TY - JOUR
T1 - Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes
AU - Gargiulo, Giuseppe
AU - Carrara, Greta
AU - Frigoli, Enrico
AU - Vranckx, Pascal
AU - Leonardi, Sergio
AU - Ciociano, Nestor
AU - Campo, Gianluca
AU - Varbella, Ferdinando
AU - Calabro, Paolo
AU - Garducci, Stefano
AU - Iannone, Alessandro
AU - Briguori, Carlo
AU - Ando, Giuseppe
AU - Crimi, Gabriele
AU - Limbruno, Ugo
AU - Garbo, Roberto
AU - Sganzerla, Paolo
AU - Russo, Filippo
AU - Lupi, Alessandro
AU - Cortese, Bernardo
AU - Ausiello, Arturo
AU - Ierna, Salvatore
AU - Esposito, Giovanni
AU - Zavalloni, Dennis
AU - Santarelli, Andrea
AU - Sardella, Gennaro
AU - Tresoldi, Simone
AU - de Cesare, Nicoletta
AU - Sciahbasi, Alessandro
AU - Zingarelli, Antonio
AU - Tosi, Paolo
AU - van't Hof, Arnoud
AU - Omerovic, Elmir
AU - Brugaletta, Salvatore
AU - Windecker, Stephan
AU - Valgimigli, Marco
PY - 2018/3/20
Y1 - 2018/3/20
N2 - 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.
AB - 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.
KW - acute coronary syndrome
KW - bivalirudin
KW - GP IIb/IIIa inhibitor
KW - heparin
KW - MATRIX
KW - ACUTE MYOCARDIAL-INFARCTION
KW - PRIMARY PCI
KW - IIB/IIIA INHIBITORS
KW - INTERVENTION
KW - TRIAL
U2 - 10.1016/j.jacc.2018.01.033
DO - 10.1016/j.jacc.2018.01.033
M3 - Article
C2 - 29544607
SN - 0735-1097
VL - 71
SP - 1231
EP - 1242
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 11
ER -