Evaluation of PTCA to Improve Long-term Outcome by c7E3 GP IIb/IIIa receptor (abciximab) blockade - EPILOG

Description:

Abciximab for death, MI and revascularization in percutaneous intervention.

Hypothesis:

Use of abciximab, a platelet glycoprotein IIb/IIIa inhibitor, to reduce the acute complications of percutaneous intervention may be associated with additional costs and increased morbidity if coronary artery bypass graft surgery (CABG) is later required.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 2,792
Female: 0

Patient Populations:

Patients undergoing coronary intervention (such as percutaneous transluminal coronary angioplasty [PTCA], atherectomy, or stenting.

Primary Endpoints:

Death and myocardial infarction

Drug/Procedures Used:

Standard-dose heparin, 100 U/kg bolus titrated to an activated clotting time of >300 s (without abciximab); low-dose heparin, 70 U/kg bolus to achieve an activated clotting time >200 s (with abciximab); abciximab, 0.25 mg/kg bolus plus 0.125 æg/kg/m

Concomitant Medications:

Aspirin

Principal Findings:

Study was prematurely stopped because of a highly significant reduction in the primary endpoint in the group receiving abciximab.

At 30 days, the composite event rate was 11.7 percent in the group assigned to placebo with standard-dose heparin; 5.2 percent in the group assigned to abciximab with low-dose heparin (hazard ratio, 0.43; 95 percent confidence interval, 0.30 to 0.60; P<0.001); and 5.4 percent in the group assigned to abciximab with standard-dose heparin (hazard ratio, 0.45; 95 percent confidence interval, 0.32 to 0.63; P<0.001).

Without abciximab, diabetics had higher rates of death or MI, and of target vessel revascularization than non-diabetics. Abciximab in diabetics undergoing PTCA reduces the rate of death or MI in diabetics at 30 days and 6 months at least as effectively as in non-diabetics, but does not reduce target vessel revascularization.

Patients with small infarcts (enzyme-leaks) after PTCA do have impaired outcome at six months. The reduction of both larger and smaller infarcts by abciximab represents a significant clinical advantage.

Interpretation:

Study was prematurely stopped because of a highly significant reduction in the primary endpoint in the group receiving abciximab.

References:

1. Circulation 1996;93:637. Interim review
2. New Engl J Med 1997;336:1689-96. Final results

Clinical Topics: Anticoagulation Management, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery, Cardiac Surgery and Heart Failure, Heart Failure and Cardiac Biomarkers

Keywords: Platelet Aggregation Inhibitors, Atherectomy, Heparin, Coronary Disease, Immunoglobulin Fab Fragments, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Platelet Membrane Glycoproteins, Diabetes Mellitus, Platelet Membrane Glycoprotein IIb


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