Cardio Actualidad 2009 - Intervencionismo

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Dr. Manel Sabaté Tenas
Congreso de las enfermedades cardiovasculares 2009 - Barcelona 24/10/2009

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  • Exhibit 6
  • NOTE THAT THESE ARE ALL STUDIES, NOT JUST DIABETES STUDIES. References: MAIN-COMPARE: K. B. Seung et al. , N Engl J Med 358 , 1781 (2008). Hong 2005: S. J. Hong et al. , Catheter Cardiovasc Interv 64 , 75 (2005). ERACI II: A. E. Rodriguez et al. , J Am Coll Cardiol 46 , 582 (2005). Ben-Gal 2006: Y. Ben-Gal et al. , Ann Thorac Surg 82 , 1692 (2006). SoS: J. Booth et al. , Circulation , CIRCULATIONAHA.107.739144 (2008). Naples Registry: C. Briguori et al. , The American Journal of Cardiology 99 , 779 (2007). LE MANS: P. Buszman et al. , Am J Cardiol 96 , 205H (2007). Cedars-Sinai: A. J. White et al. , JACC: Cardiovascular Interventions 1 , 236 (2008). Clevelend Clinic: S. J. Brener et al , Am J Cardiol 101 , 169 (2008). ARTS I: P. W. Serruys et al. , N Engl J Med 344 , 1117 (2001). Seoul Registry: D. W. Park et al. , Circulation 117 , 2079 (2008). Yang, 2007: Z. K. Yang et al. , J Interv Cardiol 20 , 10 (2007). ARTS II: P. W. Serruys et al. , J Am Coll Cardiol 46 , 575 (2005).
  • NOTE THAT THESE ARE ALL STUDIES, NOT JUST DIABETES STUDIES. References: MAIN-COMPARE: K. B. Seung et al. , N Engl J Med 358 , 1781 (2008). Hong 2005: S. J. Hong et al. , Catheter Cardiovasc Interv 64 , 75 (2005). Naples Registry: C. Briguori et al. , The American Journal of Cardiology 99 , 779 (2007). Cedars-Sinai: A. J. White et al. , JACC: Cardiovascular Interventions 1 , 236 (2008). ARTS I: P. W. Serruys et al. , N Engl J Med 344 , 1117 (2001). Seoul Registry: D. W. Park et al. , Circulation 117 , 2079 (2008). ARTS II: P. W. Serruys et al. , J Am Coll Cardiol 46 , 575 (2005).
  • Cardio Actualidad 2009 - Intervencionismo

    1. 1. INTERVENCIONISMO CARDIACO Manel Sabaté H. Clínic, Barcelona
    2. 2. Intervencionismo Cardiaco 2008-09 <ul><li>Tratamiento de la enfermedad multivaso y/o TCI: </li></ul><ul><ul><li>ICP vs. Cirugía en enfermedad de 3 v y/o TCI: Syntax 2 años </li></ul></ul><ul><ul><li>ICP en TCI: ISAR-Left Main; Main Compare; LeMans Registry </li></ul></ul><ul><li>Stent farmacoactivos de 2ª generación: </li></ul><ul><ul><li>SPIRIT IV, COMPARE trials. </li></ul></ul><ul><ul><li>NEVO II </li></ul></ul>
    3. 3. Intervencionismo Cardiaco 2008-09 <ul><li>Tratamiento de la enfermedad multivaso y/o TCI: </li></ul><ul><ul><li>ICP vs. Cirugía en enfermedad de 3 v y/o TCI: Syntax 2 años </li></ul></ul><ul><ul><li>ICP en TCI: ISAR-Left Main; Main Compare; LeMans Registry </li></ul></ul><ul><li>Stent farmacoactivos de 2ª generación: </li></ul><ul><ul><li>SPIRIT IV, COMPARE trials. </li></ul></ul><ul><ul><li>NEVO II </li></ul></ul>
