Stentys cairo14

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

APPO I_EuroIntervention-Aug2011.pdf

• 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



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


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

Stentys cairo14

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