title: The comparative safety and effectiveness of bivalirudin versus heparin monotherapy in patients on dialysis undergoing percutaneous coronary intervention: Insights from the Blue Cross Blue Shield of Michigan cardiovascular consortium.
abstract: BACKGROUND
  Dialysis patients are at a higher risk of bleeding after percutaneous coronary intervention (PCI); however, due to their exclusion from randomized clinical trials, the optimal antithrombotic regimen for this population remains unknown. We sought to evaluate the comparative safety and effectiveness of bivalirudin monotherapy versus unfractionated heparin (UFH) monotherapy in dialysis patients undergoing PCI.
  
  
  METHODS
  We included dialysis patients who underwent PCI in a multicenter registry between January 2010 and September 2015 at 47 Michigan hospitals. We compared in-hospital outcomes between bivalirudin versus UFH; excluding those treated with glycoprotein IIb/IIIa inhibitors. Optimal full matching was used to account for the nonrandom use of these drugs.
  
  
  RESULTS
  Of 177,963 patients who underwent PCI, 4,303 (2.4%) were on dialysis. Among those, 1,257 (29.2%) received bivalirudin monotherapy and 2,112 (49.1%) received UFH monotherapy. Patients treated with bivalirudin had fewer comorbidities. After matching, there were no significant differences in outcomes between those who received bivalirudin versus UFH: bleeding (adjusted odds ratio: 0.67; 95% confidence interval: 0.41-1.07; P = 0.093); major bleeding (0.81; 0.19-3.50; P = 0.77); transfusion (1.01; 0.77-1.33; P = 0.96); repeat PCI (0.57; 0.14-2.24; P = 0.42); stent thrombosis (0.56; 0.05-5.83; P = 0.63); and death (0.84; 0.46-1.51; P = 0.55).
  
  
  CONCLUSIONS
  We found no significant differences in in-hospital outcomes between bivalirudin and UFH monotherapy among dialysis patients undergoing PCI. Randomized clinical trials are needed to determine the optimal anticoagulant regimen for this population. © 2017 Wiley Periodicals, Inc.
authors.affiliation: Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan.
authors.forename: Devraj
authors.initials: D
authors.lastname: Sukul
authors.affiliation: Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan.
authors.forename: Milan
authors.initials: M
authors.lastname: Seth
authors.affiliation: Detroit Medical Center-Cardiovascular Institute, Detroit, Michigan.
authors.forename: Theodore
authors.initials: T
authors.lastname: Schreiber
authors.affiliation: Division of Cardiology, Henry Ford Health System, Detroit, Michigan.
authors.forename: Akshay
authors.initials: A
authors.lastname: Khandelwal
authors.affiliation: McLaren-Northern Michigan Regional Hospital, Petoskey, Michigan.
authors.forename: Louis A
authors.initials: LA
authors.lastname: Cannon
authors.affiliation: Department of Cardiovascular Medicine, St. John Hospital and Medical Center, Detroit, Michigan.
authors.forename: Thomas A
authors.initials: TA
authors.lastname: LaLonde
authors.affiliation: Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan.|Cardiovascular Medicine, VA Ann Arbor Healthcare System, Ann Arbor, Michigan.
authors.forename: Hitinder S
authors.identifier: http://orcid.org/0000-0002-1646-0218
authors.initials: HS
authors.lastname: Gurm
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D054598:Blue Cross Blue Shield Insurance Plans; D057186:Comparative Effectiveness Research; D003324:Coronary Artery Disease / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D016015:Logistic Models; D008297:Male; D008824:Michigan; D008875:Middle Aged; D016017:Odds Ratio; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation; D057216:Propensity Score; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012042:Registries; D006435:Renal Dialysis / Q000009:adverse effects; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D013927:Thrombosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: anticoagulant; chronic kidney disease; dialysis; outcomes; percutaneous coronary intervention