Titax Tct 2007

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Titax Tct 2007

  1. 1. TITAX AMI Trial Pasi Karjalainen, MD, PhD Department of Cardiology Satakunta Central Hospital, Pori, Finland Clinical trial registration information www.clinicaltrials.com Unique identifier: NCT00495664
  2. 2. Disclosure Statement of Financial Interest I, ( Pasi Karjalainen ) DO NOT have a financial interest / arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
  3. 3. 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
  4. 4. 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 Finland Sweden Russia * Pori * Turku * Oulu * Kokkola * Kuopio * Jyväskylä Norway Estonia
  5. 5. <ul><li>Inclusion Criteria: </li></ul><ul><li>• Written informed consent </li></ul><ul><li>• Age > 18 years </li></ul><ul><li>• Patient with symptoms and </li></ul><ul><li>signs of myocardial </li></ul><ul><li>infarction requiring PCI </li></ul><ul><li>Exclusion Criteria: </li></ul><ul><li>• Prior PCI on target vessel </li></ul><ul><li>(restenosis) </li></ul><ul><li>• Unprotected LM disease </li></ul><ul><li>• Ostial lesion </li></ul><ul><li>• Contraindication to aspirin, </li></ul><ul><li>heparins, clopidogrel, </li></ul><ul><li>(allergy / risk for bleeding) </li></ul><ul><li>• Life expectancy < 12 months </li></ul><ul><li>• Stent length needed > 28 mm </li></ul>Inclusion / Exclusion
  6. 6. 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 Primary Endpoint: MACE at 1 Year Independent Endpoint Committee
  7. 7. Sample Size Calculation: Karjalainen P, et al. J Invasive Cardiol 2006;18:462-468 Expected MACE at one year based on PORI stent registry (202 AMI patients) TITANOX 7% versus TAXUS-Liberte 16% Two-sided test for differences in independent proportions with 5 % alpha and 80% power  x n=102 n=100
  8. 8. TITAX AMI trial <ul><li>• Primary Endpoint </li></ul><ul><li>- MACE at 12- months including </li></ul><ul><ul><ul><li>Myocardial infarction </li></ul></ul></ul><ul><ul><ul><li>TLR (PCI or CABG) </li></ul></ul></ul><ul><ul><ul><li>Cardiac death </li></ul></ul></ul><ul><li>• Secondary Endpoints </li></ul><ul><li>- Composite of cardiac death or recurrent MI </li></ul><ul><li>- All cause death </li></ul><ul><li>- Stent Thrombosis </li></ul>
  9. 9. Definition of Stent Thrombosis The Academic Research Consortium (ARC) <ul><li>Definite: </li></ul><ul><li>- Acute coronary syndrome and angiographic (or autopsy) confirmation of stent thrombosis </li></ul><ul><li>Probable: </li></ul><ul><li>- Any unexplained death within the first 30 days </li></ul><ul><li>- Target vessel related AMI </li></ul><ul><li>Possible: </li></ul><ul><li>- Any unexplained death from 30 days after PCI </li></ul>
  10. 10. Baseline Patient Characteristics 0.81 96 (45) 116 (54) GP IIb/IIIa Inhibitors, n (%) 0.14 97 (46) 83 (39) Acute STEMI, n (%) 0.06 40 (19) 26 (12) Thrombolysis, n (%) 0.18 97 (46) 113 (53) History of smoking, n (%) 0.21 151 (72) 141 (66) Hyperlipidemia, n (%) 0.70 13 (6) 16 (7) Previous CABG, n (%) 0.04 10 (5) 22 (10) Previous PCI, n (%) 0.08 33 (16) 48 (22) Diabetes, n (%) 0.82 157 (74) 162 (76) Male sex, n (%) 0.72 64 ± 11 64 ± 11 Age (mean ± SD) P value PES (211) TITANOX (214)
  11. 11. Lesion Characteristics 0.16 24 (11) 35 (16) C 0.54 138 (65) 147 (69) B1 / B2 Complex Lesions, n (%) 0.84 9 (4) 10 (5) Bypass Graft (venous) 0.50 1 (0.5) 0 (0) Left Main 0.92 60 (28) 62 (29) RCA 0.48 50 (24) 44 (21) LCX 0.63 91 (43) 98 (46) LAD Infarct-related Vessel, n (%) P value PES (211) TITANOX (214)
  12. 12. Procedural and Lesion Characteristics 0.13 19 (9) 30 (14) Multivessel PCI, n (%) 0.21 207 (98.1) 213 (99.5) Acute Procedural Success, n (%) 0.19 3.11 ± 0.45 3.16 ± 0.42 Stent diameter, (mm) 0.26 19.2 ± 7.2 18.5 ± 6.4 Total stent length, (mm) 0.24 1.1 ± 0.4 1.1 ± 0.3 No of stents per lesion, n (%) 0.48 17.7 ± 5.3 17.4 ± 4.5 Stent length, (mm) 0.47 13.2 ± 6.4 13.6 ± 5.6 Lesion length, (mm) 0.35 3.11 ± 0.50 3.16 ± 0.45 RVD, (mm) P Value PES ( 211) TITANOX ( 214)
