Alvimedica @ JIM 2021: “The latest updates of ReCre8 all-comers RCT with short DAPT”
During the JIM Congress 2021, Dr. Stella presented a lecture titled: “The latest updates of ReCre8 all-comers RCT with short DAPT””.
The ReCre8 is a prospective, multicentre, randomized, non-inferiority “all-comers population” study comparing Cre8 to Resolute Integrity. The study Primary endpoint is TLF @12 months.
In the overall population both stents resulted equally effective and safe, but analysing the 1-month DAPT and DM patients subgroups Cre8 results are more favourable with lower Late ST in 1-month DAPT population and numerically lower events in overall DM patients. Commenting the subgroup results, Dr. Stella stated: “Looking to DES Efficacy, in the ReCre8 diabetic patients subgroup, Cre8™ provides more favorable results vs. Resolute in the overall DM population with a statistical superiority reduction in the Insulin Dependent DM patients arm. Since diabetic disease occurs very frequently in HBR patient population, not only Cre8™ can reduce ischemic events but thanks to lower TLR rate it can contribute to reduce bleeding events in HBR diabetic patients.”
Cre8TM is a polymer-free drug eluting stent embedding unique technologies:
- Abluminal Reservoir Technology: Polymer-free technology that allows a sustained drug elution, exclusively directed towards the vessel wall, for up to 2-3 months.
- Amphilimus™ formulation (Sirolimus + Fatty acid): Enhanced drug bioavailability, permeability and maximized product overall safety and efficacy specifically in diabetic patients.
- Bio Inducer Surface coating: 2nd generation pure carbon coating for optimal haemo-compatibility vs. lumen blood flow.