1 of 18 90671521 Presented by Gregg W. Stone, MD, ACC 2011. PROMUS Stent is a private-labeled Xience...
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Transcript of 1 of 18 90671521 Presented by Gregg W. Stone, MD, ACC 2011. PROMUS Stent is a private-labeled Xience...
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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%
0.7%
1.9%
2.9%
0.1%
1.1%0.9%
1.9%
2.7%
0%
4%
8%
12%
TVR TLR Cardiac Death MI QMI NQMI ARC ST(Def/Prob)
Incid
ence
Rat
e (%
)
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
ence
Rat
e (%
)
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)