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

2021; European Association of Percutaneous Cardiovascular Interventions; Volume: 16; Issue: 13 Linguagem: Inglês

10.4244/eij-d-20-00501

1969-6213

Ziad A. Ali, Ulf Landmesser, Keyvan Karimi Galougahi, Akiko Maehara, Mitsuaki Matsumura, Richard Shlofmitz, Giulio Guagliumi, Matthew J. Price, Jonathan Hill, Takashi Akasaka, Francesco Prati, Hiram G. Bezerra, William Wijns, Gary S. Mintz, Ori Ben‐Yehuda, Robert McGreevy, Zhen Zhang, Richard Rapoza, Nick E.J. West, Gregg W. Stone,

Cardiac Imaging and Diagnostics

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