0.2 percent for XIENCE V and 1.0 percent for
TAXUS). The ARC definitions of stent thrombosis were developed to eliminate
variability in the definitions across various drug eluting stent trials.

\"From these results, it is clear that XIENCE V can deliver sustained benefits to
patients over the long term,\" said John M. Capek, Ph.D., executive vice president,
Medical Products, Abbott. \"We continue to be pleased with the way XIENCE V is
performing, with outstanding results that are consistent with what we have seen
throughout the SPIRIT III trial.\"

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.


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The primary endpoint of the SPIRIT III trial was in-segment late loss at eight
months, wherein XIENCE V demonstrated superiority to TAXUS with a statistically
significant 50 percent reduction in late loss (mean, 0.14 mm for XIENCE V vs. 0.28
mm for TAXUS). In-segment late loss is a measure of vessel renarrowing. In the
co-primary endpoint of TVF at nine months, XIENCE V demonstrated statistical
non-inferiority compared to TAXUS with an observed 20 percent reduction in TVF (7.2
percent for XIENCE V vs. 9.0 percent for TAXUS).

Additionally, in the pre-specified secondary endpoint of MACE, XIENCE V demonstrated
a 43 percent reduction at nine months (4.6 percent for XIENCE V vs. 8.1 percent for
TAXUS) and a 42 percent reduction in MACE at one year (6.0 percent for XIENCE V vs.
10.3 percent for TAXUS) compared to TAXUS.

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 October 2006.
XIENCE V is currently an investigational device in the United States and Japan, and
is under review for approval by the FDA. Abbott expects to gain FDA approval for
XIENCE V in the second quarter of 2008.

Abbott also supplies a private-label version of XIENCE V to Boston Scientific called
the PROMUST 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 www.abbottvascular.com/presskit.




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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 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 www.abbott.com.


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Contact Details: Tanvi Sharma
Positive Communications
9871058649

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