title: The impact of bivalirudin on percutaneous coronary intervention-related bleeding.
abstract: We studied the clinical and economic impact of bivalirudin in clinical practice.
  
  
  
  Consecutive patients undergoing PCI via the common femoral artery for stable, unstable, or atypical angina, silent ischaemia, or non-ST-elevation myocardial infarction indications during 2007-2008 were prospectively studied. In-hospital bleeding events were systematically assessed and classified as either major or minor. Use of bivalirudin, vascular closure devices, heparin and/or glycoprotein (GP) IIb/IIIa inhibitor was at the operator's discretion. Among 1,364 patients, 503 received bivalirudin and 861 received usual care consisting of either heparin monotherapy (n=687) or heparin+GP IIb/IIIa (n=174). Any post-PCI bleeding occurred in 356 (26.1%) patients, including 32 (2.3%) major and 324 (23.8%) minor events. Compared with usual care, bivalirudin was associated with reduced bleeding before adjustment (any: 17.3% vs. 31.2%, P<0.001; major: 1.2% vs. 3.0%, P=0.03; minor: 16.1% vs. 28.2%, P<0.01) and after propensity-matching (OR 0.46, 95% CI 0.34-0.63, P<0.001). Use of vascular closure devices was associated with an increase in any bleeding (32.2% vs. 17.7%, P<0.001), primarily due to an increase in minor bleeding (30.8% vs. 14.1%, P<0.001) while there was a significant decrease in major bleeding (1.4% vs. 3.7%, P=0.007). Bivalirudin was associated with total hospitalisation costs that were lower than usual care (mean cost savings, $463/patient; 95% CI 1,594 less to 621 more).
  
  
  
  In this prospective PCI cohort, bivalirudin was associated with reduced major and minor bleeding without a significant increase in hospital costs compared with other anticoagulation regimens. Closure device use was associated with decreased major but increased minor bleeding.
authors.affiliation: Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA.
authors.forename: Jason B
authors.initials: JB
authors.lastname: Lindsey
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: Joshua M
authors.initials: JM
authors.lastname: Stolker
authors.forename: Sameer K
authors.initials: SK
authors.lastname: Meht
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Mahoney
authors.forename: Katherine
authors.initials: K
authors.lastname: Robertus
authors.forename: John A
authors.initials: JA
authors.lastname: House
authors.forename: Kevin
authors.initials: K
authors.lastname: Kennedy
authors.forename: Lisa
authors.initials: L
authors.lastname: Riggs
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.forename: Steven P
authors.initials: SP
authors.lastname: Marso
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003365:Costs and Cost Analysis; D005260:Female; D006629:Hirudins; D017721:Hospital Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D019106:Postoperative Hemorrhage / Q000191:economics* / Q000453:epidemiology*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; C074619:bivalirudin