Results from the Registre Français de la FFR, published in Circulation and presented at the American Heart Association annual meeting (16–20 November, Dallas, USA), indicates that a Fractional Flow Reserve (FFR)-guided revascularisation strategy that diverges from the strategy suggested by angiography does not increase the risk of major adverse cardiovascular events (MACE) at one year.
Study authors Eric Van Belle (Heart Catheterisation Laboratory, Hôpital Cardiologique, Lille, France) and others write that prior to the registry, there have been no reports on the use of FFR in patients referred for diagnostic angiography (previous studies have concentrated on patients selected for percutaneous coronary intervention) or how reclassification of the revascularisation strategy following FFR affects outcomes. They note that the registry was designed to: “Evaluate the rate of reclassification of the patient coronary revascularisation strategy by performing FFR at the time of diagnostic angiography, and its impact on one-year clinical outcomes.”
Patients were included in the registry if they had at least one angiographically ambiguous lesion in a major coronary vessel evaluated by FFR. Based on angiography alone, of the 1,000 patients in the registry overall, 55% of patients would have been assigned to medical therapy and 45% would have been assigned to revascularisation (38% to PCI and 7% to coronary artery bypass grafting). With additional diagnostic information from FFR, 58% were assigned to medical therapy and 42% were assigned to revascularisation. However, Van Belle et al report that—on an individual patient level—use of FFR led to reclassification of revascularisation strategy in 43% of patients. They add: “Such reclassification was observed in 33% of a priori [ie. angiography alone] medical patients, 56% of a priori PCI patients, and 51% of a priori CABG patients.”
According to the results of the registry, at one year, the rate of MACE in the 464 patients whose revascularisation strategy has been reclassified following FFR did not differ significantly from the MACE rate of patients whose strategy remained the same—11.2% vs. 11.9% (p=0.78). There was also no difference between the reclassified patients and the non-reclassified patients in the rate of freedom from angina at one year (>94% vs. >91%, respectively; p=0.75). Van Belle note that in three subgroups—diabetic patients requiring insulin, patients with decreased left ventricular ejection fraction, and those with three-vessel coronary artery disease—reclassification with FFR continued to be safe.
The authors conclude that the study demonstrates that: “In this population, the use of FFR is associated with reclassification of the revascularisation decision in about half of patients. It further demonstrates that it is safe to pursue a revascularisation strategy divergent from that suggest by angiography alone, but guided by FFR measurement.”
Van Belle told Cardiovascular News: “The results of the present study further support the concept of a ‘coronary physiology-guided treatment’ of patients with coronary artery disease. It suggests in particular that in the near feature a coronary angiography will no longer be interpreted without the FFR results and that FFR will become a mandatory and fully-integrated part of any diagnostic coronary angiography investigation.”