Transcript REACH Registry: Background

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
Global REACH Registry Objectives
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
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.
Global REACH Registry Inclusion
Criteria
Must include:
Signed
written
informed
consent
Patients aged
≥45 years
1. Documented
cerebrovascular disease
Ischemic stroke or TIA
(CVD)
2. Documented
coronary disease
Angina, MI, angioplasty/
stent/bypass
(CAD)
3. Documented historical
or current intermittent
claudication associated
with ABI <0.9
(PAD)
At least
of four
criteria
1
At least
atherothrombotic
risk factors
3
1. Male aged 65 years
or female aged 70
years
2. Current smoking
>15 cigarettes/day
3. Type 1 or 2
diabetes
4. Hypercholesterolemia
5. Diabetic nephropathy
6. Hypertension
7. ABI <0.9 in either
leg at rest
8. Asymptomatic carotid
stenosis 70%
9. Presence of at least
one carotid plaque
ABI, ankle-brachial index; MI, myocardial infarction; TIA, transient ischemic attack.
1. Ohman EM et al, on behalf of the REACH Registry Investigators. Am Heart J 2006;151(4):786.e1-10.
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.
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 last
follow-up)
Subject Data
Form: Section
4
(progression
since last
follow-up)
Subject Data
Form: Section 5
(progression
since last
follow-up)
Patient
details,
history and
clinical
examination
Regular
medications
Employment
status
Clinical outcomes
Vascular interventions
Regular medications
Employment status
*Timelines are for worldwide participation; local timelines will be shorter
Global Physician Selection
Participating physicians
Pre-defined at start of Registry
How were
they selected?
Based on local practice population
• General practitioners, specialists
Mainly office-based, some hospital representation
What is
their profile?
Representative of:
• Local environment
• Country geography
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)
9.7%
3.5%
86.8%
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.
Global Patient Selection: Patients
Fitting Inclusion Criteria
Patients
Recruitment at each site
Maximum 20 per site
How were
they selected?
What is
their profile?
Within overall Registry timelines
Patient inclusion criteria
• Documented atherothrombotic disease, or with ≥3
atherothrombotic risk factors
Real-life setting
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 abstracts
owing to a subsequent database lock
US Patient Characteristics at Baseline
Total
% of population
Symptomatic
(n=25,686)
(n=19,069)
Multiple RF
only
(n=6,617)
Mean age (SD), yr
70.0 (10.4)
70.3 (10.4)
69.2 (10.3)
Men
57.0
60.7
46.4
Diabetes
51.7
43.6
74.7
Hypertension
87.5
85.7
92.9
Hypercholesterolemia
82.6
80.7
87.8
Overweight (BMI ≥25, <30)
35.8
37.3
31.5
Obesity (BMI ≥30)
42.1
38.8
51.6
Former smoker
43.1
47.2
31.3
Current smoker
14.4
13.4
17.3
BMI, body mass index; RF, risk factors; SD, standard deviation.
1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.
US Vascular Disease Profile
PAD + CAD (6%)
PAD only (4%)
CVD + PAD (1%)
CVD only (15%)
CAD only (62%)
CAD + CVD + PAD (2%)
CAD + CVD (11%)
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 (%)
100
90
85.7 88.1 88.0
84.2
79.1
80
Patients (%)
CAD population
CVD population
PAD population
71.8
70
60
52.7
50
44.1 44.4
40
39.8
35.8 35.2
30
21.4
20
12.5 14.3
10
0
Treated
Hypertension
Treated Hypercholesterolemia
Treated
Diabetes
Obesity
(BMI ≥30)
1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.
