American College of Cardiology Presented by Dr. Michel R. Le May CAPITAL AMI Trial Combined Angioplasty and Pharmacological Intervention Versus Thrombolytics Alone in Acute Myocardial Infarction Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Michel R. Le May

CAPITAL AMI Trial 170 patients presenting with ST elevation acute MI with chest pain ≥30 minutes and within six hours of symptom onset Randomized, open-label, multicenter Thrombolytic Therapy Full-dose Tenectaplase (TNK) n=84 Thrombolytic Therapy, Transfer, and PCI Full-dose Tenectaplase (TNK) followed by transfer and subsequent percutaneous coronary intervention (PCI) n=86 Endpoints (30 days and 6 months): Composite of death, reinfarction, recurrent unstable ischemia, or stroke Presented at ACC Scientific Sessions 2004

In-Hospital Reinfarction In-Hospital Recurrent Unstable Ischemia CAPITAL AMI Trial In-Hospital Composite Event Rate p=0.017 In-Hospital Reinfarction p=0.046 In-Hospital Recurrent Unstable Ischemia p=0.02 % TNK TNK+PCI TNK TNK+PCI The composite in-hospital event rate of death, reinfarction, recurrent unstable ischemia, or stroke was lower in the TNK+PCI arm compared with the TNK alone arm, driven by a reduction in reinfarction and recurrent unstable ischemia. Presented at ACC Scientific Sessions 2004

CAPITAL AMI Trial TIMI Major Bleed EF at Day 7 EF at Day 30 p=NS EF at Day 7 p=NS EF at Day 30 p=NS PCI was performed in 91% of patients in the combination therapy arm. In the TNK alone arm, 47% of patients underwent PCI during the index hospitalization. Anterior MI location was present in 49% in the TNK alone arm and 52% in the TNK+PCI arm. There was no difference in TIMI major bleed or ejection fraction (EF) at day 7 or day 30. % TNK TNK+PCI TNK TNK+PCI TNK TNK+PCI Presented at ACC Scientific Sessions 2004

30-Day Recurrent Unstable Ischemia CAPITAL AMI Trial Primary Composite Endpoint at 30 days p=0.034 30-Day Reinfarction 30-Day Recurrent Unstable Ischemia TNK TNK+PCI TNK TNK+PCI % Composite event rate remained lower in the TNK+PCI arm at 30 days, again driven by reductions in reinfarction and recurrent unstable ischemia, with no difference in mortality (2.3% vs. 3.6%). Length of hospital stay shorter in the TNK+PCI arm (5 vs. 6 days, p=0.009). Presented at ACC Scientific Sessions 2004

CAPITAL AMI Trial Among patients with STEMI, treatment with full-dose TNK with transfer for PCI was associated with a lower rate of the composite of death, reinfarction, recurrent unstable ischemia, or stroke at 30 days compared with TNK alone, without an increased risk of major bleeding. Results of the present trial differ from earlier trials such as the TIMI II trial, which showed no benefit of medical therapy plus percutaneous transluminal coronary angioplasty (PTCA) over medical therapy alone. Differing results are not unexpected, given the substantial changes in practice patterns since the earlier trials (widespread use of stents, optimal anticoagulation, and use of thienopyridines). Event rates at 6 months are pending.