STEEPLE: Safety and efficacy of enoxaparin in percutaneous coronary intervention patients

September 06, 2005

Results of the STEEPLE trial to be announced at the Hotline session today by Pr Gilles Montalescot, the trial's principal investigator, have the potential to revise current procedural anticoagulation using standard uncertain ACT-driven unfractionated heparin (UFH) in percutaneous coronary intervention (PCI). STEEPLE (Safety and efficacy of enoxaparin in elective percutaneous coronary intervention: an international randomized evaluation) is the first large scale, prospective, open label, randomized, controlled clinical trial comparing intravenous (iv) enoxaparin and UFH in the catheterization laboratory.

The study was conducted with 3,528 patients from 124 sites and nine countries in Europe, North America and Australasia undergoing non emergent PCI randomized to iv enoxaparin (0.5 mg/kg or 0.75 mg/kg) or an activated clotting time (ACT)-adjusted UFH regimen, stratified by the operator's choice of glycoprotein (GP) IIb/IIIa inhibitor use. The primary endpoint was to evaluate the safety of iv enoxaparin compared with iv UFH measuring the incidence of non-coronary artery bypass graft (CABG)-related major and minor bleeding up to 48 hours following index PCI. The main secondary efficacy endpoint was the percentage of patients reaching target anticoagulation levels at the beginning and end of the procedure. A secondary efficacy composite endpoint consisted of non-CABG-major bleeding up to 48 hours, all cause mortality, non-fatal myocardial infarction, or urgent target vessel revascularization at 30 days. The data may confirm earlier results from small and non comparative trials that have shown enoxaparin to be simple and effective and not associated with excessive bleeding in patients undergoing PCI with or without GP IIb/IIIa inhibitors.1
1: Borentain M, Montalescot G, Bouzamondo A, Choussat R, Hulot JS, Lechat P. Catheter Cardiovasc Interv 2005;65:212-21.

European Society of Cardiology

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