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	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by O'Neill, W. W. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Despite its limitations, unfractionated heparin has been the standard anticoagulant used during percutaneous coronary intervention (PCI). Several small studies have suggested that intravenous enoxaparin may be a safe and effective alternative. Our primary aim was to assess the safety of enoxaparin as compared with that of unfractionated heparin in elective PCI.

Methods In this prospective, open-label, multicenter, randomized trial, we randomly assigned 3528 patients with PCI to receive enoxaparin (0.5 or 0.75 mg per kilogram of body weight) or unfractionated heparin adjusted for activated clotting time, stratified according to the use or nonuse of glycoprotein IIb/IIIa inhibitors. The primary end point was the incidence of major or minor bleeding that was not related to coronary-artery bypass grafting. The main secondary end point was the percentage of patients in whom the target anticoagulation levels were reached.

Results Enoxaparin at a dose of 0.5 mg per kilogram was associated with a significant reduction in the rate of non–CABG-related bleeding in the first 48 hours, as compared with unfractionated heparin (5.9% vs. 8.5%; absolute difference, –2.6; 95% confidence interval [CI], –4.7 to –0.6; P=0.01), but the higher enoxaparin dose was not (6.5% vs. 8.5%; absolute difference, –2.0; 95% CI, –4.0 to 0.0; P=0.051). The incidence of major bleeding was significantly reduced in both enoxaparin groups, as compared with the unfractionated heparin group. Target anticoagulation levels were reached in significantly more patients who received enoxaparin (0.5-mg-per-kilogram dose, 79%; 0.75-mg-per-kilogram dose, 92%) than who received unfractionated heparin (20%, P<0.001).

Conclusions In elective PCI, a single intravenous bolus of 0.5 mg of enoxaparin per kilogram is associated with reduced rates of bleeding, and a dose of 0.75 mg per kilogram yields rates similar to those for unfractionated heparin, with more predictable anticoagulation levels. The trial was not large enough to provide a definitive comparison of efficacy in the prevention of ischemic events. (ClinicalTrials.gov number, NCT00077844 [ClinicalTrials.gov] .)

Source Information

From Institut de Cardiologie, Centre Hospitalier Universitaire Pitié–Salpêtrière, Paris (G.M.); the Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); the Montreal Heart Institute, Université de Montréal, Montreal (R.G.); the Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ (M.C.); the Service de Cardiologie, Hôpital Bichat, Paris (P.G.S.); Department of Cardiology, Flinders Medical Center, Adelaide, SA, Australia (P.E.G.A.); Abteilung Innere Medizin III, Universitätsklinikum Freiburg, Freiburg, Germany (C.B.); the Division of Cardiology, Federico 2nd University, Naples, Italy (M.C.); Fuqua Heart Center of Atlanta at Piedmont Hospital, Atlanta (S.B.K.); the Division of Cardiology, Duke University Medical Center, Durham, NC (R.A.H.); University Hospital Gasthuisberg, Leuven, Belgium (W.J.D.); Servicio de Cardiología, Hospital Universitario, Madrid (C.M.); and the Division of Cardiology, University of Kentucky, Lexington (S.R.S.).

Address reprint requests to Dr. Montalescot at Institut de Cardiologie, Bureau 2-236, Centre Hospitalier Universitaire Pitié–Salpêtrière, 47 Boulevard de l'Hôpital, 75013 Paris, France, or at gilles.montalescot{at}psl.aphp.fr.

Full Text of this Article

Related Letters:

Enoxaparin in Elective Percutaneous Coronary Intervention
Bhala N., Hamon M., Riddell J. W., Karthikeyan G., Pasceri V., Schuler J., Altenberger J., Heigert M., Montalescot G., White H. D., Steinhubl S. R.
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N Engl J Med 2006; 355:2788-2791, Dec 28, 2006. Correspondence

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