Optical Coherence Tomography-Based Functional Stenosis Assessment: FUSION-A Prospective Multicenter Trial.

IF 6.1 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Circulation: Cardiovascular Interventions Pub Date : 2024-04-01 Epub Date: 2024-03-25 DOI:10.1161/CIRCINTERVENTIONS.123.013702

Allen Jeremias, Akiko Maehara, Mitsuaki Matsumura, Richard A Shlofmitz, Aziz Maksoud, Takashi Akasaka, Hiram G Bezerra, William F Fearon, Habib Samady, Bruce Samuels, Joshua Rapkin, Ajay Gopinath, Nutte Tarn Teraphongphom, Jana Buccola, Ziad A Ali

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引用次数: 0

Abstract

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 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%; P=0.01) and specificity (76.6% versus 75%; P=0.01). The area under the curve was 0.88 (95% CI, 0.84-0.92; P<0.0001).

Conclusions: 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.

Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04356027.

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基于光学相干断层扫描的功能性狭窄评估：FUSION--前瞻性多中心试验

背景：血管内成像和冠状动脉内生理学均可用于指导和优化经皮冠状动脉介入治疗，但两者很少同时使用。虚拟血流储备（VFR）是一种基于光学相干断层扫描（OCT）的分数血流储备（FFR）模型，有助于评估冠状动脉病变的生理意义。我们的目的是验证中度冠状动脉狭窄的 VFR 评估：FUSION（基于 OCT 的冠状动脉狭窄功能诊断验证）是一项多中心、前瞻性、观察性研究，比较了 OCT 导出的 VFR 和有创 FFR。VFR是从基于三维管腔形态的集合参数血流模型中数学推导出来的。研究对象为接受冠状动脉造影术、血管中度狭窄（40%-90%）、需要进行生理评估的患者。研究机构对 VFR 分析结果保密，所有 OCT 和 FFR 数据均由独立的核心实验室审核。主要终点是 VFR 相对于作为参考标准的 FFR 的灵敏度和特异性，每个终点都根据预设的性能目标进行了测试：经核心实验室审查后，来自美国 25 个中心 224 名患者的 266 条血管被纳入分析范围。平均血管造影直径狭窄率为 65.5%±14.9%，平均 FFR 为 0.83±0.11。使用二元截断点 0.80，VFR 与 FFR 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%的置信度下限达到了灵敏度（71.6% 对 70%；P=0.01）和特异度（76.6% 对 75%；P=0.01）的预设性能目标。曲线下面积为 0.88（95% CI，0.84-0.92；PC 结论：OCT 导出的 VFR 在预测有创 FFR 方面具有很高的灵敏度和特异性。将高分辨率血管内成像与成像衍生生理学结合起来，作为经皮冠状动脉介入治疗的辅助手段，可能会带来协同效益：URL: https://clinicaltrials.gov; Unique identifier：NCT04356027。

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来源期刊

Circulation: Cardiovascular Interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

1.80%

发文量

221

审稿时长

6-12 weeks

期刊介绍： Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.

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