global reach registry: study design

Regional and Practice Variation in Adherence to Guideline Recommendations

for Secondary and Primary Prevention Among Outpatients with Atherothrombosis or Risk Factors in the US: A Report From

the REACH Registry

Amit Kumar, Gregg C. Fonarow, Kim A. Eagle, Alan T. Hirsch, Robert M. Califf, Mark J. Alberts, William E. Boden, P. Gabriel

Steg, Mingyuan Shao, Deepak L. Bhatt, Christopher P. Cannon, on behalf of the REACH Registry Investigators

Global REACH Registry: Study Design

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 Aims: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


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



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)


4(progression



5(progression


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?


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

GP or Internist

Cardiologist

Endocrinologist, Neurologist, Vascular Surgeon, Angiologist, Other

1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):91-97.

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?


REACH Registry:Adherence to Primary and Secondary

Prevention Guidelines in the US

Background and Objectives

Proven risk-reducing therapies for patients with or at risk for atherothrombotic events include antihypertensive, antiplatelet, antidiabetic, and lipid-lowering agents

Hospital-based studies have shown that better adherence to guideline-recommended risk-reducing therapies improves clinical outcomes

This analysis of the US cohort of the REACH Registry was undertaken to analyze the use of risk-reducing therapies for both primary and secondary atherothrombosis prevention, stratified by US Census Region and physician specialty

1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(3).

Patient Characteristics at Baseline – Stratified by US Census Region


Total(N = 25,686)

Northeast(n = 4775)

Midwest(n = 6267)

South(n = 9865)

West(n = 4507)

Symptomatic, % 74.2 72.5 76.4 74.5 72.5

Asymptomatic, % 25.8 27.5 23.6 25.5 27.5

Men, % 57.0 57.9 56.0 55.7 60.3

≥65 years of age, % 69.1 71.4 69.5 66.0 72.4

Caucasian, % 80.2 83.8 87.2 76.6 74.4

African American, % 10.8 9.8 9.6 14.8 4.8

Hispanic, % 5.5 3.3 1.6 6.2 11.7

Asian, % 2.8 2.6 1.3 1.7 8.0

Diabetes, % 51.7 49.6 50.8 52.5 53.2

Hypertension, % 87.5 87.6 87.9 88.0 85.9

Hypercholesterolemia, % 82.6 85.1 82.6 81.4 82.6

Obesity, % 42.1 43.4 45.3 42.1 36.9

Overweight, % 35.8 34.4 35.5 36.0 36.7

Former smoker, % 43.1 41.5 43.4 42.5 45.3

Current smoker, % 14.4 13.5 14.5 15.8 11.8

US Patient Characteristics at Baseline – Stratified by Physician Specialty


General Practitioner(N = 11,662)

Internist(n = 11,711)

Cardiologist(n = 2401)

Endocrin-ologist(n = 840)

Other(n = 1249)

Symptomatic,% 71.6 73.6 93.9 63.0 76.1

Asymptomatic, % 28.4 26.4 6.1 37.0 23.9

Men, % 55.4 56.8 66.7 60.1 53.4

≥65 years old, % 66.4 72.8 67.8 64.6 70.4

Caucasian, % 80.1 78.8 84.1 84.0 73.5

African American, % 10.3 11.8 7.3 5.9 13.8

Hispanic, % 6.2 5.2 4.9 4.7 8.7

Asian, % 2.7 3.6 2.8 4.4 3.0

Diabetes, % 52.2 52.0 36.1 89.2 53.2

Hypertension, % 88.1 88.6 81.7 87.8 89.2

Hypercholesterolemia, % 81.4 83.4 87.0 88.1 77.4

Obesity, % (BMI ≥30 kg/m2) 44.4 40.7 34.5 50.7 39.9

Overweight, % (BMI 25 to <30 kg/m2)

34.6 36.6 40.9 32.1 34.5

Former smoker, % 41.3 43.6 51.7 42.5 39.1

Current smoker, % 16.8 12.8 10.4 11.4 13.3

Use of Risk-Reducing Medications at Baseline in US Patients – Total Population


Antidiabetes Medication Use at Baseline Among US Patients with Diabetes or Elevated Glucose – Stratified by Physician Specialty


General Pract.

(n = 6051)

Internist(n = 6058)

Cardiol-ogist

(n = 862)


Other(n = 646)

Total

≥1 Antidiabetic, % 91.9 90.6 90.3 97.1 91.4 91.6

Insulin,% 26.0 27.7 29.1 53.4 36.4 28.6

Biguanide, % 45.5 41.2 35.5 42.0 32.7 42.6

Sulfonylurea, % 47.4 45.0 42.0 39.6 39.5 45.4

Thiazolidinedione, % 33.6 31.1 27.5 32.6 28.3 32.1

Other Antidiabetic, % 8.1 8.8 9.7 7.9 10.8 8.3

Antihypertensive Medication Use at Baseline Among US Patients with Diagnosed Hypertension or Elevated BP at Enrollment – Stratified by Physician Specialty


General Pract.

