title: Treatment effects of eptifibatide in planned coronary stent implantation in patients with chronic kidney disease (ESPRIT Trial).
abstract: The role of platelet glycoprotein IIb/IIIa inhibitor therapy in patients with mild renal impairment is not well characterized. Our objective was to explore the associations of creatinine clearance (CrCl) with outcomes in a trial of eptifibatide therapy in patients who underwent percutaneous coronary intervention (PCI). We analyzed 48-hour and 30-day outcomes of patients enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial. Patients were randomly assigned to placebo or eptifibatide as an adjunct to stent implantation (1,755 with CrCl > or =60 ml/min and 289 with CrCl <60 ml/min). CrCl was calculated using the Cockcroft and Gault formula, and the associations of CrCl with outcomes were evaluated using logistic regression models. Patients with CrCl <60 ml/min were more likely to be older, women, hypertensive, and have a history of coronary artery bypass surgery, stroke, or peripheral vascular disease. The interaction of eptifibatide with CrCl had borderline significance for the 30-day outcome (p = 0.109). Treatment effect trended toward a greater magnitude in patients with lower CrCl (60 ml/min) (odds ratio 0.53, confidence interval 0.34 to 0.83) compared with those with higher CrCl (90 ml/min) (odds ratio 0.68, confidence interval 0.49 to 0.94). An accompanying increase in bleeding risk also was not apparent with lower CrCl. The treatment effect of eptifibatide is realized regardless of renal function and trends toward being greater in patients with mild renal impairment.
authors.affiliation: Division of Nephrology and Duke Institute for Renal Outcomes and Health Policy, Durham, North Carolina 27705, USA. redda001@mc.duke.edu
authors.forename: Donal N
authors.initials: DN
authors.lastname: Reddan
authors.forename: John Conor
authors.initials: JC
authors.lastname: O'Shea
authors.forename: Ian J
authors.initials: IJ
authors.lastname: Sarembock
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Williams
authors.forename: Karen S
authors.initials: KS
authors.lastname: Pieper
authors.forename: Edward
authors.initials: E
authors.lastname: Santoian
authors.forename: William F
authors.initials: WF
authors.lastname: Owen
authors.forename: Michael M
authors.initials: MM
authors.lastname: Kitt
authors.forename: James E
authors.initials: JE
authors.lastname: Tcheng
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D016009:Chi-Square Distribution; D003327:Coronary Disease / Q000150:complications / Q000188:drug therapy* / Q000628:therapy; D003404:Creatinine / Q000378:metabolism; D004311:Double-Blind Method; D000077542:Eptifibatide; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications*; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D015607:Stents; D016896:Treatment Outcome
chemical_list: D010455:Peptides; D010975:Platelet Aggregation Inhibitors; D003404:Creatinine; D000077542:Eptifibatide