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JOSE F. DIAZ
JUAN RAMON JIMENEZ UNIVERSITY HOSPITAL
HUELVA, SPAIN
Self-Apposing® coronary stents: Do they make a difference?
Overdilation
DissectionPerforation
No reflow
MalappositionUnderexpansion
Stentthrombosis Restenosis
3.5 4.5
How important is stent sizing ?
Limitations of current stent technology
• Tubular shape does not fully conform to variable lumen geometry
• Large size differences cannot be accommodated
• Maximum lumen size achieved at implantation
• Size mismatch in primary PCI
• High pressure post dilatation
STENTYS Self-Apposing® Stent
Disconnectableinterconnector
DisconnectionDisconnectorsalong the stent
• Self-expanding nitinol stent deployed by retracting a sheath (no balloon)
• Bare or Paclitaxel-eluting with biostable polymer
• 6 French, single-wire, rapid exchange
• Disconnecting struts for side-branch access
Stent Strut
5 – 8 µm
Abluminal
Polymer Polysulfone, well proven hemocompatible, non inflammatory, and non thrombogenicalso used in dialysis and bone replacement indications
Excipient Polyvinylpyrrolidone(PVP) originally used as blood plasma substitute
2 – 5 µm
DrugSirolimus, mixed into the polymer with the excipient (1.4µg/mm²), is then released as excipient dissolves
Upon activation the Polymer forms a smooth non thrombogenic surface and remains biostable
Sirolimus Elution from a biostable polymer
Technical Specifications
1. Data held on file.
Radial Force Foreshortening Recoil
Cell Area
Size selection
* At the vessel size boundaries, it is recommended to choose the smaller size.
SizeLength in
vessel (mm)Indicated Vessel
Diameter
Maximum Vessel
Diameter
Side-BranchDiameter (mm)
Small
17
~2.5 to 3.0mm 4.0mm >2.2022
27
Medium
17
~3.0 to 3.5mm 5.0mm >2.2522
27
Large
17
~3.5 to 4.5mm 6.0mm >2.5022
27
STENTYS stent designed for perfect apposition in coronary anatomies with diameter discrepancy
Smaller Diameter
(tapering)
Enlarged Diameter
(aneurysm)
Large vessels
CE Mark indications
Ectatic vesselsBy-pass grafts Tapering vessels
BifurcationAcute Coronary Syndrome
New indications
Currently under “Investigational Device Exemption” trial in the United States
Not for sale in the United States
Primary angioplasty (anterior MI)
58 year-old male
smoker, hypertensive
Thrombus-containing
lesion
12
LM
LAD
13
thrombectomy
Thrombus unchanged
4.5-3.5x27 self-expanding DES
3x15 NC balloon
4x15 NC balloon
result
LAD
LM
Perfect apposition
LAD
CX
CX
LM
STENTYS Clinical ProgramAPPOSITION (STEMI)
IFeasibility trial: Single Arm – STENTYS BMS (N=25)
3 day and 6 month QCA and IVUS
IIRandomized trial: STENTYS BMS vs ABBOTT VISION/Medtronic Driver (N=80)
3 day QCA and OCT, 6 month clinical
III“Real life” study: Single arm – STENTYS BMS & DES (N=1000)
30 day and 12, 24 month MACE
IVRandomized trial: STENTYS Sirolimus DES(S) vs Medtronic Resolute (N=150)
4 or 9 month OCT
VIDE - Randomized trial: STENTYS BMS vs ABBOTT Multi-link (N=880)
12 month TVF, IVUS/OCT sub-study – ENROLLMENT IN PROGRESS
OPEN (Bifurcation)
IFeasibility trial: Single Arm – STENTYS BMS & DES (N=60)
6 month QCA and IVUS
II“Real life” study: Single Arm – STENTYS DES (N=200)
6 month MACE, OCT sub-group
ADEPT (SVG)
SVGRandomized trial: STENTYS BMS vs STENTYS DES (N=80)
6 months QCA – late loss – ENROLLMENT IN PROGRESS
All-comers
