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
www.wdhz.de
erbel@uk-essen.de

Erbel et al., Lancet 2007;369(9576):1869-75

 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
• Purpose metal stent in the treatment of a single de novo
lesion in a native coronary artery

• Prospective, multi-center, consecutive, non-

• Design randomized FIM (First In Man – coronary) study

MACE rate after 4 months <30 % comparable to

• Hypotheses BMS

Erbel et al., Lancet 2007;369(9576):1869-75

 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):1869-75

 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):1869-75

 PROGRESS STUDY
Procedure Details

• 2.5 mm x 15 mm pre PTCA

• < 16 atm AMS implantation
3.0 mm 3.5 mm
• AMS size
10 mm 15 mm
• < 16 atm post dilatation if necessary
• double marker balloon
• angiogram/IVUS before and after implantation

Erbel et al., Lancet 2007;369(9576):1869-75

 PROGRESS
Study Protocol

Screen Treat- 1d 1m 4m 6m 12 m
ing ment post post post post post
±7d ±1w ±2w ±4w

Clinical follow-
X X X X X X
up

CK (CK-MB)/
X X
Troponin I

QCA X X

IVUS X X

MRI (subgr.)* X X X

*MRI for analysis of degradation kinetics

Erbel et al., Lancet 2007;369(9576):1869-75
 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 13 % 8/63

- average stent number 1.1 ± 0.3

Erbel et al., Lancet 2007;369(9576):1869-75

 PROGRESS Study

MLD: MLD stent:

1,05 ± 0,38 2,47 ± 0,37
100
Cumultive distribution %

80

60
Gain:
1,41 ± 0,46
40

20

0
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):1869-75

 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
 Computed Tomography
16 MSCT: AMS Stent
A B

bms- AMS
stent C D Stent

AMS Stent
BMS Stent

Lind et al Heart 91:1604, 2005

 Micro CT of AMS and BMS

Mg-Stent bare metal

stent

1 mm

Malyar et al 2006
 GIRO 065-001 C-R

Acute result

After AMS Stent

implantation

after 18 days
Erbel et al JACC
2005
 Absorbable Metal Stent (AMS)

MLDf/u: MLDstent:
1,34 ± 0,49 2,47 ± 0,37
100
cumulative distribution %

80

60
Loss:
1,08 ± 0,49
40

20

0
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):1869-75

 QCA Analysis
Parameter before after 4 - Months

Ref MLD/mm 2.76 2.67

± 0.47 ± 0.46
MLD/mm 1.05 2.47 1.34
± 0.38 ± 0.37 ± 0.49
Acute gain/mm 1.41
± 0.46

Late loss/mm 1.08

± 0.49
D % Stenosis 62 13 48
± 13 ±6 ± 17

Erbel et al., Lancet 2007;369(9576):1869-75

 PROGRESS STUDY

Time of TLR
100

80
TLR events

60
4 Months Angiography
40

20

0
0 30 60 90 120 150 180 210 240 270 300 330 360

days after intervention

Erbel et al., Lancet 2007;369(9576):1869-75

 PROGRESS STUDY
Hospital 30-days 4-Months
% N % N % N

MACE
Mortality 0 0 0 0 0 0

Q- MI (Q- mit CK or 0 0 0 0 0 0
CK-MB)
Non Q - MI (CK 2 x 0 0 0 0 0 0
UNL)
Ischemia 0 0 0 0 23.8 15
driven TLR

Erbel et al., Lancet 2007;369(9576):1869-75

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):1869-75

17
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):1869-75

 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