New stent technologyMagnesium-alloy

The Progress-AMS StudyRaimund Erbel,

M Haude, Th Konorza, D BoeseDepartment of Cardiology

West-German Heart Center EssenUniversity Duisburg-Essen

www.wdhz.deerbel@uk-essen.de

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 STUDY

Principal 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

Cu

mu

ltiv

e d

istr

ibu

tio

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 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 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

ula

tive

dis

trib

uti

on

%

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

QCA Analysis

Parameter before after 4 - Months

Ref MLD/mm 2.76 2.67 ± 0.47 ± 0.46

MLD/mm 1.05 2.47 1.34 ± 0.38 ± 0.37 ± 0.49

Acute gain/mm 1.41 ± 0.46

Late loss/mm 1.08 ± 0.49

D % 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

TL

R e

ven

tsPROGRESS 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