Ziad Ali1,2,3, MD, DPhil; Ulf Landmesser4,5,6, MD; Keyvan Karimi Galougahi1,2, MD, PhD; Akiko Maehara1,2, MD; Mitsuaki Matsumura2, BS; Richard A. Shlofmitz3, MD; Giulio Guagliumi7, MD; Matthew J. Price8, MD; Jonathan M. Hill9, MD; Takashi Akasaka10, MD; Francesco Prati11, MD; Hiram G. Bezerra12, MD; William Wijns13,14, MD, DPhil; Gary S. Mintz2, MD; Ori Ben-Yehuda1,2, MD; Robert J. McGreevy15, PhD; Zhen Zhang15, PhD; Richard R. Rapoza15, PhD; Nick E.J. West15, MD; Gregg W. Stone2,16, MD
1. Center for Interventional Vascular Therapy, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY, USA; 2. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA; 3. St. Francis Hospital, Roslyn, NY, USA; 4. Department of Cardiology, Charité-University Medicine Berlin, Berlin, Germany; 5. Berlin Institute of Health, Berlin, Germany; 6. German Centre for Cardiovascular Research, Berlin, Germany; 7. Ospedale Papa Giovanni XXIII, Bergamo, Italy; 8. Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA, USA; 9. Royal Brompton Hospital, London, United Kingdom; 10. Wakayama Medical University, Wakayama, Japan; 11. San Giovanni Hospital and CLI Foundation, Rome, Italy; 12. Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH, USA; 13. The Lambe Institute for Translational Research, NUI Galway, Galway, Ireland; 14. Saolta University Healthcare Group, Galway, Ireland; 15. Abbott Vascular, Santa Clara, CA, USA; 16. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA
Aims: Randomised 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, multicentre, randomised 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 randomise between 2,490 and 3,656 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 randomised arm, and (2) target vessel failure, the composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target vessel revascularisation. Clinical follow-up will continue for up to two years. The trial is currently enrolling, and the principal results are expected in 2022.
Conclusions: The large-scale ILUMIEN IV randomised 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. Trial registration: NCT03507777