ILUMIEN IV OPTICAL PCI
Trial question
What is the role of optical coherence tomography-guided PCI in patients undergoing PCI?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 2487
2487 patients (563 female, 1924 male).
Inclusion criteria: adult patients with medication-treated diabetes or complex coronary artery lesions undergoing PCI.
Key exclusion criteria: ST-segment elevation MI ≤ 24 hours from onset of ischemic symptoms; CrCl ≤ 30 mL/min/1.73 m² and not on dialysis; hypotension, shock, or need for mechanical support or intravenous vasopressors; congestive HF; unstable ventricular arrhythmias.
Interventions
N=1233 OCT-guided PCI (use of optical coherence tomography during PCI procedure).
N=1254 angiography-guided PCI (use of angiography for PCI procedure).
Primary outcome
Minimum stent area after percutaneous coronary intervention
5.72 mm²
5.36 mm²
5.7 mm²
4.3 mm²
2.9 mm²
1.4 mm²
0.0 mm²
OCT-guided
PCI
Angiography-guided
PCI
Significant
increase ▲
Significant increase in minimum stent area after PCI (5.72 mm² vs. 5.36 mm²; MD 0.36, 95% CI 0.21 to 0.51).
Secondary outcomes
No significant difference in target vessel failure at 2 years (7.4% vs. 8.2%; HR 0.9, 95% CI 0.67 to 1.19).
No significant difference in death (2.7% vs. 3.6%; HR 0.73, 95% CI 0.47 to 1.16).
No significant difference in MI (4.8% vs. 6%; HR 0.8, 95% CI 0.56 to 1.13).
Safety outcomes
No significant differences in PCI-related angiographic complications, procedure-related thrombotic events.
Significant difference in stent thrombosis (0.5% vs. 1.4%).
Conclusion
In adult patients with medication-treated diabetes or complex coronary artery lesions undergoing PCI, OCT-guided PCI was superior to angiography-guided PCI with respect to minimum stent area after PCI.
Reference
Ziad A Ali, Ulf Landmesser, Akiko Maehara et al. Optical Coherence Tomography-Guided versus Angiography-Guided PCI. N Engl J Med. 2023 Oct 19;389(16):1466-1476.
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