First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial
Authors' conclusion
In this first-in-human experience, an ultrathin IBS was safe and effective for the treatment of de novo non-complex coronary lesions up to 3-year follow-up.
Study context
- Population
- Patients with a single de novo non-complex coronary lesion treated with an ultrathin sirolimus-eluting iron bioresorbable scaffold (IBS)
- Participants
- 45 patients
- Exposure
- Cohort 1 vs Cohort 2
- Cohort 1n = 30
- Cohort 2n = 15
- Outcome
- Coprimary: target lesion failure (TLF) and angiographic in-scaffold late lumen loss (LLL)
- Follow-up
- 6 months
Methodological detailsprospective, open-label, Enrolled April 2018 to January 2019, Patients randomly assigned to 2 follow-up cohorts; clinical follow-up annually up to 5 years
- Prospective
- Open-label
- Enrolled April 2018 to January 2019
- Patients randomly assigned to 2 follow-up cohorts; clinical follow-up annually up to 5 years
Main finding
As reported in the abstract
Target lesion failure (TLF) rate
2.2%
In-scaffold late lumen loss (LLL) (mean±SD), mm
0.33±0.27 mm
Observational data: associations, not effects.
Further findings
TLF and in-scaffold LLL · 3 years
- TLF rate
- 6.7%
- In-scaffold LLL (mean±SD), mm
- 0.37±0.57 mm
- TLF due to clinically indicated target lesion revascularisation in all cases
Covered struts by optical coherence tomography (OCT)
- Covered struts at 6 months
- 99.8%
- Covered struts after 1 year
- 100%
Strut absorption rate · 3 years
- Strut absorption rate
- 95.4%
Death, MI or stent thrombosis · 3 years
- Deaths, MIs or stent thromboses
- 0
Original publication
First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial. EuroIntervention. Published 19 June 2023. doi:10.
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