Giuseppe Gargiulo1, Greta Carrara2, Enrico Frigoli3, Pascal Vranckx4, Sergio Leonardi5, Nestor Ciociano6, Gianluca Campo7, Ferdinando Varbella8, Paolo Calabrò9, Stefano Garducci10, Alessandro Iannone11, Carlo Briguori12, Giuseppe Andò13, Gabriele Crimi14, Ugo Limbruno15, Roberto Garbo16, Paolo Sganzerla17, Filippo Russo18, Alessandro Lupi19, Bernardo Cortese20, Arturo Ausiello21, Salvatore Ierna22, Giovanni Esposito23, Dennis Zavalloni24, Andrea Santarelli25, Gennaro Sardella26, Simone Tresoldi27, Nicoletta de Cesare28, Alessandro Sciahbasi29, Antonio Zingarelli30, Paolo Tosi31, Arnoud van 't Hof32, Elmir Omerovic33, Salvatore Brugaletta34, Stephan Windecker3, Marco Valgimigli35. 1. Department of Cardiology, Bern University Hospital, Bern, Switzerland; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy. 2. Advice Pharma Group S.r.l., Milan, Italy. 3. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 4. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and Faculty of Medicine and Life Sciences Hasselt University, Hasselt, Belgium. 5. SC Terapia Intensiva Cardiologica, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 6. EUSTRATEGY Association, Forli', Italy. 7. Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona (FE), Italy; Maria Cecilia Hospital, GVM Care and Research, Cotignola (RA), Italy. 8. Cardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3, Turin, Italy. 9. Division of Cardiology, Department of Cardiothoracic Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy. 10. Struttura complessa di Cardiologia ASST di Vimercate, Italy. 11. Department of Cardiology, ASL3 Ospedale Villa Scassi, Genoa, Italy. 12. Interventional Cardiology Unit, Clinica Mediterranea, Naples, Italy. 13. Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino", University of Messina, Messina, Italy. 14. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and Faculty of Medicine and Life Sciences Hasselt University, Hasselt, Belgium; SC Cardiologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 15. UO Cardiologia, Azienda USL Toscana Sudest, Grosseto, Italy. 16. Interventional Cardiology Unit, Ospedale San Giovanni Bosco, Turin, Italy. 17. ASST Bergamo ovest, Ospedale di Treviglio (BG), Italy. 18. Cardiovascular Interventional Unit, Cardiology Department, S.Anna Hospital, Como, Italy. 19. University Hospital "Maggiore della Carità", Novara, Italy. 20. ASST Fatebenefratelli-Sacco, Milan, Italy; Fondazione Monasterio-CNR-Regione Toscana, Toscana, Italy. 21. Casa di Cura Villa Verde, Taranto, Italy. 22. Simple Departmental Emodynamic Structure, Ospedale Sirai-Carbonia, Carbonia, Italy. 23. Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy. 24. Humanitas Research Hospital, IRCCS, Rozzano, Italy. 25. Cardiovascular Department, Infermi Hospital, Rimini, Italy. 26. Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, "Sapienza", University of Rome, Rome, Italy. 27. Struttura complessa di Emodinamica, ASST Monza, Ospedale di Desio, Italy. 28. Policlinico San Marco, Zingonia, Italy. 29. Interventional Cardiology, Sandro Pertini Hospital, Rome, Italy. 30. Clinic of Cardiovascular Disease, IRCCS Policlinico San Martino, Genoa, Italy. 31. Mater Salutis Hospital-Legnago, Verona, Italy. 32. Maastricht University Medical Center, and Zuyderland MC, Maastricht, the Netherlands. 33. Sahlgrenska University Hospital, Göteborg, Sweden. 34. Clinic Cardiovascular Institute, University Hospital Clinic, IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer), Barcelona, Spain. 35. Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch.
