CID's Cre8 Drug-Eluting Stent Demonstrates Sustained Efficacy at 24 Months in NEXT Study

December 11, 2012—CID s.p.a. (Carbostent & Implantable Devices, Saluggia, Italy) announced that the 24-month clinical data for the NEXT trial, which is evaluating the company's Cre8 drug-eluting stent (DES), were presented in October during the “Next Generation DES and Bioabsorbable Scaffolding” session at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida.

According to CID, the NEXT trial is a prospective first-in-man study comparing the CID reservoir-based, polymer-free Cre8 DES versus Taxus Liberté (Boston Scientific Corporation, Natick, MA). NEXT is an international, multicenter, randomized trial. Didier Carrié, MD, PhD, Chief of the Interventional Cath-Lab at Hôpital de Rangueil in Toulouse, France, and principal investigator of the study, has detailed the study background, as well as the main findings of this clinical experience at 6 and 24 months.

The company stated that the NEXT study showed Cre8 DES superiority versus Taxus Liberté at 6 months in terms of in-stent late lumen loss, with a high statistically significant difference (0.14 ± 0.36 mm, Cre8 vs 0.34 ± 0.40 mm, Taxus; P < .0001). The clinical outcomes at 24 months showed a low incidence of cumulative cardiac death, myocardial infarction, and target lesion revascularization, resulting in an overall major adverse cardiac event rate of 6.7% for the Cre8.

CID noted that these data confirm the stability of its DES results between 12 and 24 months, supporting the hypothesis that no-polymeric DES (ie, no long-term inflammatory trigger) should provide lower long-term event catch-up. Dr Carriè pointed out that the same consistency of data at 24 months has been obtained in the diabetic subgroup (29% of the overall population in the Cre8 arm). These outcomes suggest that the device may result in improved DES performance in complex settings, such as in diabetic patients.

The company's Cre8 clinical program aims to prove that the Cre8 device allows for a shortening in dual-antiplatelet therapy duration every time it is needed and an increase in DES efficacy in patients at high risk of restenosis. The first results of these proposals will be disclosed in at the EuroPCR 2013
conference in Paris on May 21–24, 2013.