The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

OPtical Coherence Tomography Guided Coronary Stent IMplantation Compared to Angiography: A Multicenter Randomized TriaL in PCI – Design and Rationale of ILUMIEN IV: OPTIMAL PCI

DOI: 10.4244/EIJ-D-20-00501

1. Centre for Interventional Vascular Therapy, Division of Cardiology, New York-Presbyterian Hospital/Columbia University Medical Centre, New York, NY USA; Clinical Trials Centre, Cardiovascular Research Foundation, New York, NY, USA; St. Francis Hospital, Roslyn, NY, USA, United States
2. Department of Cardiology, Charité – University Medicine Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany; German Centre for Cardiovascular Research, Berlin, Germany
3. Center for Interventional Vascular Therapy, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY USA; Clinical Trials Center, Cardiovascular Research Foundation, New York, NY USA
4. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY USA
5. St. Francis Hospital, Roslyn, NY
6. Ospedale Papa Giovanni XXIII, Bergamo, Italy
7. Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA
8. Royal Brompton Hospital, London, United Kingdom
9. Wakayama Medical University, Wakayama, Japan
10. San Giovanni Hospital and CLI Foundation, Rome, Italy
11. Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH
12. The Lambe Institute for Translational Research, NUI Galway, Galway, Ireland; Saolta University Healthcare Group, Galway, Ireland
13. Abbott Vascular, Santa Clara, CA
14. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY USA; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY
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AIMS: Randomized trials have demonstrated improvement in clinical outcomes with intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI. The ILUMIEN III trial demonstrated non-inferiority of an optical coherence tomography (OCT)- versus IVUS-guided PCI strategy in achieving similar post-PCI lumen dimensions. ILUMIEN IV is a large-scale, multicenter, randomized trial designed to demonstrate the superiority of OCT- versus angiography-guided stent implantation in patients with high-risk clinical characteristics (diabetes) and/or complex angiographic lesions in achieving larger post-PCI lumen dimensions and improving clinical outcomes.

METHODS AND RESULTS: ILUMIEN IV is a prospective, single-blind clinical investigation that will randomize between 2490 and 3656 patients using an adaptive design to OCT-guided versus angiography-guided coronary stent implantation in a 1:1 ratio. The primary endpoints are: (1) Post-PCI minimal stent area assessed by OCT in each randomized arm, and (2) target vessel failure, the composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization. Clinical follow-up will continue for up to 2 years. The trial is currently enrolling, and the principal results are expected in 2022.

CONCLUSIONS: The large-scale ILUMIEN IV randomized controlled trial will evaluate the effectiveness of OCT-guided versus angiography-guided PCI in improving post-PCI lumen dimensions and clinical outcomes in patients with diabetes and/or with complex coronary lesions.

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