September 2, 2009 (Barcelona, Spain) — Follow-up data from the Fractional Flow Reserve versus Angiography for Guiding PCI in Patients with Multivessel Coronary Artery Disease (FAME) trial confirm the one-year results showing that the routine measurement of fractional flow reserve (FFR) during angioplasty significantly improves clinical outcomes when compared with traditional angiography-guided treatment.
"The study is good news because after the year you're always wondering if the advantage will be maintained," lead investigator Dr Nico Pijls (Catharina Hospital, Eindhoven, Netherlands) told heartwire . "We see at 18 months that there is a further improvement in the functional class in favor of the FFR-guided group, and what is also really surprising is that the number of patients free from angina is increasing, which is often not the case in these studies."
The results of the study were presented here today at the European Society of Cardiology 2009 Congress.
The FAME study, previously reported by heartwire , included 1005 patients with multivessel disease and randomized them to angiography- or FFR-guided PCI. Myocardial FFR is a measure of the functional severity of coronary lesions and is calculated from pressure measurements made during coronary angiography. In FAME, patients with lesions with FFR <0.80 received a drug-eluting stent, while those with FFR >0.80 were did not. In the angiography arm, all lesions with >50% stenosis were revascularized.
Similar to the one-year results, 18-month data showed a significant absolute reduction in the primary composite end point of death, MI, CABG surgery, or repeat PCI of 5.3% among patients randomized to the FFR-guided revascularization compared with angiography-guided interventions. Also, investigators reported benefits in various subgroups, including those with and without diabetes, unstable-angina patients, and non-ST-segment-elevation-MI patients.
"If there is no ischemia, there is no benefit to stenting," said Pijls. "In a trial like COURAGE, there were some ischemic lesions that were treated medically, and that's no good. What we need are good selection criteria to tell us which lesions are ischemic and which lesions are not. They all look the same unless we have a way of showing us the dangerous ones."
Tackling the Middle-Ground Lesions
Dr Thomas Luescher (University of Zurich, Switzerland), the featured discussant of FAME during the hotline session, said the "important results" confirm data showing that only hemodynamically important lesions lead to events. Despite this, he is not sure whether the results will change clinical practice, but he noted that procedure times were similar in both treatment arms and that the time is ripe for altering how clinicians decide which lesions to stent.
"If we follow the advice given by FAME, we should stop to take a quick and dirty look at our lesions and try to address them more appropriately," said Luescher. He added that clinicians don't need to go overboard, but FFR would be particularly helpful in lesions of between 50% and 70% stenosis.
Dr Alfred Bove (Temple University Medical Center, Philadelphia, PA), commenting on the study to journalists, agreed with Luescher, saying that an assessment of hemodynamics might be most valuable in these "middle-ground" patients as a way to preserve their lifestyle downstream from the procedure.
"If you have a patient who has a questionable lesion and you put a stent in, you've really changed that patient's life a lot," said Bove. "It's always a drug-eluting stent now, and these drug-eluting stents complicate the patient's life later on, from anything from dental cleaning to colonoscopy. So if you could eliminate the group of patients who don't need therapy by using the flow wire it would have an impact in this middle-ground area."
An economic analysis of the data showed that the use of FFR also saves money, by reducing future events as well as by reducing the number of stents used during the procedure, making it one of the "rare situations in medicine in which a new innovative treatment not only improves outcomes but is also cost saving," said Pijls. He told heartwire that since the presentation of FAME one year ago and its subsequent publication in the New England of Journal of Medicine, worldwide use of pressure wires for FFR measurements has increased by almost 100%, and he thinks use will continue to grow, especially as the data are strengthened with further follow-up. More FAME data will be presented at TCT 2009 in San Francisco, CA, in three weeks.
To access complete presentation slides (pdfs), click here.
RADI Medical Systems sponsored the FAME study with an unrestricted research grant.
Heartwire from Medscape © 2009 Medscape, LLC
Cite this: FFR-Guided PCI Benefits Confirmed at 18 Months: The FAME Study - Medscape - Sep 02, 2009.