St. Francis Hospital & Heart Center, Roslyn, NY (A.J., R.A.S., Z.A.A.).
Cardiovascular Research Foundation, New York, NY (A.J., A.M., M.M., Z.A.A.).
Circ Cardiovasc Interv. 2024 Apr;17(4):e013702. doi: 10.1161/CIRCINTERVENTIONS.123.013702. Epub 2024 Mar 25.
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.
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.
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 were 82.0%, 80.4%, and 82.9%, respectively. The 97.5% lower confidence bound met the prespecified performance goal for sensitivity (71.6% versus 70%; =0.01) and specificity (76.6% versus 75%; =0.01). The area under the curve was 0.88 (95% CI, 0.84-0.92; <0.0001).
OCT-derived VFR demonstrates high sensitivity and specificity for predicting invasive FFR. Integrating high-resolution intravascular imaging with imaging-derived physiology may provide synergistic benefits as an adjunct to percutaneous coronary intervention.
URL: https://clinicaltrials.gov; Unique identifier: NCT04356027.
血管内影像学和冠状动脉内生理学都可用于指导和优化经皮冠状动脉介入治疗；然而，它们很少同时使用。虚拟血流储备（VFR）是一种基于光学相干断层扫描（OCT）的血流储备分数（FFR）模型，有助于评估冠状动脉病变的生理意义。我们旨在验证中间冠状动脉狭窄的 VFR 评估。
FUSION（基于 OCT 的冠状动脉狭窄功能诊断的验证）是一项多中心、前瞻性、观察性研究，比较了 OCT 衍生的 VFR 与有创 FFR。VFR 是通过基于 3 维管腔形态的集总参数流量模型数学推导出来的。纳入了接受冠状动脉造影检查且需要生理评估的中间血管造影狭窄（40%-90%）的患者。研究地点对 VFR 分析是盲的，所有 OCT 和 FFR 数据均由独立的核心实验室进行审查。主要终点是 VFR 与作为参考标准的 FFR 的敏感性和特异性，两者均针对预定的性能目标进行了测试。
经核心实验室审查后，224 名患者的 266 支血管纳入 25 个美国中心的分析。平均血管造影直径狭窄为 65.5%±14.9%，平均 FFR 为 0.83±0.11。VFR 与 FFR 采用二进制截断点 0.80 相比的总体准确性、敏感性和特异性分别为 82.0%、80.4%和 82.9%。97.5%的置信区间下限符合敏感性（71.6%与 70%；=0.01）和特异性（76.6%与 75%；=0.01）的预定性能目标。曲线下面积为 0.88（95%CI，0.84-0.92；<0.0001）。
OCT 衍生的 VFR 对预测有创 FFR 具有较高的敏感性和特异性。将高分辨率血管内成像与成像衍生生理学相结合，可能作为经皮冠状动脉介入治疗的辅助手段提供协同效益。
