Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes
Marco Valgimigli, 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, MATRIX Investigators, Maria Salomone, Enrico Frigoli, Pierpaolo Occhilupo, Veronica Lodolini, Monia Monti, Maria Grazia Mazzone, Erika Delos, Maria Teresa Caruso, Maggie Testa, Nestor Ciociano, Maurizio Lazzero, Davide Gazzotti, Lorenzo Cagliari, Leila Shahmohammadi, Martina Caiazza, Vittorio Virga, Elena Guerra, Eva Michalska, Sara Castellini, Vincenzo Serino, Gabriella Visconti, Gianluca Pendenza, Monica Portolan, Marco Anzini, Elisa Silvetti, Tiziana Coco, Francesco Costa, Sara Ariotti, Linda Valli, Marianna Adamo, Marcello Marino, Pascal Vranckx, Sergio Leonardi, Pierluigi Tricoci, Peter Jüni, Martina Rothenbühler, Dik Heg, Marco Valgimigli, Andrea Gagnor, Paolo Calabrò, Paolo Rubartelli, Stefano Garducci, Giuseppe Andò, Andrea Santarelli, Mario Galli, Roberto Garbo, Ezio Bramucci, Salvatore Ierna, Carlo Briguori, Bernardo Cortese, Ugo Limbruno, Roberto Violini, Patrizia Presbitero, Nicoletta de Cesare, Paolo Sganzerla, Arturo Ausiello, Paolo Tosi, Gennaro Sardella, Manel Sabate, Salvatore Brugaletta, Giovanni Saccone, Pietro Vandoni, Antonio Zingarelli, Armando Liso, Stefano Rigattieri, Emilio Di Lorenzo, Carlo Vigna, Cataldo Palmieri, Camillo Falcone, Raffaele De Caterina, Marcello Caputo, Giovanni Esposito, Alessandro Lupi, Pietro Mazzarotto, Fernando Varbella, Tiziana Zaro, Marco Nazzaro, Sunil V Rao, Arnoud W J van't Hof, Elmir Omerovic, Paolo Calabrò, Arnoud W J van't Hof, Manel Sabate, Salvatore Brugaletta, Elmir Omerovic, Gianluca Campo, Marco Valgimigli, Lucia Uguccioni, Corrado Tamburino, Patrizia Presbitero, Dennis Zavalloni-Parenti, Fabio Ferrari, Roberto Ceravolo, Andrea Santarelli, Fabio Tarantino, Paolo Calabrò, Giampaolo Pasquetto, Giovanni Esposito, Salvatore Ierna, Gavino Casu, Stefano Mameli, Maria Letizia Stochino, Nicoletta de Cesare, Pietro Mazzarotto, Alberto Cremonesi, Francesco Saia, Giovanni Saccone, Fabio Abate, Ugo Limbruno, Andrea Picchi, Roberto Violini, Marco Nazzaro, Roberto Garbo, Salvatore Colangelo, Giacomo Boccuzzi, Paolo Tosi, Vincenzo Guiducci, Carlo Vigna, Antonio Zingarelli, Andrea Gagnor, Ferdinando Varbella, Stefano Garducci, Tiziana Zaro, Simone Tresoldi, Pietro Vandoni, Marco Contarini, Armando Liso, Antonio Dellavalle, Salvatore Curello, Fabio Mangiacapra, Paolo Rubartelli, Rosario Evola, Giuseppe Andò, Cataldo Palmieri, Camillo Falcone, Francesco Liistro, Manuela Creaco, Antonio Colombo, Alaide Chieffo, Andrea Perkan, Stefano De Servi, Dionigi Fischetti, Stefano Rigattieri, Alessandro Sciahbasi, Edoardo Pucci, Enrico Romagnoli, Claudio Moretti, Luciano Moretti, Raffaele De Caterina, Marcello Caputo, Marco Zimmarino, Paolo Sganzerla, Maurizio Ferrario, Ezio Bramucci, Emilio Di Lorenzo, Carlo Briguori, Maurizio Turturo, Roberto Bonmassari, Carlo Penzo, Bruno Loi, Ciro Mauro, Arturo Ausiello, Anna Sonia Petronio, Gabriele Gabrielli, Gennaro Sardella, Antonio Micari, Flavia Belloni, Alessandro Lupi, Francesco Amico, Marco Comeglio, Claudio Fresco, Arnoud W J van't Hof, Nicolas Van Mieghem, Roberto Diletti, Evelyn Regar, Elmir Omerovic, Salvatore Brugaletta, Manel Sabaté, Joan Antoni Gómez Hospital, José Francisco Díaz Fernández, Vicente Mainar, Jose Maria de la Torre Hernandez, Marco