- Hi, I'm Frederik Zimmermann. I'm from the Catharina Hospital in Eindhoven in the Netherlands and I will talk about the quality of life analysis, the FAME 3 Trial.
So, previous studies have shown that revascularisation improves quality of life and more so after CABG than PCI. However, previous trials did not use FFR to guide PCI and did not use second-generation drug-eluting stents, both of which have been shown to improve outcome. For that reason, the FAME 3 study was conducted, which was an investigator-initiated, multicentre, international, randomised controlled trial in 48 sites worldwide, comparing FFR-guided PCI with CABG in patients with three-vessel disease. As presented by Dr Fearon last year at TCT, and also published in New England Journal of Medicine, PCI did not meet noninferiority with respect to MACE at one year. However, if you look at the event rates compared to previous trials, then the event rates are lower and the differences between PCI and CABG narrow. So in light of the smaller differences in event rates, the quality of life angina status, as well as working status, becomes much more important for clinical decision making.
Study Design and Patient Cohort
So, for this quality of life analysis, our primary endpoint was the EQ-5D summary index at one year. We assessed quality of life at baseline, one month and 12 months, as well as the Visual Analogue Scale of the EQ-5D. Angina status and working status were also assessed at that point but also at six months.
We found that quality of life at one year was identical between the FFR-guided PCI group and the CABG group. However, FFR-guided PCI resulted in faster improvement of quality of life. We also found that the angina was dramatically decreased over both forms of revascularisation, with no differences at 12 months and working. And patients in the CABG arm worked less at one month. Interestingly, if we looked at a pre-specified subgroup analysis of patients younger than 65 years old at time of randomisation, we found that patients in the CABG group worked less at one month but also at six months and 12 months.
Take-home Messages for Clinicians
In light of the low event rates, it's all about shared decision-making with the patients. And we now have the data. We're very confident that the quality of life improves faster after FFR-guided PCI, with no differences also with respect to angina at one year.
Further Study Required
It will also be important to look at longer follow-up. So, we will also follow patients for up to five years. We will do the quality of life analysis at three and five years. I have to say, though, that in previous studies such as SYNTAX and FREEDOM, the main findings did not change that much beyond one year, with respect to quality of life.