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

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.

• Authors: Pascal Vranckx, Sergio Leonardi, Matteo Tebaldi, Simone Biscaglia, Giovanni Parrinello, Sunil V Rao, Roxana Mehran, Marco Valgimigli
• Journal: European heart journal (Eur Heart J) Vol. 35 Issue 37 Pg. 2524-9 (Oct 01 2014) ISSN: 1522-9645 [Electronic] England
• PMID: 24755007 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Validation Study)
• Copyright: Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: [email protected].

Chemical References

• Platelet Aggregation Inhibitors
• Clopidogrel
• Ticlopidine
• Aspirin

Topics

• Administration, Oral
• Aged
• Aspirin (administration & dosage, adverse effects)
• Clopidogrel
• Epidemiologic Methods
• Female
• Hemorrhage (classification, mortality)
• Humans
• Male
• Middle Aged
• Myocardial Infarction (mortality, therapy)
• Percutaneous Coronary Intervention (mortality)
• Platelet Aggregation Inhibitors (administration & dosage, adverse effects)
• Recurrence
• Ticlopidine (administration & dosage, adverse effects, analogs & derivatives)