Baptista Sergio Bravo, Raposo Luís, Santos Lino, Ramos Ruben, Calé Rita, Jorge Elisabete, Machado Carina, Costa Marco, Infante de Oliveira Eduardo, Costa João, Pipa João, Fonseca Nuno, Guardado Jorge, Silva Bruno, Sousa Maria-João, Silva João Carlos, Rodrigues Alberto, Seca Luís, Fernandes Renato
From the Cardiology Department, Hospital Prof. Doutor Fernando Fonseca, Amadora, Portugal (S.B.B.); Cardiology Department, Hospital Santa Cruz, CHLO, Carnaxide, Portugal (L.R.); Cardiology Department, Centro Hospitalar Vila Nova de Gaia, Portugal (L.S.); Cardiology Department, Hospital Santa Marta, Centro Hospitalar Lisboa Central, Portugal (R.R.); Cardiology Department, Hospital Garcia de Orta, Almada, Portugal (R.C.); Cardiology Department, Centro Hospitalar e Universitário de Coimbra, Portugal (E.J.); Cardiology Department, Hospital Divino Espirito Santo, Ponta Delgada, Portugal (C.M.); Unidade de Intervenção Cardiovascular, Hospital Geral do Centro Hospitalar e Universitário de Coimbra, Portugal (M.C.); Cardiology Department, Hospital Santa Maria, Centro Hospitalar Lisboa Norte, Portugal (E.O.); Cardiology Department, Hospital de Braga, Portugal (J.C.); Cardiology Department, Centro Hospitalar Tondela-Viseu, Viseu, Portugal (J.P.); Cardiology Department, Centro Hospitalar Setúbal, Portugal (N.F.); Cardiology Department, Hospital Santo André, Centro Hospitalar Leiria-Pombal, Portugal (J.G.); Cardiology Department, Hospital Dr. Nélio Mendonça, Funchal, Portugal (B.S.); Cardiology Department, Hospital Geral Santo António, Centro Hospitalar do Porto, Portugal (J.S.); Cardiology Department, Centro Hospitalar São João, Porto, Portugal (J.S.); Cardiology Department, Centro Hospitalar Tâmega e Sousa, Penafiel, Portugal (A.R.); Cardiology Department, Centro Hospitalar Trás-os-Montes e Alto Douro, Unidade Hospitalar Vila Real, Portugal (L.S.); and Cardiology Department, Hospital Espírito Santo, Évora, Portugal (R.F.).
Circ Cardiovasc Interv. 2016 Jul;9(7). doi: 10.1161/CIRCINTERVENTIONS.115.003288.
Penetration of fractional flow reserve (FFR) in clinical practice varies extensively, and the applicability of results from randomized trials is understudied. We describe the extent to which the information gained from routine FFR affects patient management strategy and clinical outcome.
Nonselected patients undergoing coronary angiography, in which at least 1 lesion was interrogated by FFR, were prospectively enrolled in a multicenter registry. FFR-driven change in management strategy (medical therapy, revascularization, or additional stress imaging) was assessed per-lesion and per-patient, and the agreement between final and initial strategies was recorded. Cardiovascular death, myocardial infarction, or unplanned revascularization (MACE) at 1 year was recorded. A total of 1293 lesions were evaluated in 918 patients (mean FFR, 0.81±0.1). Management plan changed in 406 patients (44.2%) and 584 lesions (45.2%). One-year MACE was 6.9%; patients in whom all lesions were deferred had a lower MACE rate (5.3%) than those with at least 1 lesion revascularized (7.3%) or left untreated despite FFR≤0.80 (13.6%; log-rank P=0.014). At the lesion level, deferral of those with an FFR≤0.80 was associated with a 3.1-fold increase in the hazard of cardiovascular death/myocardial infarction/target lesion revascularization (P=0.012). Independent predictors of target lesion revascularization in the deferred lesions were proximal location of the lesion, B2/C type and FFR.
Routine FFR assessment of coronary lesions safely changes management strategy in almost half of the cases. Also, it accurately identifies patients and lesions with a low likelihood of events, in which revascularization can be safely deferred, as opposed to those at high risk when ischemic lesions are left untreated, thus confirming results from randomized trials.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01835808.
临床实践中血流储备分数（FFR）的应用差异很大，随机试验结果的适用性研究不足。我们描述了从常规FFR获得的信息在多大程度上影响患者管理策略和临床结局。
前瞻性纳入多中心登记研究中接受冠状动脉造影且至少有1处病变接受FFR检测的非选择性患者。按病变和患者评估FFR驱动的管理策略变化（药物治疗、血运重建或额外的负荷成像），并记录最终和初始策略之间的一致性。记录1年时的心血管死亡、心肌梗死或非计划血运重建（MACE）情况。共评估了918例患者的1293处病变（平均FFR为0.81±0.1）。406例患者（44.2%）和584处病变（45.2%）的管理计划发生了改变。1年时MACE发生率为6.9%；所有病变均延期处理的患者MACE发生率较低（5.3%），低于至少有1处病变接受血运重建的患者（7.3%）或尽管FFR≤0.80但未治疗的患者（13.6%；对数秩检验P=0.014）。在病变层面，FFR≤0.80的病变延期处理与心血管死亡/心肌梗死/靶病变血运重建风险增加3.1倍相关（P=0.012）。延期病变中靶病变血运重建的独立预测因素为病变的近端位置、B2/C型和FFR。
对冠状动脉病变进行常规FFR评估在近半数病例中安全地改变了管理策略。此外，它能准确识别事件发生可能性低的患者和病变，对于这些患者和病变，血运重建可安全延期，而与缺血性病变未治疗时高风险的患者和病变形成对比，从而证实了随机试验的结果。