Valgimigli, 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, MATRIX Investigators, Maria Salomone, Enrico Frigoli, Pierpaolo Occhilupo, Veronica Lodolini, Monia Monti, Maria Grazia Mazzone, Erika Delos, Maria Teresa Caruso, Maggie Testa, Nestor Ciociano, Maurizio Lazzero, Davide Gazzotti, Lorenzo Cagliari, Leila Shahmohammadi, Martina Caiazza, Vittorio Virga, Elena Guerra, Eva Michalska, Sara Castellini, Vincenzo Serino, Gabriella Visconti, Gianluca Pendenza, Monica Portolan, Marco Anzini, Elisa Silvetti, Tiziana Coco, Francesco Costa, Sara Ariotti, Linda Valli, Marianna Adamo, Marcello Marino, Pascal Vranckx, Sergio Leonardi, Pierluigi Tricoci, Peter Jüni, Martina Rothenbühler, Dik Heg, Marco Valgimigli, Andrea Gagnor, Paolo Calabrò, Paolo Rubartelli, Stefano Garducci, Giuseppe Andò, Andrea Santarelli, Mario Galli, Roberto Garbo, Ezio Bramucci, Salvatore Ierna, Carlo Briguori, Bernardo Cortese, Ugo Limbruno, Roberto Violini, Patrizia Presbitero, Nicoletta de Cesare, Paolo Sganzerla, Arturo Ausiello, Paolo Tosi, Gennaro Sardella, Manel Sabate, Salvatore Brugaletta, Giovanni Saccone, Pietro Vandoni, Antonio Zingarelli, Armando Liso, Stefano Rigattieri, Emilio Di Lorenzo, Carlo Vigna, Cataldo Palmieri, Camillo Falcone, Raffaele De Caterina, Marcello Caputo, Giovanni Esposito, Alessandro Lupi, Pietro Mazzarotto, Fernando Varbella, Tiziana Zaro, Marco Nazzaro, Sunil V Rao, Arnoud W J van't Hof, Elmir Omerovic, Paolo Calabrò, Arnoud W J van't Hof, Manel Sabate, Salvatore Brugaletta, Elmir Omerovic, Gianluca Campo, Marco Valgimigli, Lucia Uguccioni, Corrado Tamburino, Patrizia Presbitero, Dennis Zavalloni-Parenti, Fabio Ferrari, Roberto Ceravolo, Andrea Santarelli, Fabio Tarantino, Paolo Calabrò, Giampaolo Pasquetto, Giovanni Esposito, Salvatore Ierna, Gavino Casu, Stefano Mameli, Maria Letizia Stochino, Nicoletta de Cesare, Pietro Mazzarotto, Alberto Cremonesi, Francesco Saia, Giovanni Saccone, Fabio Abate, Ugo Limbruno, Andrea Picchi, Roberto Violini, Marco Nazzaro, Roberto Garbo, Salvatore Colangelo, Giacomo Boccuzzi, Paolo Tosi, Vincenzo Guiducci, Carlo Vigna, Antonio Zingarelli, Andrea Gagnor, Ferdinando Varbella, Stefano Garducci, Tiziana Zaro, Simone Tresoldi, Pietro Vandoni, Marco Contarini, Armando Liso, Antonio Dellavalle, Salvatore Curello, Fabio Mangiacapra, Paolo Rubartelli, Rosario Evola, Giuseppe Andò, Cataldo Palmieri, Camillo Falcone, Francesco Liistro, Manuela Creaco, Antonio Colombo, Alaide Chieffo, Andrea Perkan, Stefano De Servi, Dionigi Fischetti, Stefano Rigattieri, Alessandro Sciahbasi, Edoardo Pucci, Enrico Romagnoli, Claudio Moretti, Luciano Moretti, Raffaele De Caterina, Marcello Caputo, Marco Zimmarino, Paolo Sganzerla, Maurizio Ferrario, Ezio Bramucci, Emilio Di Lorenzo, Carlo Briguori, Maurizio Turturo, Roberto Bonmassari, Carlo Penzo, Bruno Loi, Ciro Mauro, Arturo Ausiello, Anna Sonia Petronio, Gabriele Gabrielli, Gennaro Sardella, Antonio Micari, Flavia Belloni, Alessandro Lupi, Francesco Amico, Marco Comeglio, Claudio Fresco, Arnoud W J van't Hof, Nicolas Van Mieghem, Roberto Diletti, Evelyn Regar, Elmir Omerovic, Salvatore Brugaletta, Manel Sabaté, Joan Antoni Gómez Hospital, José Francisco Díaz Fernández, Vicente Mainar, Jose Maria de la Torre Hernandez
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.).
Source: PubMed