The Bleeding Academic Research Consortium (BARC) scale independently and incrementally predicted 1-year mortality in patients with acute coronary syndrome (ACS) but without ST-segment elevation (STE), according to data published in the Journal of the American College of Cardiology.
The BARC scale was designed to standardize bleeding end point definitions and reporting in cardiovascular trials. To validate the scale, researchers investigated the relationship between BARC-classified bleeding and mortality. They also evaluated BARC’s prognostic value against the Thrombolysis In Myocardial Infarction (TIMI) scale, and the Global Use of Strategies to Open Occluded Arteries (GUSTO) scale.
“In patients with non-STE [NSTE] ACS, bleeding is a composite end point associated with a risk of mortality over the course of the subsequent year,” the authors wrote. “The BARC criteria capture most overt bleeding events and therefore form a meaningful tool for assessment of the safety of antithrombotic therapy.”
Researchers used data from the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trial to examine the association between BARC bleeding and mortality.
The TRACER study was a multicenter, global, randomized, double-blind trial that compared a loading dose of 40 mg vorapaxar against placebo followed by a 2.5 mg/d maintenance dose for patients with NSTE-ACS with high risk for recurrent ischemic events.
To validate the BARC scale, researchers analyzed bleeding in 12 944 patients with ACS and without STE, with or without invasive strategy. The median follow-up period was 502 days and the primary outcome was all-cause death.
Noncoronary artery bypass graft (CABG) bleeding occurred in 1998 (15.4%) of patients, according to the BARC scale. Bleeding occurred in 484 (3.7%) patients, according to the TIMI scale and in 514 (4.0%) patients, according to the GUSTO scale. CABG-related bleeding (BARC 4) occurred in 155 (1.2%) of patients.
Patients with grades 2, 3, or 4 bleeding on the BARC scale had a significant increase in mortality risk compared with patients without bleeding (BARC grades 0 or 1). Risk of death was highest within 30 days after bleeding (hazard ratio [HR]: 7.35; 95% confidence interval [CI]: 5.59-9.68; P<.0001) and remained significant up to a year.
Non-CABG BARC grades revealed progressively increased mortality, but grade 4 BARC bleeds were significantly associated with mortality only within the first 30 days (HR: 10.05; 95% CI: 5.41-18.69; P<.0001).
Researchers concluded that the inclusion of BARC bleeding (grades 2, 3, or 4) improved the 1-year mortality model to an extent comparable to TIMI major or minor and GUSTO moderate or severe criteria.
“These data add to the clinical validity of the BARC classification that, by integrating elements of both GUSTO and TIMI scales, may be helpful to standardize bleeding end point definitions in clinical investigations and may thus be used in addition to or in substitution of these 2 scales,” they wrote.
“Further studies are needed to develop methods for integrated assessment of both safety and efficacy to reflect the net clinical benefit of antithrombotic interventions in randomized trials and clinical practice.”
Vranckx P, White HD, Huang Z, et al. Validation of BARC bleeding criteria in patients with acute coronary syndromes: the TRACER Trial. J Am Coll Cardiol. 2016;67(18):2135-2144. doi: 10.1016/j.jacc.2016.02.056.