• Bernard De Bruyne, Nico H J Pijls, Bindu Kalesan, Emanuele Barbato, Pim A L Tonino, Zsolt Piroth, Nikola Jagic, Sven Möbius-Winkler, Sven Mobius-Winckler, Gilles Rioufol, Nils Witt, Petr Kala, Philip MacCarthy, Thomas Engström, Keith G Oldroyd, Kreton Mavromatis, Ganesh Manoharan, Peter Verlee, Ole Frobert, Nick Curzen, Jane B Johnson, Peter Jüni, William F Fearon, and FAME 2 Trial Investigators.
• Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium. bernard.de.bruyne@olvz-aalst.be
• N. Engl. J. Med. 2012 Sep 13; 367 (11): 991-1001.

BackgroundThe preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone.MethodsIn patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.ResultsRecruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary end-point event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P<0.001). Among patients in the registry, 3.0% had a primary end-point event.ConclusionsIn patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01132495.).

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