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Impact of Diabetes Mellitus on Long-term Outcomes in the Drug-Eluting Stent Era. Raisuke Iijima, Gjin Ndrepepa, Julinda Mehilli, Christina Markwardt, Olga Bruskina, Jürgen Pache, Maryam Ibrahim, Albert Schömig, and Adnan Kastrati.

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slide1

Impact of Diabetes Mellitus on

Long-term Outcomes in the

Drug-Eluting Stent Era

Raisuke Iijima, Gjin Ndrepepa, Julinda Mehilli,

Christina Markwardt, Olga Bruskina, Jürgen Pache,

Maryam Ibrahim, Albert Schömig, and Adnan Kastrati.

Deutsches Herzzentrum & Medizinische Klinik rechts der Isar,

Technische Universtität, Munich, Germany,

Published in the Am Heart J. 2007;154:688-93

slide2

Background

  • Diabetes mellitus is associated with an increased risk of restenosis, stent thrombosis and death after bare-metal stent implantation.
  • Drug-eluting stents (DES) are the most successful strategy for the prevention of restenosis.
  • However, the impact of diabetes on angiographic and clinical outcomes has not been assessed in a large number of patients with a long-term follow-up after treatment with DES. Specifically, it is not known whether the reduction in restenosis by DES in diabetic patients is translated into a improved survival.
slide3

Methods

2557 consecutive patients

  • Between August 2002 and June 2005.
  • DES implantation (sirolimus- or paclitaxel-eluting stents) in native coronary arteries.
  • Stable or unstable angina.

Diabetic

727 patients

Non-Diabetic

1830 patients

  • Primary end points (at 3 years follow-up)
  • Target lesion revascularization (clinical restenosis)
  • Mortality
  • Secondary end points
  • Binary angiographic restenosis
  • Stent thrombosis
  • Composite of death or myocardial infarction
slide4

Clinical features of the study patients

Diabetic

Non-Diabetic

n=727 (%)

n=1830 (%)

p value

Age, year

68.2 ± 9.2

65.5 ± 10.8

<.001

female, n

199 (27.4)

362 (19.8)

<.001

Current smoker, n

90 (12.4)

256 (14.0)

.28

Hypertension, n

467 (64.2)

1031 (56.3)

<.001

Hyperlipidemia, n

530 (72.9)

1326 (72.5)

.82

Angina class

.05

1

233 (32.1)

624 (34.1)

2

219 (30.1)

566 (30.9)

3

130 (17.9)

358 (19.6)

4

145 (19.9)

282 (15.4)

Prior myocardial infarction, n

285 (39.2)

651 (35.6)

.09

Prior CABG, n

86 (11.8)

184 (10.1)

.19

slide5

Initial angiographic features

Diabetic

Non-Diabetic

n=727 (%)

n=1830 (%)

p value

Multiple coronary disease, n

663 (91.2)

1489 (81.4)

<.001

<.001

52.6 ± 13.4

55.9 ± 12.4

Baseline LVEF, %

Complex (B2/C) lesion, n

563 (77.4)

1371 (74.9)

.18

Target vessel

304 (41.8)

814 (44.5)

.22

LAD, n

152 (20.9)

462 (25.2)

.02

RCA, n

219 (30.1)

444 (24.3)

.002

LCx, n

52 (7.2)

110 (6.0)

.29

Left main artery, n

Vessel size, mm

2.68 ± 0.56

2.75 ± 0.55

.002

MLD, mm

1.06 ± 0.48

1.11 ± 0.50

.02

Diameter stenosis, %

60.7 ± 15.1

60.1 ± 15.5

.49

Lesion length, mm

13.6 ± 7.7

13.3 ± 7.6

.37

slide6

Procedure-related characteristics

Diabetic

Non-Diabetic

n=727 (%)

n=1830 (%)

p value

Type of DES

.21

Sirolimus-eluting stent, n

392 (54.0)

1037 (57.0)

Paclitaxel-eluting stent, n

335 (46.0)

793 (43.0)

Abciximab therapy, n

89 (12.2)

243 (13.3)

.48

Stent length, mm

23.2 ± 9.5

22.7 ± 8.8

.21

Max balloon pressure, atm

14.6 ± 3.0

14.6 ± 2.9

.86

Balloon-vessel ratio

1.15 ± 0.12

1.15 ± 0.12

.46

MLD, mm

2.56 ± 0.49

2.65 ± 0.49

<.001

Diameter stenosis, %

8.8 ± 7.2

8.1 ± 7.0

.03

slide10

Independent predictors of 3-year mortality

by Cox proportional hazards model

Hazard ratio

Variable

P value

[95% Cl]

Diabetes

1.63 [1.23 to 2.17]

<0.001

Age (for 10-year increase)

1.97 [1.68 to 2.31]

<0.001

Smoking

2.15 [1.46 to 3.17]

<0.001

Arterial hypertension

0.55 [0.41 to 0.73]

<0.001

LVEF (for 10% decrease)

1.28 [1.16 to 1.41]

<0.001

Angina class (class IV vs. class I)

1.61 [1.07 to 2.43]

0.014

slide11

Summary

  • The present study includes the largest series of patients to have received
  • DES in “real world” practice who have undergone routine f/u angiogram.
  • With regard to restenosis, DES implantation in diabetic patients
  • is associated with favorable results comparable to those achieved in
  • non-diabetic patients, clearly demonstrating the ability of DES to offset
  • diabetes-associated increased risk of restenosis after PCI.
  • 3-year Kaplan-Meier estimates of mortality were 17.3% in diabetic
  • patients vs. 7.8% in non-diabetic patients, with an odds ratio of 2.10
  • (95% CI 1.61-2.74, P< .001).
  • 3-year Kaplan-Meier estimates of stent thrombosis were 2.2% in
  • diabetic patients vs. 1.0% in non-diabetic patients, with an odds ratio of
  • 2.17 (95% CI 1.09-4.33, p= .027).
  • After adjustment in the multivariable analysis, diabetes remained an
  • independent predictor of 3-year mortality with a hazard ratio of 1.63
  • (95% CI 1.23-2.17, P< .001).
slide12

Conclusions

  • DES attenuates diabetes-associated excess risk of restenosis.
  • However, risk of death and thrombotic complications remains higher in patients with diabetes than in non-diabetic patients even in the DES era.