"Fractional Flow Reserve-Guided PCI versus Angiography for Multivessel Evaluation (FAME) Study". The New England Journal of Medicine. 2009. 360(3):213-224. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
In patients with multivessel coronary artery disease undergoing PCI, does FFR-guided PCI reduce major adverse cardiac events when compared with standard angiography-guided PCI?
In patients with multivessel CAD undergoing PCI, FFR-guided PCI significantly reduces the rates of death, nonfatal MI, and repeat revascularization at 1 year in comparison with angiography-guided PCI.
FFR measures the pressure difference across a coronary stenosis to assess its physiological significance and guide interventions. FFR-guided PCI focuses on treating ischemia-producing stenoses while deferring stenting of non-ischemic lesions. This approach was evaluated in the FAME study, which demonstrated that routine measurement of FFR in addition to angiography significantly reduces major adverse cardiac events in patients undergoing PCI with drug-eluting stents.
As of the time of the study, no guidelines were provided for the use of FFR-guided PCI versus angiography-guided PCI in patients with multivessel CAD.
- Multicenter, randomized, controlled trial - N=1005 patients with multivessel CAD - Angiography-guided PCI (n=496) - FFR-guided PCI (n=509) - Setting: 20 centers in the United States and Europe - Enrollment: January 2006 to September 2007 - Follow-up: 1 year - Analysis: Intention-to-treat - Primary outcome: Composite rate of death, nonfatal MI, and repeat revascularization at 1 year
Inclusion Criteria - Multivessel coronary artery disease (≥50% stenosis in ≥2 of the 3 major epicardial coronary arteries) - Indication for PCI
Exclusion Criteria - Significant left main coronary artery disease - Previous coronary-artery bypass surgery - Myocardial infarction with ST-segment elevation (unless occurred ≥5 days before PCI) - Other specified clinical criteria
Baseline Characteristics - Mean age: 64 years - Male: 75.4% - Mean number of lesions: 2.7 (angiography group) and 2.8 (FFR group) - SYNTAX score: Similar between groups
- Angiography-guided PCI underwent stenting of all indicated lesions based solely on angiographic appearance. - FFR-guided PCI underwent stenting only if the FFR was 0.80 or less, indicating ischemia-causing stenoses.
Primary Outcomes - Composite rate of death, nonfatal MI, and repeat revascularization at 1 year: 18.3% angiography group, 13.2% FFR group (P=0.02)
- Death: 3.0% angiography group, 1.8% FFR group (P=0.19) - Myocardial infarction: 8.7% angiography group, 5.7% FFR group (P=0.07) - Repeat revascularization: 9.5% angiography group, 6.5% FFR group (P=0.08)
Supported by unrestricted research grants from Radi Medical Systems and Stichting Vrienden van het Hart Zuidoost Brabant. Medtronic provided limited financial support to some centers by tailoring the price of the Endeavor stents to the local reimbursement system.
Complete study reference information and its findings on the advantages of FFR-guided PCI.