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

Barcelona, Spain (ots/PRNewswire) -

- Patients Treated with XIENCE V in SPIRIT III Trial Experience
Better Long-Term Clinical Outcomes, Lower Rates of Stent Thrombosis
than Patients Treated with TAXUS

Long-term data presented for the first time today from the SPIRIT
III trial, Abbott's U.S. pivotal trial studying the XIENCE(TM) V
Everolimus Eluting Coronary Stent System, demonstrated that XIENCE V
continues to deliver clinically superior benefits for patients
compared to the TAXUS(R) 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:

-- 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 n 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.

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(R) 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 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.

*Event rates are based on Kaplan-Meier estimates; p-values are
for descriptive purposes only.

Web site: http://www.abbott.com

ots Originaltext: Abbott Laboratories
Im Internet recherchierbar: http://www.presseportal.de

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