new stent technology: magnesium-alloy
TRANSCRIPT
New stent technologyMagnesium-alloy
The Progress-AMS StudyRaimund Erbel,
M Haude, Th Konorza, D BoeseDepartment of Cardiology
West-German Heart Center EssenUniversity Duisburg-Essen
Erbel et al., Lancet 2007;369(9576):1869-75
• 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
• Design• Prospective, multi-center, consecutive, non-
randomized FIM (First In Man – coronary) study
MACE rate after 4 months <30 % comparable to BMS • Hypotheses
Clinical Performance and Angiographic Results of the Coronary Stenting with Absorbable Metal Stents The PROGRESS-AMS Study
Erbel et al., Lancet 2007;369(9576):1869-75
PROGRESS STUDYPrincipal Investigator Raimund Erbel, MD, Essen, Germany
Co-Chairman Ron Waksman, MD, Washington, USA
Raimund Erbel, MD, Essen, GermanySteering 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, IsraelIVUS 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
• 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
PROGRESS STUDYProcedure Details
Erbel et al., Lancet 2007;369(9576):1869-75
PROGRESS Study Protocol
Screening
Treat-ment
1 dpost
1 m post ± 7 d
4 m post ± 1 w
6 m post ± 2 w
12 m post± 4 w
Clinical follow-up X X X X X X
CK (CK-MB)/ Troponin I X X
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
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
PROGRESS STUDY
Erbel et al., Lancet 2007;369(9576):1869-75
PROGRESS Study
0,0 0,5 1,0 1,5 2,0 2,5 3,0 3,5 4,0
100
80
60
40
20
0
MLD [mm]
MLD:1,05 ± 0,38
MLD stent:2,47 ± 0,37
Gain:1,41 ± 0,46
Cum
ultiv
e di
strib
utio
n %
Erbel et al., Lancet 2007;369(9576):1869-75
Magnet Resonance Imaging of AMS The MRI compatible Stent
Magnetom, (Sonata, 1.5 T, Siemens)
Eggebrecht et al Circulation 112, 303 – 4, 2005
• optimal vessel imaging• no stent artefacts,• AMS not visible
Computed Tomography 16 MSCT: AMS Stent
A B
C D
Lind et al Heart 91:1604, 2005
bms- stent
AMS Stent
AMS StentBMS Stent
Mg-Stent bare metal stent
1 mm
Micro CT of AMS and BMS
Malyar et al 2006
After AMS Stent implantation
after 18 days
Acute result
Erbel et al JACC 2005
GIRO 065-001 C-R
Absorbable Metal Stent (AMS)
0,0 0,5 1,0 1,5 2,0 2,5 3,0 3,5 4,0
100
80
60
40
20
0
MLD [mm]
MLDstent:2,47 ± 0,37
MLDf/u:1,34 ± 0,49
Loss:1,08 ± 0,49
cum
ulat
ive
dist
ribut
ion
%
Erbel et al., Lancet 2007;369(9576):1869-75
QCA AnalysisParameter before after 4 - Months
Ref MLD/mm 2.76 2.67 ± 0.47 ± 0.46MLD/mm 1.05 2.47 1.34 ± 0.38 ± 0.37 ± 0.49Acute gain/mm 1.41 ± 0.46
Late loss/mm 1.08 ± 0.49D % Stenosis 62 13 48 ± 13 ± 6 ± 17
Erbel et al., Lancet 2007;369(9576):1869-75
Time of TLR
0
20
40
60
80
100
0 30 60 90 120 150 180 210 240 270 300 330 360
days after intervention
TLR
eve
nts
PROGRESS STUDY
4 Months Angiography
Erbel et al., Lancet 2007;369(9576):1869-75
% N % N % N
MACE Mortality 0 0 0 0 0 0
Q- MI (Q- mit CK or CK-MB)
0 0 0 0 0 0
Non Q - MI (CK 2 x UNL)
0 0 0 0 0 0
Ischemia driven TLR
0 0 0 0 23.8 15
Hospital 30-days 4-Months
PROGRESS STUDY
Erbel et al., Lancet 2007;369(9576):1869-75
17
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
Baseline values
Vasomotion Testing after Magnesium Stent
Erbel et al., Lancet 2007;369(9576):1869-75
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
Acetylcholine testing
Vasomotion Testing after Magnesium Stent
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