The REALITY Study Results

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

Study Design

Moderately Complex Lesions Baseline Demographics*

* p=ns

Moderately Complex Lesions Baseline Characteristics*

* p=ns

In the REALITY Study :

Excellent Delivery Success and Unsurpassed Clinical Outcomes Excellent Delivery Success*

* p=ns

† Final diameter stenosis < 30% (with the assigned device)

In the REALITY Study :

Excellent Delivery Success and Unsurpassed Clinical Outcomes Unsurpassed Clinical Outcomes*

* p=ns

‡ 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

In the REALITY Study :

Superior in Key Angiographic Outcomes Key Angiographic Outcomes (QCA)

* Relative Risk Reduction

† Minimum Lumen Diameter

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.

In the REALITY Study :

Lower Stent Thrombosis Stent Thrombosis : Actual Treatment 

A 78 % Relative Risk Reduction

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.

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.

The REALITY Study Results : 

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 (> 97% at 30 d) 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 < 0.001)- significantly larger in-stent minimum lumen diameter (p < 0.001)- significantly lower in-stent diameter stenosis (p < 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.