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FAME II: Positive results upheld for FFR-guided PCI plus medical therapy
MUNICH — Confirming earlier reports, fractional flow reserve-guided PCI plus best available medical therapy decreased the need for urgent revascularization among patients with stable CAD compared with best available medical therapy alone, according to FAME II trial data presented here.
However, “in patients with functionally nonsignificant stenosis, medical therapy alone resulted in an excellent outcome, regardless of the angiographic appearance of the stenosis,” trial investigator Bernard De Bruyne, MD, PhD, with the Cardiovascular Center Onze-Lieve-Vrouw Kliniek, Belgium, said during a press conference.
Benard De Bruyne
The FAME II trial enrolled 1,220 patients with stable CAD who had angiographically assessed one-, two- or three-vessel CAD and were appropriate candidates for PCI. Of these patients, 888 were randomly assigned to PCI guided by fractional flow reserve (FFR; PressureWire Aeris and PressureWire Certus, St. Jude Medical) plus best available medical therapy (n=447) or best available medical therapy alone (n=441) if they had at least one functionally significant stenosis (FFR ≤.80); the remaining 332 patients with an FFR ≥.80 were enrolled in the registry and received best available medical therapy.
The primary endpoint was defined as a composite of death, MI or urgent revascularization. De Bruyne and colleagues reported a primary endpoint rate of 4.3% in the FFR-guided PCI group and 12.7% in the best available medical therapy group at 7 months, which was driven by a lower rate of unplanned hospitalizations for urgent revascularization for those treated with PCI (0.7% vs. 9.5%; P<.001). According to the researchers, nearly half of urgent revascularizations in the medical therapy group were triggered by an MI or evidence of ischemia on electrocardiography (for PCI vs. medical therapy: HR=0.13; 95% CI, 0.04-0.43). For those patients in the registry, a primary endpoint rate of 3% was reported.
“In patients with stable CAD, FFR-guided PCI improves patient outcome compared with medical therapy alone,” De Bruyne said. “This improvement … is driven by a dramatic decrease in the need for urgent revascularization for ACS.”
Due to the significant between-group differences in the primary endpoint, the trial was halted prematurely.
These results were published simultaneously by The New England Journal of Medicine. – by Brian Ellis
For more information:
DeBruyne B. Hot Line III: Late breaking trials on arrhythmia and CAD. Presented at: the European Society of Cardiology Congress; Aug. 25-29, 2012; Munich.
DeBruyne B. N Eng J Med. 2012;doi:10.1056/nejmoa1205361.
Disclosure: Dr. DeBruyne reports receiving research contracts from and consulting for St. Jude Medical. The trial was funded by St. Jude Medical.
Perspective
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FAME II is a very important contemporary trial conducted in patients with stable ischemic heart disease. Although preliminary data were presented at EuroPCR and in a company-issued press release before that, seeing the results in their complete form was even more striking for me. The fact that the study was profoundly positive in that PCI was able to safely reduce unplanned hospitalizations leading to urgent revascularization (a second procedure) within a 6-month timeframe is very encouraging. The time to event curves in the manuscript indicate an even more pronounced and continued benefit to 1 year favoring FFR-guided PCI over medical therapy alone. These data clearly demonstrate that the benefit of ischemia-guided PCI in patients with stable CAD extends beyond quality of life and symptom relief to preventing future unplanned hospitalizations for suspected ACS.