基于血流储备分数指导的 PCI 的 5 年结果。
Five-Year Outcomes with PCI Guided by Fractional Flow Reserve.
机构信息
From the Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium (P.X., S.F., E.B., G.G.T., B.D.B.); the Department of Cardiology, Catharina Hospital, and the Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven (N.H.J.P., P.A.L.T.), and Isala Klinieken, Zwolle (J.-H.D.) - all in the Netherlands; Stanford University Medical Center and Palo Alto Veterans Affairs (VA) Health Care Systems, Stanford, CA (W.F.F.); Rigshospitalet University Hospital, Copenhagen (T.E.); Klinikum der Universität München-Campus-Innenstadt, Munich (S.K.), Heart Center Leipzig, Leipzig (A.L.), and Heart Center Dresden, Dresden (A.L.) - all in Germany; the Cardiovascular Hospital, Lyon, France (G.R.); Gottsegen Hungarian Institute of Cardiology, Budapest, Hungary (G.G.T., Z.P.); Karolinska Institutet at Södersjukhuset, Stockholm (N.W.), and Örebro University Hospital, Örebro (O.F.) - both in Sweden; Masaryk University and University Hospital, Brno (P.K.), and Na Homolce Hospital, Prague (M.M.) - both in the Czech Republic; Clinical Center Kragujevac, Kragujevac, Serbia (N.J.); Atlanta VA Medical Center, Decatur (K.M.), and Emory University School of Medicine, Atlanta (H.S.) - both in Georgia; Tulane University Heart and Vascular Institute, New Orleans (A.I.); Golden Jubilee National Hospital, Glasgow, United Kingdom (K.O.); Cardiology Unit, Azienda Ospedalieria Universitaria di Ferrara, Ferrara, and Maria Cecilia Hospital, Gruppo Villa Maria Care and Research, Cotignola - both in Italy (G.C.); Clinical Trials Unit Bern, University of Bern, Bern, Switzerland (M.R.); and the Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto (P.J.).
出版信息
N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22.
BACKGROUND
We hypothesized that fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) would be superior to medical therapy as initial treatment in patients with stable coronary artery disease.
METHODS
Among 1220 patients with angiographically significant stenoses, those in whom at least one stenosis was hemodynamically significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus medical therapy or to medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy and were entered into a registry. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.
RESULTS
A total of 888 patients underwent randomization (447 patients in the PCI group and 441 in the medical-therapy group). At 5 years, the rate of the primary end point was lower in the PCI group than in the medical-therapy group (13.9% vs. 27.0%; hazard ratio, 0.46; 95% confidence interval [CI], 0.34 to 0.63; P<0.001). The difference was driven by urgent revascularizations, which occurred in 6.3% of the patients in the PCI group as compared with 21.1% of those in the medical-therapy group (hazard ratio, 0.27; 95% CI, 0.18 to 0.41). There were no significant differences between the PCI group and the medical-therapy group in the rates of death (5.1% and 5.2%, respectively; hazard ratio, 0.98; 95% CI, 0.55 to 1.75) or myocardial infarction (8.1% and 12.0%; hazard ratio, 0.66; 95% CI, 0.43 to 1.00). There was no significant difference in the rate of the primary end point between the PCI group and the registry cohort (13.9% and 15.7%, respectively; hazard ratio, 0.88; 95% CI, 0.55 to 1.39). Relief from angina was more pronounced after PCI than after medical therapy.
CONCLUSIONS
In patients with stable coronary artery disease, an initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent revascularization at 5 years than medical therapy alone. Patients without hemodynamically significant stenoses had a favorable long-term outcome with medical therapy alone. (Funded by St. Jude Medical and others; FAME 2 ClinicalTrials.gov number, NCT01132495 .).
背景
我们假设，在稳定型冠状动脉疾病患者中，与单纯药物治疗相比，血流储备分数（FFR）指导的经皮冠状动脉介入治疗（PCI）作为初始治疗可带来更好的效果。
方法
在 1220 例存在造影明确狭窄的患者中，至少有一处狭窄存在血流动力学意义（FFR，≤0.80）的患者被随机分为 FFR 指导下的 PCI 加药物治疗组或单纯药物治疗组。所有狭窄的 FFR 均大于 0.80 的患者接受药物治疗并进入登记处。主要终点是死亡、心肌梗死或紧急血运重建的复合终点。
结果
共 888 例患者接受了随机分组（PCI 组 447 例，药物治疗组 441 例）。5 年时，PCI 组的主要终点发生率低于药物治疗组（13.9%比 27.0%；风险比，0.46；95%置信区间[CI]，0.34 至 0.63；P<0.001）。差异主要来自紧急血运重建，PCI 组中有 6.3%的患者发生了紧急血运重建，而药物治疗组有 21.1%（风险比，0.27；95%CI，0.18 至 0.41）。PCI 组与药物治疗组在死亡率（分别为 5.1%和 5.2%；风险比，0.98；95%CI，0.55 至 1.75）或心肌梗死（分别为 8.1%和 12.0%；风险比，0.66；95%CI，0.43 至 1.00）方面无显著差异。PCI 组与登记处队列的主要终点发生率无显著差异（分别为 13.9%和 15.7%；风险比，0.88；95%CI，0.55 至 1.39）。与单纯药物治疗相比，PCI 后患者心绞痛缓解更为明显。
结论
在稳定型冠状动脉疾病患者中，与单纯药物治疗相比，初始 FFR 指导的 PCI 策略可显著降低 5 年时死亡、心肌梗死或紧急血运重建的主要复合终点发生率。无血流动力学意义狭窄的患者单独接受药物治疗可获得良好的长期预后。（由圣犹达医疗等资助；FAME 2 临床试验.gov 编号，NCT01132495）。
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