Marco Valgimigli1, Enrico Frigoli, Sergio Leonardi, Martina Rothenbühler, Andrea Gagnor, Paolo Calabrò, Stefano Garducci, Paolo Rubartelli, Carlo Briguori, Giuseppe Andò, Alessandra Repetto, Ugo Limbruno, Roberto Garbo, Paolo Sganzerla, Filippo Russo, Alessandro Lupi, Bernardo Cortese, Arturo Ausiello, Salvatore Ierna, Giovanni Esposito, Patrizia Presbitero, Andrea Santarelli, Gennaro Sardella, Ferdinando Varbella, Simone Tresoldi, Nicoletta de Cesare, Stefano Rigattieri, Antonio Zingarelli, Paolo Tosi, Arnoud van 't Hof, Giacomo Boccuzzi, Elmir Omerovic, Manel Sabaté, Dik Heg, Peter Jüni, Pascal Vranckx. 1. From the Swiss Cardiovascular Center Bern, Bern University Hospital (M.V.), Clinical Trials Unit and Institute of Social and Preventive Medicine (M.R., D.H.), and Institute of Primary Health Care (P.J.), University of Bern, Bern, Switzerland; Thoraxcenter, Erasmus Medical Center, Rotterdam (M.V.), and Isala Klinieken, Zwolle (A.H.) - both in the Netherlands; EUSTRATEGY Association, Forli (E.F.), Unità Operativa Complessa Cardiologia, Dipartimento CardioToracoVascolare, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L., A.R.), Cardiology Unit, Ospedali Riuniti di Rivoli (A.G., F.V.), and San Giovanni Bosco Hospital (R.G., G.B.), Turin, Division of Cardiology, Department of Cardiothoracic Sciences, Second University of Naples (P.C.), Department of Advanced Biomedical Sciences, Division of Cardiology, Federico II University of Naples (G.E.), and Clinica Mediterranea (C.B.), Naples, Azienda Ospedaliera Ospedale Civile di Vimercate, Desio (S.G.), Department of Cardiology, ASL3 Ospedale Villa Scassi (P.R.), and IRCCS Azienda Ospedaliera Universitaria San Martino (A.Z.), Genoa, Azienda Ospedaliera Universitaria Policlinico Gaetano Martino, University of Messina, Messina (G.A.), Unità Operativa Cardiologia, ASL 9 Grosseto, Grosseto (U.L.), Azienda Ospedaliera Ospedale Treviglio-Caravaggio, Treviglio (P.S.), Azienda Ospedaliera Sant'Anna, Como (F.R.), University Hospital Maggiore della Carita, Novara (A.L.), Ospedale Fatebenefratelli, Milan (B.C.), Casa di Cura Villa Verde, Taranto (A.A.), Ospedale Sirai-Carbonia, Carbonia (S.I.), IRCCS Humanitas, Rozzano (P.P.), Cardiovascular Department, Infermi Hospital, Rimini (A.S.), Policlinico Umberto I, Sapienza University of Rome (G.S.), and Interventional Cardiology Unit, Sandro Pertini Hospital Rome (S.R.), Rome, Azienda Ospedaliera Ospedale di Desio, Desio (S.T.), Policlinico San Marco, Zingonia (N.C.), and Mater Salutis Hospital, Legnago (P.T.) - all in Italy; Sahlgrenska University Hospital, Göteborg, Sweden (E.O.); Hospi
Abstract
BACKGROUND: Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. METHODS: We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. RESULTS: The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34). CONCLUSIONS: In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).
RCT Entities:
BACKGROUND: Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. METHODS: We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. RESULTS: The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34). CONCLUSIONS: In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).
Authors: Emanuele Barbato; Paul J Barton; Jozef Bartunek; Sally Huber; Borja Ibanez; Daniel P Judge; Enrique Lara-Pezzi; Craig M Stolen; Angela Taylor; Jennifer L Hall Journal: J Cardiovasc Transl Res Date: 2015-10-09 Impact factor: 4.132
Authors: Alexander C Fanaroff; Derek Cyr; Megan L Neely; Jeffery Bakal; Harvey D White; Keith A A Fox; Paul W Armstrong; Renato D Lopes; E Magnus Ohman; Matthew T Roe Journal: Circ Cardiovasc Qual Outcomes Date: 2018-12
Authors: Łukasz Kołtowski; Jacek Legutko; Krzysztof J Filipiak; Artur Dziewierz; Stanisław Bartuś; Paweł Buszman; Piotr Buszman; Dariusz Ciećwierz; Maciej Dąbrowski; Sławomir Dobrzycki; Robert Gil; Jarosław Gorący; Marek Grygier; Miłosz Jaguszewski; Janusz Kochman; Jacek Kubica; Wiktor Kuliczkowki; Piotr Lodziński; Andrzej Ochała; Krzysztof Reczuch; Adam Witkowski; Wojciech Wojakowski; Jarosław Wójcik; Dariusz Dudek Journal: Cardiol J Date: 2019 Impact factor: 2.737