Another Chapter in the PCI Vs. CABG Saga | ACC 2025

Clinical trials comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) for patients with severe triple-vessel heart disease have tended to favor CABG when it comes to death, stroke and myocardial infarction, especially when they are computed as a composite score.

William F. Fearon, M.D.

Results presented today at the American College of Cardiology (ACC) Scientific Session in Chicago suggested that the gap between PCI and CABG has narrowed, although the data showed that patients who had undergone CABG still had a lower rate of myocardial infarction over the five-year study and a lower rate of repeat revascularization.

The results of the five-year follow-up were published simultaneously in The Lancet, and William F. Fearon, M.D., the first author and principal investigator, and his colleagues say in the abstract that the results will provide “contemporary evidence to allow improved shared decision-making between physicians and patients.”

In a brief interview at a press conference held before he presented FAME 3 results at the ACC meeting, Fearon, who is chief of interventional cardiology at Stanford University School of Medicine, said the updated data can help physicians and patients decide between PCI and CABG (which is pronounced “cabbage”) and more accurately weigh tradeoffs. For example, he said, some people might accept the elevated risk of myocardial infarction seen in the PCI group in exchange for avoiding the recovery period after CABG.

One of the discussants at the press conference, Akshay Khandelwal, M.D., MBA, system chair, cardiovascular medicine, at the Allegheny Health Network in Pittsburgh, said the results “add to the conversation” and that clarifying shared decision-making could help make sure that “every patient gets the right treatment strategy” individualized to their comorbidity and desire.

Khandelwal also said it was time to move away from framing PCI and CABG adversarial choices, and the press conference moderator, Roxana Mehran, M.D., agreed.

“I think, in short, war games are over. I think we are all here to serve our patients. All of us — our surgical colleagues, our interventionists, our cardiologists,” said Mehran, who is a professor and is director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Wiener Cardiovascular Institute at Mount Sinai School of Medicine in New York.

Results presented today

The five-year follow-up FAME 3 results come after PCI failed to meet the test of noninferiority to CABG after one year of follow-up. In 2022, Fearon and his colleagues reported results in the New England Journal of Medicine based on three years of follow-up that found that PCI was not inferior to CABG using a composite end point that included death, myocardial infarction, stroke, or repeat revascularization at one year.

Roxana Mehran, M.D.

The prespecified composite end point in the five-year results that Fearon presented today was limited to death, stroke and myocardial infarction and did not include revascularization. Using that end point, there were 119 events (16%) among the 757 patients randomly assigned to PCI and 101 (14%) among the 743 randomly assigned to CABG, a difference that was not statistically significant. Similarly, there was no statistical difference in deaths (53 [7%] in the PCI group vs. 51 [7%] in the CABG group) or stroke (14 [2%] in the PCI group vs. 21 [3%] in the CABG group).

But when it came to myocardial infarction and repeat revascularization, the CABG group fared better over the five years of follow-up. There were 60 (8%) myocardial infarctions in the PCI group compared with 38 (5%) in the CABG group, and there were 112 repeat revascularizations in the PCI group compared with 55 (8%) in the CABG group.

At the press conference, Fearon compared the FAME 3 results to those from an earlier, widely cited trial comparing PCI and CABG called SYNTAX, showing that the gap between PCI and CABG on outcomes such as the number of deaths had closed in the FAME 3 five-year follow-up study. He noted the improvements to PCI as it was performed in FAME 3: Fractional flow reserve, which measures pressure gradients in blocked vessels, helps identify the lesions that are candidates for stenting and drug-eluting stents release drugs that inhibit the growth of tissue that can block an artery after a stent has been placed. The stents used in FAME 3, made by Medtronic, released zotarolimus, an analogue to sirolimus.

In The Lancet article, one of the limitations listed by Fearon and his colleagues is that only one-quarter of the CABG patients received the multiple arterial grafts that current guidelines recommend. At the press conference, Fearon noted that the proportion is, however, larger than the proportion seen in a database maintained by the Society of Thoracic Surgeons.

One passage in The Lancet article echoed what Fearon said about tradeoffs at the press conference: “Although CABG is associated with a longer initial hospitalization, higher procedural complication and a higher rate of rehospitalization in the early period, PCI carries an increased risk of repeat revascularization and myocardial infarction over the long-term follow-up. This trade-off should be carefully considered in clinical decision-making.”

Patients were enrolled into the FAME 3 trial between Aug. 25, 2014, and Nov. 28, 2019, at 48 hospitals in the United States and Canada, North America, Europe, Asia and Australia. The average age was 65, and 82% were men and 93% were White. Patients had to have blockages of at least 50% in three of the major arteries supplying blood to the heart (“three-vessel disease”) but no blockages in the left main coronary artery.

Those assigned to CABG underwent bypass surgery. Those assigned to the second group first had FFR measured; only narrowed arteries with an FFR score of 0.8 or less underwent PCI to place a drug-eluting stent.