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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/26234

Title: Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes
Authors: Gargiulo, Giuseppe
Carrara, Greta
Frigoli, Enrico
Vranckx, Pascal
Leonardi, Sergio
Ciociano, Nestor
Campo, Gianluca
Varbella, Ferdinando
Calabro, Paolo
Garducci, Stefano
Iannone, Alessandro
Briguori, Carlo
Ando, Giuseppe
Crimi, Gabriele
Limbruno, Ugo
Garbo, Roberto
Sganzerla, Paolo
Russo, Filippo
Lupi, Alessandro
Cortese, Bernardo
Ausiello, Arturo
Ierna, Salvatore
Esposito, Giovanni
Zavalloni, Dennis
Santarelli, Andrea
Sardella, Gennaro
Tresoldi, Simone
de Cesare, Nicoletta
Sciahbasi, Alessandro
Zingarelli, Antonio
Tosi, Paolo
van't Hof, Arnoud
Omerovic, Elmir
Brugaletta, Salvatore
Windecker, Stephan
Valgimigli, Marco
Issue Date: 2018
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 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) (c) 2018 by the American College of Cardiology Foundation.
Notes: Valgimigli, M (reprint author), Bern Univ Hosp, Dept Cardiol, Freiburgstr 4, CH-3010 Bern, Switzerland, marco.valgimigli@insel.ch
URI: http://hdl.handle.net/1942/26234
DOI: 10.1016/j.jacc.2018.01.033
ISI #: 000427463400007
ISSN: 0735-1097
Category: A1
Type: Journal Contribution
Appears in Collections: Research publications

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