EXCELLA BD Randomized Clinical Study
The EXCELLA BD Trial was a randomized, prospective, multicenter, single-blind, non-inferiority study evaluating the DESyne® BD Novolimus Eluting Coronary Stent System (CSS) with resorbable polylactide-based polymer compared to the Endeavor Zotarolimus Eluting Coronary Stent System. The primary and principal secondary endpoints were: in-stent late lumen loss and a device-oriented composite endpoint (DoCE) comprised of cardiac death, target vessel myocardial infarction (MI) and clinically-indicated target lesion revascularization (TLR).
- 146 patients enrolled at 10 sites world-wide
- Principal Investigators: Alexandre Abizaid, MD, PhD, Stefan Verheye, MD, PhD
- Clinical follow-up at 30 days, 6, 9, 12 months, and 2 – 5 years
- Angiographic and IVUS (sub-set of patients) follow-up at 6 months
- Primary endpoint: in-stent late lumen loss
- If non-inferiority was met, then tested for superiority
- Available stent sizes: 2.5, 3.0 and 3.5mm diameters in lengths of 14, 18 and 28mm
- Drug dose – 5mcg per mm of stent length
- Polymer bioabsorption rate: 6 – 9 months
The DESyne® BD stent was shown to be not only non-inferior (p<0.001) but also superior (p< 0.001) to the Endeavor stent for the primary endpoint of in-stent late lumen loss (0.12±0.17 vs. 0.67±0.47, p < 0.001). IVUS results mirrored the angiographic results demonstrating a statistically significant reduction in percent neointimal obstruction for the DESyne BD stent versus the Endeavor stent (3.6±4.2% vs. 20.7±14.2, p<0.001). Clinical event rates through six months, and remained low through 3 years, were low and similar for both groups (DoCE – 2.7% vs. 3.2%, p=1.00), DESyne BD vs. Endeavor).
In the EXCELLA BD randomized clinical trial, the DESyne® BD Novolimus Eluting Coronary Stent System with resorbable polymer demonstrated superior results to the control Endeavor stent for the primary endpoint of in-stent late lumen loss. Clinical event rates are low demonstrating the safety of the DESyne BD stent.