From Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., D.-W.P., M.H., PH.L., S.-J.K., S.-W.L., Y.-H.K., C.W.L., S.-W.P., S.-J.P.); Ulsan University Hospital, South Korea (E.-S.S.); Seoul National University Hospital, South Korea (B.-K.K.); Keimyung University Dongsan Medical Center, Daegu, South Korea (C.-W.N.); Inje University Ilsan Paik Hospital, South Korea (J.-H.D.); Pusan National University Yangsan Hospital, Busan, South Korea (J.H.K.); Seoul National University Bundang Hospital, Bundang, South Korea (I.-H.C.); Wonju Christian Hospital, South Korea (J.-H.Y.); The Catholic University of Korea, Daejeon St Mary's Hospital, South Korea (S.-H.H.); The Catholic University of Korea, Seoul St Mary's Hospital, South Korea (K.-B.S.); Seoul Metropolitan Government - Seoul National University Boramae Medical Center, South Korea (W.-Y.C.); Gangneung Asan Hospital, South Korea (S.-Y.Y.); Daegu Catholic University Medical Center, South Korea (J.B.L.); Chungnam National University Hospital, Daejeon, South Korea (S.W.C.); Dong-A Medical Center, Busan, South Korea (K.P.); Pusan National University Hospital, Busan, South Korea (T.J.H.); and Chungbuk National University Hospital, Cheongju, South Korea (S.Y.L.).
Circulation. 2017 Jun 6;135(23):2241-2251. doi: 10.1161/CIRCULATIONAHA.116.024433. Epub 2017 Mar 29.
We evaluated the prognosis of deferred and revascularized coronary stenoses after fractional flow reserve (FFR) measurement to assess its revascularization threshold in clinical practice.
The IRIS-FFR registry (Interventional Cardiology Research In-cooperation Society Fractional Flow Reserve) prospectively enrolled 5846 patients with ≥1coronary lesion with FFR measurement. Revascularization was deferred in 6468 lesions and performed in 2165 lesions after FFR assessment. The primary end point was major adverse cardiac events (cardiac death, myocardial infarction, and repeat revascularization) at a median follow-up of 1.9 years and analyzed on a per-lesion basis. A marginal Cox model accounted for correlated data in patients with multiple lesions, and a model to predict per-lesion outcomes was adjusted for confounding factors.
For deferred lesions, the risk of major adverse cardiac events demonstrated a significant, inverse relationship with FFR (adjusted hazard ratio, 1.06; 95% confidence interval, 1.05-1.08; <0.001). However, this relationship was not observed in revascularized lesions (adjusted hazard ratio, 1.00; 95% confidence interval, 0.98-1.02; =0.70). For lesions with FFR ≥0.76, the risk of major adverse cardiac events was not significantly different between deferred and revascularized lesions. Conversely, in lesions with FFR ≤0.75, the risk of major adverse cardiac events was significantly lower in revascularized lesions than in deferred lesions (for FFR 0.71-0.75, adjusted hazard ratio, 0.47; 95% confidence interval, 0.24-0.89; =0.021; for FFR ≤0.70, adjusted hazard ratio 0.47; 95% confidence interval, 0.26-0.84; =0.012).
This large, prospective registry showed that the FFR value was linearly associated with the risk of cardiac events in deferred lesions. In addition, revascularization for coronary artery stenosis with a low FFR (≤0.75) was associated with better outcomes than the deferral, whereas for a stenosis with a high FFR (≥0.76), medical treatment would be a reasonable and safe treatment strategy.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01366404.
我们评估了血流储备分数（FFR）测量后延迟和血运重建的冠状动脉狭窄的预后，以评估其在临床实践中的血运重建阈值。
IRIS-FFR 注册研究（介入心脏病学研究合作学会血流储备分数）前瞻性纳入了 5846 例接受 FFR 测量的≥1 支冠状动脉病变患者。6468 处病变延迟血运重建，2165 处病变在 FFR 评估后进行血运重建。主要终点是中位随访 1.9 年时的主要不良心脏事件（心脏死亡、心肌梗死和再次血运重建），并按病变进行分析。在多支病变患者中，边际 Cox 模型考虑了相关数据，预测病变水平预后的模型调整了混杂因素。
对于延迟病变，主要不良心脏事件的风险与 FFR 呈显著负相关（校正危险比，1.06；95%置信区间，1.05-1.08；<0.001）。然而，在血运重建病变中并未观察到这种关系（校正危险比，1.00；95%置信区间，0.98-1.02；=0.70）。对于 FFR≥0.76 的病变，延迟与血运重建病变之间的主要不良心脏事件风险无显著差异。相反，对于 FFR≤0.75 的病变，血运重建病变的主要不良心脏事件风险明显低于延迟病变（对于 FFR 0.71-0.75，校正危险比，0.47；95%置信区间，0.24-0.89；=0.021；对于 FFR≤0.70，校正危险比 0.47；95%置信区间，0.26-0.84；=0.012）。
这项大型前瞻性注册研究表明，FFR 值与延迟病变中心脏事件的风险呈线性相关。此外，对于低 FFR（≤0.75）的冠状动脉狭窄进行血运重建的结果优于延迟，而对于高 FFR（≥0.76）的狭窄，药物治疗将是一种合理且安全的治疗策略。
