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The New England Journal of Medicine Publishes the STEEPLE Study Which Demonstrated Superior Safety Profile of LOVENOX(r) (Enoxaparin Sodium Injection) Vs. Unfractionated Heparin (UFH) in Patients Undergoing Non-Emergent Percutaneous Coronary Intervention

Paris (ots/PRNewswire)

The New England Journal of Medicine
publishes the international STEEPLE trial (Safety and Efficacy of
Enoxaparin in Percutaneous Coronary Intervention (PCI): An
International Randomized Evaluation), which showed that a single
intravenous bolus of enoxaparin of 0.5 mg/kg is associated with
significantly less bleeding, and both studied doses were associated
with more predictable anticoagulation levels and similar efficacy
than the current standard, unfractionated heparin (UFH), in patients
undergoing elective PCI or coronary angioplasty.
PCI is a treatment procedure that unblocks coronary arteries that
have narrowed due to atherosclerosis or atherothrombosis, without
performing surgery. PCI refers to the broad group of percutaneous
techniques that are capable of relieving coronary narrowing and keep
the coronary artery open: balloon angioplasty, or implantation of
intracoronary stent. Elective PCI is performed in non-emergency
cases, when the patient is not in an acute phase of coronary arterial
disease (CAD).
STEEPLE was an international, prospective, randomized, open-label,
parallel group trial evaluating the safety and efficacy of a single
intravenous bolus of enoxaparin 0.5 mg/kg and 0.75 mg/kg versus
Activated Clotting Time (ACT)-adjusted intravenous UFH in patients
undergoing non-emergency PCI. The study was conducted in 3,528
patients in 124 sites in 9 countries (Australia, Belgium, Canada,
Italy, France, Germany, New Zealand, Spain and US). The primary
endpoint of the trial was the incidence of major and minor bleeding
at 48 hours after the index PCI (excluding bypass graft [CABG]
bleeding). The main secondary endpoint was the achievement of
therapeutic anticoagulation at the beginning and end of the
procedure.
"UFH has been the standard anticoagulant used during PCI
procedures, and the STEEPLE trial was the first large scale,
randomized, controlled, open-label trial to compare intravenous
enoxaparin to UFH during PCI," said Gilles Montalescot, MD, PhD
Professor of Cardiology, Hopital la Pitie-Salpetriere Institut du
Coeur in Paris, France and Chairman of the Steering Committee for the
STEEPLE trial.
In the STEEPLE trial, enoxaparin was associated with reduced
bleeding. The incidence of major and minor bleeding (primary
endpoint) was 31% lower in the enoxaparin 0.5 mg/kg group (5.9% vs.
8.5%, P=0.01), which was statistically significant for superiority,
while the enoxaparin 0.75 mg/kg group was non-inferior to UFH (6.5%
vs. 8.5%, P=0.051). Major bleeding was also reduced by 57% in both
enoxaparin groups versus UFH.
The study also showed that enoxaparin is associated with a
fourfold increase in the rate of patients achieving target
anticoagulation levels compared with UFH (79% for enoxaparin 0.5
mg/kg and 92% for enoxaparin 0.75 mg/kg versus 20% for UFH
[P<0.001]).
In response to the Data Monitoring Committee (DMC), the low-dose
enoxaparin arm (0.5 mg/kg) of the trial was prematurely terminated in
November 2004. This was based on an apparent but significant increase
in all-cause mortality versus the UFH group. Subsequent evaluations
of the causes of mortality suggest no link between the enoxaparin
group and ischemic events.
"The STEEPLE trial showed intravenous enoxaparin as an alternative
to UFH in the non-emergency PCI setting," said Steven R. Steinhubl,
MD, one of the study's lead investigators and Director of
Cardiovascular Research and Education, Associate Professor of
Medicine, Division of Cardiology, University of Kentucky. "Enoxaparin
can be administered as a single IV bolus and requires no routine
anticoagulation monitoring."
Lovenox is the most widely used LMWH and has been very extensively
studied in acute coronary syndrome in more than 50,000 patients.
The STEEPLE trial was sponsored by sanofi-aventis.
For more details please refer to complete prescribing information
or visit www.lovenox.com
About sanofi-aventis
Sanofi-aventis 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. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in
New York (NYSE: SNY).

Contact:

Sanofi-aventis press contact: Salah Mahyoui, +33-6-73-68-78-88

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