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Updated: Jul 11, 2026
Evaluation of Coronary Flow Reserve After Myocardial Ischemia Reperfusion in Rats
Published on: June 28, 2019
Rationale and design of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) study
William F Fearon1, Pim A L Tonino, Bernard De Bruyne
1Division of Cardiovascular Medicine, Stanford University Medical Center, Stanford, CA 94305, USA. wfearon@stanford.edu
Insights
Fractional flow reserve (FFR) guidance improves decisions for stenting in multivessel coronary artery disease compared to angiography alone. This randomized trial shows FFR reduces major adverse cardiac events, enhancing patient outcomes in percutaneous coronary intervention.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Coronary angiography is standard for multivessel coronary artery disease stenting decisions, despite limitations.
- Invasive physiologic guidance, specifically fractional flow reserve (FFR), may enhance decision-making accuracy.
Purpose of the Study:
- To compare angiographic guidance versus FFR guidance for stent implantation in multivessel coronary artery disease.
- To evaluate the efficacy of FFR-guided stenting in reducing major adverse cardiac events.
Main Methods:
- Multicenter, randomized clinical trial comparing two guidance strategies: angiography vs. FFR.
- Patients with >50% stenosis in ≥2 major epicardial vessels were randomized.
- FFR < 0.80 determined the need for stenting in the FFR-guided arm.
Main Results:
- The primary endpoint is a composite of major adverse cardiac events at 1 year.
- Secondary endpoints include individual adverse events, cost-effectiveness, and quality of life.
- Long-term outcomes at 30 days, 6 months, 2 years, and 5 years will be assessed.
Conclusions:
- The FAME study is the first large, multicenter, randomized trial to assess FFR's role in multivessel percutaneous coronary intervention.
- FFR guidance is investigated as a superior method for optimizing stent implantation decisions.
Background:
Although its limitations for diagnosing critical coronary artery disease are well described, coronary angiography remains the predominant method for guiding decisions about stent implantation in patients with multivessel coronary artery disease. However, some have suggested that invasive physiologic guidance may improve decision making.
Trial Design:
The objective of this multicenter, randomized clinical trial is to compare the efficacy of 2 strategies, one based on angiographic guidance to one based on physiologic guidance with fractional flow reserve (FFR), for deciding which coronary lesions to stent in patients with multivessel coronary disease. Eligible patients must have coronary narrowings > 50% diameter stenosis in > or = 2 major epicardial vessels, > or = 2 of which the investigator feels require drug-eluting stent placement. Patients with previous coronary bypass surgery or left main coronary disease are excluded. Based on angiographic evaluation, the investigator notes the lesions that require stenting. The patient is then randomly assigned to either angiographic guidance or FFR guidance. Patients assigned to angiographic guidance undergo stenting as planned. Patients assigned to FFR guidance first have FFR measured in each diseased vessel and only undergo stenting if the FFR is < or = 0.80. The primary end point of the study is a composite of major adverse cardiac events, including death, myocardial infarction, and repeat coronary revascularization, at 1 year. Secondary end points will include the individual adverse events, cost-effectiveness, quality of life, and 30-day, 6-month, 2-year, and 5-year outcomes.
Conclusion:
The FAME study will examine for the first time in a large, multicenter, randomized fashion the role of measuring FFR in patients undergoing multivessel percutaneous coronary intervention.
