Multi center, prospective, randomized, single blind, consecutive enrollment evaluation of the elixir desynetm novolimus-eluting coronary stent system with durable polymer compared to the endeavor zota

Abstract

Aims: To evaluate the long term safety and efficacy of the Elixir DESyneTM Novolimus-Eluting Coronary Stent System (CSS) compared to the Endeavor Zotarolimus-Eluting CSS through assessment of clinical, angiographic, and IVUS endpoints through 3 years. Method and results: 210 patients were randomized 2:1 either to the DESyne CSS loaded with 5mcg per mm of stent length of Novolimus, a sirolimus metabolite, eluted via a durable methacrylate polymer, or to the Endeavor CSS loaded with 10mcg per mm of stent length of Zotarolimus eluted via a durable phosphoryl choline polymer. All patients were analyzed for the primary endpoint of late lumen loss (LLL) assessed by QCA at 9 months. All patients also underwent evaluation for secondary endpoints which included a Device-orientated Composite Endpoint (DoCE) defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization (TLR); clinically-indicated Target Vessel Revascularization (TVR); and stent thrombosis all evaluated at 1, 6, 9, and 12 months and annually through 5 years. View this table: Table 1: 9-month Angiographic, IVUS and Conclusion: The study met the non-inferiority endpoint and also demonstrated superiority of the DESyne CSS as compared to control (Endeavor). Long term clinical results through 3 years and a review of angiographic and IVUS results will be presented.