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Intracoronary Stenting and Antithrombotic Regimen Rapid Early Action for Coronary Treatment - ISAR REACT
Description:
The goal of the ISAR REACT study was to evaluate whether treatment with the glycoprotein (GP) IIb/IIIa inhibitor abciximab reduces postprocedure ischemic complications in low-risk patients pretreated with clopidogrel who undergo coronary stenting.
Study Design
Study Design:
Patients Enrolled: 2,159
Mean Follow Up: 30 days
Mean Patient Age: Mean age 66 years
Female: 23%
Mean Ejection Fraction: Mean EF 60%
Patient Populations:
Coronary disease with elective PCI
Exclusions:
ACS, acute MI within 14 days, ST-segment depression, positive biomarkers, insulin-dependent diabetes, chronic total occlusions, ejection fraction (EF) ≤30%, thrombus presence, or lesions in bypass grafts
Primary Endpoints:
Composite rate of death, MI, and urgent TVR within 30 days
Secondary Endpoints:
30-day incidence of bleeding complications and clinical outcome at one year
Drug/Procedures Used:
Prior to the intervention, patients were randomized to either abciximab (0.25 mg/kg bolus + 0.125 µg/kg/min for 12 hours) and reduced dose heparin (n=1079) or placebo and standard dose heparin (n=1080). All patients were treated with high-dose clopidogrel (600 mg for at least two hours prior to percutaneous coronary intervention [PCI]). All patients received open label unfractionated heparin (UFH) 70 U/kg bolus, and the placebo group received an additional blinded 70 U/kg bolus of UFH.
Concomitant Medications:
Clopidogrel (600 mg for at least two hours before the PCI; 2 x 75 mg/d through discharge and 75 mg/d for four weeks). All patients received open label UFH 70 U/kg bolus, and the placebo group received an additional blinded 70 U/kg bolus of UFH.
Principal Findings:
There was no difference in the primary end point of 30-day death, myocardial infarction (MI), or urgent target vessel revascularization (TVR) between the abciximab versus placebo arm (4.2% vs. 4.0%, p=0.82).
There was also no difference in any component of the composite: death 0.3% in each arm; Q wave MI 0.4% versus 0.5%; non-Q wave MI 3.3% in each arm; urgent TVR 0.9% versus 0.7% for abciximab versus placebo, respectively, all p=NS.
Neither thrombolysis in myocardial infarction (TIMI) major (1.1% vs. 0.7%, p=0.37) or TIMI minor bleed (2.5% vs. 1.9%, p=0.38) differed between the abciximab versus placebo arm, although thrombocytopenia occurred more frequently (0.9% vs. 0%), as did transfusion (2.4% vs. 0.9%).
Interpretation:
Among low-risk patients with coronary disease pretreated with high-dose clopidogrel and undergoing elective coronary stenting, treatment with the GP IIb/IIIa inhibitor abciximab was not associated with a reduction in the primary composite end point of death, MI, or urgent TVR at 30 days. The patients enrolled in this trial were very low risk, excluding patients with insulin-dependent diabetes, acute coronary syndrome (ACS), and positive biomarkers.
These data cannot be extrapolated to higher risk patients, such as ACS patients. Further studies are needed in such higher-risk populations. Additionally, the clopidogrel loading dose at 600 mg was higher than the usual 300 mg loading dose commonly used with PCI. Mean duration of pretreatment with clopidogrel was not available, but was a minimum of two hours.
References:
Kastrati A, et al. A Clinical Trial of Abciximab in Elective Percutaneous Coronary Intervention after Pretreatment with Clopidogrel. N Engl J Med 2004;350:232-8.
Presented at Late-Breaking Clinical Trials, ACC 2003.
Keywords: Myocardial Infarction, Acute Coronary Syndrome, Platelet Aggregation Inhibitors, Heparin, Ticlopidine, Insulins, Immunoglobulin Fab Fragments, Diabetes Mellitus, Platelet Membrane Glycoprotein IIb, Thrombocytopenia, Percutaneous Coronary Intervention
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