RIPCORD Published: FFR Frequently Leads to Change in Management of Stable Patients
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Routine use of fractional flow reserve (FFR) to evaluate the functional significance of lesions in stable patients presenting with chest pain led to a change in management plan in about one-fourth of cases initially based on coronary angiography alone, according to a study published online March 18, 2014, ahead of print in Circulation: Cardiovascular Interventions. Additionally, the number of coronary arteries considered to have significant disease by angiography alone was incorrect one-third of the time.
Results of the RIPCORD (Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain) study were originally presented at EuroPCR in May 2013.
A team led by Nick Curzen, PhD, of University Hospital Southampton NHS Foundation Trust (Southampton, United Kingdom), enrolled 200 patients with stable chest pain and suspected CAD at 10 centers. All patients underwent diagnostic angiography, after which the supervising cardiologist decided on a management plan of either medical treatment alone, PCI, CABG, or more information required. Next, a different interventional cardiologist performed FFR assessment of all epicardial vessels or major branches of at least 2.25 mm in diameter to determine hemodynamic significance (< 0.8).
Substantial Changes in Management with FFR
After reviewing both sets of data for each patient, the supervising cardiologist changed the original management plans of 53 patients (26%) and kept the initial plan in 74% (P < 0.001). Of 72 patients originally slated for medical management, 9 (12.5%) were switched to revascularization after FFR data were obtained. Conversely, medical management was ultimately recommended for 89 patients, 25 of whom (28.1%) were originally slated for revascularization.
In 45% of patients, angiography alone led to a recommendation of PCI in at least 1 vessel, but FFR determined no physiologically significant stenoses in 26.7% of these cases. Additionally, 15 patients were originally deemed ‘more information required’ after angiography, but after FFR assessment only 1 patient remained in this category.
Looking at the number of diseased vessels in each patient, the addition of FFR data changed this figure in 64 cases (32%) compared with angiography alone. In 81 of 200 cases, patients were labeled as not having significant CAD after angiography, but in 22% of these FFR was < 0.8, including 1 patient with 3-vessel disease. By contrast, there were 89 cases with no hemodynamically significant CAD after FFR, although angiography originally labeled 24 of them with single-vessel disease and 1 each with 2- and 3-vessel disease.
In analysis of separate coronary artery territories, angiography got the indication for revascularization incorrect for the LAD in 18% of patients based on FFR evaluation. In addition, angiography wrongly suggested revascularization of the left circumflex in 13.5% of patients and of the RCA in 8.5%.
There were 4 serious adverse events recorded in 3 patients: emergency PCI because of an occluded RCA, emergency CABG because of an LAD dissection that was subsequently complicated by a deep vein thrombosis, and ventricular fibrillation during FFR assessment.
In an email with TCTMD, William F. Fearon, MD, of Stanford University Medical Center (Stanford, CA), said RIPCORD provides “further evidence regarding the inadequacy of the coronary angiogram. The fact that the management plan changed in 26% of patients and 32% of lesions after measurement of FFR is remarkable.”
Additionally, he noted, “many operators believe FFR assessment will lead to performance of fewer PCIs. [However,] in this study there were 81 patients in whom medical therapy was the plan based on the angiogram. After FFR assessment, 22% of these actually had significant disease.”
Herbert Aronow, MD, MPH, of St. Joseph Mercy Hospital (Ypsilanti, MI), told TCTMD in a telephone interview, “RIPCORD describes an evolution in our ability to make management decisions in patients with stable coronary disease. It lays the groundwork for a potential paradigm shift in how we routinely assess these patients.”
Still, he commented that the study was small and thus “not meant to be definitive.” That said, “The results are very… provocative in the sense that we may be able to do better than we currently are. We may be able to more appropriately send people for revascularization or not send people to revascularization based on the addition of FFR to a routine diagnostic coronary angiography,” Dr. Aronow observed.
Broad Clinical Value of FFR Needs Verification
The addition of FFR will not lead to the elimination of diagnostic angiography, especially invasive diagnostic angiography, according to Dr. Aronow. “Even with the advances we’ve seen in CT angiography of the coronaries, there are still those patients in whom we can’t get images that are satisfactory,” he said. “I do think there will be a shift away from invasive coronary angiography and toward noninvasive coronary angiography as time goes on, so I do think that the numbers of diagnostic studies performed will shrink over time.”
The question of the incremental value of FFR above and beyond coronary angiography will be further answered in subsequent studies with larger cohorts and more specific lesion subsets, Dr. Aronow said. “I think that if we were to see a much larger study, we would have greater confidence in the results in that they would be more representative of the patients that we would typically see on a day-to-day basis,” he noted.
Dr. Fearon added that the FAME 3 study, comparing FFR-guided PCI to CABG “should provide further useful information regarding the role of FFR in guiding revascularization strategies.”
Lastly, Dr. Aronow focused on the question of the cost of a paradigm shift. There might be more complications, additional contrast, or increased radiation that are all associated with FFR, he explained. “It could ultimately result in us changing the way we do things, [in] such that we have to stop the procedure and bring [the patient] back for their coronary intervention more often than we do right now…. But the cost-effectiveness of that type of strategy would need to be evaluated… in a much larger study,” he suggested.
The mean age of patients was 64 years and 75% were men. FFR was associated with 70 mL of extra contrast and 342 seconds of extra fluoroscopy screening time above and beyond the requirements for angiography alone.
Curzen N, Rana O, Nicholas Z, et al. Does routine pressure wire assessment influence management strategy at coronary angiography for diagnosis of chest pain? The RIPCORD study. Circ Cardiovasc Interv. 2014;Epub ahead of print.
Yael L. Maxwell is Senior Medical Journalist for TCTMD and Section Editor of TCTMD's Fellows Forum. She served as the inaugural…Read Full Bio
- The study was funded by an unrestricted research grant from St. Jude Medical.
- Dr. Curzen reports receiving research grants from Haemonetics, Medtronic, and St. Jude Medical and speaker/consultancy fees from Abbott Vascular, Boston Scientific, Daiichi-Sankyo, Haemonetics, Medtronic, and St. Jude Medical.
- Dr. Fearon reports receiving research support from St. Jude Medical.
- Dr. Aronow reports no relevant conflicts of interest.