title: Relationship between renal function and outcomes in high-risk patients with non-ST-segment elevation acute coronary syndromes: results from SYNERGY.
abstract: BACKGROUND
  Chronic kidney disease (CKD) is a risk factor for coronary heart disease and bleeding with antithrombotic therapy in patients with acute coronary syndromes (ACS). We evaluated the effect of renal function on efficacy and outcomes in high-risk patients with NSTE ACS in the SYNERGY trial.
  
  
  METHODS
  Creatinine clearance (CrCl) at the time of randomization was analyzed as a continuous variable added to multivariable logistic regression models for 30-day death or MI, non-CABG-associated TIMI major bleeding, GUSTO severe bleeding, and transfusion in the overall study population, patients undergoing coronary angiography, and patients undergoing PCI.
  
  
  RESULTS
  Of 9838 patients with a CrCl value, 70.6% (N=6950) had CrCl≥60 mL/min, 27.8% (N=2732) had CrCl 30-59 mL/min, and 1.6% (N=156) had CrCl<30 mL/min. No randomized treatment by CrCl interaction test was found to be statistically significant, suggesting renal insufficiency affected enoxaparin and unfractionated heparin outcomes similarly. After adjustment, CrCl was an independent predictor of 30-day death or MI (OR 1.06, 95% CI 1.03-1.09), TIMI major bleeding (OR 1.06, 95% CI 1.02-1.10), GUSTO severe bleeding (OR 1.10, 95% CI 1.03-1.17), and transfusion (OR 1.07, 95% CI 1.04-1.11).
  
  
  CONCLUSIONS
  Patients with CKD had higher rates of 30-day death or MI and bleeding than those without CKD, regardless of randomized antithrombin therapy. While this analysis suggests that there is a rise in bleeding events as CrCl falls for patients in either treatment group, it is unknown whether a reduction in dose would decrease bleeding risk.
authors.affiliation: Department of Pharmacy Practice and Pharmacy Administration, Philadelphia College of Pharmacy, University of the Sciences in Philadelphia, Philadelphia, PA, USA. s.spinle@usp.edu
authors.forename: Sarah A
authors.initials: SA
authors.lastname: Spinler
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Mahaffey
authors.forename: Dianne
authors.initials: D
authors.lastname: Gallup
authors.forename: Glenn N
authors.initials: GN
authors.lastname: Levine
authors.forename: James J
authors.initials: JJ
authors.lastname: Ferguson
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.forename: Richard
authors.initials: R
authors.lastname: Gallo
authors.forename: John
authors.initials: J
authors.lastname: Ducas
authors.forename: Shaun G
authors.initials: SG
authors.lastname: Goodman
authors.forename: Elliott
authors.initials: E
authors.lastname: Antman
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: Luigi
authors.initials: L
authors.lastname: Biasucci
authors.forename: Richard C
authors.initials: RC
authors.lastname: Becker
authors.forename: Jacques J
authors.initials: JJ
authors.lastname: Col
authors.forename: Marc
authors.initials: M
authors.lastname: Cohen
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D054058:Acute Coronary Syndrome / Q000150:complications / Q000503:physiopathology* / Q000628:therapy; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D006328:Cardiac Catheterization; D003404:Creatinine / Q000378:metabolism; D004562:Electrocardiography; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate / Q000502:physiology*; D006801:Humans; D007668:Kidney / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D051437:Renal Insufficiency / Q000209:etiology* / Q000378:metabolism / Q000503:physiopathology; D012307:Risk Factors
chemical_list: D005343:Fibrinolytic Agents; D003404:Creatinine