Скачать презентацию FREEDOM Trial Future REvascularization Evaluation in patients with Скачать презентацию FREEDOM Trial Future REvascularization Evaluation in patients with

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FREEDOM Trial Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel FREEDOM Trial Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease

Regional Update as of October 9, 2008 1417 patients US - 296 Canada – Regional Update as of October 9, 2008 1417 patients US - 296 Canada – 295 Europe- 348 Poland – 79 Spain – 75 Germany – 69 France - 49 a. Italy - 29 UK – 11 Israel – 11 Switzerland – 6 Czech Republic – 19 Brazil – 234 Argentina – 55 Mexico - 38 Colombia -17 Australia – 59 New Zealand – 26 India - 49 136 sites US – 46 sites Canada – 18 sites Mexico – 1 site South America - 12 sites Argentina – 5 sites Brazil – 4 sites Colombia – 2 sites Europe – 36 sites Italy – 3 sites France – 5 sites Spain – 6 sites Switzerland – 1 site Germany – 7 sites Poland – 6 sites UK – 3 sites Israel – 3 sites Czech Republic -2 sites Australia – 15 sites New Zealand – 3 sites India – 6 sites

FREEDOM Recruitment 1417 1408 1298 2005 2006 2007 2008 FREEDOM Recruitment 1417 1408 1298 2005 2006 2007 2008

Top 5 Recruiting Sites Worldwide US a. Mount Sinai Medical Center CANADA a. Vancouver Top 5 Recruiting Sites Worldwide US a. Mount Sinai Medical Center CANADA a. Vancouver Hospital and Health Sciences Center • Montreal Heart Institute SOUTH AMERICA • In. Cor Heart Institute • Institute Dante Pazzanese of Cardiology

SUCCESSES a. FREEDOM is now the largest database of diabetic subjects with multivessel coronary SUCCESSES a. FREEDOM is now the largest database of diabetic subjects with multivessel coronary disease

SUCCESSES a. Multidisciplinary approach to risk factor modification with oversight from the Diabetes and SUCCESSES a. Multidisciplinary approach to risk factor modification with oversight from the Diabetes and medical management committee has been effective Variable (Means) Baselin 1 yr f/u e LDL mg/dl 89. 5 79. 3 HDL 40. 1 mg/dl TG mg/dl 192. 8 42. 2 165. 6

SUCCESSES a. Newsletters, bulletins and patient diaries well received b. United States/ Canada trial SUCCESSES a. Newsletters, bulletins and patient diaries well received b. United States/ Canada trial coordinators meeting held c. Provision of stents, clopidogrel and abciximab well worked out worldwide d. Small group conference calls with Dr. Fuster and Investigators arranged on a weekly basis to identify obstacles to recruitment or

ROOM FOR IMPROVEMENT Variable (Means) Baseline 1 yr f/u Hb. A 1 C 7. ROOM FOR IMPROVEMENT Variable (Means) Baseline 1 yr f/u Hb. A 1 C 7. 6 SBP mm/Hg 133. 9 134 DBP mm/Hg 76. 0 75. 7 Current smoker 15. 0% 7. 6% Waist cm 103. 6 104. 2 Smoking %

Baseline Demographics Treatment Arm A B (N=593) (N=592) Age (mean) 63. 4 63. 0 Baseline Demographics Treatment Arm A B (N=593) (N=592) Age (mean) 63. 4 63. 0 Female 28. 9% 29. 5% Diabetes Mellitus: Type I 4. 8% Hypertension 83. 9% 84. 7% Hyperlipidemia 85. 1% 81. 9%

Diabetes Complications Treatment Arm A (N=593) B (N=592) 18. 0% 18. 9% a. Diabetic Diabetes Complications Treatment Arm A (N=593) B (N=592) 18. 0% 18. 9% a. Diabetic nephropathy 4. 9% 8. 6% a. Diabetic neuropathy 11. 2% 8. 8% a. Diabetic foot ulcer 2. 8% 0. 7% a. Diabetic retinopathy 6. 3% 7. 6% a. Extremity amputation 1. 2% 0. 2% a. Duration of diabetes (years) 10. 1 10. 3 PVD above diaphragm 1. 9% 3. 4% PVD below diaphragm 10. 0% 8. 3% Complications associated with diabetes

Baseline Results Mean Treatment Arm A (N=593) B (N=592) Hb. Alc % 7. 9 Baseline Results Mean Treatment Arm A (N=593) B (N=592) Hb. Alc % 7. 9 7. 6 LDL mg/d. L 91. 4 92. 0 HDL mg/d. L 39. 4 40. 0 Triglycerides mg/d. L 196. 9 173. 3 Creatinine mg/d. L 1. 1 SPB mm/Hg 135 133 DBP mm/Hg 77 76 103. 5 103. 3 Waist circumference

