《血流储备分数指导下的 PCI 与冠状动脉旁路移植术的比较》。
Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery.
机构信息
From the Division of Cardiovascular Medicine and Stanford Cardiovascular Institute (W.F.F., M.A.H., A.C.Y.), the Quantitative Sciences Unit (D.L., V.Y.D., M.D.), and the Departments of Health Policy (M.A.H.) and Cardiothoracic Surgery (Y.J.W.), Stanford University, and the Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine (K.W.M.), Stanford, and the VA Palo Alto Health Care System, Palo Alto (W.F.F.) - all in California; Catharina Hospital, Eindhoven (F.M.Z., A.H.M.S., P.A.L.T., N.H.J.P.), and Isala Hospital, Zwolle (J.-H.E.D.) - both in the Netherlands; Cardiovascular Center Aalst, Aalst (B.D.B., F.C.), and Centre Hospitalier Universitaire de Charleroi, Charleroi (A.A.) - both in Belgium; Lausanne University Center Hospital, Lausanne, Switzerland (B.D.B.); Gottsegen National Cardiovascular Center, Budapest, Hungary (Z.P., L.S.); the Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Vilnius University, and Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania (G.D., G.K.); Centre Hospitalier de l'Université de Montréal, Montreal (S.M.), and Southlake Regional Health Centre, Newmarket, ON (S.E.S.M.) - both in Canada; Oxford University Hospitals NHS Foundation Trust, Oxford (R.K.), Golden Jubilee National Hospital, Glasgow (K.G.O., N.A.-A.), and Wythenshawe Hospital, Manchester (J.S.) - all in the United Kingdom; Danderyd University Hospital (N.Ö.-P.) and Karolinska Institutet (N.Ö.-P., N.W.), Solna, and Sahlgrenska University Hospital, Gothenburg (O.A.) - all in Sweden; Clinical Hospital Centre Zemun, University of Belgrade, Belgrade, Serbia (N.J.); Medical Faculty of Masaryk University and University Hospital Brno, Brno, Czech Republic (P.K.); Kings College Hospital, London (P.M., O.W.); the Atlanta VA Healthcare System, Decatur, GA (K.M.); Rigshospitalet, Copenhagen (T.E.), and Aarhus University Hospital, Aarhus (E.H.C.) - both in Denmark; Houston Methodist Hospital, Houston (M.J.R.); and Montefiore Medical Center, New York (Y.K.).
出版信息
N Engl J Med. 2022 Jan 13;386(2):128-137. doi: 10.1056/NEJMoa2112299. Epub 2021 Nov 4.
BACKGROUND
Patients with three-vessel coronary artery disease have been found to have better outcomes with coronary-artery bypass grafting (CABG) than with percutaneous coronary intervention (PCI), but studies in which PCI is guided by measurement of fractional flow reserve (FFR) have been lacking.
METHODS
In this multicenter, international, noninferiority trial, patients with three-vessel coronary artery disease were randomly assigned to undergo CABG or FFR-guided PCI with current-generation zotarolimus-eluting stents. The primary end point was the occurrence within 1 year of a major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction, stroke, or repeat revascularization. Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio. Secondary end points included a composite of death, myocardial infarction, or stroke; safety was also assessed.
RESULTS
A total of 1500 patients underwent randomization at 48 centers. Patients assigned to undergo PCI received a mean (±SD) of 3.7±1.9 stents, and those assigned to undergo CABG received 3.4±1.0 distal anastomoses. The 1-year incidence of the composite primary end point was 10.6% among patients randomly assigned to undergo FFR-guided PCI and 6.9% among those assigned to undergo CABG (hazard ratio, 1.5; 95% confidence interval [CI], 1.1 to 2.2), findings that were not consistent with noninferiority of FFR-guided PCI (P = 0.35 for noninferiority). The incidence of death, myocardial infarction, or stroke was 7.3% in the FFR-guided PCI group and 5.2% in the CABG group (hazard ratio, 1.4; 95% CI, 0.9 to 2.1). The incidences of major bleeding, arrhythmia, and acute kidney injury were higher in the CABG group than in the FFR-guided PCI group.
CONCLUSIONS
In patients with three-vessel coronary artery disease, FFR-guided PCI was not found to be noninferior to CABG with respect to the incidence of a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. (Funded by Medtronic and Abbott Vascular; FAME 3 ClinicalTrials.gov number, NCT02100722.).
背景
与经皮冠状动脉介入治疗（PCI）相比，三血管病变患者接受冠状动脉旁路移植术（CABG）的效果更好，但缺乏以血流储备分数（FFR）指导的 PCI 研究。
方法
在这项多中心、国际、非劣效性试验中，三血管病变患者被随机分配接受 CABG 或使用新一代佐他莫司洗脱支架的 FFR 指导的 PCI。主要终点是在 1 年内发生主要心脏或脑血管不良事件，定义为任何原因导致的死亡、心肌梗死、卒中和再次血运重建。FFR 指导的 PCI 不劣于 CABG 的预先设定上限为危险比的 95%置信区间小于 1.65。次要终点包括死亡、心肌梗死或卒中等的复合终点；还评估了安全性。
结果
共有 1500 名患者在 48 个中心接受随机分组。接受 PCI 治疗的患者平均植入（±SD）3.7±1.9 枚支架，接受 CABG 治疗的患者植入 3.4±1.0 个远端吻合口。随机分配至 FFR 指导的 PCI 组的患者在 1 年内发生主要复合终点的发生率为 10.6%，而随机分配至 CABG 组的患者发生率为 6.9%（危险比，1.5；95%置信区间[CI]，1.1 至 2.2），这与 FFR 指导的 PCI 不劣效性不符（非劣效性 P=0.35）。FFR 指导的 PCI 组的死亡率、心肌梗死或卒中的发生率为 7.3%，CABG 组为 5.2%（危险比，1.4；95%CI，0.9 至 2.1）。CABG 组的大出血、心律失常和急性肾损伤的发生率高于 FFR 指导的 PCI 组。
结论
在三血管病变患者中，与 CABG 相比，FFR 指导的 PCI 在 1 年内死亡、心肌梗死、卒中和再次血运重建的复合发生率方面并未显示出非劣效性。（由美敦力和雅培血管公司资助；FAME 3 临床试验.gov 编号，NCT02100722）。
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