Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery.
Details
Serval ID
serval:BIB_DD29B6C1C9F5
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery.
Journal
The New England journal of medicine
Working group(s)
FAME 3 Investigators
Contributor(s)
Bhindi R., Brady P., Yong A., Yan T., Ng M., Plunkett B., Layland J., Newcomb A., Sapontis J., Smith J., Asrress K., De Bruyne B., Casselman F., Aminian A., El Nakadi B., Mansour S., Noiseux N., Miner S., Peniston C., Chong A.Y., Glineur D., Minhas K., Raab M., Kala P., Nemec P., Engstroem T., Thyregod G., Christiansen E., Modrau I., Rioufol G., Farhat F., Piroth Z., Szekely L., Park S.J., Choo S.J., Davidavicius G., Kalinauskas G., Pijls NHJ, Zimmermann F.M., Van Straten B., Dambrik H.J., Bruinsma B., Bech GJW, Hoohenkerk GJW, Larsen A.I., Haaverstad R., Menon M., El Gamel A., Jagic N., Sreckovic M., Rosic M., Beleslin B., Putnik S., Witt N., Corbascio M., Ostlund-Papadogeorgos N., Angeras O., Jeppsson A., Oldroyd K., Berry C., Watkins S., Al-Attar N., MacCarthy P., Wendler O., Curzen N., Miskolczi S., Sunil O., Sarma J., Barnard J., Tapp L., Baker T., Redwood S., Young C., Kharbanda R., Sayeed R., Fearon W.F., Woo Y.J., Mavromatis K., Nguyen D., Matthai W.H., Atluri P., Vidovich M., Eng M., Perez-Tamayo A., Yong C., Fearon W., Giacomini J., Burdon T., Tadros P., Zorn G., Shah A., Reardon M., Myers P., Reddy S., Ragosta M., Ailawadi G., Azemi T., Cheema M., Underhill D., Hagberg R., Booth D., Lotfi A., Stamou S., Pijls NHJ, Woo J., Yeung A.C., Desai M., Lu D., Ding V., Yang J., Kapphahn K., Kern M., Min J., Benharash P., Mahaffey K., Tai W.A., Hong M., Lin S., Jones W., Patel M., Honda Y., Kobayashi Y., Hlatky M.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Publication state
Published
Issued date
13/01/2022
Peer-reviewed
Oui
Volume
386
Number
2
Pages
128-137
Language
english
Notes
Publication types: Comparative Study ; Equivalence Trial ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
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.
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.
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.
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.).
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.
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.
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, Coronary Stenosis/surgery, Female, Fractional Flow Reserve, Myocardial, Humans, Kaplan-Meier Estimate, Length of Stay, Male, Middle Aged, Operative Time, Percutaneous Coronary Intervention/adverse effects, Percutaneous Coronary Intervention/methods, Reoperation, Stents
Pubmed
Web of science
Open Access
Yes
Create date
16/11/2021 9:31
Last modification date
18/11/2023 7:08
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