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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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    ISAR DESIRE 2ISAR DESIRE 2

    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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    ISAR DESIRE 2ISAR DESIRE 2

    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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    ISAR DESIRE 2ISAR DESIRE 2

    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