PMID- 29544607
OWN - NLM
STAT- MEDLINE
DCOM- 20190729
LR  - 20190729
IS  - 1558-3597 (Electronic)
IS  - 0735-1097 (Linking)
VI  - 71
IP  - 11
DP  - 2018 Mar 20
TI  - Bivalirudin or Heparin in Patients Undergoing Invasive Management of 
      Acute Coronary Syndromes.
PG  - 1231-1242
LID - S0735-1097(18)30245-6 [pii]
LID - 10.1016/j.jacc.2018.01.033 [doi]
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).
CI  - Copyright (c) 2018 American College of Cardiology Foundation. Published by Elsevier 
      Inc. All rights reserved.
FAU - Gargiulo, Giuseppe
AU  - Gargiulo G
AD  - Department of Cardiology, Bern University Hospital, Bern, Switzerland; Department 
      of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
FAU - Carrara, Greta
AU  - Carrara G
AD  - Advice Pharma Group S.r.l., Milan, Italy.
FAU - Frigoli, Enrico
AU  - Frigoli E
AD  - Department of Cardiology, Bern University Hospital, Bern, Switzerland.
FAU - Vranckx, Pascal
AU  - Vranckx P
AD  - Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa 
      Ziekenhuis, and Faculty of Medicine and Life Sciences Hasselt University, 
      Hasselt, Belgium.
FAU - Leonardi, Sergio
AU  - Leonardi S
AD  - SC Terapia Intensiva Cardiologica, Fondazione IRCCS Policlinico San Matteo, 
      Pavia, Italy.
FAU - Ciociano, Nestor
AU  - Ciociano N
AD  - EUSTRATEGY Association, Forli', Italy.
FAU - Campo, Gianluca
AU  - Campo G
AD  - Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona 
      (FE), Italy; Maria Cecilia Hospital, GVM Care and Research, Cotignola (RA), 
      Italy.
FAU - Varbella, Ferdinando
AU  - Varbella F
AD  - Cardiology Unit, Ospedali Riuniti di Rivoli, ASL Torino 3, Turin, Italy.
FAU - Calabro, Paolo
AU  - Calabro P
AD  - Division of Cardiology, Department of Cardiothoracic Sciences, University of 
      Campania "Luigi Vanvitelli", Naples, Italy.
FAU - Garducci, Stefano
AU  - Garducci S
AD  - Struttura complessa di Cardiologia ASST di Vimercate, Italy.
FAU - Iannone, Alessandro
AU  - Iannone A
AD  - Department of Cardiology, ASL3 Ospedale Villa Scassi, Genoa, Italy.
FAU - Briguori, Carlo
AU  - Briguori C
AD  - Interventional Cardiology Unit, Clinica Mediterranea, Naples, Italy.
FAU - Ando, Giuseppe
AU  - Ando G
AD  - Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino", University of 
      Messina, Messina, Italy.
FAU - Crimi, Gabriele
AU  - Crimi G
AD  - 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.
FAU - Limbruno, Ugo
AU  - Limbruno U
AD  - UO Cardiologia, Azienda USL Toscana Sudest, Grosseto, Italy.
FAU - Garbo, Roberto
AU  - Garbo R
AD  - Interventional Cardiology Unit, Ospedale San Giovanni Bosco, Turin, Italy.
FAU - Sganzerla, Paolo
AU  - Sganzerla P
AD  - ASST Bergamo ovest, Ospedale di Treviglio (BG), Italy.
FAU - Russo, Filippo
AU  - Russo F
AD  - Cardiovascular Interventional Unit, Cardiology Department, S.Anna Hospital, Como, 
      Italy.
FAU - Lupi, Alessandro
AU  - Lupi A
AD  - University Hospital "Maggiore della Carita", Novara, Italy.
FAU - Cortese, Bernardo
AU  - Cortese B
AD  - ASST Fatebenefratelli-Sacco, Milan, Italy; Fondazione Monasterio-CNR-Regione 
      Toscana, Toscana, Italy.
FAU - Ausiello, Arturo
AU  - Ausiello A
AD  - Casa di Cura Villa Verde, Taranto, Italy.
FAU - Ierna, Salvatore
AU  - Ierna S
AD  - Simple Departmental Emodynamic Structure, Ospedale Sirai-Carbonia, Carbonia, 
      Italy.
FAU - Esposito, Giovanni
AU  - Esposito G
AD  - Department of Advanced Biomedical Sciences, Federico II University of Naples, 
      Naples, Italy.
