EuroPCR 23: FAME III Three-Year Follow-Up
Published: 18 May 2023
EuroPCR 23 – In this late-breaking science interview, we are joined by Prof Frederick Zimmermann (Catharina Hospital, NL) to discuss the findings from a 3-year follow-up of the FAME III trial.
The objective of the FAME 3 trial was to demonstrate the noninferiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared to coronary artery bypass grafting (CABG) in patients with three-vessel disease. Eligible patients were randomly assigned to either FFR-guided PCI (757) or CABG (743) in a 1:1 ratio. The results at 3 years demonstrate no significant difference in death, MI and stroke at 3 years.
- What is the importance of the FAME 3 trial?
- Could you provide a brief overview of the methodology used and the patient population involved in the FAME 3 trial?
- What are the key findings at three years?
- What are some of the limitations of this trial?
- In the context of three-vessel disease, which patients would potentially benefit from FFR-guided PCI?
- What are the next steps and what are the remaining knowledge gaps?
Recorded on-site at EuroPCR 2023, Paris.
Editors: Mirjam Boros, Jordan Rance
Video Specialist: Oliver Miles, Dan Brent
"Thanks for having me. I'm Frederick Zimmerman from the Catharina Hospital in Eindhoven.
Why is the FAME 3 Trial Important?
In previous studies showed better outcomes after CABG versus PCI in patients with three vessel disease. But in those previous trials, PCI was performed based on the angio and either BR middle stents or first-generation drug eluting stents were used. And we now know that FFR-guided PCI outperforms angio-guided PCI and that second-generation drug aluminum stents outperform either bare metal stents or first-generation drug-eluting stents. So for that reason, Fame Three was designed comparing guided PCI with second generation drug eluting stents versus CABG in patients with three-vessel disease. Not including the left main.
Could you provide a brief overview of the methodology used and the patient population involved in the FAME 3 trial?
There was an investigator initiated multicenter randomized trial in 48 sites in North America, Europe and Asia and Australia. Patients were randomized to either FFR guided PCI or CABG in a one-to-one fashion. And our primary endpoint was the composite of death, MI stroke and repeat revascularization at one year. That was published in the New England Journal of Medicine in 2022.Now, here we present the prespecified key secondary endpoint that we prespecified from the start.
What are the key findings at three years?
Looking at the composite of death, MI, stroke at three years. The key findings were that there was no significant difference in the prespecified composite endpoint of death, MI, stroke at three years with a p value of 0.07. If you look at individual endpoints, that was identical in both groups as well as stroke, and there was a lower rate of MI and repeat revascularization after CABG.
What are some of the limitations of this trial?
The use of intravascular imaging was somewhat low in this trial, only 12%, and of course, longer follow-up is needed to compare outcomes over the long term.
In the context of three-vessel disease, which patients would potentially benefit from FFR-guided PCI?
We looked at subgroup analyses and we found, particularly in patients with a low syntax group, syntax score group, that PCI had a favourable outcome compared with CABG. In patients with a higher syntax score, CABG outperformed PCI.
What are the next steps and what are the remaining knowledge gaps?
We're following those patients up to five years. We're looking at more subgroup analyses are coming out in the following months, as well as a quality-of-life analyses and also the economic evaluation."