Accuracy of instantaneous wave-free ratio and fractional flow reserve derived from single coronary angiographic projections

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American heart journal Pub Date : 2025-10-01 Epub Date: 2025-03-11 DOI:10.1016/j.ahj.2025.03.001

Yoshinobu Onuma MD, Ph.D , Kai Ninomiya MD , Krischan Sjauw MD , Peter Damman MD , Hitoshi Matsuo MD, PhD , Clemens von Birgelen MD, PhD , Emelyne Sevestre BA , Masafumi Ono MD, PhD , Neil O'Leary PhD , Scot Garg MD, PhD , Martijn A. van Lavieren PhD , Becky Inderbitzen MSE , Takashi Akasaka MD, PhD , Javier Escaned MD, PhD , Manesh R. Patel MD , Patrick W. Serruys MD, PhD , ReVEAL iFR Investigators

{"title":"Accuracy of instantaneous wave-free ratio and fractional flow reserve derived from single coronary angiographic projections","authors":"Yoshinobu Onuma MD, Ph.D , Kai Ninomiya MD , Krischan Sjauw MD , Peter Damman MD , Hitoshi Matsuo MD, PhD , Clemens von Birgelen MD, PhD , Emelyne Sevestre BA , Masafumi Ono MD, PhD , Neil O'Leary PhD , Scot Garg MD, PhD , Martijn A. van Lavieren PhD , Becky Inderbitzen MSE , Takashi Akasaka MD, PhD , Javier Escaned MD, PhD , Manesh R. Patel MD , Patrick W. Serruys MD, PhD , ReVEAL iFR Investigators","doi":"10.1016/j.ahj.2025.03.001","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Angiography-derived fractional flow reserve (FFR) software has been developed using pressure wire based FFR as the reference, however most software requires 2 angiographic views ≥25 degrees apart limiting their clinical utility. This study aims to validate in a prospective multi-center registry the diagnostic performance of a novel angiography derived instantaneous wave-free ratio (Angio-iFR, Royal Philips, Amsterdam) with pressure wire-based iFR as reference.</div></div><div><h3>Methods</h3><div>Coronary angiograms were obtained from patients with coronary artery lesions of between 40% and 90% severity and both iFR and FFR measurements. The pressure wire's position was documented during contrast injection in 2 angiographic views. Angio-iFR/FFR was computed at this exact position by independent corelab analysts blinded to physiological data. The primary end point was the sensitivity and specificity of the Angio-iFR compared to the corresponding invasively measured iFR values. The study was powered to meet prespecified performance goals for sensitivity (75%) and specificity (80%).</div></div><div><h3>Results</h3><div>A total of 441 patients were enrolled in 32 centers in Europe, Japan, and the United States. Paired Angio-iFR and wire-iFR were available in 398 vessels. The mean iFR was 0.90 (standard deviation: 0.11) with 31.9% of vessels having an iFR≤0.89. Angio-iFR software showed excellent feasibility (97%), and a median analysis time of 55 s. The per-vessel sensitivity and specificity of Angio-iFR was 77% (95% confidence interval [CI]: 69%-84%) and 49% (95% CI: 41%-54%) respectively, which fell below the performance goals.</div></div><div><h3>Conclusions</h3><div>Angio-iFR did not achieve prespecified diagnostic performance against pressure wire-based iFR. Further software refinements are warranted.</div></div><div><h3>Trial registration</h3><div>Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR), NCT0385750, <span><span>https://clinicaltrials.gov/study/NCT03857503</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"288 ","pages":"Pages 111-121"},"PeriodicalIF":3.5000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American heart journal","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0002870325000717","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/11 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Angiography-derived fractional flow reserve (FFR) software has been developed using pressure wire based FFR as the reference, however most software requires 2 angiographic views ≥25 degrees apart limiting their clinical utility. This study aims to validate in a prospective multi-center registry the diagnostic performance of a novel angiography derived instantaneous wave-free ratio (Angio-iFR, Royal Philips, Amsterdam) with pressure wire-based iFR as reference.

Methods

Coronary angiograms were obtained from patients with coronary artery lesions of between 40% and 90% severity and both iFR and FFR measurements. The pressure wire's position was documented during contrast injection in 2 angiographic views. Angio-iFR/FFR was computed at this exact position by independent corelab analysts blinded to physiological data. The primary end point was the sensitivity and specificity of the Angio-iFR compared to the corresponding invasively measured iFR values. The study was powered to meet prespecified performance goals for sensitivity (75%) and specificity (80%).

Results

A total of 441 patients were enrolled in 32 centers in Europe, Japan, and the United States. Paired Angio-iFR and wire-iFR were available in 398 vessels. The mean iFR was 0.90 (standard deviation: 0.11) with 31.9% of vessels having an iFR≤0.89. Angio-iFR software showed excellent feasibility (97%), and a median analysis time of 55 s. The per-vessel sensitivity and specificity of Angio-iFR was 77% (95% confidence interval [CI]: 69%-84%) and 49% (95% CI: 41%-54%) respectively, which fell below the performance goals.

Conclusions

Angio-iFR did not achieve prespecified diagnostic performance against pressure wire-based iFR. Further software refinements are warranted.

Trial registration

Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR), NCT0385750, https://clinicaltrials.gov/study/NCT03857503.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

从单次冠状动脉造影投影得出的瞬时无波比和分流储备的准确性。

背景：血管造影衍生的分数血流储备（FFR）软件已经开发出来，使用基于压力线的FFR作为参考，然而大多数软件需要两个血管造影视图≥25度，限制了其临床应用。本研究旨在通过前瞻性多中心注册验证一种新型血管造影衍生瞬时无波比（Angio-iFR, Royal Philips, Amsterdam）的诊断性能，并以压力丝iFR为参考。方法：对冠状动脉病变严重程度在40-90%之间的患者进行冠状动脉造影，并测量iFR和FFR。在注射造影剂时，在两张血管造影图上记录了压力丝的位置。血管ifr /FFR是由独立的相关实验室分析员在这个位置计算的，他们不知道生理数据。主要终点是与相应的有创测量iFR值相比，血管iFR的敏感性和特异性。该研究的灵敏度（75%）和特异性（80%）达到了预先设定的性能目标。结果：共有441名患者在欧洲、日本和美国的32个中心入组。在398条血管中进行了配对血管ifr和导线ifr。平均iFR为0.90（标准差：0.11），31.9%的血管iFR≤0.89。Angio-iFR软件显示了极好的可行性（97%），平均分析时间为55秒。血管ifr的单血管敏感性和特异性分别为77%（95%置信区间[CI]: 69-84%）和49% (95%CI: 41- 54%)，低于性能目标。结论：相对于压力丝iFR，血管iFR没有达到预先规定的诊断性能。进一步的软件改进是有保证的。试验注册：血管iFR （ReVEAL iFR）的放射成像验证和评估，NCT0385750, https://clinicaltrials.gov/study/NCT03857503。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.