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FAME II: FFR-guided PCI improves 2-year outcomes in stable CAD
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BARCELONA, Spain — Compared with medical therapy alone, patients with stable CAD who also received fractional flow reserve-guided PCI experienced a reduction in the composite endpoint of all-cause death, nonfatal MI or urgent revascularization at 2 years. This difference was mainly driven by lower rates of urgent revascularization, according to new data from the FAME II trial.
“In patients with stable CAD, PCI is superior to medical therapy provided FFR is used to guide the procedure and [second-generation] DES are implanted,” Bernard De Bruyne, MD, PhD, FAME II investigator, said during a press conference.
As reported previously, the 7-month results of FAME II were presented by De Bruyne, of the Cardiovascular Center Aalst, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium, at ESC Congress 2012. For the new analysis, De Bruyne and colleagues looked at the 2-year outcomes of FFR-guided PCI with new-generation drug-eluting stents plus medical therapy (n=447) or medical therapy alone (n=441) in patients with stable CAD.
Bernard De Bruyne
An additional 332 patients with an FFR >0.8 were enrolled in a registry and treated with medical therapy. “There was a very high [rate of] compliance in [these] patients, which is at odds with clinical practice,” De Bruyne said, adding that it is important to realize that there are discrepancies between real-world practice and clinical studies.
FFR-guided PCI consisted of the use of the PressureWire Certus or PressureWire Aeris FFR measurement systems (St. Jude Medical). In one-quarter of patients scheduled for PCI, there were no hemodynamically significant stenosis, De Bruyne said.
The primary composite endpoint — all-cause death, nonfatal MI or urgent revascularization at 2 years — was significantly lower in patients in the FFR-guided PCI cohort (8.1% vs. 19.5%; HR=0.39; 95% CI, 0.26-0.57; P<.001), which was driven primarily by the lower rate of urgent revascularization in the PCI group (4% vs. 16.3%; HR=0.23; 95% CI, 0.14-0.38; P<.001). There were no significant differences between groups in the rates of death or MI.
Moreover, urgent revascularization triggered by MI or ischemic changes occurred less often in the FFR-guided PCI cohort (3.4% vs. 7%; P=.01).
Landmark analysis data also revealed a lower rate of death or MI from 8 days to 2 years in the FFR-guided PCI group (4.6% vs. 8%; P=.04).
In addition, De Bruyne said that patients in whom the stenosis are not able to induce ischemia (FFR >0.8) do well with medical therapy alone. – by Brian Ellis
For more information:
De Bruyne B. Hot Line IV: Myocardial Infarction. Presented at: the European Society of Cardiology Congress; Aug. 30-Sept. 3, 2014; Barcelona, Spain.
De Bruyne B. N Engl J Med. 2014;doi:10.1056/nejmoa1408758.
Disclosure: The study was supported by St. Jude Medical. De Bruyne reports that his institution receives grant support and consulting fees on his behalf from St. Jude Medical.
Perspective
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Anthony A. Bavry, MD, MPH
The 2-year results of FAME II are good, and they’re even stronger than what was initially reported at 7 months. They performed a landmark analysis and found that the primary outcome, which was death, MI or repeat revascularization, was lower in the PCI group compared with the optimal medical therapy group. But what was surprising is that there was also a reduction in death or MI in that later time point. It’s important to note that there’s an early hazard, an increased risk of death or MI, from day 0 to day 7 from PCI. This reflects some periprocedural MI, but then later on it looked like there was benefit, which was sustained over time. So I think this is an important study and an important extension of the 7-month findings.
In terms of the use of FFR, it appears to be increasing in the United States and abroad, but it’s still less than what might be considered a “sweet spot.” What that amount is, however, is unknown. Nevertheless, the rate is still likely lower than what it ideally should be in the cath lab. There still might be a bias to stent a lesion rather than interrogate it, knowing that after interrogating it, you might have to leave it alone and medically treat the lesion, but that’s okay if it’s the right thing for the patient.
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