Background:We evaluate the prognostic value of measuring fractional flow reserve (FFR) after percutaneous coronary intervention (post-PCI FFR) and intravascular imaging in patients undergoing PCI for 3-vessel coronary artery disease in the FAME 3 trial (Fractional Flow Reserve versus Angiography for Multivessel Evaluation).Methods:The FAME 3 trial is a multicenter, international, randomized study comparing FFR-guided PCI with coronary artery bypass grafting in patients with multivessel coronary artery disease. PCI was not noninferior with respect to the primary end point of death, myocardial infarction, stroke, or repeat revascularization at 1 year. Post-PCI FFR data were acquired on a patient and vessel-related basis. Intravascular imaging guidance was tracked. The primary end point is a comparison of target vessel failure (TVF) defined as a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization at 1 year based on post-PCI FFR values. Cox regression with robust SEs was used for analysis.Results:Of the 757 patients randomized to PCI, 461 (61%) had post-PCI FFR measurement and 11.1% had intravascular imaging performed. The median post-PCI FFR was 0.89 [IQR‚ 0.85–0.94]. On a vessel-level, post-PCI FFR was found to be a significant predictor of TVF univariately (hazard ratio=0.67 [95% CI‚ 0.48–0.93] for 0.1 unit increase, P=0.0165). On a patient-level, the single lowest post-PCI FFR value was also found to be a significant predictor of TVF univariately (hazard ratio=0.65 [95% CI‚ 0.48–0.89] for 0.1 unit increase, P=0.0074). Post-PCI FFR was an independent predictor of TVF in multivariable analysis adjusted for key clinical parameters. Outcomes were similar between patients who had intravascular imaging guidance and those who did not.Conclusions:Post-PCI FFR measurement was a significant predictor of TVF on a vessel and patient level and an independent predictor of outcomes in a population with complex 3-vessel coronary artery disease eligible for coronary artery bypass grafting. The limited use of intravascular imaging did not affect outcomes.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT02100722.

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复杂冠状动脉疾病患者经皮冠状动脉介入治疗后测量血流储备分数的预后价值：来自 FAME 3 试验的见解

背景：我们在 FAME 3 试验（分数流量储备与血管造影）中评估经皮冠状动脉介入治疗（PCI 后 FFR）和血管内成像对接受 PCI 治疗 3 支冠状动脉疾病的患者的预后价值方法：FAME 3 试验是一项多中心、国际、随机研究，比较 FFR 引导的 PCI 与冠状动脉旁路移植术在多支冠状动脉疾病患者中的效果。就死亡、心肌梗死、卒中或 1 年时再次血运重建的主要终点而言，PCI 并非劣效性。PCI 后 FFR 数据是在患者和血管相关的基础上获得的。跟踪血管内成像引导。主要终点是根据 PCI 后 FFR 值比较靶血管衰竭 (TVF)，定义为 1 年时心源性死亡、靶血管心肌梗死和靶血管血运重建的复合结果。使用具有稳健 SE 的 Cox 回归进行分析。结果：在随机接受 PCI 的 757 名患者中，461 名 (61%) 进行了 PCI 后 FFR 测量，11.1% 进行了血管内成像。PCI 后 FFR 中位数为 0.89 [IQR，0.85–0.94]。在血管水平上，发现 PCI 后 FFR 是单变量 TVF 的重要预测因子（风险比 = 0.67 [95% CI，0.48–0.93]，增加 0.1 个单位，461 (61%) 人进行了 PCI 后 FFR 测量，11.1% 人进行了血管内成像。PCI 后 FFR 中位数为 0.89 [IQR，0.85–0.94]。在血管水平上，发现 PCI 后 FFR 是单变量 TVF 的重要预测因子（风险比 = 0.67 [95% CI，0.48–0.93]，增加 0.1 个单位，461 (61%) 人进行了 PCI 后 FFR 测量，11.1% 人进行了血管内成像。PCI 后 FFR 中位数为 0.89 [IQR，0.85–0.94]。在血管水平上，发现 PCI 后 FFR 是单变量 TVF 的重要预测因子（风险比 = 0.67 [95% CI，0.48–0.93]，增加 0.1 个单位，P = 0.0165）。在患者层面，单个最低的 PCI 后 FFR 值也被发现是 TVF 单变量的显着预测因子（风险比 = 0.65 [95% CI，0.48–0.89] 增加 0.1 个单位，P=0.0074）。在根据关键临床参数调整的多变量分析中，PCI 后 FFR 是 TVF 的独立预测因子。接受血管内成像指导的患者和未接受血管内成像指导的患者的结果相似。结论：PCI 后 FFR 测量是血管和患者水平 TVF 的重要预测指标，也是复杂 3 支冠状动脉人群结果的独立预测指标适合冠状动脉旁路移植术的动脉疾病。血管内成像的有限使用不影响结果。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT02100722。