Claudio Moretti, M.D. Division of Cardiology, University of Turin, Turin, Italy

Diabetes mellitus in patients Diabetes mellitus in patients undergoing percutaneous drug-undergoing percutaneous drug-

eluting stent implantation: eluting stent implantation: short and long-term resultsshort and long-term results

Claudio Moretti, M.D.Claudio Moretti, M.D.Division of Cardiology, University of Turin, Turin, ItalyDivision of Cardiology, University of Turin, Turin, Italy

on behalf of the University of Turin Registry Investigators:on behalf of the University of Turin Registry Investigators:G. Longo, F. D’Ascenzo, A. Gonella, A. Pullara, G. Biondi Zoccai, G. Longo, F. D’Ascenzo, A. Gonella, A. Pullara, G. Biondi Zoccai,

F. Sciuto, P.L. Omedè, G. P. Trevi, I. SheibanF. Sciuto, P.L. Omedè, G. P. Trevi, I. Sheiban

The introduction of drug-eluting stents (DES) has markedlyThe introduction of drug-eluting stents (DES) has markedlyimproved mid-term results of percutaneous coronaryimproved mid-term results of percutaneous coronaryintervention (PCI) in diabetics. intervention (PCI) in diabetics.

Furthermore it is unclear whether the risk-benefit balanceFurthermore it is unclear whether the risk-benefit balanceof DES in diabetics is maintained also at long-term and in of DES in diabetics is maintained also at long-term and in

insulin requiring patients. insulin requiring patients.

We aimed to appraise long-term outcomes of diabeticWe aimed to appraise long-term outcomes of diabeticpatients treated with PCI with DES, stratifying according topatients treated with PCI with DES, stratifying according toinsulin therapy.insulin therapy.

Background

Methods

Patients undergoing PCI with DES from July 2002 to June 2004 at our center, and thus

eligible for at least 5-year follow-up

N=1277

non-insulin-requiring diabetics

275/1277 (22%)

without diabetes

954/1277 (75%)

insulin-requiring diabetics

37/1277 (3%)

The primary end-point was the long-term rate of majorThe primary end-point was the long-term rate of major

adverse cardiac events (MACE, ie the composite of death,adverse cardiac events (MACE, ie the composite of death,

myocardial infarction, or target vessel revascularization).myocardial infarction, or target vessel revascularization).

Secondary end-points were the individual components of Secondary end-points were the individual components of MACE, as well as death divided according to its etiology.MACE, as well as death divided according to its etiology.

We also considered stent thrombosis according to theWe also considered stent thrombosis according to the

Academic Research Consortium definitions.Academic Research Consortium definitions.

Methods

Clinical characteristics of patients

There were significant differences across groups in prevalence of male gender (respectively, 32%, 81% and 75%, p<0.001), and DES usage (54%, 34% and 30%, p=0.007).

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

male DES usage

without diabetes

non-insulin-requiringdiabetics


p< 0.001 p= 0.007

81%

75%

32%

54%

34%

30%

insulin-requiring diabetics non-insulin-requiring diabetics without diabetes

65 + 11

67 + 10

65 + 9.6

Age of patients

The mean age of patients is comparable in the three groups.

Early clinical outcomes

0%

1%

2%

3%

4%

5%

6%

7%

8%

MACE death myocardialinfarction


non-insulin-requiringdiabetics

without diabetes

p= 0.78 p= 0.71 p= 0.02

30-day MACE occurred with similar frequency in the three groups (8%, 7% and 6%, p=0.78), with death in 3%, 2%, and 1% (p=0.71) and myocardial infarction in 5%, 2% and 1% (p=0.02).

