title: The use of intravenous enoxaparin in elective percutaneous coronary intervention in patients with renal impairment: results from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial.
abstract: BACKGROUND
  The STEEPLE trial assessed outcomes of patients undergoing elective percutaneous coronary intervention randomized to receive a bolus of intravenous enoxaparin (0.5 or 0.75 mg/kg, n = 2,298) or activated clotting time-adjusted unfractionated heparin (UFH, n = 1,230), stratified according to planned glycoprotein IIb/IIIa inhibitor use.
  
  
  METHODS
  In this subanalysis, we assessed outcomes in patients with renal impairment (creatinine clearance < or =60 mL/min, n = 659).
  
  
  RESULTS
  Major bleeding occurred more often in patients with renal impairment compared with those without (2.7% vs 1.5%, P = .04). Enoxaparin was associated with less major bleeding than UFH with normal renal function (0.9% for enoxaparin 0.5 mg/kg or 1.0% for enoxaparin 0.75 mg/kg vs 2.6%, respectively; both P = .01 vs UFH), with a trend toward less major bleeding with impaired renal function (2.6% or 1.8% vs 3.8%, P = .18 for enoxaparin 0.5 mg/kg and P = .47 for 0.75 mg/kg vs UFH). Minor bleeding rates were similar irrespective of renal function or anticoagulation regimen. The incidence of death, nonfatal myocardial infarction, or urgent target-vessel revascularization was similar between patients with and without renal impairment (5.7% vs 6.5%, P = .45). In patients with renal impairment, event rates were 6.2% or 5.3% with enoxaparin vs 5.6% with UFH (P = nonsignificant). Target anticoagulation levels were achieved 4 to 5 times more often with enoxaparin compared with UFH in patients with normal and impaired renal function (both P < .0001).
  
  
  CONCLUSIONS
  A single bolus of enoxaparin was associated with similar ischemic events and a trend for less major bleeding compared with UFH in patients with renal impairment undergoing percutaneous coronary intervention. Enoxaparin can be administered safely without dose adjustment in these patients.
authors.affiliation: Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. harveyw@adhb.govt.nz
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: Ph Gabriel
authors.initials: PG
authors.lastname: Steg
authors.forename: Philip E
authors.initials: PE
authors.lastname: Aylward
authors.forename: Christoph
authors.initials: C
authors.lastname: Bode
authors.forename: Steve
authors.initials: S
authors.lastname: Steinhubl
authors.forename: Gilles
authors.initials: G
authors.lastname: Montalescot
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000008:administration & dosage*; D017558:Elective Surgical Procedures; D017984:Enoxaparin / Q000008:administration & dosage*; D005260:Female; D006470:Hemorrhage / Q000209:etiology*; D006493:Heparin / Q000008:administration & dosage; D006801:Humans; D007275:Injections, Intravenous; D007674:Kidney Diseases / Q000150:complications*; D008297:Male; D011446:Prospective Studies
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D006493:Heparin