WASHINGTON, D.C.—Routine measurement of fractional flow reserve (FFR) during DES-stenting in patients with multi-vessel disease is superior to current angiography guided treatment, according to the FAME late-breaking clinical trial presented Tuesday at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
Nico H.J. Pijls, MD, PhD, from the Catharina Hospital in Eindhoven, the Netherlands, presented the trial on behalf of the FAME [Fractional Flow Reserve versus Angiography for Multivessel Evaluation] investigators. The randomized trial was conducted in 1,000 patients in 20 centers throughout the U.S. and Europe.
In multivessel coronary disease (MVD), Pijls said that identifying which stenoses cause ischemia is difficult, and non-invasive tests are often unreliable in MVD and coronary angiography often results in both under- or overestimation of functional stenosis severity.
The patient in the study has stenosis ? 50 percent in at least two of the three major epicardial vessels, which were amendable for stenting. The patients with previous PCI were not excluded. However, the investigators excluded patients with left main disease or previous bypass surgery; STEMI with CK more than 1000 U/l within last five days; and extremely tortuous or calcified coronary arteries.
The primary endpoint was composite of death, MI or repeat revascularization at one year.
The investigators analyzed 496 patients with angiography-guided PCI and 509 patients FFR-guided PCI.
Pijls reported that on average, there were 2.7 lesions per patients in angiography group and 2.7 in the FFR group. The primary endpoint of composite death, MI, CABG or repeat-PCI at one-year was 18.4 percent in the angiography group and 13.2 percent in the FFR group.
He also said that the average cost of $6,007 in the angiography group and $5,332 in the FFR group, and the average days spent in the hospital was 3.7 for the angiography group and 3.4 for the FFR group.
As a result, he concluded that the routine measurement of FFR during PCI with DES in patients with multi-vessel disease when compared to current angiography guided approach improves outcomes by reducing the rate of the composite endpoint of death, MI, re-PCI and CABG at one year by about 30 percent and reduces mortality and MI at one year at about 35 percent.
Therefore, while Pijls said that FFR should be a routine procedure during stenting and the number of FFR use is increasing, it is not widespread.
Roxana Mehran, MD, professor of medicine at Columbia University Medical Center, who moderated the presentation, said that while this is an advanced and exciting procedure, more data will be needed to further increase the use of FFR.
RADI Medical Systems provided an unrestricted institutional research grant to perform the FAME study.