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FAME 2: Reshaping the approach to patients with stable coronary artery disease.
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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