1. Le retour des stents auto-expansibles ?
Didier CARRIE
CHU TOULOUSE RANGUEIL
High Tech Marseille
Jeudi 26 Janvier 2012
Aucun conflit d’intérêt

2. 1986 : 1ère implantation de stent coronaire Jacques Puel
WALLSTENT IVA PROXIMALE

3. POURQUOI CE RETOUR 25 ANS APRES ?
MEILLEURE CONNAISSANCE DU VAISSEAU
MALAPPOSITION
THROMBOSE INTRASTENT

4. DE LA PLAQUE D ’ATHEROSCLEROSE
EVOLUTION
DE LA PLAQUE D ’ATHEROSCLEROSE
REMODELAGE VASCULAIRE
Surface de la lumière longtemps conservée, tant que la surface de la plaque est < 40% de la surface totale de la paroi vasculaire
Défaut de remodelage accidents aigus
Glagov NEJM 87; Mc Pherson 86-92

5. Risque : sous dimensionner le stent dans le SCA
Le vasospasme comme conséquence des STEMI
IRA-proximal
IRA-distal 4
3.48*
3.15
Diamètre coronaire (mm)
2.42* 2
1.96
*: p<0.05 vs basal
Basal
(+nitrés)
Après stent
a-bloqueurs
IRA : Infarct related artery
Risque : sous dimensionner le stent dans le SCA
Gregorini et al. Circulation 1999;99:482

6. Pôle Cardiovasculaire et Métabolique
Cook S, Circulation 2007
Pôle Cardiovasculaire et Métabolique

7. Predictors of stent thrombosis (ACS/STEMI)
Van Werkum JW, JACC 2009

8. Pôle Cardiovasculaire et Métabolique
Concept
Self-expanding, Self apposing Nitinol stent which can increase in size after implantation
Reduce acute and acquired malapposition
Minimize embolization and no-reflow by avoiding aggressive post dilatation
Pôle Cardiovasculaire et Métabolique

9. Radial force
Data on Stentys files

10. SITUATIONS ANATOMIQUES POTENTIELLEMENT FAVORABLES ?
Syndrome Coronaire Aigu ST+ (thrombus)
Incongruence Artérielle ou veineuse
Bifurcation

11. Background: stent sizing dilemma in STEMI
3.0? 3.5?
3.0
3.5
Malapposition
Underexpansion
Overdilation
Stent
thrombosis
No reflow
Restenosis
Dissection/ Perforation

12. Pôle Cardiovasculaire et Métabolique
OCT à 9mois
Gonzalo et al Jacc Intervention 2009
Pôle Cardiovasculaire et Métabolique

13. STENTYS Clinical Proof
Study
Indication
Stent
Follow-up
# patients
MACE
OPEN I
Bifurcation
DES
6 months 27
3.7%
APPOSITION I & II
STEMI
BMS
12 months 68
8.8%
APPOSITION III
BMS/ DES
30 days, interim
600
3.8% all patients,
2.4% Cohort B*
* In Cohort B (N=210), post dilatation was generally recommended, at low pressures
OPEN I: S. Verheye et al., Eurointervention 2011;7:
APPOSITION I & II – 12 month results presented at TCT 2011 by S. IJsselmuiden
APPOSITION III – interim 30 day results presented at TCT 2011 by K.T. Koch

14. APPOSITION I
DESIGN: Prospective, non-randomized, single-arm, multi-center feasibility study
OBJECTIVE: To evaluate the safety and efficacy of the STENTYS® stent in AMI
ENDPOINTS:
Stent apposition and expansion at 3 days
MACE at discharge and at 30 days
Independent monitoring: Medpass
Core lab: Cardialysis
Statistical analysis: INSERM U970 (Paris);
Prof. J.P. Tijssen (Amsterdam)
25 patients enrolled between March 2009 and October 2009 in 5 European clinical sites
25 patients with STENTYS® stent
Angiographic and IVUS follow-up at 6 months
IVUS at 0 and 3 days
Clinical follow-up at 30 days
Post-PCI IVUS image of a STENTYS stent in AMI patient
IVUS image 3 days after procedure in this patient: 19% increase in reference lumen area
Results: IVUS at baseline and 3 days
Mean Reference area (distal) (mm²)
+19%
Mean Stent area (mm²)
+18%
Mean Lumen area (mm²)
+17%
Minimum Lumen area (mm²)
p<0.02
G. Amoroso et al. EuroIntervention 2011;7:

