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Fractional Flow Reserve–Guided PCI as Compared with Coronary Bypass Surgery

Open access
Fearon, William F., Zimmermann, Frederik M., De Bruyne, Bernard, Piroth, Zsolt, van Straten, Albert H.M., Szekely, Laszlo, Davidavičius, Giedrius, Kalinauskas, Gintaras, Mansour, Samer, Kharbanda, Rajesh, Östlund-Papadogeorgos, Nikolaos, Aminian, Adel, Oldroyd, Keith G., Al-Attar, Nawwar, Jagic, Nikola, Dambrink, Jan-Henk E., Kala, Petr, Angerås, Oskar, MacCarthy, Philip, Wendler, Olaf, Casselman, Filip, Witt, Nils, Mavromatis, Kreton, Miner, Steven E.S., Sarma, Jaydeep, Engstrøm, Thomas, Christiansen, Evald H., Tonino, Pim A.L., Reardon, Michael J., Lu, Di, Ding, Victoria Y., Kobayashi, Yuhei, Hlatky, Mark A., Mahaffey, Kenneth W., Desai, Manisha, Woo, Y. Joseph, Yeung, Alan C., Pijls, Nico H.J.·2022·New England Journal of Medicine

Abstract

BACKGROUND: Patients with three-vessel coronary artery disease have been found to have better outcomes with coronary-artery bypass grafting (CABG) than with percutaneous coronary intervention (PCI), but studies in which PCI is guided by measurement of fractional flow reserve (FFR) have been lacking. METHODS: In this multicenter, international, noninferiority trial, patients with three-vessel coronary artery disease were randomly assigned to undergo CABG or FFR-guided PCI with current-generation zotarolimus-eluting stents. The primary end point was the occurrence within 1 year of a major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction, stroke, or repeat revascularization. Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio. Secondary end points included a composite of death, myocardial infarction, or stroke; safety was also assessed. RESULTS: A total of 1500 patients underwent randomization at 48 centers. Patients assigned to undergo PCI received a mean (±SD) of 3.7±1.9 stents, and those assigned to undergo CABG received 3.4±1.0 distal anastomoses. The 1-year incidence of the composite primary end point was 10.6% among patients randomly assigned to undergo FFR-guided PCI and 6.9% among those assigned to undergo CABG (hazard ratio, 1.5; 95% confidence interval [CI], 1.1 to 2.2), findings that were not consistent with noninferiority of FFR-guided PCI (P = 0.35 for noninferiority). The incidence of death, myocardial infarction, or stroke was 7.3% in the FFR-guided PCI group and 5.2% in the CABG group (hazard ratio, 1.4; 95% CI, 0.9 to 2.1). The incidences of major bleeding, arrhythmia, and acute kidney injury were higher in the CABG group than in the FFR-guided PCI group. CONCLUSIONS: In patients with three-vessel coronary artery disease, FFR-guided PCI was not found to be noninferior to CABG with respect to the incidence of a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. (Funded by Medtronic and Abbott Vascular; FAME 3 ClinicalTrials.gov number, NCT02100722.).

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Authors
Fearon, W. F., Zimmermann, F. M., De Bruyne, B., Piroth, Z., van Straten, A. H. M., Szekely, L., Davidavičius, G., Kalinauskas, G., Mansour, S., Kharbanda, R., Östlund-Papadogeorgos, N., Aminian, A., Oldroyd, K. G., Al-Attar, N., Jagic, N., Dambrink, J.-H. E., Kala, P., Angerås, O., MacCarthy, P., Wendler, O., Casselman, F., Witt, N., Mavromatis, K., Miner, S. E. S., Sarma, J., Engstrøm, T., Christiansen, E. H., Tonino, P. A. L., Reardon, M. J., Lu, D., Ding, V. Y., Kobayashi, Y., Hlatky, M. A., Mahaffey, K. W., Desai, M., Woo, Y. J., Yeung, A. C., & Pijls, N. H. J.
Venue
New England Journal of Medicine
Published
2022-01-13
Volume
386
Issue
2
Pages
128-137
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W3211158953
Cited by
359
References
18
FWCI
51.69
Type
journal article
Language
en
Open access
gold

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CoChat. (2026). Citation check: Fractional Flow Reserve–Guided PCI as Compared with Coronary Bypass Surgery. https://app.cochat.ai/papers/10.1056/nejmoa2112299
The paper
Fearon, W. F., Zimmermann, F. M., De Bruyne, B., Piroth, Z., van Straten, A. H. M., Szekely, L., Davidavičius, G., Kalinauskas, G., Mansour, S., Kharbanda, R., Östlund-Papadogeorgos, N., Aminian, A., Oldroyd, K. G., Al-Attar, N., Jagic, N., Dambrink, J.-H. E., Kala, P., Angerås, O., MacCarthy, P., . . . Pijls, N. H. J. (2022). Fractional Flow Reserve–Guided PCI as Compared with Coronary Bypass Surgery. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2112299

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

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.