19. Study Outline: COMPARE trial Clinical events were adjudicated by an independent CEC Target vessel revascularizations were analysed by an independent QCA core lab.
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
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
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
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™
28.
Notas del editor
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).