Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes

Giuseppe Gargiulo, Greta Carrara, Enrico Frigoli, Pascal Vranckx, Sergio Leonardi, Nestor Ciociano, Gianluca Campo, Ferdinando Varbella, Paolo Calabrò, Stefano Garducci, Alessandro Iannone, Carlo Briguori, Giuseppe Andò, Gabriele Crimi, Ugo Limbruno, Roberto Garbo, Paolo Sganzerla, Filippo Russo, Alessandro Lupi, Bernardo CorteseArturo Ausiello, Salvatore Ierna, Giovanni Esposito, Dennis Zavalloni, Andrea Santarelli, Gennaro Sardella, Simone Tresoldi, Nicoletta de Cesare, Alessandro Sciahbasi, Antonio Zingarelli, Paolo Tosi, Arnoud van 't Hof, Elmir Omerovic, Salvatore Brugaletta, Stephan Windecker, Marco Valgimigli

Research output: Contribution to journalArticle

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).

Original languageEnglish
Pages (from-to)1231-1242
Number of pages12
JournalJournal of the American College of Cardiology
Volume71
Issue number11
DOIs
Publication statusPublished - Mar 20 2018

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Platelet Glycoprotein GPIIb-IIIa Complex
Heparin
Acute Coronary Syndrome
Hemorrhage
Stroke
Myocardial Infarction
Safety
bivalirudin
Stents
Thrombosis
Mortality

Cite this

Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes. / Gargiulo, Giuseppe; Carrara, Greta; Frigoli, Enrico; Vranckx, Pascal; Leonardi, Sergio; Ciociano, Nestor; Campo, Gianluca; Varbella, Ferdinando; Calabrò, Paolo; Garducci, Stefano; Iannone, Alessandro; Briguori, Carlo; Andò, 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.

In: Journal of the American College of Cardiology, Vol. 71, No. 11, 20.03.2018, p. 1231-1242.

Research output: Contribution to journalArticle

Gargiulo, G, Carrara, G, Frigoli, E, Vranckx, P, Leonardi, S, Ciociano, N, Campo, G, Varbella, F, Calabrò, P, Garducci, S, Iannone, A, Briguori, C, Andò, G, Crimi, G, Limbruno, U, Garbo, R, Sganzerla, P, Russo, F, Lupi, A, Cortese, B, Ausiello, A, Ierna, S, Esposito, G, Zavalloni, D, Santarelli, A, Sardella, G, Tresoldi, S, de Cesare, N, Sciahbasi, A, Zingarelli, A, Tosi, P, van 't Hof, A, Omerovic, E, Brugaletta, S, Windecker, S & Valgimigli, M 2018, 'Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes', Journal of the American College of Cardiology, vol. 71, no. 11, pp. 1231-1242. https://doi.org/10.1016/j.jacc.2018.01.033
Gargiulo, Giuseppe ; Carrara, Greta ; Frigoli, Enrico ; Vranckx, Pascal ; Leonardi, Sergio ; Ciociano, Nestor ; Campo, Gianluca ; Varbella, Ferdinando ; Calabrò, Paolo ; Garducci, Stefano ; Iannone, Alessandro ; Briguori, Carlo ; Andò, 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. / Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes. In: Journal of the American College of Cardiology. 2018 ; Vol. 71, No. 11. pp. 1231-1242.
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title = "Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes",
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).",
author = "Giuseppe Gargiulo and Greta Carrara and Enrico Frigoli and Pascal Vranckx and Sergio Leonardi and Nestor Ciociano and Gianluca Campo and Ferdinando Varbella and Paolo Calabr{\`o} and Stefano Garducci and Alessandro Iannone and Carlo Briguori and Giuseppe And{\`o} and Gabriele Crimi and Ugo Limbruno and Roberto Garbo and Paolo Sganzerla and Filippo Russo and Alessandro Lupi and Bernardo Cortese and Arturo Ausiello and Salvatore Ierna and Giovanni Esposito and Dennis Zavalloni and Andrea Santarelli and Gennaro Sardella and Simone Tresoldi and {de Cesare}, Nicoletta and Alessandro Sciahbasi and Antonio Zingarelli and Paolo Tosi and {van 't Hof}, Arnoud and Elmir Omerovic and Salvatore Brugaletta and Stephan Windecker and Marco Valgimigli",
note = "Copyright {\circledC} 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.",
year = "2018",
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doi = "10.1016/j.jacc.2018.01.033",
language = "English",
volume = "71",
pages = "1231--1242",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
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number = "11",

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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 - Calabrò, Paolo

AU - Garducci, Stefano

AU - Iannone, Alessandro

AU - Briguori, Carlo

AU - Andò, 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

N1 - Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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).

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).

U2 - 10.1016/j.jacc.2018.01.033

DO - 10.1016/j.jacc.2018.01.033

M3 - Article

C2 - 29544607

VL - 71

SP - 1231

EP - 1242

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 11

ER -