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Randomized Controlled Trial
. 2025 Jan 27;18(2):145-153.
doi: 10.1016/j.jcin.2024.09.045. Epub 2024 Dec 18.

Clinical Relevance of Discordance Between Physiology- and Imaging-Guided PCI Strategies in Intermediate Coronary Stenosis

Affiliations
Randomized Controlled Trial

Clinical Relevance of Discordance Between Physiology- and Imaging-Guided PCI Strategies in Intermediate Coronary Stenosis

Jinlong Zhang et al. JACC Cardiovasc Interv. .

Abstract

Background: Recent randomized clinical trials have demonstrated the benefits of intravascular imaging (IVI)-guided percutaneous coronary intervention (PCI) over angiography-guided PCI. However, the role of angiography-based physiological assessment during IVI-guided PCI remains unclear.

Objectives: This study aimed to explore the discrepancies and significance of angiography-based physiological assessments in IVI-guided PCI.

Methods: In the international multicenter randomized FLAVOUR (Fractional Flow Reserve and Intravascular Ultrasound for Clinical Outcomes in Patients With Intermediate Stenosis) trial, angiography-based physiological assessment was retrospectively performed using the Murray law-based quantitative flow ratio (μQFR). In this post hoc analysis, patients were categorized based on intravascular ultrasound (IVUS)-guided treatment decisions (PCI or deferral) and μQFR as follows: negative μQFR with deferral of PCI (DEFER), negative μQFR with PCI (PERFORM), and positive μQFR with PCI (REFERENCE). The primary outcome was major adverse cardiovascular events, defined as a composite of death, myocardial infarction, and target vessel revascularization at the 24-month follow-up.

Results: Of the 784 patients, 34.4% (270/784), 29.3% (230/784), and 31.5% (247/784) were categorized into the DEFER, PERFORM, and REFERENCE groups, respectively. Physiological assessment led to substantial reclassification, encompassing 48.2% (230/477) of patients who underwent IVUS-guided PCI. The REFERENCE group showed a higher risk for major adverse cardiovascular events at 2 years compared with the PERFORM group (adjusted HR: 2.46; 95% CI: 1.13-5.35; P = 0.023). However, the primary outcomes in the DEFER and PERFORM groups were similar (adjusted HR: 0.88; 95% CI: 0.37-2.11; P = 0.779). The quality of life at 2 years was comparable among the 3 groups (P = 0.198).

Conclusions: Angiography-based physiological assessments can offer additional prognostic insights for patients undergoing IVI-guided PCI. IVUS-guided PCI may not be advantageous in patients with functionally insignificant lesions.

Keywords: drug-eluting stent(s); fractional flow reserve; intravascular ultrasound; percutaneous coronary intervention; quantitative flow ratio.

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Conflict of interest statement

Funding Support and Author Disclosures The FLAVOUR trial was funded by Boston Scientific. It was also supported by grants from the Patient-Centered Clinical Research Coordinating Center (HI19C0481 and HC19C0305) funded by the Ministry of Health and Welfare and from the Ministry of Food and Drug Safety (RS-2023-00215667). The study funders had no role in trial design, data collection, analysis, and interpretation, or writing of the manuscript. Dr Joo-Yong Hahn has received research grants from Abbott Korea, Biosensors International Group, Biotronik, Boston Scientific Corporation, and Medtronic. Dr Bon-Kwon Koo has received institutional research grants from Abbott Vascular, Boston Scientific Corporation, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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