The American College of Cardiology Presented by Dr. Raimund Erbel PROGRESS-1 Trial Clinical Performance and Angiographic Results of the Coronary Stenting and Absorbable Metal Stents (PROGRESS-1) Trial Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Raimund Erbel

PROGRESS-1 Trial: Background PROGRESS-1 is the first-in-man study of an absorbable stent Absorbable stents are a promising option for several patient types: Children with congenital birth defects requiring frequent reintervention Young patients where the vessels are still growing Older patients who had earlier revascularization and need subsequent stenting in the same lesion, thus avoiding stent-in-stent complications with multiple interventions Presented at ACC 2006

PROGRESS-1 Trial: Study Design 63 patients with single de novo lesion in a native coronary artery, lesion length ≤13mm, vessel diameter between 3.0 mm and 3.5 mm, and diameter stenosis 50% to 99% 30% female, mean age 61.3 years, mean follow-up 4 months, pretreatment with aspirin and clopidogrel 300mg Absorbable metal stent Repeat Angiography and intravascular ultrasound (IVUS) at 4 months Clopidogrel treatment (75mg) for at least 6 months Primary Endpoint: major adverse cardiac events (MACE) <30% at 4 months, defined as cardiac death, nonfatal MI, and ischemia-driven target lesion revascularization (TLR) Presented at ACC 2006

PROGRESS-1 Trial: Primary Endpoint Primary endpoint of MACE <30% at 4 months was met with an event rate of 23.8%, driven entirely by ischemia-driven TLR There were no deaths, myocardial infarction, or in-stent thrombosis Any TLR was performed in 38.1% Late lumen loss from baseline to 4 months was 1.09 mm Presented at ACC 2006

PROGRESS-1 Trial: Culprit Lesion Vessels Location of Target Vessel (%) Target vessel was roughly split among major epicardials Presented at ACC 2006

PROGRESS-1 Trial: Sub-analyses Mean Percent Diameter Stenosis (%) Mean Minimum Lumen Diameters (mm) Presented at ACC 2006

PROGRESS-1 Trial: Limitations Data from this trial has only been collected and assessed up to 4 months from baseline More data must be collected to assess the absorbable metal stent’s efficacy in the longterm This trial looks at a small patient population and did not perform evaluation with a control arm Larger randomized studies must be conducted to fully assess the efficacy of the absorbable stent Presented at ACC 2006

PROGRESS-1 Trial: Summary Among patients with a single de novo lesion in a native coronary artery, use of an absorbable metal stent was safe, with no deaths or MIs and a moderate rate of ischemia-driven TLR (23.8%) by 4 months. The ischemia-driven revascularization rates were moderate compared to drug-eluting stent trials. Absolute percent diameter stenosis was relatively high at 4 months (48%). Presented at ACC 2006