PMID- 29769167 OWN - NLM STAT- MEDLINE DCOM- 20190730 LR - 20190730 IS - 1969-6213 (Electronic) IS - 1774-024X (Linking) VI - 15 IP - 3 DP - 2019 Jun 12 TI - 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. PG - e269-e278 LID - EIJ-D-18-00247 [pii] LID - 10.4244/EIJ-D-18-00247 [doi] AB - 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. FAU - Gargiulo, Giuseppe AU - Gargiulo G AD - Department of Cardiology, Bern University Hospital, Bern, Switzerland and Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy. FAU - da Costa, Bruno R AU - da Costa BR FAU - Frigoli, Enrico AU - Frigoli E FAU - Palmieri, Cataldo AU - Palmieri C FAU - Nazzaro, Marco Stefano AU - Nazzaro MS FAU - Falcone, Camillo AU - Falcone C FAU - Liso, Armando AU - Liso A FAU - Vigna, Carlo AU - Vigna C FAU - Abate, Fabio AU - Abate F FAU - Comeglio, Marco AU - Comeglio M FAU - Diletti, Roberto AU - Diletti R FAU - Gabrielli, Gabriele AU - Gabrielli G FAU - Di Lorenzo, Emilio AU - Di Lorenzo E FAU - Mazzarotto, Pietro AU - Mazzarotto P FAU - Zimarino, Marco AU - Zimarino M FAU - Moretti, Claudio AU - Moretti C FAU - Colombo, Antonio AU - Colombo A FAU - Penzo, Carlo AU - Penzo C FAU - Pasquetto, Giampaolo AU - Pasquetto G FAU - Brugaletta, Salvatore AU - Brugaletta S FAU - Ferrari, Fabio AU - Ferrari F FAU - Casu, Gavino AU - Casu G FAU - Guiducci, Vincenzo AU - Guiducci V FAU - Dellavalle, Antonio AU - Dellavalle A FAU - Liistro, Francesco AU - Liistro F FAU - Mauro, Ciro AU - Mauro C FAU - Van't Hof, Arnoud W J AU - Van't Hof AWJ FAU - Omerovic, Elmir AU - Omerovic E FAU - Curello, Salvatore AU - Curello S FAU - de la Torre Hernandez, Jose Maria AU - de la Torre Hernandez JM FAU - De Servi, Stefano AU - De Servi S FAU - Belloni, Flavia AU - Belloni F FAU - Windecker, Stephan AU - Windecker S FAU - Valgimigli, Marco AU - Valgimigli M LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial DEP - 20190612 PL - France TA - EuroIntervention JT - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology JID - 101251040 RN - 0 (Anticoagulants) RN - 0 (Antithrombins) RN - 0 (Hirudins) RN - 0 (Peptide Fragments) RN - 0 (Recombinant Proteins) RN - 9005-49-6 (Heparin) RN - TN9BEX005G (bivalirudin) MH - *Acute Coronary Syndrome/therapy MH - Anticoagulants MH - Antithrombins MH - Female MH - Heparin/*therapeutic use MH - Hirudins MH - Humans MH - Male MH - Peptide Fragments/*therapeutic use MH - *Percutaneous Coronary Intervention MH - Recombinant Proteins/therapeutic use MH - Treatment Outcome EDAT- 2018/05/18 06:00 MHDA- 2019/07/31 06:00 CRDT- 2018/05/18 06:00 PHST- 2018/05/18 06:00 [pubmed] PHST- 2019/07/31 06:00 [medline] PHST- 2018/05/18 06:00 [entrez] AID - EIJ-D-18-00247 [pii] AID - 10.4244/EIJ-D-18-00247 [doi] PST - epublish SO - EuroIntervention. 2019 Jun 12;15(3):e269-e278. doi: 10.4244/EIJ-D-18-00247.