title: Safety of bivalirudin during percutaneous coronary interventions in patients with abnormal renal function.
abstract: BACKGROUND
  Chronic kidney disease is associated with an increased risk of ischemic and bleeding complications after percutaneous coronary intervention (PCI). Bivalirudin, a direct thrombin inhibitor, has been shown to reduce adverse bleeding events compared to unfractionated heparin in patients undergoing PCI. However, the effect of diminished renal function on the safety and efficacy of bivalirudin for PCI is unknown. We aimed to test the safety of bivalirudin in routine practice and to assess whether this benefit was influenced by renal function.
  
  
  RESULTS
  The interaction between renal impairment and benefit from bivalirudin was assessed in 115 consecutive patients (age 68.5+/-12.1, 45% female) undergoing PCI. Bivalirudin dosing was adjusted based on renal function. Creatinine clearance (CrCl) was calculated using the Cockroft-Gault formula. The composite endpoints of in-hospital death, myocardial infarction or revascularization and bleeding events were assessed. Overall, these events occurred in 10 (8.7%) patients. Patients with a CrCl<60 ml/min had a significantly increased risk for in-hospital complications (18.6 versus 2.78%, P = 0.011). Univariate analysis for MACE and bleeding were significant for CrCl<60 ml/min OR: 2.54 (95% CI: 1.61-39.7, P = 0.011), age OR: 3.29 (95% CI: 1.07-1.39, P<0.001) and female gender OR: 2.1 (95% CI: 0.036-0.89, P = 0.036). Risk of complications increased with decreasing renal function: 2.7, 14.2, and 37.5% for CrCl of >60, 30-60 or <30 ml/min, respectively, P = 0.002).
  
  
  CONCLUSIONS
  Advanced age, renal dysfunction, and female gender remain important risk factors for ischemic and bleeding complications in patients undergoing PCI with bivalirudin.
authors.affiliation: Department of Medicine, Division of Cardiology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
authors.forename: Ariel
authors.initials: A
authors.lastname: Roguin
authors.forename: Benjamin A
authors.initials: BA
authors.lastname: Steinberg
authors.forename: Stanley P
authors.initials: SP
authors.lastname: Watkins
authors.forename: Jon R
authors.initials: JR
authors.lastname: Resar
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D000991:Antithrombins / Q000627:therapeutic use*; D015897:Comorbidity; D003327:Coronary Disease / Q000453:epidemiology* / Q000628:therapy*; D003404:Creatinine / Q000652:urine; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006629:Hirudins; D006801:Humans; D007676:Kidney Failure, Chronic / Q000453:epidemiology*; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D012307:Risk Factors
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D003404:Creatinine; C074619:bivalirudin