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

Fortuni, Federicoa,b; Crimi, Gabrielea; Morici, Nucciac,d; De Luca, Giuseppee; Alberti, Luca Paolof; Savonitto, Stefanog; De Servi, Stefanof

Journal of Cardiovascular Medicine: December 2019 - Volume 20 - Issue 12 - p 818–824
doi: 10.2459/JCM.0000000000000888
Research articles: Coronary artery disease
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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 I2 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 (I2 99.3%) and BARC 3 or 5 (I2 97.5%) bleedings. Increasing age [β coefficient 0.4% (0.2–0.6%); P < 0.001] and renal impairment [β 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 [β 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.

aDivision of Cardiology, Fondazione IRCCS Policlinico San Matteo

bDepartment of Molecular Medicine, Unit of Cardiology, University of Pavia, Pavia

cIntensive Cardiac Care Unit and De Gasperis Cardio Center, ASST Grande Ospedale Metropolitano Niguarda

dDepartment of Clincal Sciences and Community Health, Universita’ degli Studi di Milano, Milan

eAOU Maggiore della Carita’, Universita’ del Piemonte Orientale, Novara

fIRCCS Multimedica, Sesto San Giovanni, Milan

gOspedale A. Manzoni, Lecco, Italy

Correspondence to Federico Fortuni, MD, Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Piazzale Golgi 1, 27100 Pavia, Italy Tel: +39 382503158; fax: +39 382503159; e-mail: fortuni.ff9@gmail.com

Received 5 July, 2019

Revised 18 September, 2019

Accepted 21 September, 2019

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© 2019 Italian Federation of Cardiology. All rights reserved.