Coronary interventions

Optical coherence tomography-guided coronary stent implantation compared to angiography: a multicentre randomised trial in PCI – design and rationale of ILUMIEN IV: OPTIMAL PCI

EuroIntervention 2021;16:1092-1099. DOI: 10.4244/EIJ-D-20-00501

Ziad Ali
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

Sign in to read and download the full article

Forgot your password?

No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from

intravascular ultrasoundoptical coherence tomographypercutaneous coronary interventionstent optimisation
Coronary interventionsStents and scaffolds
Read next article
Target lesion revascularisation of bioresorbable metal scaffolds: a case series study and literature review

Latest news