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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 ) Stentn = 762 Number of Sites:132 (U.S., EU, Japan & Asia Pacific Region) Presented by:Gregg W. Stone, MD; ACC 2011
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2 of 18 90671521 *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. Incidence Rate (%) 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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3 of 18 90671521 Incidence Rate (%) p=0.25p=0.96 PLATINUM Workhorse 12-Month Additional Clinical Outcomes p=0.83p=0.58p=0.12p=0.59p=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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4 of 18 90671521 PLATINUM Workhorse Significant Reduction in Bail-out Stenting Incidence Rate (%) p=0.004 p=0.36 p=0.01 p=0.06 Overall RateCited 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)
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