During the Late Breaking Trials session at Euro PCR 2013, CID SpA, a leading company in interventional medicine, has released for the first time the Demonstr8 randomised trial results. This study compares strut coverage at three months of the polymer-free Cre8™ DES to the Abbott® Co-Cr BMS at 1 month. The stents’ strut coverage is evaluated with OCT.

Prof. Francesco Prati, principal investigator of the study, has presented the primary endpoint during the lecture titled “Randomised comparison between a novel DES and a BMS to assess neointima coverage by OCT evaluation: the Demonstr8 study”. The study rationale was to assess if strut coverage at three months of the polymerfree Cre8 DES, once it becomes a BMS after complete drug elution, is equivalent to a standard BMS, such as the Abbott® Co-Cr Vision, in patients with coronary artery disease. Cre8™ proved to be non-inferior to the BMS with a high statistically significant difference (RUTTS score < 30%; 99.75% CRE8™ vs. 99.55% BMS; p < 0.0001). With these findings it is possible to assess that Cre8TM could allow three months DAPT duration since at this point of time it has become a BMS; and its endothelization is comparable to a standard BMS for which the guidelines recommend 1 month DAPT. The study has also shown that Cre8™ DES was superior to BMS in terms of neointima thickness, even if the OCT measurement was assessed at 3 months for Cre8 vs 1 month for BMS, confirming that the excellent safety features of Cre8TM have been proven without any impact on device efficacy (neointima thickness; 0.08mm CRE8™ vs. 0.18mm BMS; p<0.0001).

At the end of the presentation, Prof. Prati commented: "The perfect, regular and thin coverage seen for Cre8 in the Demonstr8 trial, coupled with the unique Abluminal Reservoir Technology empowered by the Bio Inducer surface and the lack of any polymer, makes it the only DES able to safely interface with blood and vessel as a standard BMS after only 3 months. This sets a new benchmark in safety profile for a DES"

Commenting on the Demonstr8 study results, Franco Vallana, President and C.E.O. of CID SpA stated: “The Demonstr8 study outcomes, as well as those proven in the previous publications, make us more and more aware of how important Cre8’s unique features can be for cardiologists and their patients. In the search for a safer DES, we are proud to have been able to show that Cre8 is as nicely covered as a standard BMS, and aim at a reduction of dual antiplatelet therapy to three months, minimizing the cost of care as well as drug side effects”.

Source:CID SpA