Author + information
- Alexandre Abizaid,
- Joachim Schofer,
- Roberto Botelho,
- Stefan Verheye,
- Ricardo Costa,
- Luiz Fernando Tanajura,
- Lynn Morrison,
- Sara Toyloy and
- Peter Fitzgerald
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 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 secondary endpoints including 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; 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 QCA endpoints at 6 months including: in-segment LLL, percent diameter stenosis, 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 (DoCE 2.7% vs. 3.2%, p= 1.00). Clinical results through 24 months and complete QCA and IVUS results will be presented.
This randomized study evaluating the DESyne BD CSS met the non-inferiority endpoint and also demonstrated superiority for in-stent LLL as compared to the concurrent control. The clinical results through 24 months and complete QCA and IVUS results will be presented.
Poster Sessions, Expo North
Monday, March 11, 2013, 9:45 a.m.-10:30 a.m.
Session Title: Therapeutic Approaches in Chronic CAD and Stable Ischemic Heart Disease
Abstract Category: 11. Chronic CAD/Stable Ischemic Heart Disease: Therapy
Presentation Number: 1281-63
- 2013 American College of Cardiology Foundation