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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%