The titanium nitride oxide stent an alternative to DES

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The titanium nitride oxide stent an alternative
to DES

• Adam de Belder MD FRCP
• Sussex Cardiac Centre
• BSUH
• on behalf of Hexacath

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Advanced Angioplasty 2008 Declaration of interest
I have received an honorarium for this talk from
Hexacath
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Are DES the answer to all coronary problems?

• Late stent thrombosis
• Polymer issue and re-endothelialisation
• Negative late loss
• Prolonged antiplatelet therapy
• Evidence for life prolongation

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Etc
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Late stent thrombosis
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DES IMPEDE RE-ENDOTHELIALIZATION
Incomplete DES endothelialization
BMS fully endothelialized
CYPHER 16 months post implantation with
uncomplete endothelialization
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DES IMPEDES RE-ENDOTHELIALIZATION
BMS 100 RE-ENDOTHELIALIZED
DES lt50 RE-ENDOTHELIALIZED
40 MONTHS AFTER IMPLANTATION
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NEGATIVE LATE LOSS

Circulation 2007
Negative Late Loss territory
Negative Late Loss territory
50 OF THE CYPHER TREATED PATIENTS
HAVE A NEGATIVE LATE LOSS
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DES INDUCE NEGATIVE LATE LOSS
30 of patients treated with XienceV have
a negative Late Loss
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DES ?ADVANTAGE OVER TIME
SCAAR STUDY
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GI complications of Dual Antiplatelet Therapy

• Aspirin suppresses gastroduodenal mucosal PG
  synthesis leading to mucosal damage
• Aspirin life threatening bleeding and
  perforation 3
• Aspirin risk is dose related
• OR for 75mgs is 2.3
• OR for 300mg is 3.9
• Enteric coating makes little difference

Vallurupalli NG, Goldhaber SZ Circulation
2006113e655-e658
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GI complications of Dual Antiplatelet Therapy

• No data that clopidogrel causes mucosal damage,
  but in 1 study, clopidogrel used in a cohort of
  patients with previous peptic ulceration lead to
  significant GI bleeding in 12
• Combination of aspirin and clopidogrel leads to
  overt GI bleeding in first 30 days in 1.3
• In CURE, risk of bleeding was higher in the high
  dose aspirin(200mg)/placebo arm (3.7), than the
  clopidogrel/aspirin (75mg) combination (3)

Vallurupalli NG, Goldhaber SZ Circulation
2006113e655-e658
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Ideal stent

• Would reduce restenosis without the need for
  toxic drugs
• No negative late loss
• Be thrombosis free short and long-term
• Avoid the need for long-term antiplatelet therapy
• Superior biomechanical properties, with very low
  profile and flexibility

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Non-DES coated stents

• Metallic implants are passive with high
  corrosion resistance, and are protected by the
  continued presence of a stable oxide break down
  the oxide and corrosion will start
• Titanium alloys have the highest degree of
  corrosion resistance of all metal alloys used in
  human medicine
• Thrombogenicity of metals/alloys relates to the
  electrode potential Ti alloys are very
  thromboresistant.

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TITAN-2 BAS Stent

• Laser cut slotted tube 316LSS
• Coated with thin atomic layer of titanium-NO
• Helicoidal design flexibility with excellent
  radial force
• NO particles
• Titanium coating extremely strong
• Fatigue tests no fracturing

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FUNDAMENTAL EVIDENCE
1-TITANIUM-NO MINIMIZES RBC DAMAGES
FACT Red blood cells adherent to titanium
appear to be almost normal
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FUNDAMENTAL EVIDENCE
1-TITANIUM-NO MINIMIZES RBC DAMAGES
FACT In comparison red blood cells adherent to
LTI carbon appear to be damaged
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FUNDAMENTAL EVIDENCE
2- TITANIUM-NO MINIMIZES P. AGGREGATION
On the Titanium no platelet aggregation was
found
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FUNDAMENTAL EVIDENCE
2-TITANIUM-NO MINIMIZES P. AGGREGATION
FACT No platelet adherence were found on the
surface of titanium
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FUNDAMENTAL EVIDENCE
2-TITANIUM-NO MINIMIZES P. AGGREGATION
FACT In comparison platelet aggregation is
found on the surface of LTI carbon
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FUNDAMENTAL EVIDENCE
3-TITANIUM-NO MINIMIZES FIBRIN GROWTH
Almost no fibrin was found on the Titanium
oxide films
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FUNDAMENTAL EVIDENCE
3-TITANIUM-NO MINIMIZES FIBRIN GROWTH
FACT No fibrin was found on the surface of
titanium
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FUNDAMENTAL EVIDENCE
3-TITANIUM-NO MINIMIZES FIBRIN GROWTH
FACT In comparison there is a large amount of
fibrin on the surface of LTI carbon
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FUNDAMENTAL EVIDENCE

