The Titan-2 (HexaCath) Titanium Nitride Oxide Coated...
Transcript of The Titan-2 (HexaCath) Titanium Nitride Oxide Coated...
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The Titan-2 (HexaCath) Titanium Nitride Oxide Coated stent:Do Clinical Trial Results Suggest Lower
Restenosis?
Morris Mosseri, MD FESC
Head of Cardiology DivisionMeir Medical Center, Kfar-Sava Israel
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I DO NOT have a financial
interest/arrangement or affiliation with the
organization that could be perceived as a
real or apparent conflict of interest in the
context of the subject of this presentation.
Disclosure Statement of Financial Interest
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TiNOX
The Titan stent is a balloon expandable stent with
a helical design made of stainless steel and
coated with Titanium-Nitride-Oxide (TiNOX)
Background
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It completely prevents
discharge of nickel, chromium
and molybdenum
TiNOX Mechanisms of Action
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Minimizes RBC’s damage
Minimizes Fibrin Growth
Inhibits Platelet Aggregation
Titanium-NO LTI Carbon
It reduces inflammationFeng Zhang et al, J of Biomed Mater Res 42: 128-133, 1998
TiNOX Mechanisms of Action
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It promotes healing
TITANIUM OXIDES PROMOTE RE-ENDOTHELIALIZATION
Hung-I Yeh et al, J of Biomed Mater Res 76A: 835-841, 2006
TiNOX Mechanisms of Action
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Stent Coating With Titanium-Nitride-Oxide for
Reduction of Neointimal Hyperplasia in Pigs
% Intima Reduction
(%)
-60
-40
-20
0TiNOX 1 TiNOX 2
Neointimal Hyperplasia
(mm
2)
0
1
2
3
4
Uncoated TiNOX 1TiNOX 1 TiNOX 2
p<0.02
p<0.02
p=0.8
Windecker S et al. Circulation 2001;104:928-33
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Do Clinical Trial Results
Suggest Lower Restenosis?
First Registry: 6 months angiographic results
Randomized Clinical Trial vs. BMS
Real World Data
Registries
Comparative analysis with BMS and DES registries
High risk patients data
Randomized Clinical Trial vs. DES
Comparative registries with BMS and DES
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First TiNOX Registry
(for CE approval)
Six months angiographic follow up was
completed in 81 patients
• Late loss 0.54 mm
• Binary angiographic restenosis 14%
Camenzind et al
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A Randomized Study Comparing a Titanium-
Nitride-Oxide Coated With an Uncoated Stent
For Coronary Revascularization
Stephan Windecker, Adnan Kastrati,
Bernhard Meier, Otto Hess
Swiss Cardiovascular Center Bern, Switzerland
Circulation 2005
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Study DesignRandomized, single-blind, multicenter trial
Study
N=92
Uncoated
X stent
N=47
Coated
X stent
N=45
R
Primary endpoint: Late lumen loss at 6 months
Secondary endpoint: MACE at 30 days and 6 months
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Net Luminal Gain
1.55
1.03
0
0.5
1
1.5
2
2.5
Coated
(n=42)
Uncoated
(n=43)
P=0.003
Late Loss
P=0.03
0.55
0.90
0
0,4
0,8
1,2
1,6
Coated
(n=42)
Uncoated
(n=43)
Study – QCA Results at 6 Monthsm
m
mm
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0 0
7 7
2 2
2723
0
10
20
30
40
Death MI TLR MACE
Coated Uncoated
%
ns ns
RR 74%
P=0.02
RR 69%
P=0.07
Study – Clinical Results at 6 Months
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0
.2
.4
.6
.8
1
0 1 2 3 4 5 6
TL
R
Years
p=0.05
TiNOX
ControlTLR
The TINOX 1-Trial5 year Follow-up
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0
.2
.4
.6
.8
1
MA
CE
0 1 2 3 4
Years
p=0.03
TiNOX
Control
5 6
The TINOX 1-Trial5 year Follow-up
MACE
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The Titan StentData from the Israeli National Registry
