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TITAX AMI Trial

A Prospective, Randomized Trial Comparing TI TAN-2 ® Stent and TAX US-Liberte ® Stent in A cute M yocardial I nfarction 24-months Clinical Follow-Up. TITAX AMI Trial. Y. Giraud-Sauveur on behalf of P.Karjalainen, MD, PhD : Principal Investigator BCIS 2009 London, UK. TITAX AMI trial.

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TITAX AMI Trial

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  1. A Prospective, Randomized Trial Comparing TITAN-2®Stent and TAXUS-Liberte® Stent in Acute Myocardial Infarction 24-months Clinical Follow-Up TITAX AMI Trial Y. Giraud-Sauveur on behalf of P.Karjalainen, MD, PhD : Principal Investigator BCIS 2009 London, UK

  2. TITAX AMI trial P Karjalainen, MD, PhD Juhani Airaksinen, Antti Ylitalo, Matti Niemelä, Kari Kervinen, Mikko Pietilä, Jussi Sia, Kai Nyman, Petri Tuomainen, Timo Mäkikallio for the TITAX AMI Investigators All investigators state that no relationships exist related to this presentation

  3. Multifunctional Anti-restenotic Effect Titanium-NO Mechanisms of Action Inhibits Platelet Aggregation - Stabilizes microtubules to inhibit smooth muscle cell migration and proliferation - Stable and durable Translute Polymer * Vascular compatible, biocompatible * Controlled and consistent dose release of paclitaxel Minimizes Fibrin Growth Reduces Inflammation Promotes Healing

  4. Comparison of titanium-nitride-oxide-coated TITAN-2® Stent to the paclitaxel-eluting TAXUS-Liberte® stent resulted in: • Comparable clinical outcome at 1-Year • Secondly, although the overall risk of stent thrombosis was low, it concentrated on the use of TAXUS-Liberte® stent • In addition, stent thrombosis occurred in 3 patients after premature discontinuation of clopidogrel. Background: TITAX AMI at 1-YearEurointerv 2008;4:234-241 TCT 2007, Late Breaking Trial

  5. Participating Centers in Finland Purpose of the TITAX AMI trial Initiated by the investigators A Prospective, Multi-center, Randomized Trial that Compares the Implantation of Titanium-Nitride-Oxide Coated Stents to Paclitaxel-Eluting Stents for Acute Myocardial Infarction Norway Finland Sweden * Oulu Russia * Kokkola * Kuopio * Jyväskylä * Pori * Turku Estonia

  6. Inclusion Criteria: •Written informed consent • Age > 18 years • Patient with symptoms and signs of myocardial infarction requiring PCI Exclusion Criteria: •Prior PCI on target vessel (restenosis) • Unprotected LM disease • Ostial lesion • Contraindication to aspirin, heparins, clopidogrel, (allergy / risk for bleeding) • Life expectancy < 12 months • Stent length needed > 28 mm Inclusion / Exclusion

  7. TITAX AMI trial: Study Design 425 Patients Presenting Acute Myocardial Infarction Requiring PCI Written Informed Consent Randomization 1:1 TITAN-2® stent (Hexacath) Titanium-Nitride-Oxide Coated Stent (TITANOX) 214 Patients TAXUS-Liberte® stent (Boston) Paclitaxel-Eluting Stent (PES) 211 Patients Primary Endpoint: MACE at 1 Year Independent Endpoint Committee

  8. TITAX AMI trial •Primary Endpoint MACE at 12- months including • Myocardial infarction • TLR (PCI or CABG) • Cardiac death •Secondary Endpoints - Composite of cardiac death or recurrent MI - All cause death - Stent Thrombosis

  9. Definition of Stent ThrombosisThe Academic Research Consortium (ARC) Definite: - Acute coronary syndrome and angiographic (or autopsy) confirmation of stent thrombosis Probable: - Any unexplained death within the first 30 days - Target vessel related AMI Possible: - Any unexplained death from 30 days after PCI

  10. Baseline Patient Characteristics * L= Liberte

  11. Lesion Characteristics * L= Liberte

  12. Procedural and Lesion Characteristics * L= Liberte

  13. Antiplatelet Agent Utilization Extended clopidogrel treatments beyond 12 months were discouraged * L= Liberte

  14. Patient Flow - Clinical Randomized (N=425) TITAN-2® stent (N=214/214) TAXUS-Liberte® stent (N=211/211) 1-Year follow-up (N=425/425; 100%) 1 = Lost to f/u Lost to f/u = 0 24 months follow-up (N=424/425; 99.8%) TITAN-2® stent (N=214/214) TAXUS-Liberte® stent (N=210/211)

  15. TITAX AMI trialMACE at 12, 18 and 24 months % p = 0.5

  16. TITAX AMI trialMACE at 12, 18 and 24 months % p = 0.04 p = 0.5

  17. TITAX AMI trialMACE at 12, 18 and 24 months % p = 0.006 p = 0.04 p = 0.5

  18. TITAX AMI trialMI at 12, 18 and 24 months % p < 0.001 p = 0.004 NS

  19. TITAX AMI trialCardiac Death at 12, 18 and 24 months % p = 0.02 p = 0.02 NS

  20. TITAX AMI trialTLR at 12, 18 and 24 months % NS NS NS

  21. TITAX AMI trialDefinite Stent Thrombosis at12, 18 and 24 months % p = 0.001 p = 0.003 p = 0.03

  22. TITAX AMI trialMI or Cardiac Death at 12, 18 and 24 months % p < 0.001 p = 0.001 p = 0.08

  23. • Late follow up (12 to 24 months) after the clopidogrel discontinuation showed higher rates of: - Myocardial Infarction - Cardiac Death - MACE with the use of TAXUS-Liberte® stent • Secondly, the incidence of Stent Thrombosis (ARC definition) was significantly higher in the TAXUS-Liberte® stent group • TITAN-2®stent: non-inferior 24-months rate of TLR TITAX AMI trial:Conclusions (24 months follow-up)

  24. Possible limitations: • Small sample size (425 patients) • Thrombolysis therapy not excluded Strengths of the study: • Initiated by the investigators, no sponsors • Prospective, randomized, multicenter study • Primary clinical end point • New ARC definition of stent thrombosis TITAX AMI trial

  25. TITAX AMI trial P Karjalainen, MD, PhD Juhani Airaksinen, Antti Ylitalo, Matti Niemelä, Kari Kervinen, Mikko Pietilä, Jussi Sia, Kai Nyman, Petri Tuomainen, Timo Mäkikallio for the TITAX AMI Investigators Thank You! Kiitos!

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