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

被引:43
作者
Gargiulo, Giuseppe [1 ,2 ]
Carrara, Greta [3 ]
Frigoli, Enrico [1 ]
Vranckx, Pascal [4 ,5 ]
Leonardi, Sergio [6 ]
Ciociano, Nestor [7 ]
Campo, Gianluca [8 ,9 ]
Varbella, Ferdinando [10 ]
Calabro, Paolo [11 ]
Garducci, Stefano [12 ]
Iannone, Alessandro [13 ]
Briguori, Carlo [14 ]
Ando, Giuseppe [15 ]
Crimi, Gabriele [4 ,5 ,16 ]
Limbruno, Ugo [17 ]
Garbo, Roberto [18 ]
Sganzerla, Paolo [19 ]
Russo, Filippo [20 ]
Lupi, Alessandro [21 ]
Cortese, Bernardo [22 ,23 ]
Ausiello, Arturo [24 ]
Ierna, Salvatore [25 ]
Esposito, Giovanni [2 ]
Zavalloni, Dennis [26 ]
Santarelli, Andrea [27 ]
Sardella, Gennaro [28 ]
Tresoldi, Simone [29 ]
de Cesare, Nicoletta [30 ]
Sciahbasi, Alessandro [31 ]
Zingarelli, Antonio [32 ]
Tosi, Paolo [33 ]
van't Hof, Arnoud [34 ,35 ]
Omerovic, Elmir [36 ]
Brugaletta, Salvatore [37 ]
Windecker, Stephan [1 ]
Valgimigli, Marco [1 ]
机构
[1] Bern Univ Hosp, Dept Cardiol, Freiburgstr 4, CH-3010 Bern, Switzerland
[2] Federico II Univ Naples, Dept Adv Biomed Sci, Naples, Italy
[3] Advice Pharma Grp Srl, Milan, Italy
[4] Hasselt Univ, Dept Cardiol & Crit Care Med, Hartctr Hasselt, Jessa Ziekenhuis, Hasselt, Belgium
[5] Hasselt Univ, Fac Med & Life Sci, Hasselt, Belgium
[6] Fdn IRCCS Policlin San Matteo, SC Terapia Intens Cardiol, Pavia, Italy
[7] EUSTRATEGY Assoc, Forli, Italy
[8] Azienda Osped Univ Ferrara, Cardiovasc Inst, Cona, FE, Italy
[9] Maria Cecilia Hosp, GVM Care & Res, Cotignola, RA, Italy
[10] ASL Torino 3, Osped Riuniti Rivoli, Cardiol Unit, Turin, Italy
[11] Univ Campania Luigi Vanvitelli, Div Cardiol, Dept Cardiothorac Sci, Naples, Italy
[12] Struttura Complessa Cardiol ASST Vimercate, Vimercate, MB, Italy
[13] ASL3 Osped Villa Scassi, Dept Cardiol, Genoa, Italy
[14] Clin Mediterranea, Intervent Cardiol Unit, Naples, Italy
[15] Univ Messina, Azienda Osped Univ Policlin Gaetano Martino, Messina, Italy
[16] Fdn IRCCS Policlin San Matteo, SC Cardiol, Pavia, Italy
[17] Azienda USL Toscana Sudest, UO Cardiol, Grosseto, Italy
[18] Osped San Giovanni Bosco, Intervent Cardiol Unit, Turin, Italy
[19] Osped Treviglio BG, ASST Bergamo Ovest, Treviglio, BG, Italy
[20] St Anna Hosp, Cardiovasc Intervent Unit, Dept Cardiol, Como, Italy
[21] Univ Hosp Maggiore Carita, Novara, Italy
[22] ASST Fatebenefratelli Sacco, Milan, Italy
[23] Fdn Monasterio CNR Reg Toscana, Toscana, Italy
[24] Casa Cura Villa Verde, Taranto, Italy
[25] Osped Sirai Carbonia, Simple Dept Emodynam Struct, Carbonia, Italy
[26] Humanitas Res Hosp, IRCCS, Rozzano, Italy
[27] Infermi Hosp, Cardiovasc Dept, Rimini, Italy
[28] Sapienza Univ Rome, Dept Cardiovasc Resp Nephrol Anesthesiol & Gee, Policlin Umberto I, Rome, Italy