M. MosseriOn Behalf of the Israeli Working Group
on Interventional Cardiology
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Real-World Multi-Center (9 hospitals) Registry
To assess the 30 day and 6 month
Outcome of the Titan Stent
Purpose
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• High risk patients` clinical profile
• Complex lesion morphology
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MACE follow up
180 days (%)30 days (%)Type
00Death
10TVR – PCI
20TVR – CABG
00QWMI
00NQWMI
30Total
Mosseri M et al. Cardiovasc Revasc Med 6(1); 2-6, 2005
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Extended Registry of 296 patients
6 months - % (no)30 days - % (no)Type
0.7% (2)0.3% (1)Death
5.7% (17)
(TLR-5.4%)
0.6% (2)TVR *
5.1% (15)0.6% (2)PCI
0.6% (2)0CABG
0.3% (1)0.3% (1)QWMI
0.3% (1)0.3% (1)NQWMI
7.0% (21)1.2% (5)Total MACE
6.3% (19)1.0% (3)
Total Pts with MACE
(hierarchical analysis)
Mosseri et al, EuroIntervention 2: 192-196; 2006
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Comparative Results of the TiNOX with BMS and DES
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Comparison of TiNOX-1 with SIRTAX 2 Trial
TLR
0
5
10
Cu
mu
lativ
e I
ncid
en
ce
of
TL
R (
%)
0 6 12 18 24Follow-up (months)
Sirolimus eluting stent Paclitaxel eluting stent
Post-SIRTAX Patients
SES:
1.5%
PES:
5.5%
Titanium4.3%
HR=0.57
(0.32-1.01)
P=0.05
SES:
4.1%
PES:
6.9%
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SIRTAX 2 TrialMACE
0
5
10
15
20
Cu
mu
lative
In
cid
en
ce
of
MA
CE
(%
)
0 6 12 18 24Follow-up (months)
Sirolimus eluting stent Paclitaxel eluting stent
Post-SIRTAX Patients
HR=0.71
(0.50-0.99)
P=0.04
SES:
12.9%
PES:
17.4%
SES:
7.1%
PES:
11.7%Titanium10.4%
Comparison of TiNOX-1 with SIRTAX 2 Trial
MACE
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0.01.02.03.04.05.06.07.08.09.0
10.011.012.013.014.015.0
TVR MACE Death
Isr Bare stents
Isr E-Cypher 6 mts
Isr Titan 6 mts
%
Comparison of the Titan registry with the E-Cypher
and another 17 Israeli BMS registries at 6 months
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PORI Registry (FINLAND)
Pasi Karjalainen, MD, PhD
EuroIntervention 2: 187-191; 2006
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12 Months MACE Composition
0.5
2.5
4.55
0
10.9
2.5
3.9
10.3
4.9
3.4
13.7
3.34.3
9.2
7.1
1.6
17.9
0
4
8
12
16
20
Cardiac
Death
Overall
Death
AMI TLR ST MACE
TITANOX
PES
BMS
%
p = 0.03
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36 Months MACE Composition
1
5.57.5
13.9
3.4
6.4
19.1
23.5
6
8.7
14.7
31.5
0
10
20
30
40
Cardiac Death Overall Death AMI MACE
TITANOX
PES
BMS
%
p < 0.001
p = 0.003
[0.002] [ <0.001 ]
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Titan in High Risk Patients
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9 HOSPITALS IN SPAIN; 156 PATIENTS; 197 STENTS; 6 MONTHS CLINICAL FOLLOW-UP
THE TIBET REGISTRYM. Valdés, J. Fernández, A. Bethencourt, E. Pérez,
I. Calvo, JR López, A. Martínez, R Valdesuso, J Moreu
DESIGNED TO DEFINETHE CLINICAL EFFICACY
OF TITAN IN DIABETIC PATIENTS
TCT 2004
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1/155
155158
156158
4/155
2/155
11155
16155
2/155
DEATH
0.64
2.58
1.29 1.29
7.09
10.3
0
3
6
9
12
CARDIAC NON CARDIAC UNKNOWN QwMI TLR MACE
1/155
4/155
2/155
DEATH
11155
16155
2/155
6 MONTHS FOLLOW-UP
%
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RVD mm 3,02
LESION LENGHT mm 18,34
MLD PRE mm 0,81
MLD POST STENT mm 2,55
MLD 9 M FOLLOW-UP mm 1,99
% STENOSIS PRE % 73,22
% STENOSIS POST % 15,5
% STENOSIS 9 MONTHS % 29,67
ACUTE GAIN mm 1,74
LATE LOSS mm 0,56
LATE LOSS INDEX 0,32
9 MONTHS ANGIOGRAPHIC FOLLOW-UP. PATIENTS: 38/45 (84,44). STENTS: 62/72 (83,78%)
7 patients refused repeat angiography. All asymptomatic
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31.6
