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

William F Fearon; Frederik M Zimmermann; Bernard De Bruyne; Zsolt Piroth; Albert H M van Straten; Laszlo Szekely; Giedrius Davidavičius; Gintaras Kalinauskas; Samer Mansour; Rajesh Kharbanda; Nikolaos Östlund-Papadogeorgos; Adel Aminian; Keith G Oldroyd; Nawwar Al-Attar; Nikola Jagic; Jan-Henk E Dambrink; Petr Kala; Oskar Angerås; Philip MacCarthy; Olaf Wendler; Filip Casselman; Nils Witt; Kreton Mavromatis; Steven E S Miner; Jaydeep Sarma; Thomas Engstrøm; Evald H Christiansen; Pim A L Tonino; Michael J Reardon; Di Lu; Victoria Y Ding; Yuhei Kobayashi; Mark A Hlatky; Kenneth W Mahaffey; Manisha Desai; Y Joseph Woo; Alan C Yeung; Nico H J Pijls; FAME 3 Investigators

doi:10.1056/NEJMoa2112299

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

William F Fearon, Frederik M Zimmermann, Bernard De Bruyne, Zsolt Piroth, Albert H M van Straten, Laszlo Szekely, Giedrius Davidavičius, Gintaras Kalinauskas, Samer Mansour, Rajesh Kharbanda, Nikolaos Östlund-Papadogeorgos, Adel Aminian, Keith G Oldroyd, Nawwar Al-Attar, Nikola Jagic, Jan-Henk E Dambrink, Petr Kala, Oskar Angerås, Philip MacCarthy, Olaf WendlerFilip Casselman, Nils Witt, Kreton Mavromatis, Steven E S Miner, Jaydeep Sarma, Thomas Engstrøm, Evald H Christiansen, Pim A L Tonino, Michael J Reardon, Di Lu, Victoria Y Ding, Yuhei Kobayashi, Mark A Hlatky, Kenneth W Mahaffey, Manisha Desai, Y Joseph Woo, Alan C Yeung, Nico H J Pijls, FAME 3 Investigators

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.).

Original language	English
Journal	The New England journal of medicine
Volume	386
Issue number	2
Pages (from-to)	128-137
Number of pages	10
ISSN	0028-4793
DOIs	https://doi.org/10.1056/NEJMoa2112299
Publication status	Published - 13 Jan 2022

Keywords

Aged
Cardiovascular Diseases/epidemiology
Coronary Artery Bypass/adverse effects
Coronary Stenosis/mortality
Female
Fractional Flow Reserve, Myocardial
Humans
Kaplan-Meier Estimate
Length of Stay
Male
Middle Aged
Operative Time
Percutaneous Coronary Intervention/adverse effects
Reoperation
Stents

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10.1056/NEJMoa2112299

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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., ... FAME 3 Investigators (2022). Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery. The New England journal of medicine, 386(2), 128-137. https://doi.org/10.1056/NEJMoa2112299

Fearon, WF, Zimmermann, FM, De Bruyne, B, Piroth, Z, van Straten, AHM, Szekely, L, Davidavičius, G, Kalinauskas, G, Mansour, S, Kharbanda, R, Östlund-Papadogeorgos, N, Aminian, A, Oldroyd, KG, Al-Attar, N, Jagic, N, Dambrink, J-HE, Kala, P, Angerås, O, MacCarthy, P, Wendler, O, Casselman, F, Witt, N, Mavromatis, K, Miner, SES, Sarma, J, Engstrøm, T, Christiansen, EH, Tonino, PAL, Reardon, MJ, Lu, D, Ding, VY, Kobayashi, Y, Hlatky, MA, Mahaffey, KW, Desai, M, Woo, YJ, Yeung, AC, Pijls, NHJ & FAME 3 Investigators 2022, 'Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery', The New England journal of medicine, vol. 386, no. 2, pp. 128-137. https://doi.org/10.1056/NEJMoa2112299

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title = "Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery",

