title: Prospective validation of the Bleeding Academic Research Consortium classification in the all-comer PRODIGY trial.
abstract: OBJECTIVE
  The Bleeding Academic Research Consortium (BARC) classification has been proposed by consensus to standardize bleeding endpoint definition and reporting in cardiovascular clinical trials. There are no prospective studies on its prognostic impact.
  
  
  RESULTS
  We explored the association of BARC-defined bleeding with mortality and compared its prognostic value against two validated bleeding scales: the Thrombolysis in Myocardial Infarction (TIMI) and the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) scales. Non-coronary artery bypass graft (CABG)-related bleedings within the PRODIGY trial were prospectively adjudicated by a blinded Clinical Event Committee and analysed according to multiple statistical modelling. At 2 years, bleeding occurred in 143 patients (7.1%) according to BARC Type 2, 3, or 5; in 50 patients (2.5%) according to TIMI minor or major; and in 61 patients (3.1%) according to GUSTO moderate or severe. One hundred sixty-three patients died (8.1%). After multivariable modelling, BARC Type 2, 3, or 5 bleeding was associated with increased 2-year mortality [hazard ratio (HR): 3.77; 95% confidence interval (CI): 2.37-5.98]. Bleeding Academic Research Consortium Type 3 or 5 was associated with an increased mortality rate at 2 years (adjusted HR: 7.72; 95% CI: 4.75-12.54) similar to that provided by TIMI (HR: 7.64, 95% CI: 4.53-12.87) or GUSTO (HR: 7.36, 95% CI: 4.38-12.34) criteria.
  
  
  CONCLUSIONS
  In a contemporary, all-comer percutaneous coronary intervention trial actionable BARC bleedings were associated with increased risk of mortality with BARC Type 3 or 5 bleedings providing a similar mortality risk to that posed by TIMI or GUSTO scales.
authors.affiliation: Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium Department of Cardiology, Thoraxcentre, Erasmus Medical Center, Rotterdam, The Netherlands Thoraxcentre, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Pascal
authors.initials: P
authors.lastname: Vranckx
authors.affiliation: Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Leonardi
authors.affiliation: Department of Cardiology, University of Ferrara, Ferrara, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Tebaldi
authors.affiliation: Department of Cardiology, University of Ferrara, Ferrara, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Biscaglia
authors.affiliation: Medical Statistics Unit, University of Brescia, Brescia, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Parrinello
authors.affiliation: The Duke Clinical Research Institute, Durham, NC, USA.
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.affiliation: Mount Sinai School of Medicine, New York, NY, USA.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: Thoraxcentre, Erasmus Medical Center, Rotterdam, The Netherlands m.valgimigli@erasmusmc.nl vlgmrc@unife.it.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects; D000077144:Clopidogrel; D004812:Epidemiologic Methods; D005260:Female; D006470:Hemorrhage / Q000145:classification* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality* / Q000628:therapy; D062645:Percutaneous Coronary Intervention / Q000401:mortality*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin
keywords: Aspirin; Bleeding; Bleeding Academic Research Consortium; Clopidogrel; Dual anti-platelet therapy; Mortality; Percutaneous coronary intervention