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

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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

• 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

• Patient cohort included complex cases and lesions

• 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)