Hôpital Sacré-Cœur de Montréal, Université de Montreal, QC, Canada.
Emory University/Atlanta VA Medical Center, Atlanta, Georgia.
Catheter Cardiovasc Interv. 2020 Oct 1;96(4):E423-E431. doi: 10.1002/ccd.28827. Epub 2020 Mar 14.
The use and clinical outcomes of fractional flow reserve (FFR)-guided revascularization in patients presenting with either stable coronary artery disease (CAD) or an acute coronary syndrome (ACS) in daily clinical practice are uncertain.
To prospectively characterize the frequency of the change in treatment plan when FFR is performed compared to the initial decision based on angiography alone and procedure-related outcomes.
We undertook a prospective, multicenter, multinational, open-label, observational study of coronary physiologic measurements during clinically indicated coronary angiography. The treatment plan, including medical therapy, PCI or CABG, was prospectively recorded before and after performing FFR. Adverse events were pre-defined and prospectively recorded per local investigators (PRESSUREwire; ClinicalTrials.gov identifier: NCT02935088).
Two thousand two hundred and seventeen subjects were enrolled in 70 hospitals across 15 countries between October 2016-February 2018. The mean FFR (all measurements) was 0.84. The treatment plan based on angiography-alone changed in 763/2196 subjects (34.7%) and 872/2931 lesions (29.8%) post-FFR. In the per-patient analysis, the initial treatment plan based on angiography versus the final treatment plan post-FFR were medical management 1,350 (61.5%) versus 1,470 (66.9%) (p = .0017); PCI 717 (32.7%) versus 604 (27.5%) (p = .0004); CABG 119 (5.4%) versus 121 (5.5%) (p = .8951). The frequency of intended revascularization changed from 38.1 to 33.0% per patient (p = .0005) and from 35.5 to 29.6% per lesion (p < .0001) following FFR.
On an individual patient basis, use of FFR in everyday practice changes the treatment plan compared to angiography in more than one third of all-comers selected for physiology-guided managements. FFR measurement is safe, providing incremental information to guide revascularization decisions.
在日常临床实践中，对稳定型冠心病（CAD）或急性冠状动脉综合征（ACS）患者进行分流量储备（FFR）指导的血运重建的使用和临床结果尚不确定。
前瞻性描述与单独基于血管造影的初始决策相比，FFR 检查时治疗计划改变的频率以及与操作相关的结果。
我们进行了一项前瞻性、多中心、多国、开放标签、观察性研究，对临床指征性冠状动脉造影期间的冠状动脉生理学测量进行研究。在进行 FFR 之前和之后，前瞻性地记录治疗计划，包括药物治疗、PCI 或 CABG。根据当地研究者（PRESSUREwire；ClinicalTrials.gov 标识符：NCT02935088）预先定义并前瞻性地记录不良事件。
2016 年 10 月至 2018 年 2 月，在 15 个国家的 70 家医院共纳入 2217 例患者。平均 FFR（所有测量值）为 0.84。基于血管造影的初始治疗计划在 763/2196 例患者（34.7%）和 872/2931 例病变（29.8%）中发生改变。在逐个患者的分析中，基于血管造影的初始治疗计划与 FFR 后最终治疗计划相比，接受药物治疗的患者为 1350 例（61.5%）比 1470 例（66.9%）（p =.0017）；接受 PCI 的患者为 717 例（32.7%）比 604 例（27.5%）（p =.0004）；接受 CABG 的患者为 119 例（5.4%）比 121 例（5.5%）（p =.8951）。每位患者的拟行血运重建的频率从 38.1%降至 33.0%（p =.0005），每个病变的拟行血运重建的频率从 35.5%降至 29.6%（p < .0001）。
在日常临床实践中，与单独血管造影相比，在为生理学指导治疗选择的所有患者中，超过三分之一的患者使用 FFR 会改变治疗计划。FFR 测量是安全的，为指导血运重建决策提供了增量信息。
