Sirolimus-Eluting Iron Bioresorbable Scaffolds vs Everolimus-Eluting Stents for Percutaneous Coronary Intervention: A Randomized Trial (IRONMAN II)
Primary result · Lesion-level in-segment LLLResult — go to the resultDifference 0.08 mm 95% CI −0.02 to 0.18Authors' conclusion
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.
Study context
- Population
- Patients with CAD, myocardial ischemia and 1 or 2 de novo target lesions
- Participants
- 518 patients
- Comparison
- Iron bioresorbable scaffold (IBS) vs cobalt chromium everolimus-eluting stents (CoCr-EES)
- IBSn = 259
- CoCr-EESn = 259reference
- Primary endpoint
- Angiographic in-segment late lumen loss (LLL)
- Follow-up
- 2 years
Methodological detailsprospective, multicentre (36 centres in China), single-blinded, non-inferiority
- Prospective
- Multicentre (36 centres in China)
- Single-blinded
- Non-inferiority
Primary result
Lesion-level in-segment LLL
Difference
0.08 mm
95% CI −0.02 to 0.18
P = 0.03 for non-inferiority
By group
IBS vs CoCr-EES
difference 0.08 mm (95% CI −0.02 to 0.18); P for non-inferiority = 0.03
As reported in the abstract
Secondary outcomes
| Outcome | IBS | CoCr-EES | Difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Target vessel QFR (powered secondary) · 2 years | mean 0.90 (SD 0.13) | mean 0.92 (SD 0.09) | −0.02 (−0.04 to 0) | P for non-inferiority = 0.05 | |
| OCT flow area (powered secondary) · 2 years | mean 6.92 (SD 3.48) mm² | mean 6.64 (SD 2.44) mm² | 0.27 (−0.09 to 0.63) | P for non-inferiority < 0.0001 | |
| −0.500.51Difference (linear scale) |
| Outcome | IBS | CoCr-EES | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Target lesion failure · 2 years | 7.4% | 5.4% | 1.37 (0.69–2.73) | P = 0.37 | |
| 0.20.5125Hazard ratio (log scale) |
- Optical coherence tomography (OCT) flow area (powered secondary): OCT in first 25 participant pairs
Patient-oriented composite endpoint, death, MI
- No significant between-group differences
Safety
Events
| Outcome | IBS | CoCr-EES |
|---|---|---|
| Device thrombosis | 0 | 1 |
Binary restenosis and revascularization
- Higher with IBS; most events non-ischemia-driven
Original publication
Sirolimus-Eluting Iron Bioresorbable Scaffolds vs Everolimus-Eluting Stents for Percutaneous Coronary Intervention: A Randomized Trial (IRONMAN II). J Am Coll Cardiol. Published 11 February 2026. doi:10.
Summarised from the published abstract; every number is checked against it