15. Pôle Cardiovasculaire et Métabolique
20% lumen area increase
At implantation
3 day follow-up
Pôle Cardiovasculaire et Métabolique

16. Pôle Cardiovasculaire et Métabolique
Evolution over time
Baseline
6 months
2 years
Pôle Cardiovasculaire et Métabolique

17. Long term expansion by IVUS
Stabilization of stent expansion below unconstrained diameter (6.5mm)
+25%
+3%
Mean stent diameter
Time
Pôle Cardiovasculaire et Métabolique

18. APPOSITION II
DESIGN: International, prospective, randomized, two-arm multi-center trial
OBJECTIVE: To compare the STENTYS® Stent with balloon-expandable stents in AMI
ENDPOINTS:
Stent strut apposition and expansion at 3 days (measured by OCT)
days and 6 months
Independent monitoring: Genae
Core Lab: Cardialysis
80 STEMI patients enrolled between 12/09 and 06/10 in 9 European centerssites
STENTYS® stent
Clinical follow-up at 30 days and 6 months
Invasive follow-up at 3 days (QCA, OCT)
VISION / Driver
p<0.001
Balloon-expandable Stent - Day 3
STENTYS® Stent – Day 3
Patients with Stent Malapposition
Presented by R.J. van Geuns & S.Verheye at TCT 2010
* Stent Malapposition defined as more than 5% of struts malapposed under OCT.

19. STENTYS® Coronary Stent
Balloon vs Self-expanding
Day 0
Day 3
Balloon-expandable stent
STENTYS® Coronary Stent

20. Optical Coherence Tomography
Stentys
n=40
Control
n=36
P Value
Post-PCI
Mean Lumen area (mm2)
7.88 ± 2.32
8.92 ± 2.22 NS
Mean Stent area (mm2)
7.57 ± 2.29
8.95 ± 2.38
Stent volume (mm3)
191 ± 65
210 ± 83
3 days follow-up
8.99 ± 2.39
8.81 ± 2.18
9.02 ± 2.36
8.76 ± 2.26
228 ± 72
206 ± 86
15% increase 20

21. APPOSITION III
DESIGN: Prospective, non-randomized, single-arm, multi-center trial
OBJECTIVE: To evaluate the safety and performance of the STENTYS stent in routine clinical practice in a large population of STEMI patients
PRIMARY ENDPOINT:
MACE at 12 months
SECONDARY ENDPOINTS:
MACE at 30 days and 24 months
PROCEDURAL GUIDELINES on post-dilatation:
Cohort A: only when residual stenosis > 30%
Cohort B: recommended, at low pressures
1000 patients to be enrolled in 40 European clinical sites
600 patients enrolled to date
Cohort A: 390 patients
Cohort B: 210 patients
Clinical follow-up at 30 days
Interim analysis
Interim results: MACE at 30 days
All patients
(N=600)
Cohort B (N=210)
Death
0.8%
0.9%
Re-AMI
1.5%
1.0%
Clinically-driven TLR
0.5%
Total
3.8%
2.4%
MACE at 30 days in STEMI trials
Interim results presented at TCT 2011 by K. Koch

