Elsevier

American Heart Journal

Volume 154, Issue 4, October 2007, Pages 632-636
American Heart Journal

Trial Design
Rationale and design of the fractional flow reserve versus angiography for multivessel evaluation (FAME) study

https://doi.org/10.1016/j.ahj.2007.06.012Get rights and content

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.

Section snippets

Study design

The objective of the FAME study is to compare the clinical outcomes and cost-effectiveness of an FFR-guided PCI strategy to an angiography-guided one in patients with multivessel CAD. FAME is a multicenter, international, prospective, randomized trial including men and women aged ≥18 years in whom multivessel PCI is planned. Eligible patients must have lesions that are ≥50% narrowed and that the investigator feels require stenting in ≥2 major epicardial vessels. The vessels must be large enough

References (28)

Cited by (75)

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    The present study is a patient-level, post hoc, pooled analysis of the FFR-guided revascularization/deferral cohorts from 3 randomized controlled trials (Figure 1) (12–14). The detailed study protocols for each study have been published previously (15–17). In brief, FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) is a prospective, randomized, controlled, multicenter trial investigating the superiority of FFR-guided PCI over angiography-guided PCI in patients presenting with stable angina, unstable angina, or non–ST-segment elevation myocardial infarction (NSTEMI) (NCT00267774) (12,15).

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