European Society of Cardiology

European Society of Cardiology

September 03, 2015
3 min read

FAME: FFR-guided PCI lowers long-term major adverse cardiac event risk

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact

LONDON — Patients with multivessel CAD who underwent fractional flow reserve-guided PCI experienced fewer major adverse cardiac events than those treated with angiography-guided PCI up to 2 years after the procedure, according to data presented at the European Society of Cardiology Congress.

The absolute difference in events between the groups persisted at 5 years but lost statistical significance, the researchers reported.

The multicenter trial included 1,005 adult patients with multivessel CAD who were randomly assigned angiography-guided PCI (n = 496) or FFR-guided PCI (n = 509). Researchers evaluated stenoses requiring PCI before randomization. Patients who received angiography-guided PCI underwent revascularization for all stenoses; those in the FFR-guided group underwent PCI for stenotic arteries with an FFR of 0.8 or lower, representing 63% of evaluated stenoses in this group.

Incidence of major adverse cardiac events at 1 year, including all-cause mortality, MI and repeat revascularization, was the primary endpoint of the study. Major adverse cardiac events at 2 and 5 years were secondary endpoints, along with the individual components of major adverse cardiac events at 1, 2 and 5 years; researchers reported results from 5-year follow-up in 865 evaluable patients.

Patients who underwent angiography-guided PCI had more stents placed per patient (mean, 2.7 vs. 1.9; P < .0001).

Nico H.J. Pijls, MD, PhD, of Catharina Hospital in Eindhoven, Netherlands, said during a presentation here that the 1-year major adverse cardiac event rate was approximately 30% lower in the FFR-guided group compared with the angiography-guided group. Rates of death/MI also were significantly lower with angiography-guided PCI. This effect persisted at 2 years, he noted.

Major adverse cardiac events had occurred in 31% of the angiography-guided PCI group vs. 28% of the FFR-guided group at 5 years (RR = 0.91; 95% CI, 0.75-1.1). Multivariate analysis adjusting for potential confounders did not significantly alter the results. Individually, all-cause mortality occurred in 10% of the angiography-guided group and 9% of the FFR-guided group (RR = 0.88; 95% CI, 0.59-1.29), MI occurred in 12% and 9% (RR = 0.81; 95% CI, 0.56-1.16) and repeat revascularization occurred in 17% and 15%, respectively (RR = 0.9; 95% CI, 0.68-1.2). None of these differences were statistically significant.

The researchers observed a significant interaction between treatment strategy and sex, favoring men in the FFR-guided group (P = .027 for interaction). In analysis limited to men, the primary endpoint occurred in 34% of those in the angiography-guided PCI group and 27% of the FFR-guided group (RR = 0.8; 95% CI, 0.64-0.99).

Pijls said the FAME study was powered for only 1 year, and that although the difference between FFR- and angiography-guided PCI did not persist at 5 years, “what is important is that the benefit achieved in the first 2 years is maintained in the next 3 years.” He also noted an absolute reduction in all-cause mortality of 1.2% at 1 year with FFR-guided PCI, which remained stable during follow-up.

“We can conclude that in patients with multivessel disease, FFR-guided PCI compared to angiography-guided PCI results in a significant decrease in adverse events up to 2 years, while thereafter the risk of both groups evolved in parallel,” Pijls said. “This persistent clinical benefit is achieved with fewer stents and less resource utilization, and this 5-year follow-up affirms the long-term benefit and safety of FFR-guided PCI in patients with multivessel disease.”

The 5-year follow-up data were simultaneously published in The Lancet. by Adam Taliercio


Pijls NHJ, et al. Clinical Trial Update I. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 2, 2015; London.

van Nunen LX, et al. Lancet. 2015;doi:10.1016/S0140-6736(15)00057-4.

Disclosure: Several researchers report receiving grants or consulting/personal fees from St. Jude Medical, which provided funding for the study. Please see the full study for a list of all other researchers’ relevant financial disclosures.