OCT-Guided vs Angiography-Guided Coronary Stent Implantation in Complex Lesions: An ILUMIEN IV Substudy
- PMID: 38759907
- DOI: 10.1016/j.jacc.2024.04.037
OCT-Guided vs Angiography-Guided Coronary Stent Implantation in Complex Lesions: An ILUMIEN IV Substudy
Abstract
Background: ILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided vs angiography-guided stent implantation in patients with high-risk clinical characteristics and/or complex angiographic lesions.
Objectives: The authors aimed to specifically examine outcomes in the complex angiographic lesions subgroup.
Methods: From the original trial population (N = 2,487), high-risk patients without complex angiographic lesions were excluded (n = 514). Complex angiographic lesion characteristics included: 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended 2-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were: 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACEs) (cardiac death, target-vessel myocardial infarction [MI], or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization.
Results: The postpercutaneous coronary intervention (PCI) MSA was larger in the OCT-guided (n = 992) vs angiography-guided (n = 981) group (5.56 ± 1.95 mm2 vs 5.26 ± 1.81 mm2; difference, 0.30; 95% CI: 0.14-0.47; P < 0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% vs 4.9%; HR: 0.63; 95% CI: 0.40-0.99; P = 0.04). TVF was not significantly different between groups (7.3% vs 8.8%; HR: 0.82; 95% CI: 0.59-1.12; P = 0.20).
Conclusions: In complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE, the composite of cardiac death, target-vessel MI, or stent thrombosis, compared with angiography-guided PCI at 2 years, but did not significantly improve TVF. (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in PCI; NCT03507777).
Keywords: optical coherence tomography; percutaneous coronary intervention; prognosis; stent.
Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures Abbott Vascular provided funding for this study. Dr Ali has received institutional grants from Abbott, Abiomed, Acist Medical, Boston Scientific, Cardiovascular Systems Inc, Medtronic, Opsens Medical, Philips, and Shockwave Medical; has received personal fees from Amgen, AstraZeneca, and Boston Scientific; and has received equity from Elucid, Lifelink, SpectraWAVE, Shockwave, and Vital Connect. Dr Landmesser has received lecture fees and advisory fees from AstraZeneca, Amgen, Sanofi, Berlin Chemie, and Abbott; has received advisory fees from The Medicines Company; and has received grant support, lecture fees, and advisory fees from Bayer and Novartis. Dr Maehara has been a consultant for Boston Scientific; has received speaker honoraria from Nipro; and is on the advisory board of SpectraWAVE. Dr Matsumura is a consultant for Terumo and Boston Scientific. Dr Leistner has received personal fees and nonfinancial support from Abbott Vascular; has received personal fees from Boston Scientific; and has received grants from DZHK (German Center for Cardiovascular Research). Dr Guagliumi has received grants from Boston Scientific during the conduct of the TRANSFORM-OCT main study; has received research grants from Abbott Vascular, InfraReDx, and Amgen; and is a consultant for Abbot and InfraReDx. Dr Canova is a consultant for Abbott Vascular and Boston Scientific; and has received grants from Amarin Pharma Inc, Amgen, Bristol Myers Squibb Company, Daiichi-Sankyo, Sanofi, and Terumo. Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Abbott Vascular and Boston Scientific; has received consulting honoraria from W.L. Gore, Biotronik, and Philips Medical; has received consulting honoraria and speaker fees from Medtronic; has received consulting honoraria from Shockwave and Innovheart; and has equity in InterShunt. Dr Hill has received speaker honoraria and institutional grants from Abbott, Abiomed, Boston Scientific, and Shockwave Medical; and has received equity from Shockwave. Dr Akasaka has received institutional research grants from Abbott Japan, Daiichi-Sankyo, Nipro, and Terumo; and serves as a consultant for Terumo. Dr Bezerra serves as a consultant for Abbott Vascular and Gentuity. Dr Wijns has received institutional research grants and personal honoraria from Micro Port. Drs McGreevy, McNutt, Nie, and Phalakornkule, and Ms Buccola are employees of Abbott Vascular. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, and Boehringer Ingelheim; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Adona Medical, Daiichi-Sankyo, Oxitope, HighLife, Elixir, Remote Cardiac Enablement, Aria, Abiomed, Cardiac Success, and Millennia Biopharma; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWAVE, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; and his employer, Mount Sinai Hospital, receives research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Inc, Phillips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-Wave. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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