@article{5480e7b522cf4e71aa90b759ae032977,
title = "Impact of sex on comparative outcomes of bivalirudin versus unfractionated heparin in patients with acute coronary syndromes undergoing invasive management: a pre-specified analysis of the MATRIX trial",
abstract = "Aims: Our aim was to assess whether bivalirudin compared with unfractionated heparin (UFH) is associated with consistent outcomes in males and females with acute coronary syndrome (ACS) undergoing invasive management.Methods and results: In the MATRIX programme, 7,213 patients were randomised to bivalirudin or UFH. Patients in the bivalirudin group were subsequently randomly assigned to receive or not a post-PCI bivalirudin infusion. The 30-day co-primary outcomes were major adverse cardiovascular events (MACE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACE or major bleeding. The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target vessel revascularisation (TVR), definite stent thrombosis (ST), or NACE. The rate of MACE was not significantly lower with bivalirudin than with heparin in male (rate ratio [RR] 0.90, 95% confidence interval [CI]: 0.75-1.07; p=0.22) and female patients (RR 1.06, 95% CI: 0.80-1.40; p=0.67) without significant interaction (p(int) =0.31), nor was the rate of NACE (males: RR 0.85, 95% CI: 0.72-1.01; p=0.07; females: RR 0.98, 95% CI: 0.76-1.28; p=0.91; p(int) 0.38). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent TVR, definite ST, or NACE (males: RR 0.84, 95% CI: 0.66-1.07; - 0.15; females: RR 1.06, 95% CI: 0.74-1.53; p=0.74; p(int )=0.28).Conclusions: In ACS patients, the rates of MACE and NACE were not significantly lower with bivalirudin than with UFH in both sexes. The rate of the composite of urgent TVR, definite ST, or NACE was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion in both sexes.",
keywords = "access, acs/nste-acs, acuity, acute myocardial-infarction, adjunctive pharmacotherapy, association, events, intervention, mortality, replace-2, stemi, therapy, MORTALITY, EVENTS, REPLACE-2, THERAPY, ACS/NSTE-ACS, STEMI, ACUTE MYOCARDIAL-INFARCTION, ACUITY, INTERVENTION, ASSOCIATION, ACCESS",
author = "G. Gargiulo and {da Costa}, B.R. and E. Frigoli and C. Palmieri and M.S. Nazzaro and C. Falcone and A. Liso and C. Vigna and F. Abate and M. Comeglio and R. Diletti and G. Gabrielli and {Di Lorenzo}, E. and P. Mazzarotto and M. Zimarino and C. Moretti and A. Colombo and C. Penzo and G. Pasquetto and S. Brugaletta and F. Ferrari and G. Casu and V. Guiducci and A. Dellavalle and F. Liistro and C. Mauro and {van't Hof}, A.W.J. and E. Omerovic and S. Curelle and J.M.D. Hernandez and {De Servi}, S. and F. Belloni and S. Windecker and M. Valgimigli",
note = "Funding Information: The trial was sponsored by the Societ{\`a} Italiana di Cardiologia Invasiva (GISE, a non-profit organisation), which received grant support from The Medicines Company and Terumo. This substudy did not receive any direct or indirect funding. Funding Information: The trial was sponsored by the Societ? Italiana di Cardiologia Invasiva (GISE, a non-profit organisation), which received grant support from The Medicines Company and Terumo. This substudy did not receive any direct or indirect funding. Funding Information: G. Gargiulo reports research grant support from the Cardiopath PhD programme. M. Zimarino reports personal fees from AstraZeneca, outside the submitted work. G. Casu reports personal fees from Boston Scientific and Bayer SpA, outside the submitted work. V. Guiducci reports personal fees from Bayer, outside the submitted work. F. Liistro reports personal fees from Medtronic, outside the submitted work. J.M. de la Torre Hernandez reports unrestricted grants from Boston Scientific and Abbott and being on the advisory panel for Medtronic, Boston Scientific and Abbott, outside the submitted work. A. van {\textquoteleft}t Hof reports grants and personal fees from The Medicines Company, during the conduct of the study, grants from Medtronic, grants and personal fees from AstraZeneca, and grants and personal fees from Daiichi Sankyo, outside the submitted work. E. Omerovic reports personal fees for advisory board work from Boston Scientific and Bayer, and an institutional grant from AstraZeneca, outside the submitted work. S. Windecker reports research contracts to the institution from Amgen, Abbott, Biotronik, Boston Scientific, and St. Jude Medical, outside the submitted work. M. Valgimigli reports grants from The Medicines Company and Terumo, during the study, grants from AstraZeneca, and personal fees from Abbott, Amgen, and Bayer, outside the submitted work. The other authors have no conflicts of interest to declare. Publisher Copyright: {\textcopyright} Europa Digital & Publishing 2019. All rights reserved.",
year = "2019",
month = jun,
day = "1",
doi = "10.4244/EIJ-D-18-00247",
language = "English",
volume = "15",
pages = "e269--e278",
journal = "Eurointervention",
issn = "1774-024X",
publisher = "Europa Digital & Publishing",
number = "3",
}