CID released the results of Demonstr8 randomised trial results at a late-breaking trials session at EuroPCR (21–24 May, Paris, France). The study, presented by principal investigator Francesco Prati, showed that the Cre8 drug-eluting stent was non-inferior to a bare metal stent with a high statistically significant difference (RUTTS Score <30%; 99.75% CRE8™ vs.99.55% BMS; p<0.0001).
The study rationale was to assess if strut coverage at three months of the polymer-free Cre8 drug-eluting stent, once it becomes bare metal sent after complete drug-elution, is equivalent to a standard bare metal sent, such as the Abbott Vascular Vision, in patients with coronary artery disease.
According to a company press release, with the findings of the study, it is now possible to assess if Cre8 could allow three months’ dual antiplatelet therapy duration—since at this point of time it has become a bare metal stent and its endothelisation is comparable to a standard bare metal stent (for which the guidelines recommend one month month’s dual antiplatelet therapy).
The study has also shown that the drug-eluting stent was superior to the bare metal stent in terms of neointima thickness, even if the optical coherence tomography measurement was assessed at three months for Cre8 vs. one month for the bare metal stent. The press released reported that this confirms that the safety features of Cre8 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, 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 bioInducer surface and the lack of any polymer, makes it the only drug-eluting stent able to safely interface with blood and vessel as a standard bare metal stent after only three months. This sets a new benchmark in safety profile for a drug-eluting stent.”