Table 8

Overview of randomized controlled trials

Study/authorFaglia et al.69DIAD68DYNAMIT64FACTOR-6467DADDY-D70
Year of publication20052009201120142015
Patients (n)141 (+1)a1123615899520
Inclusion criteriaT2DMT2DMT2DMT1DM or T2DMT2DM
 45–76 years50–75 years50–75 years♂ aged ≥50 years/♀ aged ≥55 years, DM for ≥3 years50–75 years
 ≥2 other CVRFs ≥2 other CVRFs♂ aged ≥40 years/ ♀ aged ≥45 years, DM for ≥5 yearsCV risk ≥10%
     Sinus rhythm
     Able to do EET
Mean age (years)60.160.863.961.561.9
Male sex (%)55.653.554.552.280.0
Screening testEET and SEMPIEET or MPICTCA and CAC scoreEET
Positive screening test (%)21.15.9 moderate or large defects21.5 positive or uncertain11.9 moderate; 10.7 severe7.6
Treatment strategyICA and cardiac follow-up if any test was positiveAt the referring physician’s discretionAccording to the cardiologist’s decisionRecommendation based on stenosis severity and CAC scoreICA if EET positive
ICA performed after positive test (%)93.315.255.947.385.0
Mean follow-up (years)4.54.83.54.03.6
Annual rate of major CEs (%)1.90.61.00.81.4
Main results of screeningSignificant ↓ of major and all CEsNon-significant ↓ of major CEsNon-significant ↓ of MI; no effect on combined CEsNon-significant ↓ of combined CEsNon-significant ↓ of major CEs, but significant ↓ in those aged >60 years
Study/authorFaglia et al.69DIAD68DYNAMIT64FACTOR-6467DADDY-D70
Year of publication20052009201120142015
Patients (n)141 (+1)a1123615899520
Inclusion criteriaT2DMT2DMT2DMT1DM or T2DMT2DM
 45–76 years50–75 years50–75 years♂ aged ≥50 years/♀ aged ≥55 years, DM for ≥3 years50–75 years
 ≥2 other CVRFs ≥2 other CVRFs♂ aged ≥40 years/ ♀ aged ≥45 years, DM for ≥5 yearsCV risk ≥10%
     Sinus rhythm
     Able to do EET
Mean age (years)60.160.863.961.561.9
Male sex (%)55.653.554.552.280.0
Screening testEET and SEMPIEET or MPICTCA and CAC scoreEET
Positive screening test (%)21.15.9 moderate or large defects21.5 positive or uncertain11.9 moderate; 10.7 severe7.6
Treatment strategyICA and cardiac follow-up if any test was positiveAt the referring physician’s discretionAccording to the cardiologist’s decisionRecommendation based on stenosis severity and CAC scoreICA if EET positive
ICA performed after positive test (%)93.315.255.947.385.0
Mean follow-up (years)4.54.83.54.03.6
Annual rate of major CEs (%)1.90.61.00.81.4
Main results of screeningSignificant ↓ of major and all CEsNon-significant ↓ of major CEsNon-significant ↓ of MI; no effect on combined CEsNon-significant ↓ of combined CEsNon-significant ↓ of major CEs, but significant ↓ in those aged >60 years

Reproduced/adapted with permission.

♂ = men; ♀ = women; CAC = coronary artery calcium; CE = cardiac event (major CE = cardiac death or MI); CTCA = computed tomography coronary angiography; CV = cardiovascular; CVRF = cardiovascular risk factor; DADDY-D = Does coronary Atherosclerosis Deserve to be Diagnosed earlY in Diabetic patients?; DIAD = Detection of Ischaemia in Asymptomatic Diabetics; DYNAMIT = Do You Need to Assess Myocardial Ischemia in Type 2 Diabetes; DM = diabetes mellitus; EET = exercise electrocardiogram test; FACTOR-64 = Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64; ICA = invasive coronary angiography; MI = myocardial infarction; MPI = radionuclide myocardial perfusion imaging; RCT = randomized controlled trial; SE = stress echocardiography; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.

a

One patient excluded for early non-cardiac death was reincluded.

