1 of 18 90671521 Presented by Gregg W. Stone, MD, ACC 2011. PROMUS Stent is a private-labeled Xience...

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1 of 18 90671521 Presented by Gregg W. Stone, MD, ACC 2011. PROMUS Stent is a private-labeled Xience V Everolimus Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific Corporation. XIENCE V is a registered trademark of Abbott Cardiovascular Systems, Inc. PROMUS and PROMUS Element are trademarks of Boston Scientific Corporation or its affiliates. PLATINUM Workhorse RCT 12-Month Clinical Results Study Objective: Evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions Study Design: Prospective, randomized, controlled, single-blind, non- inferiority trial in patients with up to 2 de novo target lesions; lesion length ≤24 mm; reference vessel diameter 2.5 – 4.25 mm Primary Endpoint: Target Lesion Failure at 12-months (Ischemia-Driven TLR, target vessel MI, or target vessel cardiac death) Additional Endpoints: Components of TLF, ARC ST (Def/Prob), Technical Success, Clinical Procedural Success Patient Population: PROMUS Element Stent n = 768 PROMUS (XIENCE V ) Stent n = 762 Number of Sites: 132 (U.S., EU, Japan & Asia Pacific Region)

Transcript of 1 of 18 90671521 Presented by Gregg W. Stone, MD, ACC 2011. PROMUS Stent is a private-labeled Xience...

Page 1: 1 of 18 90671521 Presented by Gregg W. Stone, MD, ACC 2011. PROMUS Stent is a private-labeled Xience V Everolimus Eluting Coronary Stent System manufactured.

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Presented by Gregg W. Stone, MD, ACC 2011. PROMUS Stent is a private-labeled Xience V Everolimus Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific Corporation. XIENCE V is a registered trademark of Abbott Cardiovascular Systems, Inc. PROMUS and PROMUS Element are trademarks of Boston Scientific Corporation or its affiliates.

PLATINUM Workhorse RCT12-Month Clinical Results

Study Objective: Evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions

Study Design: Prospective, randomized, controlled, single-blind, non-inferiority trial in patients with up to 2 de novo target lesions; lesion length ≤24 mm; reference vessel diameter 2.5 – 4.25 mm

Primary Endpoint: Target Lesion Failure at 12-months (Ischemia-Driven TLR, target vessel MI,

or target vessel cardiac death)

Additional Endpoints: Components of TLF, ARC ST (Def/Prob), Technical Success, Clinical Procedural Success

Patient Population: PROMUS Element Stent n = 768PROMUS (XIENCE V) Stent

n = 762 Number of Sites: 132 (U.S., EU, Japan & Asia Pacific Region)

Presented by: Gregg W. Stone, MD; ACC 2011

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0.4%

1.6%1.9%

3.2%

0.8%0.8%

1.9%

3.5%

0%

4%

8%

12%

TLF ID-TLR TV-MI TV-Cardiac Death

*TLF=Ischemia-driven (ID) target lesion revascularization (TLR), or cardiac death/myocardial infarction (MI) related to the target vessel (TV). **Primary endpoint of per protocol TLF non-inferiority was met (PROMUS Stent = 2.9%, PROMUS Element Stent = 3.4%, p(non-inf)==0.001) . Presented by Gregg W. Stone, MD, ACC 2011. PROMUS Stent is a private-labeled Xience V Everolimus Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific Corporation. XIENCE V is a registered trademark of Abbott Cardiovascular Systems, Inc. PROMUS and PROMUS Element are trademarks of Boston Scientific Corporation or its affiliates.

Incid

ence

Rat

e (%

)

PROMUS Element™ Stent(n = 768)

PROMUS™ (XIENCE V™)Stent (n = 762)

p=0.72 p=0.14

PLATINUM Workhorse 12-Month Primary Endpoint and Components

p=0.96 p=0. 51

Primary Endpoint of TLF* Non-Inferiority Met**

Graph shows Intent-to-treat population.

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1.2%0.4%

0.9%0.4%0.7%

1.8%

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2.9%

0.1%

1.1%0.9%

1.9%

2.7%

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TVR TLR Cardiac Death MI QMI NQMI ARC ST(Def/Prob)

Incid

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Rat

e (%

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p=0.25p=0.96

PLATINUM Workhorse 12-Month Additional Clinical Outcomes

p=0.83 p=0.58 p=0.12 p=0.59 p=0.99

Graph shows Intent-to-treat population.TVR: target vessel revascularization. ST: stent thrombosis. Presented by Gregg W. Stone, MD, ACC 2011. PROMUS Stent is a private-labeled Xience V Everolimus Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific Corporation. XIENCE V is a registered trademark of Abbott Cardiovascular Systems, Inc. PROMUS and PROMUS Element are trademarks of Boston Scientific Corporation or its affiliates.

PROMUS Element™ Stent(n = 768)

PROMUS™ (XIENCE V™)Stent (n = 762)

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PLATINUM Workhorse Significant Reduction in Bail-out Stenting

1.7%

3.4%

4.7%

9.8%

0.7%1.4%

3.8%

5.9%

0%

4%

8%

12%

Unplanned (Bail-out)Stenting

Procedural Complications Inadequate LesionCoverage

Other Reasons

Incid

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Rat

e (%

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p=0.004 p=0.36 p=0.01 p=0.06

Overall Rate Cited Reason for Bail-out Stent

Presented by Gregg W. Stone, MD, ACC 2011. PROMUS Stent is a private-labeled Xience V Everolimus Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific Corporation. XIENCE V is a registered trademark of Abbott Cardiovascular Systems, Inc. PROMUS and PROMUS Element are trademarks of Boston Scientific Corporation or its affiliates.

PROMUS Element™ Stent(n = 768)

PROMUS™ (XIENCE V™)Stent (n = 762)