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Statements

Subject Item
n2:RIV%2F00216208%3A11120%2F13%3A43907648%21RIV14-MSM-11120___
rdf:type
skos:Concept n16:Vysledek
dcterms:description
The optimal anticoagulant for patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) managed with an invasive strategy remains controversial. 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. 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. 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. The primary efficacy outcome was the composite of all-cause death or new myocardial infarction through day 7. 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. 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. Results were consistent across prespecified subgroups. Otamixaban did not reduce the rate of ischemic events relative to unfractionated heparin plus eptifibatide but did increase bleeding. These findings do not support the use of otamixaban for patients with NSTE-ACS undergoing planned early percutaneous coronary intervention. The optimal anticoagulant for patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) managed with an invasive strategy remains controversial. 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. 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. 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. The primary efficacy outcome was the composite of all-cause death or new myocardial infarction through day 7. 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. 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. Results were consistent across prespecified subgroups. Otamixaban did not reduce the rate of ischemic events relative to unfractionated heparin plus eptifibatide but did increase bleeding. These findings do not support the use of otamixaban for patients with NSTE-ACS undergoing planned early percutaneous coronary intervention.
dcterms:title
Anticoagulation with Otamixaban and Ischemic Events in Non-ST-Segment Elevation Acute Coronary Syndromes the TAO Randomized Clinical Trial Anticoagulation with Otamixaban and Ischemic Events in Non-ST-Segment Elevation Acute Coronary Syndromes the TAO Randomized Clinical Trial
skos:prefLabel
Anticoagulation with Otamixaban and Ischemic Events in Non-ST-Segment Elevation Acute Coronary Syndromes the TAO Randomized Clinical Trial Anticoagulation with Otamixaban and Ischemic Events in Non-ST-Segment Elevation Acute Coronary Syndromes the TAO Randomized Clinical Trial
skos:notation
RIV/00216208:11120/13:43907648!RIV14-MSM-11120___
n16:predkladatel
n19:orjk%3A11120
n3:aktivita
n12:N
n3:aktivity
N
n3:cisloPeriodika
11
n3:dodaniDat
n11:2014
n3:domaciTvurceVysledku
n13:2228734
n3:druhVysledku
n14:J
n3:duvernostUdaju
n8:S
n3:entitaPredkladatele
n10:predkladatel
n3:idSjednocenehoVysledku
61388
n3:idVysledku
RIV/00216208:11120/13:43907648
n3:jazykVysledku
n18:eng
n3:klicovaSlova
fondaparinux; global registry; antiplatelet therapies; unfractionated heparin; myocardial-infarction; factor xa inhibitor
n3:klicoveSlovo
n6:unfractionated%20heparin n6:factor%20xa%20inhibitor n6:fondaparinux n6:antiplatelet%20therapies n6:global%20registry n6:myocardial-infarction
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[64E6B91CC3DA]
n3:nazevZdroje
JAMA-Journal of the American Medical Association
n3:obor
n17:FA
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
35
n3:rokUplatneniVysledku
n11:2013
n3:svazekPeriodika
310
n3:tvurceVysledku
Widimský, Petr
n3:wos
000324500300021
s:issn
0098-7484
s:numberOfPages
11
n7:doi
10.1001/jama.2013.277165
n15:organizacniJednotka
11120