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document
Argatroban for elective percutaneous coronary intervention : the ARG-E04 multi-center study . UNLABELLED The synthetic arginine-derived direct thrombin inhibitor argatroban is an attractive anticoagulant for percutaneous coronary intervention ( PCI ) , because of its rapid onset and offset , and its hepatic elimination . Argatroban was approved for PCI in patients with heparin-induced thrombocytopenia ( HIT ) . However , there are limited data about argatroban in non-HIT patients . The objective of this open-label , multiple-dose , controlled study was to examine the safety and efficacy of argatroban in patients undergoing elective PCI . METHODS AND RESULTS Of 140 patients randomized to three argatroban dose groups ( ARG250 , ARG300 , and ARG350 with 250 , 300 , or 350 μg/kg bolus , followed by 15 , 20 , or 25 μg/kg/min infusion ) and one unfractionated heparin ( UFH ) group ( 70-100 IU/kg bolus ) , 138 patients were analyzed . Argatroban dose-dependently prolonged activated clotting time ( ACT ) with more patients reaching the minimum target ACT after the initial bolus injection ( ARG250 : 86.1 % , ARG300 : 89.5 % , and ARG350 : 96.8 % ) compared to 45.5 % in UFH ( p < 0.001 ) . The patient proportion who did not require additional bolus injections to start PCI was significantly higher in argatroban than in UFH ( p ≤ 0.002 ) . Consequently , the time to start of PCI was shortened in argatroban groups . Composite incidences of death , myocardial infarction , and urgent revascularization until day 30 were not significantly different between the groups ( ARG250 : 2.8 % , ARG300 : 0.0 % , ARG350 : 3.2 % vs. UFH : 3.0 % ) . Major bleeding was observed only in UFH ( 3.0 % ) , while minor bleeding occurred in ARG350 ( 3.2 % ) and UFH ( 6.1 % , n.s. ) . CONCLUSION Argatroban dose-dependently increases coagulation parameters and , compared to UFH , demonstrates a superior predictable anticoagulant effect in patients undergoing elective PCI .
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Intervention_Pharmacological
Argatroban
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Intervention_Pharmacological
argatroban
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Intervention_Physical
percutaneous coronary intervention ( PCI )
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Intervention_Pharmacological
Argatroban
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Intervention_Pharmacological
argatroban
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Intervention_Pharmacological
argatroban
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Intervention_Pharmacological
argatroban
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Intervention_Pharmacological
ARG250
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Intervention_Pharmacological
ARG300
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Intervention_Pharmacological
ARG350
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Outcome_Other
safety and efficacy
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Outcome_Physical
activated clotting time ( ACT )
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Outcome_Physical
additional bolus injections
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Outcome_Physical
time to start of
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Outcome_Mortality
death
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Outcome_Adverse-effects
myocardial infarction , and urgent revascularization
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Outcome_Adverse-effects
bleeding
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Outcome_Adverse-effects
minor bleeding