FFR-guided PCI No Better Than CABG in Improving QOL: FAME 3 Trial
In patients with three-vessel coronary artery disease (CAD), large, randomized trials have demonstrated that coronary revascularization improves the quality of life, with better outcomes after coronary artery bypass grafting (CABG) than after percutaneous coronary intervention (PCI).
A recent study suggests that PCI did not meet the criterion set for noninferiority regarding MACCE (major adverse cardiac and cerebrovascular events) at one year when compared with CABG despite advancement. The study findings were published in the journal Circulation on April 02, 2022.
CABG and PCI have been compared in many randomized trials, but prior studies have not incorporated the latest developments in PCI, particularly the use of fractional flow reserve (FFR) guidance. Therefore, Dr William F. Fearon and his team conducted a study to evaluate the impact of fractional flow reserve (FFR) guidance and current generation, zotarolimus drug-eluting stents (DES) on the quality of life after PCI compared with CABG.
The Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 trial is a multicenter, international trial with patients with three-vessel CAD. In this trial, the researchers evaluated 1500 patients and randomly assigned them to either CABG or FFR-guided PCI. They measured quality of life using the European Quality of Life-5 Dimensions (EQ-5D) questionnaire at baseline, 1 and 12 months. They assessed the Canadian Cardiovascular Class (CCS) angina grade and working status at the same time points and 6 months. The major objective assessed was to compare the EQ-5D summary index at 12 months. They also assessed the angina grade and work status.
Key findings of the study:
- Upon analysis, the researchers found that the EQ-5D summary index at 12 months did not differ between the PCI and CABG groups (difference=0.001).
- They noted that the trajectory of EQ-5D over the 12 months differed between PCI and CABG: at 1 month, EQ-5D was 0.063 higher in the PCI group.
- They found a similar trajectory for the EQ visual analogue scale.
- They noted that the proportion of patients with CCS 2 or greater angina at 12 months was 6.2% vs 3.1% (OR=2.5), respectively in the PCI group compared with the CABG group.
- However, they found a greater percentage of younger patients (<65 years old) were working at 12 months in the PCI group compared with the CABG group (68% vs 57%, OR=3.9).
The authors concluded, "In the FAME 3 trial, quality of life after FFR-guided PCI with current generation DES compared with CABG was similar at one year. The rate of significant angina was low in both groups and not significantly different. The trajectory of improvement in quality of life was significantly better after PCI, as was working status in those less than 65 years old."
For further information:
DOI: https://doi.org/10.1161/CIRCULATIONAHA.122.060049