Baseline Diabetes Meds Treatment Arm A (N=593) B (N=592) Insulin 35. 3% 28. 9% Baseline Diabetes Meds Treatment Arm A (N=593) B (N=592) Insulin 35. 3% 28. 9% Sulfonylurea 40. 8% 47. 9% Glyburide 17. 9% 22. 1% Glipizide 5. 4% 6. 6% Glimepiride 5. 4% 5. 8% Sulfonylurea – other 12. 2% 14. 0% Biguanides 52. 5% 52. 3% Alpha-Glucosidase inhibitor 2. 0% 1. 5% Thiazolidinedione 9. 7% 10. 1% a. Rosiglitazone 64. 9% 59. 3% a. Pioglitazone 35. 1% 40. 7% Repaglinide 1. 0% 1. 2% Nateglinide 0. 3% 0. 0%

History of Present Illness A (N=593) B (N=592) Stable Coronary Heart Disease 68. 3% History of Present Illness A (N=593) B (N=592) Stable Coronary Heart Disease 68. 3% 71. 4% Acute Coronary Syndrome (ACS) ST elevation MI(>72 hrs prior to admission Non-ST elevation ACS 31. 7% 17. 1% 82. 9% 28. 6% 17. 3% 82. 7% NYHA CHF Classification (Class III/IV excluded) Class I 74. 5% 72. 6%

Baseline Meds Treatment Arm A (N=593) B (N=592) Lipid Lowering agents 85. 9% 86. Baseline Meds Treatment Arm A (N=593) B (N=592) Lipid Lowering agents 85. 9% 86. 0% Statins 95. 9% 96. 8% Fibrates 5. 7% 5. 0% Ezetemibe 5. 5% 5. 8% Niacin 0. 8% 1. 6% Omega-3 fatty acids 0. 4% 1. 0% Others 2. 2% 0. 4%

Baseline Cardiac Meds Treatment Arm A (N=593) B (N=592) ACE Inhibitor 76. 8% 79. Baseline Cardiac Meds Treatment Arm A (N=593) B (N=592) ACE Inhibitor 76. 8% 79. 3% ARB 17. 8% 19. 0% Aldosterone Antagonist 4. 2% 4. 0% Loop Diuretic 14. 6% 11. 8% 16. 4% 16. 5% 84. 4% 84. 2% 35. 0% 38. 7% 46. 7% 44. 3% a. Thiazide diuretic Beta Blocker a. Calcium Channel Blocker Nitrates

PCI Procedure Summary PCI/DES Staging: % unstaged procedure % staged procedures involving >1 hospitalization PCI Procedure Summary PCI/DES Staging: % unstaged procedure % staged procedures involving >1 hospitalization 65. 9% 34. 1% 67. 7% Mean total # of lesions attempted across all stages 3. 6 ± 1. 4 Mean total # drug-eluting stents placed per patient (across all stages) 4. 2 ± 1. 9 Reopro used during index procedure (stage 1 for staged procedures) 54. 9% Heparin administered 83. 1% Bivalirudin administered 16. 3%

Lesion Characteristics in PCI/DES Arm Lesions Reference vessel diameter (mm): <2. 5 -3. 0 Lesion Characteristics in PCI/DES Arm Lesions Reference vessel diameter (mm): <2. 5 -3. 0 -3. 5 -4. 0 >4. 0 16. 1% 47. 7% 26. 8% 8. 4% 0. 9% Chronic total occlusion 4. 6% Bifurcation lesion 11. 3% Balloon angioplasty alone 3. 6% Direct stenting 27. 0%

Planned Treatment Strategy for CABG at Time of Qualifying Angiogram Planned Strategy Qualifying Angiogram Planned Treatment Strategy for CABG at Time of Qualifying Angiogram Planned Strategy Qualifying Angiogram (N=1165) Vessels intended to graft: a. LAD D 1 D 2 D 3 RCA RAMUS CIRCUMFLEX OM 1 OM 2 OM 3 LPDA RPLV AM Complete revascularization anticipated 95. 4% 29. 8% 5. 8% 0. 3% 47. 5% 7. 0% 24. 6% 42. 9% 22. 5% 5. 3% 3. 5% 28. 3% 5. 0% 0. 8% 86. 3%

CABG Procedure Summary CABG Off – pump 22. 1% LIMA to LAD 88. 2% CABG Procedure Summary CABG Off – pump 22. 1% LIMA to LAD 88. 2%