TY - JOUR
T1 - Bivalirudin or unfractionated heparin in acute coronary syndromes
AU - Valgimigli, Marco
AU - Frigoli, Enrico
AU - Leonardi, Sergio
AU - Rothenbühler, Martina
AU - Gagnor, Andrea
AU - Calabrò, Paolo
AU - Garducci, Stefano
AU - Rubartelli, Paolo
AU - Briguori, Carlo
AU - Andò, Giuseppe
AU - Repetto, Alessandra
AU - Limbruno, Ugo
AU - Garbo, Roberto
AU - Sganzerla, Paolo
AU - Russo, Filippo
AU - Lupi, Alessandro
AU - Cortese, Bernardo
AU - Ausiello, Arturo
AU - Ierna, Salvatore
AU - Esposito, Giovanni
AU - Presbitero, Patrizia
AU - Santarelli, Andrea
AU - Sardella, Gennaro
AU - Varbella, Ferdinando
AU - Tresoldi, Simone
AU - De Cesare, Nicoletta
AU - Rigattieri, Stefano
AU - Zingarelli, Antonio
AU - Tosi, Paolo
AU - Van't Hof, Arnoud
AU - Boccuzzi, Giacomo
AU - Omerovic, Elmir
AU - Sabaté, Manel
AU - Heg, Dik
AU - Jüni, Peter
AU - Vranckx, Pascal
PY - 2015/9/10
Y1 - 2015/9/10
N2 - 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.)
AB - 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.)
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U2 - 10.1056/NEJMoa1507854
DO - 10.1056/NEJMoa1507854
M3 - Article
C2 - 26324049
AN - SCOPUS:84941286905
VL - 373
SP - 997
EP - 1009
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 11
ER -