The FAME 2 trial will improve treatment strategies for patients with stable ischemic heart disease. FAME 2 indicates that angioplasty and stenting (also known as percutaneous coronary intervention, or PCI) plus the best available medications results in better outcomes than medications alone for patients who have significant blockages in their heart arteries, as measured by a test known as Fractional Flow Reserve (FFR). With these results, heart doctors gain new evidence to guide decisions about use of PCI.
FAME 2 is an important clinical trial in part because it enrolled consecutive patients with stable coronary artery disease, a patient group whose treatment strategy has been the subject of active debate since the 2007 presentation of COURAGE, which ultimately randomized less than 10 percent of eligible patients. In FAME 2, FFR was performed on every patient to confirm that “hemodynamically significant” (or “tight”) blockages in their coronary arteries were limiting blood flow. The patients with hemodynamically significant blockages were then randomized to PCI plus the best medications available or medications alone.
The results of FAME 2 have been anticipated since earlier this year, when it was announced that an independent safety monitoring board halted the trial early, essentially deeming it unsafe to deny PCI to any study patients whose coronary blockages were found to be significant according to FFR.
Today, the FAME 2 investigators provided further details on the study results:
- Patients who received PCI plus medications were significantly less likely to require an unplanned hospitalization leading to urgent revascularization to stop a heart attack or control symptoms that became unstable; this finding favoring PCI over medications alone emerged within 6 months of randomization.
- The patients treated with PCI plus medications experienced greater symptom relief than those on medications alone.
- The patients who underwent PCI less frequently required treatment with anti-anginal medications compared to those receiving medications alone.
The findings from FAME II are now the best data currently available to inform treatment decisions for patients with stable coronary artery disease. These data clearly demonstrate that the benefit of PCI plus medical therapy in stable patients with ischemia-producing lesions extends beyond symptom relief and quality of life. Unlike COURAGE, the study additionally reflects the current use of evidence-based tests (such as FFR) and modern treatment options (including the use of second-generation drug-eluting stents) and their combined roles in improving patient outcomes. The results of the recently launched and ongoing NIH-funded ISCHEMIA study will provide further clarity when its results are available in approximately 2018.
BACKGROUND ON STABLE CORONARY ARTERY DISEASE AND FFR
Patients with stable heart disease have blockages in the arteries of their heart. When these blockages limit the amount of blood able to flow through the artery, physicians refer to them as “hemodynamically significant” or “tight.” These “tight” blockages are often the cause of unpleasant and frightening symptoms, such as chest discomfort, shortness of breath, and fatigue.
During a cardiac catheterization procedure (or diagnostic angiogram), interventional cardiologists may use Fractional Flow Reserve (FFR) to measure how “tight” a blockage is. FFR is determined by a carefully calibrated sensor that measures the blood pressure upstream and downstream of a blockage after the administration of adenosine. If the FFR finds the difference between the two measurements is significant, then the blockage is considered to be tight. FFR, which has been shown to correlate very well with non-invasive stress testing, is considered to be complementary to a conventional angiogram, particularly when the tightness of a blockage is difficult to establish by angiography or when patients have not have non-invasive stress testing.