From the Hungarian Institute of Cardiology, Budapest, Hungary (Z.P.); University Heart Centre Graz, Medical University Graz, Austria (G.G.T.); Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands (P.A.L.T., N.H.J.P.); Cardiovascular Center Aalst, Belgium (G.G.T., E.B., B.D.B.); Department of Advanced Biomedical Sciences, University of Naples Federico II, Italy (E.B.); Institute of Social and Preventive Medicine, University of Bern, Switzerland (S.A.); Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Switzerland (S.A.); Southampton University Hospital NHS Trust, England (N.C.); Cardiovascular Hospital, Lyon, France (G.R.); Department of Biomedical Engineering, Eindhoven University of Technology, the Netherlands (N.H.J.P.); Division of Cardiovascular Medicine, Stanford University Medical Center, CA (W.F.F.); and St. Michael's Hospital, University of Toronto, Canada (P.J.).
Circ Cardiovasc Interv. 2017 Aug;10(8). doi: 10.1161/CIRCINTERVENTIONS.116.005233.
The predictive value of fractional flow reserve (FFR) measured immediately after percutaneous coronary intervention (PCI) with drug-eluting stent placement has not been prospectively investigated. We investigated the potential of post-PCI FFR measurements to predict clinical outcome in patients from FAME 1 and 2 trials (Fractional Flow Reserve or Angiography for Multivessel Evaluation).
All patients of FAME 1 and FAME 2 who had post-PCI FFR measurement were included. The primary outcome was vessel-oriented composite end point at 2 years, defined as vessel-related cardiovascular death, vessel-related spontaneous myocardial infarction, and ischemia-driven target vessel revascularization. Eight hundred thirty-eight vessels in 639 patients were analyzed. Baseline FFR values did not differ between vessels with versus without vessel-oriented composite end point (0.66±0.11 versus 0.63±0.14, respectively; =0.207). Post-PCI FFR was significantly lower in vessels with vessel-oriented composite end point (0.88±0.06 versus 0.90±0.06, respectively; =0.019). Comparing the 2-year outcome of lower and upper tertiles of post-PCI FFR significant difference was found favoring upper tertile in terms of overall vessel-oriented composite end point (9.2% versus 3.8%, respectively; hazard ratio, 1.46; 95% confidence interval, 1.02-2.08; =0.037) and target vessel revascularization (7.0% versus 2.4%, respectively; hazard ratio, 1.59; 95% confidence interval, 1.03-2.46; =0.037). When adjusted to sex, hypertension, diabetes mellitus, target vessel, serial stenosis, and baseline percentage diameter stenosis, a strong trend was preserved in terms of target vessel revascularization (harzard ratio, 1.55; 95% confidence interval, 0.97-2.46; =0.066), favoring the upper tertile. Post-PCI FFR of 0.92 was found to have the highest diagnostic accuracy; however, the positive likelihood ratio remained low (<1.4).
A higher post-PCI FFR value is associated with a better vessel-related outcome. However, its predictive value is too low to advocate its use as a surrogate clinical end point.
经皮冠状动脉介入治疗（PCI）后即刻测量的血流储备分数（FFR）的预测价值尚未得到前瞻性研究。我们研究了 FAME 1 和 2 试验（血流储备分数或多血管评估的血管造影）中 PCI 后 FFR 测量预测患者临床结局的潜力。
所有接受 PCI 后 FFR 测量的 FAME 1 和 FAME 2 患者均纳入研究。主要终点为 2 年时的血管终点复合终点，定义为与血管相关的心血管死亡、与血管相关的自发性心肌梗死和缺血驱动的靶血管血运重建。共分析了 639 例患者的 838 支血管。基线 FFR 值在有血管终点复合终点的血管和无血管终点复合终点的血管之间无差异（分别为 0.66±0.11 和 0.63±0.14；=0.207）。有血管终点复合终点的血管的 PCI 后 FFR 显著降低（分别为 0.88±0.06 和 0.90±0.06；=0.019）。比较 2 年时较低和较高三分位组的结果，发现较高三分位组在总体血管终点复合终点方面有显著优势（分别为 9.2%和 3.8%；危险比，1.46；95%置信区间，1.02-2.08；=0.037）和靶血管血运重建（分别为 7.0%和 2.4%；危险比，1.59；95%置信区间，1.03-2.46；=0.037）。在校正性别、高血压、糖尿病、靶血管、串联狭窄和基线直径狭窄百分比后，靶血管血运重建仍存在明显趋势（危险比，1.55；95%置信区间，0.97-2.46；=0.066），支持较高三分位组。发现 PCI 后 FFR 为 0.92 时具有最高的诊断准确性；然而，阳性似然比仍然较低（<1.4）。
较高的 PCI 后 FFR 值与更好的血管相关结局相关。然而，其预测价值太低，不能主张将其用作替代临床终点。
