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

NCT ID: NCT07308860

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2030-06-30

Brief Summary

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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

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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

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Coronary Artery Disease

Keywords

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CABG FFR-guided PCI quality of life repeat revascularization long term mortality 3-vessel CAD angina 10-year mortality stroke cardiac death stent PCI myocardial infarction multicenter coronary artery bypass clinical trial coronary artery disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FFR-guided PCI group

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

FFR-guided PCI

Intervention Type PROCEDURE

Coronary stenting compared with coronary bypass surgery

CABG group

These patients underwent coronary artery bypass grafting surgery

CABG

Intervention Type PROCEDURE

Coronary artery bypass surgery

Interventions

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FFR-guided PCI

Coronary stenting compared with coronary bypass surgery

Intervention Type PROCEDURE

CABG

Coronary artery bypass surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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William Fearon

MD, Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

References

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Fearon WF, Zimmermann FM, Ding VY, Takahashi K, Piroth Z, van Straten AHM, Szekely L, Davidavicius G, Kalinauskas G, Mansour S, Kharbanda R, Ostlund-Papadogeorgos N, Aminian A, Oldroyd KG, Al-Attar N, Jagic N, Dambrink JE, Kala P, Angeras O, MacCarthy P, Wendler O, Casselman F, Witt N, Mavromatis K, Miner SES, Sarma J, Engstrom T, Christiansen EH, Tonino PAL, Reardon MJ, Otsuki H, Kobayashi Y, Hlatky MA, Mahaffey KW, Desai M, Woo YJ, Yeung AC, Pijls NHJ, De Bruyne B. Outcomes after fractional flow reserve-guided percutaneous coronary intervention versus coronary artery bypass grafting (FAME 3): 5-year follow-up of a multicentre, open-label, randomised trial. Lancet. 2025 Apr 26;405(10488):1481-1490. doi: 10.1016/S0140-6736(25)00505-7. Epub 2025 Mar 30.

Reference Type RESULT
PMID: 40174598 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/40174598/

Related Info

Other Identifiers

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1R01HL179196-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

83374

Identifier Type: -

Identifier Source: org_study_id