Table 8

Overview of randomized controlled trials

Study/authorFaglia et al.69DIAD68DYNAMIT64FACTOR-6467DADDY-D70
Year of publication20052009201120142015
Patients (n)141 (+1)a1123615899520
Inclusion criteriaT2DMT2DMT2DMT1DM or T2DMT2DM
 45–76 years50–75 years50–75 years♂ aged ≥50 years/♀ aged ≥55 years, DM for ≥3 years50–75 years
 ≥2 other CVRFs ≥2 other CVRFs♂ aged ≥40 years/ ♀ aged ≥45 years, DM for ≥5 yearsCV risk ≥10%
     Sinus rhythm
     Able to do EET
Mean age (years)60.160.863.961.561.9
Male sex (%)55.653.554.552.280.0
Screening testEET and SEMPIEET or MPICTCA and CAC scoreEET
Positive screening test (%)21.15.9 moderate or large defects21.5 positive or uncertain11.9 moderate; 10.7 severe7.6
Treatment strategyICA and cardiac follow-up if any test was positiveAt the referring physician’s discretionAccording to the cardiologist’s decisionRecommendation based on stenosis severity and CAC scoreICA if EET positive
ICA performed after positive test (%)93.315.255.947.385.0
Mean follow-up (years)4.54.83.54.03.6
Annual rate of major CEs (%)1.90.61.00.81.4
Main results of screeningSignificant ↓ of major and all CEsNon-significant ↓ of major CEsNon-significant ↓ of MI; no effect on combined CEsNon-significant ↓ of combined CEsNon-significant ↓ of major CEs, but significant ↓ in those aged >60 years
Study/authorFaglia et al.69DIAD68DYNAMIT64FACTOR-6467DADDY-D70
Year of publication20052009201120142015
Patients (n)141 (+1)a1123615899520
Inclusion criteriaT2DMT2DMT2DMT1DM or T2DMT2DM
 45–76 years50–75 years50–75 years♂ aged ≥50 years/♀ aged ≥55 years, DM for ≥3 years50–75 years
 ≥2 other CVRFs ≥2 other CVRFs♂ aged ≥40 years/ ♀ aged ≥45 years, DM for ≥5 yearsCV risk ≥10%
     Sinus rhythm
     Able to do EET
Mean age (years)60.160.863.961.561.9
Male sex (%)55.653.554.552.280.0
Screening testEET and SEMPIEET or MPICTCA and CAC scoreEET
Positive screening test (%)21.15.9 moderate or large defects21.5 positive or uncertain11.9 moderate; 10.7 severe7.6
Treatment strategyICA and cardiac follow-up if any test was positiveAt the referring physician’s discretionAccording to the cardiologist’s decisionRecommendation based on stenosis severity and CAC scoreICA if EET positive
ICA performed after positive test (%)93.315.255.947.385.0
Mean follow-up (years)4.54.83.54.03.6
Annual rate of major CEs (%)1.90.61.00.81.4
Main results of screeningSignificant ↓ of major and all CEsNon-significant ↓ of major CEsNon-significant ↓ of MI; no effect on combined CEsNon-significant ↓ of combined CEsNon-significant ↓ of major CEs, but significant ↓ in those aged >60 years

Reproduced/adapted with permission.

♂ = men; ♀ = women; CAC = coronary artery calcium; CE = cardiac event (major CE = cardiac death or MI); CTCA = computed tomography coronary angiography; CV = cardiovascular; CVRF = cardiovascular risk factor; DADDY-D = Does coronary Atherosclerosis Deserve to be Diagnosed earlY in Diabetic patients?; DIAD = Detection of Ischaemia in Asymptomatic Diabetics; DYNAMIT = Do You Need to Assess Myocardial Ischemia in Type 2 Diabetes; DM = diabetes mellitus; EET = exercise electrocardiogram test; FACTOR-64 = Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64; ICA = invasive coronary angiography; MI = myocardial infarction; MPI = radionuclide myocardial perfusion imaging; RCT = randomized controlled trial; SE = stress echocardiography; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.

a

One patient excluded for early non-cardiac death was reincluded.

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