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

Giuseppe Gargiulo, Bruno R. da Costa, Enrico Frigoli, Cataldo Palmieri, Marco Stefano Nazzaro, Camillo Falcone, Armando Liso, Carlo Vigna, Fabio Abate, Marco Comeglio, Roberto Diletti, Gabriele Gabrielli, Emilio Di Lorenzo, Pietro Mazzarotto, Marco Zimarino, Claudio Moretti, Antonio Colombo, Carlo Penzo, Giampaolo Pasquetto, Salvatore BrugalettaFabio Ferrari, Gavino Casu, Vincenzo Guiducci, Antonio Dellavalle, Francesco Liistro, Ciro Mauro, Arnoud W.J. van’t Hof, Elmir Omerovic, Salvatore Curello, Jose Maria de la Torre Hernandez, Stefano de Servi, Flavia Belloni, Stephan Windecker, Marco Valgimigli

Research output: Contribution to journalArticlepeer-review

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 (pint=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; pint=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; p=0.15; females: RR 1.06, 95% CI: 0.74-1.53; p=0.74; pint=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.
Original languageEnglish
Pages (from-to)e269-e277
JournalEuroIntervention
Volume15
Issue number3
DOIs
Publication statusPublished - Jun 1 2019

Keywords

  • ACS/NSTE-ACS
  • Adjunctive pharmacotherapy
  • STEMI

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