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CYPHER is Preferred in Diabetics!

CYPHER is Preferred in Diabetics!. Stephan Windecker University Hospital Bern Switzerland. Conflict of Interest Statement. Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.

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CYPHER is Preferred in Diabetics!

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  1. CYPHER is Preferred in Diabetics! Stephan Windecker University Hospital Bern Switzerland

  2. Conflict of Interest Statement Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Physician NameCompany/Relationship Stephan Windecker Biotronik (Consultant) Cordis (Consultant) Boston Scientific (Speakers Bureau) Abott (Speakers Bureau)

  3. Risk of Restenosis in the Bare Metal Stent EraDiabetic vs Nondiabetic Patients P=0.001 OR=1.6 1.4-1.9 P<0.001 P=0.001 P<0.001 P=ns P=0.02 % N=230 N=300 N=84 N=2255 N=1439 N=4808

  4. Mechanism of Restenosis in Diabetic Patients Late Loss Elezi S et al. JACC 1998;32:1866 Neointimal Hyperplasia Kornowski et al. Circulation 1997;95:1366 P<0.001 P<0.001 Late Loss (mm) Intimal Hyperplasia (%)

  5. Impact of Restenosis on Prognosis in Diabetic Patients Restenosis Elezi S et al. JACC 1998;32:1866 Mortality Van Belle E et al. Circulation 2001;103:1218 P<0.001 P<0.001 Restenosis: Independent Predictor of Mortality! Mortality @ 10 years (%) (%) P=0.04 603 diabetic patients undergoing PTCA between 1987-1995

  6. DIABETES: Randomized Comparison of CYPHER vs Bare Metal Stent in Diabetic Patients Sabate M et al. Circulation 2005;112:2175-83 RVD: 2.34 mm; Mean lesion length: 15.0 mm Late Loss Restenosis TLR mm % %  72% P<0.001  77% P<0.001 P<0.001 N=103 N=101 N=80 N=80 N=103 N=101

  7. Indirect Comparison of Randomized Trials With CYPHER vs TAXUS Stratified According to DMStettler C et al. Heart 2006;92:650-7 SES DM Non-DM Age Female RVD SIRIUS 279 778 62 29% 2.80 E-SIRIUS 81 271 62 29% 2.55 C-SIRIUS 24 76 61 31% 2.63 DIABETES 160 - 67 38% 2.34 RAVEL 44 194 61 24% 2.62 SES-SMART 64 193 64 28% 2.20 Total (N) 652 1458 2.52 PES DM Non-DM Age Female F/u TAXUS I 11 49 65 11% 2.97 TAXUS II 76 453 60 24% 2.75 TAXUS IV 318 996 63 28% 2.75 TAXUS VI 89 357 63 24% 2.78 Total (N) 494 1885 2.81

  8. Indirect Comparison of Randomized Trials With CYPHER vs TAXUS Stratified According to DM Stettler C et al. Heart 2006;92:650-7 Non-Diabetic Patients P=0.03 RVD=2.52 mm (CYPHER) vs RVD=2.81 mm (TAXUS) P=0.045 Diabetic Patients P=0.31 P=0.70 Relative Risk Reduction (%)

  9. Problems With Indirect Comparisons and Registries • Different definitions of TLR/TVR • CYPHER: • Symptoms and DS% >50% • Asymptomatic and DS% >70% • TAXUS: • Ischemia and DS% >50% • Symptoms and DS% >70% • Different rates of follow-up angiography • SIRIUS: 66% • TAXUS IV: 43%

  10. RESEARCH vs T-SEARCHOng A et al. JACC 2005;45:1135-41 Real World Registry Protocol-driven repeat angiography in the following subgroups: SES (40%) -LM -Bifurcation -CTO -very small vessels -long stent length -acute MI PES (27%) -LM -bifurcation -vulnerable plaque study Reangiography 27% 40% SES: 3.7% PES: 5.4% SES: 1.6% PES: 4.1%

  11. Why CYPHER is Superior • Late loss and restenosis in diabetic patients

  12. Direct Comparison CYPHER vs TAXUS Late Loss – Overall Population In-Stent Late Loss @ 8 Months P<0.001 P<0.001 P=0.02 P<0.001 P=0.007 P=0.02 P<0.001 P<0.001 mm

  13. Direct Comparison CYPHER vs TAXUS Late Loss – Diabetic Patients In-Stent Late Loss @ 8 Months P<0.001 P=0.02 P<0.001 mm N=102 N=103 N=66 N=59 N=244 N=241

