NCT07308860

Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Extended

Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Extended A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Coronary artery disease, or narrowing of the blood vessels that provide blood to the heart, is the most common cause of death in the United States and can be treated with either coronary bypass surgery or coronary stent placement. This study will evaluate outcomes, including death and quality of life, at 10 years in 1,500 patients with coronary disease who have already been randomized to either bypass surgery or stenting.

Detailed description

Coronary artery disease (CAD) remains the major cause of morbidity and mortality in adults in the United States. In patients with 3-vessel CAD not involving the left main coronary artery, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) can improve outcomes. Older studies have shown that the more invasive option, CABG, significantly reduces mortality during long-term follow-up compared with PCI. However, these studies did not use contemporary methods to perform PCI, such as measuring an index called fractional flow reserve (FFR) with a coronary pressure wire or using current- generation drug-eluting stents (DES), both of which significantly improve outcomes after PCI. The Fractional flow reserve versus Angiography for Multivessel Evaluation (FAME) 3 trial randomized 1,500 patients to FFR-guided PCI with current generation DES or to CABG and found that at 5 years there was no significant difference in the composite of death, myocardial infarction (MI) or stroke between the two strategies. There was a reduction in MI in the CABG group. Longer-term follow-up is critical to determine if contemporary PCI results in similar survival as CABG. The primary aim of this project is to determine if 10-year mortality is different after FFR-guided PCI compared with CABG. Investigators will perform 10-year follow-up in the 1,500 patients randomized in the FAME 3 trial to determine if FFR-guided PCI is non-inferior to CABG with respect to mortality. Secondary aims include assessing quality of life and angina relief at 10 years in the two groups. Additionally, investigators will compare individual rates of secondary clinical outcomes including MI, stroke, and repeat revascularization at 10-year follow-up after PCI or CABG.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	FFR-guided PCI	Coronary stenting compared with coronary bypass surgery
PROCEDURE	CABG	Coronary artery bypass surgery

Timeline

• Start date: 2025-08-01
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: United States