Cardiovascular Ischemic Event Rates in Outpatients With Symptomatic

Atherothrombosis or Risk Factors in the United States: Insights From the

REACH Registry

Kim A. Eagle, Alan T. Hirsch, Robert M. Califf, Mark J. Alberts, P. Gabriel Steg, Christopher P. Cannon, Danielle

M. Brennan, Deepak L. Bhatt, on behalf of the REACH Registry Investigators

Global REACH Registry: Study Design

Information shown may differ slightly from the published trial design owing to a subsequent protocol amendment

Primary Objective:To explore the impact of both classic and new risk factors on the prevalence of cardiovascular (CV)

ischemic events among patients with, or at high risk for, atherothrombotic disease, on an

international basis

Global REACH Registry Objectives

Additional Aim:Assess use of risk management strategies and 1-, 2-,

3- and 4-year outcomes in a broad outpatient population encompassing various geographic regions

and physician specialties

1. Ohman EM et al, on behalf of the REACH Registry Investigators. Am Heart J 2006;151(4):786.e1-10.

Must include:

Signedwritten

informedconsent

Patients aged≥45 years

At least of four criteria1

1. Documented cerebrovascular diseaseIschemic stroke or TIA

(CVD)

2. Documentedcoronary diseaseAngina, MI, angioplasty/stent/bypass

(CAD)

3. Documented historicalor current intermittentclaudication associatedwith ABI <0.9

(PAD)

At least atherothrombotic risk factors3

1. Male aged 65 yearsor female aged 70 years

2. Current smoking>15 cigarettes/day

3. Type 1 or 2diabetes

4. Hypercholesterolemia

5. Diabetic nephropathy

6. Hypertension

7. ABI <0.9 in eitherleg at rest

8. Asymptomatic carotidstenosis 70%

9. Presence of at leastone carotid plaque

Global REACH Registry Inclusion Criteria

1. Ohman EM et al, on behalf of the REACH Registry Investigators. Am Heart J 2006;151(4):786.e1-10.

ABI, ankle-brachial index; MI, myocardial infarction; TIA, transient ischemic attack.

Global REACH Registry Exclusion Criteria

• Anticipated difficulty in patient returning for follow-up visit

• Patient is currently hospitalized

• Patient is currently participating in a clinical trial

1. Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

*Timelines are for worldwide participation; local timelines will be shorter

Global REACH Registry Timeline

Baseline Follow-up at 12 3 months

Follow-up at 24 3 months

Follow-up at 33 3 months

Follow-up at 45 3 months

Timing* Dec 2003 to June 2004

From baseline time

Last follow-up March 2006

June 2006 to June 2007

June 2007 to June 2008

Required Data

Subject Data Form:

Section 1

Subject Data Form: Section 2

(progression since baseline)

Subject Data Form: Section

3(progression

since lastfollow-up)

Subject Data Form: Section

4(progression

since lastfollow-up)

Subject Data Form: Section

5(progression

since lastfollow-up)

Patient details,

history and clinical

examinationRegular

medicationsEmployment

status

Clinical outcomesVascular interventionsRegular medicationsEmployment status

Participating physicians

Pre-defined at start of Registry

Based on local practice population• General practitioners, specialists

Mainly office-based, some hospital representation

Representative of:• Local environment• Country geography

Global Physician Selection

How were they selected?

What is their profile?

1. Ohman EM et al, on behalf of the REACH Registry Investigators. Am Heart J 2006;151(4):786.e1-10.

Main Specialty Breakdown of US Practitioner Involvement (n=1,599)

GP or Internist

Cardiologist

Endocrinologist, Neurologist, Vascular Surgeon, Angioloist, Other

1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

86.8%9.7%3.5%

Patients

Recruitment at each site

Maximum 20 per site

Within overall Registry timelines

Patient inclusion criteria• Documented atherothrombotic disease, or with ≥3 atherothrombotic risk factors

Real-life setting

Global Patient Selection: Patients Fitting Inclusion Criteria

How were they selected?

What is their profile?

1. Ohman EM et al, on behalf of the REACH Registry Investigators. Am Heart J 2006;151(4):786.e1-10.

REACH Registry: US Baseline Results

Data shown may differ slightly from published abstractsowing to a subsequent database lock

US Patient Characteristics at Baseline

87.8

92.9

74.7

46.4

Multiple RF only

(n=6,617)

80.782.6Hypercholesterolemia

85.787.5Hypertension

43.651.7Diabetes

60.7

% of populationSymptomatic

(n=19,069)

57.0

Total(n=25,686)

Men

69.2 (10.3)70.3 (10.4)70.0 (10.4)Mean age (SD), yr

17.3

31.3

51.6

13.414.4Current smoker

47.243.1Former smoker

38.842.1Obesity (BMI ≥30)

31.537.335.8Overweight (BMI ≥25, <30)

1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

BMI, body mass index; RF, risk factors; SD, standard deviation.

