title: Impact of worsening renal dysfunction on the comparative efficacy of bivalirudin and platelet glycoprotein IIb/IIIa inhibitors: insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium.
abstract: BACKGROUND
  Use of bivalirudin has been associated with a reduction in the incidence of bleeding in patients undergoing percutaneous coronary intervention. Patients with chronic kidney disease, a known predictor of post-percutaneous coronary intervention bleeding, are under-represented in clinical trials.
  
  
  RESULTS
  We evaluated the outcome of 64,052 patients who underwent percutaneous coronary intervention from 2007 to 2009 at 33 hospitals in Michigan and were treated with bivalirudin (28,378) or with heparin and glycoprotein IIb/IIIa inhibitors (35,674). Propensity-matched analysis was adjusted for the nonrandomized use of the 2 strategies. Patients treated with bivalirudin were older, had a lower glomerular filtration rate, and had more comorbidities. Use of bivalirudin was associated with fewer transfusions (2.8% versus 4.2%; P<0.0001), gastrointestinal bleeds (0.5% versus 1.3%; P<0.0001), and vascular complications (1.0% versus 2.5%; P<0.0001), with no difference in survival. Bleeding complications were more common with worsening renal function, but use of bivalirudin was associated with less bleeding across the continuum of renal dysfunction.
  
  
  CONCLUSIONS
  The risk of bleeding after percutaneous coronary intervention increases with worsening chronic kidney disease. Bivalirudin was associated with a dramatically reduced risk of bleeding across all categories of renal dysfunction. Our study findings suggest that bivalirudin monotherapy is an acceptable, if not the more appropriate alternative, to heparin and glycoprotein IIb/IIIa inhibitors in patients with chronic kidney disease.
authors.affiliation: From the Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan Medical Center, Ann Arbor (E.P., H.S.G.); Department of Biostatistics, University of Michigan, Ann Arbor (M.Z.); Department of Internal Medicine, Oakwood Hospital and Medical Center, Dearborn, MI (A.R.); Department of Internal Medicine, St. John Providence Health System, Detroit, MI (T.A.L.); and Department of Internal Medicine, Detroit Medical Center, MI (C.L.G.).
authors.forename: Emily
authors.initials: E
authors.lastname: Perdoncin
authors.forename: Min
authors.initials: M
authors.lastname: Zhang
authors.forename: Arthur
authors.initials: A
authors.lastname: Riba
authors.forename: Thomas A
authors.initials: TA
authors.lastname: LaLonde
authors.forename: Cindy L
authors.initials: CL
authors.lastname: Grines
authors.forename: Hitinder S
authors.initials: HS
authors.lastname: Gurm
mesh_terms: D000368:Aged; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use; D054598:Blue Cross Blue Shield Insurance Plans; D015897:Comorbidity; D003324:Coronary Artery Disease / Q000453:epidemiology / Q000628:therapy*; D005260:Female; D006470:Hemorrhage / Q000453:epidemiology; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D007668:Kidney / Q000503:physiopathology*; D008297:Male; D008824:Michigan; D008875:Middle Aged; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000453:epidemiology / Q000503:physiopathology; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; C074619:bivalirudin
keywords: anticoagulants; hemorrhage; kidney