Clinical Outcome Following  Percutaneous Coronary Intervention  Using Titanium-Nitride-Oxide  Coated Stents in Routine Cli...
Stent Coating With Titanium-Nitride-Oxide for Reduction of Neointimal Hyperplasia   in Pigs Windecker S et al.  Circulatio...
TiNOX Study Design Randomized, single-blind, multicenter trial Windecker S et al.  Circulation  2005;111:2617-22 TiNOX Stu...
Late Loss  P=0.004 TiNOX Study – QCA Results at 6 Months Windecker S et al.  Circulation  2005;111:2617-22 mm Binary Reste...
TiNOX Study - MACE at 6 Months  Windecker S et al.  Circulation  2005;111:2617-22 % ns ns  RR 70% P=0.006  RR 65% P=0.02
Use of DES 2005 2007
 
Titan Registry – Patient Demographics Titanium N=507 Mean age (years)  67    12  Male gender  78% Cardiovascular risk fac...
Titan Registry – Clinical Presentation 33% 26% STEMI NSTEMI/UA 50% Left ventricular ejection fraction (%) 56% Multivessel ...
Titan Registry – Procedural Characteristics Titanium N= 507 Number of lesions per patient 1.5  0.5 Number of stents per l...
Titan Registry MACE ( Composite of Death, MI, or TVR) .6 .7 .8 .9 1 cum. event free survival 0 100 200 300 Time (days) 89....
Titan Registry TLR .8 .85 .9 .95 1 0 100 200 300 Time (days) cum. event free survival 95.7 %
Titan Registry Stent Thrombosis .9 .92 .94 .96 .98 1 0 100 200 300 Time (days) cum. event free survival 99.2 %
One Year Clinical Outcome %
MACE and TLR Diabetic vs Non-Diabetic Patients % P=0.06 P<0.001
SIRTAX II and Titan Registry Patient Demographics Titan Sirolimus Paclitaxel  Stent Eluting Stent Eluting Stent   p N=507 ...
Procedural Characteristics Titanium Sirolimus Paclitaxel P Eluting Stent  Eluting Stent Lesions N= 760 N= 643 N= 603 Numbe...
SIRTAX II and Titan Registry Major Adverse Cardiac Events HR=0.71 (0.50-0.99) P=0.04 SES: 12.9% PES: 17.4% SES: 7.1% PES: ...
SES: 1.5% PES: 5.5% Titanium: 4.3% HR=0.57 (0.32-1.01) P=0.05 SES: 4.1% PES: 6.9% SIRTAX II and Titan Registry Target Lesi...
Titan Registry 0 1 2 3 4 Time since PCI in years 0 1 2 3 4 5 Cumulative incidence, % Incidence density 1.0 / 100 pt years ...
Titan Registry - Conclusions <ul><li>Titanium-Nitride-Oxide coated stents are safe and effective in complex patients enrol...
Symptomatic Coronary Artery Disease Exclusion: Acute STEMI Vessel Diameters:  ≥ 2.25 –  ≤ 4.0 mm Stent Diameters:  2.25 – ...
One Year Clinical Outcome %
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Lecture Pr Windecker

