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FREEDOM Trial
Future REvascularization Evaluation in patientswith Diabetes mellitus: Optimal management of
Multivessel disease
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Regional Update as of October9, 2008
136 sitesUS
46 sites
Canada 18 sitesMexico 1 siteSouth America - 12 sitesArgentina 5 sitesBrazil 4 sitesColombia 2 sites
Europe
36 sitesItaly 3 sitesFrance 5 sitesSpain 6 sitesSwitzerland 1 siteGermany 7 sitesPoland 6 sitesUK
3 sites
Israel 3 sitesCzech Republic -2 sitesAustralia 15 sitesNew Zealand 3 sitesIndia 6 sites
1417 patients
US - 296Canada 295Europe- 348Poland 79Spain 75
Germany
69France - 49Italy - 29UK 11Israel 11Switzerland 6Czech Republic 19
Brazil
234Argentina 55Mexico - 38Colombia -17Australia 59New Zealand 26India - 49
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ecru men
2005 2006 2007 2008
1298
14081417
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op ecru t ng tesWorldwide
US Mount Sinai Medical Center
CANADA Vancouver Hospital and Health Sciences
Center Montreal Heart Institute
SOUTH AMERICA InCor Heart Institute Institute Dante Pazzanese of Cardiology
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SUCCESSES
FREEDOM is now the
largest database ofdiabetic subjects withmultivessel coronarydisease
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SUCCESSES
Multidisciplinaryapproach to risk
factor modificationwith oversight fromthe Diabetes andmedical
managementcommittee has beeneffective
Variable(Means)
Baseline
1 yr f/u
LDLmg/dl 89.5 79.3
HDLmg/dl
40.1 42.2
TG mg/dl 192.8 165.6
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SUCCESSES
Newsletters, bulletins and patientdiaries well received
United States/ Canada trialcoordinators meeting held
Provision of stents, clopidogrel andabciximab well worked outworldwide
Small group conference calls withDr. Fuster and Investigatorsarranged on a weekly basis to
identify obstacles to recruitment or
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ROOM FOR
IMPROVEMENT
Variable(Means)
Baseline 1 yr f/u
HbA1C 7.6 7.6
SBP mm/Hg 133.9 134
DBP mm/Hg 76.0 75.7
Smoking %
Current smoker 15.0% 7.6%
Waist cm 103.6 104.2
B li D hi
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Baseline Demographics
Treatment Arm
A(N=593)
B(N=592)
Age (mean) 63.4 63.0
Female 28.9% 29.5%
Diabetes Mellitus: Type I 4.8% 4.8%
Hypertension 83.9% 84.7%
Hyperlipidemia 85.1% 81.9%
Di b t C li ti
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Diabetes Complications
Treatment Arm
A
(N=593)
B
(N=592)
Complications associated with diabetes 18.0% 18.9%
Diabetic nephropathy 4.9% 8.6%Diabetic neuropathy 11.2% 8.8%
Diabetic foot ulcer 2.8% 0.7%
Diabetic retinopathy 6.3% 7.6%
Extremity amputation 1.2% 0.2%
Duration of diabetes (years) 10.1 10.3
PVD above diaphragm 1.9% 3.4%
PVD below diaphragm 10.0% 8.3%
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Baseline Results
Mean Treatment Arm
A(N=593)
B(N=592)
HbAlc % 7.9 7.6
LDL mg/dL 91.4 92.0
HDL mg/dL 39.4 40.0
Triglycerides mg/dL 196.9 173.3
Creatinine mg/dL 1.1 1.1
SPB mm/Hg 135 133
DBP mm/Hg 77 76
Waist circumference 103.5 103.3
Base ne D a etes Me s
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Base ne D a etes Me s
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%
Sulfonylureaother 12.2% 14.0%
Biguanides 52.5% 52.3%
Alpha-Glucosidase inhibitor 2.0% 1.5%
Thiazolidinedione 9.7% 10.1%
Rosiglitazone 64.9% 59.3%
Pioglitazone 35.1% 40.7%
Repaglinide 1.0% 1.2%
Nateglinide 0.3% 0.0%
Hi f P Ill
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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%
Base ne Me s
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Base ne Me s
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%
Base ne ar ac Me s
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Base ne ar ac Me sTreatment 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%
Thiazide diuretic 16.4% 16.5%
Beta Blocker 84.4% 84.2%
Calcium Channel Blocker 35.0% 38.7%
Nitrates 46.7% 44.3%
PCI P d S
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PCI Procedure Summary
PCI/DESStaging: % unstaged procedure% staged 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%
L i Ch t i ti i PCI/DES A
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Lesion Characteristics in PCI/DES Arm
Lesions
Reference vessel diameter (mm):
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%
Pl d T t t St t f CABG t Ti f
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Planned Treatment Strategy for CABG at Time ofQualifying Angiogram
Planned Strategy Qualifying Angiogram(N=1165)
Vessels intended to graft:LADD1D2D3
RCARAMUSCIRCUMFLEXOM1OM2OM3LPDARPDARPLVAM
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%
Complete revascularization anticipated 86.3%
CABG P d S
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CABG Procedure Summary
CABG
Off pump 22.1%
LIMA to LAD 88.2%