Key result
FFR-guided PCI plus optimal medical therapy significantly reduced the composite of death, non-fatal MI, and urgent revascularization compared to medical therapy alone (8.1% vs. 19.5%, HR 0.39) in patients with stable ischemic heart disease.
Why the study?
Does FFR-guided PCI plus medical therapy improve outcomes compared to medical therapy alone in patients with stable ischemic heart disease?
RCT (n=888)
Open-label
Randomized
Does FFR-guided PCI plus medical therapy improve outcomes compared to medical therapy alone in patients with stable ischemic heart disease?
This editorial discusses the rationale for the FAME 2 trial, highlighting the hypothesis that FFR-guided PCI is superior to medical therapy alone in stable ischemic heart disease by accurately identifying ischemic lesions.
Contrary to its central role in patients with acute coronary syndromes (ACS), percutaneous coronary intervention (PCI) in stable ischemic heart disease (SIHD) remains largely restricted to patients in whom medical treatment fails to control symptoms, or those with a large area of myocardium at risk and/or high risk findings on non-invasive testing.(1,2) These recommendations are based on a number of studies - the largest of which is COURAGE - that failed to show any reduction in mortality or myocardial infarction (MI) with PCI compared to optimal medical therapy (OMT) in this group of patients.(3) A possible limitation in these studies was relying on visual assessment of angiographic stenoses (which is now well-known to be imprecise) to determine lesions responsible for myocardial ischemia. Non-invasive stress testing - including imaging - may also be inaccurate in patients with multivessel coronary artery disease.(4,5) These limitations have inadvertently led to the inclusion of patients with non-ischemic lesions in these studies, which may have diluted any potential benefit with PCI. Given the superiority of fractional flow reserve (FFR) in identifying ischemic lesions compared to angiography, Fractional flow reserve versus Angiography for Multivessel Evaluation 2 (FAME 2) investigators hypothesized that when guided by FFR, PCI plus medical therapy would be superior to medical therapy alone in patients with SIHD.
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Ahmed ElGuindy (2015) conducted an RCT in Stable ischemic heart disease (n=888). FFR-guided percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) vs. Optimal medical therapy (OMT) alone was evaluated on Composite of death, non-fatal myocardial infarction, and urgent revascularization (HR 0.39, 95% CI 0.26-0.57, p=<0.001). FFR-guided PCI plus optimal medical therapy significantly reduced the composite of death, non-fatal MI, and urgent revascularization compared to medical therapy alone (8.1% vs. 19.5%, HR 0.39) in patients with stable ischemic heart disease.
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