  14. 1 0.04 0.1 0.5 2 10 25 Risk Ratio Favours PES Favours SES Direct Comparison CYPHER vs TAXUS Binary Restenosis – Overall Population Risk Ratio (95% CI) % Weight ISAR-DESIRE 0.66 ( 0.35, 1.24) 9.8 ISAR-DIABETES 0.42 ( 0.18, 0.96) 6.1 SIRTAX 0.56 ( 0.35, 0.91) 15.2 CORPAL 0.67 ( 0.41, 1.09) 14.8 REALITY 0.86 ( 0.65, 1.14) 30.6 ISAR-SMART 3 0.60 ( 0.36, 1.00) 13.8 Long DES II 0.29 ( 0.11, 0.76) 4.6 PROSIT 0.43 ( 0.17, 1.10) 5.0 0.63 ( 0.51, 0.79), I2=21.3% Overall

  15. Direct Comparison CYPHER vs TAXUS Binary Restenosis – Diabetic Patients In-Segment Restenosis @ 8 Months RR 15% P=0.20 P=0.11 P=0.02 % N=102 N=103 N=66 N=59 N=244 N=242 N=412 N=404

  16. 1 0.04 0.1 0.5 2 10 25 Risk Ratio Favours PES Favours SES Direct Comparison CYPHER vs TAXUS TLR – Overall Population Risk Ratio % Weight (95% CI) TAXI 2.94 ( 0.31, 27.80) 1.0 ISAR-DESIRE 0.42 ( 0.19, 0.92) 7.3 ISAR-DIABETES 0.53 ( 0.23, 1.21) 6.6 SIRTAX 0.55 ( 0.36, 0.86) 18.3 CORPAL 0.64 ( 0.36, 1.11) 12.7 REALITY 0.96 ( 0.64, 1.44) 20.0 BASKET 0.50 ( 0.22, 1.14) 6.6 ISAR-SMART 3 0.43 ( 0.23, 0.80) 10.8 Zhang et al 0.73 ( 0.36, 1.45) 9.0 Long DES II 0.32 ( 0.12, 0.86) 4.8 PROSIT 0.33 ( 0.09, 1.19) 2.9 Overall 0.59 ( 0.47, 0.74) ,I2=16.1% N=2901 N=2853

  17. Direct Comparison CYPHER vs TAXUS TLR – Diabetic Patients Target Lesion Revascularization @ 12 Months P=0.06 P=0.30 P=0.02 RR 23% % N=125 N=125 N=108 N=93 N=186 N=192 N=419 N=410

  18. Individual Patient Data Meta-Analysis Risk of TLR and Diabetes Target Lesion Revascularization N Risk Ratio & 95% CI 0.60 (0.42,0.86) No Diabetes P=0.006 I2=0% 1,928 Diabetes 0.54 (0.22,1.33) 887 P=0.18 I2=65% NIDDM 0.78 (0.43,1.38) 602 P=0.39 I2=0% Insulin dependent Diabetes 0.61 (0.06,6.46) 256 P=0.68 I2=71% 0.2 1 5 Pooled 2,786 Favors SES Favors PES Random Effects Model Data from ISAR-DESIRE, ISAR-DIABETES, REALITY, SIRTAX

  19. Individual Patient Data Meta-Analysis Risk of TLR and NIDDM Target Lesion Revascularization N Risk Ratio & 95% CI 0.78 (0.43,1.38) P=0.39 I2=0% NIDDM 602 ISAR-DESIRE 0.47 (0.04,5.31) ISAR-DIABETES 0.76 (0.29,1.99) SIRTAX 0.54 (0.14,2.00) REALITY 1.00 (0.40,2.59) 0.2 1 5 Favors SES Favors PES Random Effects Model Data from ISAR-DESIRE, ISAR-DIABETES, REALITY, SIRTAX

  20. Individual Patient Data Meta-Analysis Risk of TLR and IDDM Target Lesion Revascularization N Risk Ratio & 95% CI 0.61 (0.06,6.46) P=0.68, I2=71% P=0.68 I2=71% IDDM 256 ISAR-DIABETES 0.13 (0.02,1.21) SIRTAX 0.26 (0.03,2.35) REALITY 6.50 (0.73,58.0) 0.2 1 5 Favors SES Favors PES Random Effects Model Data from ISAR-DESIRE, ISAR-DIABETES, REALITY, SIRTAX

