Study Design

Patients Enrolled: 1,572
Mean Follow-Up: 30 days
Mean Patient Age: median age, 63 years
Female: 27%

Inclusion Criteria:

ST elevation >4 mm symptom onset ≥30 minutes and ≤12 hours; no upper age limit

Exclusions:

Age <18 years; thrombolytic treatment within the last 30 days acute MI within the last 30 days; high risk during transportation (cardiogenic shock or severe heart failure with hypotension, persistent life-threatening arrhythmias or need for mechanical ventilation); LBBB; any cardiac condition requiring immediate surgical intervention; severe valvular or pericardial disease; severe noncardiac disease (life expectancy <12 months); active bleeding or bleeding diathesis; history of stroke in the past 3 months; major surgery or significant trauma in the past 1 month; severe hypertension after initial treatment (systolic >200 mm Hg or diastolic >110 mm Hg); expected time between randomization and arrival in the catheterization laboratory >3 hours for patients randomized in referral hospitals and >2 hours for patients randomized in invasive hospitals; infection with sepsis; aortic aneurysm with thrombus diagnosed previously; no femoral pulse or known difficulty with arterial access or bilateral femoral vascular grafts; previous coronary bypass grafting; severe renal failure; NIDDM treated with metformin within the last 48 hours; patients in whom compliance with follow-up is doubtful or unlikely; pregnancy or lactation and females of childbearing potential not using adequate birth control.

Primary Endpoints:

Composite of death from any cause, clinical reinfarction, or disabling stroke at 30 days; procedure-related reinfarction was not included in the primary endpoint.

Secondary Endpoints:

Composite endpoint of mortality + clinical reinfarction + significant disabling stroke at end of study period. Total mortality at end of study period. Cardiac mortality at end of study period. Angina pectoris free survival without AMI at end of study period. Quality of life at follow-up after 30 days, 1 year, 3 years and 5 years. Costs analysis at follow-up after 30 days, 1 year, 3 years and 5 years.

Drug/Procedures Used:

Patients were randomized to primary PCI or front loaded tPA - 15 mg bolus over 1-3 minutes + infusion of 0.75 mg/kg over 30 minutes (not to exceed 50 mg) + 0.5 mg/kg over 60 minutes (not to exceed 35 mg) Patients randomized to PCI were transferred to referring center if catheterization lab facilities were not available on-site.

Concomitant Medications:

Aspirin (300 mg initially followed by 75-150 mg daily) Heparin (5000 U bolus + 1000 U/hr infusion for at least 48 hours in patients randomized to tPA; 10,000 U bolus + additional heparin to keep the ACT between 350-450 seconds during procedure in patients randomized to PCI)