[29] Osped Desio, ASST Monza, Struttura Complessa Emodinam, Desio, MB, Italy
[30] Policlin San Marco, Zingonia, Italy
[31] Sandro Pertini Hosp, Intervent Cardiol, Rome, Italy
[32] IRCCS Policlin San Martino, Clin Cardiovasc Dis, Genoa, Italy
[33] Mater Salutis Hosp Legnago, Verona, Italy
[34] Maastricht Univ, Med Ctr, Maastricht, Netherlands
[35] Zuyderland MC, Maastricht, Netherlands
[36] Sahlgrens Univ Hosp, Gothenburg, Sweden
[37] Univ Hosp Clin, IDIBAPS Inst Invest Biomed August Pi & Sunyer, Clin Cardiovasc Inst, Barcelona, Spain
关键词
acute coronary syndrome; bivalirudin; GP IIb/IIIa inhibitor; heparin; MATRIX; MYOCARDIAL-INFARCTION; IIB/IIIA INHIBITORS; PRIMARY PCI; INTERVENTION;
D O I
10.1016/j.jacc.2018.01.033
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:1231 / 1242
页数:12
相关论文
共 12 条
[1]   Bivalirudin versus heparin with or without glycoprotein IIb/IIIa inhibitors in patients with STEMI undergoing primary PCI: An updated meta-analysis of 10,350 patients from five randomized clinical trials [J].
Capodanno, Davide ;
Gargiulo, Giuseppe ;
Capranzano, Piera ;
Mehran, Roxana ;
Tamburino, Corrado ;
Stone, Gregg W. .
EUROPEAN HEART JOURNAL-ACUTE CARDIOVASCULAR CARE, 2016, 5 (03) :253-262
[2]   Bivalirudin versus Heparin Monotherapy in Myocardial Infarction [J].
Erlinge, D. ;
Omerovic, E. ;
Frobert, O. ;
Linder, R. ;
Danielewicz, M. ;
Hamid, M. ;
Swahn, E. ;
Henareh, L. ;
Wagner, H. ;
Hardhammar, P. ;
Sjogren, I. ;
Stewart, J. ;
Grimfjard, P. ;
Jensen, J. ;
Aasa, M. ;
Robertsson, L. ;
Lindroos, P. ;
Haupt, J. ;
Wikstrom, H. ;
Ulvenstam, A. ;
Bhiladvala, P. ;
Lindvall, B. ;
Lundin, A. ;
Todt, T. ;
Ioanes, D. ;
Ramunddal, T. ;
Kellerth, T. ;
Zagozdzon, L. ;
Gotberg, M. ;
Andersson, J. ;
Angeras, O. ;
Ostlund, O. ;
Lagerqvist, B. ;
Held, C. ;
Wallentin, L. ;
Schersten, F. ;
Eriksson, P. ;
Koul, S. ;
James, S. .
NEW ENGLAND JOURNAL OF MEDICINE, 2017, 377 (12) :1132-1142
[3]   Developing drugs for use before, during and soon after percutaneous coronary intervention [J].
Gargiulo, Giuseppe ;
Moschovitis, Aris ;
Windecker, Stephan ;
Valgimigli, Marco .
EXPERT OPINION ON PHARMACOTHERAPY, 2016, 17 (06) :803-818
[4]   Bivalirudin vs Heparin With or Without Tirofiban During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction The BRIGHT Randomized Clinical Trial [J].
Han, Yaling ;
Guo, Jincheng ;
Zheng, Yang ;
Zang, Hongyun ;
Su, Xi ;
Wang, Yu ;
Chen, Shaoliang ;
Jiang, Tiemin ;
Yang, Ping ;
Chen, Jiyan ;
Jiang, Dongju ;
Jing, Quanmin ;
Liang, Zhenyang ;
Liu, Haiwei ;
Zhao, Xin ;
Li, Jing ;
Li, Yi ;
Xu, Bo ;
Stone, Gregg W. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2015, 313 (13) :1336-1346
[5]   Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial [J].