US Vascular Disease Profile

CAD only (62%)

CAD + CVD (11%)

CVD only (15%)

CVD + PAD (1%)

PAD only (4%)

PAD + CAD (6%)

CAD + CVD + PAD (2%)

1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

US Risk Factor Prevalence by Vascular Disease (%)

CAD population

CVD population

PAD population

0

10

20

30

40

50

60

70

80

90

100

TreatedHypertension

Treated Hyper-cholesterolemia

Treated Diabetes

Obesity(BMI ≥30)

Current Smoker

Pat

ien

ts (

%)

85.7 88.1 88.084.2

71.8

79.1

44.1 44.4

52.7

39.835.8 35.2

12.5 14.3

21.4

1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

US Medication Use at Baseline

86.9

70.6

66.9

61.6

Multiple RF only

(n=6,617)

82.883.9≥1 Lipid-Lowering Agent

38.947.0≥1 Antidiabetic Agent

91.385.1Any Antithrombotic Agent

81.7

% of populationSymptomatic

(n=19,069)

76.5

Total(n=25,686)

≥1 Antiplatelet Agent

94.593.793.9≥1 Antihypertensive Agent

1.96.25.1Claudication Medications

2.624.218.7Nitrates/Other Antiaginals

1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

US Medication Use by Vascular Disease (%)

CAD population

CVD population

PAD population

0

10

20

30

40

50

60

70

80

90

100

≥1 Antihyper-tensive Agent

Any Antithrom-botic Agent

Pat

ien

ts (

%)

94.8 92.5 93.1

83.277.7

80.9

91.8 91.9 90.0

39.3 39.4

47.9

86.4

73.5

81.6

≥1 AntiplateletAgent

≥1 AntidiabeticAgent

≥1 Lipid-LoweringAgent

1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

REACH Registry:US One-Year Follow-up Analysis

Data shown may differ slightly from published abstractsowing to a subsequent database lock

Cumulative Event Rates for the US REACH Population

1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

Kaplan-Meier Event Rate CurvesREACH registry US 12 months outcome

Time, month

0 1 2 3 4 5 6 7 8 9 10 11 12

Eve

nt R

ate,

%

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

CV Death, MI, StrokeCV DeathNon-fatal MINon-fatal Stroke

One-Year Outcomes for the US REACH Population

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Nonfatal Stroke CV Death All-Cause DeathNonfatal MI

%p

atie

nts

0.0

2.5

5.0

7.5

10.0

12.5

15.0

17.5

Overall

Total Symptomatic

At Risk Asymptomatic

CV Death, Stroke, MI Other outcomes leading tohospitalization

CV Death, Stroke, MI, Otheroutcomes leading to

hospitalization

%p

atie

nts

All values are adjusted for age and sex.Error bars represent 95% confidence intervals.

4.3 5.0

2.3

10.7

12.8

5.1

13.115.4

6.6

1.41.6

0.8

1.61.8

1.11.5

1.7

0.6

2.6

2.9

1.3

1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

0

5

10

15

20

25

30

35

CAD only

CVD only

PAD only

PAD +CVD

CAD + PAD

CAD + CVD

CAD + CVD + PAD

CV Death, Stroke, MI Other outcomes leading tohospitalization

CV Death, Stroke, MI, Otheroutcomes leading to

hospitalization

%p

atie

nts

0

1

2

3

4

5

6

7

8

9

Nonfatal Stroke Nonfatal MI CV Death All-Cause Death

%p

atie

nts

One-Year Outcomes for the US REACH Population by Vascular Disease

0

5

10

15

20

25

30

35

CAD only

CVD only

PAD only

PAD +CVD

CAD + PAD

CAD + CVD

CAD + CVD + PAD

CV Death, Stroke, MI Other outcomes leading tohospitalization

CV Death, Stroke, MI, Otheroutcomes leading to

hospitalization

%p

atie

nts

0

1

2

3

4

5

6

7

8

9

Nonfatal Stroke Nonfatal MI CV Death All-Cause Death

%p

atie

nts

4.06.1

3.0

5.06.5 6.8

9.9 12.28.1

8.6

9.7

17.2 18.1

23.0

14.211.8 10.9

11.9

20.5 21.1

25.8

0.8

3.7

0.7

2.2

0.7

2.8

3.0

1.7 1.3 0.7

1.6

2.3 2.3

3.3

1.5 1.4

1.5

1.1 3.3

1.9

4.0

2.5 2.3

2.6

3.05.0

3.7

5.5

All values are adjusted for age and sex.Error bars represent 95% confidence intervals.

1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

0.0

2.5

5.0

7.5

10.0

12.5

15.0

17.5

Caucasian

African American

Hispanic

Asian

CV Death, Stroke, MI Other outcomes leading tohospitalization

CV Death, Stroke, MI, Otheroutcomes leading to

hospitalization

%p

atie

nts

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

Nonfatal Stroke Nonfatal MI CV Death All-Cause Death

%p

atie

nts

One-Year Outcomes for the US REACH Population by Ethnic Group

All values are adjusted for age and sex.Error bars represent 95% confidence intervals.

4.24.6 4.4

5.1

10.611.4

12.2 10.7 12.9

14.0 14.4 12.7

1.3

1.9

1.1

1.5

1.6 1.4

2.0

2.4

1.51.6 1.3 1.1

2.62.4 1.7

2.4

1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

Participating organizations

The REACH Registry is sponsored jointly by

and endorsed by

For further information on theREACH Registry go to:

http://www.REACHRegistry.org