(n = 10,255)

Internist(n = 10,350)

Cardiol-ogist

(n = 1955)


Other(n = 1106)

Total

≥1 Antihypertensive, % 99.1 99.1 98.9 98.9 99.0 99.1

ACE Inhibitor,% 51.3 47.8 50.9 51.6 43.6 49.6

ARB, % 27.0 30.7 25.2 32.7 28.1 28.3

β-Blocker, % 50.3 52.3 70.5 46.2 49.6 52.6

Ca2+ Channel Blocker, % 35.5 37.9 32.0 27.6 38.8 36.0

Diuretic, % 52.7 53.4 48.9 50.8 52.3 52.9

Other Antihypertensive, % 12.4 13.6 14.3 15.6 19.0 13.2

Use of Risk-Reducing Medications in the US – Overall Population

0

10

20

30

40

50

60

70

80

90

100

AntiplateletAgent

Statin ACE-I/ARB β-Blocker ≥3 of 4(2° Prev)

Pat

ien

ts (

%) 76.5 76.7

81.776.5 77.1

67.965.3

50.4

57.4

65.6

75.379.1


≥2 of 3(1° Prev)

Total (N = 25,686)

Secondary Prevention (n = 19,069)

Primary Prevention (n = 6617)

61.6

Use of Risk-Reducing Medications in the Secondary Prevention Population – Stratified by US Census Region

0

10

20

30

40

50

60

70

80

90

100

AntiplateletAgent

Statin ACE-I/ARB β-Blocker ≥3 of 4(2° Prev)

Pat

ien

ts (

%)

82.3 81.183.080.6

75.077.4

64.7 66.4

52.9

64.7


81.0

63.4

55.2

75.2

64.758.9

65.670.7

63.766.4

Northeast (n = 3462)

Midwest (n = 4786)

South (n = 7353)

West (n = 3267)

Use of Risk-Reducing Medications in the Primary Prevention Population – Stratified by US Census Region

0

10

20

30

40

50

60

70

80

90

100

AntiplateletAgent

Statin ACE-I/ARB ≥2 of 3(1° Prev)

Pat

ien

ts (

%) 62.4

59.162.1

79.774.9

77.5 76.0 75.077.3


62.2

78.978.274.7

79.780.575.4

Northeast (n = 1313)

Midwest (n = 1481)

South (n = 2512)

West (n = 1240)

Use of Risk-Reducing Medications in the Secondary Prevention Population – Stratified by Physician Specialty

0

10

20

30

40

50

60

70

80

90

100

AntiplateletAgent


Pat

ien

ts (

%)

81.879.1

84.2 82.6

70.066.0

52.551.6

56.0


78.8

70.273.9

68.3

74.2

66.2

56.7

β-Blocker

General Practitioner (n = 8352)

Internist (n = 8615)

Cardiologist (n = 2254)

Endocrinologist (n = 529)

Other (n = 951)83.7

57.5

66.7

77.181.0

74.3

64.3

55.2

62.9

Use of Risk-Reducing Medications in the Primary Prevention Population – Stratified by Physician Specialty

0

10

20

30

40

50

60

70

80

90

100

AntiplateletAgent


Pat

ien

ts (

%)

61.9 60.261.2

79.675.5

71.3

78.9 79.5


57.1

76.874.5

83.0

General Practitioner (n = 3310)

Internist (n = 3096)

Cardiologist (n = 147)

Endocrinologist (n = 311)

Other (n = 298)

74.4

80.478.1

61.5

76.3

82.879.7

76.3

Baseline Predictors for Use of ≥3 of 4 Medication Classes in the US Secondary Prevention Population


OR, 4.59; P < 0.0001

OR, 1.76; P < 0.0001

OR, 1.62; P < 0.0001

OR, 1.55; P < 0.0001

OR, 1.40; P < 0.0001

OR, 1.27; P < 0.0001

OR, 1.22; P = 0.0029

OR, 1.22; P = 0.0072

OR, 1.19; P < 0.0001

OR, 1.14; P = 0.0063

OR, 1.13; P = 0.0044

OR, 0.79; P = 0.0095

OR, 0.86; P = 0.0014

OR, 0.86; P = 0.0001

OR, 0.82; P < 0.0001

OR, 0.81; P < 0.0001

OR, 0.78; P = 0.0060

OR, 0.71; P < 0.0001

OR, 0.68; P < 0.0001

OR, 0.60; P < 0.0001

Conclusions

Guideline-recommended primary and secondary preventive therapies were underused across US census regions and physician specialties

Among US Census regions, patients in the Northeast showed the highest use of preventive medication use, the South the lowest

Among physician specialties, cardiologists showed the highest prescription of preventive medication use

To improve use of guideline-recommended primary and secondary prevention, novel physician- and patient-centered approaches may be necessary


Participating organizations

The REACH Registry is sponsored jointly by

and endorsed by

For further information on theREACH Registry go to:

http://www.REACHRegistry.org

global reach registry: study design

Documents