Shahzad, Adeel ;
Kemp, Ian ;
Mars, Christine ;
Wilson, Keith ;
Roome, Claire ;
Cooper, Rob ;
Andron, Mohammed ;
Appleby, Clare ;
Fisher, Mike ;
Khand, Aleem ;
Kunadian, Babu ;
Mills, Joseph D. ;
Morris, John L. ;
Morrison, William L. ;
Munir, Shahzad ;
Palmer, Nick D. ;
Perry, Raphael A. ;
Ramsdale, David R. ;
Velavan, Periaswamy ;
Stables, Rod H. .
LANCET, 2014, 384 (9957) :1849-1858
[6]   Bivalirudin Started during Emergency Transport for Primary PCI [J].
Steg, Philippe Gabriel ;
Van 't Hof, Arnoud ;
Hamm, Christian W. ;
Clemmensen, Peter ;
Lapostolle, Frederic ;
Coste, Pierre ;
Ten Berg, Jurrien ;
Van Grunsven, Pierre ;
Eggink, Gerrit Jan ;
Nibbe, Lutz ;
Zeymer, Uwe ;
dell' Orto, Marco Campo ;
Nef, Holger ;
Steinmetz, Jacob ;
Soulat, Louis ;
Huber, Kurt ;
Deliargyris, Efthymios N. ;
Bernstein, Debra ;
Schuette, Diana ;
Prats, Jayne ;
Clayton, Tim ;
Pocock, Stuart ;
Hamon, Martial ;
Goldstein, Patrick .
NEW ENGLAND JOURNAL OF MEDICINE, 2013, 369 (23) :2207-2217
[7]   Bivalirudin during primary PCI in acute myocardial infarction [J].
Stone, Gregg W. ;
Witzenbichler, Bernhard ;
Guagliumi, Giulio ;
Peruga, Jan Z. ;
Brodie, Bruce R. ;
Dudek, Dariusz ;
Kornowski, Ran ;
Hartmann, Franz ;
Gersh, Bernard J. ;
Pocock, Stuart J. ;
Dangas, George ;
Wong, S. Chiu ;
Kirtane, Ajay J. ;
Parise, Helen ;
Mehran, Roxana .
NEW ENGLAND JOURNAL OF MEDICINE, 2008, 358 (21) :2218-2230
[8]   Procedural Anticoagulation in Myocardial Infarction [J].
Stone, Gregg W. .
NEW ENGLAND JOURNAL OF MEDICINE, 2017, 377 (12) :1198-1200
[9]   Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes [J].
Valgimigli, M. ;
Frigoli, E. ;
Leonardi, S. ;
Rothenbuehler, M. ;
Gagnor, A. ;
Calabro, P. ;
Garducci, S. ;
Rubartelli, P. ;
Briguori, C. ;
Ando, G. ;
Repetto, A. ;
Limbruno, U. ;
Garbo, R. ;
Sganzerla, P. ;
Russo, F. ;
Lupi, A. ;
Cortese, B. ;
Ausiello, A. ;
Ierna, S. ;
Esposito, G. ;
Presbitero, P. ;
Santarelli, A. ;
Sardella, G. ;
Varbella, F. ;
Tresoldi, S. ;
de Cesare, N. ;
Rigattieri, S. ;
Zingarelli, A. ;
Tosi, P. ;
van 't Hof, A. ;
Boccuzzi, G. ;
Omerovic, E. ;
Sabate, M. ;
Heg, D. ;
Jueni, P. ;
Vranckx, P. .
NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (11) :997-1009
[10]   Bivalirudin in Current Practice Melius Abundare Quam Deficere? [J].
Valgimigli, Marco ;
Gargiulo, Giuseppe .
JACC-CARDIOVASCULAR INTERVENTIONS, 2016, 9 (13) :1321-1323