Clinical Performance and Angiographic Results of Clinical Performance and Angiographic Results of the Coronary Stenting and Absorbable Metal Stents the Coronary Stenting and Absorbable Metal Stents

(PROGRESS-1) Trial(PROGRESS-1) Trial

Clinical Performance and Angiographic Results of Clinical Performance and Angiographic Results of the Coronary Stenting and Absorbable Metal Stents the Coronary Stenting and Absorbable Metal Stents

(PROGRESS-1) Trial(PROGRESS-1) Trial

Presented atPresented atThe American College of CardiologyThe American College of Cardiology

Scientific Session 2006Scientific Session 2006

Presented by Dr. Raimund ErbelPresented by Dr. Raimund Erbel

PROGRESS-1 TrialPROGRESS-1 TrialPROGRESS-1 TrialPROGRESS-1 Trial

www. Clinical trial results.org

PROGRESS-1 Trial: BackgroundPROGRESS-1 Trial: BackgroundPROGRESS-1 Trial: BackgroundPROGRESS-1 Trial: Background

• PROGRESS-1 is the first-in-man study of an absorbable stent PROGRESS-1 is the first-in-man study of an absorbable stent

• Absorbable stents are a promising option for several patient types:Absorbable stents are a promising option for several patient types:

– Children with congenital birth defects requiring frequent Children with congenital birth defects requiring frequent reinterventionreintervention

– Young patients where the vessels are still growingYoung patients where the vessels are still growing

– Older patients who had earlier revascularization and need Older patients who had earlier revascularization and need subsequent stenting in the same lesion, thus avoiding stent-in-subsequent stenting in the same lesion, thus avoiding stent-in-stent complications with multiple interventions stent complications with multiple interventions

• PROGRESS-1 is the first-in-man study of an absorbable stent PROGRESS-1 is the first-in-man study of an absorbable stent

• Absorbable stents are a promising option for several patient types:Absorbable stents are a promising option for several patient types:

– Children with congenital birth defects requiring frequent Children with congenital birth defects requiring frequent reinterventionreintervention

– Young patients where the vessels are still growingYoung patients where the vessels are still growing

– Older patients who had earlier revascularization and need Older patients who had earlier revascularization and need subsequent stenting in the same lesion, thus avoiding stent-in-subsequent stenting in the same lesion, thus avoiding stent-in-stent complications with multiple interventions stent complications with multiple interventions

Presented at ACC 2006Presented at ACC 2006

www. Clinical trial results.org

PROGRESS-1 Trial: Study DesignPROGRESS-1 Trial: Study DesignPROGRESS-1 Trial: Study DesignPROGRESS-1 Trial: Study Design

Presented at ACC 2006Presented at ACC 2006

Primary Endpoint: major adverse cardiac events (MACE) Primary Endpoint: major adverse cardiac events (MACE) <30% <30% at 4 months, defined as at 4 months, defined as cardiac death, nonfatal MI, and ischemia-driven target lesion revascularization (TLR)cardiac death, nonfatal MI, and ischemia-driven target lesion revascularization (TLR)

Primary Endpoint: major adverse cardiac events (MACE) Primary Endpoint: major adverse cardiac events (MACE) <30% <30% at 4 months, defined as at 4 months, defined as cardiac death, nonfatal MI, and ischemia-driven target lesion revascularization (TLR)cardiac death, nonfatal MI, and ischemia-driven target lesion revascularization (TLR)

Absorbable metal stentAbsorbable metal stent

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

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

Repeat Angiography and intravascular ultrasound (IVUS) at

4 months

Repeat Angiography and intravascular ultrasound (IVUS) at

4 months

Clopidogrel treatment (75mg) for at least 6 monthsClopidogrel treatment (75mg) for at least 6 months

www. Clinical trial results.org

PROGRESS-1 Trial: Primary EndpointPROGRESS-1 Trial: Primary EndpointPROGRESS-1 Trial: Primary EndpointPROGRESS-1 Trial: Primary Endpoint

Presented at ACC 2006Presented at ACC 2006

Primary endpoint of MACE <30% at 4 months was met with an event rate of 23.8%, driven entirely by ischemia-driven TLR

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

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PROGRESS-1 Trial: Culprit Lesion VesselsPROGRESS-1 Trial: Culprit Lesion VesselsPROGRESS-1 Trial: Culprit Lesion VesselsPROGRESS-1 Trial: Culprit Lesion Vessels

