Progress - AMS Study Erbel

8/14/2019 Progress - AMS Study Erbel

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New stent technology

Magnesium-alloyThe Progress-AMS Study

Raimund Erbel,

M Haude, Th Konorza, D BoeseDepartment of Cardiology

West-German Heart Center Essen

University Duisburg-Essen

www.wdhz.de

[email protected]

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

http://www.wdhz.de/

http://www.wdhz.de/



• Purpose• To evaluate the clinical feasibility of an

absorbable metal stent in the treatment of a single de novo lesion in a native coronaryartery

• 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




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, USAQCA Core laboratory Cardialysis, Rotterdam, The Netherlands

Data Coordinating Ron Waksman, MD, Washington, USA

Study Coordination Stefan Wagner, PhD, Erlangen, Germany




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




• 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 STUDY Procedure Details




PROGRESSStudy Protocol

Screening

Treat-ment

1 dpost

1 mpost

± 7 d

4 mpost

± 1 w

6 mpost

± 2 w

12 mpost

± 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 kineticsErbel 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




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

Cumulti v

edistribution

%




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 Tomography16 MSCT: AMS Stent

A B

C D

Lind et al Heart 91:1604, 2005

bms-

stent

AMS

Stent

AMS Stent

BMS 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 JACC2005

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

cumulat iv

edistribution

%






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

T L R e

v e n t s

PROGRESS STUDY

4 Months Angiography




% 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 xUNL)

0 0 0 0 0 0

Ischemia

driven TLR

0 0 0 0 23.8 15

Hospital 30-days 4-Months

PROGRESS STUDY




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 afterMagnesium Stent




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 afterMagnesium Stent




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 Dr ug elution and AMS

delayed degradation – Dream concept*

* Please listen to R Waksman in the next session, room 6

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Progress - AMS Study Erbel