Weatherhead PET Center, Division of Cardiology, Department of Medicine, McGovern Medical School at UTHealth and Memorial Hermann Hospital, Houston, Texas, USA.
Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.
JACC Cardiovasc Interv. 2021 Sep 13;14(17):1904-1913. doi: 10.1016/j.jcin.2021.07.041.
The aim of this study was to assess clinical outcomes after combined pressure and flow assessment of coronary lesions.
Although fractional flow reserve (FFR) remains the invasive reference standard for revascularization, approximately 40% of stenoses have discordant coronary flow reserve (CFR). Optimal treatment for these disagreements remains unclear.
A total of 455 subjects with 668 lesions were enrolled from 12 sites in 6 countries. Only lesions with reduced FFR and CFR underwent revascularization; all other combinations received initial medical therapy.
Fourteen percent of lesions had FFR ≤0.8 but CFR ≥2.0 while 23% of lesions had FFR >0.8 but CFR <2.0. During 2-year follow-up, the primary endpoint of composite all-cause death, myocardial infarction, and revascularization in lesions with FFR ≤0.8 but CFR ≥2.0 (10.8% event rate) compared with lesions with FFR >0.8 and CFR ≥2.0 (6.2% event rate) exceeded the prespecified +10% noninferiority margin (P = 0.090). Target vessel failure models using both continuous FFR and continuous CFR found that only higher FFR was associated with reduced target vessel failure (Cox P = 0.007) after initial medical treatment. Central core laboratory review accepted 69.8% of all tracings with mean differences of <0.01 for FFR and <0.02 for CFR, indicating no material impact on clinical measurements or outcomes.
All-cause death, myocardial infarction, and revascularization after 2 years was not noninferior between lesions with FFR ≤0.8 but CFR ≥2.0 and lesions with FFR >0.8 and CFR ≥2.0. These results do not support using invasive CFR ≥2.0 to defer revascularization for lesions with reduced FFR if the patient would otherwise be a candidate on the basis of the entire clinical scenario and treatment preference.
本研究旨在评估冠状动脉病变压力与血流联合评估的临床结局。
尽管血流储备分数（FFR）仍是血运重建的有创参考标准，但约 40%的狭窄病变存在冠状动脉血流储备（CFR）不一致的情况。对于这些不一致的最佳治疗方法仍不清楚。
本研究共纳入来自 6 个国家 12 个中心的 455 名患者的 668 处病变。仅对 FFR 降低且 CFR 降低的病变进行血运重建；所有其他组合的病变均接受初始药物治疗。
14%的病变 FFR≤0.8，但 CFR≥2.0；23%的病变 FFR>0.8，但 CFR<2.0。在 2 年随访期间，FFR≤0.8 但 CFR≥2.0 的病变（复合终点发生率为 10.8%）与 FFR>0.8 且 CFR≥2.0 的病变（复合终点发生率为 6.2%）相比，主要终点（全因死亡、心肌梗死和血运重建）发生率超过了预设的+10%非劣效性边界（P=0.090）。使用连续 FFR 和连续 CFR 的靶血管失败模型发现，仅较高的 FFR 与初始药物治疗后的靶血管失败风险降低相关（Cox P=0.007）。中心核心实验室评估接受了所有 69.8%的描记，FFR 的平均差值<0.01，CFR 的平均差值<0.02，这表明对临床测量或结局没有实质性影响。
2 年后，FFR≤0.8 但 CFR≥2.0 的病变与 FFR>0.8 且 CFR≥2.0 的病变相比，全因死亡、心肌梗死和血运重建发生率无显著差异。如果基于整个临床情况和治疗偏好，患者符合血运重建标准，则这些结果不支持使用侵入性 CFR≥2.0 来延迟 FFR 降低的病变血运重建。
