van de Hoef Tim P, Stegehuis Valérie E, Madera-Cambero Maribel I, van Royen Niels, van der Hoeven Nina W, de Waard Guus A, Meuwissen Martijn, Christiansen Evald H, Eftekhari Ashkan, Niccoli Giampaolo, Lockie Tim, Matsuo Hitoshi, Nakayama Masafumi, Kakuta Tsunekazu, Tanaka Nobuhiro, Casadonte Lorena, Spaan Jos A E, Siebes Maria, Tijssen Jan G P, Escaned Javier, Piek Jan J
Department of Cardiology, University Medical Center, Utrecht, the Netherlands; Department of Cardiology, Amsterdam UMC - location VU University Medical Center, Amsterdam, the Netherlands.
Department of Cardiology, Amsterdam UMC - location Academic Medical Center, Amsterdam, the Netherlands.
Int J Cardiol. 2023 Apr 15;377:9-16. doi: 10.1016/j.ijcard.2023.01.009. Epub 2023 Jan 11.
The role of combined FFR/CFR measurements in decision-making on coronary revascularization remains unclear. DEFINE-FLOW prospectively assessed the relationship of FFR/CFR agreement with 2-year major adverse cardiac event (MACE) and target vessel failure (TVF) rates, and uniquely included core-laboratory analysis of all pressure and flow tracings. We aimed to document the impact of core-laboratory analysis on lesion classification, and the relationship between core-laboratory fractional flow reserve (FFR) and coronary flow reserve (CFR) values with clinical outcomes and angina burden during follow-up.
In 398 vessels (348 patients) considered for intervention, ≥1 coronary pressure/flow tracing was approved by the core-laboratory. Revascularization was performed only when both FFR(≤0.80) and CFR(<2.0) were abnormal, all others were treated medically.
MACE was lowest for concordant normal FFR/CFR, but was not significantly different compared with either discordant group (low FFR/normal CFR: HR:1.63; 95%CI:0.61-4.40; P = 0.33; normal FFR/low CFR: HR:1.81; 95%CI:0.66-4.98; P = 0.25). Moreover, MACE did not differ between discordant groups treated medically and the concordant abnormal group undergoing revascularization (normal FFR/low CFR: HR:0.63; 95%CI:0.23-1.73;P = 0.37; normal FFR/low CFR: HR:0.70; 95%CI:0.22-2.21;P = 0.54). Similar findings applied to TVF.
Patients with concordantly normal FFR/CFR have very low 2-year MACE and TVF rates. Throughout follow-up, there were no differences in event rates between patients in whom revascularization was deferred due to preserved CFR despite reduced FFR, and those in whom PCI was performed due to concordantly low FFR and CFR. These findings question the need for routine revascularization in vessels showing low FFR but preserved CFR.
FFR/CFR联合测量在冠状动脉血运重建决策中的作用仍不明确。DEFINE-FLOW前瞻性评估了FFR/CFR一致性与2年主要不良心脏事件（MACE）和靶血管失败（TVF）发生率之间的关系，并独特地纳入了对所有压力和血流描记图的核心实验室分析。我们旨在记录核心实验室分析对病变分类的影响，以及核心实验室血流储备分数（FFR）和冠状动脉血流储备（CFR）值与随访期间临床结局及心绞痛负担之间的关系。
在398支血管（348例患者）中考虑进行干预，核心实验室批准了≥1份冠状动脉压力/血流描记图。仅当FFR（≤0.80）和CFR（<2.0）均异常时才进行血运重建，其他所有患者均接受药物治疗。
FFR/CFR均正常的患者MACE最低，但与任何一组不一致的患者相比无显著差异（低FFR/正常CFR：HR：1.63；95%CI：0.61 - 4.40；P = 0.33；正常FFR/低CFR：HR：1.81；95%CI：0.66 - 4.98；P = 0.25）。此外，药物治疗的不一致组与接受血运重建的一致异常组之间的MACE无差异（正常FFR/低CFR：HR：0.63；95%CI：0.23 - 1.73；P = 0.37；正常FFR/低CFR：HR：0.70；95%CI：0.22 - 2.21；P = 0.54）。TVF也有类似发现。
FFR/CFR均正常的患者2年MACE和TVF发生率极低。在整个随访过程中，尽管FFR降低但CFR保留而延期进行血运重建的患者与因FFR和CFR均低而进行PCI的患者之间的事件发生率无差异。这些发现质疑了对FFR低但CFR保留的血管进行常规血运重建的必要性。
