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

Stanford University

Status: Active, not recruiting

Conditions: Coronary Artery Disease

Treatments: Procedure: FFR-guided PCI; Procedure: CABG

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07308860

83374

1R01HL179196-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 21 years with angina and/or evidence of myocardial ischemia

2. Three vessel CAD, defined as ≥ 50% diameter stenosis by visual estimation in each of the three major epicardial vessels or major side branches, but not involving left main coronary artery, and amenable to revascularization by both PCI and CABG as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if only the left anterior descending artery (LAD) and left circumflex have

   ≥50% stenosis

3. Willing and able to provide informed, written consent

Exclusion criteria

1. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, carotid revascularization), however a maze procedure or pulmonary vein isolation is allowed
2. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
3. Recent STEMI (<5 days prior to randomization)
4. Ongoing Non STEMI with biomarkers (cardiac troponin) still rising
5. Known left ventricular ejection fraction <30%
6. Life expectancy < 2 years
7. Requiring renal replacement therapy
8. Undergoing evaluation for organ transplantation
9. Participation or planned participation in another clinical trial, except for observational registries
10. Pregnancy
11. Inability to take dual antiplatelet therapy or anticoagulation and single antiplatelet therapy for at least six months
12. Previous CABG
13. Left main disease requiring revascularization
14. Extremely calcified or tortuous vessels precluding FFR measurement
15. Any target lesion with in-stent drug-eluting stent restenosis
16. More than one major epicardial vessel which is chronically occluded

Trial design

1,500 participants in 2 patient groups

FFR-guided PCI group

Description:

These patients have undergone fractional flow reserve-guided percutaneous coronary intervention

Treatment:

Procedure: FFR-guided PCI

CABG group

Description:

These patients underwent coronary artery bypass grafting surgery

Treatment:

Procedure: CABG