Journal article
Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes.
- Gargiulo G Department of Cardiology, Bern University Hospital, Bern, Switzerland; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
- Carrara G Advice Pharma Group S.r.l., Milan, Italy.
- Frigoli E Department of Cardiology, Bern University Hospital, Bern, Switzerland.
- Vranckx P Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and Faculty of Medicine and Life Sciences Hasselt University, Hasselt, Belgium.
- Leonardi S SC Terapia Intensiva Cardiologica, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
- Ciociano N EUSTRATEGY Association, Forli', Italy.
- Campo G Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona (FE), Italy; Maria Cecilia Hospital, GVM Care and Research, Cotignola (RA), Italy.
- Varbella F Cardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3, Turin, Italy.
- Calabrò P Division of Cardiology, Department of Cardiothoracic Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
- Garducci S Struttura complessa di Cardiologia ASST di Vimercate, Italy.
- Iannone A Department of Cardiology, ASL3 Ospedale Villa Scassi, Genoa, Italy.
- Briguori C Interventional Cardiology Unit, Clinica Mediterranea, Naples, Italy.
- Andò G Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino", University of Messina, Messina, Italy.
- Crimi G 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.
- Limbruno U UO Cardiologia, Azienda USL Toscana Sudest, Grosseto, Italy.
- Garbo R Interventional Cardiology Unit, Ospedale San Giovanni Bosco, Turin, Italy.
- Sganzerla P ASST Bergamo ovest, Ospedale di Treviglio (BG), Italy.
- Russo F Cardiovascular Interventional Unit, Cardiology Department, S.Anna Hospital, Como, Italy.
- Lupi A University Hospital "Maggiore della Carità", Novara, Italy.
- Cortese B ASST Fatebenefratelli-Sacco, Milan, Italy; Fondazione Monasterio-CNR-Regione Toscana, Toscana, Italy.
- Ausiello A Casa di Cura Villa Verde, Taranto, Italy.
- Ierna S Simple Departmental Emodynamic Structure, Ospedale Sirai-Carbonia, Carbonia, Italy.
- Esposito G Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
- Zavalloni D Humanitas Research Hospital, IRCCS, Rozzano, Italy.
- Santarelli A Cardiovascular Department, Infermi Hospital, Rimini, Italy.
- Sardella G Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, "Sapienza", University of Rome, Rome, Italy.
- Tresoldi S Struttura complessa di Emodinamica, ASST Monza, Ospedale di Desio, Italy.
- de Cesare N Policlinico San Marco, Zingonia, Italy.
- Sciahbasi A Interventional Cardiology, Sandro Pertini Hospital, Rome, Italy.
- Zingarelli A Clinic of Cardiovascular Disease, IRCCS Policlinico San Martino, Genoa, Italy.
- Tosi P Mater Salutis Hospital-Legnago, Verona, Italy.
- van 't Hof A Maastricht University Medical Center, and Zuyderland MC, Maastricht, the Netherlands.
- Omerovic E Sahlgrenska University Hospital, Göteborg, Sweden.
- Brugaletta S Clinic Cardiovascular Institute, University Hospital Clinic, IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer), Barcelona, Spain.
- Windecker S Department of Cardiology, Bern University Hospital, Bern, Switzerland.
- Valgimigli M Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch.
- 2018-03-17
Published in:
- Journal of the American College of Cardiology. - 2018
GP IIb/IIIa inhibitor
MATRIX
acute coronary syndrome
bivalirudin
heparin
Acute Coronary Syndrome
Aged
Coronary Artery Bypass
Electrocardiography
Female
Hematologic Agents
Hemorrhage
Heparin
Hirudins
Humans
Intraoperative Care
Male
Middle Aged
Peptide Fragments
Percutaneous Coronary Intervention
Platelet Glycoprotein GPIIb-IIIa Complex
Postoperative Complications
Recombinant Proteins
Treatment Outcome
English
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).
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).
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.jacc.2018.01.033
- PMID 29544607
- Persistent URL
- https://folia.unifr.ch/global/documents/247441
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