22. APPOSITION IV Study Design
DESIGN Prospective, randomized, two- arm multi-center study
OBJECTIVE To compare the endothelization of the STENTYS® DES with a balloon- expandable DES in AMI
ENDPOINTS
% of uncovered struts at 4 & 9 months
MACE up to 12 months
60 STEMI patients
STENTYS® DES stent
Conventional DES stent
Time need for endotheliazation
OCT & QCA at & 9 months months
Clinical FU at months 22

23. SITUATIONS ANATOMIQUES POTENTIELLEMENT FAVORABLES ?
Syndrome Coronaire Aigu ST+ (thrombus)
Incongruence Artérielle ou veineuse
Bifurcation

24. Pôle Cardiovasculaire et Métabolique
Courtesy of Dr Souteyrand (Clermont-Ferrand)
Pôle Cardiovasculaire et Métabolique

25. SITUATIONS ANATOMIQUES POTENTIELLEMENT FAVORABLES ?
Syndrome Coronaire Aigu ST+ (thrombus)
Incongruence Artérielle ou veineuse
Bifurcation

26. SELF-EXPANDING STENT PLATFORM
DEDICATED BIFURCATION STENT
Conical shape
Does no cover the carina itself
SELF EXPANDING STENT
Nitinol platform
Excellent wall apposition
Spans both vessels at the same time
Two models:
Reference diameter 3.0 ± 0.25 mm
Max*. proximal stent diameter = 3.75 mm
Max*. distal stent diameter = 6.00 mm
Reference diameter 3.5 ± 0.25 mm
Max*. proximal stent diameter = 4.25 mm
Max*. distal stent diameter = 6.50 mm
Lengths 11 and 14 mm

27. The Axxess™ stent implantation sequence
Two wires 1
Position 2
Deploy partially at carina 3
Advance 4 4
Deploy 5
Sheath off 6
Simulations
Simulations

28. Biolimus A9TM / Abluminal Biodegradable Polymer Bifurcation DES Axxess™ Clinical Program
AXXESS PLUS
N=139
DIVERGE
N=302
AXXENT
N=33
France and Germany
Pilot study using bare metal stent Axxess Platform
In-segment restenosis at 6 months
6 month follow-up completed, study completed
Europe, Brazil and New Zealand
FIM Safety and performance evaluation of Axxess DES
In-stent late loss at 6 months
5 year follow-up completed, study completed
Europe, Australia and New Zealand
Evaluated best practices from AXXESS PLUS
MACE1 at 9 months
3 year follow-up available, follow-up planned up to 5 years
Europe
Pilot study for Axxess Left Main DES
MACE2 at 6 months
12 month follow-up available, study completed
COBRA3
N=40
Randomized multicenter trial to compare Axxess DES along with BioMatrix Flex™ with Cullotte technique using Xience V®
Stent strut coverage assessed by OCT at 9 months
Enrolling

29. DIVERGE - MACE Components 3-year Outcomes
Death MI
id-TLR
Agostoni P., oral presentation, EuroPCR 2011
Any In-segment bifurcation restenosis:
6.4% (9/140 at 9 months)1,2
Verheye S. et al, J Am Coll Cardiol, 2009
Verheye S. et al, oral presentation, TCT 2009
Pôle Cardiovasculaire et Métabolique

30. DIVERGE - Stent Thrombosis up to 3 Years
Protocol
ARC
Definite*
Probable
Possible
Acute
(In-hospital)
Subacute
(30 days)
0.7%
Late
(>30 days - 1 year)
0.3%§
Very Late
(1 year - 3 years)
1.0%
2.4%
Pôle Cardiovasculaire et Métabolique

31. Pôle Cardiovasculaire et Métabolique
CONCLUSION
Balloon-expandable stents’ efficacy may be limited by :
- Mal apposition
- Over expansion
- Side branch occlusion
Stentys® and Axxess self-apposing stents for STEMI and Bifurcation have been proven :
To be feasible
To be safe
To be effective ?
Pôle Cardiovasculaire et Métabolique

32. Strut Width
Data on Stentys files