The EMERALD TrialDiabetic Substudy

EMERALD Diabetic Analysis

To compare myocardial perfusion and To compare myocardial perfusion and infarct sizes in diabetic and non-diabetic infarct sizes in diabetic and non-diabetic patients undergoing primary patients undergoing primary percutaneous coronary intervention (PCI) percutaneous coronary intervention (PCI) in the EMERALD (in the EMERALD (EEnhanced nhanced MMyocardial yocardial EEfficacy and fficacy and RRemoval by emoval by AAspiration of spiration of LLiberated iberated DDebris) trial for ST-segment ebris) trial for ST-segment elevation myocardial infarctionelevation myocardial infarction

To compare myocardial perfusion and To compare myocardial perfusion and infarct sizes in diabetic and non-diabetic infarct sizes in diabetic and non-diabetic patients undergoing primary patients undergoing primary percutaneous coronary intervention (PCI) percutaneous coronary intervention (PCI) in the EMERALD (in the EMERALD (EEnhanced nhanced MMyocardial yocardial EEfficacy and fficacy and RRemoval by emoval by AAspiration of spiration of LLiberated iberated DDebris) trial for ST-segment ebris) trial for ST-segment elevation myocardial infarctionelevation myocardial infarction

Objective

Marso et al. Am J Cardiol 2007;100:206-210Ref

EMERALD Diabetic AnalysisStudy Design

N=501

Distol Embolic Protection

(N=252)

Control(N=249)

Diabetes(n=19)

No Diabetes(n=233)

Diabetes(n=43)

No Diabetes(n=206)

Primary OutcomeST-resolution at 30 minutes

Infarct size at days 5-14

Secondary OutcomeFinal TIMI flow

Myocardial blushAngiographic complications

Inclusion• Age>18 years• Acute myocardial infarction >6 hours• ST-elevation ≥2mm in ≥contiguous leads,

LBBB

Exclusion• Multivessel PCI• Unprotected left main PCI• Expected CABG within 30 days

Marso et al. Am J Cardiol 2007;100:206-210 Ref

EMERALD Diabetic AnalysisBaseline Characteristics

Marso et al. Am J Cardiol 2007;100:206-210Ref

DMDM(N = 62)(N = 62)

No DMNo DM(N = 439)(N = 439)

P-ValueP-Value

Age (years)Age (years) 5959 5959 0.790.79

Men (%)Men (%) 7777 7979 0.870.87

Body Mass Index (kg/mBody Mass Index (kg/m22)) 2828 2727 0.0650.065

Hypertension (%)Hypertension (%) 6161 3434 <0.001<0.001

Dyslipidemia (%)Dyslipidemia (%) 4444 2222 0.00040.0004

Symptom onset to first balloon Symptom onset to first balloon inflation (min)inflation (min)

217217 218218 0.570.57

Prior myocardial infarction (%)Prior myocardial infarction (%) 1111 1111 1.01.0

Prior coronary bypass (%)Prior coronary bypass (%) 33 33 1.01.0

Prior percutaneous intervention (%)Prior percutaneous intervention (%) 1010 1010 1.01.0

EMERALD Diabetic AnalysisAngiographic & Procedural Characteristics

Marso et al. Am J Cardiol 2007;100:206-210Ref

DM(N = 62)

No DM(N = 439)

P-Value

Diseased arteries (%)

1 42 51 0.22

2 34 34 1.0

3 42 15 0.095

Infarct related coronary artery (%)

Left anterior descending 46 39 0.33

Right 39 51 0.10

Left circumflex 15 10 0.27

Initial TIMI flow (%)

0 60 56 0.58

1 2 11 0.03

2 12 14 0.69

3 27 19 0.17

EMERALD Diabetic AnalysisAngiographic & Procedural Characteristics

DMDM(n=62)(n=62)

No DMNo DM(n=439)(n=439)

P-P-ValueValue

Initial myocardial blush grade (%)Initial myocardial blush grade (%)

00 6464 7070 0.360.36

11 99 1313 0.520.52

22 1717 1111 0.190.19

33 1010 66 0.250.25

Ejection fraction (%)Ejection fraction (%) 5050 4747 0.870.87

Marso et al. Am J Cardiol 2007;100:206-210Ref

EMERALD Diabetic AnalysisPrimary Outcomes

91.7

33.9

44.6

12

90.2

15.7

65

2.20

10

20

30

40

50

60

70

80

90

100

Final TIMI 3 Flow Final MBG 0/1 30-Min CompleteSTR

6-MonthMortality

Pat

ient

s (%

)