Current
Smoker
US Medication Use at Baseline
Total
% of population
Symptomatic
(n=25,686)
(n=19,069)
Multiple RF
only
(n=6,617)
≥1 Antihypertensive Agent
93.9
93.7
94.5
≥1 Antiplatelet Agent
76.5
81.7
61.6
Any Antithrombotic Agent
85.1
91.3
66.9
≥1 Antidiabetic Agent
47.0
38.9
70.6
≥1 Lipid-Lowering Agent
83.9
82.8
86.9
Nitrates/Other Antiaginals
18.7
24.2
2.6
Claudication Medications
5.1
6.2
1.9
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 (%)
100
94.8 92.5 93.1
90
91.8 91.9 90.0
83.2
77.7
80
Patients (%)
CAD population
CVD population
PAD population
86.4
80.9
81.6
73.5
70
60
47.9
50
39.3 39.4
40
30
20
10
0
≥1 Antihypertensive Agent
≥1 Antiplatelet
Agent
Any Antithrombotic Agent
≥1 Antidiabetic ≥1 Lipid-Lowering
Agent
Agent
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 abstracts
owing to a subsequent database lock
Cumulative Event Rates for the US
REACH Population
Kaplan-Meier Event Rate Curves
REACH registry US 12 months outcome
5.0
4.5
4.0
Event Rate, %
3.5
3.0
CV Death, MI, Stroke
CV Death
Non-fatal MI
Non-fatal Stroke
2.5
2.0
1.5
1.0
0.5
0.0
0
1
2
3
4
5
6
7
8
9
10
11
Time, month
1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.
12
One-Year Outcomes for the US
REACH Population
Overall
Total Symptomatic
At Risk Asymptomatic
17.5
%patients
15.0
15.4
13.1
12.8
12.5
10.7
10.0
6.6
7.5
5.0
4.3
5.1
5.0
2.3
2.5
0.0
CV Death, Stroke, MI
Other outcomes leading to
hospitalization
CV Death, Stroke, MI, Other
outcomes leading to
hospitalization
3.5
2.9
2.6
%patients
3.0
2.5
2.0
1.5
1.0
1.4
1.6
1.6
1.8
1.7
1.5
1.3
1.1
0.8
0.6
0.5
0.0
Nonfatal Stroke
Nonfatal MI
CV Death
All-Cause Death
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.
%patients
%patients
One-Year Outcomes for the US REACH
Population by Vascular Disease
35
35
30
30
25
25
20
20
15
15
10
10
5
5
0
0
CAD only
CADonly
only
CVD
CVDonly
only
PAD
PAD only
%patients
%patients
25.8
20.5 21.1
17.2 18.1
11.9
9.7
9.9
5.0
6.1
4.0
12.2
8.1
6.5 6.8
14.2
8.6
11.8 10.9
3.0
CV Death, Stroke, MI
CV Death, Stroke, MI
Other outcomes leading to
Other
outcomes leading to
hospitalization
hospitalization
CV Death, Stroke, MI, Other
CV Death,
Stroke,
outcomes
leading
to MI, Other
outcomes leading to
hospitalization
hospitalization
5.5
2.2
76
65
1.6
3.0
3.3
1.1 3.3
2.8
0.7
0.8
3.0
4.0
3.7
54
43
10
0
All values are adjusted for age and sex.
Error bars represent 95% confidence intervals.
23.0
9
98
87
32
21
PAD +CVD
PAD+ +CVD
CAD
PAD
CAD
+
PAD
CAD + CVD
CAD+ +CVD
CVD
CAD
+ PAD
CAD + CVD + PAD
0.7
Nonfatal Stroke
Nonfatal Stroke
2.3 2.3
1.7 1.3 0.7
Nonfatal MI
Nonfatal MI
1.5
2.6
1.9
5.0
3.7
2.5 2.3
1.5 1.4
CV Death
CV Death
All-Cause Death
All-Cause Death
1. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.
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.
Caucasian
African American
Hispanic
Asian
17.5
%patients
15.0
12.5
14.4
14.0
11.4
12.2
10.7
12.7
12.9
10.6
5.1
10.0
4.2
7.5
4.6
4.4
5.0
2.5
0.0
CV Death, Stroke, MI
Other outcomes leading to
hospitalization
2.4
4.5
4.0
%patients
3.5
2.0
2.0
1.5
1.9
3.0
2.5
CV Death, Stroke, MI, Other
outcomes leading to
hospitalization
1.1
1.6 1.4
1.3
2.6
2.4
2.4
1.7
1.6 1.3 1.1
1.5
1.5
1.0
0.5
0.0
Nonfatal Stroke
Nonfatal MI
CV Death
All-Cause Death
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 the
REACH Registry go to:
http://www.REACHRegistry.org