血流储备分数指导下经皮冠状动脉介入治疗的5年结局 - NEJM医学前沿
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血流储备分数指导下经皮冠状动脉介入治疗的5年结局
Five-Year Outcomes with PCI Guided by Fractional Flow Reserve


Panagiotis Xaplanteris ... 心脑血管疾病 • 2018.07.19
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FAME 研究5年结果:稳定型冠心病FFR指导下的PCI持续获益

 

史冬梅*,于一,刘巍

首都医科大学附属北京安贞医院心内科

*通讯作者

 

FAME 五年结果速览

FAME Ⅱ研究1开始于2010年5月,旨在比较血流储备分数(FFR)指导下的PCI联合最优化药物治疗(OMT)与单纯OMT的中远期疗效。研究共纳入欧洲和北美洲28个国家的1,220例稳定型冠心病患者,这些患者均存在心绞痛症状,而且冠脉造影证实至少存在一处冠脉病变狭窄程度大于50%(靶病变)。研究者对靶病变进行FFR测量,首先将所有靶病变FFR均>0.80的患者归为注册组(332例),该组患者仅接受最优化药物治疗。然后将至少有一处FFR≤0.80的患者再随机分为介入+药物治疗组(PCI+OMT组,447例)和单纯药物治疗组(OMT组,441例)。该研究的主要复合终点由全因死亡、心肌梗死(MI)和紧急血运重建组成。

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摘要


背景

我们假设,在稳定型冠心病患者中,作为初始治疗,血流储备分数(FFR)指导下的经皮冠状动脉介入治疗(PCI)优于药物治疗。

 

方法

在1,220例血管造影显著狭窄的患者中,本研究将有至少1处血流动力学显著(FFR≤0.80)的狭窄的患者随机分组,给予FFR指导下的PCI+药物治疗或单纯药物治疗。所有狭窄FFR>0.80的患者都接受了药物治疗,并被注册。主要终点为由死亡、心肌梗死或紧急血运重建组成的复合终点。

 

结果

总共888例患者被随机分组(PCI组447例患者和药物治疗组441例患者)。5年时,PCI组主要终点的发生率低于药物治疗组(13.9% vs. 27.0%;风险比,0.46;95%置信区间[CI],0.34~0.63;P<0.001)。差异由紧急血运重建引起,PCI组6.3%的患者和药物治疗组21.1%的患者接受了紧急血运重建(风险比,0.27;95% CI,0.18~0.41)。PCI组和药物治疗组的死亡率(分别为5.1%和5.2%;风险比,0.98;95% CI,0.55~1.75)或心肌梗死发生率(分别为8.1%和12.0%;风险比,0.66;95% CI,0.43~1.00)无显著差异。PCI组和注册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,0.55~1.39)。PCI治疗后的心绞痛缓解比药物治疗后明显。

 

结论

在稳定型冠心病患者中,作为初始治疗,与单纯药物治疗相比,采用FFR指导下的PCI策略时,5年时由死亡、心肌梗死或紧急血运重建组成的复合主要终点的发生率显著较低。对于无血流动力学显著狭窄的患者,单纯药物治疗获得了良好的远期结局(由圣犹达医疗[St. Jude Medical]等资助;FAME 2在ClinicalTrials.gov注册号为NCT01132495)。





作者信息

Panagiotis Xaplanteris, M.D., Ph.D., Stephane Fournier, M.D., Nico H.J. Pijls, M.D., Ph.D., William F. Fearon, M.D., Emanuele Barbato, M.D., Ph.D., Pim A.L. Tonino, M.D., Ph.D., Thomas Engstrøm, M.D., Ph.D., Stefan Kääb, M.D., Jan-Henk Dambrink, M.D., Ph.D., Gilles Rioufol, M.D., Ph.D., Gabor G. Toth, M.D., Zsolt Piroth, M.D., Nils Witt, M.D., Ole Fröbert, M.D., Petr Kala, M.D., Axel Linke, M.D., Nicola Jagic, M.D., Martin Mates, M.D., Kreton Mavromatis, M.D., Habib Samady, M.D., Ph.D., Anand Irimpen, M.D., Keith Oldroyd, M.D., Gianluca Campo, M.D., Martina Rothenbühler, Ph.D., Peter Jüni, M.D., and Bernard De Bruyne, M.D., Ph.D. for the FAME 2 Investigators*
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.). Address reprint requests to Dr. De Bruyne at the Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Moorselbaan 164, B-9300 Aalst, Belgium, or at bernard.de.bruyne@olvz-aalst.be. *A list of the FAME 2 Investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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