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Five-Year Outcomes with PCI Guided by Fractional Flow Reserve

Open access
Xaplanteris, Panagiotis, Fournier, Stephane, Pijls, Nico H.J., Fearon, William F., Barbato, Emanuele, Tonino, Pim A.L., Engstrøm, Thomas, Kääb, Stefan, Dambrink, Jan-Henk, Rioufol, Gilles, Toth, Gabor G., Piroth, Zsolt, Witt, Nils, Fröbert, Ole, Kala, Petr, Linke, Axel, Jagic, Nicola, Mates, Martin, Mavromatis, Kreton, Samady, Habib, Irimpen, Anand, Oldroyd, Keith, Campo, Gianluca, Rothenbühler, Martina, Jüni, Peter, De Bruyne, Bernard·2018·New England Journal of Medicine

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 .).

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Metadata

Authors
Xaplanteris, P., Fournier, S., Pijls, N. H. J., Fearon, W. F., Barbato, E., Tonino, P. A. L., Engstrøm, T., Kääb, S., Dambrink, J.-H., Rioufol, G., Toth, G. G., Piroth, Z., Witt, N., Fröbert, O., Kala, P., Linke, A., Jagic, N., Mates, M., Mavromatis, K., Samady, H., Irimpen, A., Oldroyd, K., Campo, G., Rothenbühler, M., Jüni, P., & De Bruyne, B.
Venue
New England Journal of Medicine
Published
2018-07-19
Volume
379
Issue
3
Pages
250-259
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2803470415
Cited by
866
References
19
FWCI
95.67
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. https://app.cochat.ai/papers/10.1056/nejmoa1803538
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Xaplanteris, P., Fournier, S., Pijls, N. H. J., Fearon, W. F., Barbato, E., Tonino, P. A. L., Engstrøm, T., Kääb, S., Dambrink, J.-H., Rioufol, G., Toth, G. G., Piroth, Z., Witt, N., Fröbert, O., Kala, P., Linke, A., Jagic, N., Mates, M., Mavromatis, K., . . . De Bruyne, B. (2018). Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1803538

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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.