SAN FRANCISCO — Percutaneous coronary interventions (PCIs) have consistently been found to be less cost-effective than coronary artery bypass grafting (CABG) over the long term, but a new randomized controlled trial could change that narrative. 

At the 5-year mark, the cost of PCIs was 30% lower, and quality-adjusted life-years (QALYs) were numerically higher than those for CABG. “PCI was the preferred alternative for treatment of multivessel coronary artery disease,” reported Mark A. Hlatky, MD, cardiologist and professor of health policy and of medicine at Stanford University School of Medicine in Stanford, California, who presented the findings at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 meeting and published simultaneously in JACC.

The new analysis was drawn from the multinational FAME 3 trial, which randomized 1500 patients with three-vessel coronary disease to undergo CABG or PCI guided by fractional flow reserve (FFR). This tool measures the severity of stenosis to predict the benefit from revascularization. Also different from previous comparative trials, participants in the PCI arm received a zotarolimus-eluting stent.

When published in November 2021, FAME showed PCI was noninferior to CABG at 1 year for the composite primary outcome of death from any cause, myocardial infarction, stroke, or repeat revascularization.

The purpose of the new analysis at 5 years was to compare the two strategies for cost and quality of life. Previous studies, such as the 2014 SYNTAX trial, found CABG to be more effective and less costly than PCI for multivessel disease.

At 5 years, mortality rates in the two arms were identical, at 7.2%. The hazard ratio (HR) for the composite primary outcome of events was numerically larger in the PCI arm (HR, 1.16), but the difference did not reach statistical significance (95% CI, 0.89-1.52; P = .27). 

The cumulative costs of CABG were 30% higher ($39,900 vs $25,667; P < .001) over that period, while secondary outcomes for quality of life appeared to favor PCI. Although this did not include QALYs, which were numerically but not significantly better in the patients who underwent PCI (4.05 vs 4.03), quality of life as measured with the European Quality of Life-5 Dimensions score improved more rapidly after PCI. 

At 1 year, employment rates were above baseline in the PCI group but below baseline in the CABG group. Despite a decline in employment rates in both groups over the subsequent 4 years of follow-up, the rates remained significantly greater in the PCI group (56% vs 47%; P = .025).

Symptoms, such as angina, did not differ significantly between the two groups over time. Only two baseline factors appeared to affect cost: age > 65 years, which was associated with a 12% lower cost (P = .006), and male sex, which was linked with a 13.5% higher cost (P = .036).

Cost Advantage of PCI Is Robust

Hlatky characterized the cost advantage of PCI over CABG as “robust” across sensitivity analyses. For example, the incremental cost-effectiveness ratio (ICER) for CABG relative to PCI was more than $150,000 in 98% of bootstrap replications. In lifetime projections, QALYs associated with CABG remained inferior to those of PCI across multiple projections.

In addition to SYNTAX, the 2013 FREEDOM trial and the 2022 EXCEL trial also found CABG to be more cost-effective than PCI. The ICER at 5 years, favoring CABG in SYNTAX, FREEDOM, and EXCEL trials, were $128,000, $116,000, and $315,000, respectively.

According to Hlatky, the reason for the comparable cost-effectiveness of PCI and CABG in FAME 3 was that mortality rates over time were the same. Due to the higher 5-year mortality rates of PCI in SYNTAX (14.6% vs 9.2%), FREEDOM (16.3% vs 10.9%), and EXCEL (13.0% vs 13.9%), the lower procedural costs of PCI were unable to overcome the QALY disadvantage.

Additional follow-up is unlikely to change that conclusion, according to Hlatky. “While it is theoretically possible that a long-term survival advantage for CABG could emerge over further follow-up of FAME 3, it seems implausible,” he said, pointing out that prior long-term trials with CABG and PCI support this assertion.

Hlatky did not specifically attribute any specific advances in PCI technology and procedural steps, such as the type of stent or the use of FFR guidance, as potential explanations for the long-term advantage of PCI over CABG in FAME, but he did say that changes in contemporary practice provided a rationale for the new study.

The reduced cost of PCI relative to CABG, which was accompanied by a faster recovery and a suggestion of better long-term quality of life, is certainly of interest and may change perceptions of the relative role of these two strategies in multivessel disease, according to one expert, but he does not think the data is necessarily practice-changing.

“I am not sure that this study is going to change people’s minds about PCI relative to CABG because economic factors are only one element that goes into that decision,” said David J. Cohen, MD, director of academic affairs at St. Francis Hospital in Roslyn, New York. 

However, Cohen, who since 2021 has been the director of clinical and outcomes research for the Cardiovascular Research Foundation, which holds the annual TCT meeting, said the findings were meaningful.

“The FAME 3 economic study does nicely demonstrate how far the field of interventional cardiology has come over the past 30 years to where PCI can really hold its own against CABG, even in patients with 3-vessel coronary disease,” he said.

FAME 3 received financial support from Medtronic and Abbott Vascular. Hlatky reported having a financial relationship with Boehringer Ingelheim. Cohen reported having financial relationships with Abbott Vascular, Ancora, Boston Scientific, CathWorks, Corvia, Edwards Lifesciences, Medtronic, Philips, and TherOx. 

Ted Bosworth is a freelance writer in New York City.