15.55 17.6
5.10
5
10
15
20
25
30
35
BMS TITAN SES TAXUS
BMS TITAN SES TAXUS
16
7.09 7.25.2
0
2
4
6
8
10
12
14
16
18
20
BMS TITAN SES TAXUS
BMS TITAN SES TAXUS% %
ANGIOGRAPHIC RESTENOSIS AND TLR IN DIABETICS
Restenosis TLR
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TITAX AMI Trial
A Prospective, Randomized Multi-Center Trial(Findland) Comparing Titanium-Nitride-Oxide-
Coated Stent and Paclitaxel-Eluting Stent
in Acute MI
P Karjalainen,
J. Airaksinen, A. Ylitalo, M. Niemelä, K. Kervinen, M. Pietilä, J. Sia, K. Nyman, P. Tuomainen, T. Mäkikallio
PCR 2007
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TITAX AMI trial: Study Design
425 Patients Presenting Acute
Myocardial Infarction Requiring PCI
Written Informed Consent
Randomization 1:1
TITAN® stent (Hexacath)
Titanium-Nitride-Oxide Coated Stent
(TITANOX)
214 Patients
TAXUS-Liberte® stent (Boston)
Paclitaxel-Eluting Stent
(PES)
211 Patients
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TITAX AMI trial
• Primary Endpoint
- MACE at 12- months including
• MI
• TLR
• Cardiac death
• Secondary Endpoints
- Composite of cardiac death or recurrent MI
- All cause death
- Stent Thrombosis (ARC definition)
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TITAX AMI trialPrimary Endpoint: 12 and 18 months
4.2
9.3
0.5
10.3
8.17.1
1.9
12.8
4.2
9.3
0.5
10.3
11.8
9.5
3.8
17.1
0
5
10
15
20
Myocardial
Infarction
TLR Cardiac
Death
MACE
TITAN 12
TAXUS 12
Column 6
TITAN 18
TAXUS 18
%
p = 0.04
p = 0.02
p = 0.004
12 12 12121818 18 18
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TITAX AMI trialSecondary Endpoints: 12 and 18 months
4.2
2.3
0.9
8.5
2.8
4.34.23.3
0.9
13.7
4.7
7.6
0
5
10
15
20
MI or Cardiac
Death
All cause death Stent
Thrombosis*
Titan 12
Taxus 12
Column 6
Titan 18
Taxus 18
%
p = 0.03
p = 0.001
* ARC definition
p = 0.001
1818 1212 12 18
![Page 38: The Titan-2 (HexaCath) Titanium Nitride Oxide Coated stentcardionef.com/arch_up/TITAN2ClinicalProgram.pdf · The Titan-2 (HexaCath) Titanium Nitride Oxide Coated stent: ... J. Sia,](https://reader033.fdocuments.us/reader033/viewer/2022051509/5ad51c0b7f8b9a0d2d8d34d9/html5/thumbnails/38.jpg)
TITAX AMI trialStent Thrombosis: 12 and 18 months
0.50
0.50.9
3.3
0.5 0.5
4.3
0.50
0.50.9
5.2
0.5
1.9
7.6
0
5
10
Definite Probable Possible ARC
definition
Titan 12
Taxus 12
Column 6
Titan 18
Taxus 18
%
p = 0.003
p = 0.03
p = 0.03
p = 0.001
p = 0.04
![Page 39: The Titan-2 (HexaCath) Titanium Nitride Oxide Coated stentcardionef.com/arch_up/TITAN2ClinicalProgram.pdf · The Titan-2 (HexaCath) Titanium Nitride Oxide Coated stent: ... J. Sia,](https://reader033.fdocuments.us/reader033/viewer/2022051509/5ad51c0b7f8b9a0d2d8d34d9/html5/thumbnails/39.jpg)
Do Clinical Trial Results Suggest Lower Restenosis?
• Restenosis rate of the Titan stent is
significantly lower than of BMS (RCT)
• Restenosis rate of the Titan stent in
acute MI patients at 18 months is equal
to PES (RCT)
Conclusions
![Page 40: The Titan-2 (HexaCath) Titanium Nitride Oxide Coated stentcardionef.com/arch_up/TITAN2ClinicalProgram.pdf · The Titan-2 (HexaCath) Titanium Nitride Oxide Coated stent: ... J. Sia,](https://reader033.fdocuments.us/reader033/viewer/2022051509/5ad51c0b7f8b9a0d2d8d34d9/html5/thumbnails/40.jpg)
Do Clinical Trial Results Suggest Lower Restenosis?
• Safety of the Titan stent is better than
PES in terms of stent thrombosis and
long term incidence of MI and cardiac
death both in acute MI (RCT) and the
general population (PORI registry).
Conclusions
![Page 41: The Titan-2 (HexaCath) Titanium Nitride Oxide Coated stentcardionef.com/arch_up/TITAN2ClinicalProgram.pdf · The Titan-2 (HexaCath) Titanium Nitride Oxide Coated stent: ... J. Sia,](https://reader033.fdocuments.us/reader033/viewer/2022051509/5ad51c0b7f8b9a0d2d8d34d9/html5/thumbnails/41.jpg)