FAU - Zavalloni, Dennis
AU  - Zavalloni D
AD  - Humanitas Research Hospital, IRCCS, Rozzano, Italy.
FAU - Santarelli, Andrea
AU  - Santarelli A
AD  - Cardiovascular Department, Infermi Hospital, Rimini, Italy.
FAU - Sardella, Gennaro
AU  - Sardella G
AD  - Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and 
      Geriatric Sciences, Policlinico Umberto I, "Sapienza", University of Rome, Rome, 
      Italy.
FAU - Tresoldi, Simone
AU  - Tresoldi S
AD  - Struttura complessa di Emodinamica, ASST Monza, Ospedale di Desio, Italy.
FAU - de Cesare, Nicoletta
AU  - de Cesare N
AD  - Policlinico San Marco, Zingonia, Italy.
FAU - Sciahbasi, Alessandro
AU  - Sciahbasi A
AD  - Interventional Cardiology, Sandro Pertini Hospital, Rome, Italy.
FAU - Zingarelli, Antonio
AU  - Zingarelli A
AD  - Clinic of Cardiovascular Disease, IRCCS Policlinico San Martino, Genoa, Italy.
FAU - Tosi, Paolo
AU  - Tosi P
AD  - Mater Salutis Hospital-Legnago, Verona, Italy.
FAU - van 't Hof, Arnoud
AU  - van 't Hof A
AD  - Maastricht University Medical Center, and Zuyderland MC, Maastricht, the 
      Netherlands.
FAU - Omerovic, Elmir
AU  - Omerovic E
AD  - Sahlgrenska University Hospital, Goteborg, Sweden.
FAU - Brugaletta, Salvatore
AU  - Brugaletta S
AD  - Clinic Cardiovascular Institute, University Hospital Clinic, IDIBAPS (Institut 
      d'Investigacions Biomediques August Pi i Sunyer), Barcelona, Spain.
FAU - Windecker, Stephan
AU  - Windecker S
AD  - Department of Cardiology, Bern University Hospital, Bern, Switzerland.
FAU - Valgimigli, Marco
AU  - Valgimigli M
AD  - Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic 
      address: marco.valgimigli@insel.ch.
LA  - eng
SI  - ClinicalTrials.gov/NCT01433627
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Am Coll Cardiol
JT  - Journal of the American College of Cardiology
JID - 8301365
RN  - 0 (Hematologic Agents)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Platelet Glycoprotein GPIIb-IIIa Complex)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
CIN - J Am Coll Cardiol. 2018 Mar 20;71(11):1243-1245. PMID: 29544608
MH  - *Acute Coronary Syndrome/diagnosis/drug therapy/surgery
MH  - Aged
MH  - Coronary Artery Bypass/*adverse effects/methods
MH  - Electrocardiography/methods
MH  - Female
MH  - Hematologic Agents/administration & dosage/adverse effects/classification
MH  - Hemorrhage/chemically induced/prevention & control
MH  - *Heparin/administration & dosage/adverse effects
MH  - *Hirudins/administration & dosage/adverse effects
MH  - Humans
MH  - Intraoperative Care/methods
MH  - Male
MH  - Middle Aged
MH  - *Peptide Fragments/administration & dosage/adverse effects
MH  - Percutaneous Coronary Intervention/*adverse effects/methods
MH  - Platelet Glycoprotein GPIIb-IIIa Complex/antagonists & inhibitors
MH  - *Postoperative Complications/classification/etiology
MH  - Recombinant Proteins/administration & dosage/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - GP IIb/IIIa inhibitor
OT  - MATRIX
OT  - acute coronary syndrome
OT  - bivalirudin
OT  - heparin
EDAT- 2018/03/17 06:00
MHDA- 2019/07/30 06:00
CRDT- 2018/03/17 06:00
PHST- 2017/11/19 00:00 [received]
PHST- 2018/01/11 00:00 [revised]
PHST- 2018/01/12 00:00 [accepted]
PHST- 2018/03/17 06:00 [entrez]
PHST- 2018/03/17 06:00 [pubmed]
PHST- 2019/07/30 06:00 [medline]
AID - S0735-1097(18)30245-6 [pii]
AID - 10.1016/j.jacc.2018.01.033 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2018 Mar 20;71(11):1231-1242. doi: 10.1016/j.jacc.2018.01.033.