The results of the international STEEPLE trial (Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention (PCI): An International Randomized Evaluation), has been published in The New England Journal of Medicine.
The said trial revealed that a single intravenous bolus of enoxaparin of 0.5 mg/kg is associated with significantly less major bleeding, and both studied doses were associated with more predictable anticoagulation levels and similar efficacy than unfractionated heparin, UFH (the current standard), in patients undergoing elective PCI or coronary angioplasty.
PCI, a non-surgical treatment procedure that unblocks coronary arteries that have narrowed due to atherosclerosis or atherothrombosis, 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.
"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.
"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."
The STEEPLE trial was sponsored by Sanofi-Aventis (NYSE: SNY, EPA: SAN), the maker of LOVENOX® (enoxaparin sodium injection).
Read more details of the trial results from the Sanofi-Aventis Press Release (a pdf file).
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