Komiyama Kota, Tanabe Kengo, Taguchi Eiji, Sakamoto Tomohiro, Nakanishi Rine, Okubo Ryo, Saito Akira, Asano Taku, Ikuta Akihiro, Kadota Kazushige, Nozaki Yui O, Fujimoto Shinichiro
Division of Cardiology, Mitsui Memorial Hospital.
Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center.
Int Heart J. 2025 May 31;66(3):337-344. doi: 10.1536/ihj.24-534. Epub 2025 May 15.
Coronary computed tomography angiography-derived fractional flow reserve (FFR) is useful for noninvasively detecting coronary artery disease. This procedure has been covered by health insurance reimbursement in the United Kingdom, the United States of America, and Japan. This is the first study to investigate the 1-year outcomes of the FFR, with management covered by health insurance from the DiscoverY of Novel Assessment Myocardial IsChemia by FFR (DYNAMIC-FFR) registry.In this multicenter DYNAMIC-FFR registry, 410 participants who underwent FFR analysis under health insurance reimbursement were prospectively enrolled at six Japanese sites between October 2019 and November 2021. In accordance with recent guidelines, all participants received appropriate revascularization and/or optimal medication therapy after FFR. The following clinical outcomes through the 1-year defined major adverse cardiovascular event (MACE) were investigated: all-cause death, cardiovascular events including non-fatal myocardial infarction, and unplanned hospitalization for acute coronary syndrome leading to revascularization.Of the six MACE cases, four (1.6%) occurred in participants with an FFR value ≤ 0.80, whereas two (1.3%) occurred in a participant with an FFR value > 0.80.This analytical study based on the DYNAMIC-FFR registry for cardiovascular conditions found no significant difference in 1-year MACE between FFR≤ 0.80 and > 0.80 following guideline-based therapy. The registry was started shortly after reimbursement and had limited statistical power and selection bias. Further studies with sufficient statistical power are required.
冠状动脉计算机断层扫描血管造影衍生的血流储备分数(FFR)有助于无创检测冠状动脉疾病。该检查在英国、美国和日本已纳入医保报销范围。这是第一项通过新型评估心肌缺血的FFR发现(DYNAMIC - FFR)注册研究来调查FFR医保覆盖管理下1年结局的研究。
在这项多中心DYNAMIC - FFR注册研究中,2019年10月至2021年11月期间,在日本的六个地点前瞻性纳入了410名在医保报销范围内接受FFR分析的参与者。根据最新指南,所有参与者在FFR检查后均接受了适当的血运重建和/或最佳药物治疗。对以下通过1年定义的主要不良心血管事件(MACE)的临床结局进行了调查:全因死亡、包括非致命性心肌梗死在内的心血管事件,以及导致血运重建的急性冠状动脉综合征的非计划住院。
在6例MACE病例中,4例(1.6%)发生在FFR值≤0.80的参与者中,而2例(1.3%)发生在FFR值>0.80的参与者中。
这项基于DYNAMIC - FFR注册研究的心血管疾病分析研究发现,在基于指南的治疗后,FFR≤0.80和>0.80的患者1年MACE无显著差异。该注册研究在报销后不久启动,统计效力有限且存在选择偏倚。需要进行具有足够统计效力的进一步研究。