Final EXCELLA II Results Published for Elixir Medical's DESyne Stent Systems
January 9, 2017—Javaid Iqbal, MRCP, PhD, et al reported the final 5-year outcomes from the EXCELLA II trial online ahead of print in EuroIntervention. EXCELLA II is an evaluation of the CE Mark–approved DESyne novolimus-eluting stent (NES) systems (Elixir Medical Corporation) compared to the Endeavor zotarolimus-eluting stent (ZES) system (Medtronic). Novolimus, a metabolite of sirolimus, has been specifically developed to provide efficacy similar to currently available agents at a lower dose and thus requires a lower polymer load, noted the investigators.
As summarized in EuroIntervention, EXCELLA II is a prospective, multicenter, single-blind, noninferiority clinical trial. Patients (n = 210) with a maximum of two de novo lesions in two different epicardial vessels were randomized 2:1 to treatment with either NES (n = 139) or ZES (n = 71).
At 5-year follow-up, patients in the NES group had a significantly lower incidence of the patient-oriented (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.32–0.87; P = .013) and device-oriented (HR, 0.38; 95% CI, 0.17–0.83; P = .011) composite endpoints. There was no difference in cardiac death and definite/probable stent thrombosis between the two groups; however, there was a trend toward reduced myocardial infarction and repeat revascularization in the NES group at 5-year follow-up.
The incidence of device- and patient-oriented events was significantly lower in the NES group at 5-year follow-up. Further studies that are adequately powered for clinical outcomes are warranted, concluded the EXCELLA II investigators in EuroIntervention.