Key Points:
- Patients undergoing coronary angiography were randomized to undergo fractional flow reserve pressure wiring of all lesions with >30% stenosis amenable to stenting versus coronary angiography alone.
- After enrollment of 1,100 patients and one year of follow up there was no difference in the primary outcome of total hospital cost or quality of life and angina status.
- While there were no differences in any of the prespecified secondary outcomes, including death, stroke and unplanned revascularization, almost 15% of patients undergoing coronary angiography alone required further testing to determine lesion significance.
The original RIPCORD study was a proof of concept trial that enrolled 200 patients with angina undergoing coronary angiography to either receive fractional flow reserve (FFR) measurements of all stenoses >30% and amenable to stenting, or to undergo conventional coronary angiography without FFR. The study found that the addition of FFR changed management of lesions in 26% of patients. These findings led to the larger scale RIPCORD2 trial, the results of which were presented by Dr. Nicholas Curzen (University Hospital Southampton, United Kingdom) in a Hot Line session at the European Society of Cardiology 2021 Congress today.
The investigators sought to determine whether FFR in addition to coronary angiography would affect resource utilization, overall cost, and of course, quality of life or angina in those who received it. 1100 patients with angina or non-ST segment elevation MI already undergoing diagnostic coronary angiography were randomized across 17 centers in the United Kingdom. Operators in the investigational arm were instructed to perform FFR in any lesion greater than 2.25 mm in diameter that would be amenable to coronary stenting or surgical revascularization, regardless of the presence of angiographic disease.
The median age was 64 years and 75% of participants were men. There was no difference in the prespecified primary outcomes of (a) total hospital costs: £4,510 (interquartile range [IQR] 2721–7415) for FFR plus angiography versus £4,136 (IQR 2613–7015) for angiography alone (p=0.137) and (b) quality of life and angina severity at one year.
With respect to the prespecified secondary outcomes, there were no significant differences between groups in the number of strokes, deaths myocardial infarctions, and unplanned revascularization. 14.7% of the participants in the coronary angiography alone group required subsequent testing to determine ischemia, compared to just 2% in the FFR group.
“Perhaps the pressure wire is best used in patients who are considered for revascularization, particularly PCI, in order to ensure that you are treating the correct vessel, as was shown in the FAME trial so nicely, said Dr. Curzen regarding the results, “Systematic FFR leads to longer procedural times, more contrast administration, more radiation, and more rates of dissection without an observed benefit. Perhaps the pressure wire is not the tool for routine use at the diagnostic stage.”
The results of RIPCORD-2 show, once again, that diagnostic tools often do not confer a benefit beyond the clinical circumstances in which they were studied. FFR should be reserved for further information in patients who may undergo treatment of diseased vessels, as a component of the treatment algorithm, rather than the primary driver.