Key result
Sirolimus-eluting iron bioresorbable scaffold matches everolimus-eluting stents for 2-year late lumen loss.
Why the study?
The novel sirolimus-eluting iron bioresorbable scaffold demonstrated safety and efficacy in a nonrandomized first-in-human study but had not been compared with contemporary cobalt chromium everolimus-eluting stents in a randomized trial.
Does a sirolimus-eluting iron bioresorbable scaffold reduce 2-year angiographic in-segment late lumen loss compared to everolimus-eluting stents in patients with coronary artery disease?
RCT (n=518)
Single-blind
1:1
Yes
Does a sirolimus-eluting iron bioresorbable scaffold reduce 2-year angiographic in-segment late lumen loss compared to everolimus-eluting stents in patients with coronary artery disease?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“After the two years followup, we found that the first IBS was non-inferior to cobalt chromium EES for the primary endpoint of the angiographic late lumen loss at two years. We also demonstrated that the two powered secondary endpoints, the first target of QFR and the cross-sectional mean flow area by OCT, was also non-inferiority compared with the EES. The third clinical outcomes with a composite outcomes was comparable between the two arms including the instance of the death, myocardial infarction and the device thrombosis.”
“Ongoing follow-up through five years will provide insight into whether fewer adverse events might accrue with the IBS after its complete bioresorption at three years compared with the permanent metallic drug-eluting stents.”
The novel sirolimus-eluting iron bioresorbable scaffold is noninferior to contemporary everolimus-eluting stents for 2-year angiographic late lumen loss, though longer follow-up is required to assess late clinical benefits.
BACKGROUND: The novel thin-strut sirolimus-eluting iron bioresorbable scaffold (IBS) demonstrated safety and efficacy in a nonrandomized first-in-human study. OBJECTIVES: The objective of this study was to compare the IBS with contemporary metallic cobalt chromium everolimus-eluting stents (CoCr-EES) in patients with coronary artery disease. METHODS: IRONMAN-II was a prospective, multicenter, single-blinded, noninferiority randomized trial across 36 centers in China. Eligible patients had myocardial ischemia and 1 or 2 de novo target lesions. Patients were randomly assigned (1:1) to IBS or CoCr-EES, with allocation masked. Optical coherence tomography (OCT) was performed in the first 25 participant pairs. Clinical follow-up was scheduled at 1, 6, and 12 months, and annually to 5 years, with angiographic and OCT follow-up at 2 years. The primary endpoint was 2-year angiographic in-segment late lumen loss (LLL). Powered secondary endpoints included target vessel quantitative flow ratio (QFR) and OCT-derived cross-sectional mean flow area. Other secondary endpoints included target lesion failure (cardiac death, target vessel myocardial infarction [MI], or ischemia-driven target vessel revascularization), the patient-oriented composite endpoint (all-cause death, MI, or any revascularization), their individual components, and device thrombosis. RESULTS: Between March 10 and December 13, 2022, 518 patients were randomized to IBS (n = 259) or CoCr-EES (n = 259). At 2 years, lesion-level in-segment LLL was 0.28 (0.52) mm with IBS and 0.23 (0.43) mm with CoCr-EES (difference: 0.08 mm; 95% CI: -0.02 to 0.18; P CONCLUSIONS: In IRONMAN-II, the sirolimus-eluting IBS was noninferior to CoCr-EES for 2-year in-segment LLL, QFR, and OCT-derived flow area. Clinical event rates were also comparable between groups although non-ischemia-driven revascularization rates were higher after IBS. Longer-term follow-up is necessary to demonstrate whether late benefits are realized after complete IBS resorption. (A Clinical Investigation to Evaluate the Safety and Efficacy of IBS in Patients With Coronary Artery Disease; NCT05206084).
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Gao et al. (2026) conducted an RCT in Coronary artery disease (n=518). Sirolimus-eluting iron bioresorbable scaffold (IBS) vs. Cobalt chromium everolimus-eluting stents (CoCr-EES) was evaluated on 2-year angiographic in-segment late lumen loss (LLL) (MD 0.08 mm, 95% CI -0.02 to 0.18). The sirolimus-eluting iron bioresorbable scaffold was noninferior to everolimus-eluting stents for 2-year in-segment late lumen loss (difference 0.08 mm; 95% CI -0.02 to 0.18).
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