New Clinical Data Show Enoxaparin Significantly Reduces the Risk of Repeat Heart Attacks and Stroke in Patients Undergoing Percutaneous Coronary Intervention (PCI)

Geschrieben am 04-09-2006

Barcelona (ots/PRNewswire) -

- Results of the PCI-ExTRACT Sub-Study

Results of the PCI-ExTRACT-TIMI 25 study announced today at the
World Congress of Cardiology-European Society of Cardiology 2006 in
Barcelona, showed that among patients with ST-segment elevation
myocardial infarction (STEMI) who initially received fibrinolytic
therapy and adjunctive antithrombotic therapy with either enoxaparin
or unfractionated heparin and subsequently underwent PCI, the
enoxaparin strategy reduced the risk of death or recurrent heart
attacks during the treatment phase before PCI and this benefit
persisted after PCI for up to 30 days. Fewer patients in the
enoxaparin group had to undergo PCI compared to those in the UFH

These advantages of enoxaparin were observed without an increase
in the risk of major bleeding between the enoxaparin and UFH groups
(1.4% and 1.6% respectively).

The PCI-ExTRACT-TIMI 25 study was a pre-planned prospective
analysis of the subgroup of the 4,676 patients in the ExTRACT-TIMI 25
(Enoxaparin and Thrombosis Reperfusion for Acute Myocardial
InfarCtion Treatment, Thrombosis In Myocardial Infarction - Study 25)
trial (1). The ExTRACT-TIMI 25 trial was a randomized controlled
clinical study of 20,479 patients in 48 countries between October
2002 and October 2005.

Patients in the PCI-ExTRACT-TIMI 25 study received adjunctive
anticoagulation therapy with either enoxaparin or UFH in a blinded
fashion during fibrinolysis and underwent subsequent PCI.
Anticoagulation treatment was continued in those patients who had
PCI. The aim of the study was to determine whether enoxaparin was
associated with superior efficacy and safety compared to UFH in the
PCI setting. The main outcomes were death or repeat heart attacks
through 30 days (10.7% of the enoxaparin and 13.8% of the UFH
patients, 0.77 relative risk, 95% CI 10%-34%; p=0.001). Secondary
outcomes included stroke and bleeding rates. There were fewer strokes
both before and after PCI among patients treated with enoxaparin
compared with those who received UHF (0.3% vs 0.9%, RR 0.30,

"We believe that these results are important because they show
that enoxaparin is a more effective treatment for STEMI patients
undergoing PCI compared to UFH, the current standard treatment of
care. These results indicate that adding enoxaparin for
anticoagulation supports a practice pattern in which PCI is performed
at some time following fibrinolytic administration. As the use of
enoxaparin both delays the onset and reduces the occurrence of repeat
heart attacks, the window of opportunity to perform PCI following
fibrinolytic administration is larger than that with UFH." said C.
Michael Gibson, MS, MD of the TIMI Study Group, Harvard Medical
School, Boston Massachusetts.

"Moreover, not only does enoxaparin provide a seamless transition
to the catheterisation laboratory without the need for additional
antithrombin inhibition, it also removes the need for monitoring in
the catheterisation laboratory, thereby offering an attractive and
more practical alternative to the cumbersome and uncertain
administration requirements of UFH anticoagulation." added Dr Gibson.

With more than 1 million PCI procedures now performed worldwide
each year(2), the PCI- ExTRACT-TIMI 25 results are timely to address
unmet needs in medical therapy in the contemporary era of PCI.
Unfractionated heparin has been the mainstay anticoagulant during PCI
procedures, despite its limitations. The PCI-ExTRACT-TIMI 25 study
confirms that enoxaparin is an effective, safe, and easy to use
antithrombin in patients undergoing PCI for ST-elevation heart

These results, consistent with the results of the STEEPLE(3) study
showing the superior safety profile of enoxaparin versus UFH in
patients undergoing elective PCI, contribute to building a more
complete picture of the use of enoxaparin in all thrombosis settings,
and further add to the 50,000 patients who have participated in
cardiovascular trials of enoxaparin to date.

The PCI-ExTRACT-TIMI 25 study was sponsored by sanofi-aventis.

About percutaneous coronary intervention (PCI)

PCI is a treatment procedure that unblocks coronary arteries that
have narrowed due to atherosclerosis or atherothrombosis. The
procedure restores coronary arterial flow (or coronary perfusion) in
an acutely or sub-acutely occluded artery during acute myocardial
infarction or unstable angina. PCI includes balloon angioplasty and
implantation of intracoronary stent. The main long-term concern of
PCI is re-stenosis. However, the use of coated and drug-eluting
stents has been shown to reduce this risk.