34.9%

28.6%

36.5%

0%

10%

20%

30%

40%

LAD LCx RCA

34.9%

28.6%

36.5%

0%

10%

20%

30%

40%

LAD LCx RCA

• Target vessel was Target vessel was roughly split among roughly split among major epicardialsmajor epicardials

Location of Target Vessel (%)Location of Target Vessel (%)

Presented at ACC 2006Presented at ACC 2006

www. Clinical trial results.org

PROGRESS-1 Trial: Sub-analysesPROGRESS-1 Trial: Sub-analysesPROGRESS-1 Trial: Sub-analysesPROGRESS-1 Trial: Sub-analyses

Presented at ACC 2006Presented at ACC 2006

62%

12%

48%

0%10%20%30%40%50%60%70%

Pre-PCI ImmediatelyPost-PCI

4 monthfollow-up

62%

12%

48%

0%10%20%30%40%50%60%70%

Pre-PCI ImmediatelyPost-PCI

4 monthfollow-up

Mean Percent Diameter Stenosis (%)Mean Percent Diameter Stenosis (%)

1.05

2.46

1.37

0.00

0.50

1.00

1.50

2.00

2.50

3.00

Pre-PCI ImmediatelyPost-PCI

4 monthfollow-up

1.05

2.46

1.37

0.00

0.50

1.00

1.50

2.00

2.50

3.00

Pre-PCI ImmediatelyPost-PCI

4 monthfollow-up

Mean Minimum Lumen Diameters (mm)Mean Minimum Lumen Diameters (mm)

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PROGRESS-1 Trial: LimitationsPROGRESS-1 Trial: LimitationsPROGRESS-1 Trial: LimitationsPROGRESS-1 Trial: Limitations

• Data from this trial has only been collected and Data from this trial has only been collected and assessed up to 4 months from baselineassessed up to 4 months from baseline

• More data must be collected to assess the More data must be collected to assess the absorbable metal stent’s efficacy in the longtermabsorbable metal stent’s efficacy in the longterm

• This trial looks at a small patient population and did This trial looks at a small patient population and did not perform evaluation with a control armnot perform evaluation with a control arm

• Larger randomized studies must be conducted to fully Larger randomized studies must be conducted to fully assess the efficacy of the absorbable stentassess the efficacy of the absorbable stent

• Data from this trial has only been collected and Data from this trial has only been collected and assessed up to 4 months from baselineassessed up to 4 months from baseline

• More data must be collected to assess the More data must be collected to assess the absorbable metal stent’s efficacy in the longtermabsorbable metal stent’s efficacy in the longterm

• This trial looks at a small patient population and did This trial looks at a small patient population and did not perform evaluation with a control armnot perform evaluation with a control arm

• Larger randomized studies must be conducted to fully Larger randomized studies must be conducted to fully assess the efficacy of the absorbable stentassess the efficacy of the absorbable stent

Presented at ACC 2006Presented at ACC 2006

www. Clinical trial results.org

PROGRESS-1 Trial: SummaryPROGRESS-1 Trial: SummaryPROGRESS-1 Trial: SummaryPROGRESS-1 Trial: Summary

• Among patients with a single de novo lesion in a native Among patients with a single de novo lesion in a native coronary artery, use of an absorbable metal stent was coronary artery, use of an absorbable metal stent was safe, with no deaths or MIs and a moderate rate of safe, with no deaths or MIs and a moderate rate of ischemia-driven TLR (23.8%) by 4 months.ischemia-driven TLR (23.8%) by 4 months.

• The ischemia-driven revascularization rates were moderate The ischemia-driven revascularization rates were moderate compared to drug-eluting stent trials.compared to drug-eluting stent trials.

• Absolute percent diameter stenosis was relatively high at 4 Absolute percent diameter stenosis was relatively high at 4 months (48%).months (48%).

• Among patients with a single de novo lesion in a native Among patients with a single de novo lesion in a native coronary artery, use of an absorbable metal stent was coronary artery, use of an absorbable metal stent was safe, with no deaths or MIs and a moderate rate of safe, with no deaths or MIs and a moderate rate of ischemia-driven TLR (23.8%) by 4 months.ischemia-driven TLR (23.8%) by 4 months.

• The ischemia-driven revascularization rates were moderate The ischemia-driven revascularization rates were moderate compared to drug-eluting stent trials.compared to drug-eluting stent trials.

• Absolute percent diameter stenosis was relatively high at 4 Absolute percent diameter stenosis was relatively high at 4 months (48%).months (48%).

Presented at ACC 2006Presented at ACC 2006