Pr

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The REALITY Study Results
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• REALITY Study Design
• The REALITY Study
• Prospective randomized clinical trial to evaluate
  the safety and efficacy of CYPHER
  Sirolimus-eluting Coronary Stent and TAXUS
  Paclitaxel-eluting Coronary Stent
•  
• An international multi-center (90 sites) study
  involving 1 353 patients
• All data adjudicated by independent committees
• ? Moderately complex, de novo lesions in smaller
  vessels

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Study Design
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Moderately Complex Lesions   Baseline
Demographics
pns
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Moderately Complex Lesions   Baseline
Characteristics
pns
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In the REALITY Study Excellent Delivery Success
and Unsurpassed Clinical Outcomes   Excellent
Delivery Success
Final diameter stenosis lt 30 (with the
assigned device)
pns
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In the REALITY Study Excellent Delivery Success
and Unsurpassed Clinical Outcomes   Unsurpassed
Clinical Outcomes
Cardiac death, MI, TVR These results should
be read in conjunction with the clinical results
described in the full product labeling for these
devices. For indications, contraindications,
warnings, and precautions see attached Essential
Prescribing Information.
Cardiac death, MI, emergent bypass surgery, or
repeat TLR
pns
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In the REALITY Study Superior in Key
Angiographic Outcomes   Key Angiographic Outcomes
(QCA)
Relative Risk Reduction Minimum Lumen Diameter
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In the REALITY Study Superior in Key
Angiographic Outcomes   Lower Late Loss
In-Stent and in the Margins
These results should be read in conjunction with
the clinical results described in the full
product labeling for these devices. For
indications, contraindications, warnings, and
precautions see attached Essential Prescribing
Information.
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In the REALITY Study Lower Stent
Thrombosis   Stent Thrombosis Actual
Treatment   A 78 Relative Risk
Reduction
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In the REALITY Study Lower Stent
Thrombosis   Antiplatelet Therapy (APT)
Compliance (30 d)   Greater than 97
dual APT compliance at 30 days for both
groups   Aspirin and thienopyridine
(clopidogrel or ticlopidine) as per
labeling   These results should be read in
conjunction with the clinical results described
in the full product labeling for these devices.
For indications, contraindications, warnings, and
precautions see attached Essential Prescribing
Information.
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In the REALITY Study A Closer Look Thrombosis
Outcomes   Thrombosis Patient Outcomes Actual
Treatment
These results should be read in conjunction with
the clinical results described in the full
product labeling for these devices. For
indications, contraindications, warnings, and
precautions see attached Essential Prescribing
Information.
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• The REALITY Study Results
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• CYPHER Stent showed superior safety
• Significantly lower thrombosis rate for CYPHER
  Stent vs. TAXUS Stent 0.4 vs. 1.8 (p 0.02)
  a 78 Relative Risk Reduction
• ? Despite a high rate of dual APT compliance (gt
  97 at 30 d)
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• CYPHER Stent showed unsurpassed efficacy
• No difference in delivery success rate
• Superior angiographic outcomes (at 8 m)
• - significantly lower late loss in-stent and in
  the margins (p lt 0.001)
• - significantly larger in-stent minimum lumen
  diameter (p lt 0.001)
• significantly lower in-stent diameter stenosis
  (p lt 0.001)
• ? Unsurpassed efficacy TLR 5.0 In-lesion
  binary restenosis 9.6

These results should be read in conjunction with
the clinical results described in the full
product labeling for these devices. For
indications, contraindications, warnings, and
precautions see attached Essential Prescribing
Information.