Impact of Optical Coherence Tomography-Based Post-PCI Physiology Assessment to Predict Clinical Outcomes: An ILUMIEN-IV Substudy
- PMID: 40406943
- DOI: 10.1016/j.jacc.2025.05.019
Impact of Optical Coherence Tomography-Based Post-PCI Physiology Assessment to Predict Clinical Outcomes: An ILUMIEN-IV Substudy
Abstract
Background: A novel optical coherence tomography (OCT)-based physiology assessment technique, virtual flow reserve (VFR), has been demonstrated to perform as a reliable surrogate for invasive physiology.
Objectives: The authors sought to examine the performance of post-percutaneous coronary intervention (PCI) VFR as a predictor of 2-year clinical outcomes independent from the OCT-based minimal stent area (MSA).
Methods: The ILUMIEN IV (Optical Coherence Tomography [OCT] Guided Coronary Stent Implantation Compared With Angiography: A Multicenter Randomized Trial in PCI) trial prospectively recruited 2,487 patients with diabetes or high-risk coronary lesions randomizing to OCT- vs angiography-guided drug-eluting stent implantation. All patients with single-lesion treatment who had a final OCT imaging available underwent retrospective post-PCI VFR analysis offline. Of 2,128 eligible patients, VFR analysis was successfully performed in 2,057 (96.6%). Independent OCT predictors for the primary endpoint of 2-year target vessel failure (TVF), a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target vessel revascularization, were evaluated by multivariable analysis.
Results: The median post-PCI VFR was 0.90 (Q1-Q3: 0.86-0.92), with a significant difference in VFR observed between the angiography- and OCT-guided groups (0.89 [Q1-Q3: 0.86-0.92] vs 0.90 [Q1-Q3: 0.87-0.92]; P < 0.001). By multivariable analysis, both MSA (per 1 mm2) and VFR (per 0.1 mm Hg/mm Hg) were independent predictors of 2-year TVF. Overall, MSA, proximal edge dissection and VFR independently predicted both TVF and target lesion failure.
Conclusions: Post-PCI OCT-based VFR assessment is predictive of 2-year clinical outcomes independent of MSA. Online VFR analysis can provide operators with an immediate assessment of post-PCI physiology in addition to OCT anatomy, providing incremental value in assessing procedural success and informing on clinical prognosis (ILUMIEN IV [Optical Coherence Tomography (OCT) Guided Coronary Stent Implantation Compared With Angiography: A Multicenter Randomized Trial in PCI]; NCT03507777).
Keywords: intracoronary imaging; optical coherence tomography; percutaneous coronary intervention; stent optimization.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures Dr Johnson has received consulting and speaker fees from Abbott Vascular, Boston Scientific, and Terumo; and has received research grants from Abbott Vascular. Dr Bergmark has received grant support through his institution from Ionis, Pfizer, Abbott Vascular, Philips, Inari, AstraZeneca, MedImmune, and Amgen; and has received consulting fees from Boston Scientific, Shockwave, Abbott Vascular, Abiomed, Bain Life Sciences, Bolt, Terumo, SpectraWAVE, CSI, and Endovascular Engineering. Dr Croce has received grant support from Abbott, Takeda, Teleflex, and CSI; has received honoraria from Abbott, Biotronik, Philips, Abiomed, CSI, Takeda, and Cordis; and is a major stock shareholder in Dyad Medical. Dr Pelligrini has received speaker fees from Abbott Vascular and GE Healthcare. Dr Maehara has received consulting fees from Boston Scientific and Amgen; and has received advisory board fees from SpectraWave and Canon. Dr Gori has received speakeŕs honoraria from Shockwave, Abbott, AstraZeneca, BMS, and Novartis; and has received research grants from Abbott and Shockwave. Dr Pinilla-Echevetti has served as a consultant and speaker, received research grant support, and served on the advisory board for Abbott Vascular; and has served on the advisory board for Philips. Dr Wollmuth has received speaker bureau fees from Abiomed, Abbott Vascular, Boston Scientific, and Shockwave; and has received consulting fees from Abiomed and Boston Scientific. Dr Gonzalo has received research grants from Abbott; and has received consulting and speaker fees from Abbott, Boston Scientific, Abiomed, Shockwave, Cordis, and Philips. Dr Kao has received research grants from Medtronic and Elixir; and has received honorarium for speaker board from Abbott Vascular, Asahi INTECC, B Braun, Biotronik, Boston Scientific, Medtronic, and Terumo. Dr Guagliumi has received consulting fees from Abbott Vascular, GE Healthcare, Panovision Scientific, TerraQuantum, and Innova HTS. Dr Phalakornkule, Dr Ediebah, Ms McNutt, Dr Chin, Dr op den Buijs, and Ms Buccola are employees of Abbott Vascular. Dr Landmesser has received lecture fees and advisory fees from AstraZeneca, Amgen, and Sanofi; and has received grant support, lecture fees, and/or advisory fees from Abbott and Novartis. 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 equity from Elucid, Lifelink, Spectrawave, Shockwave, and Vital Connect. Dr Stone has received speaker honoraria from Medtronic, Amgen, and Boehringer Ingelheim; has received consulting fees from Robocath, Daiichi-Sankyo, Vectorious, Miracor, Apollo Therapeutics, Cardiac Success, Occlutech, Millennia Biopharma, Ablative Solutions, Oxitope, Impulse Dynamics, Remote Cardiac Enablement, Valfix, Zoll, HeartFlow, Shockwave, Adona Medical, Abbott, HighLife, Elixir, Elucid Bio, Aria, Alleviant, FBR Medical, Myochron, Colibri, Bioventrix, MedHub, and Asceneuron; and has equity/options from Cardiac Success, Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Valfix, and Xenter; and their employer, Mount Sinai Hospital, has received research grants from Shockwave, Biosense-Webster, Bioventrix, Abbott, Abiomed, Cardiovascular Systems Inc, Phillips, Vascular Dynamics, Pulnovo, V-wave, and PCORI (via Weill Cornell Medical Center). Dr Jeremias has received consulting fees from Abbott Vascular, ACIST Medical, Philips, Boston Scientific, Shockwave, and CathWorks.
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