From Assistance Publique-Hôpitaux de Paris (AP-HP), Department of Cardiology, Hôpital Européen Georges Pompidou, Université de Paris, INSERM, Paris Centre de Recherche Cardiovasculaire (E.P., D.B., N.D.), AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique, Sorbonne Université, INSERM Unité 698 (T.S.), Université de Paris, INSERM Unité 1148, and Hôpital Bichat, AP-HP (P.G.S.), Sorbonne Université, ACTION Study Group, Institut de Cardiologie (AP-HP), INSERM UMRS 1166, Hôpital Pitié-Salpêtrière (G.M., J.S.), Clinical Research Unit Eco Ile de France, Hôpital Hôtel Dieu, AP-HP (I.D.-Z., A.B.), the Department of Cardiology, Hôpital Lariboisière, AP-HP, INSERM Unité 942, Université de Paris (J.-G.D.), the Department of Cardiology, Hôpital Bichat, AP-HP, French Alliance for Cardiovascular Trials, INSERM Unité 1148, Laboratory for Vascular Translational Science, Université de Paris (G.D.), the Clinical Research Unit and Centre d'Investigation Clinique 1418 INSERM, George Pompidou European Hospital, AP-HP (A.C.N., G. Chatellier), and the French Alliance for Cardiovascular Trials (E.P., T.S., P.G.S., G.L., D.B., G.D., N.D.), Paris, Centre Hospitalier Universitaire (CHU) de Nîmes, Nîmes (G. Cayla), Service de Cardiologie, AP-HP, Université de Paris Est Créteil, Hôpitaux Universitaires Henri Mondor, Créteil, and Unité 955-Mondor Institute for Biomedical Research, Equipe 03, INSERM, Ecole Nationale Vétérinaire d'Alfort, Maisons-Alfort (R.G.), Hôpital du Bon Secours, Metz (K.K.), Clinique St. Martin (J.-F.M.) and the Cardiology Department, Caen University Hospital (V.R.), Caen, the Department of Cardiology, CHU Clermont-Ferrand, CNRS UMR 6602, Université Clermont Auvergne, Clermont-Ferrand, the Cardiac Intensive Care Unit, Heart and Lung Institute, CHU Lille (P.M.), and the Heart and Lung Institute, University Hospital of Lille, Institut Pasteur of Lille, INSERM Unité 1011 (G.L.), Lille, and the Intensive Cardiac Care Unit, Department of Cardiology, Rangueil University Hospital, and the Medical School, Toulouse III Paul Sabatier University, Toulouse (T.L.), Groupement de Coopération Saintaire de Cardiologie de la Côte Basque, Centre Hospitalier de la Côte Basque, Bayonne (J.-N.L.), the Cardiology Department, Hôpitaux de Chartres, Chartres (G.R.), and Physiopathologie et Epidémiologie Cérébro-Cardiovasculaires, Equipe d'Accueil (EA 7460), University of Bourgogne Franche-Comté, and the Cardiology Department, University Hospital Center of Dijon Bourgogne, Dijon (Y.C.) - all in France; Cardiovascular Center Aalst, Aalst, Belgium (B.D.B.); and the Department of Cardiology, Lausanne University Center Hospital, Lausanne, Switzerland (B.D.B.).
N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.
In patients with ST-elevation myocardial infarction (STEMI) who have multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions (complete revascularization) is superior to treatment of the culprit lesion alone. However, whether complete revascularization that is guided by fractional flow reserve (FFR) is superior to an angiography-guided procedure is unclear.
In this multicenter trial, we randomly assigned patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery to receive complete revascularization guided by either FFR or angiography. The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year.
The mean (±SD) number of stents that were placed per patient for nonculprit lesions was 1.01±0.99 in the FFR-guided group and 1.50±0.86 in the angiography-guided group. During follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the FFR-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; P = 0.31). Death occurred in 9 patients (1.5%) in the FFR-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively.
In patients with STEMI undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization at 1 year. However, given the wide confidence intervals for the estimate of effect, the findings do not allow for a conclusive interpretation. (Funded by the French Ministry of Health and Abbott; FLOWER-MI ClinicalTrials.gov number, NCT02943954.).
对于 ST 段抬高型心肌梗死（STEMI）合并多支血管病变的患者，非罪犯病变的经皮冠状动脉介入治疗（PCI）（完全血运重建）优于仅治疗罪犯病变。然而，血流储备分数（FFR）指导下的完全血运重建是否优于血管造影指导的方法尚不清楚。
在这项多中心试验中，我们随机分配了成功接受梗死相关动脉 PCI 的 STEMI 合并多支血管病变患者，以接受 FFR 或血管造影指导的完全血运重建。主要终点是 1 年内任何原因导致的死亡、非致死性心肌梗死或计划外住院导致紧急血运重建的复合终点。
FFR 指导组每例患者非罪犯病变放置的支架平均数（±标准差）为 1.01±0.99，血管造影指导组为 1.50±0.86。在随访期间，FFR 指导组有 32 例（5.5%）患者和血管造影指导组有 24 例（4.2%）患者发生主要终点事件（危险比，1.32；95%置信区间，0.78 至 2.23；P=0.31）。FFR 指导组有 9 例（1.5%）患者死亡，血管造影指导组有 10 例（1.7%）患者死亡；非致死性心肌梗死分别为 18 例（3.1%）和 10 例（1.7%）；计划外住院并导致紧急血运重建分别为 15 例（2.6%）和 11 例（1.9%）。
在接受完全血运重建的 STEMI 患者中，FFR 指导策略与血管造影指导策略相比，1 年内死亡、心肌梗死或紧急血运重建的风险没有显著获益。然而，鉴于效应估计的置信区间较宽，目前的研究结果无法得出明确的结论。（由法国卫生部和雅培资助；FLOWER-MI 临床试验.gov 编号，NCT02943954。）
