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Cardiac Outcomes after Screening

for Asymptomatic Coronary Artery Disease


in Patients with Type 2 Diabetes
in the DIAD Study
A Randomized Clinical Trial

Frans J Th Wackers, MD

IAD
D
Diabetes Mellitus
• Risk Factor for Coronary Artery Disease (CAD)
• Heart Attacks, Cardiac Death 2-4 x more often
• Cause of Death: 65 % Cardiovascular
• CAD often Unrecognized
No Angina
Silent Heart Attacks
Sudden Cardiac Death
Already Advanced Before Symptoms

Heart Disease Often Missed in Diabetes


Screening
Asymptomatic Diabetic Patients
• Early Detection CAD

--> Early Treatment

--> Improved Outcome?


Detection of Ischemia in
Asymptomatic Diabetics
Prospective Randomized Study
14 Centers in US and Canada

A D
DI
Principal
Principal Investigators
Investigators
Frans
FransJ. J. Th.
Th. Wackers,
Wackers,MDMD
Deborah
DeborahChyun,Chyun,RN,
RN,MSN,
MSN, PhD
PhD
Silvio
Silvio Inzucchi,
Inzucchi,MDMD
Lawrence
Lawrence Young,
Young, MD
MD
Jan
Jan Davey,
Davey,RN, RN, MSN
MSN Wackers et al. Diabetes Care 27; 1954-1961, 2004
Goals of DIAD Study
In Asymptomatic Pts with Type 2 Diabetes:
1. What is Prevalence of
Silent Heart Disease on Screening?

2. Do Results of Screening
Predict Outcomes?

3. Does Screening Affect


Patient Treatment
and Cardiac Outcomes?
Inclusion Criteria

• Type 2 Diabetes
• Age 50-75 Yrs
• No Known Heart Disease
• Normal Electrocardiogram
• No Prior Testing within 3 Yrs
Jul 2000 - Aug 2002
1,123 Pts Randomized

561 Pts 562 Pts


Stress No testing
Cardiac Imaging

Standard Medical Care

5 year Follow-up 5 year Follow-up

“Screening” “No Screening”


Adenosine Stress Perfusion Imaging

defect

Stress

Rest

CAD Ischemic ECG Changes


Results Routine Screening
n = 522

Normal
409 (78%)

Abnormal
113 (22%)
Abnormal Screening
• Small defect 10 %
• Moderate-Large defect 6 %
• Nonperfusion (ECG) 6%
Wackers et al. Diabetes Care 27; 1954-1961, 2004
Subsequent Clinical Care
Both Randomized Groups:

• At Discretion of Primary Medical Providers


• Contemporary Medical Care
• Additional Diagnostic Procedures
• Coronary Revascularization

Except for Screening, No Intervention


5 Year Follow-Up DIAD
Completed Sept 2007

Primary End Points:


• Cardiac Death
• Heart Attack
23 Cardiac Events: 2.9 % (0.6% / yr)

• Cardiac Death: 15 Pts (1.4 %)

• Heart Attack: 17 Pts (1.5 %)


Cardiac Death and Heart Attacks
Cumulative Incidence Cardiac Events 0.06

Screening
No Screening

0.04

3.0 %
2.7 %
0.02

Log-rank
P = NS

0
0 1 2 3 4 5
Years
Cardiac Death and Heart Attacks: Screening Results
Cumulative Incidence Cardiac Events 0.16
Normal
Small defect
0.14 Moderate or large defect
12.1 %
Nonperfusion abnormality (ECG)
0.12

0.10

0.08

6.7 %
0.06

Log-rank
0.04 P = .005
2.0 %
0.02
2.0 %
0
0 1 2 3 4 5
Years
Primary End Points (5-Yr)

Screening No Screening
n = 561 n = 562 p

Cardiac Death 8 (1.4%) 7 (1.2%) ns

Heart Attack 7 (1.3%) 10 (1.7%) ns


Secondary End Points (5-Yr)

Screening No Screening
n = 561 n = 562 p

Unstable Angina 4 (0.7%) 3 (0.5%) ns


Heart Failure 7 (1.2%) 7 (1.2%) ns
Stroke 10 (1.8%) 5 (0.9%) ns
Revascularization 31 (5.5%) 44 (7.8%) ns
Procedures During Study

Screening No Screening
n = 561 n = 562 p

Non-Protocol
Stress Tests 118 (21%) 170 (30%) 0.0005

Abnormal 28 (24%) 45 (26%) ns


Coronary
Angiography 80 (14%) 66 (12%) ns
Abnormal 40 (50%) 44 (66%) 0.05
Change Medication Baseline vs. 5 Years
2001 ADA Recommendations

80
* * * *
60
% patients

40

20
Aspirin Statin ACE Anti-HTN
0
0 5 0 5 0 5 0 5 Year in
Study
Screening No Screening p < 0.001
Asymptomatic Pts with
Type 2 Diabetes Mellitus:
- Truly Asymptomatic
- Normal Rest ECG

• Silent CAD Occurs in ~ 25%


• Severe CAD in only 6%
• Stress Screening Predicts Outcome
• Overall Outcome Favorable (4.8 yrs: 3 % CE)
• Screening Does not Alter (Favorable) Outcome
Conclusion
In Asymptomatic Patients with Diabetes:

• Routine Screening for Silent CAD is


NOT Recommended:
• Low Yield
• Low Event Rate
• No Effect Outcome
• Prohibitively Expensive
• Not Cost-Effective
Anno 2009 Type 2 Diabetes
Without Known CAD:
• Contemporary Medical Care
• Close Follow-up
• Aggressive Primary Medical Prevention
• Specialized Testing when Clinically Indicated

--> Favorable Outcome


DIAD Patients Representative Cohort?
No:
• Willing to Participate in Study
• Self-referred
• No Symptoms
• Normal Rest ECG
• HbA1c 7.1+1.5%
Yes:
• Middle-aged: 60.7+6.6 yrs
• Diabetes Duration: 8+7 yrs
• BMI: 31+6
• No Activity at all: 34%
• Unable to Exercise: 50%
• Insulin: 22%, Oral: 63%
• > 2 Risk Factors 60%

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