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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).

ots Originaltext: sanofi-aventis Group
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