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EXCELLA BD Randomized Clinical Study

OVERVIEW

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

RESULTS

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). 

CONCLUSIONS

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.