SIZINGAll-comers registry: STENTYS BMS & DES in ACS (STEMI, NSTEMI) and stable patients (bifurcation, ectatic, tapered, aneurysm, SVG) (N=3000) – ENROLLMENT IN PROGRESS
STEMI program
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: MedpassCore lab: CardialysisStatistical 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) +19%
p<0.02
G. Amoroso et al. EuroIntervention 2011;7:428-436
• 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)‒ MACE @30 days and 6 months
Independent monitoring: GenaeCore Lab: Cardialysis
80 STEMI patients enrolled between 12/09 and 06/10 in 9 European sites
STENTYS® stent
Clinical follow-up at 30 days and 6 months
Invasive follow-up at 3 days (QCA, OCT)
VISION / Driver
Balloon-expandable Stent - Day 3 STENTYS® Stent – Day 3
APPOSITION II
0%
28%
0%
10%
20%
30%STENTYS
Controlp<0.001
Patients with Stent Malapposition
J Am Coll Cardiol Intv. 2012;5(12):1209-1219
APPOSITION III
24
• DESIGN: Prospective, non-randomized, single-arm, multi-center study
• OBJECTIVE: Evaluate safety and performance of the STENTYS stent in routine clinical practice in 1000 STEMI patients
• ENDPOINTS:‒ MACE at 1, 12 and 24 months
(MACE defined as cardiac death, target vessel re-MI, emergent CABG, or clinically-driven TVR)
1000 patients enrolled between Jun 2010 and Feb 2012
at 50 European sites
Clinical FU in-hospital and at 1 month
Clinical FU at 1 and 2 years
30 day results presented at PCR 2012 by G. Amoroso1 year results presented at ACC.13 by G. Montalescot
Hierarchical MACE 30 days 1 year
Death 1.2% 2.0%
Re-AMI 1.0% 1.2%
Clinically driven TLR 1.3% 6.1%
Total 3.5% 9.3%
APPOSITION III: Comparative Studies
25
Cardiac Death at 1 year
Pooled analysis conducted by the ACTION Study Group on the most recent studies representing 19,767 patients since 2006
3.9%
2.0%
0%
1%
2%
3%
4%
5%
6%
7%
Importance of Post-Dilation
26
APPOSITION III – 1 year resultsPost-dilation: yes vs no
Cardiac death or TV-MI
Kaplan-Meier curves
• DESIGN: Prospective, randomized, two-arm,
multi-center study
• OBJECTIVE: To compare the endothelization of
the STENTYS SES with a balloon-expandable
DES in AMI
• ENDPOINTS:
• Late malapposition (9 months)
• Strut coverage @ 4 and 9 months
• MACE up to 12 months
150 STEMI patients
STENTYS Sirolimus
OCT & QCA at 4 months
Clinical FU at 12 months
OCT & QCA at 9 months
APPOSITION IV
27
Balloon Expandable Stent – 4 m STENTYS Stent – 4 m
31.6%
3.8%0.0%
20.0%
40.0% STENTYS
Resolute
P=0.03
Stents with all covered struts at 4 months
MEDTRONICResolute
• DESIGN: Prospective, randomized, two-arm, multi-center study (FDA-approved IDE study)
• OBJECTIVE: To prove the non-inferiority of the STENTYS BMS compared to the Abbott Multi-link Vision stent in STEMI patients
• PRIMARY ENDPOINT:‒ TVF at 12 months
• SECONDARY ENDPOINT:‒ Acute Stent Apposition (IVUS sub-study)
• PRINCIPAL INVESTIGATORS:- Maurice Buchbinder and Roxana Mehran
• STEERING COMMITTEE:‒ M.Buchbinder, D.Cutlip, M.Leon, R.Mehran,
A.Yeung, K.Koch, G. Montalescot, R.J. van Geuns
880 STEMI patients in ~60 international sites in US and worldwide
STENTYS BMS
IVUS/OCT substudy
(120 patients)
Clinical FU at 12 months
AbbottMulti-link Vision
Clinical FU at 30 days
APPOSITION V - STEMI
Enrollment terminated
Outside of STEMI
Disconnection Technology
2. Inflate balloon at low pressure
