{"id":"37e126f4526a","type":"article","url":"https://hartvaat.nl/2018/07/19/5-jaarsuitkomsten-van-ffr-geleide-pci-nejm-fame-2/","title":"5-jaarsuitkomsten van FFR-geleide PCI: NEJM FAME 2","title_en":"Five-Year Outcomes with PCI Guided by Fractional Flow Reserve.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1803538","source_url":"https://doi.org/10.1056/NEJMoa1803538","authors":["Panagiotis Xaplanteris","Stephane Fournier","Nico H J Pijls","William F Fearon","Emanuele Barbato","Pim A L Tonino","Thomas Engstrøm","Stefan Kääb","Jan-Henk Dambrink","Gilles Rioufol","Gabor G Toth","Zsolt Piroth","Nils Witt","Ole Fröbert","Petr Kala","Axel Linke","Nicola Jagic","Martin Mates","Kreton Mavromatis","Habib Samady","Anand Irimpen","Keith Oldroyd","Gianluca Campo","Martina Rothenbühler","Peter Jüni","Bernard De Bruyne"],"significance":9,"published":"2018-07-19","source_date":"2018-07-19","image":"","kennis":["https://hartvaat.nl/kennis/coronairlijden/stemi/","https://hartvaat.nl/kennis/coronairlijden/esc-richtlijn-chronisch-coronairlijden-2024/"],"congress":"","summary_en":"The 5-year FAME 2 results confirmed the sustained benefit of FFR-guided PCI over medical therapy alone in patients with stable coronary disease and hemodynamically significant stenoses. The long-term data strengthened the role of fractional flow reserve in guiding revascularization decisions.","created":"2026-07-03T10:27:22Z","updated":"2026-07-03T13:26:37Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"NEJM FAME 2 5-jaarsresultaten die het langetermijnvoordeel bevestigen van FFR-geleide PCI versus medicamenteuze therapie bij stabiel coronairlijden met functioneel significante stenosen.","abstract_original":"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 .)."}