  13. 13. 30-days Follow-up 0.019 10 (4.7) 2 (0.9) Recurrent MI or cardiac death, n (%) 0.99 3 (1.4) 3 (1.4) Death from any cause, n (%) 0.06 0.10 0.31 6 (2.8) 5 (2.4) 1 (0.5) 1 (0.5) 1 (0.5) 0 (0) Stent thrombosis, n (%) Definite, n (%) Probable, n (%) 0.018 12 (5.7) 3 (1.4) MACE, n (%) 0.15 2 (0.9) 0 (0) Death from cardiac causes, n (%) 0.31 6 (2.8) 3 (1.4) TLR, n (%) 0.031 9 (4.3) 2 (0.9) Myocardial infarction, n (%) P value PES (211) TITANOX (214)
  14. 14. 6-months Follow-up 0.27 13 (6.2) 8 (3.7) Recurrent MI or cardiac death, n (%) 0.72 3 (1.4) 4 (1.9) Death from any cause, n (%) 0.031 0.06 0.31 7 (3.3) 6 (2.8) 1 (0.5) 1 (0.5) 1 (0.5) 0 (0) Stent thrombosis, n (%) Definite, n (%) Probable, n (%) 1.0 15 (7.1) 16 (7.5) MACE, n (%) 0.15 2 (0.9) 0 (0) Death from cardiac causes, n (%) 0.12 7 (3.3) 15 (7.0) TLR, n (%) 0.37 12 (5.7) 8 (3.7) Myocardial infarction, n (%) 211 (100) 214 (100) Complete data available, n (%) P value PES (211) TITANOX (214)
  15. 15. 12-months FU: Primary Endpoints % p = 0.1 p = 0.5 p = 0.2 p = 0.5 Complete data available: TITANOX 97.7 % vs. PES 98.1 %
  16. 16. 12-months FU: Secondary Endpoints % p = 0.08 p = 0.8 p = 0.031
  17. 17. 12-months FU: Stent Thrombosis % p = 0.031 p = NS p = NS
  18. 18. Characteristics of ST cases 16 3.0 12 + 0 STEMI PES 8 NSTEMI STEMI STEMI STEMI NSTEMI STEMI NSTEMI NSTEMI STEMI NSTEMI Indication of index PCI 0 + + + 0 + 0 0 0 0 Thrombolysis therapy + + + + 0 0 0 + + + GP IIb/IIIa 20 3.0 12 PES 6 28 3.0 12 PES 7 16 2.25 12 PES 2 24 2.5 12 PES 3 24 3.5 12 PES 9 16 3.0 12 PES 5 20 2.5 12 PES 4 24 2.5 12 PES 1 16 3.0 6 TITANOX 2 19 mm 3.0 mm 3 months TITANOX 1 Stent length Stent diameter Clopidogrel prescription
  19. 19. Characteristics of ST cases 16 3.0 12 Alive STEMI PES 8 NSTEMI STEMI STEMI STEMI NSTEMI STEMI NSTEMI NSTEMI STEMI NSTEMI Indication of index PCI DIED DIED Alive DIED Alive Alive Alive Alive Alive DIED OUTCOME 20 3.0 12 PES 6 28 3.0 12 PES 7 16 2.25 12 PES 2 24 2.5 12 PES 3 24 3.5 12 PES 9 16 3.0 12 PES 5 20 2.5 12 PES 4 24 2.5 12 PES 1 16 3.0 6 TITANOX 2 19 mm 3.0 mm 3 months TITANOX 1 Stent length Stent diameter Clopidogrel prescription
  20. 20. Antiplatelet Therapy During ST 0 0 0 Discontinuation of aspirin 1 1 1 Discontinuation of clopidogrel 2 0 6 Dual antiplatelet therapy >180 days n = 3 30-180 days n = 1 0-30 days n = 7
  21. 21. 12-months FU: NSTEMI vs. STEMI % p = NS p = NS p = NS p = NS p = NS
  22. 22. 12-months Follow-up Multivariable Predictors: The variables significantly ( P < 0.05) associated with dependent variables in univariate analyses were included in multivariable analyses Results of the logistic regression are presented using odds ratios and their 95% confidence intervals. A two-sided P value < 0.05 was required for statistical significance • Primary Endpoint No predictors • TLR No predictors • Stent Thrombosis No predictors
  23. 23. TITAX AMI trial: Conclusions <ul><li>• B oth TITANOX coated stent and PES resulted in comparable clinical outcome. </li></ul><ul><li>• Secondly, although the overall risk of stent thrombosis was low, it concentrated on the use of PES. </li></ul><ul><li>• Stent thrombosis occurred in 3 patients after premature discontinuation of clopidogrel. </li></ul>
  24. 24. TITAX AMI trial <ul><li>Possible limitations: </li></ul><ul><li>• Small sample size (425 patients) </li></ul><ul><li>• Thrombolysis therapy not excluded </li></ul><ul><li>Strengths of the study: </li></ul><ul><li>• Initiated by the investigators, no sponsors </li></ul><ul><li>• Prospective, randomized, multicenter study </li></ul><ul><li>• Primary clinical end point </li></ul><ul><li>• New ARC definition of stent thrombosis </li></ul>
  25. 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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