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N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22.

Five-Year Outcomes with PCI Guided by Fractional Flow Reserve.

Author information

1
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.).

Abstract

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 .).

PMID:
29785878
DOI:
10.1056/NEJMoa1803538
[Indexed for MEDLINE]

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