1. 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

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. PROGRESS-1 Trial: Sub-analyses
Mean Percent Diameter Stenosis (%)
Mean Minimum Lumen Diameters (mm)
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