absorbable metal stent, clinical update and dreams ... · courtesy of dr miles dalby royal brompton...
TRANSCRIPT
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Absorbable Metal Stent, Clinical Update and DREAMS: Concept and preclinical Data
Ron Waksman, MDRon Waksman, MDProfessor of Medicine (Cardiology) Georgetown University,Professor of Medicine (Cardiology) Georgetown University,
Associate Director Division of CardiologyAssociate Director Division of Cardiology
Washington Hospital Center Washington DCWashington Hospital Center Washington DC
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Complete occlusion of the left pulmonary artery after de-banding and closure of the arterial duct with a clip (the device with three markers is for calibration purposes)
Peter Zartner, M. D., Pediatric CardiologyUniversity of Erlangen-Nuremberg, Germany
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3Peter Zartner, M. D., Pediatric CardiologyUniversity of Erlangen-Nuremberg, Germany
Crossing the stenosis with a guide wire angiography revealed reperfusion
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4Peter Zartner, M. D., Pediatric CardiologyUniversity of Erlangen-Nuremberg, Germany
Implantation procedure of Mg Stent 3.0/10mm with a contrast filled balloon catheter
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5Peter Zartner, M. D., Pediatric CardiologyUniversity of Erlangen-Nuremberg, Germany
At one week follow up after Mg Stent the left lung was reperfused
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Different to permanent stents: • Leaves no stent behind long-term (no chronic
inflammation, no long-term impact on local vasomotion)
• No “Full metal jacket” makes later treatments of the same segment easier (e.g., surgical bypass)
• MRI / CT compatibility (allows non-invasive follow-ups)
• Potentially: no late stent thrombosis and no need for prolonged antiplatelet therapy
Why bio-absorbable stents?
Provides stent scaffolding and radial strength properties as long as needed to ensure an open lumen - same as a permanent stent
AND
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Absorbable Metal Stent
Magnesium and the human body
Essential element for human body, involved in the synthesis of more than 300 enzymes
Physiologically occurrence: 4th most common mineral
Quantity in human body: ~ 20 g
Daily need (adult): ~ 350 mg
Quantity in the intracellular space: > 40%
BIOTRONIK AMS features
Weight of a 3.0x10mm stent: ~ 3 mg
Complete absorption: ≈ 12 weeks
Biocompatibility – BIOTRONIK Magnesium Alloy
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First generation AMS device (AMS 1)
Available sizes
• Diameter: 3.0 and 3.5mm
• Length: 10mm and 15 mm
Magnesium alloy device• Weight of a magnesium stent: ~
3 mg• Complete absorption: several
months• High collapse pressures
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Analysis of degradation products by EDX analysis
Mg alloy beforedegradation
Conversion layer:
soft shell of Ca(PO4)2 Mg alloy after 13 days
in porcine blood
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Compatibility of AMS in MRI and multi-slice CT
Magnetom (Sonata, 1.5 T, Siemens)
• No stent artefact• Optimal vessel
lumen imaging
Dr. R. Erbel, ACC06 presentation
16 Multi Slice CT
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CT compatibility of AMS
A B
C D
Bare Metal Stent
AbsorbableMetal Stent
Lind et al, Heart 91:1604, 2005
16-row MSCT
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First in Man Coronary Study
of AMS 1: PROGRESS 1
Clinical Performance and Angiographic Results of the Coronary Stenting with Absorbable Metal Stents
Principal Investigator: Prof. Raimund Erbel
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PROGRESS AMS 1
Purpose To evaluate the clinical feasibility of the 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
Patients The study included 63 patients at 8 international clinical sites
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PROGRESS: Clinical Results
MACE MACE 0 00 0 15 23.815 23.8 2 3.32 3.3 17 27.917 27.9
DeathDeath 0 00 0 0 00 0 0 00 0 0 00 0
Myocardial Myocardial InfarctionInfarction
0 00 0 0 00 0 0 00 0 0 00 0
Ischemic Driven Ischemic Driven TLRTLR
0 00 0 15 23.815 23.8 2 3.32 3.3 17 27.917 27.9
In In HospitalHospital
N %N %
4 4 MonthsMonthsN %N %
44--12 12 MonthsMonthsN %N %
12 12 MonthsMonthsN %N %
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15
0
20
40
60
80
100
0 30 60 90 120 150 180 210 240 270 300 330Days Post Intervention
Isch
em
ic T
LR
Occ
urr
en
ce
4-m
on
th A
NG
IO
TLR occurrence in PROGRESS 1
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NLD 014-002
Post Implantation
4 Months
28 Months
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17 17
AUS 004-001
Post Implantation
4 Months
16 Months
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0
50
100
150
200
250
300
Index 4month FU long term FU
Stent Volume
Lumen Volume
Vessel Volume
Stent CSA
IH Volume
IVUS AnalysisIVUS Analysis
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IVUS Stent VolumeIVUS Stent Volume
0
20
40
60
80
100
120
140
160
180
0 10 20 30
FU time(month)
Sten
t Vol
ume
PTID 4 1
PTID 9 2
PTID 12 5
PTID 12 7
PTID 14 2PTID 14 3
PTID 14 7
PTID 14 11
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IVUS CSA
0
1
2
3
4
5
6
7
8
9
0 10 20 30
FU time(month)
Ste
nt C
SA
PTID 4 1PTID 9 2PTID 12 5PTID 12 7PTID 14 2PTID 14 3PTID 14 7PTID 14 11
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IVUS Intimal Hyperplasia Volume
0
5
10
15
20
25
30
35
0 5 10 15 20 25 30
FU time(month)
IH V
olum
ePTID 4 1PTID 9 2PTID 12 5PTID 12 7PTID 14 2PTID 14 3PTID 14 7PTID 14 11
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pre I.S.D.N.
post I.S.D.N.
