The New England Journal of Medicine Publication of SPIRIT IV Trial Results Confirm Superior Safety and Efficacy of Abbott's XIENCE V(R) Drug Eluting Stent Compared to TAXUS

By Abbott, PRNE
Tuesday, May 4, 2010

Separate, Retrospective SPIRIT IV Cost-Effectiveness Analysis Presented Earlier this Year Concludes XIENCE V Is Economically Dominant Compared to TAXUS

ABBOTT PARK, Illinois, May 5, 2010 - Findings from Abbott's SPIRIT IV trial, one of the largest randomized
clinical trials comparing two drug eluting stents, with 3,690 U.S.-based
patients, were published today in The New England Journal of Medicine. The
published study results show that one year after a stenting procedure,
patients treated with Abbott's market-leading XIENCE V(R) Everolimus Eluting
Coronary Stent System were significantly less likely to have a major adverse
event such as a heart attack, repeat procedure or cardiac death, compared to
patients treated with a TAXUS(R) Express2(TM) Paclitaxel-Eluting Coronary
Stent System (TAXUS). The SPIRIT IV trial also showed that patients treated
with XIENCE V were considerably less likely to experience a blood clot (stent
thrombosis) compared to patients treated with TAXUS. These results were
originally presented during the September 2009 Transcatheter Cardiovascular
Therapeutics (TCT) conference.

In the SPIRIT IV trial's primary endpoint of target lesion failure (TLF),
XIENCE V demonstrated a statistically superior 38 percent reduction compared
to TAXUS at one year (4.2 percent for XIENCE V vs. 6.8 percent for TAXUS,
p-value=0.001). TLF is defined as a composite measure of important efficacy
and safety outcomes for patients and includes cardiac death, heart attack
attributed to the target vessel (target vessel myocardial infarction), and
ischemia-driven target lesion revascularization (TLR). The SPIRIT IV trial
also found that the one-year rate of blood clots (stent thrombosis) with
XIENCE V is among the lowest reported to date with any drug eluting stent
(0.29 percent per Academic Research Consortium definition of
definite/probable stent thrombosis).

In a subgroup analysis of more than 1,100 patients with diabetes, who
typically are sicker and have more challenging artery disease, XIENCE V
demonstrated a numerically lower TLF rate compared to TAXUS at one year (6.4
percent for XIENCE V vs. 6.9 percent for TAXUS, p-value=0.80). In the
critical safety endpoint of stent thrombosis as presented during TCT 2009,
XIENCE V demonstrated a 40 percent reduction compared to TAXUS in patients
with diabetes (per ARC definition of definite/probable stent thrombosis, 0.80
percent for XIENCE V vs. 1.33 percent for TAXUS, p-value=0.52).

"With more than 3 million stent procedures being performed annually
worldwide, determining the safety and efficacy differences between various
drug eluting stents has important implications for societal health," said
Gregg W. Stone, M.D., professor of medicine at Columbia University Medical
Center; immediate past chairman of the Cardiovascular Research Foundation in
New York; and principal investigator of the SPIRIT IV trial. "With nearly
4,000 patients studied, SPIRIT IV represents the largest randomized trial of
two drug eluting stents completed to date, and found that the
everolimus-eluting stent significantly reduces a patient's risk of
experiencing a heart attack, stent thrombosis, or the need for a repeat
procedure within one year, compared to the paclitaxel-eluting stent. Based on
these results, and results from the 1,800-patient COMPARE study conducted in
the Netherlands, the everolimus-eluting stent has set a new standard for
patient safety and efficacy."

Separately, in a recent retrospective cost-effectiveness analysis of
SPIRIT IV data, researchers found that the clinical benefits offered by
XIENCE V translated into lower overall medical costs at one year after the
stenting procedure. The SPIRIT IV cost-effectiveness analysis, presented by
David Cohen, M.D., MSc, of St. Luke's Mid America Heart Institute in Kansas
City, Mo.
, in March 2010 at the Optimizing PCI Outcomes symposium sponsored
by the Cardiovascular Research Foundation, found that one-year total medical
costs (initial hospitalization plus follow-up) were approximately US$150
lower for patients treated with XIENCE V than those treated with TAXUS. When
costs not related to the original treated vessel (
non-target-vessel-revascularization) were excluded, the one-year medical
costs were approximately US$450 lower with XIENCE V than TAXUS. The XIENCE V
and TAXUS stents are competitively priced.