Abstract
BACKGROUND: Contrasting evidence exists on the comparative efficacy and safety of bivalirudin and unfractionated heparin (UFH) in relation to the planned use of glycoprotein IIb/IIIa inhibitors (GPIs). OBJECTIVES: This study assessed the efficacy and safety of bivalirudin compared with UFH with or without GPIs in patients with acute coronary syndrome (ACS) who underwent invasive management. METHODS: In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) program, 7,213 patients were randomly assigned to receive either bivalirudin or UFH with or without GPIs at discretion of the operator. The 30-day coprimary outcomes were major adverse cardiovascular events (MACEs) (a composite of death, myocardial infarction, or stroke), and net adverse clinical events (NACEs) (a composite of MACEs or major bleeding). RESULTS: Among 3,603 patients assigned to receiveUFH, 781 (21.7%) underwent planned treatment with GPI before coronary intervention. Bailout use of GPIs was similar between the bivalirudin and UFH groups (4.5% and 5.4%) (p = 0.11). At 30 days, the 2 coprimary endpoints of MACEs and NACEs, as well as individual endpoints of mortality, myocardial infarction, stent thrombosis or stroke did not differ among the 3 groups after adjustment. Compared with the UFH and UFH+GPI groups, bivalirudin reduced bleeding, mainly the most severe bleeds, including fatal and nonaccess site-related events, as well as transfusion rates and the need for surgical access site repair. These findings were not influenced by the administered intraprocedural dose of UFH and were confirmed at multiple sensitivity analyses, including the randomly allocated access site. CONCLUSIONS: In patients with ACS, the rates of MACEs and NACEs were not significantly lower with bivalirudin than with UFH, irrespective of planned GPI use. However, bivalirudin significantly reduced bleeding complications, mainly those not related to access site, irrespective of planned use of GPIs. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX [MATRIX]; NCT01433627).
RCT Entities:
BACKGROUND: Contrasting evidence exists on the comparative efficacy and safety of bivalirudin and unfractionated heparin (UFH) in relation to the planned use of glycoprotein IIb/IIIa inhibitors (GPIs). OBJECTIVES: This study assessed the efficacy and safety of bivalirudin compared with UFH with or without GPIs in patients with acute coronary syndrome (ACS) who underwent invasive management. METHODS: In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) program, 7,213 patients were randomly assigned to receive either bivalirudin or UFH with or without GPIs at discretion of the operator. The 30-day coprimary outcomes were major adverse cardiovascular events (MACEs) (a composite of death, myocardial infarction, or stroke), and net adverse clinical events (NACEs) (a composite of MACEs or major bleeding). RESULTS: Among 3,603 patients assigned to receive UFH, 781 (21.7%) underwent planned treatment with GPI before coronary intervention. Bailout use of GPIs was similar between the bivalirudin and UFH groups (4.5% and 5.4%) (p = 0.11). At 30 days, the 2 coprimary endpoints of MACEs and NACEs, as well as individual endpoints of mortality, myocardial infarction, stent thrombosis or stroke did not differ among the 3 groups after adjustment. Compared with the UFH and UFH+GPI groups, bivalirudin reduced bleeding, mainly the most severe bleeds, including fatal and nonaccess site-related events, as well as transfusion rates and the need for surgical access site repair. These findings were not influenced by the administered intraprocedural dose of UFH and were confirmed at multiple sensitivity analyses, including the randomly allocated access site. CONCLUSIONS: In patients with ACS, the rates of MACEs and NACEs were not significantly lower with bivalirudin than with UFH, irrespective of planned GPI use. However, bivalirudin significantly reduced bleeding complications, mainly those not related to access site, irrespective of planned use of GPIs. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX [MATRIX]; NCT01433627).
Authors: Cho Yeow Koh; Norrapat Shih; Christina Y C Yip; Aaron Wei Liang Li; Weiming Chen; Fathiah S Amran; Esther Jia En Leong; Janaki Krishnamoorthy Iyer; Grace Croft; Muhammad Ibrahim Bin Mazlan; Yen-Lin Chee; Eng-Soo Yap; Dougald M Monroe; Maureane Hoffman; Richard C Becker; Dominique P V de Kleijn; Vaishali Verma; Amita Gupta; Vijay K Chaudhary; A Mark Richards; R Manjunatha Kini; Mark Y Chan Journal: Nat Commun Date: 2021-11-25 Impact factor: 14.919
Authors: Flávia B B Arantes; Fernando R Menezes; Andre Franci; Carlos J D G Barbosa; Talia F Dalçoquio; Carlos A K Nakashima; Luciano M Baracioli; Remo H M Furtado; Quintiliano S S Nomelini; José A F Ramires; Roberto Kalil Filho; José C Nicolau Journal: Adv Ther Date: 2019-11-22 Impact factor: 3.845
Authors: Amir Faour; Nicholas Collins; Trent Williams; Arshad Khan; Craig P Juergens; Sidney Lo; Darren L Walters; Derek P Chew; John K French Journal: PLoS One Date: 2021-10-26 Impact factor: 3.240