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

• Purpose

• To evaluate the clinical feasibility of an absorbable metal stent in the treatment of a single de novo lesion in a native coronary artery • Prospective, multi-center, consecutive, nonrandomized FIM (First In Man – coronary) study

• Design

• Hypotheses

MACE rate after 4 months <30 % comparable to BMS

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

PROGRESS STUDY
Principal Investigator Co-Chairman Steering Committee Raimund Erbel, MD, Essen, Germany Ron Waksman, MD, Washington, USA Raimund Erbel, MD, Essen, Germany Ron Waksman, MD, Washington, USA Bernd Heublein † , MD, Hannover, Germany CEC & DSMB IVUS Core laboratory QCA Core laboratory Data Coordinating Study Coordination Jan Bart Hak, PhD, Groningen, NL Martial Hamon, MD, Caen, France Rafael Beyar, MD, Haifa, Israel Neil J. Weissman, MD, Washington, USA Cardialysis, Rotterdam, The Netherlands Ron Waksman, MD, Washington, USA Stefan Wagner, PhD, Erlangen, Germany Erbel et al., Lancet 2007;369(9576):1869-75

PROGRESS STUDY
Australia Belgium Germany Netherlands Switzerland UK USA M Horrigan, Melbourne, AUS B de Bruyne & W Wijns, Aalst, BE M Haude, S Sack, D Boese, R Erbel, DE JJRM Bonnier & J Koolen, Eindhoven F Eberli & T Lüscher, Zurich, CH P Erne, Luzern, CH C Di Mario & C Ilsley, London, UK 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- 1 d ing ment post Clinical followup CK (CK-MB)/ Troponin I QCA IVUS MRI (subgr.)* X X X X X X X X X X X 1m post ±7d X 4m post ±1w X 6m post ±2w X 12 m post ±4w X

*MRI for analysis of degradation kinetics Erbel et al., Lancet 2007;369(9576):1869-75

PROGRESS STUDY
PCI Procedure Characteristics - pre dilatation • pressure (8 atm, 20 sec) - AMS pressure, atm - post dilatation - post dilatation pressure, atm - 2nd stent - average stent number 100 % 9 ± 2.1 16 ± 0.9 67 % 16 ± 3.9 13 % 1.1 ± 0.3 8/63 42/63 n 63/63

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

PROGRESS Study
MLD:
1,05 ± 0,38
100

MLD stent:
2,47 ± 0,37

Cumultive distribution %

80 60 40 20 0 0,0 0,5 1,0 1,5 2,0 2,5 3,0 3,5 4,0

Gain:
1,41 ± 0,46

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

bmsstent

C

D

AMS 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 2005 JACC

Absorbable Metal Stent (AMS)
MLDf/u:
1,34 ± 0,49
cumulative distribution %
100 80 60 40 20 0 0,0 0,5 1,0 1,5 2,0 2,5 3,0 3,5 4,0

MLDstent:
2,47 ± 0,37

Loss:
1,08 ± 0,49

MLD [mm]

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

QCA Analysis
Parameter Ref MLD/mm MLD/mm Acute gain/mm Late loss/mm D % Stenosis 62
± 13

before 2.76
± 0.47

after

4 - Months 2.67
± 0.46

1.05
± 0.38

2.47
± 0.37

1.34
± 0.49

1.41
± 0.46

1.08
± 0.49

13
±6

48
± 17

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

PROGRESS STUDY
100 80 TLR events 60 40 20 0 0 30 60 90 120 150 180 210 240 270 300 330 360 days after intervention

Time of TLR

4 Months Angiography

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

PROGRESS STUDY
% MACE Mortality Q- MI (Q- mit CK or CK-MB) Non Q - MI (CK 2 x UNL) Ischemia driven TLR 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 23.8 0 0 0 15
Hospital

N

%

30-days

N

%

4-Months

N

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

Vasomotion Testing after Magnesium Stent
Baseline values
Stenosis diameteer (%) Stenosis area ( %) MLD (mm) MLA (mm²) Reference diameter (mm) Reference area (mm²) Vessel segment length(mm) Stenosis length (mm) 39.1 62.9 1.67 2.19 2.74 5.90 27.1 13.5

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

Vasomotion Testing after Magnesium Stent
Acetylcholine testing
Stenosis diameter (%) Stenosis area (%) MLD (mm) 56.4 81.0 1.16

MLA (mm²) Reference diameter (mm) Reference area (mm²) Vessel segment length (mm) Stenosis length (mm)

1.06 2.67 5.59 25.3 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

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