"The cost-effectiveness analysis of SPIRIT IV shows that a stent designed
to deliver outstanding clinical benefits can deliver economic benefits as
well," said Dr. Cohen, who is the lead investigator of the SPIRIT IV
cost-effectiveness analysis. "Since the findings were derived from a
multicenter, comparative trial with only clinical follow-up, these results
may be generalizable to most U.S. practice settings."

"The SPIRIT IV data, published today in The New England Journal of
Medicine, have changed clinical practice as more and more physicians around
the world have embraced the XIENCE V drug eluting stent. With the additional
SPIRIT IV cost-effectiveness analysis, we have observed favorable economic
data based upon the strong clinical results. These findings should prove
valuable as hospitals evaluate different treatment options for coronary
artery disease patients," said Charles A. Simonton, M.D., FACC, FSCAI,
divisional vice president, Medical Affairs, and chief medical officer, Abbott
Vascular.

More About SPIRIT IV Results

Clinically, in addition to demonstrating superiority in the primary
endpoint of TLF, XIENCE V demonstrated a statistically significant 46 percent
reduction in TLR (repeat procedure) compared to TAXUS at one year (2.5
percent for XIENCE V vs. 4.6 percent for TAXUS, p-value=0.001). TLR is one of
the major secondary endpoints of the SPIRIT IV trial.

Per protocol definition of stent thrombosis (blood clots) at one year,
XIENCE V demonstrated an observed 80 percent reduction compared to TAXUS
(0.17 percent for XIENCE V vs. 0.85 percent for TAXUS, p-value=0.004). Per
Academic Research Consortium (ARC) definition of definite/probable stent
thrombosis, XIENCE V demonstrated an observed 74 percent reduction compared
to TAXUS at one year (0.29 percent for XIENCE V and 1.10 percent for TAXUS,
p-value=0.004). The ARC definitions of stent thrombosis were developed to
harmonize the definition of stent thrombosis across various drug eluting
stent trials.

In a retroactive look at the economics of using XIENCE V versus TAXUS
from the SPIRIT IV trial, it was observed that XIENCE V was economically
dominant over TAXUS based upon the clinical results. At one year, total
medical costs (initial hospitalization plus follow-up) were US$146 lower per
patient with XIENCE V than with TAXUS. When costs not related to the original
treated vessel (non-target-vessel-revascularization) were excluded, the
difference between the two stents became more pronounced, amounting to a cost
savings of US$439 per patient with XIENCE V compared to TAXUS (p=0.02).
Excluding the costs not related to the original treated vessel reflects the
cost difference specific to the performance of the two stents.

The SPIRIT IV cost-effectiveness analysis was based on a retrospective
review of prospectively collected medical resource utilization for all
patients enrolled in the SPIRIT IV trial for initial hospitalization and one
year after enrollment. Cardiovascular hospitalizations, revascularization
procedures, diagnostic catheterization and dual-anti-platelet therapy costs
were included. The analysis assumed equal stent costs for the XIENCE V and
TAXUS stents.

More About XIENCE V

Abbott's market-leading 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.

In some geographies, Abbott 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). 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 is a global leader in cardiac and vascular care with
market-leading products and an industry-leading pipeline. Abbott Vascular
offers a comprehensive cardiac and vascular devices portfolio, including
products for coronary artery disease, vessel closure, endovascular disease,
and structural heart 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 83,000 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.

Media, Jonathon Hamilton, +1-408-845-3491, or Jennie Kim, +1-408-845-1755, or Financial, Larry Peepo, +1-847-935-6722, or Tina Ventura, +1-847-935-9390, all of Abbott

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