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Fractional Flow Reserve and Instantaneous Wave-Free Ratio as Predictors of the Placebo-Controlled Response to Percutaneous Coronary Intervention in Stable Coronary Artery Disease

医学 部分流量储备 传统PCI 经皮冠状动脉介入治疗 心脏病学 冠状动脉疾病 内科学 安慰剂 心绞痛 随机对照试验 心肌梗塞 冠状动脉造影 替代医学 病理
作者
Michael Foley,Christopher Rajkumar,Fiyyaz Ahmed‐Jushuf,Florentina Simader,Shayna Chotai,Henry Seligman,Krzysztof Macierzanka,John R. Davies,Thomas R. Keeble,Peter O’Kane,Peter Haworth,Helen Routledge,Tushar Kotecha,Gerald J. Clesham,Rupert Williams,Jehangir Din,Sukhjinder Nijjer,Nick Curzen,Manas Sinha,Ricardo Petraco,James C. Spratt,Sayan Sen,Graham D. Cole,Frank E. Harrell,James P. Howard,Dárrel P. Francis,Matthew Shun‐Shin,Rasha Al‐Lamee
出处
期刊:Circulation [Lippincott Williams & Wilkins]
标识
DOI:10.1161/circulationaha.124.072281
摘要

Background: The Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina (ORBITA-2) provided evidence for the role of percutaneous coronary intervention (PCI) for angina relief in stable coronary artery disease (CAD). Fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are often used to guide PCI, however their ability to predict placebo-controlled angina improvement is unknown. Methods: Participants with angina, ischemia, and stable CAD were enrolled and antianginal medications were stopped. Participants reported angina episodes daily for 2 weeks using the ORBITA-app. At the research angiogram, FFR and iFR were measured. After sedation and auditory isolation, participants were randomized to PCI or placebo, before entering a 12-week blinded follow-up phase with daily angina reporting. The ability of FFR and iFR, analyzed as continuous variables, to predict the placebo-controlled effect of PCI, was tested using Bayesian proportional odds modelling. Results: Invasive physiology data were available in 279 patients (140 PCI and 139 placebo). The median (IQR) age was 65 years (59.0 to 70.5) and 223 (79.9%) were male. Median FFR was 0.60 (0.46 to 0.73) and median iFR was 0.76 (0.50 to 0.86). The lower the FFR or iFR, the greater the placebo-controlled improvement with PCI across all endpoints. There was strong evidence that a patient with an FFR at the lower quartile would have a greater placebo-controlled improvement in angina symptom score with PCI than a patient at the upper quartile (FFR 0.46 vs. 0.73: OR 2.01, 95% CrI 1.79 to 2.26, Pr(Interaction)>99.9%). Similarly, there was strong evidence that a patient with an iFR at the lower quartile would have a greater placebo controlled improvement in angina symptom score with PCI than a patient with an iFR at the upper quartile (iFR 0.50 vs. 0.86: OR 2.13, 95% CrI 1.87 to 2.45, Pr(Interaction) >99.9%). The relationship between benefit and physiology was seen in both Rose angina and Rose nonangina. Conclusions: Physiological stenosis severity, as measured by FFR and iFR, predicts placebo-controlled angina relief from PCI. Invasive coronary physiology can be used to target PCI to those patients who are most likely to experience benefit.

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