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 EspositoPatrizia 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

Research output: Contribution to journalArticlepeer-review

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.)

Original languageEnglish
Pages (from-to)997-1009
Number of pages13
JournalNew England Journal of Medicine
Volume373
Issue number11
DOIs
Publication statusPublished - Sep 10 2015

ASJC Scopus subject areas

  • Medicine(all)

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