RIPCORD2: No additional benefit of systematic FFR at diagnostic angiography for chest pain
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Adding fractional flow reserve assessment of all epicardial vessels at the time of diagnostic coronary angiography did not reduce costs or improve quality of life compared with angiography alone in patients with chest pain.
Further, this strategy did not reduce major adverse clinical events or revascularization events, according to results of the RIPCORD2 trial presented at the European Society of Cardiology Congress.
“RIPCORD2 is the first completed randomized trial of systematic FFR vs. angiography alone at the stage of the diagnostic angiogram. It shows no advantage of this strategy in terms of cost, quality of life, events or management,” Nicholas Curzen, BM(Hons), PhD, FRCP, with University Hospital Southampton NHS Foundation Trust, U.K., said during the Hot Line session.
RIPCORD2 results
RIPCORD2 evaluated whether systematic routine FFR assessment of all epicardial coronary vessels at the time of the diagnostic angiogram would provide superior resource utilization, quality of life and clinical outcomes compared with angiography assessment alone.
In the first, proof-of-concept RIPCORD study, results of which were reported in 2014, when systematic FFR data were added to the initial assessment from coronary angiography, the management plan changed in 25% of patients with chest pain.
The open-label, randomized controlled RIPCORD2 trial enrolled 1,100 patients undergoing invasive coronary angiography for suspected angina or non-ST elevation MI with 30% or greater stenosis in at least one coronary artery suitable for PCI or CABG (mean age, 64 years; 75% men) at 17 centers in the U.K. The only exclusion was vessels with < 3 TIMI grade flow, Curzen said.
Patients were randomly assigned to angiography alone, in which assessment and management was decided according to angiographic appearance only, or to systematic FFR after angiography, in which assessment and management was decided according to angiographic appearance and FFR of all arteries of revascularization caliber.
A median of four vessels per patient were examined with FFR. Routine FFR was associated with a significantly longer procedure time (69 minutes vs. 42 minutes), more contrast used (206 mL vs. 146 mL) and higher radiation dose (6,608.7 cGy/cm2 vs. 5,029.7 cGy/cm2; P < .001 for all). The rate of complications was 1.8% in the FFR group.
At 1 year, there was no difference in total hospital costs (P = .137) or quality of life using the EuroQol-5 Dimension Visual Analog Scale (P = .88) between the FFR and angiography-only groups, Curzen said.
Additional testing after the cath lab was performed in 14.7% of the angiography-only group compared with 1.8% of the FFR group.
Clinical events, including death, stroke, MI and unplanned revascularization, were also similar at 1 year (P = .64).
There was also no difference in the distribution of the management strategy for patients referred to medical therapy alone, PCI or CABG. In those assigned FFR, the management strategy was chosen immediately after the procedure in 98% of patients, whereas a further test was required in 14.7% of patients in the angiography-only group.
Routine vs. targeted use
Discussion following the trial focused on the use of routine systematic FFR in this broad patient population.
“FFR data are likely to have made an impact in individuals, but this cannot be detected in the comparison of populations. It is likely that FFR is of most clinical value when targeted to specific patient groups, for example, those being considered for PCI with multivessel disease, rather than routinely,” Curzen said.
Discussant Robert A. Byrne, MB BCh, PhD, director of cardiology at Mater Private Hospital, Dublin, chair of cardiovascular research at the RCSI University of Medicine and Health Sciences and head of the Cardiovascular Research Institute Dublin, noted that “a high proportion of patients [in RIPCORD2] had relatively low-complexity CAD. About 75% of patients had zero or single-vessel disease, where perhaps the triage decision was already quite straightforward, and the use of pressure wire had a lesser impact on the overall treatment strategy than was chosen.”
Discussant Roxana Mehran, MD, professor of medicine and director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Weiner Cardiovascular Institute at Icahn School of Medicine at Mount Sinai, said, “I want to make sure that our audience doesn’t walk away [thinking that] FFR is useless.” Mehran said it will be important to see additional analyses, including a sex analysis.
“It is important that, independent of the results of the study, this will not affect already established indications for FFR, namely the hemodynamic relevance of a stenosis or the guidance of PCI in multivessel disease,” Marco Roffi, MD, FACC, FESC, full professor of cardiology, vice chairman of cardiology and director of the interventional cardiology unit at the University Hospital of Geneva, Switzerland, said during the discussion. “In this patient population, it is very difficult, if not impossible, to improve quality of life. Also, resource utilization in the group that had angiography only was very limited ... possibly because the patients had low burden of CAD.”
Perspective
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RIPCORD2 begets other questions. Being an all-U.K. study, we would want to ask the question about which guidelines the operators were following to determine angiographically whether or not a patient should have PCI, or whether it was left to the operator judgement. This comes back to the whole reason why we have FFR — we’re trying to take the guesswork out of this. Has this study taken the guesswork out of whether or not FFR is helpful?
In conclusion, this study is helpful in clinical practice and for guidelines showing that routine FFR with angiography is not useful and should be avoided.
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Curzen N, et al. Hot Line: RIPCORD2. Presented at: European Society of Cardiology Congress; Aug. 27-30, 2021 (virtual meeting).
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