Optical coherence tomography- vs angiography-guided coronary stent implantation in calcified lesions: the ILUMIEN IV trial
Authors' conclusion
In the ILUMIEN IV trial, OCT-guided PCI in patients with angiographically determined moderately or severely calcified lesions reduced the 2-year rate of TVF compared with angiography-guided PCI, an effect that was not seen in patients with lesions with no or mild angiographic calcium.
Study context
- Population
- Patients with a single percutaneous coronary intervention (PCI) target lesion; calcification (none, mild, moderate, severe) graded by angiographic core laboratory
- Participants
- 2,114 patients
- Comparison
- Optical coherence tomography (OCT)-guided vs angiography-guided PCI in calcified lesions
- Primary endpoint
- Primary imaging endpoint: post-PCI minimal stent area (MSA) by OCT; primary clinical endpoint: Target-vessel failure (TVF):
- Cardiac death
- Target-vessel myocardial infarction (TV-MI)
- Ischaemia-driven target-vessel revascularization
- Follow-up
- 2 years
Methodological detailssubgroup analysis by angiographic lesion calcification
- Subgroup analysis by angiographic lesion calcification
Primary result
As reported in the abstract
TVF by lesion calcification (subgroups)
OCT guidance vs Angiography guidanceAdjusted hazard ratio (95% CI)
Moderate/severe calcification (n = 1082)
0.62(0.40–0.96)
- No/mild calcification (n = 1032); no significant difference
- aHR 1.48 (95% CI 0.90–2.44)
Further findings
Post-PCI MSA, moderate/severe calcification · OCT n = 544; angiography n = 538
P = 0.03
| Outcome | OCT guidance | Angiography guidance | aHR (95% CI) | P value | |
|---|---|---|---|---|---|
| Serious MACE, moderate/severe calcification · 2 years | 2.8% | 4.7% | 0.49 (0.25–0.95) | P = 0.03 | |
| TV-MI, moderate/severe calcification · 2 years | 1.9% | 4.0% | 0.36 (0.17–0.79) | P = 0.01 | |
| 0.10.31310Adjusted hazard ratio (log scale) |
Safety
| Outcome | OCT guidance | Angiography guidance | aHR (95% CI) | P value | |
|---|---|---|---|---|---|
| Stent thrombosis, moderate/severe calcification · 2 years | 0.2% | 1.5% | 0.11 (0.01–0.89) | P = 0.04 | |
| 0.050.21520Adjusted hazard ratio (log scale) |
Original publication
Optical coherence tomography- vs angiography-guided coronary stent implantation in calcified lesions: the ILUMIEN IV trial. Eur Heart J. Published 5 June 2025. doi:10.
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