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EXCELLA II Randomized Clinical Study

OVERVIEW

The EXCELLA II Trial was a randomized, prospective, multicenter, single-blind, non-inferiority study evaluating the DESyne® Novolimus Eluting Coronary Stent System (CSS) compared to the Endeavor Zotarolimus Eluting Coronary Stent System in the treatment of up to two de novo native coronary artery lesions. 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 vessel revascularization (TVR).

  • 210 patients enrolled at 21 sites world-wide
  • Principal Investigators: Patrick W. Serruys, MD, PhD, Alexandre Abizaid, MD, PhD, John Ormiston, MBChB, Stefan Windecker, 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 9 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

RESULTS

The DESyne® 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 (0.11±0.32 vs. 0.63±0.42, p < 0.001).  IVUS results mirrored the angiographic results demonstrating a statistically significant reduction in percent neointimal obstruction rate for the DESyne stent versus the Endeavor stent (4.5±5.1% vs. 20.9±11.3, p<0.001).

Clinical event rates were low and similar for both groups (DoCE - 2.9% vs. 5.6%, p=0.45), DESyne vs. Endeavor).  Clinical results continue to favor the DESyne Stent through 5 year follow-up (DoCE 4.3% vs 7.0 %, p= 0.51 and 4.3% vs 9.9%, p-0.18 for DESyne vs. Endeavor).

CONCLUSIONS

In the EXCELLA II randomized clinical trial, the DESyne® Novolimus Eluting Coronary Stent System demonstrated superior results to the control Endeavor stent for the primary endpoint of in-stent late lumen loss. Clinical event rates are low for 5 years for the DESyne stent.