4-TITANIUM-NO MINIMIZES INFLAMMATION
Titanium-NO offers a most biocompatible arterial
interface and acts as an unbreakable barrier
against the release of toxic ions.
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FUNDAMENTAL EVIDENCE
5-TITANIUM-NO PROMOTES RE-ENDOTHELIALIZATION
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FUNDAMENTAL EVIDENCE

5-TITANIUM-NO PROMOTES RE-ENDOTHELIALIZATION
FACT Titanium Oxides have proven to speed up
the re-endothelialization process in comparison
to stainless steel or nitinol.
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NO PRESENCE ON STENT SURFACE
6-NEW FINDINGS
Recent in vitro tests have shown the presence of
NO on the surface of the TITAN2 BAS stent while
no NO presence was found on the surface of the
BMS.
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ANIMAL EVIDENCE
THE ANIMAL MODEL
Bare Stent
Titanium-NO coated stent

Titanium Nitride Oxide Vs 316L in porcine
model47 reduction of neointimal hyperplasia
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ANIMAL EVIDENCE
THE ANIMAL MODEL
REMINDER ! Sirolimus (Cypher) in porcine model50
reduction of neointimal hyperplasia
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Thats all very well.what about the clinical
evidence
1-THE TINOX RANDOMISED TRIAL
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TINOX TRIAL

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TINOX TRIAL
LATE LOSS REDUCTION
0.90mm
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0.55mm
(p0.03)
TITANIUM -NO
BMS
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RANDOMIZED STUDIES VS DES

THE TITAX TRIAL (Titan2 Vs Taxus) (n400pts)
Primary Endpoint MACE _at_ 6 months, 1 year, 2
years Results MACE _at_ 6 months 7.7 Titan2 vs
10.3 Taxus
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CLINICAL STUDIES
TITAN Vs PES/SES IN SV
Clinical Comparative study Titan/PES/SES 173 Pts
(Titan2) Vs 88 Pts (Taxus) Vs 207 Pts (Cypher) in
small vessels Titan2 TLR _at_ 19 months 7.3
Taxus TLR _at_ 12 months 8.1 Cypher TLR _at_ 14
months 6.1
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THE FINNISH REGISTRY
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A 12-Months Clinical Outcome after Implantation
of Titanium Nitride Oxide Coated Stents,
Paclitaxel Eluting Stents or Bare-Metal Stents in
an Unselected Population

• P Karjalainen, MD,
• Department of Cardiology,
• Satakunta Central Hospital,
• PORI, Finland

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12- MONTHS FOLLOW-UP
ANOVA. e Bonferroni correction for multiple
comparison. e TITANOX vs. PES, p 0.023
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12-MONTHS MACE COMPOSITION
TITANOX (n201) PES (n204) BMS
(n184)

Control Angiography TITANOX 20
PES 19 BMS 22
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THE TIBET STUDY
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SIRIUS Vs TIBET 100 Diabetics
CLINICAL STUDIES
TIBET STUDY VS SIRIUS DIABETICS (QCA/IVUS)
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Publication EuroIntervention 2006
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THE ISRAELI REGISTRY
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TITAN-2 BIO ACTIVE STENT SAFETY
1-LOWEST ACUTE SUB ACUTE LEVELS OF
THROMBOSIS WITH NO LATE OR VERY LATE
THROMBOSIS
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TITAN-2 BIO ACTIVE STENT SAFETY

2-ABSENCE OF POLYMER
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BIO ACTIVE STENT DURABILITY
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TITAN-2 BAS STENT

• No polymer
• No drug
• Biocompatible coating
• No negative late loss
• No late or very late stent thrombosis
• Superior results to BMS
• .worth a look