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Prospective validation of the Bleeding Academic Research Consortium classification in the all-comer PRODIGY trial

Pascal Vranckx1, Sergio Leonardi2, Matteo Tebaldi3

  • 1Department 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.

European Heart Journal
|April 24, 2014
PubMed

Insights

The Bleeding Academic Research Consortium (BARC) classification identifies bleeding events in cardiovascular trials. BARC Type 3 or 5 bleedings predict mortality similarly to TIMI and GUSTO scales.

Area of Science:

  • Cardiovascular Medicine
  • Clinical Trials Methodology
  • Hemorrhagic Event Classification

Background:

  • Standardized bleeding definitions are crucial for cardiovascular clinical trials.
  • The Bleeding Academic Research Consortium (BARC) classification was developed by consensus for this purpose.
  • The prognostic impact of BARC-defined bleeding in prospective studies remains largely unexamined.

Purpose of the Study:

  • To assess the prognostic value of BARC-defined bleeding in predicting mortality.
  • To compare the predictive performance of BARC criteria against established bleeding scales (TIMI and GUSTO).
  • To analyze bleeding events and mortality in a contemporary, all-comer percutaneous coronary intervention trial.

Main Methods:

  • Prospective adjudication of non-coronary artery bypass graft (CABG)-related bleeding events by a blinded Clinical Event Committee within the PRODIGY trial.
  • Analysis of bleeding occurrences (BARC Type 2, 3, or 5; TIMI minor/major; GUSTO moderate/severe) and 2-year mortality.
  • Multivariable statistical modeling to determine the association between bleeding types and mortality risk.

Main Results:

  • At 2 years, 7.1% of patients experienced BARC Type 2, 3, or 5 bleeding, 2.5% had TIMI minor/major bleeding, and 3.1% had GUSTO moderate/severe bleeding.
  • BARC Type 2, 3, or 5 bleeding was significantly associated with increased 2-year mortality (HR: 3.77).
  • BARC Type 3 or 5 bleeding demonstrated a similar mortality risk prediction as TIMI and GUSTO criteria (adjusted HRs ranging from 7.36 to 7.72).

Conclusions:

  • Actionable BARC bleedings are associated with an elevated risk of mortality in patients undergoing percutaneous coronary intervention.
  • BARC Type 3 or 5 bleeding classifications offer prognostic value comparable to TIMI and GUSTO scales.
  • These findings support the utility of BARC criteria for risk stratification in cardiovascular trials.
Abstract

Keywords:
AspirinBleedingBleeding Academic Research ConsortiumClopidogrelDual anti-platelet therapyMortalityPercutaneous coronary intervention

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