Prospective validation of the bleeding academic research consortium classification in the all-comer PRODIGY trial

Pascal Vranckx, Sergio Leonardi, Matteo Tebaldi, Simone Biscaglia, Giovanni Parrinello, Sunil V. Rao, Roxana Mehran, Marco Valgimigli

Research output: Contribution to journalArticlepeer-review

Abstract

Aims 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.

Methods and 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.

Original languageEnglish
Pages (from-to)2524-2529
Number of pages6
JournalEuropean Heart Journal
Volume35
Issue number37
DOIs
Publication statusPublished - Oct 1 2014

Keywords

  • Aspirin
  • Bleeding
  • Bleeding academic research consortium
  • Clopidogrel
  • Dual anti-platelet therapy
  • Mortality
  • Percutaneous coronary intervention

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

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