The Study to Assess AMI Treated With Balloon Angioplasty.

This is an international, multicenter (up to 52 sites), randomized, single-blind study in patients with an acute myocardial infarction treated with the CYPHER™ (Sirolimus-eluting) stent as compared to the bare stents.

Patients with de novo native coronary artery lesions will be treated with the CYPHER™ (Sirolimus-eluting) stent or a bare stent. Subjects will be followed at 30 days, 6 months and at 1, 3, 4 and 5 years post-procedure. 200 subjects will have an angiographic follow-up at 8 months.

Inclusion criteria

• Have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following:

• ST segment elevation >=1mm in standard leads and >=2mm in 2 or more contiguous precordial leads with reciprocal ST depression
• New or presumably new left bundle branch block (LBBB)
• The culprit lesion must be identified on a de novo native coronary artery and an emergency angioplasty must be possible. The culprit site must be visualized before the stent implantation;

Exclusion criteria

• Killip class > 2 upon arrival to the cath-lab;
• Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
• Evidence of massive thrombus in the infarct related artery distally to the culprit lesion;
• Documented left ventricular ejection fraction <=30%;
• Target lesion is located in an arterial or venous by-pass graft;
• ECG documented evidence of prior myocardial infarction;
• Patient who received thrombolytic therapy for the current AMI before enrollment in this study.