Yoshinobu Onuma, Kai Ninomiya, Krischan Sjauw, Peter Damman, Hitoshi Matsuo, Clemens von Birgelen, Emelyne Sevestre, Masafumi Ono, Neil O'Leary, Scot Garg, Martijn A van Lavieren, Becky Inderbitzen, Takashi Akasaka, Javier Escaned, Manesh R Patel, Patrick W Serruys
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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 two 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 40-90% severity and both iFR and FFR measurements. The pressure wire's position was documented during contrast injection in two 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 seconds. 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.
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.
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