Abbott's XIENCE V(R) Continues to Outperform TAXUS With Sustained Clinical Advantages and Impressive Long-Term Safety Results in SPIRIT III Trial

San Francisco (ots/PRNewswire) -

- Market-Leading XIENCE V Demonstrates Single-Digit Rate of Major
Adverse Cardiac Events (MACE) at Three Years and a 43 Percent
Reduction vs. TAXUS

- No Additional Stent Thrombosis between Two and Three Years, and
Impressive Low Rate of Very Late Stent Thrombosis for XIENCE V

Long-term data presented today from the SPIRIT III pivotal U.S.
clinical trial demonstrated that the observed clinical advantages of
Abbott's market-leading XIENCE V(R) Everolimus Eluting Coronary Stent
System continued to increase as compared to the TAXUS(R) Express2
Paclitaxel-Eluting Coronary Stent System (TAXUS). At three years,
XIENCE V demonstrated a 43 percent reduction in the risk of major
adverse cardiac events (MACE) compared to TAXUS (9.1 percent for
XIENCE V vs. 15.7 percent for TAXUS, p-value=0.003)*. MACE is an
important composite clinical measure of safety and efficacy outcomes
for patients, defined as cardiac death, heart attack (myocardial
infarction or MI), or ischemia-driven target lesion revascularization
(ID-TLR driven by lack of blood supply). The three-year results from
the SPIRIT III trial will be presented today by Gregg W. Stone, M.D.,
professor of medicine at Columbia University Medical Center, during
the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference
in San Francisco.

"The SPIRIT III results clearly demonstrate that at three years,
patients continue to benefit from having been treated with the XIENCE
V stent rather than the TAXUS stent, with fewer repeat cardiac
procedures and fewer heart attacks in patients who received XIENCE
V," said Dr. Stone, who is also immediate past chairman of the
Cardiovascular Research Foundation, New York; and principal
investigator of the SPIRIT III trial.

XIENCE V demonstrated an impressive low rate of very late stent
thrombosis (one to three years) with no additional events between two
and three years. Per protocol, XIENCE V demonstrated a 0.2 percent**
very late stent thrombosis rate compared to 1.0 percent for TAXUS
(p-value=0.10) at three years. Per Academic Research Consortium (ARC)
definition of definite/probable stent thrombosis, the rate of very
late stent thrombosis at three years was 0.3 percent** for XIENCE V
and 1.0 percent for TAXUS (p-value=0.34). The ARC definitions of
stent thrombosis were developed to eliminate variability in the
definitions across various drug eluting stent trials.

Key Results from SPIRIT III

In the 1,002-patient SPIRIT III trial, XIENCE V demonstrated the
following key results out to three years:

- A 43 percent reduction in the risk of MACE compared to TAXUS
(9.1 percent for XIENCE V vs. 15.7 percent for TAXUS, p-value=0.003).
- A 43 percent reduction in the risk of Target Lesion Failure (TLF)
compared to TAXUS (8.3 percent for XIENCE V vs. 14.4 percent for TAXUS,
p-value=0.005). TLF is a composite measure of important efficacy and
safety outcomes for patients, defined as cardiac death, target vessel MI
and TLR.
- A 30 percent reduction in the risk of Target Vessel Failure (TVF)
compared to TAXUS (13.5 percent for XIENCE V vs. 19.2 percent for TAXUS,
p-value=0.03). TVF is a composite clinical measure of safety and
efficacy outcomes defined as cardiac death, MI or ischemia-driven
target vessel revascularization (TVR).
- A 42 percent reduction in the risk of heart attacks (MI) compared
to TAXUS (3.7 percent for XIENCE V vs. 6.3 percent for TAXUS,
p-value=0.07).
- A 39 percent reduction in the risk of ID-TLR compared to TAXUS
(5.4 percent for XIENCE V vs. 8.9 percent for TAXUS, p-value=0.05).
- Per protocol definition, a 0.2 percent** rate of very late stent
thrombosis compared to 1.0 percent for TAXUS (p-value=0.10). Per ARC
definition of definite/probable stent thrombosis, the rate of very late
stent thrombosis was 0.3 percent** for XIENCE V and 1.0 percent for
TAXUS (p-value=0.34).

