progress-ams-mld, mm 1.4 ±0.5 - mld post ( mm ) 2.5 ±0.4 - % d stenosis post ams 12.4 ±5.6 - late...
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Clinical Performance and Angiographic Results of the Coronary Stenting with Absorbable Metal Stents
The PROGRESS-AMS Study
Jacques Koolen MD PhD FSCAI
R. Erbel, J.J.R.M. Bonnier, J.J. Koolen, C. Di Mario, C. Ilsley, B. De Bruyne, W. Wijns, M. Horrigan, F. Eberli, T. Lüscher, P. Erne, R. Waksman,
For the PROGRESS-AMS investigators group
PROGRESS-AMS
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Background• Coronary stent implantation provides- excellent vessel wall scaffolding- prevents coronary dissection- blocks elastic recoil- reduces restenosis rate
but- means permanent foreign body- limits further revascularization- reduces vasomotion with DES- limited use in children
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Mg-Stent Metall-Stent
1 mm
Mikro CT of AMS and BMS
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• 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 efficacy• Hypothesis
Clinical Performance and Angiographic Results of the Coronary Stenting with Absorbable Metal Stents
The PROGRESS-AMS Study
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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, NLMartial Hamon, MD, Caen, FranceRafael Beyar, MD, Haifa, Israel
IVUS Core laboratory Neil J. Weissman, MD, Washington, USA
QCA Core laboratory Cardialysis, The Netherlands
Data Coordinating Ron Waksman, MD, Washington, USA
Study Coordination Stefan Wagner, PhD, Erlangen, Germany
Unrestricted Grant Biotronik, Berlin Germany
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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 J Koolen, H Bonnier, Eindhoven
Switzerland F Eberli & T Lüscher, Zurich, CHP Erne, Luzern, CH
UK C Di Mario & C Ilsley, London, UK
USA R Waksman, Washington, USA
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PROGRESS STUDY
• Primary Hypothesisto demonstrate feasibility and safety being in the range of currently available stent systems with MACE rate after 4 months <30 % (max. 18 events) comparable to BMS efficacy
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Major Adverse Cardiac Events at 4 M
defined as– cardiac death– nonfatal myocardial infarction– ischemia driven TLR
PROGRESS STUDYprimary endpoint
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PROGRESS STUDYInclusion Criteria
• patient ≥ 18 years of age• ischemia (stable or unstable angina, or
a positive stress test)• single de novo lesion in native vessels • 3.0 to 3.5 mm reference diameter • < 15 mm lesion length• ≥ 50% and < 100% diameter stenosis• normal CK / CK-MB / troponin I
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• 75-100 mg of Aspirin • 300 mg of clopidogrel
75 mg for at least 6 months • heparin• GP-IIb/IIIa Inhibitor at the physician's discretion
PROGRESS Study Medication
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• essential mineral ~ 350 mg/day• Mg body content 20 g• antiarrhythmic properties• calcium antagonist properties• positive effects in AMI (meta analysis)• reduction of restenosis (single study)• no allergyB Heublein, et al.EHJ 21: 286, 2000
Heublein B et al Heart 89: 651 – 6, 2003
Why magnesium as absorbable material?
3 – 4.5 mg Mg
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Light Microscopy
Scanning Electron Microscopy
Absorbable Metal StentMg Alloy~ 93 % magnesium,
and 7 % rare earthsrapid neoendothelialisationlow thrombogeneity2 months degradation time
Heublein B et al Heart 89: 651 – 6, 2003
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• 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, because the AMS
fluoroscopically not visible• angiogram/IVUS before and after implantation
PROGRESS STUDYProcedure Details
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PROGRESS Study Protocol
X
6 m post± 2 w
XXXMRI (subgr.)*
XXIVUS
XXQCA
XXCK (CK-MB)/ Troponin I
XXXXXClinical follow-up
12 m post± 4 w
4 m post± 1 w
1 m post± 7 d
1 dpost
Treat-ment
Screening
*MRI for analysis of degradation kinetics
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1/631.6• Prior CVA, % (n)6/639.5• Unstable Angina, % (n)26/6341.3• Prior MI, % (n)
3/634.8• Insulin dependent, % (n)
15/63
41/6339/6330/63
11/6344/6369.8• Males, % (n)
23.8• Prior PCI, % (n)
65.1• Hypertension , % (n)61.9• Hypercholesterolemia, % (n)47.6• Smoking History, % (n)
17.4• Diabetes, % (n)
61.3 ± 9.5 • Age, yrs
PROGRESS STUDYN = 63
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n%Lesion Location
0/6340/6323/6318/6322/6323/630/63
36.5Discrete* (<10mm in length)63.5Tubular* (10 -15 mm )
0Diffuse* (>20 mm in length)
28.6LCX34.9LAD36.5RCA
0Left Main
PROGRESS STUDY
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16 ± 0.9- AMS pressure, atm
42/6367 %- post dilatation16 ± 3.9- post dilatation pressure, atm
nPCI Procedure Characteristics
8/63
63/63
13 % 1.1 ± 0.3
- 2nd stent - average stent number
9 ± 2.1– pressure (8 atm, 20 sec)
100 %- pre dilatation
PROGRESS STUDY
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Magnetic Resonance Imaging of AMSthe MRI compatible stent