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.).",

keywords = "Aged, Cardiovascular Diseases/epidemiology, Coronary Artery Bypass/adverse effects, Coronary Stenosis/mortality, Female, Fractional Flow Reserve, Myocardial, Humans, Kaplan-Meier Estimate, Length of Stay, Male, Middle Aged, Operative Time, Percutaneous Coronary Intervention/adverse effects, Reoperation, Stents",

author = "Fearon, {William F} and Zimmermann, {Frederik M} and {De Bruyne}, Bernard and Zsolt Piroth and {van Straten}, {Albert H M} and Laszlo Szekely and Giedrius Davidavi{\v c}ius and Gintaras Kalinauskas and Samer Mansour and Rajesh Kharbanda and Nikolaos {\"O}stlund-Papadogeorgos and Adel Aminian and Oldroyd, {Keith G} and Nawwar Al-Attar and Nikola Jagic and Dambrink, {Jan-Henk E} and Petr Kala and Oskar Anger{\aa}s and Philip MacCarthy and Olaf Wendler and Filip Casselman and Nils Witt and Kreton Mavromatis and Miner, {Steven E S} and Jaydeep Sarma and Thomas Engstr{\o}m and Christiansen, {Evald H} and Tonino, {Pim A L} and Reardon, {Michael J} and Di Lu and Ding, {Victoria Y} and Yuhei Kobayashi and Hlatky, {Mark A} and Mahaffey, {Kenneth W} and Manisha Desai and Woo, {Y Joseph} and Yeung, {Alan C} and Pijls, {Nico H J} and {FAME 3 Investigators}",

note = "Copyright {\textcopyright} 2021 Massachusetts Medical Society.",

year = "2022",

month = jan,

day = "13",

doi = "10.1056/NEJMoa2112299",

language = "English",

volume = "386",

pages = "128--137",

journal = "The New England journal of medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "2",

}

TY - JOUR

T1 - Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery

AU - Fearon, William F

AU - Zimmermann, Frederik M

AU - De Bruyne, Bernard

AU - Piroth, Zsolt

AU - van Straten, Albert H M

AU - Szekely, Laszlo

AU - Davidavičius, Giedrius

AU - Kalinauskas, Gintaras

AU - Mansour, Samer

AU - Kharbanda, Rajesh

AU - Östlund-Papadogeorgos, Nikolaos

AU - Aminian, Adel

AU - Oldroyd, Keith G

AU - Al-Attar, Nawwar

AU - Jagic, Nikola

AU - Dambrink, Jan-Henk E

AU - Kala, Petr

AU - Angerås, Oskar

AU - MacCarthy, Philip

AU - Wendler, Olaf

AU - Casselman, Filip

AU - Witt, Nils

AU - Mavromatis, Kreton

AU - Miner, Steven E S

AU - Sarma, Jaydeep

AU - Engstrøm, Thomas

AU - Christiansen, Evald H

AU - Tonino, Pim A L

AU - Reardon, Michael J

AU - Lu, Di

AU - Ding, Victoria Y

AU - Kobayashi, Yuhei

AU - Hlatky, Mark A

AU - Mahaffey, Kenneth W

AU - Desai, Manisha

AU - Woo, Y Joseph

AU - Yeung, Alan C

AU - Pijls, Nico H J

AU - FAME 3 Investigators

PY - 2022/1/13

Y1 - 2022/1/13

N2 - 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.).

AB - 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.).

KW - Aged

KW - Cardiovascular Diseases/epidemiology

KW - Coronary Artery Bypass/adverse effects

KW - Coronary Stenosis/mortality

KW - Female

KW - Fractional Flow Reserve, Myocardial

KW - Humans

KW - Kaplan-Meier Estimate

KW - Length of Stay

KW - Male

KW - Middle Aged

KW - Operative Time

KW - Percutaneous Coronary Intervention/adverse effects

KW - Reoperation

KW - Stents

UR - http://www.scopus.com/inward/record.url?scp=85120324234&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa2112299

DO - 10.1056/NEJMoa2112299

M3 - Journal article

C2 - 34735046

SN - 0028-4793

VL - 386

SP - 128

EP - 137

JO - The New England journal of medicine

JF - The New England journal of medicine

IS - 2

ER -

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

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