Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve–Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease

Abstract

BACKGROUND: Previous studies found that percutaneous coronary intervention (PCI) does not improve outcome compared with medical therapy (MT) in patients with stable coronary artery disease, but PCI was guided by angiography alone. FAME 2 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) compared PCI guided by fractional flow reserve with best MT in patients with stable coronary artery disease to assess clinical outcomes and cost-effectiveness. METHODS:A total of 888 patients with stable single-vessel or multivessel coronary artery disease with reduced fractional flow reserve were randomly assigned to PCI plus MT (n=447) or MT alone (n=441). Major adverse cardiac events included death, myocardial infarction, and urgent revascularization. Costs were calculated on the basis of resource use and Medicare reimbursement rates. Changes in quality-adjusted life-years were assessed with utilities determined by the European Quality of Life-5 Dimensions health survey at baseline and over follow-up. RESULTS:Major adverse cardiac events at 3 years were significantly lower in the PCI group compared with the MT group (10.1% versus 22.0%; P<0.001), primarily as a result of a lower rate of urgent revascularization (4.3% versus 17.2%; P<0.001). Death and myocardial infarction were numerically lower in the PCI group (8.3% versus 10.4%; P=0.28). Angina was significantly less severe in the PCI group at all follow-up points to 3 years. Mean initial costs were higher in the PCI group ($9944 versus $4440; P<0.001) but by 3 years were similar between the 2 groups ($16 792 versus $16 737; P=0.94). The incremental cost-effectiveness ratio for PCI compared with MT was $17 300 per quality-adjusted life-year at 2 years and $1600 per quality-adjusted life-year at 3 years. The above findings were robust in sensitivity analyses.CONCLUSIONS: PCI of lesions with reduced fractional flow reserve improves long-term outcome and is economically attractive compared with MT alone in patients with stable coronary artery disease.

Focused update of expert consensus statement: Use of invasive assessments of coronary physiology and structure: A position statement of the society of cardiac angiography and interventions

“…DEFER, FAME, and FAME 2 established that in SIHD, FFR‐guided PCI is superior to conservative therapy. PCI of lesions with reduced FFR improves long‐term outcome and is economically advantageous.…”

Percutaneous coronary intervention: 2017 in review

“…The 3‐year follow up of the FAME 2 trial, which prospectively randomized patients with at least one vessel coronary artery disease and an abnormal FFR (≤0.80) to PCI versus medical therapy, found FFR guided PCI to be associated with a lower MACCE (10.1% vs 22.0%, P < 0.0001). The reduction was primarily driven by a lower rate of urgent revascularization, decreased angina, and improved quality of life without a difference in death and MI.…”

Design and rationale of ischaemia-driven complete revascularisation versus usual care in patients with non-ST-elevation myocardial infarction and multivessel coronary disease: the South Limburg Myocardial Infarction (SLIM) trial

“…However, it is more specific and masking of one ischaemic area by another, more severely ischaemic, zone is avoided since every artery or segment is analysed separately [20,21]. In addition, FFR-guided revascularisation has been shown to be cost-effective [22]. A recent study has shown that FFR can reliably assess IRA infarct-related artery, PCI percutaneous coronary intervention, STEMI ST-elevation myocardial infarction, TAVI transcatheter aortic valve implantation, TIMI thrombolysis in myocardial infarction, QCA quantitative coronary angiography the haemodynamic severity of non-culprit coronary artery stenosis during the acute phase of STEMI [23].…”