    4. 4. SYNTAX Trial Design + * TAXUS Express 71% enrolled (N=3,075) All Pts with de novo 3VD and/or LM disease (N=4,337) <ul><li>Treatment preference (9.4%) </li></ul><ul><li>Referring MD or pts. refused informed consent (7.0%) </li></ul><ul><li>Inclusion/exclusion (4.7%) </li></ul><ul><li>Withdrew before consent (4.3%) </li></ul><ul><li>Other (1.8%) </li></ul><ul><li>Medical treatment (1.2%) </li></ul>TAXUS n=903 PCI n=198 CABG n=1077 CABG n=897 no f/u n=428 5yr f/u n=649 PCI all captured w/ follow up CABG 2500 750 w/ f/u vs Total enrollment N=3075 Stratification: LM and Diabetes Two Registry Arms Randomized Arms n=1800 Two Registry Arms N=1275 Randomized Arms N=1800 Heart Team (surgeon & interventionalist) PCI N=198 CABG N=1077 Amenable for only one treatment approach TAXUS * N=903 CABG N=897 vs Amenable for both treatment options Stratification: LM and Diabetes LM 33.7% 3VD 66.3% LM 34.6% 3VD 65.4% 23 US Sites 62 EU Sites
    5. 5. Patient Characteristics (II) Randomized Cohort Patient-based CABG N=897 TAXUS N=903 P value Total SYNTAX Score 29.1 ±11.4 28.4 ±11.5 0.19 Diffuse disease or small vessels, % 10.7 11.3 0.69 No. lesions, mean ± SD 4.4 ±1.8 4.3 ±1.8 0.44 3VD only, % 66.3 65.4 0.70 Left main, any, % 33.7 34.6 0.70 Left Main only 3.1 3.8 0.46 Left Main + 1 vessel 5.1 5.4 0.78 Left Main + 2 vessel 12.0 11.5 0.72 Left Main + 3 vessel 13.5 13.9 0.78 Total occlusion, % 22.2 24.2 0.33 Bifurcation, % 73.3 72.4 0.67 Trifurcation, % 10.6 10.7 0.92
    6. 6. Average Number of Stents Implanted per Patient 4.6 3.5 3.7
    7. 7. Average Total Stented Length 71 Average total stent length (mm) 86.1 73
    8. 11. MAIN-COMPARE trial n=858 (n=660-SES; n=189 PES) Lee JY et al. J Am Coll Cardiol 2009; 54:853–9
    9. 12. ISAR-LEFT MAIN trial Mehili J et al. J Am Coll Cardiol 2009;53:1760–8
    10. 13. Le Mans Registry Buszman PE et al. J Am Coll Cardiol 2009;54:1500–11
    11. 14. Intervencionismo Cardiaco 2008-09 <ul><li>Tratamiento de la enfermedad multivaso y/o TCI: </li></ul><ul><ul><li>ICP vs. Cirugía en enfermedad de 3 v y/o TCI: Syntax 2 años </li></ul></ul><ul><ul><li>ICP en TCI: ISAR-Left Main; Main Compare; LeMans Registry </li></ul></ul><ul><li>Stent farmacoactivos de 2ª generación: </li></ul><ul><ul><li>SPIRIT IV, COMPARE trials. </li></ul></ul><ul><ul><li>NEVO II </li></ul></ul>
    12. 15. SPIRIT IV trial
    13. 16. SPIRIT IV trial
    14. 17. SPIRIT IV trial
    15. 18. SPIRIT IV trial
    16. 19. Study Outline: COMPARE trial Clinical events were adjudicated by an independent CEC Target vessel revascularizations were analysed by an independent QCA core lab.
