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.