New data from the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 trial shows that after five years of follow up, patients with three-vessel coronary artery disease not involving the left main coronary artery had no significant difference in the incidence of death and stroke whether they were treated with percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) or coronary artery bypass grafting (CABG).
These findings have huge clinical implications because patients don’t usually want to have open-heart surgery.
— Dr. Yuhei Kobayashi
The results are the first to show non-inferiority of PCI versus CABG in this group of patients with severe coronary artery disease, says Yuhei Kobayashi, M.D., an interventional cardiologist at NewYork-Presbyterian and Weill Cornell Medicine, director of interventional cardiology research at NewYork-Presbyterian Brooklyn Methodist, and a co-author of the study, which was published recently in the Lancet.
“These findings have huge clinical implications because patients don’t usually want to have open-heart surgery,” Dr. Kobayashi says.
The FAME 3 trial showed similar rates of death and stroke for patients with three-vessel coronary artery disease whether they underwent FFR-guided PCI or CABG.
Study Details
The FAME 3 trial enrolled 1,500 patients across 48 hospitals in the U.S., Europe, Canada, Australia, and Asia to compare the performance of PCI versus CABG following improvements in percutaneous techniques. Participants were randomized to receive either FFR-guided PCI or CABG, and the interventions were assessed on whether they met a composite outcome of death, stroke, or myocardial infarction at one year and five years.
PCI achieves similar results compared to bypass surgery in patients with three-vessel coronary artery disease; however, we cannot say PCI is superior to CABG. We can provide similar results with both procedures up to five years.
— Dr. Yuhei Kobayashi
The one-year results, which were published in the New England Journal of Medicine in 2022, showed that PCI did not meet the criteria set for non-inferiority over CABG. However, at five years, PCI has narrowed the gap in the composite measure of all-cause death, stroke, or myocardial infarction, with incidence of that composite measure at 16% for PCI and 14.1% for CABG, which is not statistically significant.
“PCI achieves similar results compared to bypass surgery in patients with three-vessel coronary artery disease; however, we cannot say PCI is superior to CABG. We can provide similar results with both procedures up to five years,” Dr. Kobayashi says.
When taken separately, death and stroke were similar regardless of the intervention, but with PCI, the incidence of myocardial infarction was 2.9% higher and the rate of repeat revascularization was double (16% with PCI vs. 8% with CABG).
New Techniques
Historically, studies of PCI and CABG in the complex coronary anatomy had shown that PCI was inferior with higher incidences of death and myocardial infarction, but those prior studies were conducted before improvements in percutaneous techniques, such as FFR-guiding technology and improved stents. PCI is now FFR-guided, which allows interventional cardiologists to insert a small coronary pressure wire into the artery to check the arterial pressure, indicating the severity of the blockage and allowing more judicious use of the stents.
“This advancement in technology actually reduces the amount of stents we need to treat patients,” Dr. Kobayashi says.
The stents themselves have also improved, with newer-generation drug-eluting stents decreasing the risk of restenosis. The improvement in PCI is also aided by improvements in medical management, such as the greater use of statin therapy, beta-blockers, and improvement of P2Y12 inhibitors, Dr. Kobayashi says.
A Minimally Invasive Option
The FAME 3 findings should give cardiologists more confidence to recommend PCI for patients with three-vessel coronary artery disease who want a minimally invasive option because the potential risks are virtually the same as bypass.
Dr. Kobayashi says future studies may even show that PCI is superior to CABG. While the FAME 3 trial assessed FFR-guided PCI, there is even newer technology called intravascular imaging that allows surgeons to use a miniature camera in the artery to optimize the size and placement of the stent. Says Dr. Kobayashi, “The use of intravascular imaging is only around 10% or so in the FAME3 study, but this technology has also been shown to improve the outcomes of PCI. That’s the future direction, and we use intravascular imaging for 100% of our PCIs in our hospital to achieve the best possible outcome for our patients.”