Consistent Results in SPIRIT III Subgroup Analyses

In addition to the positive three-year results for the overall
study presentation, subgroup analyses from the SPIRIT III trial
demonstrated evidence of the strong performance by XIENCE V in a
variety of patients and lesion types that represent complex patients.
In patients with diabetes, the analysis showed there was no
difference at three years in MACE between XIENCE V and TAXUS (11.0
percent for XIENCE V vs. 10.3 percent in TAXUS)*** . In fact, XIENCE
V maintained a consistent rate of clinical events after the first
year (8.7 percent MACE at one year and 11.0 percent MACE at three
years), whereas TAXUS demonstrated a sustained upward trend in
clinical events from one year to three years (4.7 percent MACE at one
year and 10.3 percent MACE at three years). In patients without
diabetes, the MACE rate for TAXUS at three years was more than double
the MACE rate for XIENCE V at three years (9.1 percent for XIENCE V
vs. 18.7 percent for TAXUS).

"The SPIRIT III data clearly show that XIENCE V performs in a
consistent manner, with clinical benefits continuing to improve over
time compared to TAXUS," said Robert Hance, senior vice president,
vascular, Abbott. "We are pleased to begin this year's TCT conference
with a strong showing of data for Abbott's market-leading XIENCE V,
and look forward to presenting the highly anticipated SPIRIT IV
one-year results later this week, which should provide physicians
with additional valuable insights."

One-year results from the company's SPIRIT IV trial will be
presented on Wednesday, Sept. 23, during the first late-breaking
clinical trials session of the TCT conference. The SPIRIT IV trial is
one of the largest randomized clinical trials between two drug
eluting stents, with 3,690 patients enrolled, including more than
1,000 patients with diabetes. The study results will provide valuable
information about the efficacy and safety of XIENCE V compared to
TAXUS. The SPIRIT III trial was not designed to analyze statistical
differences in any of the patient subgroups, as the sample sizes were
too small to draw firm conclusions.

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 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 superior 50 percent reduction in late loss
(mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS, p-value =0.004).
In-segment late loss is a measure of vessel re-narrowing.

About XIENCE V

XIENCE V is used to treat coronary artery disease by propping
open a narrowed or blocked artery and releasing the drug, everolimus,
in a controlled manner to prevent the artery from becoming blocked
again following a stent procedure. XIENCE V is built upon Abbott's
market-leading bare metal stent, the MULTI-LINK VISION(R) Coronary
Stent System. The VISION platform is designed to facilitate ease of
delivery, making it easier for physicians to maneuver the stent and
treat the diseased portion of the artery.

The XIENCE V stent is available on both over-the-wire (OTW) and
rapid exchange (RX) delivery systems. Rapid exchange is the most
widely used type of delivery system because it provides physicians
additional flexibility to work as single operators during stent
procedures.

Abbott's market-leading XIENCE V drug eluting stent is
commercially available in the United States, Europe and other
international markets. XIENCE V is an investigational device in Japan
and is currently under review by Japan's Ministry of Health, Labour
and Welfare and the Pharmaceuticals and Medical Devices Agency.

Abbott also supplies a private-label version of XIENCE V to
Boston Scientific called the PROMUS(R) Everolimus-Eluting Coronary
Stent System. PROMUS is designed and manufactured by Abbott and
supplied to Boston Scientific as part of a distribution agreement
between the two companies.

Everolimus, developed by Novartis Pharma AG, is a proliferation
signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis
for use on its drug eluting stents. Everolimus has been shown to
inhibit in-stent neointimal growth in the coronary vessels following
stent implantation, due to its antiproliferative properties.

XIENCE V is indicated for improving coronary luminal diameter in
patients with symptomatic heart disease due to de novo native
coronary artery lesions (lesions less than or equal to 28 mm) with
reference vessel diameters of 2.5 mm to 4.25 mm. Additional
information about XIENCE V, including important safety information,
is available online at www.xiencev.com or
www.abbottvascular.com/en_US/content/document/eIFU_XienceV.pdf.

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.

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 72,000 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.

* Unless otherwise noted, all event rates and p-values are based
on Kaplan-Meier estimates; p-values are for descriptive purposes
only.

** Stent thrombosis rates are based on binary event rates, and
p-values are based on Fisher's Exact Test; p-values are for
descriptive purposes only.

*** Subgroup event rates are based on binary event rates.

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

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