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

Stanford University

Status: Active, not recruiting

Conditions: Coronary Disease; Coronary Stenosis

Treatments: Procedure: CABG; Device: Resolute Integrity Stent; Device: Resolute Onyx Stent; Procedure: FFR guided PCI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02100722

FAME 3

Details and patient eligibility

About

The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).

Full description

The FAME 3 trial is a multicenter, international, randomized, controlled noninferiority trial. All patients with multivessel CAD (not involving the left main) will be screened by the site's Heart Team (including but not limited to an interventional cardiologist, cardiac surgeon and research coordinator). If all agree that the patient can be treated either with FFR-guided PCI or CABG, and all inclusion criteria are met and no exclusion criteria are met, then the patient will be randomized.

Baseline clinical, functional, laboratory and electrocardiographic data will be obtained. Patients will receive treatment within 4 weeks of randomization. Patients randomized to CABG will receive state of the art therapy at the discretion of the local surgeon with a strong emphasis on arterial revascularization. Patients undergoing PCI will have FFR measured with a St. Jude Medical coronary pressure wire across all lesions. If the FFR is ≤0.80, then PCI will be performed with the Medtronic Resolute Integrity drug-eluting stent (DES) as per usual routine. If the FFR is >0.80 then PCI will be deferred.

All patients will receive medical therapy as per published guidelines. Patients will follow-up at 1 and 6 months, and 1 and 3 years with an evaluation of clinical status, functional status, medications and events. Follow-up may be extended to 5 years, if funding allows.

Core lab analyses will include formal quantitative coronary angiography (QCA) of the baseline angiograms with calculation of the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score and Functional SYNTAX Score.

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)
• 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 for 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

FFR guided PCI

Active Comparator group

Description:

Patients undergoing PCI will have FFR measured with a St. Jude Medical coronary pressure wire across all lesions. If the FFR is ≤0.80, then PCI will be performed with the Medtronic Resolute Integrity (or Onyx) drug-eluting stent (DES) as per usual routine. If the FFR is \>0.80 then PCI will be deferred. Only those sites with prior experience measuring FFR will be included in the FAME 3 trial. These patients in whom FFR of a particular lesion was not possible will be included in all analyses based on the intention to treat principle.

Treatment:

Device: Resolute Onyx Stent

Procedure: FFR guided PCI

Device: Resolute Integrity Stent

CABG

Active Comparator group

Description:

CABG will be performed as per clinical routine at each participating center. Both off-pump and on-pump surgery are acceptable, as long as the surgeon and the site are experienced in the particular technique. An internal mammary graft to the LAD should be attempted in all cases, if feasible. Complete arterial revascularization is strongly recommended, however, each center should use a conduit strategy with which they are most comfortable. All vessels ≥ 1,5 mm in diameter and with ≥ 50% stenosis should be bypassed, if technically feasible.

Treatment:

Procedure: CABG