Patients with diabetes remained at increased risk for adverse events after PCI compared with nondiabetic patients despite the use of OCT procedural guidance, and OCT guidance did not reduce TVF or serious MACE compared with angiography guidance in either diabetic or nondiabetic patients.
Key Findings
Results
Diabetic patients had significantly higher 2-year rates of target vessel failure compared with nondiabetic patients after PCI.
2-year TVF rates were 9.9% in diabetic patients vs 6.3% in nondiabetic patients
Adjusted HR: 1.48; 95% CI: 1.09-2.02; P = 0.01
This difference was observed after adjustment for differences in clinical and angiographic characteristics
The increased risk was consistent in patients with and without complex lesions (Pinteraction = 0.22)
Results
Diabetic patients had significantly higher 2-year rates of serious major adverse cardiovascular events (MACE) compared with nondiabetic patients.
2-year serious MACE rates were 5.3% in diabetic patients vs 2.7% in nondiabetic patients
Adjusted HR: 1.77; 95% CI: 1.14-2.76; P = 0.01
The increased risk was consistent in patients with and without complex lesions (Pinteraction = 0.14)
The highest 2-year rates were observed in patients with diabetes and complex lesions
Results
OCT guidance compared with angiography guidance did not reduce TVF or serious MACE in the overall randomized population.
No statistically significant reduction in TVF or serious MACE was found with OCT-guided vs angiography-guided PCI
These effects were consistent in patients with and without diabetes (Pinteraction = 0.41 for TVF and 0.20 for serious MACE)
The lack of benefit from OCT guidance was not modified by treatment of complex lesions
The trial enrolled 1,044 patients with diabetes and 1,443 without diabetes
Results
The benefit (or lack thereof) of OCT guidance over angiography guidance did not differ between diabetic and nondiabetic patients.
Pinteraction for diabetes status and OCT vs angiography guidance was 0.41 for TVF and 0.20 for serious MACE
No statistically significant interaction was detected between diabetic status and imaging modality for either endpoint
The consistency of effect was also maintained regardless of lesion complexity
Results
Patients with diabetes and complex lesions were at particularly high risk for adverse outcomes after PCI.
The highest 2-year rates of both TVF and serious MACE were observed in the subgroup of patients with both diabetes and complex lesions
The increased risk associated with diabetes was consistent regardless of whether complex lesions were present (Pinteraction = 0.22 for TVF, 0.14 for MACE)
This finding was observed across both OCT-guided and angiography-guided PCI groups
Methods
The study population consisted of patients from the ILUMIEN IV trial randomized to OCT-guided versus angiography-guided PCI, stratified by diabetes status.
Total sample: 1,044 patients with diabetes and 1,443 patients without diabetes
Patients were grouped based on diabetes status and presence of complex lesions
Follow-up period was 2 years
Study endpoints were target vessel failure (TVF) and serious major adverse cardiovascular events (MACE)
What This Means
This research examined whether using a high-resolution imaging technique called optical coherence tomography (OCT) during heart artery stenting procedures (PCI) could improve outcomes for patients with diabetes, who are known to have worse outcomes after these procedures compared to patients without diabetes. The study analyzed data from over 2,400 patients in the large ILUMIEN IV clinical trial, about 1,000 of whom had diabetes, following them for two years after their procedure.
The study found that patients with diabetes had roughly 50% higher risk of target vessel failure (a composite of heart-related death, heart attack, or repeat procedures on the treated artery) and nearly 80% higher risk of serious cardiovascular events compared to patients without diabetes, even after accounting for other differences between the groups. Patients with both diabetes and more complex artery blockages faced the highest risks of all. However, using OCT imaging to guide the stenting procedure — compared to using standard X-ray imaging alone — did not reduce these risks in either diabetic or nondiabetic patients, and there was no meaningful difference in how much OCT helped (or didn't help) between the two groups.
This research suggests that while diabetes remains a strong risk factor for worse outcomes after heart artery stenting procedures, upgrading the imaging technology used during the procedure alone may not be sufficient to close this gap. The findings highlight that patients with diabetes, especially those with complex coronary artery disease, represent a high-risk group that may need additional or different strategies beyond improved procedural guidance to improve their long-term outcomes after PCI.
Gaede L, Achenbach S, Marwan M, Shlofmitz R, Fabbiocchi F, Alfonso F, et al.. (2026). Impact of Diabetes on Outcomes of Contemporary PCI Guided by OCT vs Angiography: The ILUMIEN IV Trial.. JACC. Cardiovascular interventions. https://doi.org/10.1016/j.jcin.2026.06.028