Post on 29-Dec-2015
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.