Rationale and design of the fractional flow reserve versus angiography for multivessel evaluation (FAME) study
Received 27 March 2007; accepted 14 June 2007. published online 07 August 2007.
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 ≥2 major epicardial vessels, ≥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 ≤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.
aDivision of Cardiovascular Medicine, Stanford University Medical Center, Stanford, CA
dDepartment of Public Health, Medical Decision Making and Health Technology Assessment, UMIT—University of Health Sciences, Medical Informatics and Technology, Hall i.T., Austria
eInstitute for Technology Assessment and Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA
Reprint requests: William F. Fearon, MD, Center for Cardiovascular Technology, H3554, Division of Cardiovascular Medicine, Stanford University Medical Center, 300 Pasteur Drive, Stanford, CA 94305.
ABSTRACT