Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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Valgimigli Marco, Frigoli Enrico, Leonardi Sergio, Rothenbühler Martina, Gagnor Andrea, Calabrò Paolo, Garducci Stefano, Rubartelli Paolo, Briguori Carlo, Andò Giuseppe, Repetto Alessandra, Limbruno Ugo, Garbo Roberto, Sganzerla Paolo, Russo Filippo, Lupi Alessandro, Cortese Bernardo, Ausiello Arturo, Ierna Salvatore, Esposito Giovanni, Presbitero Patrizia, Santarelli Andrea, Sardella Gennaro, Varbella Ferdinando, Tresoldi Simone, de Cesare Nicoletta, Rigattieri Stefano, Zingarelli Antonio, Tosi Paolo, van 't Hof Arnoud, Boccuzzi Giacomo, Omerovic Elmir, Sabaté Manel, Heg Dik, Jüni Peter, Vranckx Pascal, MATRIX Investigators
Аннотация
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.).