2017 Buyer’s Guide

This buyer’s guide offers a searchable, comprehensive listing of the FDA-approved interventional devices available in the United States.

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.

 

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About Cardiac Interventions Today

Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.