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Fractional Flow Reserve–Guided PCI versus Medical Therapy in Stable Coronary Disease

Open access
De Bruyne, Bernard, Pijls, Nico H.J., Kalesan, Bindu, Barbato, Emanuele, Tonino, Pim A.L., Piroth, Zsolt, Jagic, Nikola, Möbius-Winkler, Sven, Rioufol, Gilles, Witt, Nils, Kala, Petr, MacCarthy, Philip, Engström, Thomas, Oldroyd, Keith G., Mavromatis, Kreton, Manoharan, Ganesh, Verlee, Peter, Frobert, Ole, Curzen, Nick, Johnson, Jane B., Jüni, Peter, Fearon, William F.·2012·New England Journal of Medicine

Abstract

BACKGROUND: The 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. METHODS: In 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. RESULTS: Recruitment 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. CONCLUSIONS: In 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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Metadata

Authors
De Bruyne, B., Pijls, N. H. J., Kalesan, B., Barbato, E., Tonino, P. A. L., Piroth, Z., Jagic, N., Möbius-Winkler, S., Rioufol, G., Witt, N., Kala, P., MacCarthy, P., Engström, T., Oldroyd, K. G., Mavromatis, K., Manoharan, G., Verlee, P., Frobert, O., Curzen, N., Johnson, J. B., Jüni, P., & Fearon, W. F.
Venue
New England Journal of Medicine
Published
2012-09-13
Volume
367
Issue
11
Pages
991-1001
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2133924558
Cited by
2,772
References
26
FWCI
210.45
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: Fractional Flow Reserve–Guided PCI versus Medical Therapy in Stable Coronary Disease. https://app.cochat.ai/papers/10.1056/nejmoa1205361
The paper
De Bruyne, B., Pijls, N. H. J., Kalesan, B., Barbato, E., Tonino, P. A. L., Piroth, Z., Jagic, N., Möbius-Winkler, S., Rioufol, G., Witt, N., Kala, P., MacCarthy, P., Engström, T., Oldroyd, K. G., Mavromatis, K., Manoharan, G., Verlee, P., Frobert, O., Curzen, N., . . . Fearon, W. F. (2012). Fractional Flow Reserve–Guided PCI versus Medical Therapy in Stable Coronary Disease. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1205361

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.