TY - JOUR
T1 - Sex-based differences in bleeding risk after percutaneous coronary intervention and implications for the academic research consortium high bleeding risk criteria
AU - Spirito, Alessandro
AU - Gragnano, Felice
AU - Corpataux, Noé
AU - Vaisnora, Lukas
AU - Galea, Roberto
AU - Svab, Stefano
AU - Gargiulo, Giuseppe
AU - Siontis, George C.M.
AU - Praz, Fabien
AU - Lanz, Jonas
AU - Billinger, Michael
AU - Hunziker, Lukas
AU - Stortecky, Stefan
AU - Pilgrim, Thomas
AU - Capodanno, Davide
AU - Urban, Philip
AU - Pocock, Stuart
AU - Mehran, Roxana
AU - Heg, Dik
AU - Windecker, Stephan
AU - Räber, Lorenz
AU - Valgimigli, Marco
N1 - Publisher Copyright:
© 2021 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
PY - 2021/6/15
Y1 - 2021/6/15
N2 - BACKGROUND: Female sex was not included among the high bleeding risk (HBR) criteria by the Academic Research Consortium (ARC) as it remains unclear whether it constitutes an HBR condition after percutaneous coronary intervention. We investigated whether female sex associates with HBR and assessed the performance of ARC HBR criteria separately in women and men. METHODS AND RESULTS: Among all consecutive patients undergoing percutaneous coronary intervention between 2009 and 2018, bleeding occurrences up to 1 year were prospectively collected and centrally adjudicated. All but one of the originally defined ARC HBR criteria were assessed, and the ARC HBR score generated accordingly. Among 16 821 patients, 25.6% were women. Compared with men, women were older and had lower creatinine clearance and hemoglobin values. After adjustment, female sex was independently associated with access-site (adjusted hazard ratio, 2.14; 95% CI, 1.22– 3.74; P=0.008) but not with overall or non– access-site 1-year Bleeding Academic Research Consortium 3 or 5 bleeding. This association remained consistent when the femoral but not the radial approach was chosen. The ARC HBR score discrimination, using the original criteria, was lower among women than men (c-index 0.644 versus 0.688; P=0.048), whereas a revised ARC HBR score, in which age, creatinine clearance, and hemoglobin were modeled as continuous rather than dichotomized variables, performed similarly in both sexes. CONCLUSIONS: Female sex is an independent predictor for access-site bleeding but not for overall bleeding events at 1 year after percutaneous coronary intervention. The ARC HBR framework shows an overall good performance in both sexes, yet is lower in women than men, attributable to dichotomization of age, creatinine clearance, and hemoglobin values, which are differently distributed between sexes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02241291.
AB - BACKGROUND: Female sex was not included among the high bleeding risk (HBR) criteria by the Academic Research Consortium (ARC) as it remains unclear whether it constitutes an HBR condition after percutaneous coronary intervention. We investigated whether female sex associates with HBR and assessed the performance of ARC HBR criteria separately in women and men. METHODS AND RESULTS: Among all consecutive patients undergoing percutaneous coronary intervention between 2009 and 2018, bleeding occurrences up to 1 year were prospectively collected and centrally adjudicated. All but one of the originally defined ARC HBR criteria were assessed, and the ARC HBR score generated accordingly. Among 16 821 patients, 25.6% were women. Compared with men, women were older and had lower creatinine clearance and hemoglobin values. After adjustment, female sex was independently associated with access-site (adjusted hazard ratio, 2.14; 95% CI, 1.22– 3.74; P=0.008) but not with overall or non– access-site 1-year Bleeding Academic Research Consortium 3 or 5 bleeding. This association remained consistent when the femoral but not the radial approach was chosen. The ARC HBR score discrimination, using the original criteria, was lower among women than men (c-index 0.644 versus 0.688; P=0.048), whereas a revised ARC HBR score, in which age, creatinine clearance, and hemoglobin were modeled as continuous rather than dichotomized variables, performed similarly in both sexes. CONCLUSIONS: Female sex is an independent predictor for access-site bleeding but not for overall bleeding events at 1 year after percutaneous coronary intervention. The ARC HBR framework shows an overall good performance in both sexes, yet is lower in women than men, attributable to dichotomization of age, creatinine clearance, and hemoglobin values, which are differently distributed between sexes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02241291.
KW - Academic Research Consortium
KW - Bleeding
KW - Female sex
KW - Percutaneous coronary intervention
KW - Vascular access
UR - http://www.scopus.com/inward/record.url?scp=85108303557&partnerID=8YFLogxK
U2 - 10.1161/JAHA.121.021965
DO - 10.1161/JAHA.121.021965
M3 - Article
C2 - 34098740
AN - SCOPUS:85108303557
SN - 2047-9980
VL - 10
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 12
M1 - e021965
ER -