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

Abstract

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.

Conflict of interest statement

Z.A. Ali reports institutional research grants to Columbia University and Cardiovascular Research Foundation from Abbott and Cardiovascular Systems Inc., being a consultant for Abbott, Amgen, AstraZeneca, Abiomed, Boston Scientific, Cardinal Health, Opsens Medical, and ACIST Medical, holding equity in Shockwave Medical, and receiving grants from the National Heart, Lung and Blood Institute. U. Landmesser reports being a consultant for Abbott, Boston Scientific, and Biotronik. A. Maehara reports grant support from Abbott Vascular and Boston Scientific, and being a consultant for Conavi Medical Inc. M. Matsumura reports being a consultant for Terumo Corporation. G. Guagliumi reports institutional grant support from Abbott Vascular, Boston Scientific, Infraredx, and St. Jude Medical, and being a consultant for Abbott Vascular, Boston Scientific, and St. Jude Medical. M.J. Price reports consulting fees and speaker's honoraria from Abbott Vascular, AstraZeneca, Boston Scientific, Chiesi USA, and Medtronic, consulting fees from W.L. Gore & Associates, and ACIST Medical, and grants (to the institution) from Daiichi Sankyo. J.M. Hill reports personal fees, grants and equity in Shockwave Medical, and personal fees and grants from Abbott Vascular, Boston Scientific and Abiomed. T. Akasaka reports honoraria and grants from Abbott Vascular Japan, and Daiichi-Sankyo Pharmaceutical Inc., and institutional grants from Boston Scientific, Nipro and Terumo. F. Prati reports consultant honoraria from Abbott Vascular and Amgen. H.G. Bezerra reports institutional grant support from Abbott Vascular, and consulting fees and honoraria from Abbott Vascular, Medtronic, and Abiomed. W. Wijns reports institutional grant support from Endotronix and HealthWatch, personal fees from MicroPort, and being a co-founder of Argonauts, an innovation facilitator and medical advisor of Rede Optimus Research. Gary S. Mintz reports honoraria from Boston Scientific, Philips, Terumo, and Medtronic. R.J. McGreevy, Z. Zhang, R.J. Rapoza and N.E.J. West are employees of Abbott Vascular. N.E.J. West is a stockholder in Abbott. G.W. Stone reports speaker or other honoraria from Cook, Terumo, Qool Therapeutics and Orchestra Biomed, being a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, MAIA Pharmaceuticals, Vectorious, Reva, and Matrizyme, and holding equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, MedFocus family of funds, and Valfix. O. Ben-Yehuda reports being an employee of the Cardiovascular Research Foundation, which has received research grants from Abbott Vascular. The other authors have no conflicts of interest to declare.

Figures

Figure 1.

Patient flow for screening, randomisation, and follow-up in the ILUMIEN IV trial. OCT: optical coherence tomography; PCI: percutaneous coronary intervention

Figure 2.

The algorithm for OCT-guided PCI optimisation in ILUMIEN IV. OCT-guided assessment pre-PCI through stent implantation. Vessel diameter must be assessed as the EEL-EEL diameter at the reference segments, unless the EEL cannot be identified, in which case luminal measures are used. OCT-guided optimisation post stent implantation is described per EEL-based diameter measurement and per lumen-based diameter measurement. EEL: external elastic lamina; MLA: minimal lumen area; MSA: minimal stent area; NC: non-compliant; OCT: optical coherence tomography