Diagnostic performance of angiography-derived fractional flow reserve compared to pressure wire-derived fractional flow reserve: Rationale and design of MPFFR pivotal trial.

IF 1.6 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Cardiovascular Revascularization Medicine Pub Date : 2024-09-24 DOI:10.1016/j.carrev.2024.09.015
Hyun-Wook Chu, Chang-Hwan Yoon, Donghoon Han, Won-Woo Seo, Sang-Don Park, Joon Hyung Doh, Chang-Wook Nam, Eun-Seok Shin, Bon-Kwon Koo, In-Ho Chae, Tae-Jin Youn
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Abstract

Background: Cardiovascular disease remains the leading cause of death and the use of percutaneous coronary intervention (PCI) is steadily increasing. Current guidelines advocate the use of the fractional flow reserve (FFR) to assess coronary stenosis and treatment strategies; however, invasive FFR has some limitations. Angiography-derived FFR is a potential alternative for calculating FFR from two-dimensional (2D) angiographic images, thereby reducing invasiveness and complications. A novel artificial intelligence (AI)-based angiography-derived FFR, named "MPFFR," offers automated operator-independent hemodynamic calculations; this phase 3 trial aims to validate its diagnostic performance against 2D-quantitative coronary angiography (QCA).

Methods and analysis: This pivotal MPFFR trial is a prospective, multicenter, single-blind study. This trial involves patients with coronary artery disease (CAD) from eight cardiovascular centers. Invasive FFR will be performed according to standard guidelines and defined as the reference standard. Angiography-derived FFR will be computed using a proprietary method and 2D-QCA will be performed using validated software. The primary endpoint is the area under the curve for identifying physiologically significant coronary stenosis (FFR ≤0.80), with secondary endpoints including diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and correlations between angiography-derived and invasive FFR. This study is designed to demonstrate the superiority of angiography-derived FFR over 2D-QCA and is powered to achieve this with a sample size of 240 patients. Medipixel Inc. supports the trial and is not involved in the data analysis or management.

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血管造影得出的分数血流储备与压力导线得出的分数血流储备的诊断性能比较:MPFFR 关键性试验的原理和设计。
背景:心血管疾病仍然是导致死亡的主要原因,而经皮冠状动脉介入治疗(PCI)的使用正在稳步增加。目前的指南提倡使用分数血流储备(FFR)来评估冠状动脉狭窄情况和治疗策略;然而,有创 FFR 有一些局限性。血管造影衍生 FFR 是一种从二维(2D)血管造影图像计算 FFR 的潜在替代方法,从而减少了侵入性和并发症。基于人工智能(AI)的新型血管造影衍生 FFR 被命名为 "MPFFR",可提供独立于操作者的自动血流动力学计算;该三期试验旨在验证其与二维定量冠状动脉造影(QCA)相比的诊断性能:这项关键的 MPFFR 试验是一项前瞻性、多中心、单盲研究。这项试验涉及八个心血管中心的冠状动脉疾病(CAD)患者。有创 FFR 将根据标准指南进行,并被定义为参考标准。血管造影得出的 FFR 将使用专有方法计算,2D-QCA 将使用经过验证的软件执行。主要终点是识别有生理意义的冠状动脉狭窄(FFR ≤0.80)的曲线下面积,次要终点包括诊断准确性、敏感性、特异性、阳性预测值、阴性预测值以及血管造影衍生和有创 FFR 之间的相关性。该研究旨在证明血管造影得出的 FFR 优于二维-QCA,其样本量为 240 例患者。Medipixel 公司为该试验提供支持,但不参与数据分析或管理。
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来源期刊
Cardiovascular Revascularization Medicine
Cardiovascular Revascularization Medicine CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
3.30
自引率
5.90%
发文量
687
审稿时长
36 days
期刊介绍: Cardiovascular Revascularization Medicine (CRM) is an international and multidisciplinary journal that publishes original laboratory and clinical investigations related to revascularization therapies in cardiovascular medicine. Cardiovascular Revascularization Medicine publishes articles related to preclinical work and molecular interventions, including angiogenesis, cell therapy, pharmacological interventions, restenosis management, and prevention, including experiments conducted in human subjects, in laboratory animals, and in vitro. Specific areas of interest include percutaneous angioplasty in coronary and peripheral arteries, intervention in structural heart disease, cardiovascular surgery, etc.
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