TCT 2025 — Prof Christian M Spaulding (European Hospital Georges Pompidou & INSERM U 970, FR), principal investigator of the SELUTION DeNovo trial (M.A. Med Alliance S.A.; NCT04859985), joins us to share the one year results.

This international, multicentre randomised trial enrolled over 3,300 patients at 50 sites across Europe and Asia to compare a sirolimus-eluting balloon (SEB) plus provisional DES strategy with routine DES implantation in de novo coronary lesions. Eligible patients had PCI-indicated lesions 2–5 mm in diameter and presented with chronic coronary syndrome, unstable angina, or NSTEMI. The study tests non-inferiority for target vessel failure (TVF) at 12 months and 5 years, with planned long-term follow-up to evaluate safety and clinical outcomes.

Investigators at one year reached non-inferiority with 5.5% target vessel failure rate in the SEB strategy group, 4.5% in the DES strategy group and this difference is significant with a P value of 0.02.

Interview Questions: 
1. Can you briefly outline the design and rationale of the study?
2. What were the inclusion criteria, lesion characteristics, and patient demographics that define the enrolled population?
3. What were the key one-year clinical outcomes of the two PCI strategies?
4. How often was provisional stenting used, and did any subgroups differ?
5. What do these results mean for practice, and what’s next for follow-up?

For more content from TCT 2025 head to the Late-breaking Science Video Collection.

Interviewer: Mirjam Boros
Video Editor: David Ben-Harosh 

Support: This is an independent interview produced by Radcliffe Cardiology.