Journal Club - FAME 3 Subanalysis Adds Twist to Negative Primary Results

Published On 2022-05-04 13:09 GMT   |   Update On 2022-05-04 13:09 GMT
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Ischemic heart disease is the leading cause of death globally. Coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) are the two revascularization options for ischemic heart disease. However, the choice of the most appropriate revascularization modality is controversial and has been an issue of debate.  

 choice of revascularization and the status of percutaneous coronary intervention ie PCI in treating coronary artery disease. Previously in the FAME 2 trial the researchers concluded that 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.

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And the FAME 3 triAl showed that 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.
But a new sub analysis of the FAME 3 trial has failed to show that percutaneous intervention (PCI) guided by fractional flow reserve (FFR) is non inferior to coronary artery bypass grafting (CABG) for treating three-vessel coronary artery disease. This has associated PCI with early quality of life (QOL) advantages, despite a modestly greater risk of major adverse cardiac events (MACE) at the end of 12 
months' follow-up among those treated with FFR-guided PCI.
This is in accordance to the findings presented at the annual scientific sessions of the American College of Cardiology by Dr. Frederik M. Zimmerman, MD, of Catharina Hospital in the Netherlands. 
The primary results of FAME 3 were presented at the 2021 Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the New England Journal of Medicine. Rather than confirming the hypothesis that fractional flow reserve -guided PCI is comparable with CABG for the primary composite, myocardial infarction, stroke, or revascularization, the incidence of MACE at 12 months was 10.6% in those randomized to PCI and 6.9% in the group assigned to CABG. which was significant.
Ultimately, the study did not show differences in any of these measures at the end of 12 months, but there were significant differences in QOL and employment at earlier time points. Hence, the researchers concluded that these results suggest that thought there are more MACE with FFR- guided PCI yet the potentially clinically meaningful early advantages for fractional flow reserve - guided PCI exist. 
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