CID Spa, a leading company in interventional medicine, has released the 24-month clinical data for the NEXT trial during the “Next Generation DES and Bioabsorbable Scaffolding” - Scientific Symposia at TCT 2012 on Tuesday 23 rd October.

The Next trial is a prospective, international, multicenter and randomized First In Man study comparing the CID reservoir based polymer-free Cre8™ Drug Eluting Stent (DES) versus Taxus™Liberté® (Boston Scientific).

Didier Carrié, MD, PhD, Chief of the Interventional Cath-Lab at Hôpital de Rangueil, 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 Next study showed Cre8™ DES superiority versus TAXUS™ Liberté^® at 6 months in terms of in-stent late lumen loss with high statistically significant difference (p<0.0001) - 0.14±0.36 mm Cre8™ vs. 0.34±0.40 mm Taxus™ -, while the clinical outcomes at 24 months showed a low incidence of cumulative Cardiac Death, MI and TLR, resulting in an overall Cre8™ MACE rate of 6.7%. These data confirm the CID DES results stability between 12 and 24 months supporting the hypothesis that no-polymeric DES (i.e 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 Cre8TM arm. These outcomes suggest that the device may result in an improved DES performance in complex settings – such as in diabetic patients.

The Cre8™ clinical plan has also been detailed. It aims to prove the Cre8™ allowance for a shortage in DAPT duration every time it is needed and to increase DES efficacy in patients at high-risk of restenosis. During PCR 2013 the first results of these promising proposals will be disclosed.

Source: CID Spa