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

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

September 04, 2006

-- Results of the PCI-ExTRACT Sub-Study

    BARCELONA, Sept. 4 /Xinhua-PRNewswire/ -- 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
group.

    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, p=0.006).

    "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 attack.

    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.

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