Validation of BARC Bleeding Criteria in Patients with Acute Coronary Syndromes the TRACER Trial

Pascal Vranckx, Harvey D. White, Zhen Huang, Kenneth W. Mahaffey, Paul W. Armstrong, Frans Van De Werf, David J. Moliterno, Lars Wallentin, Claes Held, Philip E. Aylward, Jan H. Cornel, Christoph Bode, Kurt Huber, José C. Nicolau, Witold Ruzyllo, Robert A. Harrington, Pierluigi Tricoci

Research output: Contribution to journalArticlepeer-review

52 Scopus citations


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
StatePublished - May 10 2016

Bibliographical note

Funding Information:
The TRACER trial was supported by Merck & Co., Inc. Dr. White has received research grants from Sanofi, Eli Lilly, the National Institutes of Health, Merck Sharpe & Dohme, AstraZeneca, GlaxoSmithKline, Daiichi-Sankyo Pharma Development, George Institute, Omthera Pharmaceuticals, Pfizer New Zealand, Intarcia Therapeutics Inc., Elsai Inc., and DalGen Products and Services; and participates in an advisory board at AstraZeneca. Dr. Mahaffey has received research grants from Amgen, Daiichi, Johnson & Johnson, Medtronic, Merck, St. Jude, and Tenax; has provided consulting or other services for the American College Cardiology, AstraZeneca, BAROnova, Bayer, Bio2 Medical, Boehringer Ingelheim, Bristol-Myers Squibb, Cubist, Eli Lilly, Elsevier, Epson, Forest, GlaxoSmithKline, Johnson & Johnson, Medtronic, Merck, Mt. Sinai, Myokardia, Omthera, Portola, Purdue Pharma, Springer Publishing, The Medicines Company, Vindico, and WebMD; and has equity in BioPrint Fitness. Dr. Van de Werf has received a research grant, honoraria for lectures, and advisory board membership from Merck & Co. Dr. Moliterno has served on a Data and Safety Monitoring Board for Janssen Pharmaceuticals; and has received research grants from Merck and AstraZeneca. Dr. Wallentin has received research grants from AstraZeneca, Merck & Co., Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, and GlaxoSmithKline; lecture fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, GlaxoSmithKline, and Merck & Co.; honoraria from Boehringer Ingelheim, AstraZeneca, Bristol-Myers Squibb/Pfizer, GlaxoSmithKline, and Merck & Co.; been a consultant/served on an advisory board from Merck & Co., Regado Biosciences, Evolva, Portola, C.S.L. Behring, Athera Biotechnologies, Boehringer Ingelheim, AstraZeneca, GlaxoSmithKline, and Bristol-Myers Squibb/Pfizer; and received travel support from Bristol-Myers Squibb/Pfizer. Dr. Held has received research grants from AstraZeneca, GlaxoSmithKline, Pfizer/Bristol-Myers Squibb, Roche, and Schering-Plough (now Merck); has served on an advisory board for AstraZeneca; and has served as a consultant for Bayer. Dr. Aylward has received a research grant from Merck & Co., AstraZeneca, Sanofi, and GlaxoSmithKline; and has received honoraria/served on a speaker bureau and advisory board for AstraZeneca, Eli Lilly, Boehringer Ingelheim, Bayer/Johnson & Johnson, Servier, and Bristol-Myers Squibb. Dr. Cornel has received consulting fees/honoraria from AstraZeneca, MSD, Eli Lilly, and Bristol-Myers Squibb/Pfizer; and travel support from Bayer and AstraZeneca. Dr. Bode has received research grants from AstraZeneca, Bayer, Boehringer Ingelheim, Merck, and Sanofi; and speakers' and consulting honoraria from Bayer, Bristol-Myers Squibb, and Daiichi-Sankyo. Dr. Huber has received lecture fees from AstraZeneca, Daiichi-Sankyo, Eli Lilly, Sanofi, and The Medicines Company; and a research grant from AstraZeneca. Dr. Nicolau has received a research grant and consultant/advisory fees from Merck; and research grants and/or personal fees (consultancy, lectures, travel support) from Sanofi, AstraZeneca, Daiichi-Sankyo, Bayer/Johnson & Johnson, and Roche, outside the submitted work. Dr. Harrington has received research grants from Merck & Co., Astra, Sanofi, Bristol-Myers Squibb, The Medicines Company, Portola Pharma, and Regado; has consulted for Merck and The Medicines Company; and has served on advisory boards for Gilead and WebMD. Dr. Tricoci has a consultant agreement and has received a research grant from Merck & Co. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Publisher Copyright:
© 2016 American College of Cardiology Foundation.


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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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