In the RIPCORD 2 trial, the clinical significance of fractional flow reserve (FFR) measurement was ascertained through use of a specific patient group. Because adding the systemic FFR measurement in clinical practice would not prevent clinical events, the benefit of FFR is limited only for specific patient groups.
TCROSS NEWS asked Dr. Hitoshi Matsuo, Gifu Heart Center, what distinguishes this from previous studies that have reported on the benefits of FFR.
Summary of the RIPCORD 2 Trial
The result of RIPCORD 2 trial was not favor in routine use of FFR at the diagnostic catheterization. In this study, patients with vessels larger than 2.25 mm and stenosis greater than 30% were randomly assigned to receive revascularization and their clinical outcomes were compared in two groups: FFR-guided and angiography-guided.
Although the examination time, amount of contrast used, and radiation exposure were significantly higher in the FFR group, a treatment strategy could be determinined without additional ischemic examinations. In contrast, 14.7% of patients in the angiography group required further ischemia testing. The primary and secondary endpoints of one-year medical costs, symptom improvement, and MACE were not significantly different. The conclusion of this study negates the usefulness of routine FFR measurement for patients with diagnostic catheterization.
Patients Included in the RIPCORD 2 Trial
Approximately 50% of the ACS patients were enrolled in the study, and 0 vessel or 1 vessel disease accounted in about 70% in both group, representing the low risk group. In the FAME trial that demonstrated the clinical efficacy of FFR-guided PCI in prospective randomized trial, the use of FFR decreased not only the number of treated lesions and coronary stents but also the amount of contrast medium as well as one year event rate, though such multivessel diseases were only included in approximately 30% of the lesions that resulted in the outcome achieved in RIPCORD 2.
In the case of 0-vessel disease, it is expected that there will be few cases of discordance between FFR and angiographic judgment (mostly defer), and in the case of 1-vessel disease, even if there are discordant cases, there will be no significant difference in symptoms or prognosis regardless of the choice of treatment, be it medical or revascularization. In addition, there was no information on whether there were differences in stenting variables between the two groups in this presentation, which should be clarified.
The Impact of FFR on Treatment Strategy
In terms of differences in treatment strategy decisions, there was no difference in the proportion of patients in the FFR or angiography groups choosing medical therapy, PCI, or CABG. However, the RIPCORD trial (2014) in the UK showed that FFR changed the treatment strategy in more than 25% of patients, and the FFR-R3F registry study in France also showed that in 43% of cases, the decision between medical therapy, PCI, and CABG was different, but the final rate of each treatment strategy was reported to be unchanged.
Therefore, it is important to note that the results of this study do not indicate that FFR-guided or angiography-guided treatment strategies are the same.
Subanalyses focusing on group analysis of ACS and CCS, differences between 0-1 and multivessel, and differences in stenosis severity between the two groups are expected to clarify some of the questions raised in this study.
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