Assessing bleeding in acute coronary syndrome using the Bleeding Academic Research Consortium definition

Background The Bleeding Academic Research Consortium (BARC) definition was proposed to overcome the heterogeneity among the many bleeding definitions. The aim of this study-level meta-analysis was to explore the incidence of BARC-assessed bleeding in acute coronary syndrome (ACS) studies and to ascertain the relation between these events and variables related to bleeding risk.Methods and Results We searched the literature for studies that reported bleeding events according to BARC criteria in ACS patients. An analysis on heterogeneity between studies in bleeding reports was performed with I-2 test. A meta-regression was conducted to explore the relation between different types of BARC bleedings and patient and procedural features. Nine studies were included in the analysis. Overall, BARC 2 rates were higher than BARC 3 or 5 rates (6.3 versus 2.6%). An extremely high level of heterogeneity was detected both for BARC 2 (I-2 99.3%) and BARC 3 or 5 (I-2 97.5%) bleedings. Increasing age [beta coefficient 0.4% (0.2- 0.6%); P < 0.001] and renal impairment [beta coefficient 1 6.5% (1-32.1%); P = 0.037] were associated with increased BARC 3 or 5 rates, whereas the use of glycoprotein IIb/IIIa inhibitors was the only factor related to an increased incidence of BARC 2 bleeding [b coefficient 2 2.3% (5.5-39%); P = 0.009].Conclusion The high level of heterogeneity in BARC bleeding reports only partially explained by bleeding risk profile suggests that a regulatory guidance to properly evaluate bleedings and to estimate the risk-benefit in clinical trials investigating different antithrombotic treatments in ACS patients is needed.