title: Predictors and impact of major hemorrhage on mortality following percutaneous coronary intervention from the REPLACE-2 Trial.
abstract: Patients undergoing percutaneous coronary intervention (PCI) have a significant risk of hemorrhagic complications. Predictors of major hemorrhage and its relation to mortality in PCI are not well defined. Baseline and periprocedural predictors of major hemorrhage and its impact on mortality in patients undergoing elective or urgent PCI randomly assigned to heparin plus planned glycoprotein IIb/IIIa inhibitor (GPI) versus bivalirudin plus provisional GPIs in the REPLACE-2 Trial were determined. Of 6,001 patients, 3.2% experienced a major hemorrhage. Independent baseline predictors of major hemorrhage included advanced age, female gender, impaired creatinine clearance, and anemia. Independent periprocedural predictors of major hemorrhage included treatment with heparin plus GPI, increased procedural duration, provisional use of GPI, increased time to sheath removal, length of intensive care unit stay, and use of an intra-aortic balloon pump (all p <0.05). Mortality rates were higher in patients with than without major hemorrhage at 30 days (5.1% vs 0.2%), 6 months (6.7% vs 1.0%), and 1 year (8.7% vs 1.9%; p <0.001 for all). Furthermore, major hemorrhage was an independent predictor of 1-year mortality (odds ratio 2.66, 95% confidence interval 1.44 to 4.92, p = 0.002). In conclusion, in patients undergoing elective or urgent PCI, major hemorrhage was an independent predictor of 1-year mortality. A number of baseline and periprocedural factors independently predicted major hemorrhage, including treatment with heparin plus GPI.
authors.affiliation: Department of Medicine, New York University School of Medicine, New York, NY, USA. frederick.feit@med.nyu.edu
authors.forename: Frederick
authors.initials: F
authors.lastname: Feit
authors.forename: Michele D
authors.initials: MD
authors.lastname: Voeltz
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Attubato
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: Derek P
authors.initials: DP
authors.lastname: Chew
authors.forename: John A
authors.initials: JA
authors.lastname: Bittl
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
authors.forename: Steven V
authors.initials: SV
authors.lastname: Manoukian
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000401:mortality; D000991:Antithrombins / Q000627:therapeutic use; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006470:Hemorrhage / Q000453:epidemiology*; D006629:Hirudins; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010446:Peptide Fragments / Q000627:therapeutic use; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D000991:Antithrombins; D005343:Fibrinolytic Agents; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; C074619:bivalirudin