Relationship between renal function and outcomes in high-risk patients with non-ST-segment elevation acute coronary syndromes: results from SYNERGY.
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.
Spinler
Sarah A
SA
Department of Pharmacy Practice and Pharmacy Administration, Philadelphia College of Pharmacy, University of the Sciences in Philadelphia, Philadelphia, PA, USA. s.spinle@usp.edu
Mahaffey
Kenneth W
KW
Gallup
Dianne
D
Levine
Glenn N
GN
Ferguson
James J
JJ
Rao
Sunil V
SV
Gallo
Richard
R
Ducas
John
J
Goodman
Shaun G
SG
Antman
Elliott
E
White
Harvey D
HD
Biasucci
Luigi
L
Becker
Richard C
RC
Col
Jacques J
JJ
Cohen
Marc
M
Harrington
Robert A
RA
Califf
Robert M
RM
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
D005343:Fibrinolytic Agents; D003404:Creatinine