Global REACH Registry: Study Design
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Transcript of 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
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, 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?
1. Ohman EM et al, on behalf of the REACH Registry Investigators. Am Heart J 2006;151(4):786.e1-10.
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
1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(3).
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
1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(3).
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
1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(3).
Antidiabetes Medication Use at Baseline Among US Patients with Diabetes or Elevated Glucose – Stratified by Physician Specialty
1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(3).
General Pract.
(n = 6051)
Internist(n = 6058)
Cardiol-ogist
(n = 862)
Endocrin-ologist(n = 748)
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
1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(3).
General Pract.
(n = 10,255)
Internist(n = 10,350)
Cardiol-ogist
(n = 1955)
Endocrin-ologist(n = 732)
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
1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(3).
≥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
1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(3).
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
1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(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
Statin ACE-I/ARB ≥3 of 4(2° Prev)
Pat
ien
ts (
%)
81.879.1
84.2 82.6
70.066.0
52.551.6
56.0
1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(3).
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
Statin ACE-I/ARB ≥2 of 3(1° Prev)
Pat
ien
ts (
%)
61.9 60.261.2
79.675.5
71.3
78.9 79.5
1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(3).
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
1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(3).
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
1. Kumar A et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(3).
Participating organizations
The REACH Registry is sponsored jointly by
and endorsed by
For further information on theREACH Registry go to:
http://www.REACHRegistry.org