Optical Coherence Tomography–Based Functional Stenosis Assessment: FUSION—A Prospective Multicenter Trial

作者：Allen Jeremias, Akiko Maehara, Mitsuaki Matsumura, Richard Shlofmitz, Aziz Maksoud, Takashi Akasaka, Hiram G. Bezerra, William F. Fearon, Habib Samady, Bruce Samuels, J. S. Rapkin, Ajay Gopinath, Nutte Teraphongphom, Jana Buccola, Ziad A. Ali · 发表于：Circulation Cardiovascular Interventions · 年份：2024 · DOI：10.1161/circinterventions.123.013702 · 被引用次数：21 · 研究领域：Coronary Interventions and Diagnostics、Optical Coherence Tomography Applications、Angiogenesis and VEGF in Cancer

BACKGROUND: Intravascular imaging and intracoronary physiology may both be used to guide and optimize percutaneous coronary intervention; however, they are rarely used together. The virtual flow reserve (VFR) is an optical coherence tomography (OCT)–based model of fractional flow reserve (FFR) facilitating the assessment of the physiological significance of coronary lesions. We aimed to validate the VFR assessment of intermediate coronary artery stenoses. METHODS: FUSION (Validation of OCT-Based Functional Diagnosis of Coronary Stenosis) was a multicenter, prospective, observational study comparing OCT-derived VFR to invasive FFR. VFR was mathematically derived from a lumped parameter flow model based on 3-dimensional lumen morphology. Patients undergoing coronary angiography with intermediate angiographic stenosis (40%–90%) requiring physiological assessment were enrolled. Investigational sites were blinded to the VFR analysis, and all OCT and FFR data were reviewed by an independent core laboratory. The coprimary end points were the sensitivity and specificity of VFR against FFR as the reference standard, each of which was tested against prespecified performance goals. RESULTS: After core laboratory review, 266 vessels in 224 patients from 25 US centers were included in the analysis. The mean angiographic diameter stenosis was 65.5%±14.9%, and the mean FFR was 0.83±0.11. Overall accuracy, sensitivity, and specificity of VFR versus FFR using a binary cutoff point of 0.80 wer...