2006-09-08

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 Medicinepublishes the international STEEPLE trial (Safety and Efficacy ofEnoxaparin in Percutaneous Coronary Intervention (PCI): AnInternational Randomized Evaluation), which showed that a singleintravenous bolus of enoxaparin of 0.5 mg/kg is associated withsignificantly less bleeding, and both studied doses were associatedwith more predictable anticoagulation levels and similar efficacythan the current standard, unfractionated heparin (UFH), in patientsundergoing elective PCI or coronary angioplasty.

PCI is a treatment procedure that unblocks coronary arteries thathave narrowed due to atherosclerosis or atherothrombosis, withoutperforming surgery. PCI refers to the broad group of percutaneoustechniques that are capable of relieving coronary narrowing and keepthe coronary artery open: balloon angioplasty, or implantation ofintracoronary stent. Elective PCI is performed in non-emergencycases, when the patient is not in an acute phase of coronary arterialdisease (CAD).

STEEPLE was an international, prospective, randomized, open-label,parallel group trial evaluating the safety and efficacy of a singleintravenous bolus of enoxaparin 0.5 mg/kg and 0.75 mg/kg versusActivated Clotting Time (ACT)-adjusted intravenous UFH in patientsundergoing non-emergency PCI. The study was conducted in 3,528patients in 124 sites in 9 countries (Australia, Belgium, Canada,Italy, France, Germany, New Zealand, Spain and US). The primaryendpoint of the trial was the incidence of major and minor bleedingat 48 hours after the index PCI (excluding bypass graft [CABG]bleeding). The main secondary endpoint was the achievement oftherapeutic anticoagulation at the beginning and end of theprocedure.

"UFH has been the standard anticoagulant used during PCIprocedures, and the STEEPLE trial was the first large scale,randomized, controlled, open-label trial to compare intravenousenoxaparin to UFH during PCI," said Gilles Montalescot, MD, PhDProfessor of Cardiology, Hopital la Pitie-Salpetriere Institut duCoeur in Paris, France and Chairman of the Steering Committee for theSTEEPLE trial.

In the STEEPLE trial, enoxaparin was associated with reducedbleeding. The incidence of major and minor bleeding (primaryendpoint) 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 bothenoxaparin groups versus UFH.

The study also showed that enoxaparin is associated with afourfold increase in the rate of patients achieving targetanticoagulation levels compared with UFH (79% for enoxaparin 0.5mg/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-doseenoxaparin arm (0.5 mg/kg) of the trial was prematurely terminated inNovember 2004. This was based on an apparent but significant increasein all-cause mortality versus the UFH group. Subsequent evaluationsof the causes of mortality suggest no link between the enoxaparingroup and ischemic events.

"The STEEPLE trial showed intravenous enoxaparin as an alternativeto UFH in the non-emergency PCI setting," said Steven R. Steinhubl,MD, one of the study's lead investigators and Director ofCardiovascular Research and Education, Associate Professor ofMedicine, Division of Cardiology, University of Kentucky. "Enoxaparincan be administered as a single IV bolus and requires no routineanticoagulation monitoring."

Lovenox is the most widely used LMWH and has been very extensivelystudied 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 informationor visit www.lovenox.com

About sanofi-aventis

Sanofi-aventis is the world's third largest pharmaceuticalcompany, ranking number one in Europe. Backed by a world-class R&Dorganization, sanofi-aventis is developing leading positions in sevenmajor therapeutic areas: cardiovascular, thrombosis, oncology,metabolic diseases, central nervous system, internal medicine, andvaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and inNew York (NYSE: SNY).

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

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

sanofi-aventis Group

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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

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