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Eur Heart J. 2014 Oct 1;35(37):2524-9. doi: 10.1093/eurheartj/ehu161. Epub 2014 Apr 21.

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

Author information

1
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.
2
Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy.
3
Department of Cardiology, University of Ferrara, Ferrara, Italy.
4
Medical Statistics Unit, University of Brescia, Brescia, Italy.
5
The Duke Clinical Research Institute, Durham, NC, USA.
6
Mount Sinai School of Medicine, New York, NY, USA.
7
Thoraxcentre, Erasmus Medical Center, Rotterdam, The Netherlands m.valgimigli@erasmusmc.nl vlgmrc@unife.it.

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.

KEYWORDS:

Aspirin; Bleeding; Bleeding Academic Research Consortium; Clopidogrel; Dual anti-platelet therapy; Mortality; Percutaneous coronary intervention

PMID:
24755007
DOI:
10.1093/eurheartj/ehu161
[Indexed for MEDLINE]
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