title: Prediction of 1-year mortality and impact of bivalirudin therapy according to level of baseline risk: A patient-level pooled analysis from three randomized trials.
abstract: OBJECTIVE
  We aimed to construct a predictive model for one-year mortality in patients undergoing invasive coronary evaluation and to examine the impact of bivalirudin on survival according to the level of baseline risk.
  
  
  BACKGROUND
  Compared to heparin plus GP IIb/IIIa inhibitors (HEP/GPI), bivalirudin decreases bleeding complications in a range of clinical presentations. The impact of preprocedural risk assessment on survival and whether this is modified by bivalirudin, has not been investigated in detail.
  
  
  METHODS
  We examined patient-level data from the REPLACE-2, ACUITY, and HORIZONS-AMI trials (n = 18,819) to construct a risk-adjusted mortality model using baseline clinical variables.
  
  
  RESULTS
  One-year mortality occurred in 287 patients (3.1%) assigned to bivalirudin and 336 patients (3.6%) assigned to HEP/GPI (HR 0.85; 95% CI, 0.73-1.00; P = 0.048). Using 11 highly significant predictors of mortality, we developed an integer-risk score to classify patients into risk tertiles. High-risk patients had a rate of 1-year mortality over 9-fold greater than low-risk patients. Consequently, the absolute mortality reduction attributed to bivalirudin was more marked in high-risk patients: 3.1% (-0.8% to 7.0%) in the overall cohort, 4.8% (0.5% to 9.2%) in the PCI cohort (P-interaction versus intermediate and low risk categories, 0.09 and P = 0.02, respectively).
  
  
  CONCLUSIONS
  In patients undergoing invasive coronary evaluation, 1-year mortality can be predicted using baseline variables. Bivalirudin treatment (versus HEP/GPI) conferred a survival benefit.
authors.affiliation: Mount Sinai Medical Center, Cardiovascular Institute, New York, New York.|Prince of Wales Hospital Clinical School, University of New South Wales, NSW, Australia.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Yu
authors.affiliation: Mount Sinai Medical Center, Cardiovascular Institute, New York, New York.|Cardiovascular Research Foundation, New York, New York.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Tim
authors.initials: T
authors.lastname: Clayton
authors.affiliation: Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: LeBauer Cardiovascular Research Foundation, Greensboro, North Carolina.
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Brodie
authors.affiliation: Helios Amper-Klinikum, Dachau, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Witzenbichler
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.affiliation: The Medicines Company, Munich, Germany.
authors.forename: Efthymios N
authors.initials: EN
authors.lastname: Deliargyris
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Bernard J
authors.initials: BJ
authors.lastname: Gersh
authors.affiliation: London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
authors.affiliation: Cardiovascular Research Foundation, New York, New York.|Columbia University Medical Center, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: Mount Sinai Medical Center, Cardiovascular Institute, New York, New York.|Cardiovascular Research Foundation, New York, New York.
authors.forename: George D
authors.initials: GD
authors.lastname: Dangas
mesh_terms: D000368:Aged; D060050:Angina, Stable / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D000789:Angina, Unstable / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D000925:Anticoagulants / Q000627:therapeutic use; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000401:mortality* / Q000517:prevention & control*; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000401:mortality*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: bivalirudin; mortality; percutaneous coronary intervention