Document Detail


Argatroban for elective percutaneous coronary intervention: the ARG-E04 multi-center study.
MedLine Citation:
PMID:  20226548     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
L Rössig; S Genth-Zotz; M Rau; G R Heyndrickx; T Schneider; D C L Gulba; M Desaga; M Buerke; S Harder; A M Zeiher;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-03-11
Journal Detail:
Title:  International journal of cardiology     Volume:  148     ISSN:  1874-1754     ISO Abbreviation:  Int. J. Cardiol.     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-03-29     Completed Date:  2011-07-27     Revised Date:  2013-05-20    
Medline Journal Info:
Nlm Unique ID:  8200291     Medline TA:  Int J Cardiol     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  214-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2010. Published by Elsevier Ireland Ltd.
Affiliation:
Department of Cardiology, Medicine III, University of Frankfurt, Germany.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00508924
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MeSH Terms
Descriptor/Qualifier:
Aged
Angina, Unstable / therapy*
Angioplasty, Balloon, Coronary*
Anticoagulants / administration & dosage,  adverse effects,  pharmacokinetics
Antithrombins / administration & dosage*,  adverse effects,  pharmacokinetics
Blood Coagulation / drug effects
Dose-Response Relationship, Drug
Female
Follow-Up Studies
Hemorrhage / chemically induced
Heparin / administration & dosage,  adverse effects,  pharmacokinetics
Humans
Male
Middle Aged
Pipecolic Acids / administration & dosage*,  adverse effects,  pharmacokinetics
Thrombosis / prevention & control*
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Antithrombins; 0/Pipecolic Acids; 74863-84-6/argatroban; 9005-49-6/Heparin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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