Anticoagulation With Otamixaban and Ischemic Events in Non–ST-Segment Elevation Acute Coronary Syndromes: The TAO Randomized Clinical Trial

IMPORTANCE The optimal anticoagulant for patients with non–ST-segment elevation acute coronary syndromes (NSTE-ACS) managed with an invasive strategy remains controversial. OBJECTIVE To compare the clinical efficacy and safety of otamixaban, a novel intravenous direct factor Xa inhibitor, with that...

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Published in:JAMA : the journal of the American Medical Association 2013-09, Vol.310 (11), p.1145-1155
Main Authors: Steg, Philippe Gabriel, Mehta, Shamir R, Pollack, Charles V, Bode, Christoph, Cohen, Marc, French, William J, Hoekstra, James, Rao, Sunil V, Ruzyllo, Witold, Ruiz-Nodar, Juan M, Sabaté, Manel, Widimsky, Petr, Kiss, Robert Gabor, Estrada, Jose Luis Navarro, Hod, Hanoch, Kerkar, Prafulla, Guneri, Sema, Sezer, Murat, Ruda, Mikhail, Nicolau, José Carlos, Cavallini, Claudio, Ebrahim, Iftikhar, Petrov, Ivo, Kim, Jae-Hyung, Jeong, Myung-Ho, Lopez, Gabriel Arturo Ramos, Laanmets, Peep, Kovar, Frantisek, Gaudin, Christophe, Fanouillere, Karen C, Minini, Pascal, Hoffman, Elaine B, Moryusef, Angele, Wiviott, Stephen D, Sabatine, Marc S
Format: Article
Language:eng ; rus
Subjects:
Acute Coronary Syndrome - complications
Acute Coronary Syndrome - drug therapy
Acute coronary syndromes
Adult
Aged
Aged, 80 and over
Anticoagulants
Anticoagulants - adverse effects
Anticoagulants - therapeutic use
Cardiology
Cause of Death
Clinical outcomes
Cyclic N-Oxides - adverse effects
Cyclic N-Oxides - therapeutic use
Double-Blind Method
Factor Xa Inhibitors
Female
Hemorrhage - chemically induced
Heparin - therapeutic use
Humans
Infusions, Intravenous
Inhibitor drugs
Injections, Intravenous
Male
Middle Aged
Myocardial Infarction - etiology
Myocardial Infarction - prevention & control
Peptides - therapeutic use
Percutaneous Coronary Intervention
Platelet Glycoprotein GPIIb-IIIa Complex - antagonists & inhibitors
Pyridines - adverse effects
Pyridines - therapeutic use
Risk
Survival Analysis
Treatment Outcome
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Summary:IMPORTANCE The optimal anticoagulant for patients with non–ST-segment elevation acute coronary syndromes (NSTE-ACS) managed with an invasive strategy remains controversial. OBJECTIVE To compare the clinical efficacy and safety of otamixaban, a novel intravenous direct factor Xa inhibitor, with that of unfractionated heparin plus downstream eptifibatide in patients with NSTE-ACS undergoing a planned early invasive strategy. DESIGN, SETTING, AND PARTICIPANTS Randomized, double-blind, active-controlled superiority trial that enrolled 13 229 patients with NSTE-ACS and a planned early invasive strategy, at 568 active sites in 55 countries and conducted between April 2010 and February 2013. A planned interim analysis was conducted for otamixaban dose selection. INTERVENTIONS Eligible participants were randomized to otamixaban (bolus and infusion, at 1 of 2 doses) or unfractionated heparin plus, at the time of percutaneous coronary intervention, eptifibatide. The otamixaban dose selected at interim analysis was an intravenous bolus of 0.080 mg/kg followed by an infusion of 0.140 mg/kg per hour. MAIN OUTCOMES AND MEASURES The primary efficacy outcome was the composite of all-cause death or new myocardial infarction through day 7. RESULTS Rates of the primary efficacy outcome were 5.5% (279 of 5105 patients) randomized to receive otamixaban and 5.7% (310 of 5466 patients) randomized to receive unfractionated heparin plus eptifibatide (adjusted relative risk, 0.99 [95% CI, 0.85-1.16]; P = .93). There were no differences for the secondary end points, including procedural thrombotic complications. The primary safety outcome of Thrombosis in Myocardial Infarction major or minor bleeding through day 7 was increased by otamixaban (3.1% vs 1.5%; relative risk, 2.13 [95% CI, 1.63-2.78]; P 
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.2013.277165