NEXT A Prospective, Randomized Trial Comparing Cre8, a Polymer-Free Stent Eluting Sirolimus, to a Paclitaxel-Eluting Stent Didier Carrié, MD,PhD On behalf.

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Presentation transcript:

NEXT A 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

Cre8 TM : 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 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) Controlled and directed elution to the vessel wall Abluminal Reservoir Technology (ART) Controlled 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 Amphilimus Formulation = Formulated Sirolimus with an organic acid Enhanced drug bioavailability, permeability and maximized product overall safety and efficacy Bio Inducer Surface (BIS) = 2 nd generation pure carbon coating Optimal haemo-compatibility vs. lumen blood flow Bio Inducer Surface (BIS) = 2 nd generation pure carbon coating Optimal haemo-compatibility vs. lumen blood flow

Clinical Angio/IVUS 12 & 24 months6 months1 month3, 4, 5 years 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 NEXT Study Design and Endpoints Patients with ischemic myocardial symptoms related to de novo lesions (max 2 in 2 different vessels) in native coronary arteries Cre8 TM (n=162 pts)  3.0 – 3.5 mm L – 20 – 25 mm TAXUS TM Liberté® (n=161 pts)  3.0 – 3.5 mm L – 20 – 25 mm 323 enrolled patients 11 European Sites Randomisation 1:1 100% angiographic f-up 20% IVUS f-up

Primary Endpoint: 6-month in-stent Late Lumen Loss 0.14± ± % Superiority p-value < Non-Inferiority p-value <

12-month Cumulative Major Adverse Cardiac Event (MACE) (Cardiac death, all MI, all TLR) p= p= /148 10/148 2/148 1/148 1/148 2/148 7/148 9/148 1/158 1/157 p=1.0000

Diabetic Subgroup 0.12± ±0.41 P= % 2/44 4/36 1/36 2/44 4/36 12-month cumulative clinical results 6-month Late Lumen Loss