Cardiac Outcomes after Screening

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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
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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
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Screening Asymptomatic Diabetic Patients
Early Detection CAD
-- Early Treatment
-- Improved Outcome?
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Detection of Ischemia in Asymptomatic Diabetics
Prospective Randomized Study 14 Centers in US and
Canada
DIAD
Principal Investigators
Frans J. Th. Wackers, MD Deborah Chyun, RN, MSN,
PhD Silvio Inzucchi, MD Lawrence Young, MD Jan
Davey, RN, MSN
Wackers et al. Diabetes Care 27 1954-1961, 2004
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Goals of DIAD Study
In Asymptomatic Pts with Type 2 Diabetes

• 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?

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Inclusion Criteria
Type 2 Diabetes Age 50-75 Yrs  No Known
Heart Disease Normal Electrocardiogram No
Prior Testing within 3 Yrs
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Jul 2000 - Aug 2002
1,123 Pts Randomized
561 Pts 562 Pts
Stress
No testing Cardiac Imaging
5 year Follow-up
5 year Follow-up
Screening No Screening
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Adenosine Stress Perfusion Imaging
defect
Stress Rest
CAD
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Results Routine Screening
n 522
Normal
409 (78)
Abnormal
113 (22)
Abnormal Screening Small defect 10
Moderate-Large defect 6 Nonperfusion (ECG)
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Wackers et al. Diabetes Care 27 1954-1961, 2004
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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
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5 Year Follow-Up DIAD Completed Sept 2007
Primary End Points Cardiac Death
Heart Attack
23 Cardiac Events 2.9 (0.6 / yr)
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Cardiac Death and Heart Attacks
0.06
0.04
Cumulative Incidence Cardiac Events
0.02
Log-rank P NS
0
0
1
2
3
4
5
Years
13
Cardiac Death and Heart Attacks Screening Results
0.16
0.14
0.12
0.10
Cumulative Incidence Cardiac Events
0.08
0.06
Log-rank P .005
0.04
0.02
0
3
1
2
4
5
0
Years
14
Primary End Points (5-Yr)
Screening No Screening n 561
n 562 p
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Secondary End Points (5-Yr)
Screening No Screening n 561
n 562 p
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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
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Change Medication Baseline vs. 5 Years
2001 ADA Recommendations

80
60
patients
40
20
Aspirin Statin ACE
Anti-HTN
0
0
0
0
0
Year in Study
Screening
No Screening
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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
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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
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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
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DIAD Patients Representative Cohort?
No Willing to Participate in Study
Self-referred No Symptoms Normal Rest ECG
HbA1c 7.11.5
Yes Middle-aged 60.76.6 yrs Diabetes
Duration 87 yrs BMI 316 No Activity at
all 34 Unable to Exercise 50 Insulin
22, Oral 63   2 Risk Factors 60