Primary PCI is defined as intervention in the culprit vessel
within 12 hours after the onset of chest pain or other symptoms of
acute myocardial infarction, without prior (full or concomitant)
thrombolytic or other clot-dissolving therapy. Elective PCI is
performed in all other less-urgent cases in patients with coronary
artery disease (CAD).

About PCI-EXTRACT TIMI 25 study

The PCI-ExTRACT-TIMI 25 study examined the use of enoxaparin
versus unfractionated heparin (UFH) among patients with ST-elevation
myocardial infarction (STEMI) who had received fibrinolytic therapy
and subsequently underwent percutaneous coronary intervention (PCI).
Data on the patients included in the PCI-ExTRACT-TIMI 25 subgroup
analysis were collected as part of the EXTRACT-TIMI 25 trial, which
was a randomised, double-blind, double-dummy, parallel group,
clinical study conducted in more than 20,000 patients in 48 countries
between October 2002 and October 2005. It was the largest,
well-controlled clinical outcomes trial for enoxaparin, a low
molecular weight heparin, in patients with STEMI.

The aim of the PCI-ExTRACT-TIMI 25 study was to determine whether
enoxaparin is superior to UFH as adjunctive therapy for fibrinolytic
therapy among patients with STEMI who subsequently undergo PCI.

A total of 20,479 subjects for whom fibrinolysis was planned were
randomised to a strategy of enoxaparin throughout the index
hospitalisation or UFH for 48 hours in a double-blind manner. The
blinded study drug was continued in the patients who underwent PCI.
The primary efficacy end point of death or nonfatal recurrent
myocardial infarction through 30 days was compared for enoxaparin vs
UFH among those patients who underwent PCI (n=4,676). Net clinical
benefit was evaluated by both the composite of all-cause mortality or
nonfatal recurrent MI or nonfatal stroke, and death or nonfatal MI or
nonfatal major bleed.

About enoxaparin

Enoxaparin is an anticoagulant of the low molecular weight heparin
(LMWH) class. Its clinical applications are linked to its
antithrombotic properties. It is used to inhibit clot formation in
venous or arterial vessels and to avoid potential acute or chronic
complications of venous or arterial thrombosis such as pulmonary
embolism, myocardial infarction or death of cardiovascular origin. As
with all anticoagulants, the most frequently reported side effect for
enoxaparin is bleeding. Clinical indications for enoxaparin may vary
from one country to another.

About Sanofi-aventis

Sanofi-aventis (NYSE: SNY) is the world's third largest
pharmaceutical company, ranking number one in Europe. Backed by a
world-class R&D organization, Sanofi-aventis is developing leading
positions in seven major therapeutic areas: cardiovascular,
thrombosis, oncology, metabolic diseases, central nervous system,
internal medicine, and vaccines.

Statements on Cautionary Factors

This press release contains forward-looking statements as defined
in the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include financial projections and estimates
and their underlying assumptions, statements regarding plans,
objectives, intentions and expectations with respect to future
events, operations, products and services, and statements regarding
future performance. Forward-looking statements are generally
identified by the words "expect," "anticipates," "believes,"
"intends," "estimates," "plans" and similar expressions. Although
Sanofi-aventis' management believes that the expectations reflected
in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are
subject to various risks and uncertainties, many of which are
difficult to predict and generally beyond the control of
Sanofi-aventis, that could cause actual results and developments to
differ materially from those expressed in, or implied or projected
by, the forward-looking information and statements. These risks and
uncertainties include risks that may arise from the Department of
Justice's criminal investigation on the Plavix(R) proposed settlement
with Apotex, the adverse impact of generic product distributed into
the market prior to the Court's injunction, the outcome of
sanofi-aventis' patent infringement litigation against Apotex and
other entities, the potential launch of a generic clopidogrel
bisulfate product by other entities, as well as those risks and
uncertainties discussed or identified in the public filings with the
SEC and the AMF made by Sanofi-aventis, including those listed under
"Risk Factors" and "Cautionary Statement Regarding Forward-Looking
Statements" in Sanofi-aventis' annual report on Form 20-F for the
year ended December 31, 2005. Other than as required by applicable
law, Sanofi-aventis does not undertake any obligation to update or
revise any forward-looking information or statements.

ots Originaltext: sanofi-aventis Group
Im Internet recherchierbar: http://www.presseportal.de

Contact: Salah Mahyaoui, +33-6-73-68-78-88,


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