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Impact of Diabetes on Outcomes of Contemporary PCI Guided by OCT vs Angiography: The ILUMIEN IV Trial.

Luise Gaede·Stephan Achenbach·Mohamed Marwan·Richard A Shlofmitz·Franco Fabbiocchi·Fernando Alfonso·Paolo Canova·David Leistner·Jana Buccola·Robert McNutt·Hong Nie·Robert McGreevy·Akiko Maehara·Ulf Landmesser·Ziad A Ali·Gregg W Stone·ILUMIEN IV Investigators
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Abstract

BACKGROUND: Patients with diabetes are at higher risk for adverse events after percutaneous coronary intervention (PCI) compared with patients without diabetes. OBJECTIVES: This study sought to assess the influence of diabetes and complex lesions on the outcomes of patients undergoing PCI with and without optical coherence tomography (OCT) guidance during a follow-up period of 2 years. METHODS: Patients in ILUMIEN IV randomized to OCT-guided vs angiography-guided PCI were grouped into those with (n = 1,044) and without diabetes (n = 1,443). Study endpoints were target vessel failure (TVF) and serious major adverse cardiovascular events (MACE). RESULTS: After adjustment for differences in clinical and angiographic characteristics, the 2-year rates of both TVF (9.9% vs 6.3%; adjusted HR: 1.48; 95% CI: 1.09-2.02; P = 0.01) and serious MACE (5.3% vs 2.7%; adjusted HR: 1.77; 95% CI: 1.14-2.76; P = 0.01) were increased in diabetic compared with nondiabetic patients, consistently in patients with and without complex lesions (Pinteraction = 0.22 and 0.14, respectively), although the highest 2-year rates were in patients with diabetes and complex lesions. In all randomized patients, OCT guidance compared with angiography guidance did not reduce TVF or serious MACE. These effects were consistent in patients with and without diabetes (Pinteraction = 0.41 and 0.20, respectively), and were not modified by treatment of complex lesions. CONCLUSIONS: In the large-scale ILUMIEN IV trial, patients with diabetes remained at increased risk for adverse events after PCI compared with nondiabetic patients despite the use of OCT procedural guidance. Patients with diabetes and complex lesions were at particularly high risk for adverse outcomes after PCI.

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HumansTomography, Optical CoherenceCoronary AngiographyFemalePercutaneous Coronary InterventionTreatment OutcomeRisk FactorsPredictive Value of TestsTime FactorsMaleAgedCoronary Artery DiseaseMiddle AgedDiabetes MellitusRisk AssessmentCoronary Vesselsdiabetesimaging-guidanceintravascular imagingoptical coherence tomographypercutaneous coronary interventionprognosisJournal ArticleRandomized Controlled TrialComparative StudyMulticenter Study

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Luise Gaede, Stephan Achenbach, Mohamed Marwan, Richard A Shlofmitz, Franco Fabbiocchi, Fernando Alfonso, Paolo Canova, David Leistner, Jana Buccola, Robert McNutt, Hong Nie, Robert McGreevy, Akiko Maehara, Ulf Landmesser, Ziad A Ali, Gregg W Stone, ILUMIEN IV Investigators. 2026-09-14. Impact of Diabetes on Outcomes of Contemporary PCI Guided by OCT vs Angiography: The ILUMIEN IV Trial.. https://doi.org/10.1016/j.jcin.2026.06.028

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Aged subjectComparative Study subjectDiabetes subjectDiabetes Mellitus subjectFemale subjectHumans subjectJournal Article subjectMale subjectMiddle Aged subjectMulticenter Study subjectOptical coherence tomography subjectRandomized controlled trials study

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