  21. Why CYPHER is Superior • Late loss and restenosis in diabetic patients • Vessel size in diabetic patients

  22. Diabetes and Vessel Size Acute MI Woodfield SL et al. JACC 1996;28:1661 Elective PCI Mehran et al. JACC 2004;43:1348 P=0.004 P=0.007 P=0.004 P=0.05 Reference Vessel Diameter (mm) Reference Vessel Diameter (mm) N=1200 N=235 N=204 N=573 N=93 N=182 N=23 N=512 N=77

  23. 1845 patients TLR 9.2% Vessel size <2.6 mm Vessel size ≥2.6 mm 7.2% 11.3% PES SES SES PES 7.2% 7.2% 7.8% 15.6% Predictive Factors of Restenosis in the Drug-Eluting Stent EraKastrati A et al. Circulation 2006;113:2293-00

  24. SIRTAX – Subgroup Analysis of CYPHER vs TAXUS in Small Vessels (<2.75 mm) RVD: 2.45 mm; Mean lesion length: 12.2 mm Late Loss Restenosis TLR mm % % P<0.001 P=0.001 P=0.001 N=181 N=185 N=132 N=134 N=132 N=134

  25. ISAR-SMART 3: Randomized Comparison of CYPHER vs TAXUS in Small Vessels (<2.80 mm)Mehilli J et al. Eur Heart J 2006;27:260-66 RVD: 2.40 mm; Mean lesion length: 12.3 mm Late Loss Restenosis TLR mm % % P<0.001 P=0.047 P=0.008 N=176 N=174 N=180 N=180 N=176 N=174

  26. Individual Patient Data Meta-Analysis Risk of TLR and Small Vessels

  27. Why CYPHER is Superior • Late Loss and restenosis in diabetic patients • Vessel size in diabetic patients • Risk of stent thrombosis in diabetic patients

  28. Diabetes as Predictor of Stent Thrombosis at One Year in The Era of Drug-Eluting Stents OR=2.0 (0.8-4.9) OR=2.8 (1.7-4.3) HR=3.7 (1.7-7.9) HR=2.3 (1.3-4.0) Odds/Hazard Ratio Urban Circulation 2006 Iakovou JAMA 2005 Kuchulakanti Circulation 2006 Bern-Rotterdam submitted

  29. 1 0.04 0.1 0.5 2 10 25 Risk Ratio Favours PES Favours SES Direct Comparison CYPHER vs TAXUS Stent Thrombosis– Overall Population Risk Ratio (95% CI) % Weight TAXI 2.94 ( 0.12, 71.37) 2.9 ISAR-DIABETES 0.33 ( 0.01, 8.10) 2.9 SIRTAX 1.12 ( 0.46, 2.74) 36.5 CORPAL 4.85 ( 0.23, 100.62) 3.2 REALITY 0.38 ( 0.13, 1.05) 27.6 BASKET 1.06 ( 0.22, 5.23) 11.5 Zhang et al 0.55 ( 0.09, 3.28) 9.2 Long DES II 5.15 ( 0.25, 106.59) 3.2 PROSIT 0.20 ( 0.01, 4.09) 3.2 Overall 0.80 ( 0.47, 1.37), I2=0%

  30. Direct Comparison CYPHER vs TAXUS Stent Thrombosis – Diabetic Patients Stent Thrombosis @ 9-12 Months P=0.28 P=.50 P=ns % N=125 N=125 N=108 N=109 N=187 N=192

  31. Direct Comparison CYPHER vs TAXUS Cardiac Mortality – Diabetic Patients Cardiac Death @ 9-12 Months P=0.34 P=0.34 P=0.52 % N=125 N=125 N=108 N=93 N=187 N=192

  32. Direct Comparison CYPHER vs TAXUS Myocardial Infarction – Diabetic Patients Myocardial Infarction @ 9-12 Months P=0.20 P=1.00 P=0.72 % N=125 N=125 N=108 N=109 N=187 N=192

  33. CYPHER is Superior in Diabetics • Because CYPHER provides in diabetic patients • Lower late loss • A trend towards lower restenosis • A trend towards lower target lesion revascularization • Because CYPHER provides in patients with small vessels, which are more prevalent in diabetic patients • Lower late loss • Lower restenosis • Lower target lesion revascularization • Patients with IDDM require further study

  34. How Can the Differences Between SIRTAX and REALITY Be Resolved? Morice MC et al. JAMA 2006;295:895-904 Windecker S et al. N Engl J Med 2005;353:653-62 No Diabetes Diabetes • RR=50% P=0.11 • RR=20% P=0.20 • RR=41% P=0.06 • RR=30% P=0.06 Restenosis % Restenosis %

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