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  • Lecture Pr Windecker

    1. 1. Clinical Outcome Following Percutaneous Coronary Intervention Using Titanium-Nitride-Oxide Coated Stents in Routine Clinical Practice <ul><li>Stephan Windecker </li></ul><ul><li>Sylvan Lötscher, Annette Lauterburg, </li></ul><ul><li>Bernhard Meier </li></ul><ul><li>Cardiology </li></ul><ul><li>University Hospital Bern </li></ul><ul><li>Switzerland </li></ul>
    2. 2. Stent Coating With Titanium-Nitride-Oxide for Reduction of Neointimal Hyperplasia in Pigs Windecker S et al. Circulation 2001;104:928-33
    3. 3. TiNOX Study Design Randomized, single-blind, multicenter trial Windecker S et al. Circulation 2005;111:2617-22 TiNOX Study N=92 Uncoated OMEGA ™ stent N=47 TiNOX coated OMEGA ™ stent N=45 R Angiographic endpoint: In-stent late lumen loss at 6 months Clinical endpoint: MACE at 30 days and 6 months
    4. 4. Late Loss P=0.004 TiNOX Study – QCA Results at 6 Months Windecker S et al. Circulation 2005;111:2617-22 mm Binary Restenosis % <ul><li>RR </li></ul><ul><li>65% </li></ul><ul><li>P=0.01 </li></ul>
    5. 5. TiNOX Study - MACE at 6 Months Windecker S et al. Circulation 2005;111:2617-22 % ns ns  RR 70% P=0.006  RR 65% P=0.02
    6. 6. Use of DES 2005 2007
    7. 8. Titan Registry – Patient Demographics Titanium N=507 Mean age (years) 67  12 Male gender 78% Cardiovascular risk factors Arterial hypertension 54% Diabetes mellitus 23% Hypercholesterolemia 47% Family history 24% Smoking 46% Previous MI 13% Previous PCI 12% Previous CABG 9%
    8. 9. Titan Registry – Clinical Presentation 33% 26% STEMI NSTEMI/UA 50% Left ventricular ejection fraction (%) 56% Multivessel disease 59% Acute coronary syndrome 41% Chronic stable angina Titanium N=507
    9. 10. Titan Registry – Procedural Characteristics Titanium N= 507 Number of lesions per patient 1.5  0.5 Number of stents per lesion 1.2  0.4 Stent diameter (mm) 2.9  0.5 Stent length per lesion (mm) 23  12
    10. 11. Titan Registry MACE ( Composite of Death, MI, or TVR) .6 .7 .8 .9 1 cum. event free survival 0 100 200 300 Time (days) 89.6 %
    11. 12. Titan Registry TLR .8 .85 .9 .95 1 0 100 200 300 Time (days) cum. event free survival 95.7 %
    12. 13. Titan Registry Stent Thrombosis .9 .92 .94 .96 .98 1 0 100 200 300 Time (days) cum. event free survival 99.2 %
    13. 14. One Year Clinical Outcome %
    14. 15. MACE and TLR Diabetic vs Non-Diabetic Patients % P=0.06 P<0.001
    15. 16. SIRTAX II and Titan Registry Patient Demographics Titan Sirolimus Paclitaxel Stent Eluting Stent Eluting Stent p N=507 N=467 N=437 Mean age (years) 67  12 63  12 65  11 <0.001 Male gender 78% 74% 76% NS Cardiovascular risk factors Arterial hypertension 54% 57% 61% NS Diabetes mellitus 23% 23% 23% NS Hypercholesterolemia 47% 52% 52% NS Family history 24% 29% 28% NS Smoking 46% 38% 32% <0.01 Previous MI 13% 13% 13% NS Previous PCI 12% 14% 15% NS Previous CABG 9% 8% 9% NS
    16. 17. Procedural Characteristics Titanium Sirolimus Paclitaxel P Eluting Stent Eluting Stent Lesions N= 760 N= 643 N= 603 Number of lesions per patient 1.5  0.5 1.4  0.6 1.4  0.6 NS Number of stents per lesion 1.2  0.4 1.2  0.5 1.2  0.5 NS Stent diameter (mm) 2.9  0.5 2.8  0.4 2.9  0.4 NS Stent length per lesion (mm) 23  12 23  12 22  11 NS Antithrombotic Treatment Titanium Sirolimus Paclitaxel Eluting Stent Eluting Stent Clopidogrel 1 month 12 months 12 months Acetylsalicylic acid indefinitely indefinitely indefinitely
    17. 18. SIRTAX II and Titan Registry Major Adverse Cardiac Events HR=0.71 (0.50-0.99) P=0.04 SES: 12.9% PES: 17.4% SES: 7.1% PES: 11.7% Titanium: 10.4%
    18. 19. SES: 1.5% PES: 5.5% Titanium: 4.3% HR=0.57 (0.32-1.01) P=0.05 SES: 4.1% PES: 6.9% SIRTAX II and Titan Registry Target Lesion Revascularization
    19. 20. Titan Registry 0 1 2 3 4 Time since PCI in years 0 1 2 3 4 5 Cumulative incidence, % Incidence density 1.0 / 100 pt years 3.3% 3.5 0.6% / year 192 definite ST cases Bern-Rotterdam Cohort Study of Drug-Eluting Stents Daemen J et al. Lancet 2007;369:667-78
    20. 21. Titan Registry - Conclusions <ul><li>Titanium-Nitride-Oxide coated stents are safe and effective in complex patients enrolled in routine clinical practice </li></ul><ul><li>As opposed to drug-eluting stents, Titanium-Nitride-Oxide coated stents require only short-term dual antiplatelet therapy </li></ul><ul><li>Rates of TLR and MACE of Titanium-Nitride-Oxide coated stents are low and deserve further evaluation in direct head-to-head comparison with drug-eluting stents </li></ul>
    21. 22. Symptomatic Coronary Artery Disease Exclusion: Acute STEMI Vessel Diameters: ≥ 2.25 – ≤ 4.0 mm Stent Diameters: 2.25 – 4.0 mm Stent Lengths: 8 - 28 mm Pre-Dilatation and Post-Dilatation @ Physicians Discretion 30 d 6 mo 8 mo 12 mo 2 -5 yrs Clinical Follow-Up Primary Endpoint: In-Stent Late Loss at 8 months Key Secondary Endpoints: MACE at 30 days, 6 months, 12 months Clinically driven TLR, TVR, & TVF at 6 and 12 months Device, Lesion and Procedure Success Anti-Platelet Therapy for a minimum of 3 months ENDEAVOR n= ~150 Sites: Switzerland (3) Randomized (1:1), Single-Blind, Multi-Center Study TiNOX n= ~150 Titanium-Nitride-Oxide Coated Stents vs. Endeavor Stent
    22. 23. One Year Clinical Outcome %

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