Background:Fractional flow reserve (FFR) is a reliable tool for the functional assessment of coronary stenoses. FFR computed tomography (CT) derived (FFR_CT) has shown to be accurate, but its clinical usefulness in patients with complex coronary artery disease remains to be investigated. The present study sought to determine the impact of FFR_CT on heart team’s treatment decision-making and selection of vessels for revascularization in patients with 3-vessel coronary artery disease.Methods:The trial was an international, multicenter study randomizing 2 heart teams to make a treatment decision between percutaneous coronary interventions and coronary artery bypass grafting using either coronary computed tomography angiography or conventional angiography. The heart teams received the FFR_CT and had to make a treatment decision and planning integrating the functional component of the stenoses. Each heart team calculated the anatomic SYNTAX score, the noninvasive functional SYNTAX score and subsequently integrated the clinical information to compute the SYNTAX score III providing a treatment recommendation, that is, coronary artery bypass grafting, percutaneous coronary intervention, or equipoise coronary artery bypass grafting-percutaneous coronary intervention. The primary objective was to determine the proportion of patients in whom FFR_CT changed the treatment decision and planning.Results:Overall, 223 patients were included. Coronary computed tomography angiography assessment was feasible in 99% of the patients and FFR_CT analysis in 88%. FFR_CT was available for 1030 lesions (mean FFR_CT value 0.64±13). A treatment recommendation of coronary artery bypass grafting was made in 24% of the patients with coronary computed tomography angiography with FFR_CT. The addition of FFR_CT changed the treatment decision in 7% of the patients and modified selection of vessels for revascularization in 12%. With conventional angiography as reference, FFR_CT assessment resulted in reclassification of 14% of patients from intermediate and high to low SYNTAX score tertile.Conclusions:In patients with 3-vessel coronary artery disease, a noninvasive physiology assessment using FFR_CT changed heart team’s treatment decision-making and procedural planning in one-fifth of the patients.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT02813473.

中文翻译：

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冠状动脉计算机断层扫描血管造影术所产生的部分血流储备对多支冠状动脉疾病患者心脏团队治疗决策的影响：SYNTAX III REVOLUTION试验的见解。

背景：分数血流储备（FFR）是用于冠状动脉狭窄功能评估的可靠工具。FFR计算机断层扫描（CT）衍生（FFR _CT）已被证明是准确的，但其在复杂冠状动脉疾病患者中的临床实用性仍有待研究。本研究旨在确定FFR _CT对3支冠状动脉疾病患者心脏团队的治疗决策和血管重建选择的影响。方法：该试验是一项国际性，多中心研究，将2个心脏团队随机分为两组使用冠状动脉计算机断层扫描血管造影或常规血管造影在经皮冠状动脉介入治疗和冠状动脉搭桥术之间做出治疗决定。心脏团队获得了FFR_CT，并且必须做出治疗决策并计划整合狭窄的功能组件。每个心脏小组都会计算解剖学SYNTAX评分，无创功能性SYNTAX评分，然后整合临床信息以计算SYNTAX评分III，从而提供治疗建议，即冠状动脉搭桥术，经皮冠状动脉介入治疗或等位冠状动脉搭桥术-经皮冠状动脉介入治疗。主要目的是确定FFR _CT改变治疗决策和计划的患者比例。结果：总共纳入了223例患者。99％的患者行冠状动脉计算机断层扫描血管造影评估是可行的，88％的患者进行FFR _CT分析是可行的。FFR_CT可用于1030个病变（平均FFR _CT值为0.64±13）。24％的FFR _CT冠状动脉计算机断层扫描血管造影患者建议进行冠状动脉搭桥术。FFR _CT的添加改变了7％的患者的治疗决定，修改了12％的血管再通选择的血管。以常规血管造影为参考，FFR _CT评估可将14％的患者从SYNTAX评分中高分为低三分位。结论：在3支冠状动脉疾病患者中，使用FFR _CT进行无创生理评估五分之一的患者改变了心脏小组的治疗决策和程序计划。临床试验注册：URL：https://www.clinicaltrials.gov。唯一标识符：NCT02813473。