Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel.
Department of Cardiology, Cardiovascular Center Aalst OLV Hospital, Aalst, Belgium.
JACC Cardiovasc Interv. 2020 Feb 24;13(4):488-497. doi: 10.1016/j.jcin.2019.10.045. Epub 2020 Jan 29.
This study sought to assess the diagnostic performance of FFRangio (CathWorks, Kfar Saba, Israel), an angiogram-derived fractional flow reserve (FFR) technology.
Despite practice guidelines recommendations, the use of coronary physiologic assessment in daily practice remains low for patients undergoing coronary angiography. Angiogram-derived FFR technologies have the potential to promote the integration of physiologic assessment in daily practice.
The study performed an analysis of pooled patient- and lesion-level data from 5 prospective cohort studies that examined the diagnostic performance of FFRangio compared with the reference standard wire-based FFR.
A total of 700 lesions from 588 patients were analyzed. Mean age was 65 years, 71% were men, and 40% presented with acute coronary syndromes. Mean FFR and FFRangio were 0.81 ± 0.12 and 0.81 ± 0.11, with 31.6% and 31.4% of lesions were in the 0.75 to 0.85 range, respectively. When using a binary cutoff FFR value of 0.80, FFRangio showed a sensitivity of 91%, a specificity of 94%, and a diagnostic accuracy of 93%. The mean difference between FFR and FFRangio was 0.00 ± 0.12. The correlation coefficient between FFR and FFRangio was 0.83 (p < 0.001). The C-statistic for FFRangio was 0.95 (p < 0.001). The accuracy of FFRangio was consistent across all subgroups examined.
In the largest reported cohort examining the performance of angiogram-derived FFR technology, FFRangio showed excellent diagnostic performance, which was robust and consistent across all patient and lesion subgroups. Additional studies are needed allow FFRangio and fulfill its potential expand the implementation of functional assessment of coronary lesions in routine clinical practice.
本研究旨在评估 FFRangio（以色列 Kfar Saba 的 CathWorks）这一基于造影的血流储备分数（FFR）技术的诊断性能。
尽管有实践指南的推荐，但在接受冠状动脉造影的患者中，生理评估在日常实践中的应用仍然较低。基于造影的 FFR 技术有可能促进生理评估在日常实践中的整合。
该研究对 5 项前瞻性队列研究的患者和病变水平数据进行了汇总分析，这些研究检查了 FFRangio 与基于导丝的参考标准 FFR 的诊断性能。
共分析了 588 例患者的 700 处病变。平均年龄为 65 岁，71%为男性，40%为急性冠状动脉综合征患者。平均 FFR 和 FFRangio 分别为 0.81±0.12 和 0.81±0.11，分别有 31.6%和 31.4%的病变处于 0.75-0.85 范围内。当使用 0.80 的二元截断 FFR 值时，FFRangio 的灵敏度为 91%，特异性为 94%，诊断准确性为 93%。FFR 和 FFRangio 之间的平均差值为 0.00±0.12。FFR 和 FFRangio 之间的相关系数为 0.83（p<0.001）。FFRangio 的 C 统计量为 0.95（p<0.001）。FFRangio 的准确性在所有检查的亚组中均一致。
在报告的最大基于造影的 FFR 技术性能队列研究中，FFRangio 表现出优异的诊断性能，且在所有患者和病变亚组中均稳健且一致。需要进一步的研究来评估 FFRangio 的性能，并发挥其潜力，扩大功能评估在常规临床实践中的应用。
