Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction

Prospective, 2 x 2 factorial single blind, randomized, multi-center trial of 3400 patients
enrolled at up to 200 centers. Patients will be randomized 1:1 in the emergency room to a)
anticoagulation with unfractionated heparin plus routine GP IIb/IIIa inhibition vs. b)
bivalirudin and bail-out GP IIb/IIIa inhibition. Following angiography, patients with lesions
eligible for stenting will then undergo a second randomization (3:1) to stent implantation
with either a) a slow rate-release paclitaxel-eluting stent (TAXUS™) or b) an otherwise
identical uncoated bare metal stent (EXPRESS2™).

Inclusion Criteria:

- Must have clinical symptoms consistent with AMI (e.g., angina or anginal
equivalent)lasting >20 minutes but <12 hours in duration;

- ST-segment elevation of >1 mm in >2 contiguous leads, or (presumably new) left bundle
branch block, or true posterior MI with ST depression of >1 mm in >2 contiguous
anterior leads;

- The patient or guardian agrees to the study protocol and the schedule of clinical and
angiographic follow-up, and provides informed, written consent.

Exclusion Criteria:

- The patient has a known hypersensitivity or contraindication to any of the following
medications:

- Heparin, pork or pork products

- Both abciximab and eptifibatide

- Aspirin

- Both Clopidogrel and Ticlopidine

- Bivalirudin

- Paclitaxel or Taxol

- The polymer components of the TAXUS™ stent (SIBS)

- Stainless steel and/or

- Contrast media;

- Prior administration of thrombolytic therapy, bivalirudin, GP IIb/IIIa inhibitors, low
molecular weight heparin or fondaparinux for this admission. Patients receiving prior
unfractionated heparin may be enrolled, and treated per randomization;

- Current use of coumadin;

- Systemic (intravenous) Paclitaxel or Taxol use within 12 months;

- Female of childbearing potential, unless a recent pregnancy test is negative, who
possibly plans to become pregnant any time after enrollment into this study;

- History of bleeding diathesis or known coagulopathy (including heparin-induced
thrombocytopenia), or will refuse blood transfusions;

- History of intra-cerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic
stroke;

- Stroke or transient ischemic attack within the past 6 months, or any permanent
residual neurologic defect;

- Gastrointestinal or genitourinary bleeding within the last 2 months, or major surgery
within six weeks;

- Recent history or known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL;

- Extensive peripheral vascular disease, such that emergent angiography and intervention
in the opinion of the investigator is likely to be difficult or complicated;

- An elective surgical procedure is planned that would necessitate interruption of
thienopyridines during the first six months post enrollment;

- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may
result in protocol non-compliance;

- Patients who are actively participating in another drug or device investigational
study, which have not completed the primary endpoint follow-up period;

- Previous enrollment in this trial;

- Patients who underwent coronary stent implantation within the past 30 days.