Abstract 18720: Multi Center, Prospective, Randomized, Single Blind, Consecutive Enrollment Evaluation a Novolimus-Eluting Coronary Stent System with Bioabsorbable Polymer Compared to a Zotarolimus-Eluting Coronary Stent System: 12- Month Clinical and 6-Month Angiographic and IVUS Results: the EXCELLA BD Study
Aims: To evaluate the safety and effectiveness of the Elixir DESyneTM BD Novolimus Eluting Coronary Stent System (CSS) with a bioabsorbable polymer compared to the Endeavor Zotarolimus Eluting Coronary Stent System through the assessment of clinical, angiographic, and IVUS endpoints.
Method and Results: 149 patients were randomized 3:1, either to the Elixir DESyne BD Novolimus Eluting CSS loaded with 5mcg per mm of stent length of Novolimus, a sirolimus metabolite, eluted via a bioabsorbable polylactide-based polymer, or to the Endeavor Zotarolimus-eluting 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 in-stent late lumen loss (LLL) assessed by QCA at 6 months. Moreover, all patients underwent evaluation for the secondary endpoints including the Device-orientated Composite Endpoint (DoCE) defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization; clinically-indicated Target Vessel Revascularization (TVR), and stent thrombosis at 1, 6, 9, and 12 months and annually through 5 years. Lesions were also evaluated for angiographic endpoints at 6 months including: in-segment LLL, percent diameter stenosis, minimal lumen diameter post-procedure and at 6 months, and angiographic binary restenosis (ABR) (≥50%). A subset of patients underwent intravascular ultrasound (IVUS) evaluation including percent (%) neointimal obstruction at 6 months. The study met the primary endpoint demonstrating both non-inferiority and superiority of the DESyne BD compared to the control (0.12±0.15 vs 0.67±0.47, p<0.001), additionally, in-stent ABR was significantly lower for DESyne BD (0% vs 7.9%, p=0.003). Excellent clinical results at 6 months were demonstrated for both devices. Clinical results through 12 months and additional angiographic and IVUS results will be presented.
Conclusion: Clinical results through 12 months and complete angiographic and IVUS results will be presented.
- © 2012 by American Heart Association, Inc.