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Int J Cardiol. 2014 Oct 20;176(3):904-9. doi: 10.1016/j.ijcard.2014.08.031. Epub 2014 Aug 13.

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

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Centro per la Lotta contro l'Infarto - Fondazione Onlus, Rome, Italy; San Giovanni-Addolorata Hospital, Rome, Italy. Electronic address:
Centro per la Lotta contro l'Infarto - Fondazione Onlus, Rome, Italy.
Azienda Ospedaliera - Universitaria S. Anna, Ferrara, Italy; Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
Università Cattolica Del Sacro Cuore, Rome, Italy.
Azienda Ospedaliera Ordine Mauriziano di Torino, Turin, Italy.
Ospedale Civile, Bassano Del Grappa, Italy.
The Zena and Michael A. Wiener Cardiovascular Institute, NY, USA.
University Medical Center Utrecht, Utrecht, The Netherlands.



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.


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.


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.


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.


Drug-eluting stent; Optical coherence tomography; Randomized controlled trial

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