Magnetom, (Sonata, 1.5 T, Siemens)
Eggebrecht et al Circulation 112, 303 – 4, 2005
• no stent artifact,• AMS not visible• optimal vessel
lumen imaging
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Computed Tomography16 MSCT AMS: the invisible stent
A B
C D
Lind et al Heart 91:1604, 2005
BareMetal Stent
Ab-sorbableMetal Stent
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27/6342.9Type B1, %
n%Lesion Classification
0/63
5/63
31/63
0Type C, %
7.9Type B2, %
49.2Type A, %
PROGRESS STUDY
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3/8 (37.5)- lesion not covered 1st stent1/8 (12.5)- suboptimal result2/8 (25.0)- others
Indication for Second Stent Implantation
2/8 (25.0)- dissection of type D, E or F
0/8 (0)- dissection of type A or B
PROGRESS STUDY
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QCA Analysis
Parameter before after 4 - month FU
Ref MLD/mm 2.76 2.66 ± 0.47 ± 0.46
MLD/mm 1.05 2.46 1.37± 0.38 0.37 0.52
Acute Gain/mm 1.45± 0.45
Late loss/mm 1.09± 0.51
D % Stenosis 62 12 48± 13 6 17
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31//57 (54.4%)- binary restenosis (%)1.4 ± 0.5- MLD, mm
2.5 ± 0.4- MLD POST ( mm )12.4 ± 5.6 - % D stenosis post AMS
1.1 ± 0.5- late lumen loss, mm
48.2 ± 17.2- % D stenosisN = 57 lesionsFOLLOW-UP at 4 months
N = 60 lesionsQCA Parameters
PROGRESS STUDY
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Post Intervention
Follow-Up (18 days)
GIRO 065-001 C-R
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23.8
0
00
%
15
0
00
n
0
0
00
%
0
0
00
n
0
0
00
n
0Q-wave MI (Q-waves with CK or CK-MB)
0Non Q wave MI (CK 2 times UNL)
0Ischemic Driven TLR
%
0DeathMACE
In Hospital 30-days 4-months
PROGRESS STUDY
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Time of TLR
0
20
40
60
80
100
0 30 60 90 120 150 180 210 240 270 300 330
Days Post Intervention
TLR
Occ
uren
cePROGRESS STUDY
4 FU angiography
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54.4% • Binary Restenosis
100%• Device Success
38.1% • TVR at 4 months38.1% • TLR at 4 months
48.2 ± 17.2• % D stenosis at 4 months1.1 ± 0.5• Late Loss (stent) at 4 months
100%• Procedural Success
Secondary Endpoints
23.8% (15/63)MACE at 4 months
PROGRESS STUDYPrimary Endpoint
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Volumetric IVUS analysis
StentedStentedsegmentsegment
DistalDistalEdgeEdge(5mm)(5mm)
ProximalProximalEdgeEdge(5mm)(5mm)
analysis in-stentanalysis ofproximal edge
analysis ofdistal edge
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-50
-45
-40
-35
-30
-25
-20
-15
-10
-5
0Vessel Stent Lumen
(mm
3 )
19±45 24
±32
45±40
Change in Volumetric IVUS Change in Volumetric IVUS parameters (Paired analysis)parameters (Paired analysis)
P=0.03 P<0.001 P<0.001
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0
25
50
% in-stent net volume obstruction
%
% In% In--stent net volume obstructionstent net volume obstruction
20.1±14.7
P<0.001
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0
25
50
% in-stent net volume obstruction
%
ControlTAXUS
% In% In--stent net volume obstructionstent net volume obstructionReduced in TAXUSReduced in TAXUS
29.4±14.0
12.2±12.4
P<0.001
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PROGRESS STUDY
Conclusions:
• PROGRESS met the primary endpoint• high technical and procedural success• AMS compatible for MRT and CT for FU• No stent thrombosis• IVUS detected degradation at 4 months• iTLR rate comparable to BMS
DES properties and/ or moredelayed degradation necessary
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PROGRESS: conclusions PROGRESS: conclusions The FIM coronary study showed:The FIM coronary study showed:
•• FeasibilityFeasibility
•• Safety: no death, no MI, no stent thrombosisSafety: no death, no MI, no stent thrombosis
•• The study met the primary endpoint < 30% of MACEThe study met the primary endpoint < 30% of MACE
•• The AMS technology platform is proven The AMS technology platform is proven
•• Was successfully delivered to the lesion (100% device Was successfully delivered to the lesion (100% device success)success)
•• Was MRI / CT compatibleWas MRI / CT compatible
•• Was absorbed as intendedWas absorbed as intended
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Absorbable Metal Stent Platform:
• Fully absorbable platform
• Proven biocompatibility throughout the entire absorption process*
• Effective scaffolding properties**
* = Animal data available at Biotronik / ** = In vitro data available at Biotronik
Controlled Drug Eluting Stent Design:
• Precise drug release kinetic and direction
• Resorbable polymer with minimal tissue/polymer contact area
• Protected non-deforming reservoirs
Outlook - Drug eluting
absorbable metal stent
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Bioabsorbable Stents Future Directions
Main challenges• Rate of degradation• Time to complete degradation• Radial force and elimination of recoil• Bioabsorbable DESFuture Applications• Coronary, Workhorse stent Vulnerable Plaque• Peripheral, SFA, tibial• Pediatric pulmonary coarctation of aorta
biliary, etc.