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Multicenter Study
. 2025 Sep 15:435:133410.
doi: 10.1016/j.ijcard.2025.133410. Epub 2025 May 21.

Predictive value of coronary lesion functional assessment using an OCT computational algorithm in the CLIMA study

Affiliations
Multicenter Study

Predictive value of coronary lesion functional assessment using an OCT computational algorithm in the CLIMA study

Flavio Giuseppe Biccirè et al. Int J Cardiol. .

Abstract

Background: Optical flow ratio (OFR) has recently been described to accurately compute coronary fractional flow reserve using optical coherence tomography (OCT), yet its prognostic impact remains unclear. The present study aimed to investigate the predictive value of coronary functional assessment, alone and combined with plaque morphology, by OCT.

Methods: In the present study, OFR software was applied to untreated coronary lesions undergoing OCT analysis in the multicenter, international, prospective CLIMA study. The primary endpoint was target-vessel failure (TVF) at 1 year, defined as a composite of cardiac death, target-vessel myocardial infarction (TV-MI) or target-vessel revascularization (TVR). The secondary endpoint was a composite of cardiac death or target segment MI.

Results: Overall, 983 patients were included (median age 66 years, 24.8 % women). Lesions with OFR ≤0.80 (n = 120) showed more frequently a minimum lumen area < 3.5 mm2 (p < 0.001), a thin-cap fibroatheroma (TCFA) (p = 0.023) and a large lipid arc >180° (p = 0.001) as compared to OFR-preserved lesions. TVF was significantly more frequent in patients with versus without OFR-detected flow-limiting lesions (10.8 % and 4.8 %; HR 2.25, 95 %CI 1.21-4.21). This association was directionally consistent for TV-MI and TVR. Patients with both TCFA and impaired OFR lesions were at the highest risk of the primary (HR 6.47, 95 %CI 2.79-15.02) and secondary endpoint (HR 5.78, 95 %CI 1.92-17.43).

Conclusions: The presence of OFR-detected flow limitation was associated with high-risk morphological features and a higher incidence of adverse events. The combined presence of TCFA and OFR-derived flow limitation was associated with the highest incidence of primary and secondary endpoints.

Keywords: Clinical outcomes; Computed fractional flow reserve; Functional assessment; Optical coherence tomography; Optical flow ratio; Thin-cap fibroatheroma.

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Conflict of interest statement

Declaration of competing interest Dr. Biccirè reported consulting or speaker fees from Abbott, Sanofi and Ultragenyx outside the submitted work. Dr. Tu has received research support from Pulse Medical Imaging. Dr. Burzotta has received speaker fees from Abiomed, Abbott, Medtronic, Daiichi-Sankyo. Dr. Räber has received institutional grants from Sanofi, Regeneron, Infraredx, Abbott, Heartflow, Boston Scientific, and Biotronik and Abbott, Amgen, AstraZeneca, Occlutech, Sanofi, Canon, and Medtronic for speaker and consultation fees outside the submitted work. Dr. Crea has received personal fees from Amgen, Astra Zeneca, Abbott, Menarini, Chiesi, Daiichi Sankyo outside the submitted work. All other authors have nothing to disclose.

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