Stents or Surgery for Triple-Vessel Disease: FAME 3 Trial Provides Key Insights

Noninvasive Stent Procedure as Effective as Surgery for Triple-Vessel Disease: FAME 3 Trial Results

In an era where medical advancements continue to evolve at a rapid pace, the latest findings from the FAME 3 trial have challenged the longstanding belief that open-heart bypass surgery (coronary artery bypass grafting or CABG) is the gold standard for patients with severe triple-vessel heart disease. The study reveals that a less invasive approach using stents, guided by fractional flow reserve (FFR), may provide comparable long-term outcomes to surgery after five years. This exciting revelation is reshaping our understanding of treatment options for patients with triple-vessel coronary artery disease (CAD), offering a potentially less invasive alternative to traditional surgery.

The FAME 3 Trial: A Revolutionary Study in Cardiovascular Medicine

Presented at the 2025 American College of Cardiology (ACC) Scientific Session and published simultaneously in The Lancet, the FAME 3 trial marks a pivotal moment in cardiology. Dr. William Fearon, Chief of Interventional Cardiology at Stanford University School of Medicine, led the trial, which involved 1,500 patients from North America, Europe, Asia, and Australia. These patients were diagnosed with triple-vessel coronary artery disease and received guideline-recommended medical treatment for their heart disease.

The trial's design was to compare two treatment approaches: coronary artery bypass grafting (CABG) surgery versus percutaneous coronary intervention (PCI) using drug-eluting stents. In particular, the trial focused on patients whose coronary artery lesions had an FFR score of 0.8 or less, indicating a significant reduction in blood flow. Those with FFR scores higher than 0.8 were managed medically.

Initial Findings: PCI Fails to Meet Early Noninferiority Criteria
At the one-year mark, PCI failed to meet the primary composite endpoint for noninferiority, which included death from any cause, stroke, heart attack, or the need for a repeat procedure. This outcome led some to question whether PCI could ever be on par with CABG in treating triple-vessel disease. However, the longer-term results, especially after three and five years, were much more promising.

Five-Year Follow-Up: PCI and CABG Show Comparable Long-Term Outcomes
By the five-year follow-up, the trial results painted a much clearer picture. Death rates in the PCI and CABG groups were virtually identical (7.2% for both groups). Stroke rates were also similar, with the PCI group showing 1.9% and the CABG group showing 3.0%. Although the PCI group experienced a higher incidence of heart attacks (8.2% vs. 5.3%) and required more repeat procedures (15.6% vs. 7.8%), the long-term results were strikingly similar between the two treatment groups.

These findings stand in stark contrast to previous studies, which suggested that CABG was superior to PCI in the long run, particularly in patients with triple-vessel coronary disease. Dr. Fearon highlighted that previous studies did not account for the significant advances in PCI technology that have occurred in the past decade, including improved stents and the development of fractional flow reserve-guided PCI.

The Evolution of Percutaneous Coronary Intervention (PCI)

A key factor that may explain the FAME 3 results is the improvement in PCI procedures over the last ten years. Fractional flow reserve (FFR) technology, which measures the pressure differences across coronary artery stenoses to assess their functional significance, has significantly enhanced the precision of PCI. By selecting the most appropriate lesions for stent placement, FFR-guided PCI ensures better outcomes and fewer complications. Moreover, the advent of newer, more effective drug-eluting stents has made PCI a safer and more effective option, even for patients with triple-vessel disease.

Dr. Fearon emphasized that these advances in PCI techniques have been transformative. "The way these procedures are performed has evolved significantly in the past decade," he noted, adding that the goal of the FAME 3 trial was to determine whether PCI, given these advancements, could perform more similarly to CABG in patients with severe triple-vessel disease.

A Paradigm Shift in the Treatment of Triple-Vessel Disease

The FAME 3 trial results are likely to provoke a reevaluation of how cardiologists approach the treatment of triple-vessel coronary artery disease. The study's findings suggest that in many cases, PCI can achieve comparable outcomes to CABG, especially when guided by the latest techniques. This opens the door for more patients to receive less invasive treatment, potentially reducing the risks, recovery time, and costs associated with surgery.

The results also highlight an important shift in how we think about the role of surgery in modern cardiology. For years, CABG has been the go-to treatment for patients with triple-vessel disease due to its proven long-term effectiveness. However, as PCI techniques have improved, it’s becoming increasingly clear that less invasive approaches can provide similar, if not identical, outcomes in certain patient populations.

Considerations for Clinical Practice: Personalized Treatment Decisions

The FAME 3 trial’s findings will likely have significant implications for clinical practice. While the data show that PCI can match CABG in terms of long-term survival and event-free rates, the decision between PCI and CABG should remain highly individualized. Factors such as the patient’s overall health, the complexity of coronary artery disease, the presence of other comorbid conditions, and the patient's preference will all play critical roles in treatment decisions.

Dr. Akshay Khandelwal, Chief of Cardiovascular Medicine at AHN Cardiovascular Institute in Detroit, Michigan, praised the FAME 3 results, stating, “In many cases, PCI can approximate surgical results, or at least should prompt a serious conversation with the patient.” The ability to offer patients a less invasive treatment option without compromising long-term outcomes is a significant step forward in personalized cardiovascular care.

Conclusion: A New Era of Cardiovascular Treatment

The FAME 3 trial has provided compelling evidence that, with the advancements in PCI technology, stenting can be just as effective as CABG in treating patients with triple-vessel coronary artery disease. As these findings make their way into clinical practice, they are likely to reshape how cardiologists approach the management of this complex condition. The ability to offer a less invasive treatment option without compromising patient outcomes will undoubtedly benefit many patients, providing a safer and more efficient alternative to traditional surgery.

As the field of interventional cardiology continues to advance, the future of treating coronary artery disease looks brighter than ever, with more options available to meet the individual needs of patients.