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PARIS -- For patients with proven ischemia, stenting substantially cuts the revascularization rate compared with optimal medical therapy alone, preliminary trial results showed.
Fractional flow reserve-guided stenting cut the urgent revascularization rate more than 11-fold to 0.6% compared with 6.0% for patients with an FFR-established stenosis but on medication alone (P<0.0001), Bernard De Bruyne, MD, PhD, of Cardiovascular Center Aalst, Belgium, and colleagues found.
The rate of any revascularization showed "an even more impressive" benefit to percutaneous coronary intervention (PCI) (1.7% versus 12.1%, HR 7.6, P<0.0001) in the FAME II study reported here at the EuroPCR meeting.
Action Points
- This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
- These preliminary data from the FAME II trial found that stenting patients with significant stenosis in at least one vessel by fractional flow reserve (FFR) testing led to a lower revascularization rate than for those treated with optimal medical therapy alone.
- Note that patients without hemodynamic ischemia by FFR who were followed on optimal medical therapy had a revascularization rate similar to the stented patients in the randomized part of the trial.
These findings affirm top-line results announced by device maker St. Jude Medical in January when enrollment in the trial was halted at the interim analysis.
The company had pointed to lower hospital readmission rates with FFR-guided PCI as well, but De Bruyne didn't present those data or the primary composite endpoint of all-cause death, documented myocardial infarction (MI), and unplanned hospitalization leading to urgent revascularization at 24 months.
Revascularization is usually a driver in such composite outcome comparisons, De Bruyne told MedPage Today at a press conference.
However, "let's be prudent," he cautioned. "Not all the data have been analyzed. We have more follow-up and more patients."
Discussants at the hotline session were optimistic, though.
David R. Holmes Jr., MD, of the Mayo Clinic in Rochester, Minn., and immediate past president of the American College of Cardiology, said the trial would likely change clinical practice.
"We should be treating ischemia, not lesions, for sure," he told attendees.
FAME II has been seen by some as a rebuttal to the COURAGE trial's finding of no difference overall in outcomes between optimal medical therapy and stenting.
De Bruyne said he saw it not as a rebuttal but as an extension or complement of it, pointing to the importance of patient selection with FFR technology.
"It is likely that in previous trials dealing with patients with non-acute coronary artery disease, a sizable proportion of patients without ischemia has been included," perhaps diluting the effect of reversing ischemia with PCI, he noted.
In the FAME II trial, 1,219 patients with stable coronary artery disease and at least one stenosis identified by FFR (0.80 or less) were randomized to receive a drug-eluting stent or optimal medical therapy. Patients were enrolled from 28 centers in Europe, the U.S., and Canada.
Patients without FFR-established lesions went into a registry while they remained on optimal medical therapy alone. Half of these patients were randomly assigned to follow-up.
Notably, those patients without functionally-important blockages appeared to do well on medication alone.
The revascularization rate for that group was the same as for those who got stenting in the randomized portion of the trial (P=0.71 for urgent revascularization and P=0.54 for any revascularization).
Another difference between FAME II and COURAGE that might account for the difference in findings was the exclusive use of drug-eluting stents in the newer trial, De Bruyne suggested.
A second study discussant, Franz-Josef Neumann, MD, of Herz-Zentrum Bad Krozingen, Germany, noted that COURAGE did show a reduction in revascularizations after PCI compared with medical therapy, but that this was offset by high periprocedural MI.
Looking at the early rates "makes me hope that there is no such issue in FAME II," he told attendees. "Once we have the final data, it may suggest revascularization for all hemodynamically relevant stenoses."
Disclosures
FAME II was supported by St. Jude Medical.
De Bruyne, Neumann, and Holmes reported having no relevant conflicts of interest to disclose.
Primary Source
European Association of Percutaneous Cardiovascular Interventions
Source Reference: De Bruyne B, et al "FAME 2" EuroPCR 2012.