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Presented at The American College of Cardiology Scientific Session 2006

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.

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Presented at The American College of Cardiology Scientific Session 2006

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  1. 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

  2. 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

  3. 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

  4. 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

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

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

  7. 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

  8. 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

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