Argatroban for elective percutaneous coronary intervention: The ARG-E04 multi-center study

Abstract 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 thrombocytope...

Full description

Saved in:
Bibliographic Details
Published in:International journal of cardiology 2011-04, Vol.148 (2), p.214-219
Main Authors: Rössig, L, Genth-Zotz, S, Rau, M, Heyndrickx, G.R, Schneider, T, Gulba, D.C.L, Desaga, M, Buerke, M, Harder, S, Zeiher, A.M
Format: Article
Language:English
Subjects:
Aged
Angina, Unstable - therapy
Angioplasty, Balloon, Coronary
Anticoagulants - administration & dosage
Anticoagulants - adverse effects
Anticoagulants - pharmacokinetics
Anticoagulation
Antithrombins - administration & dosage
Antithrombins - adverse effects
Antithrombins - pharmacokinetics
Biological and medical sciences
Blood Coagulation - drug effects
Cardiology. Vascular system
Cardiovascular
Direct antithrombin agents
Diseases of the cardiovascular system
Dose-Response Relationship, Drug
Elective PCI
Female
Follow-Up Studies
Hemorrhage - chemically induced
Heparin
Heparin - administration & dosage
Heparin - adverse effects
Heparin - pharmacokinetics
Humans
Male
Medical sciences
Middle Aged
Pipecolic Acids - administration & dosage
Pipecolic Acids - adverse effects
Pipecolic Acids - pharmacokinetics
Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
Thrombosis - prevention & control
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Abstract 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.
ISSN:0167-5273
1874-1754
DOI:10.1016/j.ijcard.2010.02.044