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.
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.
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.