byrne isar desire 2
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ISAR DESIRE 2ISAR DESIRE 2
Background
The optimal treatment strategy forin-stent restenosis is based on the axiom:
maximize acute gain
minimize late loss
ISAR-DESIRE JAMA 2005; RIBS-II JACC2006
TAXUS-V-ISR JAMA 2006; SISR JAMA 2006
In BMS-restenosis this has mosteffectively been accomplished by DES
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Background
In DES-restenosis the most effectivemanagement strategy is unclear
While repeat DES implantation seemspreferable, optimal stent type is notknown
Different DES (hetero-DES)
Same DES (homo-DES)
Lee et al.AJC2006; Cosgrave et al.AHJ2007
Garg et al. CCI2007; Byrne et al.Rev Esp Card2008
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Background
SES have proven superior to PES insubsets of patients with high-risk
features
The comparative performance of bothstents in SES treatment failure is not
known
ISAR-DESIRE JAMA 2005; ISAR-DIABETES NEJM2005
SIRTAX NEJM2005; ISAR-SMART-3 EHJ2006; Schmig et al. JACC2007
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ISAR DESIRE 2ISAR DESIRE 2
Study Objective
To compare the anti-restenotic efficacyof SES (Cypher) versus PES (Taxus) in
patients with SES-restenosis
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Study Organization
450 patients enrolled at two centresin Munich, Germany
Angiographic
follow-up at 6-8
months (84.8%)
Clinical follow-
up at 12 months
Clinical follow-
up at 12 months
Angiographic
follow-up at 6-8
months (84.9%)
SES (Cypher)
n = 225
PES (Taxus)
n = 225
Design
DESIGN: Randomized, open-
label, active-control trial
INCLUSION CRITERIA:
1. In-SES restenosis > 50%
2. Symptoms/signs of ischaemia
EXCLUSION CRITERIA:
1. Cardiogenic shock
2. Lesion in LMCA or graft3. Acute myocardial infarction
PRIMARY ENDPOINT:
In-stent late loss
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Baseline Characteristics
SES
n = 225
PES
n = 225
Age (years) 66.4 67.1
Female 20.8 25.7
Diabetes mellitus 38.2 33.8
Clinical presentation
Stable 80.0 83.3
ACS 20.0 16.7
Patients
Numbers shown are percentages
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Baseline Characteristics
SES
n = 243
PES
n = 240
Vessel size 2.78.47 2.75.48
Lesion length 12.78.3 12.57.7
Initial SES
Cypher 38.7 38.3
ISAR stent 61.3 61.7
Lesions
Numbers shown are meanSD or percentages
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Baseline Characteristics
SES
n = 243
(%)
PES
n = 240
(%)
Focal margin 21.0 18.8
Focal body 37.5 34.6
Multifocal 6.6 7.5
Diffuse/proliferative 30.0 35.8Occlusive 4.9 3.3
Lesions Restenosis Morphology
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30-Day Results
SES
n = 225
PES
n = 225
Death 0 0.4
Myocardial infarction 1.3 1.8
TLR 0 0
Death/MI/TLR 1.3 1.8
Stent thrombosis 0 0
Numbers shown are percentages; P = ns for all comparisons
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Secondary Endpoint
Binary Restenosis
19.0
20.6
0
10
20
30
40
Restenosis, in-segment
SES PES
P = 0.69%
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Death, MI or Stent Thrombosis
rate,%
months
0
10
20
30
40
50
0 2 4 6 8 10 12
SES 6.1%SES 6.1%
PP= 0.98= 0.98
Safety Endpoint
PES 6.3%PES 6.3%
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Death, MI or TLR
rate,%
months
0
10
20
30
40
50
0 2 4 6 8 10 12
Major Adverse Cardiac Events
PP= 0.71= 0.71
SES 20.4%SES 20.4%
PES 19.6%PES 19.6%
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Conclusions
Repeat DES implantation for DES-restenosis is safe out to 1 year
In cases of SES-restenosis, both SESand PES are associated with a
comparable degree of anti-restenotic
efficacy
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0.40
0.230.190.21
0.0
0.3
0.6
DESIRE DIABETES SMART-3 DESIRE-2
Late Luminal Loss
mm
SES (Cypher) Efficacy
ISAR-DESIRE JAMA 2005; ISAR-DIABETES NEJM2005
ISAR-SMART-3 EHJ2006
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Conclusions
Drug resistance at an individual patientlevel may play a contributory role in the
somewhat lower anti-restenotic efficacy
of SES in this study
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Thank You
ISAR DESIRE 2
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