title: Safety and in-hospital outcomes of bivalirudin use in dialysis patients undergoing percutaneous coronary intervention.
abstract: Chronic dialysis-dependent patients undergoing percutaneous coronary intervention (PCI) are at a greater risk of bleeding and ischemic events. Bivalirudin has been associated with fewer bleeding complications than unfractionated heparin (UFH) in patients undergoing PCI in various clinical settings. These studies, however, have systematically excluded patients dependent on chronic dialysis. We sought to assess the safety, bleeding rates, and in-hospital outcomes of bivalirudin use compared to UFH use alone in patients requiring dialysis and undergoing PCI. A retrospective analysis of 396 dialysis-dependent patients undergoing PCI from January 2000 to March 2009 was performed. Patients treated with a dose-adjusted bivalirudin regimen (n = 267) were compared to those treated with UFH alone (n = 129). The primary end point of major bleeding (hematocrit decrease > or = 15%, gastrointestinal or intracerebral bleeding) and the composite end point of in-hospital death, nonfatal Q-wave myocardial infarction, and urgent target vessel revascularization were compared between groups. The baseline characteristics were similar between the 2 groups, except for the proportion of men and nonsmokers and body mass index, which were greater in patients treated with bivalirudin. The rate of major bleeding was similar between the bivalirudin and UFH groups (3.4% vs 3.1%, respectively, p = 0.9). The rate of the composite end point (death, Q-wave myocardial infarction, urgent target vessel revascularization) was not significantly different between the 2 groups (1.8% for bivalirudin vs 0.8% for UFH group, p = 0.7). After adjustment, bivalirudin use was not associated with major bleeding (odds ratio 1.23, 95% confidence interval 0.37 to 4.13, p = 0.7). In conclusion, a dose-adjusted bivalirudin anticoagulation regimen for patients requiring chronic dialysis undergoing PCI seems to be as safe and as effective as UFH use alone. These results do not suggest the superiority of bivalirudin over UFH.
authors.affiliation: Department of Internal Medicine, Division of Cardiology, Washington Hospital Center, Washington, District of Columbia, USA.
authors.forename: Cedric
authors.initials: C
authors.lastname: Delhaye
authors.forename: Gabriel
authors.initials: G
authors.lastname: Maluenda
authors.forename: Kohei
authors.initials: K
authors.lastname: Wakabayashi
authors.forename: Itsik
authors.initials: I
authors.lastname: Ben-Dor
authors.forename: Sara D
authors.initials: SD
authors.lastname: Collins
authors.forename: Asmir I
authors.initials: AI
authors.lastname: Syed
authors.forename: Manuel A
authors.initials: MA
authors.lastname: Gonzalez
authors.forename: Michael A
authors.initials: MA
authors.lastname: Gaglia
authors.forename: Rebecca
authors.initials: R
authors.lastname: Torguson
authors.forename: Zhenyi
authors.initials: Z
authors.lastname: Xue
authors.forename: William O
authors.initials: WO
authors.lastname: Suddath
authors.forename: Lowell F
authors.initials: LF
authors.lastname: Satler
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Kent
authors.forename: Joseph
authors.initials: J
authors.lastname: Lindsay
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006470:Hemorrhage / Q000517:prevention & control*; D006493:Heparin / Q000627:therapeutic use*; D006629:Hirudins; D006801:Humans; D007297:Inpatients; D007676:Kidney Failure, Chronic / Q000628:therapy; D008297:Male; D010446:Peptide Fragments / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D006435:Renal Dialysis; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin