title: Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention.
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].).
authors.affiliation: Institut de Cardiologie, Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France. gilles.montalescot@psl.aphp.fr
authors.forename: Gilles
authors.initials: G
authors.lastname: Montalescot
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: Richard
authors.initials: R
authors.lastname: Gallo
authors.forename: Marc
authors.initials: M
authors.lastname: Cohen
authors.forename: P Gabriel
authors.initials: PG
authors.lastname: Steg
authors.forename: Philip E G
authors.initials: PE
authors.lastname: Aylward
authors.forename: Christoph
authors.initials: C
authors.lastname: Bode
authors.forename: Massimo
authors.initials: M
authors.lastname: Chiariello
authors.forename: Spencer B
authors.initials: SB
authors.lastname: King
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
authors.forename: Walter J
authors.initials: WJ
authors.lastname: Desmet
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
authors.forename: Steven R
authors.initials: SR
authors.lastname: Steinhubl
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D017984:Enoxaparin / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology; D006493:Heparin / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000401:mortality / Q000628:therapy; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D011446:Prospective Studies; D012044:Regression Analysis; D012907:Smoking / Q000097:blood; D015607:Stents
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D006493:Heparin