Randomized comparison between 3-month Cre8 DES vs. 1-month Vision/Multilink8 BMS neointimal coverage assessed by OCT evaluation: the DEMONSTRATE study

Background: It has been hypothesized that incomplete endothelialization and delayed vascular healing may trigger stent thrombosis events after drug-eluting stent (DES) implantation. We aimed to demonstrate non-inferiority in terms of neointimal coverage of novel Cre8 DES at 3 months, compared to Vision/Multilink8 Bare Metal Stent (BMS) at 1month.

Methods: The ranDomizEd coMparisOn betweeN novel Cre8 DES and BMS to assess neoinTimal coveRAge by OCT Evaluation (DEMONSTRATE) was a multicenter, randomized, parallel group study. Thirty-eight patients undergoing angioplasty of de-novo coronary lesion were randomized to Cre8 (19) or Vision/Multilink8 (19) stent placement at 6 OCT-experienced centers. Primary end-point was the Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of <30%, determined by OCT at 3 and 1 months for Cre8 and Vision/Multilink8, respectively. Percentage of uncovered/malapposed stent struts, neointimal growth and thickness were the main secondary end-points.

Results: The primary end-point of RUTTS score<30% occurred in 99.8% (899/901) of Cre8 struts and in 99.6% (1116/1121) of Vision/Multilink8 struts (difference 0.2, CI 95% -0.2 to 0.6, p for noninferiority<0.001). The percentage of uncovered/malapposed struts was comparable (0.36±0.64 vs. 0.12±0.24, p=0.145) in the two study groups, while both neointimal percentage area (8.46±5.29 vs. 19.84±15.93, p<0.001) and thickness (0.07±0.04 vs. 0.16±0.12, p<0.001) were significantly reduced by Cre8 stent.

Conclusions: The Cre8 DES at 3 months has comparable strut coverage to Vision/Multilink8 BMS at 1 month while preserving a greater efficacy in neo-intima formation reduction. Further studies to assess clinical implication of these Cre8 characteristics are warranted.