Validation of BARC Bleeding Criteria in Patients With Acute Coronary Syndromes The TRACER Trial

Pascal Vranckx, Harvey White, Zhen Huang, Kenneth Mahaffey, Paul Armstrong, F Van De Werf, David Moliterno, Lars Wallentin, Claes Held, Philip Aylward, Jan Cornel, Christoph Bode, Kurt Huber, Jose Nicolau, Witold Ruzyllo, Robert Harrington, Pierluigi Tricoci

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    64 Citations (Scopus)


    Background The Bleeding Academic Research Consortium (BARC) scale has been proposed to standardize bleeding endpoint definitions and reporting in cardiovascular trials. Validation in large cohorts of patients is needed. Objectives This study sought to investigate the relationship between BARC-classified bleeding and mortality and compared its prognostic value against 2 validated bleeding scales: TIMI (Thrombolysis In Myocardial Infarction) and GUSTO (Global Use of Strategies to Open Occluded Arteries). Methods We analyzed bleeding in 12,944 patients with acute coronary syndromes without ST-segment elevation, with or without early invasive strategy. The main outcome measure was all-cause death. Results During follow-up (median: 502 days), noncoronary artery bypass graft (CABG) bleeding occurred in 1,998 (15.4%) patients according to BARC (grades 2, 3, or 5), 484 (3.7%) patients according to TIMI minor/major, and 514 (4.0%) patients according to GUSTO moderate/severe criteria. CABG-related bleeding (BARC 4) occurred in 155 (1.2%) patients. Patients with BARC (2, 3, or 4) bleeding had a significant increase in risk of death versus patients without bleeding (BARC 0 or 1); the hazard was highest in the 30 days after bleeding (hazard ratio: 7.35; 95% confidence interval: 5.59 to 9.68; p < 0.0001) and remained significant up to 1 year. The hazard of mortality increased progressively with non-CABG BARC grades. BARC 4 bleeds were significantly associated with mortality within 30 days (hazard ratio: 10.05; 95% confidence interval: 5.41 to 18.69; p < 0.0001), but not thereafter. Inclusion of BARC (2, 3, or 4) bleeding in the 1-year mortality model with baseline characteristics improved it to an extent comparable to TIMI minor/major and GUSTO moderate/severe bleeding. Conclusions In patients with acute coronary syndromes without ST-segment elevation, bleeding assessed with the BARC scale was significantly associated with risk of subsequent death up to 1 year after the event and risk of mortality increased gradually with higher BARC grades. Our results support adoption of the BARC bleeding scale in ACS clinical trials.

    Original languageEnglish
    Pages (from-to)2135-2144
    Number of pages10
    JournalJournal of The American College of Cardiology
    Issue number18
    Publication statusPublished - 10 May 2016


    • aspirin
    • Bleeding Academic Research Consortium
    • clopidogrel
    • mortality
    • vorapaxar


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