DM

No DM

91.7

33.9

44.6

12

90.2

15.7

65

2.20

10

20

30

40

50

60

70

80

90

100

Final TIMI 3 Flow Final MBG 0/1 30-Min CompleteSTR

6-MonthMortality

Pat

ient

s (%

)

DM

No DM

Marso et al. Am J Cardiol 2007;100:206-210Ref

P=1.0

P=0.002

P=0.005

P<0.0001

EMERALD Diabetic AnalysisPrimary Outcomes

19.5

11

0

5

10

15

20

25

Final Infarct Size

% L

eft V

entr

icle

DM

No DM

19.5

11

0

5

10

15

20

25

Final Infarct Size

% L

eft V

entr

icle

DM

No DM

Marso et al. Am J Cardiol 2007;100:206-210Ref

P=0.005

EMERALD Diabetic AnalysisSecondary Outcomes

6

4

6

10

1 1 1 1

0

2

4

6

8

10

12

New CHF at 6Months

Stroke at 30Days

Stroke at 6Months

Mortality at 30Days

Pat

ien

ts (%

)

DM

No DM

6

4

6

10

1 1 1 1

0

2

4

6

8

10

12

New CHF at 6Months

Stroke at 30Days

Stroke at 6Months

Mortality at 30Days

Pat

ien

ts (%

)

DM

No DM

Marso et al. Am J Cardiol 2007;100:206-210Ref

P=0.04 P=0.002

P<0.001

P=0.02

EMERALD Diabetic AnalysisMultivariable Predictors of Complete ST-Resolution

Marso et al. Am J Cardiol 2007;100:206-210Ref

OROR 95% CI95% CI Chi-SquareChi-Square P-ValueP-Value

Current smokerCurrent smoker 1.821.82 1.09-3.041.09-3.04 5.265.26 0.020.02

Diabetes Diabetes 0.390.39 0.19-0.810.19-0.81 6.446.44 0.010.01

Prior myocardial Prior myocardial infarctioninfarction

0.370.37 0.17-0.790.17-0.79 6.586.58 0.010.01

Left anterior descending Left anterior descending ST-elevation ST-elevation myocardial infarctionmyocardial infarction

0.120.12 0.07-0.190.07-0.19 65.9165.91 <0.0001<0.0001

EMERALD Diabetic AnalysisMultivariable Predictors of 6-Month Mortality

Marso et al. Am J Cardiol 2007;100:206-210Ref

HR 95% CI Chi-Square P-Value

Diabetes 8.80 2.49-31.02 11.44 0.0007

Age 1.12 1.06-1.19 15.21 0.0001

Baseline platelets 1.01 1.00-1.01 5.36 0.0206

ST-segment resolution >70% 0.06 0.01-0.48 6.96 0.0083

EMERALD Diabetic Analysis

• Myocardial reperfusion is decreased as measured by Myocardial reperfusion is decreased as measured by incomplete ST-resolution and myocardial blush gradeincomplete ST-resolution and myocardial blush grade

• Lower rates of reperfusion are associated with greater Lower rates of reperfusion are associated with greater infarct sizes compared to non-diabetic patientsinfarct sizes compared to non-diabetic patients

• There is no additional benefit of using distal embolic There is no additional benefit of using distal embolic protection, similar to non-diabetic patientsprotection, similar to non-diabetic patients

• Myocardial reperfusion is decreased as measured by Myocardial reperfusion is decreased as measured by incomplete ST-resolution and myocardial blush gradeincomplete ST-resolution and myocardial blush grade

• Lower rates of reperfusion are associated with greater Lower rates of reperfusion are associated with greater infarct sizes compared to non-diabetic patientsinfarct sizes compared to non-diabetic patients

• There is no additional benefit of using distal embolic There is no additional benefit of using distal embolic protection, similar to non-diabetic patientsprotection, similar to non-diabetic patients

Conclusions

Marso et al. Am J Cardiol 2007;100:206-210Ref

In diabetic patients undergoing percutaneous coronary intervention: