Principal Findings:

The trial was discontinued early at the recommendation of the Data Safety Monitoring Board after 91% (483/530) of patients were enrolled due to slow recruitment. Patients had more co-morbid conditions than is often seen in ST elevation MI trials, with 66% having a history of hypertension, 9% peripheral vascular disease, and 21% Killip class ≥2. Median time from chest pain to treatment was longer in the PCI group (237 minutes vs. 210 minutes, p=0.014) and fewer patients in the PCI group had an inferior MI (49% vs. 60%, p=0.022). Final TIMI flow grade of 3 was achieved in 86.1% of patients in the PCI group. In the thrombolyic group, fibrin-specific lytics were used in 62% of patients and nonfibrin-specific lytics in 38%. During the index hospitalization, nonprotocol catheterization was performed in 51% of the thrombolytic group and PCI in 37%.

Intracranial bleeding occurred during the index hospitalization in 1.3% of the thrombolytic group and none of the PCI group (p=0.11). There was no difference in in-hospital major bleeding (5.6% for PCI vs. 6.2% for thrombolytic, p=0.79). The primary endpoint of death or disabling stroke at 30 days did not differ by treatment group (11.3% for PCI vs. 13% for thrombolytic, p=0.57). However, the secondary composite endpoint of death, disabling stroke, or reinfarction was lower in the PCI group (11.6% vs. 18%, p=0.05), driven by a reduction in reinfarction (1.6% vs. 5.4%, p=0.039).

There was no difference in the individual components of death (10% vs. 13%, p=0.48) or disabling stroke (0.8% vs. 2.2%, p=0.26). In the subgroup of patients age 70-80 years (n=352), the PCI group had a lower rate of death, disabling stroke, or reinfarction (7.7% vs. 17%, p=0.009) and a trend toward a lower rate of death or disabling stroke (7.7% vs. 12%, p=0.18). However, in the subgroup of patients age >80 years (n=130), there was no apparent difference between the PCI and the thrombolytic groups (22% each for death, disabling stroke, or reinfarction).