4. Wide opening to side branch
1. Wire and balloon through struts
3. Bridges disconnect
Open I
33
• DESIGN: Prospective, non-randomized, single-arm,
multi-center trial
• OBJECTIVE: To evaluate the safety and feasibility of
the STENTYS DES and BMS in bifurcated lesions
• ENDPOINTS:
• Procedural success
• MACE @ 30 days and 6 months
• Events adjudicated by CEC
• Independent monitoring: Medpass
• Core lab: Cardialysis
63 patients enrolled between September 2007 and August 2009 in 9 European clinical sites
60 patients with STENTYS stent: 33 patients with STENTYS BMS27 patients with STENTYS DES
Angiographic and IVUS follow-up at 6 months
Clinical follow-up at 30 days
Clinical follow-up at 3 months
Baseline angiogramAngiogram after treatment
of bifurcation lesion
6-month follow-up
angiogram
Results (Number of MACE after 6 months)
DES
Cardiac Death 0
Q-wave Myocardial Infarction 0
Non-Q-wave Myocardial Infarction
0
Clinically driven TLR 1
S. Verheye et al. EuroIntervention 2011;7:580-587
3 patients not stented
Open II
34
• DESIGN: Prospective, non-randomized, single-arm,
multi-center trial
• OBJECTIVE: To evaluate the long-term safety and
efficacy of the STENTYS PES stent in bifurcation
lesions in routine clinical practice.
• Primary Endpoint:
• MACE at 6 months
• Events adjudicated by CEC
• Independent monitoring: IKKF
• Principal Investigators: Dr Naber, Prof. Mudra
217 patients enrolled9 in 21 European clinical sites
4 patients outside criteria
5 patients not stented
208 patients analyzed
Clinical follow-up at 12 months
Clinical follow-up at 6 months
Results (MACE after 6 months)
Cardiac Death 0.5%
Emergent CABG 0%
Target Vessel MI 4.3%
Clinically driven TLR 5.3%
Total 10.1%
Presented by Dr C. Naber at TCT 2013
Predilatation: 2.5x20 mm
3x23 Biolimus DES (overlapping)
Prox-LAD
Stentys
Septal
Diagonal
2nd-septal
overlap
Biolimus DES
ADEPT - SVG
52
• DESIGN: International, randomized, prospective, multi-center, two-arm clinical study
• OBJECTIVE: To compare the STENTYS BMS with the STENTYS DES(P) in Saphenous Vein Grafts (SVG).
• ENDPOINTS:
‒ In-stent late lumen loss at six months post-procedure
‒ MACE at 30 days and 6 months
Independent monitoring and Core Lab: Diagram, Zwolle, The Netherlands
57 SVG patients in 5 EU clinical sites
STENTYS DES(P)STENTYS BMS
QCA at 6 monthsOCT sub study
Clinical FU at 1, 6 and 12 monthsEnrollment complete
• DESIGN: International, non-randomized, multi-center, “real-life” registry on acute and stable patients with a sizing dilemma.
• OBJECTIVE: To define self-expanding best practices and to evaluate the long-term safety and performance of the STENTYS BMS and DES(P) stents in routine clinical practice.
• SUBJECT POPULATION:‒ 3000 patients at 100+ sites.‒ Indications include: (N)STEMI, Bifurcations,
tapered vessels, SVGs, ectatic vessels, large vessels, etc.
• ENDPOINTS:‒ Procedural success ‒ MACE at discharge and at 12-months.
3000 patients, real-life, in ~100 centres worldwide
Clinical follow-up at discharge
Clinical follow-up at 12 months
SIZING – All-comers
Treated with STENTYS BMS or DES(P)
Patient enrollment in progress
CONCLUSIONS
Self-apposing stents help minimizing theproblem of vessel sizing
Apposition is better compared to any otherballoon-expandable stent
The rate of MACE is low
It is the perfect solution for “unusual” anatomies