The data, which were presented at the ESC Congress 2015, build upon previously-published results from the St. Jude Medical sponsored FAME trial … The FAME 3 trial is a multicenter, international, randomized, controlled noninferiority trial. What were the results of the FAME (Fractional Flow Reserve versus Angiography for Guiding PCI in Patients with Multivessel Coronary Artery Disease) trial 1? Results from the FAME II Trial: At the time trial enrollment ended, primary endpoint event occurrence (death, heart attack or urgent revascularization) was significantly lower in patients with PCI plus MT than in patients with MT alone (4.3 versus 12.7 percent).
Results from the FAME II Trial: At the time trial enrolment ended, primary endpoint event occurrence (death, heart attack or urgent revascularisation) was significantly lower in patients with PCI plus medical therapy than in patients with medical therapy alone (4.3 versus 12.7%).
Also commenting on the study for TCTMD, Gregg Stone, MD (Icahn School of Medicine at Mount Sinai, New York, NY), an ISCHEMIA investigator, stressed that the trial results do not apply to patients with ACS, patients with class III or IV angina, patients with heart failure or reduced ejection fraction, or those with left main disease. Could FAME lead the way for PCI to show superiority over medical therapy and CABG for multivessel coronary artery disease? Physiologic Lesion Assessment /FFR/ iFFR Coronary Basic 2013 Coronary CRT (Cardiovascular Research Technologies) Download slides Results In the STICH trial, there were 462 deaths over a median follow-up of 56 months. Results.
September 7, 2012 — St. Jude Medical Inc. announced results of the FAME II trial demonstrating that patients with fractional flow reserve (FFR)-guided stenting plus the best available medical therapy (MT) had superior outcomes to those treated with MT alone.
In fact, if one assessed FAME 2 as a trial of pre-emptive vs. clinically-driven PCI in patients with FFR ≤0.80, one would conclude that, in the clinically-driven arm, the need for PCI was reduced by about 90% without detriment to the patients in terms of increased death or MI. Associate Professor of Medicine Director, Interventional Cardiology Stanford University Medical Center . The FAME 2 trial sought to establish the scientific basis for an FFR-guided PCI strategy for all functionally significant stenoses, but the results make this prospect somewhat unappealing," he wrote. The FAME 2 trial sought to establish the scientific basis for an FFR-guided PCI strategy for all functionally significant stenoses, but the results make this prospect somewhat unappealing," he wrote.
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