30-DAY OUTCOMES INSULIN-REQUIRING DIABETICS

NON-INSULIN-REQUIRING DIABETICS

WITHOUT DIABETICS PP

MACE 3/37 (8,.1%) 20/275 (7.3%) 60/954 (6.3%) 0.78

Death 1/37 (2.7%) 5/275 (1.8%) 13/954 (1.4%) 0.71

Sudden death 0/37 (0%) 1/275 (0.4%) 5/954 (0.5%) 086

Non-sudded ischemic death

0/37 (0%) 3/275 (1.1%) 7/954 (0.7%) 0.71

Non-ischemic cardiac death

1/37 (2.7%) 0/275 (0%) 0/954 (0%) <0.001

Non-cardiac vascular death

0/37 (0%) 0/275 (0%) 0/954 (0%) 0

Non-cardiovascular death

0/37 (0%) 1/275 (0.4%) 0/954 (0%) 0.16

Myocardial infarction 2/37 (5.4%) 5/275 (1.8%) 8/954 (0.8%) 0.02

non Q 1/37 (2.7%) 2/275 (0.7%) 5/954 (0.5%) 0.25

Q 0/37 (0%) 1/275 (0.4%) 2/954 (0.2%) 0.85

Repeat PCI 2/37 (5.4%) 10/275 (3.6%) 43/954 (4.5%) 0.78

CABG 0/37 (0%) 1/275 (0.4%) 0/954 (0%) 0.16

Stroke 0/37 (0%) 0/275 (0%) 4/954 (0.4%) 0.51

Stent thrombosis 1/37 (2.7%) 1/275 (0.4%) 9/954 (0.9%) 0.31

Definite 0/37 (0%) 0/275 (0%) 7/954 (0.7%) 0.31

Probable 1/37 (2.7%) 1/275 (0.4%) 2/954 (0.2%) 0.02

Possible 0/37 (0%) 0/275 (0%) 0/954 (0%) 0

30- days outcomes: causes of death

0%

1%

1%

2%

2%

3%

3%

no sudden-ischemicdeath

sudden death non ischemic-cardiacdeath


p< 0.001 p= 0.7 p= 0.9

0%

10%

20%

30%

40%

50%

60%

MACE death myocardialinfarction

repeatrevascularization

definite stentthrombosis


non-insulin-requiring diabetics

without diabetes

p< 0.001 p< 0.001 p= 0.25 p= 0.11 p= 0.78

Late clinical outcomes

After a median follow-up period of 58 months, MACE occurred in 59% of patients with insulin-requiring diabetes, in 51% of non-insulin-requiring diabetics, and in 39% of non-diabetics (p<0.001), with death in 24%, 17% and 9% (p<0.001), myocardial infarction in 11%, 7%, and 5% (p=0.25), repeat revascularization in 46%, 32%, and 30% (p=0.11), and definite stent thrombosis occurred in in 0%, 1%, and 1% (p=0.78).

LATE CLINICAL OUTCOMES INSULIN-REQUIRING DIABETICS

NON-INSULIN-REQUIRING DIABETICS

WITHOUT DIABETICS P

MACE 22/37 (59.5%) 139/275 (50.6%) 371/954 (38.9%) <0.001

Death 9/37 (24.3%) 48/275 (17.5%) 81/954 (8.5%) <0.001

Sudden death 1/37 (2.3%) 10/275 (3.6%) 18/954 (1.9%) 0.229

Non-sudden ischemic death 0/37 (0%) 9/275 (3.3%) 17/954 (1.8%) 0,206

Non-ischemic cardiac death 2/37 (5.4%) 10/275 (3.6%) 11/954 (1.5%) <0.001

Non-cardiac vascular death 0/37 (0%) 2/275 (0.7%) 10/954 (1.1%) 0.74

Non-cardiovascular death 5/37 (13.5%) 16/275 (5.8%) 35/954 (3.7%) 0.007

Myocardial infarction 4/37 (10.8%) 18/275 (6.6%) 49/954 (5.1%) 0.25

non Q 1/37 (2.7%) 9/275 (3.3%) 27/954 (2.8%) 0.93

Q 0/37 (0%) 6/275 (2.2%) 2/954 (0.2%) 0.001

Repeat PCI 17/37 (45.9%) 87/275 (31.6%) 285/954 (29.7%) 0.12

CABG 1/37 (2.7%) 9/275 (3.3%) 16/954 (1.7%) 0.25

Stroke 0/37 (2.7%) 5/275 (1.8%) 25/954 (2.6%) 0.47

Stent thrombosis 1/37 (0%) 6/275 (2.2%) 16/954 (1.6%) 0.79

Definite 0/37 (0%) 3/275 (1.1%) 12/954 (1.2%) 0.78

Probable 1/37 (2.7%) 2/275 (0.7%) 2/954 (0.2%) 0.034

Possible 0/37 (0%) 1/275 (0.4%) 2/954 (0.2%) 0.86

Late clinical outcomes: causes of death

0%

2%

4%

6%

8%

10%

12%

14%

no sudden-ischemic death

sudden death non ischemic-cardiac death

non cardiac-vascular death

non cardiac death


p= 0.21 p= 0.23 p< 0.001 p= 0.74 p= 0.007

This long-term retrospective study emphasizes the veryThis long-term retrospective study emphasizes the very

high risk of long-term adverse events faced by insulinhigh risk of long-term adverse events faced by insulin

requiring and non-insulin-requiring diabetics undergoingrequiring and non-insulin-requiring diabetics undergoing

PCI with DES.PCI with DES.

Further research on additional pharmacologic treatments or Further research on additional pharmacologic treatments or hybrid revascularization strategies to mitigate their hybrid revascularization strategies to mitigate their burden of morbidity and mortality is warranted.burden of morbidity and mortality is warranted.

Conclusions

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Claudio Moretti, M.D. Division of Cardiology, University of Turin, Turin, Italy