The IMPACT-II Trial
                        ===================

1.
Tardiff BE, Califf RM, Tcheng JE, et al.
Clinical outcomes after detection of elevated cardiac enzymes in patients
undergoing percutaneous intervention. IMPACT-II Investigators. Integrilin
(eptifibatide) to Minimize Platelet Aggregation and Coronary Thrombosis-II
Journal Of The American College Of Cardiology 1999; 33 UNITED STATES:88-96
OBJECTIVES: We examined the relations of elevated creatine kinase (CK) and its
myocardial band isoenzyme (CK-MB) to clinical outcomes after percutaneous
coronary intervention (PCI) in patients enrolled in Integrilin (eptifibatide)
to Minimize Platelet Aggregation and Coronary Thrombosis-II (trial)
(IMPACT-II), a trial of the platelet glycoprotein IIb/IIIa inhibitor
eptifibatide. BACKGROUND: Elevation of cardiac enzymes often occurs after PCI,
but its clinical implications are uncertain. METHODS: Patients undergoing
elective, scheduled PCI for any indication were analyzed. Parallel analyses
investigated CK (n=3,535) and CK-MB (n=2,341) levels after PCI (within 4 to 20
h). Clinical outcomes at 30 days and 6 months were stratified by postprocedure
CK and CK-MB (multiple of the site's upper normal limit). RESULTS: Overall,
1,779 patients (76%) had no CK-MB elevation; CK-MB levels were elevated to 1
to 3 times the upper normal limit in 323 patients (13.8%), to 3 to 5 times
normal in 84 (3.6%), to 5 to 10 times normal in 86 (3.7%), and to >10 times
normal in 69 patients (2.9%). Elevated CK-MB was associated with an increased
risk of death, reinfarction, or emergency revascularization at 30 days, and of
death, reinfarction, or surgical revascularization at 6 months. Elevated total
CK to above three times normal was less frequent, but its prognostic
significance paralleled that seen for CK-MB. The degree of risk correlated
with the rise in CK or CK-MB, even for patients with successful procedures not
complicated by abrupt closure. CONCLUSIONS: Elevations in cardiac enzymes,
including small increases (between one and three times normal) often not
considered an infarction, are associated with an increased risk for short-term
adverse clinical outcomes after successful or unsuccessful PCI.

2.
Tcheng JE
Impact of eptifibatide on early ischemic events in acute ischemic coronary
syndromes: a review of the IMPACT II trial. Integrilin to Minimize Platelet
Aggregation and Coronary Thrombosis
American Journal Of Cardiology 1997; 80 UNITED STATES:21B-28B
Formation of platelet-rich thrombus superimposed on ruptured atherosclerotic
plaque has been implicated in the development of myocardial ischemia and its
clinical manifestations. The platelet glycoprotein (GP) IIb-IIIa receptor is
the final common pathway leading to platelet aggregation and thrombus
formation. GP IIb-IIIa is therefore a logical therapeutic target for
management of acute ischemic coronary syndromes and prevention of the ischemic
complications of percutaneous coronary procedures. Of the pharmaceutical
agents under development, the chimeric monoclonal antibody abciximab (ReoPro)
and the cyclic peptide eptifibatide (INTEGRILIN) are the most studied. IMPACT
II (Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis), the
phase III evaluation of eptifibatide in patients undergoing percutaneous
coronary intervention, demonstrated the effectiveness and safety of this GP
IIb-IIIa receptor inhibitor in reducing the acute adverse outcomes of invasive
management of ischemic heart disease. GP IIb-IIIa receptor blockade provides
an effective strategy for prevention of ischemic complications related to
angioplasty in patients with coronary artery disease.