Author + information
- Alexandre Abizaid1,
- Joachim Schofer2,
- Roberto Botelho3,
- Stefan Verheye4,
- Ricardo Costa5,
- Luiz Fernando Tanajura1,
- Sara Toyloy6,
- Lynn Morrison6 and
- Peter Fitzgerald7
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.
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.
Clinical results through 12 months and complete angiographic and IVUS results will be presented.
- 2013 American College of Cardiology Foundation