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
www. Clinical trial results.org 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)
www. Clinical trial results.org 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
www. Clinical trial results.org Presented at ACC 2006
PROGRESS-1 Trial: Culprit Lesion Vessels
Location of Target Vessel (%)
• Target vessel was
roughly split among
40% 34.9% 36.5% major epicardials
28.6%
30%
20%
10%
0%
LAD LCx RCA
www. Clinical trial results.org Presented at ACC 2006
PROGRESS-1 Trial: Sub-analyses
Mean Percent Diameter Stenosis (%) Mean Minimum Lumen Diameters (mm)
70% 62% 3.00
2.46
60% 2.50
48%
50%
2.00
40% 1.37
1.50
30% 1.05
20% 1.00
12%
10% 0.50
0% 0.00
Pre-PCI Immediately 4 month Pre-PCI Immediately 4 month
Post-PCI follow-up Post-PCI follow-up
www. Clinical trial results.org 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
www. Clinical trial results.org 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%).
www. Clinical trial results.org Presented at ACC 2006