A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Coronary Disease,Coronary Stenosis
Age (in years)
21+
Phase
Not Applicable
Participants needed
1500
Est. Completion Date
Dec 31, 2024
Treatment type
Interventional
Sponsor
Stanford University
ClinicalTrials.gov identifier
NCT02100722
Study number
FAME 3
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