First evidence of vessel flexibility in AMS stented area by angio pre/post nitroglycerin
GRB009-007RCA, Ø3.0
asyptomatic TLR at 4 months FU
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-10
0
10
20
30
40
PMS AMS PMS AMS
Stented segment
Reference segment
p = 0.0017
p = 0.3806
% c
hang
e in
cro
ss s
ectio
nal a
rea
post
ic IS
DN
Courtesy of Dr Miles DalbyRoyal Brompton & Harefield
Intracoronary ISDN induced vasodilatation in Permanent Metal Stent (PMS) control patients and Absorbable Metal Stent (AMS) patients within stent and in proximal reference segments at 4 months post implant.
Vessel Reactivity
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15 months after AMS implantation in human
Dr. Carlo di Mario, London
• Very thin neointima
• Perfect ingrowth of AMS
• Completed healing of the stented vessel
OCTIVUS
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Conclusions - PROGRESS 1
• The AMS technology is feasible (high technical and procedural success), absorption of the device as intended
• The AMS provided safety (no death, no MI, no stent thrombosis)
• The study met the primary endpoint (MACE <30%)
• Further improvement of the AMS 1 technology are needed to improve efficacy for coronary use
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Results PROGRESS 1 - IVUS
Negativeremodeling/recoil
Thickeningof extra-stenttissue
In-stentneointima
42% 13.5% 41%
Contribution to lumen loss
Post implantation4 months follow-up
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Improvement of AMS 1
AMS 1 is currently improved by ...
... prolonged mechanicalstability
Surface passivation
Modified Alloy
Improved stent design
... reduction ofneointima hyperplasia
“DREAMS” = Drug elution
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Selection trial - Stent structure after 4 weeks
AMS 1
AMS 1 alloy &New design
AMS 1 design &
New alloy
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Description of new AMS 2 device
Bare stent (no coating)
Special Magnesium alloy
Refined stent design
Stent range
Diameters: 3.0 and 3.5mm
Lengths: 10 and 15 mm
6F compatible system, RX catheter
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Combination trial - Angiography
0.0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
1.6
2 weeks 4 weeks
Late
Lum
en L
oss
(mm
), m
edia
nAMS 1AMS 2
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Combination trial-Representative histology 4 weeks
AMS 1 AMS 2
Source: R. Virmani, CVPath
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Combination trial -Representative stent structure at 2 weeks
AMS 1 AMS 2
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Combination trial -Representative stent structure at 4 weeks
AMS 1 AMS 2
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Histology 4 weeks
Source: R. Virmani, CVPath
AMS 1 AMS 2
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Stent structure at 3 month
AMS 1 AMS 2
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0
1
2
3
4
5
6
7
8
9
EEL IEL Stent Lumen Neointima
Are
a (m
m2)
AMS 1 (n=6)AMS 2 (n=7)
0
1
2
3
4
5
6
7
EEL IEL Stent Lumen Neointima
Are
a (m
m2)
AMS 1 (n=7)AMS 2 (n=7)
Combination trial - Histomorphometry
Source: R. Virmani, CVPath
p<0.01
p<0.01 p<0.01
p=0.20
p=0.77
p=0.027
p=0.034 p=0.034
p<0.01
p=0.75
2 weeks 4 weeks
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Status AMS 2 - Summary
• The optimization of both the Magnesium alloy and the stent design contribute to a longer stent integrity in animal
• The new AMS generation with increased integrity shows significantly improved efficacy in animal
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DREAMS concept
• Degradable carrier from Magnesium alloy
• Effective anti-proliferativ drug • Specialized proprietary matrix to
cope with degradation of Magnesium alloy- Non-permanent polymer - Optimized rate of drug elution
DREAMS=
DRug Eluting AMS
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Stent: Stent: Bioabsorbable
Magnesium AlloyDiscrete Drug
Delivery Reservoirs
Drug:Drug:
Carrier:Carrier:Bioresorbable Matrix
DREAMS DRUG-Eluting Stent System
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Brachytherapy and AMS - Study design
Domestic Pigs Domestic Pigs
24 Gy beta radiation 24 Gy beta radiation
AMS 1 stent implantation AMS 1 stent implantation
AMS 1 stent implantationAMS 1 stent implantation
Vision stent implantationVision stent implantation
SacrificeSacrifice
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Brachytherapy and AMS - Histopathology
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Brachytherapy and AMS - representative images
Vision AMS 1 AMS 1 + VBT
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AMS program
AMS 1
AMS 3Drug-eluting AMS (DREAMS) incl. surface passivation and X-ray markers
AMS 2Improved mechanical integrity by modified alloy and improved stent design
First clinical experience:AMS is “safe”
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• Safe in human coronaries
• Safe in peripheral arteries (tibial)
• Absorbed as intended < 90 days
• Fully compatible with CT or MRI angiography
• Restenosis mainly due to early recoil and neointima formation
• New Generations AMS under preclinical testing
• Resume Clinical testing to be announces
Status of AMS 2007
Thank You Thank You Thank You