From the ESC Congress 2005: Enoxaparin causes less bleeding than unfractionated heparin in PCI

A single IV bolus of enoxaparin (Lovenox, Aventis) is just as effective as and associated with less bleeding than unfractionated heparin in patients undergoing elective PCI, said Gilles Montalescot, MD. Dr Montalescot was lead investigator of STEEPLE (Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention Patients), the results of which were announced during the the ESC Congress 2005 in Stockholm, Sweden.

In STEEPLE, 3,528 patients undergoing nonemergent PCI were randomized to enoxaparin (0.5 mg/kg or 0.75 mg/kg) or unfractionated heparin, with the use of GP IIb/IIIa inhibitors at the discretion of the operator.

Enrollment in the 0.5-mg/kg enoxaparin arm was terminated just prior to its scheduled completion based on a global difference in all-cause mortality between the 3 treatment groups, but this early termination of enrollment did not affect the power of the study, said Dr Montalescot, professor of cardiology, Hôpital Pitie Salpetriere, Paris, France.

Enoxaparin is associated with a 4-fold increase in the rate of achieving target anticoagulation levels at the beginning and end of procedure compared with unfractionated heparin.

The reduction in bleeding with enoxaparin was greatest in the absence of GPIIb/IIIa inhibitor use, although the same trend was evident with use of GPIIb/IIIa inhibition but failed to reach significance because of the small patient population.

The efficacy end point-a secondary end point consisting of the composite of non-CABG major bleeding to 48 hours, all-cause mortality, nonfatal MI, or urgent target vessel revascularization at 30 days-was not significantly different between the enoxaparin and unfractionated heparin arms.

Evaluation of the causes of death found no evidence that the deaths that prompted the Data Safety Monitoring Board to recommend that enrollment in the 0.5-mg/kg enoxaparin arm be terminated were related to enoxaparin; the composite efficacy end point was in fact lowest in the 0.5-mg/kg enoxaparin arm, but not significantly so.

With the results of STEEPLE, a new treatment concept emerges, said Jean-Pierre Bassand, MD, from the Jean Minjoz University Hospital in Besançon, France. "A reduction in bleeding is now an objective of treatment that is as important as the reduction of the rate of ischemic events" in trials of coronary artery disease, ACS, or PCI, he said.