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DISCOVERY 1TO3 Trial

05/09/2018 -  

60 MVD patients with OFDI, single arm, primary endpoint TLF @ 12M. Published

Designed to:

  • Assess endothelial coverage at 1, 2 and 3 months by OFDI in patients with multivessel disease scheduled for staged PCI procedure
  • Provide a "look" in the artery with OFDI after implantation of Ultimaster
  • Investigate possibility for shorter DAPT by generating relevant clinical scientific data

 

Study Design

  • Single arm
  • 60 patients with planned staged PCI at 1M/3M
  • Total of 6 sites
  • 3 countries: France, Germany, Netherlands
  • Primary endpoint: OFDI assessed % stent strut coverage at 3M post procedure


Hypothesis: < 20% uncovered struts at 3M post procedure

DISCOVERY 1TO3 - Study Design

Primary endpoint was met with strut coverage of 95% achieved by 3 months

  • Patient cohort included complex cases and lesions
discovery_1_TO_3_Image2.png

Data are mean±SD

  • The mean (SD) number of diseased vessels per patient was 2.2 (0.5), and the mean (SD) number of lesions detected was 3.2 (1.6) 
  • The mean (SD) total number of lesions treated per patient was 2.1 (0.7) 
  • Good clinical outcomes were observed between 1 month and 1 year, with no cases of death, MI, TVR, or ST reported 
    • Incidences of TLR and TLF between 1 month and 1 year were 3.4% for both 
  • There were no significant differences in baseline patient characteristics, lesion characteristics, or procedural characteristics between the two groups 
    • 69.8% of procedures that used Ultimaster were performed using transradial access, and the overall procedure success rate was 97.8% 
  • At 5 years, there was a trend towards better clinical outcomes with Ultimaster than with Xience (statistical significance not met) 
    • Any death: 9.3% vs 10.8% (p=0.60) 
    • Any MI: 3.1% vs 5.6% (p=0.19) 
    • Stent thrombosis: 0.9% vs 1.7% (p=0.43)

References:

MI, myocardial infarction; SD, standard deviation; ST, stent thrombosis; TLF, target lesion failure; TLR, target lesion revascularisation;
TVR, target vessel revascularisation.
MVD, multivessel disease; SD, standard deviation.
Chevalier B et al. Circ Cardiovasc Interv 2017;10. pii: e004801:doi:10.1161/CIRCINTERVENTIONS.116.004801;
Chevalier B et al. Presented at EuroPCR 2017, abstract OP0698;
Iniguez-Romo A et al. Presented at EuroPCR 2018, abstract LBT8727.
Data on file at Terumo Europe.