    17. 20. Primary Endpoint Result MACE (all death, non-fatal MI and TVR) # Patients at Risk Taxus Xience P = 0.023 (log-rank test) RR = 0.69 (0.50-0.95) 9.1 % 6.2 % Taxus 903 868 865 860 853 849 842 838 833 825 823 822 819 Xience 897 872 870 867 865 864 858 854 851 849 844 842 840 Δ 1.1% Δ 2.9 %
    18. 21. Secondary Endpoint Result Stent Thrombosis (Definite & probable according to ARC) 2.6 % 0.7 % Taxus Xience P = 0.002 (log-rank test) RR = 0.26 (0.11-0.64)
    19. 22. <ul><li>The NEVO™ stent provides: </li></ul><ul><li>CoCr stent platform </li></ul><ul><li>- Flexible, conformable, thin struts, maximized vessel coverage, open cell design </li></ul><ul><li>Reservoir Technology (RES-TECHNOLOGY™) </li></ul><ul><ul><li>- Reduced contact between vessel wall and polymer </li></ul></ul><ul><li>Biodegradable polymer </li></ul><ul><li>- Rapid endothelialization </li></ul><ul><ul><li>- Inflammation scores on par with BMS </li></ul></ul><ul><ul><li>- Tailored sirolimus release achieving CYPHER ® -like tissue levels </li></ul></ul><ul><li>Sirolimus </li></ul><ul><ul><ul><li>- Largest body of clinical evidence </li></ul></ul></ul>NEVO™ Sirolimus-Eluting Stent : Cordis’ 1st RES TECHNOLOGY™ Stent
    20. 23. Reservoirs minimize tissue/polymer contact area by more than 75% 75% Reduction NEVO™: Reduced Relative Polymer Exposure
    21. 24. NEVO RES-I Study Overview 40 sites worldwide Europe, South America, Australia and New Zealand 394 subjects, stratified by diabetic status, and randomized 1:1 Single De Novo Native Coronary Artery Lesions Reference Vessel Diameter: 2.5 - 3.5 mm Lesion Length: ≤ 28 mm Primary Endpoint: 6-month in-stent late loss Sub-Study: IVUS subset (50 patients per arm) Dual antiplatelet therapy for ≥ 6 months NEVO™ Sirolimus-eluting Stent (n = 202) TAXUS® Liberté™ Paclitaxel-eluting Stent (n = 192) 30 Day 6Months 1Year 2Year 3Year 4ear Angiographic/ IVUS 5Year Clinical/ MACE 87% Angiographic follow up; 97% 180 day clinical follow up
    22. 25. P<0.001 for superiority P<0.001 Primary Endpoint Late Loss (mm) ±0.31 ±0.48 ±0.32 ±0.42 n=185 n=166 n=166 n=166 Primary Endpoint: Late Lumen Loss at 6 Months NEVO™ Taxus ® Liberte™ TCT 09, Oral presentation, J. Ormiston
    23. 26. P = 0.19 P = 0.37 P = 0.75 No reports of Emergent CABG % of patients P = 0.354 P = 0.33 6-Month MACE and Components 10 8 6 4 2 0 MACE Death MI Death or MI TLR 4.0 7.4 0.5 1.6 2.0 2.6 2.5 4.2 1.5 3.2 NEVO™ Taxus ® Liberte™ EuroPCR 09, Oral presentation, Chr. Spaulding 8/198 13/189 1/198 3/189 4/198 5/189 5/198 8/189 3/198 6/187
    24. 27. Diabetic Subgroup Analysis: In-Stent Late Lumen Loss at 6 Months EuroPCR 09, Oral presentation, Chr. Spaulding Diabetics n = 65 Non-Diabetics n = 277 0.5 0.3 0.4 0.1 0.2 0.0 P = 0.03 P < 0.001 0.17 ± 0.42 0.42 ± 0.46 0.12 ± 0.28 0.34 ± 0.46 Late loss (mm) NEVO™ Taxus ® Liberté™
    25. 28. Intervencionismo Cardiaco 2008-09 CONCLUSIONES <ul><li>La cirugía presenta mejores resultados que la ICP en pacientes con enfermedad de 3 v y/o TCI a los 2 años de seguimiento a expensas de una mayor necesidad de nueva revascularización con ICP. </li></ul><ul><li>Los pacientes con Syntax score bajo evolucionan de forma parecida entre ICP y cirugía coronaria. </li></ul><ul><li>Los pacientes con enfermedad de tronco pueden beneficiarse de la ICP. Se requieren estudios multicéntricos diseñados a este objetivo. </li></ul><ul><li>Los stent farmacoactivos de 2ª generación son más eficaces y más seguros que los de 1ª generación (Taxus ™ ) </li></ul>

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