+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Rationale and design of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 Trial: a comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease



Rationale and design of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 Trial: a comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease



American Heart Journal 170(4): 619-626.E2



Guidelines recommend coronary artery bypass graft (CABG) surgery over percutaneous coronary intervention (PCI) for the treatment of 3-vessel coronary artery disease (3-VD). The inferior results of PCI demonstrated by previous large randomized trials comparing PCI and CABG might be explained by the use of suboptimal stent technology and by the lack of fractional flow reserve (FFR) guidance of PCI. The objective of this investigator-initiated, multicenter, randomized clinical trial is to investigate whether FFR-guided PCI with new-generation stents is noninferior to CABG in patients with 3-VD, not including the left main coronary artery. Eligible patients must have ≥50% coronary stenoses in all 3 major epicardial vessels or major side branches. Patients with a nondominant right coronary artery may be included only if the left anterior descending artery and left circumflex have ≥50% stenoses. Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 fashion to either CABG or FFR-guided PCI. Coronary artery bypass graft will be performed based on the angiogram as per clinical routine. Patients assigned to FFR-guided PCI will 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 and cerebrovascular events, including death, myocardial infarction, repeat coronary revascularization, and stroke at 1 year. Key secondary end point will be a composite of death, myocardial infarction, and stroke at 3-year follow-up. Other secondary end points include the individual adverse events, cost-effectiveness, and quality of life at 2-year, 3-year, with up to 5-year follow-up. The FAME 3 study will compare in a multicenter, randomized fashion FFR-guided PCI with contemporary drug-eluting stents to CABG in patients with 3-VD.

Please choose payment method:






(PDF emailed within 0-6 h: $19.90)

Accession: 058695739

Download citation: RISBibTeXText

PMID: 26386784

DOI: 10.1016/j.ahj.2015.06.024


Related references

Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation). Circulation 137(5): 480-487, 2018

Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. Journal of the American College of Cardiology 56(3): 177-184, 2010

The impact of age on fractional flow reserve-guided percutaneous coronary intervention: a FAME (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) trial substudy. International Journal of Cardiology 177(1): 66-70, 2014

The impact of sex differences on fractional flow reserve-guided percutaneous coronary intervention: a FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) substudy. Jacc. Cardiovascular Interventions 5(10): 1037-1042, 2012

Design and rationale of the COMPARE-ACUTE trial: Fractional flow reserve-guided primary multivessel percutaneous coronary intervention to improve guideline indexed actual standard of care for treatment of ST-elevation myocardial infarction in patients with multivessel coronary disease. American Heart Journal 186: 21-28, 2017

Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial. Lancet 386(10006): 1853-1860, 2015

Cost utility of fractional flow reserve-guided percutaneous coronary intervention in multivessel coronary artery disease in Brazil. International Journal for Quality in Health Care 2018:, 2018

Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation. Journal of the American College of Cardiology 55(25): 2816-2821, 2010

Angiographic Versus Functional Severity of Coronary Artery Stenoses in the FAME Study: Fractional Flow Reserve Versus Angiography in Multivessel Evaluation. Yearbook of Cardiology 2011: 210-212, 2011

Fractional flow reserve to decide between percutaneous transluminal coronary angioplasty or coronary artery bypass grafting in patients with angiographically multivessel disease A tailored approach. Zeitschrift fuer Kardiologie 91(Suppl. 3): 113-114, 2002

Economic evaluation of fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. Circulation 122(24): 2545-2550, 2010

Tc-99m sestamibi single photon emission computed tomography for guiding percutaneous coronary intervention in patients with multivessel disease: a comparison with quantitative coronary angiography and fractional flow reserve. International Journal of Cardiovascular Imaging 26(2): 203-213, 2010

The impact of left ventricular ejection fraction on fractional flow reserve: Insights from the FAME (Fractional flow reserve versus Angiography for Multivessel Evaluation) trial. International Journal of Cardiology 204: 206-210, 2016

TCT-320 Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Left Main or Triple Vessel Disease. Journal of the American College of Cardiology 64(11): B92-B93, 2014

Fractional flow reserve-guided versus angiography-guided coronary artery bypass graft surgery. Circulation 128(13): 1405-1411, 2013