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SIRIUS: A U.S. Multicenter, Randomized, Double-Blind Study of the SIR ol I m US -Eluting Stent in De Novo Native Corona PowerPoint Presentation
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SIRIUS: A U.S. Multicenter, Randomized, Double-Blind Study of the SIR ol I m US -Eluting Stent in De Novo Native Corona - PowerPoint PPT Presentation


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SIRIUS: A U.S. Multicenter, Randomized, Double-Blind Study of the SIR ol I m US -Eluting Stent in De Novo Native Coronary Lesions. Presented at TCT 2002. SIRIUS: Study Design. n = 1,101 patients. Control Bx VELOCITY TM n = 545. De Novo Coronary Lesions Diameter: 2.5-3.5 mm

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slide1
SIRIUS:A U.S. Multicenter, Randomized, Double-Blind Study of the SIRolImUS-Eluting Stent in De Novo Native Coronary Lesions

Presented at TCT 2002

sirius study design
SIRIUS: Study Design

n = 1,101 patients

Control

Bx VELOCITYTM

n = 545

De Novo Coronary Lesions

Diameter: 2.5-3.5 mm

Length: 15-30 mm

Sirolimus-eluting

Bx VELOCITYTM

n = 556

Primary Endpoint:Target vessel failure (TVF) = cardiac death, MI or TVR (FU at 9 months)

Angiographic Substudy:First 850 pts (FU at 8 months)

IVUS Substudy:250 pts at selected sites (FU at 8 months)

TCT 2002

sirius study flow
SIRIUS: Study Flow

All Randomized Patients

n = 1,101

De-registered Control

Bx VELOCITYTM

n = 20

De-registered Sirolimus-eluting

Bx VELOCITYTM

n = 23

Control

Bx VELOCITYTM

n = 525

Sirolimus-eluting

Bx VELOCITYTM

n = 533

Angio FU at 8 Months = 84.7%

Clinical FU at 9 Months = 95.8%

Angio FU at 8 Months = 85.4%

Clinical FU at 9 Months = 95.7%

TCT 2002

slide4

SIRIUS: 8 Month Angiographic Follow-up Restenosis Rates

In-stent Restenosis

In-segment Restenosis

75% reduction

p<0.001

91% reduction

p<0.001

Sirolimus

Stent

Sirolimus

Stent

Bare

Stent

Bare

Stent

TCT 2002

slide5

SIRIUS: 8 Month Angiographic Follow-up Late Lumen Loss

In-stent

p<0.001

Proximal Margin

p<0.001

Distal Margin

p<0.001

Late Lumen Loss (mm)

Sirolimus

Stent

Sirolimus

Stent

Bare

Stent

Bare

Stent

Sirolimus

Stent

Bare

Stent

TCT 2002

slide6

SIRIUS: Restenosis Events Prevented

Number of In-segment Restenosis Events Prevented per 100 Patients

Long

Lesions

Small

Vessels

All patients

Diabetes

LAD

TCT 2002

slide7

SIRIUS: Clinical Events Through 9 Months

MACE

Target Vessel Failure*

*Primary clinical endpoint; defined as

cardiac death, MI, TVR

p<0.001

p<0.001

Sirolimus

Stent

Sirolimus

Stent

Bare

Stent

Bare

Stent

TCT 2002

slide8

SIRIUS: Diabetic Patient Restenosis Rates at 8 Month Angiographic Follow-up

n = 279 Diabetic Patients

In-stent Restenosis

In-segment Restenosis

65% reduction

p < 0.001

83% reduction

p < 0.001

Sirolimus

Stent

Sirolimus

Stent

Bare

Stent

Bare

Stent

TCT 2002

slide9

SIRIUS: Patterns of In-stent Restenosis

n = 159 Patients

Baseline Lesion Length (mm)

Restenosis Lesion Length (mm)

p = NS

p < 0.001

Sirolimus

Stent

Sirolimus

Stent

Bare

Stent

Bare

Stent

TCT 2002

slide10

SIRIUS: LAD Lesion Restenosis Rates at 8 Month Angiographic Follow-up

n = 462 LAD Lesions

In-stent Restenosis

In-segment Restenosis

76% reduction

p < 0.001

95% reduction

p < 0.001

Sirolimus

Stent

Sirolimus

Stent

Bare

Stent

Bare

Stent

TCT 2002

slide11

SIRIUS: LAD Lesion Clinical Events Through 9 Months

Follow-up

n = 462 LAD Lesions

MACE

Target Lesion Revascularization

p < 0.001

p < 0.001

Sirolimus

Stent

Sirolimus

Stent

Bare

Stent

Bare

Stent

TCT 2002

slide12

SIRIUS: Overlapping Stent Subgroup 8 Month Angiographic Follow-up

n = 344 Overlapping Stent Subgroup

In-stent Restenosis

In-segment Restenosis

Late Lumen Loss (mm)

p < 0.001

p < 0.001

p < 0.001

Sirolimus

Stent

Bare

Stent

Sirolimus

Stent

Bare

Stent

Sirolimus

Stent

Bare

Stent

TCT 2002