NEXT A Prospective, Randomized Trial Comparing Cre8, a Polymer-Free Stent Eluting Sirolimus, to a Paclitaxel-Eluting Stent

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NEXTA Prospective, Randomized Trial Comparing
Cre8, a Polymer-Free Stent Eluting Sirolimus, to
a Paclitaxel-Eluting Stent

• Didier Carrié, MD,PhD
• On behalf of NEXT Investigators
• Hôpital de Rangueil, Toulouse, France

Press Conference
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Cre8TM Distinctive Features
Polymer-Free platform Avoids all the well known
drawbacks due to the presence of a polymer
interface with blood flow or vessel wall
Abluminal Reservoir Technology (ART) Controll
ed and directed elution to the vessel wall
Amphilimus Formulation Formulated Sirolimus
with an organic acid Enhanced drug
bioavailability, permeability and maximized
product overall safety and efficacy
Bio Inducer Surface (BIS) 2nd generation pure
carbon coating Optimal haemo-compatibility
vs. lumen blood flow
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NEXT Study Design and Endpoints

• Primary Endpoint
• LLL in-stent at 6 months post-procedure

• Secondary Endpoints
• QCA measurements in-stent and in-segment at 6
  months
• IVUS measurements at 6 months (20)
• Clinical composite occurrence of death, MI, any
  revascularization at 1 and 6 months, and yearly
  up to 5 yrs
• Thrombosis throughout the study duration,
  according to ARC definition

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Primary Endpoint 6-month in-stent Late Lumen
Loss
0.340.40
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0.140.36
Superiority p-value lt 0.0001 Non-Inferiority p-value lt 0.0001
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12-month Cumulative Major Adverse Cardiac Event
(MACE) (Cardiac death, all MI, all TLR)
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Diabetic Subgroup
6-month Late Lumen Loss
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