1. New stent technology Magnesium-alloy The Progress-AMS Study
Raimund Erbel,
M Haude, Th Konorza, D Boese
Department of Cardiology
West-German Heart Center Essen
University Duisburg-Essen
Erbel et al., Lancet 2007;369(9576):

2. Hypotheses Purpose Design
Clinical Performance and Angiographic Results of the
Coronary Stenting with Absorbable Metal Stents
The PROGRESS-AMS Study
To evaluate the clinical feasibility of an absorbable metal stent in the treatment of a single de novo lesion in a native coronary artery
Purpose
Prospective, multi-center, consecutive, non-randomized FIM (First In Man – coronary) study
Design
MACE rate after 4 months <30 % comparable to BMS
Hypotheses
Erbel et al., Lancet 2007;369(9576):

3. PROGRESS STUDY
Principal Investigator Raimund Erbel, MD, Essen, Germany
Co-Chairman Ron Waksman, MD, Washington, USA
Raimund Erbel, MD, Essen, Germany
Steering Committee Ron Waksman, MD, Washington, USA
Bernd Heublein † , MD, Hannover, Germany
CEC & DSMB Jan Bart Hak, PhD, Groningen, NL
Martial Hamon, MD, Caen, France
Rafael Beyar, MD, Haifa, Israel
IVUS Core laboratory Neil J. Weissman, MD, Washington, USA
QCA Core laboratory Cardialysis, Rotterdam, The Netherlands
Data Coordinating Ron Waksman, MD, Washington, USA
Study Coordination Stefan Wagner, PhD, Erlangen, Germany
Erbel et al., Lancet 2007;369(9576):

4. PROGRESS STUDY Australia M Horrigan, Melbourne, AUS
Belgium B de Bruyne & W Wijns, Aalst, BE
Germany M Haude, S Sack, D Boese, R Erbel, DE
Netherlands JJRM Bonnier & J Koolen, Eindhoven
Switzerland F Eberli & T Lüscher, Zurich, CH
P Erne, Luzern, CH
UK C Di Mario & C Ilsley, London, UK
USA R Waksman, Washington, USA
Erbel et al., Lancet 2007;369(9576):

5. PROGRESS STUDY Procedure Details
2.5 mm x 15 mm pre PTCA
< 16 atm AMS implantation
3.0 mm mm
AMS size
10 mm mm
< 16 atm post dilatation if necessary
double marker balloon
angiogram/IVUS before and after implantation
Erbel et al., Lancet 2007;369(9576):

6. PROGRESS Study Protocol
Screening
Treat- ment
1 d post
1 m post
± 7 d
4 m post
± 1 w
6 m post
± 2 w
12 m post
± 4 w
Clinical follow-up X
CK (CK-MB)/ Troponin I
QCA
IVUS
MRI (subgr.)*
*MRI for analysis of degradation kinetics
Erbel et al., Lancet 2007;369(9576):

7. PROGRESS STUDY PCI Procedure Characteristics n - pre dilatation 100 %
63/63
pressure (8 atm, 20 sec)
9 ± 2.1
- AMS pressure, atm
16 ± 0.9
- post dilatation
67 %
42/63
- post dilatation pressure, atm
16 ± 3.9
2nd stent
- average stent number
13 %
1.1 ± 0.3
8/63
Erbel et al., Lancet 2007;369(9576):

8. PROGRESS Study MLD: MLD stent: 1,05 ± 0,38 2,47 ± 0,37
100 80 60
Gain:
1,41 ± 0,46
Cumultive distribution % 40 20
0,0
0,5
1,0
1,5
2,0
2,5
3,0
3,5
4,0
MLD [mm]
Erbel et al., Lancet 2007;369(9576):

9. Magnet Resonance Imaging of AMS The MRI compatible Stent
Magnetom,
(Sonata, 1.5 T, Siemens)
optimal vessel imaging
no stent artefacts,
AMS not visible
Eggebrecht et al Circulation 112, 303 – 4, 2005

10. Computed Tomography 16 MSCT: AMS StentB C D
bms-
stent
AMS
Stent
AMS Stent
BMS Stent
Lind et al Heart 91:1604, 2005

11. Micro CT of AMS and BMS Mg-Stent bare metal stent Malyar et al 2006
1 mm
Malyar et al

12. GIRO 065-001 C-R Acute result After AMS Stent implantation
after 18 days
Erbel et al JACC 2005

13. Absorbable Metal Stent (AMS)
MLDf/u:
1,34 ± 0,49
MLDstent:
2,47 ± 0,37
100 80 60
Loss:
1,08 ± 0,49
cumulative distribution % 40 20
0,0
0,5
1,0
1,5
2,0
2,5
3,0
3,5
4,0
MLD [mm]
Erbel et al., Lancet 2007;369(9576):

14. QCA Analysis Parameter before after 4 - Months Ref MLD/mm 2.76 2.67
± ± 0.46
MLD/mm
± ± ± 0.49
Acute gain/mm
± 0.46
Late loss/mm
± 0.49
D % Stenosis
± ± ± 17
Erbel et al., Lancet 2007;369(9576):

15. PROGRESS STUDY 4 Months Angiography
Erbel et al., Lancet 2007;369(9576):

16. PROGRESS STUDY % N MACE Mortality Q- MI (Q- mit CK or CK-MB)
Hospital
30-days
4-Months % N
MACE
Mortality
Q- MI (Q- mit CK or CK-MB)
Non Q - MI (CK 2 x UNL)
Ischemia
driven TLR
23.8 15
Erbel et al., Lancet 2007;369(9576):

17. Vasomotion Testing after Magnesium Stent
Baseline values
Stenosis diameteer (%)
39.1
Stenosis area ( %)
62.9
MLD (mm)
1.67
MLA (mm²)
2.19
Reference diameter (mm)
2.74
Reference area (mm²)
5.90
Vessel segment length(mm)
27.1
Stenosis length (mm)
13.5
Erbel et al., Lancet 2007;369(9576):

18. Vasomotion Testing after Magnesium Stent
Acetylcholine testing
Stenosis diameter (%)
56.4
Stenosis area (%)
81.0
MLD (mm)
1.16
MLA (mm²)
1.06
Reference diameter (mm)
2.67
Reference area (mm²)
5.59
Vessel segment length (mm)
25.3
Stenosis length (mm)
17.9
Erbel et al., Lancet 2007;369(9576):

19. Magnesium Stent Conclusion AMS realized with low recoil
High technical sucess
AMS permits MRT and CT based imaging
No acute or subacute stent thrombosis
iTLR rate comparable to BMS
IVUS detected degradation within 4 M
Vasomotion reactivation
Drug elution and AMS
delayed degradation – Dream concept*
* Please listen to R Waksman in the next session, room 6