Noninvasive Stents as Good as Surgery for Triple-Vessel Disease

CHICAGO — Patients with severe triple-vessel heart disease who underwent a less-invasive stent procedure fared just as well as those who underwent open-heart bypass surgery after 5 years, the FAME 3 trial shows.

The results are in marked contrast to earlier studies, which showed that patients with triple-vessel disease were less likely to die or to have a heart attack or stroke after coronary artery bypass grafting (CABG) than after percutaneous coronary intervention (PCI), said William Fearon, MD, chief of interventional cardiology at Stanford University School of Medicine in California, who presented the results today at American College of Cardiology (ACC) Scientific Session 2025, which were simultaneously published in The Lancet.

However, those studies were based on outdated data, which did not take into account improvements in PCI seen in recent years, he pointed out.

Fractional flow reserve-guided PCI has improved the ability to select which blood vessels are best suited for stents, and the current generation of drug-eluting stents are much better than their predecessors, making it worthwhile to re-evaluate the two procedures, he explained.

“The way these procedures are performed has evolved significantly in the past decade,” Fearon said. “Our aim in doing this study was to determine whether, given all of the advances that have occurred, PCI would perform more similarly to CABG in patients with triple-vessel disease.”

The FAME 3 Trial

In the FAME 3 trial, 1500 patients in North America, Europe, Asia, and Australia who received guideline-recommended medical treatment for heart disease were randomly assigned to one of two groups. One group underwent CABG surgery. In the other group, patients with narrowed arteries and a fractional flow reserve score of 0.8 or less underwent PCI to place a drug-eluting stent; those with a higher score were treated with medicine.

After 1 year, PCI did not meet the primary composite endpoint — death from any cause, stroke, heart attack, or the need for a repeat procedure — of noninferiority to CABG, but things started to look up on longer timelines. After 3 years, there were no significant differences in rates of death, stroke, or heart attack between the two procedures. That trend continued at 5 years, when death rates in the PCI and CABG groups were identical (7.2% vs 7.2%) and there was no significant difference in stroke (1.9% vs 3.0%). Patients who underwent PCI had more heart attacks than those who underwent CABG (8.2% vs 5.3%) and needed more repeat procedures (15.6% vs 7.8%).

“In previous studies, the difference in outcomes for patients with three-vessel disease favoring those treated with CABG continued to widen over time,” Fearon reported. “But in FAME 3, we did not see that. At 5 years, there were no statistically significant differences between the two groups” in the primary composite endpoint, “and the absolute difference was similar to what we saw at 3 years.”

Cardiologists have been wondering for years whether less-invasive PCI procedures could compete with invasive, but gold-standard, surgical interventions such as CABG. These data add to that conversation, said Akshay Khandelwal, MD, chief of cardiovascular medicine at the AHN Cardiovascular Institute in Detroit, Michigan.

The FAME 3 results show important strides have been made in PCI over the past decade, and “in many cases, PCI can approximate surgical results, or at least should prompt a serious conversation with the patient,” he said.

FAME 3 was funded by research grants from Medtronic, which makes the drug-eluting stent used in the study, and Abbott Vascular, which makes the fractional flow reserve measurement device used.